IS H15 (EXTRACT OF BOSWELLIA-SERRATA, INC ENSE) AN EFFICIENT SUPPLEMENTATION TO ESTABLISHED DRUG-THERAPY IN RA - RESULTS OF A DOUBLE-BLINDED PILOT TRIAL

Background: Leukotrienes and prostaglandines are important mediators o f inflammation. While prostaglandine synthesis can be influenced by NS AIDs therapeutical approaches to the 5-lipoxygenase pathway are rare. Resinous extracts of Boswellia serrata (H15, indish incense), known fr om traditional ayurvedic medicine, decrease leukotriene synthesis in v itro. Case reports suggest a clinical role for that drug. Methods: Out patients with active RA have been enrolled into a multicenter controll ed trial. Patients received 9 tablets of active drug (3600 mg) or plac ebo daily in addition to their previous therapy. Doses of NSAIDs could be adjusted on demand. Efficacy parameters, Ritchies Index for swelli ng and pain, ESR, CRP, pain on VAS and NSAID dose were documented at b aseline and 6 and 12 weeks after initiation. Mean values and medians w ere calculated to compare the groups for significant or clinically rel evant change baseline or difference between both groups at any time po int of observation. The mean NSAID dose reduction reached levels of 5. 8% (H15) and 3.1% (placebo). One patient in each group showed a good r esponse in all parameters but 4 patients in each group worsened. The o thers showed no alteration of their disease. Conclusion: Treatment wit h H15 showed no measurable efficacy. Controlled studies including a gr eater patient population are necessary to confirm or reject our result s.