| Scleroderma Clinical Trials (MAIN MENU) | | | |
| Scleroderma Clinical Trials: Completed, Negative Results | | | |
| Negative Results: Minocycline, Antibiotic |
| Warning: Minocycline (doxicycline) treatment has been proven to be ineffective for the treatment of systemic scleroderma by reliable scientific study. See Disclaimer. |
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| Research Update |
| Minocycline is not effective in systemic sclerosis: results of an open-label multicenter trial. The degree of change in the MRSS (modified Rodnan skin thickness score) was similar to that expected in the natural course of this disease. Based on these data, minocycline is not an effective therapy for SSc. PubMed. Arthritis Rheum. 2004 Feb;50(2):553-7. |
| For current treatments and clinical trials for systemic sclerosis (SSc, or scleroderma), please consult a scleroderma expert or see: |
| Scleroderma Treatments and Clinical Trials |
| Scleroderma Symptoms and Treatments (Look up individual symptom pages) |
| Scleroderma Newsroom |
| Why minocycline can cause systemic lupus - a hypothesis and suggestions for therapeutic interventions based on it. The tetracycline antibiotic minocycline is widely used in dermatology, but can sometimes cause systemic lupus erythematosus, a serious autoimmune disorder. PubMed. Med Hypotheses. 2004;63(1):31-4. (Also see: Lupus) |
| Minocycline-induced cutaneous polyarteritis nodosa. Although minocycline is an effective medication with a wide variety of clinical uses, clinicians must be aware of its potential side effects including autoimmune-related disorders such as polyarteritis nodosa or systemic lupus erythematosus. (PubMed) J Clin Rheumatol. 2007 Jun;13(3):146-9. |
| Minocycline-induced central nervous system-pulmonary hypersensitivity syndrome. Reported side-effects include hypersensitivity pneumonitis, drug-induced lupus, Antineutrophil Cytoplasmic Antibody (ANCA) ANCA-positive vasculitis, and other autoimmune syndromes. We report the second case of severe central nervous system-pulmonary syndrome in a patient taking minocycline, which required high-dose corticosteroid therapy. PubMed. Int J Dermatol 2003 Apr;42(4):316-7. |
| Introduction |
| On 5/10/98, Dr. David Trentham announced the results of a Minocycline study in the treatment of diffuse Scleroderma, in Boston, Massachusetts at the International Society for Rheumatic Studies. Simultaneously, a book about it was released by Henry Scammell. |
| Dr. David Trentham |
| Dr. Trentham is chief rheumatologist at Beth Israel hospital in Boston. The Minocycline Study was sponsored by the Road Back Foundation and the NIH (National Institute of Health). |
| Research Published in Lancet |
| This study was published in "Lancet", Vol. 352, Issue 9142, on November 28, 1998. |
| Study Recap |
| From my reading of the book Scleroderma: The Proven Therapy That Can Save Your Life by Henry Scammell, it seems that 11 people were enrolled in the study, which used (oral) Minocycline for patients with early diffuse Scleroderma. Progress was tracked only by skin scores. Five people dropped out of the study (two died of an unrelated cancer, two had Scleroderma kidney, and two people failed protocol. Of the six who finished the study, all showed improvement in skin scores and four were considered "cured." |
| Study Limitations |
| It was a very small sample of patients, and there was nearly a 50% failure rate in completing he study, which is very high, and two people (20%) died of Scleroderma renal failure within the first few months who had no evidence of renal disease beforehand. |
| This was not a double-blind test. Both the patients and the doctor knew what medication was being used. No measurements were taken of internal organ involvement. The skin scores it was based on are a purely subjective measurement. The natural course of Scleroderma is for the skin to initially harden, and then begin softening. |
| Many treatments have initially seemed promising for Scleroderma which in larger studies were proven to be of no benefit. The most recent example of this is Penicillamine (Depen), which was widely used for the treatment of Scleroderma in the U.S. until a large, double-blind study proved it to be of no benefit. |
| Hotline: Minocycline Treatment for Scleroderma. The study was sponsored in part by The Road Back Foundation and NIH. The results of this small open label study must be interpreted with extreme caution. These results do not represent a "cure" for scleroderma. American College of Rheumatology. May 14, 1998. |
