C Stevinson1, E Ernst. 1. Department of Complementary Medicine, School of Postgraduate Medicine and Health Sciences, University of Exeter, UK.
Abstract
OBJECTIVE: To investigate whether Hypericum perforatum could relieve symptoms of premenstrual syndrome in a small group of women in order to establish a hypothesis and to test methods for conducting a future randomised controlled trial. DESIGN: Prospective, open, uncontrolled, observational study. SETTING: Department of Complementary Medicine, University of Exeter. POPULATION: Nineteen women with premenstrual syndrome who were in otherwise good physical and mental health and not taking other treatments for premenstrual syndrome. METHOD:Volunteers underwent a preliminary screening interview, completed Daily Symptom Ratings for one cycle, and attended a medical screening visit before being diagnosed with premenstrual syndrome. Participants took hypericum tablets for two complete menstrual cycles (1 x 300 mg hypericum extract per day standardised to 900 microg hypericin). MAIN OUTCOME MEASURES: Symptoms were rated daily throughout the trial using a validated measure. The Hospital Anxiety and Depression scale and modified Social Adjustment Scale were administered at baseline and after one and two cycles of treatment. RESULTS: There were significant reductions in all outcome measures. The degree of improvement in overall premenstrual syndrome scores between baseline and the end of the trial was 51%, with over two-thirds of the sample demonstrating at least a 50% decrease in symptom severity. Tolerance and compliance with the treatment were encouraging. CONCLUSION: The results of this pilot study suggest that there is scope for conducting a randomised, placebo-controlled, double-blind trial to investigate the value of hypericum as a treatment for premenstrual syndrome.
RCT Entities:
OBJECTIVE: To investigate whether Hypericum perforatum could relieve symptoms of premenstrual syndrome in a small group of women in order to establish a hypothesis and to test methods for conducting a future randomised controlled trial. DESIGN: Prospective, open, uncontrolled, observational study. SETTING: Department of Complementary Medicine, University of Exeter. POPULATION: Nineteen women with premenstrual syndrome who were in otherwise good physical and mental health and not taking other treatments for premenstrual syndrome. METHOD: Volunteers underwent a preliminary screening interview, completed Daily Symptom Ratings for one cycle, and attended a medical screening visit before being diagnosed with premenstrual syndrome. Participants took hypericum tablets for two complete menstrual cycles (1 x 300 mg hypericum extract per day standardised to 900 microg hypericin). MAIN OUTCOME MEASURES: Symptoms were rated daily throughout the trial using a validated measure. The Hospital Anxiety and Depression scale and modified Social Adjustment Scale were administered at baseline and after one and two cycles of treatment. RESULTS: There were significant reductions in all outcome measures. The degree of improvement in overall premenstrual syndrome scores between baseline and the end of the trial was 51%, with over two-thirds of the sample demonstrating at least a 50% decrease in symptom severity. Tolerance and compliance with the treatment were encouraging. CONCLUSION: The results of this pilot study suggest that there is scope for conducting a randomised, placebo-controlled, double-blind trial to investigate the value of hypericum as a treatment for premenstrual syndrome.
Authors: Taghrid Asfar; Alberto J Caban-Martinez; Laura A McClure; Estefania C Ruano-Herreria; Danielle Sierra; G Gilford Clark; Daniel Samano; Noella A Dietz; Kenneth D Ward; Kristopher L Arheart; David J Lee Journal: Contemp Clin Trials Date: 2018-02-14 Impact factor: 2.226