Appetite and weight control by Hypericum perforatum and acupuncture added to lifestyle modification: study protocol for a randomized clinical trial

Abstract Introduction To compare the effects ofHypericum 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.