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


Cite item

Full Text

Open Access Open Access
Restricted Access Access granted
Restricted Access Subscription or Fee Access

Abstract

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.

Full Text

Restricted Access

About the authors

Ara Leonidovich Unanyan

I.M. Sechenov First Moscow State Medical University

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

Sergey Ernestovich Arakelov

City Clinical Hospital № 53; PFUR

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

Lusine Surenovna Polonskaya

City Clinical Hospital № 53

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

M. S Afanasyev

Gabrichevsky Diagnostic and Consultation Outpatient Clinic

MD, Director Moscow

References

  1. Джобава Э.М., Логинова К.Б. Дисменорея. Современный взгляд на этиопатогенез и терапию в практике акушера-гинеколога. Акушерство и гинекология. 2014; 11: 23-8. [Dzhobava E.M., Loginova K.B. Dysmenorrhea: The present views of etiopathogenesis and therapy in the practice of an obstetrician/gynecologist. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2014; 11: 23-8. (in Russian)]
  2. Нестеровская И.В., Осипова А.А. Неконтрацептивные эффекты гормональных контрацептивов. Часть 1. Дисменорея, эндометриоз, дисфункциональные маточные кровотечения. Акушерство, гинекология и репродукция. 2008; 6: 11-4. [Nesterovskaya I.V., Osipova A.A. Non-contraceptive effects of hormonal contraceptives. Part 1: dysmenorrhea, endometriosis, dysfunctional uterine bleeding. Akusherstvo, ginekologiya i reproduktsiya. 2008; 6: 11-4. (in Russian)]
  3. Milsom I., Sundell G., Andersch B. The influence of different combined oral contraceptives on the prevalence and severity of dysmenorrheal. Contraception. 1990; 42: 497-506.
  4. Межевитинова Е.А., Куземин А.А. К вопросу о лечении дисменореи и предменструального синдрома. Гинекология. 2001; 3(4): 133-4. [Mezhevitinova E.A., Kuzemin A.A. On the question of the treatment of dysmenorrhea and premenstrual syndrome. Ginekologiya. 2001; 3(4): 133-4. (in Russian)]
  5. Кулаков В.И., Савельева Г.М., Манухин И.Б., ред. Гинекология. Национальное руководство. М.: ГЭОТАР-Медиа; 2009. [Kulakov V.I., Savelyeva G.M., Manuhin I.B., eds. Gynecology. National guide. M.: GEOTAR-Media; 2009. (in Russian)]
  6. Черкасова Н.Ю., Фомина А.В., Филиппова О.В. Анализ рынка лекарственных средств для лечения дисменореи. Фармакоэкономика. Современная фармакоэкономика и фармакоэпидемиология. 2013; 3: 36-40. [Cherkasova N.Yu., Fomina A.Y., Filippova O.V. Analysis of drugs for the treatment of dysmenorrhea. Pharmacoeconomics. Sovremennaya farmakoekonomika i farmakoepidemiologiya. 2013; 3: 36-40. (in Russian)]
  7. Lundström V., Gréen K. Endogenous levels of prostaglandin F2 and its metabolites in plasma and endometrium of normal and dysmenorrheic women. Am. J. Obstet. Gynecol. 1978; 130(6): 640-6.
  8. Джамберардино М.А. Висцеральная боль. Международная ассоциация по изучению боли. Обновление клинической информации по боли. 2005; 13(6): 1-6. Available at: http://www.iasppain.org Доступ был осуществлен в декабре 2011. [Dzhamberardino M.A. Vistseralnaya bol. Visceral pain. International Association for the Study of Pain. Obnovlenie klinicheskoy informatsii po boli. 2005; 13(6): 1-6. Available at: http://www.iasppain.org. (in Russian)]
  9. Romics I., Molnár D.L., Timberg G., Mrklic B., Jelakovic B., Köszegi G., Blaskó G. The effect of drotaverine hydrochloride in acute colicky pain caused by renal and ureteric stones. Br. J. Urol. Int. 2003; 92(1): 92-6.
  10. Hamza M., Dionne R.A. Mechanisms of non-opioid analgesics beyond cyclooxygenase enzyme inhibition. Cur. Mol. Pharmacol. 2009; 2(1): 1-14.
  11. Lete L.I. Improvement of dysmenorrhea and premenstrual syndrome in NuvaRing users - a clinical experience program in Spain. Eur. J. Contracept. Reprod. Health Care. 2006; 11(Suppl. 1): 56.
  12. Геворкян М.А., Блинов Д.В., Смирнова С.О. Комбинированные оральные контрацептивы в лечении пациенток с синдромом поликистозных яичников. Акушерство, гинекология и репродукция. 2012; 1: 39-49. [Gevorkyan M.A., Blinov D.V., Smirnova S.O. Combined oral contraceptives in the treatment of patients with polycystic ovary syndrome. Akusherstvo, ginekologiya i reproduktsiya. 2012; 1: 39-49. (in Russian)]
  13. Дадак К. Дефицит магния в акушерстве и гинекологии. Акушерство, гинекология и репродукция. 2013; 2: 6-14. [Dadak K. Magnesium deficiency in obstetrics and gynecology. Akusherstvo, ginekologiya i reproduktsiya. 2013; 2: 6-14. (in Russian)]
  14. Громова О.А., Лиманова О.А., Торшин И.Ю. Систематический анализ фундаментальных и клинических исследований, как обоснование необходимости совместного использования эстрогенсодержащих препаратов с препаратами магния и пиридоксина. Акушерство, гинекология и репродукция. 2013; 3: 35-50. [Gromova O.A., Limanova O.A., Torshin I.Yu. Systematic analysis of basic and clinical research, as the rationale for complex use of estrogen-containing drugs with magnesium and pyridoxine. Akusherstvo, ginekologiya i reproduktsiya. 2013; 3: 35-50. (in Russian)]
  15. Kelly R. W., King A.E., Critchley H.O. Cytokine control in human endometrium. Reproduction. 2001; 21(1): 3-19.
  16. Возовик А.В., Бажукова Н.Н. Дисменорея у подростков. Репродуктивное здоровье детей и подростков. 2008; 5: 40-2. [Vozovik A.V., Bazhukova N.N. Dysmenorrhea in adolescents. Reproduktivnoe zdorove detey i podrostkov. 2008; 5: 40-2. (in Russian)]
  17. Елизаветина Г.А., Минушкин О.Н. Рациональный подход к выбору спазмолитиков для купирования абдоминальной боли. Consilium medicum. 2011; 8: 57-60. [Elizavetina G.A., Minushkin O.N. Rational approach to the choice of antispasmodics for relief of abdominal pain. Consilium medicum. 2011; 8: 57-60. (in Russian)]
  18. Леонова М.В. Клиническая фармакология Но-шпа. Методическое пособие. М.; 2011. [Leonova M.V. No-spa clinical pharmacology. Toolkit. M.; 2011. (in Russian)]

Supplementary files

Supplementary Files
Action
1. JATS XML
Download

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies