Possibilities and prospects for the use of spasmolytic agents in dysmenorrhea: Results of an international study


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Objective. To evaluate the efficacy of drotaverine (no-spa) in routine clinical practice for spasmodic abdominal pain caused by diseases of the gastrointestinal, biliary, and urinary tracts and dysmenorrhea. Subjects and methods. The M-ASAP trial is a multicenter, prospective crossover and long-term noninterventional registry-based study of the drug (3 visits), which was conducted in Mexico, Kazakhstan, and Russia. The study included a crossover (prescribed registration (PR)) phase and a prolonged (long-term registration (LREG)) one. Data on 25 consecutive patients with spasmodic abdominal pain who were eligible for the trial were documented in the PR phase and during a further observation 5 days (+3) later versus those on the first 5 consecutive eligible patients taking no-spa in the LREG phase. Pain was assessed using the numeric pain rating scale and the visual analog scale. Only spontaneous reports on adverse drug reactions were recorded. Results. The trial covered 208 physicians and 5507 patients. 75% of the patients received No-Spa®. The treatment was initiated mainly as monotherapy (72%). A total of 1116patients were included in the LREGphase (881 patients in the population in accordance with the protocol). Their mean age was 34.2±12.5 years; 86% were female. The majority (53%) of the women suffered from dysmenorrhea. They took no-spa for 5.7±4 days. 89% of the patients responded to the therapy. In the patients with dysmenorrhea, the results were statistically significant as compared to their first assessment (p < 0.0001). Conclusion. Examining the real practice of using no-spa showed that the latter rapidly relived pain in patients with spasmodic abdominal pain. The results permit the incorporation of drotaverine into national guidelines for the treatment of patients with dysmenorrhea to be recommended.

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作者简介

Ara Unanyan

I.M. Sechenov First Moscow State Medical University

Email: 9603526@mail.ru
Doctor of Medicine, professor of obstetrics and gynecology №1

Sergey Arakelov

City Clinical Hospital № 53; PFUR

Email: 53mosgkb@gmail.com
MD; assistant professor of obstetrics and gynecology Moscow

Lusine Polonskaya

City Clinical Hospital № 53

Email: ml.7951447@gmail.com
MD, head of gynecology department Moscow

M. Afanasyev

Gabrichevsky Diagnostic and Consultation Outpatient Clinic

MD, Director Moscow

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