Journal of integrative and complementary medicine · 2025
Comparison of the Effect of Hypericum perforatum Vaginal Gel and Clotrimazole Vaginal Cream on Vaginal Candida albicans Infection: A Double-Blind Randomized Clinical Trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Bozorgian Leila, Mohammadi Solmaz, Keshtvarz Hesam Abadi Ali Mohammad, Sadeghi Mansourkhani Hossein, Asfaram Arash, Doustimotlagh Amir Hossein, Mottaghipisheh Javad, Asadikalameh Zahra
Аннотация
BACKGROUND AND AIM: Vulvovaginal candidiasis (VVC), predominantly caused by Candida albicans, is a common fungal infection affecting women worldwide. This randomized, blinded clinical trial aimed to evaluate the therapeutic efficacy of Hypericum perforatum (St. John's Wort) vaginal gel in comparison with 1% clotrimazole cream for the treatment of VVC.
METHOD: In this parallel-group, double-blind, randomized clinical trial, 80 women with microbiologically confirmed C. albicans vaginitis were randomly assigned to receive either H. perforatum vaginal gel or 1% clotrimazole cream, administered intravaginally once nightly for seven consecutive nights. Randomization was performed using a block method with concealed allocation. Primary outcomes included changes in clinical symptoms-itching, discharge, burning, and inflammation-from baseline to the end of treatment, assessed both clinically and via patient self-report. All analyses were conducted on an intention-to-treat basis.
RESULTS: Both treatment groups showed significant clinical improvement. The clotrimazole group had a higher rate of itching resolution (73.7% vs. 46.2%, p = 0.04), while the St. John's Wort gel group showed greater improvement in vaginal discharge (38.5% vs. 18.4% reported no discharge, p = 0.03). No adverse events were reported in either group.
CONCLUSION: While both treatments improved symptoms, St. John's Wort gel was not superior to clotrimazole in this superiority trial. Further research is needed to explore its potential as an alternative or adjunctive therapy, particularly in specific symptom domains. Moreover, larger non-inferiority trials are required to assess comparative efficacy.
METHOD: In this parallel-group, double-blind, randomized clinical trial, 80 women with microbiologically confirmed C. albicans vaginitis were randomly assigned to receive either H. perforatum vaginal gel or 1% clotrimazole cream, administered intravaginally once nightly for seven consecutive nights. Randomization was performed using a block method with concealed allocation. Primary outcomes included changes in clinical symptoms-itching, discharge, burning, and inflammation-from baseline to the end of treatment, assessed both clinically and via patient self-report. All analyses were conducted on an intention-to-treat basis.
RESULTS: Both treatment groups showed significant clinical improvement. The clotrimazole group had a higher rate of itching resolution (73.7% vs. 46.2%, p = 0.04), while the St. John's Wort gel group showed greater improvement in vaginal discharge (38.5% vs. 18.4% reported no discharge, p = 0.03). No adverse events were reported in either group.
CONCLUSION: While both treatments improved symptoms, St. John's Wort gel was not superior to clotrimazole in this superiority trial. Further research is needed to explore its potential as an alternative or adjunctive therapy, particularly in specific symptom domains. Moreover, larger non-inferiority trials are required to assess comparative efficacy.