In a phase 2 clinical trial, researchers at Penn State University showed that LDN is a safe and effective treatment for patients with Crohn's disease.
The phase 2 clinical trial of low dose naltrexone (LDN) for the inflammatory bowel disorder Crohn’s disease conducted by Jill Smith, a Professor of Gastroenterology, and her colleagues at the College of Medicine and the Penn State Milton S. Hershey Medical Center at Pennsylvania State University confirmed results of the earlier pilot study. Results of the phase 2 trial showed that LDN therapy is safe and effective in subjects with active Crohn’s disease, an autoimmune disorder affecting as many as 500,000 Americans. Results were published in the American Journal of Gastroenterology.
Low Dose Naltrexone (LDN)
Very low doses of the opiod receptor antagonist naltrexone are reported to have powerful immune system effects that play a role in healing and repair of tissues. In addition, by blocking the opiod mu receptor, naltrexone restores the normal mu/delta opiod receptor balance needed for immune system health. Results of anecdotal studies and ongoing trials conducted worldwide over the last decade suggest that LDN offers benefits for patients with multiple sclerosis, rheumatoid arthritis, Parkinson’s and other neurodegenerative disorders, HIV infection, various autoimmune disorders, and certain types of cancer.
Crohn’s Disease Phase 2 Trial
In the Penn State study, eligible subjects with histologically and endoscopically confirmed active Crohn’s disease activity index (CDAI) score of 220-450 were enrolled in the study. All patients who had been on infliximab (Remicade) stopped using this medication at least 8 weeks prior to the start of the LDN trial. Patients who had been on other medications, using stable doses for at least 4 weeks prior to the trial, were allowed to continue on these medications during the course of the LDN study. All patients enrolled in the trial were treated with 4.5mg of naltrexone daily, given at bedtime, for a period of 12 weeks and were followed by researchers for a total of 16 weeks.
Study participants completed the inflammatory bowel disease questionnaire (IBDQ) and the short-from (SF-36) Quality of Life surveys during the trial. In addition, the CDAI score was re-evaluated every 4 weeks.
Trial Results
Trial results of the 17 patients involved in the study:
- 67 percent of patients achieved remission
- 89 percent of patients experienced an improvement in their symptoms
- Sleep disturbance was the only side effect reported by patients (reported in 7 patients)
- CDAI scores decreased significantly and remained lower than baseline 4 weeks after the completion of the trial
- Improvement was recorded in both Quality of Life surveys compared to the baseline scores
Conclusion
The conclusion of the study indicated that LDN is safe and effective for patients with Crohn’s disease, and further studies on LDN for patients with Crohn's disease are warranted.
Related Study
In a related study, Smith and other Penn State College of Medicine researchers are studying the chemical and molecular mechanisms involved in suppression of the inflammatory responses in the intestines of animals treated with naltrexone.
Resources:
Smith JP, Stock H, Bingaman S, Mauger D, Rogosnitzky M, and Zagon I, Low-dose naltrexone therapy improves active Crohn’s disease, American Journal Gastroenterology, April 2007; 102(4): 820-828
LDN: The Latest News, June 2007, LowdoseNaltrexone.org, accessed June 4, 2007.
