Updated: Mar 22, 2020
As of March 2020:
LDN available to treat coronavirus. The coronavirus pandemic asserts its power by easily attacking those with a weak, dysfunctional immune system. A vaccine for it is at least 1½ years away; and it is likely to take a year, as well, before any working COVID-19 anti-viral medication may be approved for use.
Low dose naltrexone is a safe, inexpensive, readily available immune booster; anyone taking it receives a strengthened immune system. For those in fear of COVID-19 because they were in a high-risk category, taking daily LDN removes them from that group.
The editors of this website are now recommending that action be taken at the governmental level to use LDN to fight the pandemic.
Please see the LDN Editor’s Blog here.
As of March 2018:
Immune Therapeutics to Run FDA-sanctioned Phase 3 Trial. A meeting held in January 2018, between Immune Therapeutics, Inc. and the US Food and Drug Administration (FDA) discussed future measures in the development of LDN (Brand name: Lodonal) as an oral once-a-day supplementary treatment to the standard of care for moderate to severe Crohn’s disease in adults and for mild to severe Crohn’s in pediatric patients.
The company announced that it will “immediately move forward” with its IND 067442 (Investigational New Drug) proposal for Phase 3 clinical research in patients age 12 and older who have moderate to severe Crohn’s disease. The company has agreed to conduct a 52-week study (including measuring endpoints at week 12) and to use the Crohn's Disease Activity Index as the trial’s primary endpoint. (See article here and our LDN Editor’s Blog here.)
Erasmus University in Rotterdam Recommends LDN for IBD. A recently published clinical study in The Journal of Translational Medicine reports important success in the use of low dose naltrexone for treating inflammatory bowel disease (IBD), such as Crohn’s disease and Ulcerative Colitis. Of the 47 patients with IBD who had failed all standard treatments and who then received LDN for 3 months’ time, complete remission was seen in 25.5% of patients, and clinical improvement was noted in a full 74.5%. (The published paper can be found here.)
As of February 2018:
Berkson Reports Success Treating Kidney Cancer. Burton M. Berkson MD, MS, PhD has demonstrated success for LDN in treating advanced kidney cancer. Treatment of the patient was reported in the medical journal Integrative Cancer Therapies ("The Long-Term Survival of a Patient With Stage IV Renal Cell Carcinoma Following an Integrative Treatment Approach Including the Intravenous α-Lipoic Acid/Low-Dose Naltrexone Protocol,” December 19, 2017, Burton M. Berkson MD, MS, PhD, Francisco Calvo Riera, MD). The patient is now almost ten years since his initial diagnosis. This is Berkson’s fourth published journal article to describe the successful use of LDN in a patient with advanced cancer. (The full abstract of the article can be found here.)
As of July 2017:
Original LDN Compounder Closes Down. The well known New York City metropolitan compounder of LDN, Irmat Pharmacy, has sold its business and has discontinued preparing any new supplies of low dose naltrexone.
In its place, Metro Drugs in Manhattan has shown itself to be an excellent source of compounded LDN and will now be included on our website’s list of reliable compounders.
In addition, the related section of our homepage has been updated with more accurate information on recent prices and recommended compounding pharmacies.
As of May 2016:
Nigeria Approves LDN for Prescription for HIV. Following a very successful three month “bridge trial” by NAFDAC, Nigeria’s equivalent to the USA’s FDA, approval is being granted to Immune Therapeutics, Inc. (previously named TNIB) to market its patented Lodonal (LDN) “as a ... non-toxic adjunct therapy both in the treatment of HIV/AIDS and as an immune system regulator.” Please see the entirety of the announcement from Immune Therapeutics here.
[Editor's Note: It has been thirty years since the late Dr. Bernard Bihari first discovered many of the human uses of LDN. Now, at long last, one country has recognized the safety and efficacy of low dose naltrexone. Congratulations to not only Immune Therapeutics, Inc. but also to Nigeria, which Wikipedia describes as “the ‘Giant of Africa’, owing to its large population and economy. With approximately 182 million inhabitants, Nigeria is the most populous country in Africa and the seventh most populous country in the world....As of 2015, Nigeria is the world's 20th largest economy.”]
As of December 2014:
PTSD Found to be Significantly Improved With LDN. A recently published report from Germany details important success in the use of low dose naltrexone (LDN) for treating Post-traumatic Stress Disorder (PTSD). The illness involves prolonged severe anxiety following a painful ordeal and is associated with repeated re-experiencing of such events as well as general avoidance along with gloomy thoughts and feelings. This problem has affected large numbers of troops returning from wars in Iraq and Afghanistan. An abstract of the published paper can be found here.
[Editor's Note: Because there has been no specific pharmacotherapy available for PTSD, treatment has focused on psychotherapeutic approaches, and this, in turn, has been hampered by the lack of availability of qualified therapists—which makes this report on the effectiveness of LDN, a simple medication, all the more exciting.]
As of August 2013:
TNI BioTech Aims For Phase III Clinical Trial of LDN in 2014. The CEO of TNIB, Inc., Noreen Griffin, reports that the company has now met with the FDA where it discussed the trial protocol needed for a Phase III study of LDN for the treatment of Crohn’s disease. TNIB plans to present the requested procedures to the FDA shortly, after which the trial could be launched early next year.
As of June 2013:
2013 LDN Conference Scheduled for Oct 5 in Chicago. Linda Elsegood of the LDN Research Trust UK and Dr. Mark Mandel of Roselle, Illinois have organized a full day conference, to be held near Chicago, at Harper College in Palatine, Illinois. The conference is being called the LDN 2013 AIIC Conference—speakers will focus on a number of “Auto-Immune and Immuno-modulated Conditions”. TNI Biotech, Inc. will be sponsoring one of the events. Please visit the conference website for all details.
LDN Shows Success in Patients With CRPS. Dr. Pradeek Chopra of the Department of Medicine at the Alpert Medical School at Brown University in Rhode Island and his colleague, Mark Cooper, at the Univ. of Washington in Seattle, Washington, have published a report describing two patients with unrelenting complex regional pain syndrome (CRPS), both of whose dystonia remitted with the addition of LDN to their treatment. Please see Medical Journal Articles Concerning LDN for details.
As of October 2012:
TNI Acquires Bihari’s Patents; Phase III Trial Planned. Dr. Nicholas Plotnikoff, Chairman of TNI BioTech, recently announced that his company has acquired all of Dr. Bernard Bihari's use-patents for low dose naltrexone. This will enable TNI to proceed with its plans for a phase III clinical trial within the next 12 months, as well as plans to manufacture and sell the drug. Dr. Plotnikoff, quoted on the TNI BioTech website, said:
“I worked with Dr. Bernard Bihari for many years. I believe acquiring all of the technology of Dr. Bihari will allow the company, we hope, to move forward to Phase III clinical trials in both the United States and Africa within the next 12 months. In our opinion, LDN holds great promise for the millions of people worldwide with autoimmune diseases or central nervous system disorders or who face a deadly cancer. It could prove to be the first low-cost, easy to administer, and side-effect-free therapy for cancer, HIV/AIDS, MS and Crohn’s disease.”
TNI BioTech has begun construction of a large pharmaceutical plant in Managua, Nicaragua for the production of LDN, under the trade name of IRT-103. It expects to be in operation by the end of this month and it is said to be capable of manufacturing well over one billion of the capsules annually. According to their website, the goal of TNI BioTech is “to enable mankind...to combat fatal disease by...mobilizing the body’s own immune system using TNI’s patented compound(s)”.
Dr. Plotnikoff, Emeritus Professor of Pharmacology and Psychoneuroimmunology, College of Pharmacy and College of Medicine, at the University of Illinois in Chicago, holds a PhD in Pharmacology. Prior to TNI, Dr. Plotnikoff helped direct research for Abbott Labs.
[Editor's Note: Some readers have expressed concern that the patenting and manufacture of LDN by a pharmaceutical company would increase the price of LDN for all users. Although a manufactured brand would initially have an increased price, it is probable that the price of LDN as an off-label, compounded drug should not be substantially affected. To explain why, later this month we will be posting a new entry on the LDN Editor's Blog.]
As of June 2012:
Trial of LDN for Glioma Now Recruiting Participants. Katherine B Peters, MD, PhD, a neuro-oncologist at Duke University, is the principal investigator. The placebo-controlled, randomized clinical trial will involve 72 patients, all of whom have high-grade malignant glioma. They will receive, in addition to standard chemoradiation, either placebo or LDN. The primary outcome will determine the effects of LDN on quality of life measures; however, also measured will be differences in both functional capacity and in neurocognitive function. The study is funded with a $50,000 grant from the Brain Tumor Fund for the Carolinas. For further information, please contact: Sarah Woodring at 919-684-2527. Further details about the trial can be found here.
As of March 2012:
New Internet Research Method Launched. On January 31, 2012, Transparency Life Sciences initiated a new technique for clinical research studies on the Internet, which involves the detailed participation of anyone who is interested, a method called crowdsourcing. LDN is one of just three medications on its first list. For further details, please see the Editor's Blog, March 2012.
As of November 2011:
Mali Studies on LDN for HIV/AIDS Published. Two separate studies demonstrating successful LDN use in HIV/AIDS have been published in the October issue of the peer reviewed Journal of AIDS and HIV Research. This was made possible with the financial support and guidance of neurologist Dr. Jaquelyn McCandless and her colleague husband, Jack Zimmerman, the support of Hussein Alfa Nafo, and with the work of the local research team led by Dr. Abdel Kader Traore and other health officials at the University Hospital in Bamako, Mali in Africa.(See Clinical Trials for LDN / Recently Published.)
[Editor’s Note: These long awaited scientific studies on Low Dose Naltrexone for HIV+ individuals not only have helped bring the late Dr. Bihari’s dream of a Developing Nations Project much closer to realization but also have clearly demonstrated LDN’s unique ability to strengthen the immune system. If responsible health care authorities around the globe pay proper attention to these findings, it is still possible to prevent the further deterioration of tens of millions of people who are presently HIV+.]
As of April 2011:
Successful Crohn’s Disease Trial Results Published. Jill P. Smith, MD, Professor of Gastroenterology at Pennsylvania State University's College of Medicine, and her colleagues, have published the results of their Phase II study of 40 adults with Crohn’s disease, “Therapy with the Opioid Antagonist Naltrexone Promotes Mucosal Healing in Active Crohn’s Disease: A Randomized Placebo-Controlled Trial”, in the online journal Digestive Diseases and Sciences, March 8, 2011. The 4.5mg daily dose of naltrexone proved to have very positive results, with significant improvements in the Crohn’s Disease Activity Index scores and with substantial healing demonstrated by endoscopy. (See Clinical Trials for LDN / Recently Published.)
As of December 2010:
New Book Extols LDN. Julia Schopick, a writer and public relations consultant, who posts the Honest Medicine blog, has published a new book, Honest Medicine: Effective, Time-Tested, Inexpensive Treatments for Life-Threatening Diseases, now available online. The book describes in detail four safe, lifesaving treatments, including LDN, of which the public has little awareness because each has low profitability potential for big pharma.
As of October 2010:
Met-enkephalin Successful in Treating Advanced Pancreatic Cancer. Jill Smith, MD, Professor of Gastroenterology at Hershey Medical Center, and colleagues have reported the following:
“In a prospective phase II open-label clinical trial, 24 subjects who failed standard chemotherapy for advanced pancreatic cancer were treated weekly with OGF [opioid growth factor; aka met-enkephalin] 250 μg/kg intravenously. Outcomes measured included clinical benefit, tumor response by radiographic imaging, quality of life, and survival... Clinical benefit response was experienced by 53% of OGF-treated patients compared to historical controls of 23.8% and 4.8% for gemcitabine and 5-fluorouracil (5-FU), respectively. Of the subjects surviving more than eight weeks, 62% showed either a decrease or stabilization in tumor size by computed tomography. The median survival time for OGF-treated patients was three times that of untreated patients (65.5 versus 21 days, p < 0.001).”
The original report was published as Opioid growth factor improves clinical benefit and survival in patients with advanced pancreatic cancer. Smith JP, Bingaman SI, Mauger DT, Harvey HH, Demers LM, Zagon IS. Open Access J Clin Trials. 2010 Mar 1; 2010(2):37-48.
[Ed. Note: Low Dose Naltrexone has been shown to double or triple one’s daily output of met-enkephalin.]
LDN Aware Week Observed; UK Conference Scheduled for Oct 23. As part of the International LDN Aware Week being observed October 18-24, the LDN Research Trust is offering a full-day LDN conference in Birmingham, UK this Saturday, October 23. For LDN Aware Week, a video which celebrates LDN has been made available by Linda Elsegood of LDN Research Trust. Further information about the conference and the agenda of speakers can be found here.
As of September 2010:
Community-Driven Research Opportunity Offered for LDN. Tomasz Sablinski, a physician with a background in the pharmaceutical industry, has committed himself to breaking through the barriers that block ignored discoveries such as LDN. He has joined with Daniel Reda, founder of the online site CureTogether, to form a plan for LDN, with the help of the Internet and the members of the LDN-Yahoo Group. Please read their proposal.
As of June 2010:
Several Major Clinical Trials of LDN Await Publication. Three important clinical trials of LDN have each recently completed their planned studies and are now either undergoing final statistical analysis or are awaiting peer-review medical journal publication. Until that final step is achieved, we are proscribed from reporting any significant data results. However, we are pleased to observe that various useful outcomes will be reported by all three. The trials involved:
- LDN effects in HIV/AIDS in Mali, Africa
- LDN for fibromyalgia — a randomized, double-blind study at Stanford University
- LDN for Crohn’s disease — a Phase II, randomized placebo-controlled double-blinded study at Hershey Medical Center, Penn State College of Medicine
As of May 2010:
Bernard Bihari, MD, Discoverer of the Human Uses of LDN. Following a protracted illness, Doctor Bihari died on May 16th at Beth Israel Hospital in New York City. He was 78 years old. According to his wishes, no funeral service is to be held and the body will be cremated. A memorial service is being planned for the near future.
As of April 2010:
Second European LDN Conference Imminent. The second Low Dose Naltrexone Conference in Europe will be held on Saturday, April 24th, 2010 in Glasgow, Scotland at the Thistle Hotel. The meeting, organized by Dr. Tom Gilhooly, features a variety of speakers including Dr. Jarred Younger of Stanford University, who will discuss his research results with LDN use in Fibromyalgia, Dr. Skip Lenz, and Zoe Kamen, daughter of the late composer Michael Kamen. Additional speakers include two health practitioners from Ireland, two patients with CFS, who will share their experiences with LDN, as well as Dr. Gilhooly, who will highlight newly emerging issues in MS treatment.
Please see the Glasgow LDN Conference 2010 website for information, registration, and conference contact information.
As of March 2010:
Successful LDN for MS Trial Published by UCSF Physicians. Bruce Cree, MD and co-researchers at the Multiple Sclerosis Center at University of California, San Francisco, published their study “Pilot Trial 0f Low Dose Naltrexone and Quality of Life in MS” in the online journal of the Annals of Neurology on February 19, 2010. Some 80 patients with MS were involved in this double-blind, “randomized, placebo-controlled, crossover-design study of the effects of low dose naltrexone on quality of life as measured by the multiple sclerosis quality of life inventory.” Each subject received either LDN 4.5 mg nightly or a placebo for 8 weeks, followed by one week without either, and then a further 8 weeks on the the alternate capsule. The results revealed that LDN use led to “significant improvement “ in a series of mental health quality of life measures within two months. The authors reported that the medication was “well tolerated and serious adverse events did not occur”, and that they felt “[f]urther studies with LDN in MS are warranted.” (See Clinical Trials for LDN / Recently Published.)
Phase II of LDN for Crohn’s Complete; Early Results in May. Dr. Jill Smith, Professor of Gastroenterology at Pennsylvania State University's College of Medicine, has now completed her NIH-supported Phase II study of LDN for Crohn’s disease, which involved 40 adults, and is readying it for publication. Dr. Smith intends to make the general outcomes known in an oral presentation during the first week in May 2010 at the Digestive Disease Week meetings at the New Orleans Convention Center. She remains very optimistic about the usefulness of LDN for inflammatory bowel diseases, such as Crohn’s disease. (See Clinical Trials for LDN / In Progress.)
As of December 2009:
LDN Users Conference Held in October at NIH Campus. A Low Dose Naltrexone Conference, arranged solely by Sunny (Sedlock) O’Malley, was held on October 19th, 2009 in the Lister Hill Auditorium in the National Library of Science on the campus of the National Institutes of Health. Speakers included Burt Berkson, MD, PhD, author Mary Boyle Bradley and pharmacist Dr. Skip Lenz. The conference was made possible through the substantial support of Bellevue Pharmacy of St. Louis and Skip’s Pharmacy of Boca Raton. Ms. O’Malley chose to designate the conference as a fund raiser for Dr. Jaquelyn McCandless’ clinical trial of LDN in Mali, Africa. Full audio-visual coverage of the conference is here.
UK Advocates Bring LDN Proposals to Highest Levels of Government. Members of the LDN Now group, founded by Jayne Crocker and her partner Andrew Barnett, have recent accomplishments of great importance. Robert Thomson, on behalf of LDN Now Scotland, made a presentation December 1 to the Public Petitions Committee of the Scottish Parliament on the need for LDN approval (go to minute 39 to begin the LDN presentation). On the same day, a petition requesting measures to ensure general LDN availability was delivered to 10 Downing Street. The petition had over 13,000 signatures and was given directly to Gordon Brown, the Prime Minister of the United Kingdom, by the popular doctor from the British ITV network, Chris Steele. Surf here for Dr. Steele’s comments regarding LDN.
As of September 2009:
A Personal Plea for the Mali Trial From the Editors of ldninfo.org. All LDN advocates are being requested to help Dr. Jaquelyn McCandless and her husband Jack Zimmerman complete the trial of LDN for HIV, which they have been sponsoring in Mali. Jaquelyn and Jack have personally contributed more than half of the $350,000 needed to fund the study; money which comes out of their own retirement savings. However, about $40,000 more is needed to finish this extremely important clinical trial. If just one third of LDN Yahoo Group members were to each donate some $20 on average, the goal would be met. As soon as possible, checks should be made out to: The Ojai Foundation, Africa Project, and mailed to: The Ojai Foundation, Africa Project; Post Office Box 999; Ojai, California 93024; or, please contribute online at the Ojai Foundation’s Africa Fund donations web page.
LDN Conference Planned for October. A Low Dose Naltrexone Conference arranged by Sunny (Sedlock) O’Malley will be held on October 19th, 2009 in the Lister Hill Auditorium in the National Library of Science on the campus of the National Institutes of Health (NIH). The conference theme, "Project LDN: Funding Clinical Trials," was selected because it reflects the increasing need for LDN to be recognized as a mainstream treatment protocol.
[Ed. Note: The LDN Conference of October 2009 differs from all prior US LDN conferences in that it is being organized entirely by Ms. O'Malley, with no involvement by David Gluck, MD or this website.]
Presenters scheduled to speak include Dr. Burt Berkson, Dr. Skip Lenz, and author Mary Boyle Bradley. The conference is made possible through the support of Platinum Sponsors: Bellevue Pharmacy of St. Louis and Skip’s Pharmacy, Florida. No admission fee is asked.
Ms. O’Malley has chosen to designate this conference as a fund raiser for Dr. Jacquelyn McCandless’ LDN Mali Trial. All conference attendees are requested to go to the Ojai Foundation’s Africa Fund donations web page. A minimum donation of $50.00 per attendee is suggested, but not required. To learn more about the conference and register online, visit Project LDN.
International LDN Awareness Week Launches October 19-25. This unique week aims at increasing media attention to the many thousands of patients with autoimmune diseases who are benefiting from the off-label use of LDN. Organization of the inaugural International LDN Awareness Week has been spearheaded by Linda Elsegood of the LDN Research Trust in the UK and internationally supported by SammyJo Wilkinson of LDNers.org, Julia Schopick of HonestMedicine.com, Malcolm West of Practical Communications Group, and Cris Kerr, advocate for the value of patient testimony. For further information, contact Linda Elsegood, LDN Research Trust. You may also view the International LDN Awareness Week e-book of 100 testimonials, entitled 100 Reasons Why You Should Know About LDN.
YouTube Presentation by UK TV Doctor is Pro-LDN. Dr. Chris Steele, MBE, is recorded on YouTube with a convincing talk about LDN. Jayne Crocker and Andrew Barnett, LDN advocates in the UK, promoted a petition calling for the government to help make the medication available for all. They have gained the support of thousands of people and recently added that of Dr. Steele, resident doctor on ITV's This Morning program.
As of May 2009:
Fibromyalgia Study at Stanford Successful. Description adapted from Science Daily: Ten women with fibromyalgia took part in a small pilot study at Stanford University Medical Center over a 14-week period to test the new use of a low dose of a drug called naltrexone for the treatment of chronic pain. The drug was found to reduce symptoms of pain and fatigue an average of 30 percent over placebo, according to the results of the study published April 17 online in the journal Pain Medicine. "Patients' reactions were really quite profound," said senior author Sean Mackey, MD, PhD. "Some people decided to come off other medications. Some people went back to work really improving their quality of life." The researchers are moving ahead with a second, longer-term trial of 30 patients who will be tested during a 16-week period.
As of March 2009:
New Publications Highlight LDN Stories. The past year has seen a number of new publications that explore not only individuals' remarkable experiences with LDN, but also underscore its clinical therapeutic importance.
- The Promise Of Low Dose Naltrexone Therapy: Potential Benefits in Cancer, Autoimmune, Neurological and Infectious Disorders by Elaine Moore and SammyJo Wilkinson. McFarland Publishing. “Grounded in available clinical and scientific research, this new book describes the history of low dose naltrexone, its potential therapeutic uses, the results of animal and clinical studies, the drug's physiological effects, and its pharmacological properties. A section on practical usage information includes information on its administration, and compounding pharmacies. The resource section includes a list of doctors who prescribe LDN and links to all current studies. This book should be an invaluable reference for researchers, practitioners and patients who want to understand the therapeutic potential of LDN.”
- Those Who Suffer Much Know Much by Cris Kerr of the Case Health website. “Described are the personal reports in detail of LDN use in the treatment of a wide range of diseases. The 29 case studies in this book feature Multiple Sclerosis, HIV, Hepatitis B, Primary Lateral Sclerosis, Cancer, and Crohn’s Disease.” This excellent publication, now in a new 2008 edition, is available free of charge.
- Google LDN! by Joseph Wouk. Forward by Dr. Bernard Bihari. A graphic personal account of Wouk's complete recovery from Progressive Relapsing Multiple Sclerosis as a result of LDN. Includes 100 page appendix with the latest LDN information. (Of note, Wouk’s father Herman Wouk won the Pulitzer Prize for The Caine Mutiny.)
- Up the Creek with a Paddle: Beat MS and All Autoimmune Disorders with LDN by Mary Bradley. “A simple love story that successfully humanizes the implications of a simple, generic, out-of-patent drug. The book pulls directly at the heartstrings of every person, society and Government to take a leap of faith and help the LDN campaign. It is an easy, educational and enlightening read that has been compared to having coffee with a good friend.” The first edition was printed in May 2005. Revised Second Edition became available in February 2009. Contains a Note from Dr. Bernard Bihari and a Foreword by Dr. David Gluck. Mary writes: “If you are part of a charity organization and would like to help share my story, for every book you sell through your charity I will donate to your cause.”
LDN Info Increasingly Available on Web. Low-dose naltrexone continues to stir a great deal of interest on the internet, including these recent examples:
- The Whitaker Wellness Institute has been prescribing LDN for years; now their website includes several pages on LDN, including patient success stories and in-depth articles. About Whitaker: "The Whitaker Wellness Institute was founded in 1979 by alternative medicine pioneer Julian Whitaker, MD. Over the past 30 years, the clinic has helped more than 40,000 patients achieve optimal health. Dr. Whitaker is also the author of 13 best-selling books including Reversing Heart Disease and Reversing Diabetes, as well as the popular newsletter Health & Healing, which mails to a quarter of a million households each month."
- Honest Medicine, Julia Schopick's website, features an interview in February 2009 with Burt Berkson, MD, PhD, who regularly uses LDN in his successful treatment of cancers and autoimmune diseases. Dr. Berkson, who has often presented his findings at annual LDN conferences, explains in this insightful interview his understanding of the frequent lack of readiness among most physicians to appreciate new effective therapies such as LDN.
- International LDN Websites, including those in Italy, Germany (this site focused on CIDP), and Norway. [Editor's Note: Please contact us if you have news of other international LDN websites.]
As of February 2009:
April 2009 LDN Conference First in Europe. The first Low Dose Naltrexone Conference in Europe will be held on Saturday, April 25th, 2009 at Glasgow University. Admission, including refreshment and light lunch, is free of charge. The meeting, organized by Dr.Tom Gilhooly, is aimed at both patients and doctors. It hopes to achieve several goals: to increase awareness of LDN in Europe, to highlight existing research, and to hear from those who have personally experienced the benefits of LDN use.
See the Glasgow LDN Conference 2009 Website for information, registration, and conference contact information. Those interested in financially supporting the conference can visit here and should please add “conference” as a reference to their contribution.
California Pharmacy Recommended for Compounding LDN. With the addition of the McGuff Compounding Pharmacy in California, there are now a total of eight recommended pharmacies listed on the LDN homepage. These compounders have all been able to demonstrate that a large number of their clients have all had beneficial results using the LDN they prepared. We maintain this list in order to help LDN users avoid the rather high error rates that have been a problem in the past with compounding pharmacies in general.
As of September 2008:
Trial of LDN in Children with Crohn's Disease at Penn State. Dr. Jill Smith, Professor of Gastroenterology at Penn State University, has announced a new clinical trial of LDN for youngsters with Crohn’s disease. This will include children and adolescents from ages 6 to 17 and will aim at determining the safety and effects of LDN in this group. It will also measure LDN’s effects on enkephalin and endorphin levels. Participants will receive either placebo or naltrexone for 8 weeks, then all those involved will receive low dose naltrexone during the last 8 weeks.
Parents interested in having their child join this research project should contact Sandra Bingaman, RN, at 717-531-8108. Specific and detailed information is available at the trial website.
As of May 2008:
Marked Increase in Television News Coverage of LDN. Recent weeks have seen several reports produced by major broadcast networks concerning low dose naltrexone use:
- CBS TV News Broadcast: Naltrexone "May Treat Other Diseases." Dr. Max Gomez, award-winning medical journalist for CBS-TV New York, presented a report on LDN on May 26. The video included an interview with Ronnie Raymond, who has had primary progressive MS for some 20 years and is now wheelchair bound. She feels that her use of LDN for the past year has dispelled her fatigue and restored her mental acuity. Others interviewed were David Gluck, MD, editor of this website, and Victor Falah, RPh, the chief pharmacist of Irmat compounding pharmacy. Video and article.
- ABC News Reports: LDN a "Wonder Drug?" On May 21, ABC Action News of Philadelphia reported the story of Pam Sweigart of PA whose debilitating Crohn's disease was interfering with her ability to care for her youngsters, until she obtained relief through the use of low dose naltrexone. The report also features interviews with two Penn State professors: Dr. Jill Smith, author of the first published clinical trial of LDN in humans, as well as Dr. Ian Zagon, who for over 20 years has pioneered animal research on endorphins as well as on LDN. Video and article.
- CBS News: "Wonder drug" LDN Could Help Treat Cancer, MS. This story, broadcast in February, appeared on CBS 47 (WTEV‑TV) of Jacksonville, Florida, and features an interview with Lori Miles, an MS sufferer who can now walk again, thanks to LDN. Also quoted in the piece is Dr. Daniel Kantor, neurologist and director of the Comprehensive Multiple Sclerosis Program at the Shands Jacksonville Neuroscience Institute: "I would like all of us to write to our congressmen, ask the FDA and NIH—National Institutes of Health—to fund more research about LDN." Video and viewer commentary.
Outline of Double-Blind Trial of LDN in MS Presented at AAN. Dr. Bruce Cree and colleagues of the University of California at San Francisco delivered a poster presentation summary of their recently completed trial to the American Academy of Neurology (AAN) conference in April 2008 in Chicago. Eighty patients with MS were involved in this double-blind, randomized, placebo-controlled study. Each subject received either LDN or a placebo for 8 weeks, followed by one week without either, and then a further 8 weeks on the alternate. The effects of LDN on quality of life was measured using the multiple sclerosis quality of life inventory. During the study’s time period, LDN was able to show significant benefit for mental health outcome measures but not for physical outcomes. [Ed. Note: For details of the data we must await scheduled publication in a medical journal.]
Italian Researchers Present 6-Month Pilot Study of LDN for PPMS. Dr. Maira Gironi and her colleagues of Milan, Italy presented a poster summary of their 6-month study of LDN for Primary Progressive MS to the AAN conference in Chicago in April. This open label study used a 4mg dosage of LDN in 40 patients. There were 5 dropouts, most of which appeared unrelated to the drug. Endorphin levels were measured at intervals and were seen to gradually increase throughout. This correlated with a general trend of improvement in a number of efficacy measures. Significant improvements were seen by the study’s conclusion in both fatigue and depression. [Ed. Note: Detailed data availability awaits scheduled publication in a medical journal.]
Crohn’s Disease Trial at Penn State Seeks More Volunteers. As of early May, Dr. Jill Smith, Professor of Gastroenterology at Hershey Medical Center (Pennsylvania State University), was still actively seeking more people with Crohn’s disease in order to complete her ongoing Phase II research study, which has received strong funding from the National Institutes of Health. This effort may be aided by the recent video produced by the local Philadelphia ABC TV news station, which highlighted the LDN research work of both Dr. Smith and Ian Zagon, PhD (see above). Patients interested in volunteering for the research project should contact Sandra Bingaman, RN, at 717-531-8108.
Book of Patients’ Stories of LDN Use Planned. Aletha Wittmann, whose husband experienced a dramatic reversal of his symptoms of MS with the use of LDN, is planning to collect and publish many detailed short stories from LDN users, which will help others understand the actual experiences of those using the drug. She explains that "The book will be non-profit, with any proceeds going towards further LDN research or trials." For details on the book and how to contribute, see Aletha's letter.
As of March 2008:
2008 LDN Conference First on West Coast. The Fourth Annual Low Dose Naltrexone (LDN) Conference will be held on Saturday, October 11th, 2008 on the Health Sciences Campus of the University of Southern California (USC) in Los Angeles, California. The conference theme, "A Revolution In Research", was selected because it reflects the increasing appearance of LDN articles in medical journals and the growth of LDN use in clinical practice.
See the 2008 conference page for information, registration, and conference contact info.
As of February 2008:
Study of LDN in Primary Progressive MS to be Presented at AAN. Dr. Maira Gironi and colleagues of Milan, Italy have been invited to announce the results of their recently completed pilot study to the American Academy of Neurology in April in Chicago. The six-month, multi-center trial was carried out in 40 patients, all of whom had primary progressive multiple sclerosis. Safety and efficacy of LDN on spasticity, pain and fatigue were the major outcome measures of the study, which has especial importance because reliably measured endorphin levels were documented throughout.
Conference Multimedia Updates. Third Annual LDN Conference multimedia files have now been posted, including audio and video recordings of the principal speakers. The conference was held on October 20, 2007 at Vanderbilt University in Nashville,Tennessee.
As of October 2007:
Third Annual LDN Conference Sets New Attendance Record. With a full-capacity attendance of 130, the Third Annual Low Dose Naltrexone Conference was held on Saturday, October 20th in the Student Life Center of Vanderbilt University in Nashville, Tennessee. The conference theme, "Breaking Down Barriers", underscored the quantum leap in the number of research centers at which trials of LDN have been implemented within the past year. Please see the linked page here for further information and conference multimedia.
Berkson Reports Another Cancer Success for LDN in Journal. Treatment of the patient was reported in the medical journal Integrative Cancer Therapeutics ("Reversal of signs and symptoms of a B-cell lymphoma in a patient using only low-dose naltrexone," September 2007, Berkson BM, Rubin DM, and Berkson AJ). This is Berkson’s second published journal article to describe the successful use of LDN in a patient with advanced cancer (see Latest News for April 2006).
As of September 2007:
First Scientific LDN-HIV/AIDS Trial Approved by IRB in Mali. Jaquelyn McCandless, MD and her husband Jack Zimmerman, PhD, have announced that the Institutional Review Board in Bamako, the capital of Mali, has approved the plans for the long awaited clinical trial of LDN in HIV-infected citizens of Mali.
The study, which should last for some 9 months, involves 3 study groups: LDN treatment only; LDN plus antiretroviral drugs; and only antiretroviral drugs. The volunteer subjects must be18 years of age or older and must have reduced CD4 counts in the 275 to 475 cells range at the outset. Laboratory studies will be rechecked at 12-week intervals.
The research team is led by Dr Abdel Kader Traore and other health officials at the University Hospital in Bamako. Irmat Pharmacy of Manhattan has volunteered to supply all of the needed LDN and matching placebo capsules at no cost. In addition, the plans include careful attention to counseling aimed at improving preventive health practices for women and children. [Editor’s Note: Many thanks to Mr. Seyni Nafo of Mali who has tirelessly worked to facilitate all efforts to implement this groundbreaking study.]
Dr. McCandless is actively seeking philanthropic donations (e-mail her here). For further details, please see the linked Developing Nations Project page.
As of July 2007:
NCI Distributes Summary of April LDN Conference. As noted in detail in this column dated May 2007, the National Cancer Institute held a conference on April 20th entitled “Low Dose Opioid Blockers, Endorphins, and Metenkephalin: Promising Compounds for Unmet Medical Needs.” The summary of the speakers’ remarks was collated by the NCI and is now available here. [Editor’s Note: This editor was honored to be able to deliver the introductory comments at that meeting.]
Volunteers Sought for First Clinical Trial of LDN in Fibromyalgia. The Stanford Systems Neuroscience and Pain Lab is organizing a study of LDN for the treatment of fibromyalgia. It will recruit 40 individuals who are diagnosed with fibromyalgia and who live in the California Bay Area. This study is a placebo-controlled, double-blind, and cross-over clinical trial. Participants may be taking LDN at some times, and a placebo at other times. The entire study takes 21 weeks, and participants will be taking LDN or placebo for just 12 weeks of that time. While in the study, participants will need to come to the Stanford Medical Center every two weeks for quick checkups. Individuals who want additional information should contact Dr. Jarred Younger or telephone 650-724-8783.
As of May 2007:
NCI Hosts Conference on LDN and Related Substances. On the afternoon of April 20th, at its offices in Rockville, Maryland, the National Cancer Institute (part of the US government's National Institutes of Health, or NIH) held a conference entitled “Low Dose Opioid Blockers, Endorphins, and Metenkephalin: Promising Compounds for Unmet Medical Needs.”
Following welcoming remarks from Jeffrey Abrams, MD, Chief of the Clinical Investigations Branch of the NCI, speakers included David Gluck, MD (Introductory Overview); Jill Smith, MD (Clinical Experience with LDN in Crohn’s Disease; Opioid Growth Factor in Pancreatic Cancer); John Hong, PhD (Anti-Inflammatory and Neuroprotective Effects of Naltrexone and Its Analogs); Nicholas Plotnikoff, PhD (Overview of Metenkephalin Actions in HIV Infections); Burton M. Berkson, MD, PhD (Personal Experiences with LDN for Various Cancers); Maira Gironi, MD, PhD and Filippo M. Boneschi, MD, PhD (Ongoing Pilot Study of LDN in MS: Preliminary Findings). Dr. Abrams then delivered the concluding remarks and announced his intention to prepare a written summary of the entire meeting. Once that becomes available, we intend to present it as a linked page on this website.
Second US Prospective Study of LDN in MS Announced. The MindBrain Consortium and the Department of Psychiatry of Summa Hospital System of Akron, Ohio, along with the nearby Oak Clinic for the treatment of Multiple Sclerosis, have announced a new scientific study of the effects of treating MS with low dose naltrexone. Psychologist David Pincus and his colleagues are beginning the study immediately. It is a 16 week, double-blind, randomized, placebo-controlled, crossover-design analysis of 36 patients with either progressive or relapsing-remitting MS. The study will examine symptom severity as well as any changes in quality of life, sleep patterns, and affective states.
LDN’s Effectiveness Highlighted in New Presentations. We have received permission to display the following two complete slide presentations, which portray the important therapeutic effects of LDN in a broad array of challenging human illnesses:
- Dr. Burton Berkson, MD, PhD, a clinician from Las Cruces, New Mexico, contributed a copy of his presentation from the April 2007 meeting hosted by the National Cancer Institute (see above). The slides include multiple images of CT scans and PET scans that document unprecedented remissions in heretofore terminally ill patients.
- Niles Bauer, PhD candidate, Department of Microbiology and Immunology, College of Medicine, University of Arizona, supplied a copy of a presentation to his department in March 2007. He observed “profound” improvements within a month after the start of LDN treatment in people with a wide variety of autoimmune disorders.
As of April 2007:
Funding Guaranteed for Long Awaited LDN-HIV Trial in Mali. Jaquelyn McCandless, MD and her husband Jack Zimmerman, PhD, announced last month that they have committed their own funds to reach the goal of $250,000 needed to fund the LDN-HIV trial in Mali, the first study of its kind. The couple reports: "It is clear to us that the project is definitely going to happen and so we are willing to personally guarantee the funding. Hopefully, there will be many others who share our vision and will join with us but, no matter, we can support it alone if need be." They hope to begin training all involved personnel shortly and then start the study in May if possible. For further details of the planned study, please see the Developing Nations Project.
The LDN for MS Research Fund Reaches Its Goal. The Fund has announced that it has achieved its goal of raising significant funds to encourage academic research into the effectiveness of LDN for Multiple Sclerosis (see LDN Research Funding.) A total of $25,000 was awarded to the University of California San Francisco MS Research Center, which funded half the study expenses.The study was implemented in early 2007 by neurological researcher Bruce Cree, MD, and colleagues. Further donations are no longer being sought by the Fund at this time. (For further information on the study, please see Clinical Trials for LDN.)
As of March 2007:
Bernard Bihari, MD, Discoverer of the Clinical Effects of LDN, Retires. Doctor Bihari’s office is notifying all of his patients that he will retire from his medical practice this month. In his groundbreaking clinical trial of patients with HIV/AIDS at Downstate Medical Center in 1985-86, Bihari discovered the significant effectiveness of low dose naltrexone in protecting the battered immune systems of those who were infected. With that knowledge, he entered private practice in an attempt to counter the then untreatable disease. His current letter to patients indicates that, because of a recent series of injuries, he has had to considerably restrict his activities and that now it has become necessary for him to focus exclusively on his own physical therapy and rehabilitation.
Editor’s note: As a long-time friend and colleague of Dr.Bihari, the editor is greatly saddened by this unfortunate turn of events. It is especially ill timed, since this year may well find LDN receiving long-sought recognition from academic medicine. This website will continue to broaden its content, in order to bring relevant information from doctors, researchers, and patients throughout the world to the public.
First Study Launched on LDN for MS in US. One of the premier medical centers in the US, University of California, San Francisco Medical Center, which is especially recognized in the area of neurology, has implemented a double-blind, randomized, placebo-controlled, crossover-design study of some 80 patents with multiple sclerosis. The 17 week study, designed by Dr. Bruce Cree and his colleagues, will examine the effects of low dose naltrexone on quality of life measures. (For further information on this study, please see the linked Clinical Trials page.)
LDN Continues to Show Benefits for ALS and PLS. Gary C. of Australia, who is convinced of the benefits of using LDN for his own primary lateral sclerosis, has recently updated his prior message of November 2004, in which he reported on the effects of LDN in several people with motor neuron diseases. With over two more years of experience, he continues to report unquestionable benefits for patients with PLS; and more often than not is hearing positive appraisals from patients with amyotrophic lateral sclerosis. (To read their reports in detail, please see this special update in the linked "What Others are Saying" page.)
As of January 2007:
First Study of LDN Published in US Medical Journal. Dr. Jill Smith’s original article, "Low-Dose Naltrexone Therapy Improves Active Crohn’s Disease," in the current issue of the American Journal of Gastroenterology (2007;102:1–9), officially presents LDN to the world of scientific medicine. Smith, Professor of Gastroenterology at Pennsylvania State University's College of Medicine, found that two-thirds of the patients in her pilot study went into remission and fully 89% of the group responded to treatment to some degree. She concluded that “LDN therapy appears effective and safe in subjects with active Crohn’s disease.” (For further information on Smith’s study, please see the linked Clinical Trials page.)
LDN Meeting Planned at the NIH. Jeffrey Abrams, M.D., Chief of the Clinical Investigations Branch at the National Cancer Institute, is arranging a meeting at the NCI in order to acquaint staff researchers from various of the National Institutes of Health—those involved with autoimmune diseases, neurological disorders, AIDS and cancer—with some of the research opportunities presented by LDN, metenkephalin (an endorphin-like substance produced in the adrenal medulla) and related drugs. Abrams plans to hold a half-day conference on Friday, April 20th, 2007 in Bethesda, Maryland. Invitees thus far include I. Zagon, PhD; Jill P. Smith, MD; John Hong, PhD; and Nicholas Plotnikoff, PhD; as well as physician practitioners with experiences in LDN treatment. This appears to be a long-sought opportunity to present the story of LDN and associated substances to one of the foremost research institutions in the world.
As of December 2006:
Multi-Institutional Clinical Trial of LDN for MS Has Begun in Italy. A long-awaited pilot study of low dose naltrexone therapy in multiple sclerosis has been implemented by the Milan neurological researcher, Dr. Maira Gironi. Several northern Italian hospitals began enrolling patients for the study during the first week of December. Dr. Gironi anticipates that the 6 months of LDN treatment will have been completed by early summer. Importantly, Dr. Gironi’s research team has long been a locus for significant research on endorphins in relation to illness, and this study will track accurate assessments of the patients’ beta-endorphin levels in response to their LDN treatment.
Research on Neurodegeneration Suggests a Protective Naltrexone Role. J.S. Hong, Ph.D., head of the Neuropharmacology Section of the Laboratory of Pharmacology and Chemistry at the National Institute of Environmental Health Sciences (NIEHS), finds that "morphinan" drugs, including naltrexone and naloxone, are able to reduce inflammatory reactions in microglia brain cells in animal studies. Such inflammation is believed to be central to the progressive neurodegenerative effects seen in disorders such as Parkinson’s disease and Alzheimer’s disease. Hong’s report, summarizing the role of microglia in inflammation-related neurodegeneration and the potential of therapy using morphinans, will appear in a January 2007 issue of Nature Reviews Neuroscience.
Report from Mali: Positive Conditions for HIV Trial. Jaquelyn McCandless, M.D., the neurologist who is the U.S. Medical Consultant/Coordinator for the Mali LDN HIV+ Study [see last month's Latest News, below], recently visited Mali and met with the clinical study team at Bamako University Hospital as well as the head of the Malian Ethics Committee. She was highly impressed with the university's research facility, and reports that "everyone we have met so far is very friendly, helpful, and highly interested in the success of this program." For further details of her report, please see the linked Developing Nations Project page.
As of November 2006:
Two New LDN Studies Planned at Eminent US Medical Centers. Pending institutional approvals, the year 2007 may finally see US clinical studies of LDN in multiple sclerosis and in fibromyalgia. A crossover study at the University of California, San Francisco, is being planned by neurological researcher Bruce Cree, MD. If approved, some 80 patients with MS will be involved. Contributions would surely be welcome and can be made by contacting the Clinical Studies Manager at UCSF, Dr. Elena Koryeyeva, at 415-514-2467. In addition, a post-doctoral scholar at Stanford University’s Neuroimaging and Pain Laboratory is hoping to launch a clinical study on LDN for fibromyalgia this coming year.
Animal Research at Penn State Uses LDN and a Model of MS. The National Multiple Sclerosis Society has confirmed that the NMSS “recently awarded a small Pilot Award to Ian Zagon [Ph.D.] at Pennsylvania State University in Hershey, PA for the term of 09/01/2006 through 08/31/2007 in the amount of $44,000. The title of his project is ‘Role of opioid peptides and receptors in MS.’ This study will be treating an animal model of MS daily with either a high dose of naltrexone or a low dose of naltrexone to determine whether naltrexone influences disease course.” For Zagon's description of the project, please see the linked Clinical Trials page.
Mali Plan for LDN HIV Clinical Trial Gains Support. Jaquelyn McCandless, M.D., an autism specialist who has pioneered the use of LDN for that disorder, has taken on the mantle of U.S. Medical Consultant/Coordinator for the Mali LDN HIV+ Study. Motivated by a special interest in the very difficult conditions of many women and children in Africa, Dr. McCandless and Dr. Zimmerman, her husband, are trying to raise philanthropic donations for the study (e-mail them here). They will visit Mali from December 4th through the 12th in order to work with the LDN Project health team there, which will conduct the research project.
As of October 2006:
First Phase II Trial of LDN at a US Medical Center. Dr. Jill Smith, Professor of Gastroenterology at Pennsylvania State University's College of Medicine, has begun registering patients for a Phase II study of LDN for Crohn's Disease as of last month. It will examine LDN’s efficacy in the treatment of people with Crohn's disease. See the Penn State trial website or call Sandra Bingaman, R.N., at 717-531-8108, if interested.
As of May 2006:
First US Scientific Study Reports Successful Use of LDN. The research paper—"Low-Dose Naltrexone as a Treatment For Active Crohn's Disease"—was presented on May 23rd at Digestive Diseases Week, a prestigious gastrointestinal conference, by Professor Jill Smith of the Pennsylvania State University College of Medicine.
Dr. Smith and her colleagues concluded that "LDN therapy offers an alternative safe, effective, and economic means of treating subjects with active Crohn's disease." According to the news from Penn State, the National Institutes of Health has already granted $500,000 for Dr. Smith's group to continue the study. This funding should help assure a full-fledged placebo-controlled scientific trial of LDN in Crohn's disease.
For further details, see the Clinical Trials for LDN page, Penn State's online news, and our multimedia coverage of Dr. Smith's keynote address at the Second Annual LDN Conference.
Crohn's Disease Proven to be Form of Immunodeficiency. Research reported in the Feb. 25th issue of the medical journal Lancet—"Defective Acute Inflammation in Crohn's Disease: a Clinical Investigation"—by Professor Anthony Segal and others of the Department of Medicine, University College of London, showed that multiple tests of the innate immunity of those affected by Crohn's disease revealed "a constitutionally weak immune response." (See also Latest News of December 2005, below: "Patients with MS & RA have Weak Immune Systems.")
Press Attention to LDN. In early May, the Auburn Journal (the daily newspaper of Auburn, CA) told the story of Vicki Finlayson, a 50-year-old woman who has been severely afflicted with a progressive form of multiple sclerosis since 1998. She experienced substantial relief of many of her debilitating symptoms six months ago, soon after beginning LDN. Since then, Ms Finlayson has become an ardent advocate for LDN and is planning a large fund-raising event this fall in order to support needed scientific research into LDN use for MS.
Conference Multimedia Updates. The entire set of Second Annual LDN Conference multimedia files have now been posted on the LDN Events page, including complete audio and select video clips of Dr. Jill Smith's keynote address, as well as the entire video of William Way's Advocates Panel talk on LDN for HIV.
As of April 2006:
Second Annual LDN Conference Held at NIH Campus. On April 7, 2006, at the Lister Hill Auditorium of the National Library of Medicine in Bethesda, MD, doctors, researchers, and LDN advocates gathered for a day-long series of groundbreaking presentations. The speakers included:
- Dr. Jill Smith, Professor of Gastroenterology at Hershey Medical Center, describing her two research projects—the first successful studies to be published in the US on the use of LDN in Crohn's Disease.
- Dr. Jacquelyn McCandless, pioneer in the use of LDN in treating childhood autism.
- Dr. Phil Boyle, fertility specialist and family physician in Ireland, on his impressive experiences with the use of LDN in MS, rheumatoid arthritis, and gynecologic disorders.
For a detailed report on the 2006 conference, please visit the LDN Events linked page.
Medical Journal Reports LDN Successful in Metastatic Cancer. Treatment of the patient was reported in the medical journal Integrative Cancer Therapeutics ("The Long-term Survival of a Patient With Pancreatic Cancer With Metastases to the Liver After Treatment With the Intravenous {alpha}-Lipoic Acid/Low-Dose Naltrexone Protocol," in March 2006) by Berkson BM, Rubin DM, and Berkson AJ. This is the first published journal article to describe the successful use of LDN in a patient with advanced cancer.
The authors report that "in October 2002 ...there was little hope for his survival. Today, January 2006, however, he is back at work, free from symptoms, and without appreciable progression of his malignancy."
As of January 2006:
Exciting Program for Second Annual LDN Conference. The Second Annual Low Dose Naltrexone Conference will be held on Friday, April 7th in the Lister Hill Center Auditorium of the National Library of Medicine (NLM) in Bethesda, Maryland. The conference theme, "The Future Is Now," was selected because it reflects the amazing strides that have been made in LDN research and clinical trials since our last gathering. There are already five physicians scheduled to address the attendees, among them:
- Jill Smith, MD, Professor of Gastroenterology at Hershey Medical Center, the keynote speaker, who will review the first clinical trial of LDN in the US, which she ran on the effects of LDN on Crohn's Disease; and
- Jacquelyn McCandless, MD, who is achieving remarkable success with LDN in treating childhood autism, and who will describe details of her new clinical trial.
For further information about the agenda and for specifics on where to stay and how to register, please visit the LDN Events linked page.
As of December 2005:
Patients with MS & RA have Weak Immune Systems. Research reported in the Annals of the N.Y. Academy of Sciences ("Premature Immunosenescence in Rheumatoid Arthritis and Multiple Sclerosis Patients," June 2005) studied immune system elements in over 130 people—60 patients with rheumatoid arthritis, 32 with multiple sclerosis, and 40 healthy controls. The patients showed evidence of premature aging of the immune system, which the investigators state "could be a risk factor for developing autoimmune disorders in genetically predisposed individuals in a susceptible environment." This report offers important further evidence for the correctness of the current view that LDN's action in halting the progression of autoimmune diseases is accomplished through strengthening the immune system.
LDN for HIV. Detailed reports from an HIV-infected patient, who has been taking only LDN for his disease for the past 12 months, present strong evidence for the efficacy of LDN in treating HIV. His comments are reprinted in the HIV/AIDS subsection of the linked page "What Others Are Saying About LDN" (his are the three messages dated 2005). We hope that all the developing nations that are struggling to treat their HIV-infected citizens will take note.
As of November 2005:
Evidence Emerges for LDN Use in Autism. We have recently become aware of information that Jaquelyn McCandless, MD, reported last July the results of an informal clinical study on 15 of her patients with autism, using low dose naltrexone (transdermally as a cream). According to McCandless, "8 of the 15 children had positive responses, with five of these 8 having results considered quite phenomenal according to their parents. The primary positive responses have been in the area of mood, cognition, language, and socialization. All participants who completed my study have indicated they wish to continue, and hundreds of other ASD kids have started this non-toxic, non-invasive, inexpensive intervention by now." For more information, see McCandless' original essay. Further information on LDN and autism can be found at the Autism-LDN Yahoo Group and at Autism One Radio (8/1/2005 broadcast by Dr. DeMio).
As of July 2005:
Second Annual LDN Conference: April 7, 2006. Susan Sedlock, who has volunteered to coordinate the Second Annual Low Dose Naltrexone Conference, has announced the Conference date as Friday, April 7th, 2006. The meeting will be held on the campus of the National Institutes of Health in the Lister Hill Center Auditorium of the National Library of Medicine (NLM), located approximately 5 miles from Washington D.C. in Bethesda, Maryland. The NLM/Lister Hill Center (buildings 38 & 38a) are in the southeast corner of the campus of the National Institutes of Health. For more information, or to offer volunteer support for the effort, please contact Susan Sedlock (e-mail 2002eldo@msn.com). Save the date!
Conference Multimedia Now Available. Audio, video, photos, and presenters' slides from the First Annual LDN Conference, June 2005, have now been posted to the LDN Events page of this website. Complete audio of the entire conference, as well as individual audio recordings and video excerpts of each speaker, are now online, as are video stills of each speaker and an additional collection of photographs from the conference.
As of June 2005:
LDN Conference a Success. The First Annual LDN Conference, which was held in NYC at the New York Academy of Sciences, June 11, 2005, was a success. Some 85 enthusiastic participants heard Dr. Bihari's keynote message, as well as five panels of researchers, doctors, pharmacists, and LDN advocates. Next year's conference is planned for Washington, D.C. Click here for more information on the conferences.
Crohn's Study Successful; Large-Scale Trial Planned. Dr. Jill Smith, Professor of Gastroenterology at Penn State's Hershey Medical Center, recently completed an open-label, pilot feasibility study using low-dose naltrexone in Crohn's disease. As reported previously on this website, her pilot study began in November 2003. With her permission, it was reported at the LDN Conference that she was very pleased with the results of the study, and has submitted an application to the NIH to conduct a larger placebo-controlled trial. If it were to happen, it would be the first scientific clinical trial using LDN to be accomplished at a US medical center.
First Book on LDN Published. Mary Anne Boyle Bradley's new book, Up the Creek with a Paddle: Beat MS and Many Autoimmune Disorders with Low Dose Naltrexone (LDN), has the distinction of being the very first published book devoted to the subject of LDN. The book details Bradley's own story of how she stumbled across LDN as a treatment for her husband's MS, and her activities as an LDN activist since. Bradley was a featured panelist at the First Annual LDN Conference. Her book is available from Amazon and other major booksellers.
NEJM Article Provides Proof of Principle for LDN A recent article in the New England Journal of Medicine ("Sargramostim for Active Crohn's Disease", May 26, 2005) counters a major hurdle to LDN's acceptance—the unproven (but widely held) idea that autoimmune diseases are related to an over-aggressive, overactive immune system. The NEJM article describes the effect on patients with Crohn's Disease of Granulocyte-Macrophage Colony Stimulating Factor, an injectable substance that is recognized as a stimulant to the endogenous immune system in the intestinal tract. Patients treated in the study experienced a beneficial effect. This article establishes "proof of principle" that stimulating the immune system—as LDN does—can be beneficial for autoimmune disease.
As of April 2005:
Dr. Bernard Bihari in Hospital. In the wake of a severe accidental hip fracture last year, the discoverer of the range of clinical effects of LDN has required recurrent hospitalization and may not be able to attend the June 11th LDN Conference. If he is unable to attend, it is his intention to communicate a keynote message to the conference.
As of January 2005:
First Annual LDN Conference Scheduled for Saturday, June 11, 2005. The First Annual LDN Conference will be held in New York City at the New York Academy of Sciences (NYAS). The theme of the conference will be "Working Towards Widespread Acceptance of LDN." The NYAS is located at 2 East 63rd Street between Madison Avenue and 5th Avenue in Manhattan. The meeting will take place from 9am to 4pm on Saturday, June 11, 2005.
Although the conference is a purely not-for-profit effort, a modest registration fee ($50) will be requested in order to defray the facility's charges. The NYAS indicates that the main floor conference room and restroom are wheelchair accessible.
We are hoping that you will plan to attend. The capacity of the main conference room is limited to 80 attendees, so please do not delay in registering for the conference. Further details about the meeting and the registration form can be found on the linked page, LDN Events.
As of December 2004:
Clinical Trials for LDN are Emerging At Long Last. Although, as of this month, there are yet no published medical reports of a definitive clinical trial for low dose naltrexone, there are three current clinical trials in various stages of progress—for Crohn's disease, irritable bowel syndrome, and, in Germany, a small trial for MS. In addition, there are at least five other clinical trials (in five different countries) that are being planned. Though all the plans may not come to fruition, we are finally seeing an impressive international recognition of the efficacy of low dose naltrexone. We will attempt to regularly update the information on our new linked page: Clinical Trials for LDN.
Dr. Bihari's Foundation Now on the Internet. The Foundation for Immunologic Research (FFIR), a 501(c)(3) non-profit organization founded originally in 1989 by Bernard Bihari, MD and two colleagues as the Foundation for Integrative Research, now has a page on the Internet in order to help seek increased funding. It states: "The purpose of the FFIR has always been to raise money for clinical trials of the various clinical uses of Low Dose Naltrexone. The cost of scientific clinical trials, correctly run, can range from half a million dollars for a small, brief study to the many tens of millions of dollars." See the Foundation's website.
As of November 2004:
Increasing Evidence for LDN Benefit in Motor Neuron Diseases. An Australian member of the LDN Yahoo Group who has PLS has written an article about the beneficial effects of LDN and published it in the newsletter of his regional association for those with motor neuron disease (MND). MND refers to several different disorders, including ALS (Lou Gehrig's disease), PLS (primary lateral sclerosis), and progressive muscular atrophy. Up until now, there has been no recognized treatment available for any MND.
The article reports on promising improvements on the part of three other patients with MND as well as that of the author. Of those three, at least two have definite diagnoses of ALS. Please see the original essay in What Others Are Saying About LDN.
As of August 2004:
Latest Cancer Data from Dr. Bihari. Through a review of his total clinical data through March 2004, Dr. Bihari reports that the use of LDN in some 450 patients with cancer — almost all of whom had failed to respond to standard treatments — suggests that more than 60% of patients with cancer may significantly benefit from LDN treatment. Full details are available on the linked page LDN and Cancer.
LDN Research Trust. Located in the UK, the LDN Research Trust is a charity whose mission is to raise funds toward the initiation of clinical trials for LDN. Conceived by a group of people with MS who have been helped by LDN, the first clinical trials being planned will focus on MS. Just launched this month, the informative website, www.ldnresearchtrust.org, encourages contributions and participation.
As of May 2004:
More Press Attention to LDN:
- The first known independent press coverage of LDN in the US appeared in the May 15, 2004 issue of The Brattleboro Reformer of Brattleboro, VT (www.reformer.com). It carried an extensive article — "Drug Offers Hope for MS Patients" — about a man (shown in a color photo) who describes the improvement in his MS as "unbelievable." The article includes background information about LDN and an interview with Dr. Bihari.
- A British newspaper, The Eastern Daily Press of Norfolk (www.edp24.co.uk), published an article on LDN on May 21, 2004, entitled "MS Sufferers Campaign for Drug Aid."
- An Irish newspaper, The Sunday Business Post (www.sbpost.ie), carried an article about the use of LDN for MS on May 10, 2004 entitled "MS Experimental Drug 'Could Save State Millions of Euro.'"
Latest MS Data from Dr. Bihari. In preparing a proposed clinical trial protocol for the use of LDN in the treatment of multiple sclerosis, Dr. Bihari assembled the latest data from his clinical practice. As of May 2004, Bihari has almost 400 patients with MS in his care. Of that group he knows of only two patients who showed signs or symptoms of new disease activity over the years while taking LDN treatment. One was a 41-year-old woman who, after 18 months on LDN, had an episode of optic neuritis which cleared in 4 weeks. The other was a patient who, after 8 months on LDN, had an episode of numbness in the left leg that had not been experienced previously and which cleared after 3 weeks.
As of April 2004:
Increasing Attention to LDN for MS:
- On April 12, 2004 The Herald, the venerable newspaper of Glasgow, Scotland, carried a feature article and an editorial concerning the increasing number of people who are petitioning for holding clinical trials specifically among people with MS in order that LDN could be licensed for their use. This marks the first attention we are aware of to LDN in the public press.
- A petition on the Internet, which was mounted in Ireland and the UK in order to gather support for a clinical trial of LDN in MS, already had over 3000 signatures by mid-April.
- A survey of those with MS who are taking LDN, covering a host of issues and individual comments, had gathered over 200 responses as of this writing. To see all the responses, go to the website, select "300" and press "Submit Query".
Search Feature. A new search feature has been added to the LDN website, and can be found at the top of the homepage, and at the bottom of every page of the site. To use, type in text to search for, and press enter or click the blue 'Search' button. A search engine (Google) will provide a list of pages on this website containing your search text — click on a search result to go to that page. To locate your search text on that page, use the 'Find' feature of your browser (usually accessible by typing Ctrl+F).
As of February 2004:
LDN's First US Clinical Trial Needs Your Help. As announced in our Latest News for November 2003, Jill P. Smith, MD, Professor of Medicine at Penn State's Hershey Medical Center, is currently enrolling patients in a four-month pilot study. This will test the effectiveness of a low dose of naltrexone in offering relief to patients suffering from symptoms of Crohn's Disease and, if successful, should lead to a full-fledged clinical trial.
Here is the chance that many readers of this website have been waiting for: to help LDN achieve medical verification and legitimacy through a university-sponsored scientific clinical trial. If you know anyone on the East Coast of the United States who has Crohn's disease, please ask them to consider participating in this study being held by the Hershey Medical Center of Pennsylvania State University. Cost of medication, office visits, and blood work are paid by the study. Those interested should contact the study coordinator, Sandra Bingaman, R.N., at 717-531-8108, or click here for the study website.
As of January 2004:
Pulmonary Emphysema. Dr. Bihari reports that he now has four patients in whom the inexorable downward course of pulmonary emphysema/chronic obstructive pulmonary disease (COPD) has been arrested through the use of LDN treatment. The central problem in the usual progression of COPD is almost always repeated respiratory infections. Of Bihari's patients, whose average length of LDN use has been two-and-one-half years, three have been entirely free of respiratory infections and the fourth, who is HIV positive, has had far fewer such events. As a result, their clinical conditions during this time have remained essentially stable. This highlights the potency of LDN in being able to act as a primary preventive therapy against respiratory infections in general. Many people who use LDN for a variety of reasons note a sharp decrease in their usual experience of common colds, generalized viral infections, or sinusitis.
As of December 2003:
New Page for the Website. What Others Are Saying About LDN is a new addition to the LDN website. Here one can find selected comments, which were emailed to this website or to its LDN Yahoo Group, that reflect disinterested personal or family experiences with LDN. We have made an effort to keep all names and email address identifiers obscured. It is our intention to continue adding to this page on a regular basis.
As of November 2003:
A Clinical Trial Starts. At long last, an independent clinical trial of low dose naltrexone is beginning at a medical center in the US. This represents an important recognition of the therapeutic potential of LDN. Once the trial is completed and successful, its publication should do much to persuade the medical world of the value of LDN. The study is being done on Crohn's disease, a prevalent autoimmune disease, at Penn State Hershey Medical Center. Click here for the study website.
Alzheimer's Disease. Dr. Bihari reports that he currently has three patients who have Alzheimer's disease. Since starting LDN, none of them has shown further progression, which is usually inexorable in this disorder. The initial such patient came to him four years ago to seek treatment for prevention of recurrence of colon cancer. The second patient saw Bihari some two-and-one-half years ago for treatment of non-Hodgkin's lymphoma, and the third began LDN two years ago for an autoimmune problem. Before their first visits, each of the three had been diagnosed with moderately severe Alzheimer's disease by a neurologist.
HIV/AIDS. Dr. Bihari describes a "natural experiment" unintentionally performed by one of his patients, a 42-year-old man with HIV disease who lives in Florida and whose standard medications (Kaletra, Viramune) are paid for by a governmental program. When he lost his job in May 2003 (six months ago) he decided to stop LDN in order to save money. At that time, his CD4 cell count was 950 and the CD4% was 38%. Lab tests two and one-half months later showed that the CD4 count had dropped to 590 and the CD4% was down to 31%. Three months ago, on regaining employment, he restarted his LDN — and repeat tests two weeks ago showed the CD4 count had climbed back to 968 and the CD4% had returned to 38%. Viral load had remained undetectable throughout this time. This is felt to be a good demonstration of the efficacy of LDN as a supplement to standard HIV drugs.
As of September 2003:
Parkinson's Disease. As reported earlier on this page (in May 2003 and twice in 2002), Dr. Bihari has been treating patients with PD. Parkinson's Disease is generally characterized by an inexorably progressive course. Bihari now reports that there are seven patients with the disease in his practice, all of whom have shown no progression since beginning LDN. Indeed, two of them have shown clear evidence of improvement in signs and symptoms.
Website Update. The website has begun an update as of this month, incorporating current data reported from Dr. Bihari's practice. The first updates can be seen on the home page, particularly in the section: What diseases has it been useful for and how effective is it?
As of August 2003:
Errors with LDN Rx's at Pharmacies. The FDA has found a significant error rate in compounded prescriptions for a wide number of drugs produced at randomly selected pharmacies. Dr. Bihari has reported patients with adverse effects from this problem.
Please see our report, Reliability Problem With Compounding Pharmacies, as well as a list of recommended pharmacies.
As of June 2003:
Lung Cancer. C., a 61 year old woman, previously a heavy smoker, was found to have a lesion in the right upper lobe of the lung in 1999 and a supraclavicular node in April 2001. Biopsy showed that the node was metastatic from the lung tumor. In August 2001 an MRI of the chest showed supraclavicular clusters of nodes and stellate-shaped lesions in the apex of the right upper lobe. She then started taking low dose naltrexone. She began getting quarterly C-T scans of the chest, which showed no change over the following 12 months. The C-T scan interval was changed to every 6 months. Her most recent C-T scan in the spring of 2003 continues to show no change from the August 2001 films.
Malignant Melanoma. L. is a 53 year old woman with metastatic malignant melanoma whom Dr. Bihari first saw in August 2000. Her primary skin lesion had been removed from the lower back in late 1976. A lump in the left groin was biopsy positive in December 1977. It appeared to respond to treatment with BCG in a clinical trial in January 1978. She was disease free for 20 years until a cancerous lesion appeared near the site of the original primary. It was removed surgically. She started a melanoma vaccine trial in April 1999 but developed two new skin lesions on the low back over the next six months. In February 2000 a bone scan showed a lesion in the left sixth thoracic rib, with growth evident on a repeat bone scan in April 2000, which also showed further lesions in the left sacrum and the L5 vertebra. She began taking low dose naltrexone in August 2000. She showed no growth of these three bone lesions and no appearance of new lesions over a thirty-three month period since that time. She has remained on naltrexone only.
Esophageal Cancer. Reverend X is a patient at Johns Hopkins Hospital where he received most of his medical care. He first developed problems with digestion and some pain in the mid-chest area with swallowing in April 2002. An upper GI exam in May 2002 showed narrowing and irregularity of the lower esophagus. In June 2002, a C-T scan of the chest, abdomen and pelvis showed a 2cm thickening of the lower esophagus extending into the upper stomach. Also seen were five enlarged nodes in the chest and five in the abdomen. Rev X refused chemotherapy and began low dose naltrexone in August 2002. In the following months his difficulty in swallowing has significantly decreased and his weight has stabilized. He notes an improved sense of well being. He has had no therapy but low dose naltrexone.
As of May 2003:
Parkinson's Disease. As reported earlier on this page (June 2002 and September 2002), Dr. Bihari has two male patients with PD, both of whom are doing well on LDN. He notes that both patients have remained stable with no further progression in their disease over the past year. In addition, Bihari now reports a female patient who suffered from multiple autoimmune problems, including rheumatoid arthritis and severe fibromyalgia, who had been wheelchair-bound for the past 18 years. In addition to her other diseases, this patient had a Parkinson's problem, with rigidity and tremor, most noticeable in her arms and hands. Within two months of her recently starting LDN, all of her symptoms and signs—including all signs of her Parkinson's—subsided and she was able to walk with a cane for the first time in almost two decades.
Website Improvements.
- The LDN Website can now be reached through a shorter, simpler domain name: ldninfo.org. There are no plans to eliminate or change the original domain name—the new name is provided as an additional, more convenient synonym.
- A new page, Further Questions and Answers about LDN, has been added to the website, in order to help address a variety of questions often asked by readers—questions not addressed on the homepage or disease-specific pages.
As of March 2003:
New E-mail Group. The Low Dose Naltrexone (LDN) group is an announcement and discussion group for those interested in LDN, and who wish to be notified about updates to the Low Dose Naltrexone website (www.lowdosenaltrexone.org). We expect that official announcements to the group will be fairly infrequent, typically not more than one per month. Group members not wishing to receive general discussion e-mail from other members may set their message delivery option to "Special Notices" when joining, or by logging on to the LDN Yahoo Group site and clicking on "Edit My Membership."
Fibromyalgia. Dr. Bihari reports that he has treated 24 people with fibromyalgia, 22 of whom responded dramatically to low dose naltrexone treatment (4.5mg nightly). Within a few days those 22 patients experienced a decrease of some 80% to 95% in their muscle pains. This improvement has been sustained with continuing use of the LDN. The two exceptions were notable in that they had both been on narcotic pain medications for years prior to weaning off of the narcotics in order to switch to LDN treatment. Their responses were only fair at best.
Chronic Fatigue Syndrome. In contrast to fibromyalgia, the results of LDN treatment in chronic fatigue syndrome are slower and not as dramatic. In some 40 such patients, Dr. Bihari has generally seen a gradual decrease of about 50% in complaints of fatigue—a very few cases experienced an 80% to 90% decrease. Dr. Bihari has found that the best approach is to carefully investigate these patients for chronic infections: specific searches are made for chlamydia, mycoplasma, Epstein-Barr virus, and herpes virus 6. When patients are able to be treated specifically for an active infection, along with the LDN Rx, the responses are better.
Pemphigoid. In the Latest News for September 2002, we reported Dr. Bihari's treatment of an 82 year old woman who, over a period of three months, developed blisters on her ankles, the soles of her feet, her arms and her neck, which on biopsy proved diagnostic of pemphigoid. Blisters also involved her trunk as well. This patient has now finally been weaned off all of her prednisone treatment. She remains completely free of all pemphigoid blisters on LDN only.
MS. The following e-mail was received by the website editor (personal identifiers have been changed): "Here is my update on using LDN. I started at the beginning of August, 2002. Prior to that time I used a wheelchair if I needed to walk more than 30 feet at a time. I could not drive for more than 10-15 minutes. Since LDN, I am now not using a wheelchair unless I need to walk for more than a half hour straight. I can drive for 2-3 hours at a time! My fatigue has greatly improved, but not completely eradicated. I will never stop using LDN! Thanks, L."
As of October 2002:
Possible Clinical Trials. Dr. Bihari reports that he is in discussions with both a medical center and a pharmaceutical firm concerning the possibility of two separate clinical trials to be run on LDN.
ALS. In the September 2002 Latest News (see below), we described several people with amyotrophic lateral sclerosis who were reporting measurable improvement in their ability to breathe in the months following their beginning LDN treatment. Since then, the first patient, who had been taking only 3mg of LDN nightly, notified us that both his forced vital capacity (FVC) and that of the second patient, who had been using the optimal adult 4.5mg dose, had reverted to their usual baseline capacities, but that their FVC's appeared to be remaining stable without further deterioration for many months.
As of September 2002:
ALS. In the spring of 2002, several people with amyotrophic lateral sclerosis, after reading the material about multiple sclerosis on this website, asked their neurologists to prescribe LDN for their ALS. Two patients with advanced disease showed significant improvement in their forced vital capacity. One had a 25% improvement within two months of beginning LDN and another an 11% improvement A third patient who also has advanced ALS and an impaired FVC has had significant subjective improvement in his ability to breathe and a reduction in his resting pulse from 96 to the low 80's. Given the absence of other effective treatments, the use of LDN appears to have begun spreading through the ALS community, at least to those who are in touch with the Internet.
Parkinson's Disease. In the June 2002 Latest News (Autoimmune Disease) we described a 48-year-old man with PD who had stopped LDN "because he was seeing no improvement in his condition..." In the following three months, the disease showed its first progression in nearly two years with increased tremor and rigidity in the involved arm. He resumed LDN and over the following two months experienced reversal of the progression that had occurred off of the drug. He was also able to reduce his dopamine-analogue medication by two-thirds, relieving the depression that it was producing.
Crohn's Disease. Dr. Bihari is now following eight patients with Crohn's Disease on LDN. In all eight cases, within 14-21 days the signs and symptoms of disease activity stopped. All eight have remained stable since anywhere from 2 months to 36 months.
Pemphigoid. Dr. Bihari has had the opportunity to treat one patient with pemphigoid. She is an 82 year old woman who, over a period of three months, developed blisters on her ankles, the soles of her feet, her arms and her neck, which on biopsy proved diagnostic of pemphigoid. She was referred to a dermatologist specializing in this disease who treated her with prednisone at 40 mg/day, which slowed disease progression but did not clear her blisters. When LDN was added, her blisters cleared and slowly healed over a 6-week period during which time she slowly tapered her prednisone. On her last visit, she was on both LDN and prednisone 5mg every other day with no exacerbation.
Rheumatoid Arthritis. Ten patients with this disease have been treated with LDN in recent years. In all ten patients, the joint pain and swelling cleared, in some, leaving residual joint distortion. Two of the patients stopped LDN for several weeks because of travel. Both had an immediate exacerbation. One patient who was responding well on LDN had a mild exacerbation during a period of severe marital stress.
Lipodystrophy. Two patients with this condition, caused by standard antiviral therapy for HIV infection, have had LDN added to their regimens in the past five months. One, who had mild enlargement in the neck and an increase in waist size of ten inches due to intraabdominal fat deposits, has had a reduction in waist size of three inches in the first three months of LDN and a lowering of a moderately high serum LDL-cholesterol level. The other patient, a woman, was reported in the June 2002 note (HIV/AIDS). Although the mechanism of LDN in combating lipodystrophy is unclear, it is likely to be due to its relative restoration of the normal balance between serum endorphins and serum cortisol. Usually, endorphins are quite low and cortisol moderately high in people with HIV. Lipodystrophy closely resembles the clinical picture seen in Cushing's disease, which is due to benign tumors of the adrenal cortex producing excessive quantities of cortisol. Thus, Cushing's is characterized by an imbalance between low or normal levels of endorphins and high cortisol. There are probably similar mechanisms underlying the bodily changes that are seen in both disorders.
Additional Cancer Cases. Dr. Bihari now has 32 patients with cancer in complete or partial remission whose improvement appears to be clearly attributable to LDN alone. In contrast, the vast majority of patients who consult with him for cancer tend to be on other concurrent treatments as well, which obviously interferes with drawing conclusions about LDN's role in their improvement. The successful LDN-only group includes two new breast cancer patients, one patient who had widespread metastatic renal cell carcinoma, one with Hodgkin's disease and two with non-Hodgkin's lymphoma. Other cases have included patients with non-small cell lung cancer, ovarian cancer, uterine cancer, pancreatic cancer when treated early, prostate cancer, colon cancer, malignant melanoma, throat cancer, liver cancer, chronic lymphocytic leukemia, multiple myeloma and several others.
The response rate still seems to be better the earlier the cancer is treated with LDN. Of patients who do respond, approximately 50% show an arrest of disease progression. Half of that group goes on to show shrinkage or reduction in tumor mass and, in many cases, eventual remission. Bihari has a small but increasing number of patients whose cancer growth has stopped, but who, 12 to 20 months later, have the same number and size of lesions they had when starting LDN. Within Bihari's entire practice, about 40% of patients with various kinds of cancer do not appear to noticeably respond to LDN, and some 10% have been lost to follow-up.
Of interest, there is a negligible rate of relapse in patients who are started on LDN after or during successful initial treatment with surgery (e.g., for breast cancer) or with chemotherapy (e.g., for Hodgkin's disease or non-Hodgkin's lymphoma). An oncologist and an oncology physician's assistant from the National Cancer Institute recently reviewed about 30 charts of cancer patients at Dr. Bihari's office. About half were chosen as appearing to have responded to LDN without question. With patients' permission, copies of these have been sent to the NCI for further data collection on their part for consideration for their Best Case Series.
As of June 2002:
HIV/AIDS. In early May, Dr. Bihari began treating a woman who not only had diabetes, which required a moderately high dosage of insulin (90 units daily), but who also was suffering from lipodystrophy as a complication of her AIDS therapy. At that time, Bihari noted that he expected the LDN would combat her lipodystrophy (which includes insulin resistance) and therefore would probably decrease her insulin needs. Three weeks later, he saw her again for the first time since LDN had been started. Her insulin requirements had dropped from 90 units/day to 20 units/day during those three weeks, and her "buffalo hump" (a swelling at the upper back/lower neck area characteristic of lipodystrophy) had regressed by two-thirds. Her swollen abdomen had begun to recede, enabling her, she said, to cross her legs "for the first time in a year".
Autoimmune Disease. Two people with Parkinson's Disease (PD)—the first patients with that disorder known to have been treated with LDN—have had interesting results after more than one year of medication. The first patient, a man in his mid-60's from New Jersey, had his first annual revisit to Dr. Bihari for a check-up in April 2002. His wife reported that, in contrast to all the other members of his PD monthly group meeting, he seemed to have shown no deterioration in his functional abilities throughout the past year. On a thorough neurological examination, Dr. Bihari found improvement in some signs of his Parkinson's Disease. Among these was now the absence of the glabellar sign, a primitive reflex which is consistently found in those with PD and which the patient had demonstrated the year before on his initial examination.
The second patient with PD is a 48-year-old male who began LDN one and one-half years ago. Because he was seeing no improvement in his condition (although he wasn't getting any worse), he discontinued LDN in early March 2002. He called Bihari in mid-May because he was now beginning to see, for the first time in over a year, worsening of his PD symptoms. He realized that the LDN must have been acting to interfere with the expected progression of his disease.
[Ed. Note: Given the repeated demonstration of LDN's efficacy in halting progression in all cases of MS, and the possibility of its having a therapeutic
effect in PD, it now may be timely to consider LDN in treating the full spectrum of neurodegenerative diseases whose etiology is unknown—all of which may well have a significant underpinning of immunodeficiency/autoimmunity causing the neurological syndromes. Alzheimer's disease and amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) are two prominent possibilities that spring to mind.]
Cancer. About 15 months ago, a 41-year-old man from Toronto with renal cell carcinoma, with metastatic lesions in his liver and lungs, contacted Dr. Bihari. His oncologists told him there was no effective therapy available, and he said he was anxious to try treatment with LDN. There was no further contact with the patient until three months ago when his wife called to thank Dr. Bihari. She said that he was doing quite well and that there had been complete clearing of the metastatic lesions as demonstrated by chest and abdominal CT scans.
One year ago, Dr. Bihari prescribed LDN for a 54-year-old man who had cancer of the tonsillar area in his throat along with two large metastatic lesions easily visible in his neck. He had refused the extensive head and neck surgery proposed by his physicians. They held out little hope for him. His most recent contact with Dr. Bihari was in May when he was examined. The primary tumor has decreased by one-third in size and the two neck masses have regressed by about 50%. The patient had received no radiation or chemotherapy but had tried unproven alternative treatments obtained in Mexico.
As of February 2002:
NCI Meeting Postponed. Dr. Bihari informs us that the meeting he had expected to attend this month at the National Cancer Institute (NCI) has been postponed because of NCI dissatisfaction with the auditing company they had hired to look at patient charts and collect patient data. Once NCI has arranged for an alternative auditing process, Dr. Bihari expects the meeting to be rescheduled, perhaps by late summer, 2002.
As of January 2002:
Website Update. New additions to this website include:
- Excerpts from patient interviews (LDN and HIV and The Developing Nations Project)
- Noteworthy HIV cases (LDN and HIV)
- Links to abstracts of papers referenced (LDN and Cancer and LDN and HIV)
Wegener's Granulomatosis. D. is a 62-year-old male. In February 2000, after 3 years of recurrent upper respiratory symptoms and cough, and more recent difficulty with vision, he was admitted to a Boston medical center because of suspected vasculitis. He had lost energy and could not walk more than ten to fifteen steps without having to rest. The autoimmune disease Wegener's granulomatosis was considered probable, due to an elevated sedimentation rate (80) and a positive Anti-Neutrophil Cytoplasmic Antibody [ANCA] level of 65. In May 2000, nasal tissue removed at surgery showed "necrotizing vasculitis highly suggestive of Wegener's granulomatosis." He was treated with corticosteroids for nine months, until January 2001. The ANCA test was 1.9 in July 2000, 12 in January 2001 and back up to 40 in May 2001.
D. started using low dose naltrexone (4.5mg) nightly in mid-May 2001. After several weeks he noticed a decrease in congestion and a noticeable increase in overall energy. Subsequent tests of ANCA were 16 in August 2001 and a recent test of ANCA in late December 2001 was 1.0. The patient reports a high energy level equal to that of several years back, and is enjoying a noticeable improvement in overall health.
As of December 2001:
NCI Presentation Scheduled for February 25, 2002. In the Spring of 2001, the National Cancer Institute (NCI) commissioned the RAND Corporation to examine the evidence for LDN's effectiveness in treating cancer. Three RAND investigators visited Dr. Bihari's office July 11-13. They reviewed the anonymous charts of 18 patients with cancer being treated with LDN, gathering data for an analytic presentation to the NCI. The date for that presentation has now been set for February 25, 2002.
As of August 2001:
HIV/AIDS in the Developing World. A "developing-nations project" has been initiated with the cooperation of Doctor Bihari. This aims to acquaint all of the developing nations about the potential of LDN in dealing with the AIDS pandemic.
Because people infected with HIV, whose immune system has not deteriorated below some 300 CD4+ cells, have been shown in Dr. Bihari's practice to be successfully treated with LDN alone; and because LDN is simple to take, has no side effects, and would be extremely inexpensive to manufacture in developing countries, it could well be the ideal solution for the millions of people in those countries who are already carrying the virus.
Over 25 nations around the world have just been contacted, most through their U.N. missions here in the US. Thus far, meetings have been held with representatives of missions from several countries. We are also in the process of contacting the World Health Organization, the World Bank, and other international organizations in order to help provide financial support for the nations involved in this project. For further information, please see the linked page: The Developing Nations Project
Malignant Melanoma. Dr.Bihari relates the case of a patient who lives in Australia. This man had biopsy-proven malignant melanoma diagnosed three-years ago in a 5mm-deep lesion that was removed from the skin over his left shoulder blade. One year later he developed large masses in his left armpit. These were surgically removed and proved a recurrence. He refused to accept any recommended chemotherapy and contacted Bihari in January of 2000, at which time he began LDN 3mg nightly. He called this month to say he continues to feel fine and he remains in complete remission.
As of July 2001:
During the week of July 9th, three medical professionals from the Rand Corporation, under contract with the National Cancer Institute, spent several days at Doctor Bihari's office. They reviewed the anonymous charts of 18 patients with cancer being treated with LDN. This is in preparation for a presentation at the NCI planned for November. Once the Rand professionals receive informed consent from the patients involved, they will start collecting copies of these patients' MRI's, CT scans, lab work, original biopsy slides, etc. for the purposes of the November presentation.
As of May 2001:
Dr. Bihari has now been contacted by the Rand Corporation, which is under contract with the National Cancer Institute. It is Rand's intention to come to Bihari's office in the near future and to spend the weeks necessary in order to help locate and collect the many old pathology specimens and past radiology studies on selected patients. These are the patients with cancer who have benefited from LDN and who have agreed to have their stories presented to the NCI by Dr.Bihari. Items needed include all original pathology slides as well as the actual MRI's, CT scans, X-rays, and other necessary evidence which now reside at a variety of far-flung hospitals and physicians' offices.
As of April 2001:
Doctor Bihari reports that despite continued LDN therapy, two of the patients with ovarian cancer have shown a rise in their CA-125 tumor markers. One of these patients has shown some increase in tumor bulk.
As of February 2001:
Please Contact Us. Doctor Bihari indicates that in 10 to 12 weeks he should be in Bethesda to present a detailed report on a number of his patients with cancer to the National Cancer Institute. All of these patients have experienced significant regressions and/or remissions of their disease coincident with low-dose naltrexone therapy. He makes a request of any visitors to this website who are aware of people with cancer who have benefited similarly from the use of LDN: Please send an e-mail — click here — with the name and telephone number of that person (or, if more appropriate, your phone number as a contact). Dr. Bihari will call the individual (or yourself ) to see if documentation can be made available for the National Cancer Institute. By so doing, you may hasten the day when LDN can be properly tested in large clinical trials.
Lymphoma. Letters are being sent from Dr. Bihari's office to all of his many patients with HIV/AIDS as well as to any of his patients with lymphoma, multiple myeloma, Hodgkin's disease, or lymphocytic leukemia. Dr. Bihari is informing them that recently published research has confirmed the experience in his own large practice - patients who regularly take the antiviral drug acyclovir have a strikingly diminished risk of developing lymphoma. He says: "Statistically, I should have seen at least 20 cases of non-Hodgkin's lymphoma [and 5 cases of Hodgkin's disease] in HIV patients in the last six years. The absence of any in my sizable population that is taking high-dose acyclovir supports the conclusion." The letter encourages them to call his office to discuss adding acyclovir to their regimens if it is not already utilized.
Hypericin and LDN for Hepatitis C. In a study of St. John's Wort in 15 patients with HIV in 1990, Dr. Bihari had accidentally discovered a significant benefit to liver function in two patients with hepatitis B (whereas there was no improvement in HIV markers). Bihari then began to use St. John's Wort in his private practice to treat hepatitis B and hepatitis C - patients with the former responded well, the latter not at all. Since 1995, Dr. Bihari has been able to use a very highly concentrated form of hypericin, the active ingredient found in St. John's Wort, called HY2 (manufactured by Pacific Biologic in Clayton, CA; 800-869-8783) in the treatment of people with hepatitis C. It is given along with LDN, to enhance the immune response, and in many cases with ribavirin, an antiviral. Over 60 patients have been successfully treated for hepatitis C in Dr. Bihari's practice.
As of January 2001:
One of Dr.Bihari's patients with AIDS, who lives in France, discontinued LDN in 1998 after using it for two years, just after starting an antiviral medication "cocktail". He developed early signs of lipodystrophy about six months thereafter. Although he restarted LDN 3mg in May 1999, a year later he still had a buffalo hump (though other signs of lipodystrophy had slowly cleared). In January 2001, he wrote that since he had started taking LDN in a 4.5 mg dosage beginning in October 2000 "the buffalo-hump rather rapidly dissappears. I want to inform Dr Bihari of this success." Also, further developments concerning the Parisian woman (described below in "As of December 2000") with a recurrence of metastatic malignant melanoma. Dr.Bihari reports receiving a phone call from her family. They indicated that after she had restarted the LDN and had been on it for some two months, a repeat CT scan of her chest shows the lungs are now clear — and the subcutaneous nodules on her back, which had been biopsy positive for melanoma, are no longer present.
As of December 2000:
1) Please note the following updated information regarding dosage and frequency when taking LDN:
The usual adult dosage is 3mg taken once daily at night. Because of the rhythms of the body's production of master hormones, LDN is best taken between 9pm and 3am.
A small percentage of patients who do not appear to respond to 3mg do respond when the dose is increased to 4.5mg. (If the increased dose is sustained over time, pharmacies may be able to make the capsule in a 4.5mg dosage. Alternatively, the naltrexone may be dissolved in distilled water with 1mg per ml dispensed with a 5ml medicine dropper. If LDN is used in a liquid form, it is important to keep it refrigerated.)
The therapeutic dosage range for LDN is from 1.75mg to 4.5mg every night at bedtime. Dosages below this range are likely to have no effect at all, and dosages above this range are likely to block endorphins for too long a period of time and interfere with its effectiveness.
2) Dr.Bihari reports the extraordinary case of a Parisian woman, the mother of a friend, whom he met in France in 1986. She had been diagnosed with metastatic malignant melanoma. At that time she was 44-years-old, she had four large metastases to the brain, and she had been told she had three to six months to live. Doctor Bihari shipped LDN to her from the US and she took it nightly. Nine months later, the family reported that the lesions were no longer present and she was fine.
She stayed on LDN, and Dr.Bihari received a Christmas card of thanks each year. A year ago, she discontinued LDN. She said that she decided to do it because so many years had passed and "every time I took it, I thought about my cancer."
Five to six months ago she developed a persistent cough and several small nodules on her back. A chest x-ray revealed many small nodules in the upper lobe of both lungs. A biopsy of one of the masses on her back was diagnosed as malignant melanoma, the same pathology as 14 years before. Her son-in-law called Dr.Bihari, and LDN was once again shipped over to her. Her current physicians are now utilizing chemotherapy.
As of November 2000:
Dr. Bihari reports on a patient in his late 50s who first visited in June 2000. He is a chronic cigarette smoker who, in May, was told he had metastatic non-small cell lung cancer. Many abnormal opaque areas had been seen on his chest x-ray, and a biopsy performed on a sizable mass in his right neck had confirmed the diagnosis. He had refused chemotherapy. On examination, he had a 3 x 4 x 2cm mass in his right neck. He was started on LDN in mid-June and visited Dr.Bihari again, for the first time since then, at the beginning of November. The patient reported that energy was better and his appetite was good. He had regained 15 pounds, and had returned to working full time. The volume of the neck mass appeared to have decreased by 50%. An MRI exam was scheduled for mid-month.
In addition, Dr. Bihari has related further features of the response of the first three patients with ovarian cancer who have entered his practice this year (two of whom were initially reported in the As of October 2000 note, below). His impression is that each of the patients has experienced surprisingly rapid, major response to LDN therapy:
Pt. #1 - This 51-year-old womans first visit occurred in January 2000. LDN was started in February. She has had no chemotherapy since that time.
She was diagnosed with ovarian carcinoma 6 years ago, and had had multiple surgical debulking procedures and multiple courses of chemotherapy over the intervening years. There was a large, hard mass in her left pelvic area, and, by late spring of this year, her surgeon suggested that surgery should be planned for its removal. By early summer, the patient was feeling somewhat better and requested that she have a repeat CT scan. Her surgeon reported that the mass was no longer readily felt. A repeat CT scan in mid-summer no longer demonstrated the earlier mass; peri-aortic and other involved nodes had apparently cleared; and a fluid level was seen where the mass had been. In September, the surgeon drained some of the fluid; the pathology examination found no cancer cells in the fluid. Apparently, the hard mass had evolved into a clear fluid-filled cyst.
Pt. #2 - This 39-year-old patient had a four-year history of therapy for ovarian carcinoma. She had had the usual initial pelvic surgery, followed by repeated courses of chemotherapy and 3 debulking procedures. By the time she first visited Dr. Bihari in August 2000, she was doing very poorly. She had recently dropped 15 pounds, was weak, and had had to discontinue her usual regimen of very vigorous athletics. There was an easily felt, hard mass in her left mid-abdomen over the lower descending large bowel area.
She began LDN in late August, and continued on a recently prescribed low-dose Taxol regimen that her gynecologic oncologist had prescribed. Within one week, she reported that her appetite and energy had markedly improved. Ten weeks after starting LDN, a new MRI showed that the mass was 70%-80% gone, pelvic fluid was gone, a tumor behind the gall bladder was gone, and various peri-aortic and sacral lymph nodes were no longer seen. Her CA 125 tumor marker had dropped from an initial level of 1220 to 82. The patient feels great and is back to her two hours of active athletics daily.
Pt. #3 This patient, a 49-year-old woman, is a friend of patient #2. She has a five-year history of ovarian carcinoma, with a persistently growing tumor despite repeated courses of chemotherapy and multiple debulking surgery. There was recent increased involvement of the descending colon with the disappearance of formed stools, and she was now experiencing vomiting. Hospitalization was under consideration. She had lost 15 pounds in the two weeks prior to her first visit to Dr. Bihari in early September.
She was started on LDN at that time, in addition to her existing low-dose Taxol therapy, and within ten days the signs of large bowel obstruction had disappeared. In four weeks, a repeat CA 125 revealed that this tumor marker had dropped from 1600 to 87. Within the first week of November, it was reported down to 42, and her gynecologic oncologist told her that, on abdominal-pelvic examination, he found no masses. She has regained some 25 pounds and feels wonderful. A repeat MRI is about to be performed.
As of October 2000:
Bernard Bihari, MD reports unexpectedly rapid improvement in two patients with ovarian cancer who have recently entered his practice. The first, while continuing on a low dose of Taxol, began taking LDN four months ago. Since then, her serum tumor marker (CA125) dropped from a level of 1220 to 82 within two months time; her MRI no longer shows tumor present; she has regained 15 pounds; and her energy level has rebounded so considerably that she has returned to playing vigorous athletics such as tennis and squash. The second patient had been experiencing the complication of a substantial blockage of her large bowel. Once on LDN, this cleared within several weeks; her CA125 dropped as substantially as the first patients; and she also has been able to return to work.
Also, Dr.Bihari tells us of a patient with breast cancer, diagnosed and treated elsewhere two years ago, whose course was recently complicated by a recurrence involving metastasis to the hip. Outpatient hospice services were being sought. Her walking was so badly impaired that she had to be assisted by her friends on her first office visit in June — at which time she began LDN. She revisited the office in mid-October and reported that she not only has been able to return to work but also is well enough to play tennis again.
As of August 2000:
1) Doctor Bihari has described the courses of several of his patients who have
cancer and who have apparently had significant regressions of their tumors while
taking LDN. Altogether, these patients' diagnoses include seven different types
of cancer, and in most instances they were either not using chemotherapy or
were no longer responsive to it.
The patient profiles are published in the linked page LDN and Cancer.
2) Reports have been received from patients being treated by other practitioners
that their pharmacies have been supplying a slow release form of naltrexone.
Pharmacies should be instructed not to provide LDN in an "SR"
or slow release or timed release form. Unless the low dose of naltrexone
is in an unaltered form, which permits it to reach a prompt "spike"
in the system, its therapeutic effects may be inhibited.
See also How can
I obtain LDN and what will it cost?
As of June 2000:
An important research paper by Sharp et al, published in Biochemical Pharmacology
in 1998, has just come to our attention. They demonstrated that activation of
delta-opioid receptors significantly inhibits HIV expression in acutely infected
CD4+ T cells. [Ed. note: activation of these receptors is one of the key effects
of the very endorphins that are stimulated by taking LDN.] This basic research
provides strong evidence to explain at least some of the beneficial effects
of LDN in HIV/AIDS.
See the linked page LDN and HIV/AIDS.
As of May 2000:
Bernard Bihari, MD reports four recent occurrences of surprisingly rapid clinical improvement in people with multiple sclerosis, presumably related to LDN use. Three were female patients for whom Dr. Bihari had prescribed nightly LDN.
See the linked page LDN and Multiple Sclerosis for patient profiles.
As of March 2000:
Bernard Bihari, MD tells us that, over the past 13 months (i.e., since February
1999), he has started 120 patients with various cancers on LDN. Of these, 26
have been taking LDN for more than 6 months. In the group of 26, 14 have shown
substantial reductions in tumor mass and/or tumor-related symptoms. Notably,
7 of those 14 patients, for individual reasons, have never received chemotherapy
and have been treated medically only with LDN.