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

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• 作者：Svetlana Vladislavovna Doubova ; Hortensia Reyes Morales ; Sergio Flores Hern&#xe1 ; ndez ; Mar&#xed ; a del Carmen Mart&#xed ; nez-Garc&#xed ; a ; Marcela Gonz&#xe1 ; lez de Coss&#xed ; o Ortiz ; Marco A. Ch&#xe1 ; vez
• 关键词：Psidii guajavae folium ; Primary dysmenorrhea ; Phytodrug
• 刊名：Journal of Ethnopharmacology
• 出版年：2007
• 期刊代码：26_03788741
• 类别：pha
• 出版时间：21 March 2007
• 卷：110
• 期：2
• 页码：305-310
• 文件大小：145 K

摘要

>Objective

To assess the efficacy of two different doses of a Psidii guajavae folium extract in the management of primary dysmenorrhea.

Methodology

A 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 (3 mg/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).

Results

The 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 3 mg/day extract did not show a consistent effect throughout the three cycles.

Conclusion

At a dose of 6 mg/day, the standardized phyto-drug (Psidii guajavae folium extract) reduced menstrual pain significantly compared with conventional treatment and placebo.