Paratuberculosis and Crohn's Disease: Got Milk?
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Paratuberculosis and Crohn's Disease: Got Milk?
An Attempt at a Cure
The first trial took place in London, published 1997. Researchers chose to use rifabutin and clarithromycin because they seem to complement or synergize with each other. The treatment was named RMAT, Rifabutin and Macrolide Antibiotic Therapy.
Fifty-two patients with Crohn's disease, most of whom had persistent severe symptoms resistant to conventional treatment, were studied. Six patients had to be excluded, due mostly to intolerance to the antibiotics,60 though in general the RMAT medications tend to have a much higher tolerance rate and far fewer side effects than the current immunosuppressive drugs used for Crohn's. The remaining 46 patients were treated with RMAT for about a year. Of the 46 patients who were able to tolerate RMAT, 43 went into clinical remission, for a remission rate of 94%.
A two-year follow-up was performed. The majority of patients in whom a clinical remission was initially induced remained symptom free off of all their previous medications. Similar trials in other centers have reproduced these findings.[9,10,16,44,167] The fact that some patients relapsed after treatment was stopped may point to the difficulty in eradicating the organism or perhaps that they had been re-infected. Hermon-Taylor, one of the principal investigators of the original trial, is currently recommending patients take RMAT regimen for at least 2 years. Among patients who respond to treatment, remission occurs slowly over the first three to six months of treatment. Symptoms often get worse before they get better, as in the drug treatment of other chronic mycobacterial diseases such as leprosy, perhaps due to the release of MAP antigens. 
Based on this pilot study, RMAT has the highest reported remission rate of any known treatment for Crohn's disease and the lowest reported relapse rate, including all current immunosuppressive treatments. Thought to be an incurable disease, doctors seem to have been able to induce profound long-term remissions in the majority (68.7%) of patients with Crohn's disease. Not only do patients stop having symptoms, but their intestines actually show evidence of healing, an unprecedented achievement.164 "If this were cancer," said one RMAT researcher, "we would be calling these long remissions a cure." Hermon-Taylor told the press "I've seen people who were without hope get better like magic. I've been a doctor for nearly 40 years, and it's the best thing I've ever seen in clinical medicine."
Though the preliminary results of this and other pilot studies are encouraging, Hermon-Taylor is the first to point out the limitations of the study -- it was too small and there were no controls. "We were actually denied the funding to do a randomized control trial," he said. "So I did the best that I could with what I've got." To date, according to the Cleveland Free Times article that won 1999's Project Censored Award, twenty-five of Hermon-Taylor's grant proposals submitted both here and abroad were rejected.
Chiodini estimates he's similarly submitted over two dozen grant proposals to the National Institutes of Health, the USDA, and the Crohn's and Colitis Foundation of America, but to no avail. Drug trials run in the United States have traditionally been supported by the pharmaceutical industry, but just as H. pylori threatened to deprive some of the largest corporations in the world of billions of dollars (anti-ulcer medications were the world's best-selling prescription drugs), the drug industry scores huge profits from increasingly complex and expensive maintenance Crohn's treatments, which must be administered for the rest of the patient's life.107 Needless to say, financial support from the corporate sector has not been forthcoming.
Nevertheless, these preliminary results must be reproduced to be seriously considered. Larger scale controlled studies are currently in progress to obtain better data. The most promising is a phase III clinical trial of RMAT in Australia which has been designed as a double-blind, multi-center, controlled clinical trial involving over 200 patients with Crohn's in at least seven major cities across the continent. Unfortunately, they seem to be having a problem securing patients for the study. A controlled RMAT trial has also reportedly been initiated by the National Institutes of Health.[39 ]
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