1. Appetite and weight control by Hypericum perforatum and acupuncture added to lifestyle modification: Study protocol for a randomized clinical trial
- Author
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Monirsadat Sahebkar-Khorasani, Hoda Azizi, Lida Jarahi, Roshanak Salari, Mahdi Yousefi, and Mohammad Safarian
- Subjects
medicine.medical_specialty ,Electroacupuncture ,business.industry ,medicine.medical_treatment ,media_common.quotation_subject ,Hypericum perforatum ,Appetite ,Overweight ,Anthropometry ,Placebo ,030205 complementary & alternative medicine ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Complementary and alternative medicine ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Acupuncture ,030212 general & internal medicine ,medicine.symptom ,business ,media_common - Abstract
Introduction To compare the effects of Hypericum perforatum with lifestyle modification and acupuncture for appetite and weight control in obese or overweight patients. Methods The planned sample size is 88. Participants in group I will receive electroacupuncture, Hypericum perforatum, and lifestyle modification; group II, electroacupuncture, placebo, and lifestyle modification; group III, sham electroacupuncture, Hypericum perforatum, and lifestyle modification, group IV, sham electroacupuncture, placebo, and lifestyle modification. The primary outcome is change in serum nesfatin-1 level at week 6 comparing to baseline. Secondary outcomes include appetite score and anthropometric indices. Outcomes will be assessed at baseline, week 2, 6, 12 and 24. The statistical analyses will be performed using SAS and SPSS version with a 2-sided P value of less than 0.05 considered statistically significant. Conclusions By implementing placebo for both Hypericum perforatum and acupuncture, this study may help improving the methodology of comparative effectiveness studies of different complementary medicine interventions.
- Published
- 2020