Seminal, year-long pilot trial at Harvard in 1998, with results that have ongoing relevance to treatment options today.
Minocycline in Early Diffuse Scleroderma The Lancet, Volume 352, No. 9142, p1755-1756, 28 November 1998
On November 28th, 1998, the Harvard scleroderma trial, Minocycline in Early Diffuse Scleroderma, was published in The Lancet, one of the world’s leading peer-reviewed medical journals. Its publication in this prestigious medical journal came six months after its presentation at the Sixth Biennial Congress of the International Society for Rheumatic Therapies on May 8th, 1998.
This non-blinded, small pilot trial of 11 scleroderma patients was conducted over the course of one year by Drs. David E. Trentham, Christine H. Le, and Alejandro Morales. Patients of less than three years disease duration, with no serious internal organ involvement, were selected to participate. All patients were administered minocycline at a starting dose of 50mg twice daily for the first month. The dose was then increased 100mg minocycline twice daily for the remainder of the study. In evaluations that were carried out at three-monthly intervals, this dose was found to be well tolerated.
Of the 11 trial participants, 9 improved substantially, and 6 completed the yearlong study. Of these 6 completers, 4 were found to have full resolution of their skin disease and 3 were found to be free of all disease activity in the final physician and patient assessments.
Although this preliminary trial was small, its results were unmatched in terms of symptom reversal and provided a benchmark for the safe and effective use of minocycline as a relatively benign, inexpensive treatment for a significantly disabling and painful disease with poor prognosis.
It’s pertinent to note that patient experience has demonstrated that remissions achieved by scleroderma patients being treated by minocycline may take longer than this trial permitted. Nevertheless, the results of this study are clearly reflective of the decades of clinical experience and case reports of Dr. Thomas MacPherson Brown, as documented in The New Arthritis Breakthrough and Scleroderma: The Proven Therapy That Can Save Your Life, by medical writer, Henry Scammell, and also the innumerable reported anecdotal cases that have been provided subsequently to this foundation.
In a press release, on December 1st, 1998, by Henry Scammell’s original New York publisher, M. Evans & Company, a lead author of the trial, Dr. David Trentham of Boston’s Beth Israel Hospital, the largest teaching hospital of Harvard Medical School, remarked, “I must admit we were pleasantly surprised.” Further, he stated, “Patients may live three to five to ten years, but they increasingly become more and more disabled. [This is] as close to a cure as you can get. It’s safe and highly, highly effective in a condition that previously had no real, definitive way of control.”
Further commentary about the use of minocycline for scleroderma from the clinical experience of Dr. David Trentham was provided in an article submission to this foundation upon his retirement and can be read here.
Click here to read the abstract of the Minocycline in Early Diffuse Scleroderma trial or to purchase and download the full trial publication from The Lancet website.