RANDOMIZED CONTROLLED TRIAL
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A randomized, placebo-controlled trial of Ginkgo biloba L. in treatment of premenstrual syndrome.

BACKGROUND AND OBJECTIVES: During the reproductive years, most of menstruating women experience symptoms of premenstrual syndrome (PMS), which is incapacitating in up to 10% of cases. According to complicated etiology, various therapeutic approaches have been proposed. Because PMS is a chronic situation, special attention should be paid to the side-effects of pharmacological interventions. Herbal medicine is a recent favorable therapeutic approach owing to fewer side-effects. We aimed to determine the effect of Ginkgo biloba L. on the symptoms of PMS.

METHODS: This was a single-blind, randomized, placebo-controlled trial conducted from November 2007 to April 2008. The students with PMS, living in dormitories of a medical university (Tehran), who met the inclusion criteria entered the study. The students filled out the daily symptom rating forms in two consecutive menstrual cycles. After we verified the PMS diagnosis in 90 students, the participants were randomly assigned to experiment and placebo groups and took G. biloba L. tablets (containing 40 mg leaf extracts) or placebo three times a day from the 16th day of the menstrual cycle to the 5th day of the next cycle. Data were collected using daily symptom rating forms.

RESULTS: Eighty-five (85, 94.4%) participants completed the study. The two groups were similar in terms of demographic characteristics and baseline overall severity of symptoms. After the intervention, there was a significant decrease in the overall severity of symptoms and physical and psychologic symptoms in both Ginkgo (23.68%) and placebo (8.74%) groups (p < 0.001). However, the mean decrease in the severity of symptoms was significantly more in the Ginkgo group compared to the placebo group (p < 0.001).

CONCLUSIONS: G. biloba L. can reduce the severity of PMS symptoms. Further research on active ingredients and also the efficacy and safety of various doses and treatment durations of Ginkgo are required.

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