A double-blind controlled crossover study to investigate the efficacy of salix extract on primary dysmenorrhea

Abstract

ObjectivesPrimary dysmenorrhea in the absence of pelvic pathology is a common gynecologic disorder affecting the quality of life of women of reproductive age. This study evaluates the effect of salix extract on primary dysmenorrhea. DesignThis study was a randomized crossover clinical trial. SettingThe study population included 96 female students with level two or three of primary dysmenorrhea: 48 students in the treatment group (sequence I) followed by control (sequence II) and 48 students in control group (sequence I) followed by treatment (sequence II). InterventionsThe intervention was salix capsule (400 mg daily) and the active control was mefenamic acid capsule (750 mg daily) as. Main outcomesPain intensity, measured by the visual analog scale (VAS), amount of bleeding, and severity of dysmenorrhea symptoms were outcomes. Generalized estimating equations were used for data analysis. ResultsThe demographic and menstrual characteristics of the students were homogenous between the groups. The results showed that the students in mefenamic acid group had a significantly higher level of VAS than the students in the salix group over time (1.61 ± 0.06, P < 0.001). The estimated odds of the bleeding level in the salix and mefenamic acid group were not significantly different (P = 0.31). In average, 77.39%±16.18 of the students in salix group showed no symptoms followed by 22.18%±14.08 of the students who experienced mild symptoms. Averagely, 44.58%±20.16 of the students in the mefenamic acid group had mild symptoms followed by moderate symptoms (28.12%±15.29). ConclusionsSalix extract significantly decreased dysmenorrhea in comparison to mefenamic acid, as the standard treatment of dysmenorrhea.