By Nonhlanhla Khumalo, Dedee Murrell, Fenella Wojnarowska & Gudula Kirtschig
Archives of Dermatology March 2002 Vol 138 pages 385-389.
This review is different from the usual type of review you might read about bullous diseases in that by being “systematic” it was submitted ahead of time to an independent panel of editors at the Cochrane Collaboration for Evidence-Based Medicine stating that the aim was to summarize data from randomized controlled trials (RCTs) only for the treatment of BP. In addition, how those trials are to be searched for, analyzed and compared is scrutinized.
Out of all the databases only 6 RCTs were published, including 293 patients. One trial compared prednisolone at different doses: 0.75mg/ kg/day vs 1.25mg;/kg/day, and another compared methylprednisolone with prednisolone, and neither study found a significant difference between the two groups, but the patients on the higher prednisolone doses had more severe side effects.
Two trials were of combination treatments: (i) prednisone vs prednisone and azathioprine (Imuran) and (ii) prednisolone vs prednisolone and plasma exchange; these combinations roughly halved the steroid dose needed to control BP.
One trial had 3 comparisons: prednisolone vs prednisolone and azathioprine vs prednisolone and plasma exchange; that trial did not show any benefit of these combinations over prednisolone alone.
The last trial compared prednisone to tetracycline and niacinamide, and found no statistical difference in response between the two groups, but the side effects were higher in the prednisone group.
The drawbacks of each of these studies are highlighted. This is a useful paper to read if you want to learn more about how studies for the treatment of bullous diseases should be performed.
Four of these studies were conducted in France, and the French group since published a further RCT in the New England Journal of Medicine comparing topical clobetasol vs oral prednisolone for BP.
I personally believe that dermatologists should try to collaborate more and try to do more RCTs for the rare conditions such as BP and Pemphigus to try to determine which are the most efficacious treatments, best dosing regimens, etc. To my knowledge RCTs are currently enrolling at various centres in the US (coordinated by Dr Vicky Werth in Philadelphia) and at St George Hospital in Sydney, for the dapsone as a steroid-sparing agent in patients with pemphigus vulgaris; in Germany for various PV treatments, and in France, on-going trials in BP.
Contributed by Dr. Dedee Murrell, Sydney, Australia.