Abstract
Objective
To evaluate the efficacy and safety of aceclofenac–drotaverine combination against
aceclofenac alone in patients with primary dysmenorrhoea.
Study design
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 100 mg–drotaverine 80 mg b.i.d or aceclofenac 100 mg 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 8 h (TOPAR/4 and TOPAR/8). Secondary efficacy measurements were pain-intensity difference
(PID), sum of PID over 4 and 8 h (SPID/4 and SPID/8), peak PID over 4 and 8 h and peak PR over 4 and 8 h, total study drug consumption, and patient's and investigator's global evaluation
of the efficacy.
Results
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 8 h, 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.
Conclusion
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.
Keywords
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Article info
Publication history
Published online: June 02, 2010
Accepted:
May 16,
2010
Received in revised form:
April 8,
2010
Received:
November 17,
2009
Identification
Copyright
© 2010 Elsevier Ireland Ltd. Published by Elsevier Inc. All rights reserved.
