drotaverin and Dysmenorrhea

To evaluate the efficacy and safety of aceclofenac-drotaverine combination against aceclofenac alone in patients with primary dysmenorrhoea.. This double-blind, double-dummy, randomized, comparative, multicentric study enrolled 200 women (100 women in each arm) in the age range of 18-35 years with primary dysmenorrhoea at four centers. The patients were randomly allocated to either aceclofenac 100mg-drotaverine 80 mg b.i.d or aceclofenac 100mg alone b.i.d for a maximum of 3 days. Primary efficacy parameters were total area under pain relief (PR) score up to 4 and 8h (TOPAR/4 and TOPAR/8). Secondary efficacy measurements were pain-intensity difference (PID), sum of PID over 4 and 8h (SPID/4 and SPID/8), peak PID over 4 and 8h and peak PR over 4 and 8h, total study drug consumption, and patient's and investigator's global evaluation of the efficacy.. Both treatments showed significant improvement in baseline values in all efficacy parameters. The combination was significantly superior to monotherapy in terms of TOPAR/4 (24.0 vs 18.54) (p=0.000) and TOPAR/8 (40.3 vs 35.2) (p=0.003), SPID/4 (-17.9 vs -13.88) (p=0.000) and SPID/8 (-31.06 vs -26.8) (p=0.001), peak PID/4 (-6.60 vs -5.75) (p=0.001) and peak PR/4 (8.26 vs 7.10) (p=0.000). At the end of 8h, both treatments were comparable with respect to peak PID/8 and peak PR/8 (p>0.05). The total number of doses consumed by patients treated with combination therapy was less than with monotherapy (150 vs 168 doses). The combination was significantly superior to monotherapy with respect to patient's and investigator's global evaluation of the efficacy (p=0.002 and p=0.001, respectively). Both treatments were well tolerated.. This study establishes the efficacy of aceclofenac-drotaverine combination in patients with primary dysmenorrhoea. The fixed-dose combination of aceclofenac and drotaverine should therefore be considered as a suitable, effective and well tolerated treatment option for primary dysmenorrhoea.

Topics: Adolescent; Adult; Analgesics; Cyclooxygenase Inhibitors; Diclofenac; Double-Blind Method; Drug Combinations; Dysmenorrhea; Female; Humans; Papaverine; Phosphodiesterase Inhibitors; Treatment Outcome; Young Adult

To compare efficacy and tolerability of drotaverine 80 mg and ibuprofen 400 mg in patients with primary dysmenorrhoea.. Nine-month, multicenter (11 study centers in Poland), randomised, double-blind, phase III study, conducted in two parallel group, included 345 women between the ages of 18 and 35, suffering from primary dysmenorrhoea with presence of moderate to severe pain in each of the last 3 cycles. Patients had regular menstrual cycles and used an adequate barrier contraception method with a negative pregnancy test before randomization. Patients were given 80 mg drotaverine or 400 mg 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. They were also asked to asses the tolerance of the medication (excellent, good, fair, poor).. 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 400 mg group, than in the drotaverine 80 mg group and was maximum at the 4th hour in the drotaverine 80 mg group (-1.2+/-1.18) and at the 3rd hour in the ibuprofen 400 mg group (-1.7+/-0.99). 41.8% patients treated with drotaverine and 68.6% patients treated with ibuprofen assessed drug efficacy as excellent or good. Although the patients' global assessment of tolerability was significantly better (p=0.02) with ibuprofen 400 mg (excellent or good: 86.8%), than with drotaverine 80 mg (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.. After analizing the data statistically and clinically, significant differences in favour of ibuprofen 400 mg were evidenced for efficacy criteria. Ibuprofen was more efficient and the effect was faster, than drotaverine in relieving pain in dysmenorrhoea. Both drugs were well tolerated. The reported adverse events were typical drug reactions or expected events in patients suffering from dysmenorrhoea.

Topics: Adult; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Dysmenorrhea; Female; Humans; Ibuprofen; Pain Measurement; Papaverine; Patient Satisfaction; Poland; Treatment Outcome; Women's Health

Topics: Analgesics; Analgesics, Non-Narcotic; Antipyretics; Cholelithiasis; Colic; Colitis; Duodenal Ulcer; Dysmenorrhea; Female; Humans; Kidney Calculi; Muscle Relaxants, Central; Papaverine; Parasympatholytics; Peptic Ulcer; Quinolines