Doubova Svetlana Vladislavovna, Morales Hortensia Reyes, Hernández Sergio Flores, del Carmen Martínez-García María, de Cossío Ortiz Marcela González, Soto Marco A Chávez, Arce Erika Rivera, Lozoya Xavier
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. doi: 10.1016/j.jep.2006.09.033. Epub 2006 Oct 13.
To assess the efficacy of two different doses of a Psidii guajavae folium extract in the management of primary dysmenorrhea.
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 (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).
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 3mg/day extract did not show a consistent effect throughout the three cycles.
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.
评估两种不同剂量的番石榴叶提取物治疗原发性痛经的疗效。
对197名原发性痛经女性进行了一项双盲随机临床试验。定义了四个干预组：两种提取物剂量组（3毫克/天和6毫克/天）；布洛芬组（1200毫克/天）；安慰剂组（3毫克/天）。对参与者进行了4个月的个体随访。主要结局变量是根据视觉模拟量表（VAS）测量的腹痛强度。
参与者的平均年龄为19岁；初潮发生在12岁左右。参与者的月经周期为28或29天，月经期持续5天，VAS疼痛强度平均值为8.2。在每个连续的治疗周期中，参与者的疼痛强度得分较低。在对每个周期的基线疼痛、治疗依从性和其他变量进行调整后，多元回归分析表明，接受6毫克/天提取物的组疼痛强度显著降低（p<0.001）。在第2和第3周期中这种效果得以维持，尽管疼痛强度平均值的降低幅度较小。接受3毫克/天提取物的组在三个周期中未表现出一致的效果。
与传统治疗和安慰剂相比，剂量为6毫克/天的标准化植物药（番石榴叶提取物）能显著减轻经期疼痛。
