Comparative efficacy and tolerability of drotaverine 80 mg and ibuprofen 400 mg in patients with primary dysmenorrhea – Protocol DOROTA
Journal Title: Postępy Nauk Medycznych - Year 2010, Vol 23, Issue 8
Abstract
Objective: To compare efficacy and tolerability of drotaverine 80 mg and ibuprofen 400 mg in patients with primary dysmenorrhea.Materials and methods:Nine-month, multicenter (11 study centers in Poland), randomised, double-blind, phase III study conducted in two parallel group, included 345 women between 18 and 35 years, suffering from primary dysmenorrhea for at least 6 months with presence of moderate to severe pain in each of the last 3 cycles. Patients had regular menstrual cycles (25-35 days) and used an adequate barrier contraception method with a negative pregnancy test before randomization. Patients were given 80mg drotaverine or 400mg ibuprofen and asked to assess the pain intensity rated on a 4-point categorical scale (0=none, 1=mild, 2=moderate, 3=severe) at baseline and 0.5, 1, 2, 3, 4, 5 and 6 hours after the first intake and evaluate the efficacy (excellent, good, fair, poor) at the end of the treatment period.. Results:Although the patient’s global assessment of the tolerability was significantly better (p=0.02) with ibuprofen 400mg (excellent or good: 86.8%) than with drotaverin 80mg (excellent or good: 78.4%), no relevant difference between the both groups was observed for frequency, nature, intensity and causality of the reported adverse events. Changes in pain intensity were calculated for each patient at each period according to her baseline value. The weighted sum of pain intensity differences over the 6-hour observation period (SPID-6) was calculated. The pain intensity before the first intake was comparable in the two groups.At the time-points, the decrease of pain was always greater in the ibuprofen 400mg group than in the drotaverine 80mg group and was maximum at the 4th hour in the drotaverine 80mg group (-1.2 ± 1.18) and at the 3rd hour in the ibuprofen 400mg group (1.7 ± 0.99).Conclusions:Drotaverin 80 mg is effective and slightly slower in decreasing menstrual pain then 400 mg ibuprofen.Both drugs were well tolerated. The reported emergent adverse events were known drug reactions or expected events in patients suffering from dysmenorrhea.
Authors and Affiliations
Romuald Dębski, Tomasz Niemiec, Marzena Mazurek
Keywords
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