• J Ethnopharmacol · Mar 2007

    Randomized Controlled Trial Comparative Study

    Effect of a Psidii guajavae folium extract in the treatment of primary dysmenorrhea: a randomized clinical trial.

    • Svetlana Vladislavovna Doubova, Hortensia Reyes Morales, Sergio Flores Hernández, María del Carmen Martínez-García, Marcela González de Cossío Ortiz, Marco A Chávez Soto, Erika Rivera Arce, and Xavier Lozoya.
    • Epidemiology and Health Services Research Unit "Centro Medico Nacional Siglo XXI", Mexican Institute of Social Security (IMSS), Mexico.
    • J Ethnopharmacol. 2007 Mar 21; 110 (2): 305-10.

    ObjectiveTo assess the efficacy of two different doses of a Psidii guajavae folium extract in the management of primary dysmenorrhea.MethodologyA double-blinded randomized clinical trial was conducted in 197 women with primary dysmenorrhea. Four intervention groups were defined: two extract doses (3 and 6 mg/day); ibuprofen (1200 mg/day); placebo (3mg/day). Participants were followed-up individually for 4 months. The main outcome variable was abdominal pain intensity measured according to a visual analogue scale (VAS).ResultsThe average age of participants was 19 years; menarche occurred around age 12 years. Participants had menstrual cycles of 28 or 29 days, with menstruation lasting 5 days and mean of pain intensity of 8.2 on the VAS. During each successive treatment cycle, participants experienced a lower pain intensity score. Multiple regression analysis, after adjusting each cycle for baseline pain, treatment compliance and other variables, showed that the group receiving 6 mg/day extract had significantly reduced pain intensity (p<0.001). This effect was maintained in cycles 2 and 3, although the reduction in the mean of pain intensity was lower. The group receiving the 3mg/day extract did not show a consistent effect throughout the three cycles.ConclusionAt a dose of 6 mg/day, the standardized phyto-drug (Psidii guajavae folium extract) reduced menstrual pain significantly compared with conventional treatment and placebo.

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