Efficacy and safety of Matricaria chamomilla intervention in managing menopausal symptoms: a triple-blind clinical trial

Abstract Objective Menopausal symptoms can significantly impact women's quality of life. Herbal interventions like Matricaria chamomilla (chamomile) have been suggested as potential remedies. However, their efficacy and safety remain underexplored. Methods This triple-blind clinical trial enrolled 80 postmenopausal women meeting specific criteria. Inclusion criteria included participants in early or late perimenopause, defined by a symptom score >15, FSH levels >40, or 2 years since menopause, with no significant comorbidities. Participants were randomly assigned to intervention and placebo groups. In a triple-blind clinical trial with 80 postmenopausal women (aged 47‐62) from Babol City Health Center, participants were randomly assigned to receive either chamomile (100 mg capsules with 1.2% apigenin, four times daily) or a placebo over 12 weeks. Symptoms of menopause were assessed using the Australian Menopause Association's Scorecard Symptom Questionnaire. Over 12 weeks, they received either chamomile or placebo capsules, with side effect assessments every 4 weeks. Results Notable differences were found between the intervention and control groups in the overall scores on the symptom scorecard from baseline to 12 weeks' postintervention (−10.36; 95% confidence interval [CI], −13.84 to −6.92; P < 0.001). Specific subscores also improved in the intervention group: vasomotor (−2.25; 95% CI, −3.09 to −1.42; P < 0.001), psychological (−3.74; 95% CI, −5.29 to −2.20; P < 0.001), locomotor (−2.70; 95% CI, −3.63 to −1.77; P < 0.001), and urological (−1.89; 95% CI, −2.77 to −1.00; P < 0.001). Both groups showed significant changes in total symptom scores over time ( P < 0.001). Two participants experienced side effects, including mouth sores, skin spots, and itching, in the chamomile group, which led to their dropping out of the study. Conclusions Chamomile intervention shows promise in alleviating menopausal symptoms, but its use warrants caution due to associated side effects. Further research is necessary to optimize dosage and mitigate adverse reactions for safer and more effective management of menopausal symptoms.