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Posted: Tue Feb 20, 2007 5:10 pm Post subject: new LDN study
Hello all,
I am a 4th year medical student who was diagnosed with MS about 5 years ago. I just came across this article which is about to be published in a high impact GI journal. In the interest of getting some legitimate MS/LDN trials going, it might not be a bad idea to get your hands on the article and give it to your neurologist. Does any of you see an MS specialist at an academic center?
Jill P. Smith M.D., Heather Stock M.D., Sandra Bingaman R.N., David Mauger Ph.D., Moshe Rogosnitzky, Ian S. Zagon Ph.D.
Low-Dose Naltrexone Therapy Improves Active Crohn's Disease
The American Journal of Gastroenterology (OnlineEarly Articles).
doi:10.1111/j.1572-0241.2007.01045.x
OBJECTIVES: Endogenous opioids and opioid antagonists have been shown to play a role in healing and repair of tissues. In an open-labeled pilot prospective trial, the safety and efficacy of low-dose naltrexone (LDN), an opioid antagonist, were tested in patients with active Crohn's disease.
METHODS: Eligible subjects with histologically and endoscopically confirmed active Crohn's disease activity index (CDAI) score of 220–450 were enrolled in a study using 4.5 mg naltrexone/day. Infliximab was not allowed for a minimum of 8 wk prior to study initiation. Other therapy for Crohn's disease that was at a stable dose for 4 wk prior to enrollment was continued at the same doses. Patients completed the inflammatory bowel disease questionnaire (IBDQ) and the short-form (SF-36) quality of life surveys and CDAI scores were assessed pretreatment, every 4 wk on therapy and 4 wk after completion of the study drug. Drug was administered by mouth each evening for a 12-wk period.
RESULTS: Seventeen patients with a mean CDAI score of 356 ± 27 were enrolled. CDAI scores decreased significantly (P = 0.01) with LDN, and remained lower than baseline 4 wk after completing therapy. Eighty-nine percent of patients exhibited a response to therapy and 67% achieved a remission (P < 0.001). Improvement was recorded in both quality of life surveys with LDN compared with baseline. No laboratory abnormalities were noted. The most common side effect was sleep disturbances, occurring in seven patients.
CONCLUSIONS: LDN therapy appears effective and safe in subjects with active Crohn's disease. Further studies are needed to explore the use of this compound.
doctorMS, I have some good news for you. SammyJo, who posts here, has been doing tons of work to get a trial going, and they have now got something going with UCSF. I think it is still in the planning stages, but is definitely happening.
(see here)
Also, there is a phase II study that just started in Italy,
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, 2006. 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.
Posted: Sun Jun 24, 2007 7:40 pm Post subject: Yes! We got the UCSF trial started
I have details about the patient funding efforts, and a link to the UCSF trial at LDNers.org
And now news that another tiral is starting at a hospital in Ohio, as well as the ongoing trial in Italy. So we have a start with MS research, and your doctor can now have more assurance that LDN is being recognized as a legitimate therapy.
I am now talking to Parkinson's neurologists about doing tracking trials of their patients who start LDN, and I want to help Dr McCandless with the funding for the Mali HIV trial.
Hi Sammyjo
Can you tell me what hospital in Ohio is doing research on LDN? Here in Naples, FL LDN is not known, but I am from Ohio and still keep in touch with things going on there.
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.
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