Effect of herbal Ephedra sinica and Evodia rutaecarpa on body composition and resting metabolic rate: a randomized, double-blind clinical trial in Korean premenopausal women.
BACKGROUND
As obesity is becoming an epidemic, diet programs, including low-calorie diets, are continuously being developed. It is generally believed that a low-calorie diet is commonly followed by a resting metabolic rate decrease and ultimate weight regain. Ephedra sinica and evodia rutaecarpa are known to have sympathomimetic and anti-obesity effects.


OBJECTIVE
This study was a prospective; double-blinded, randomized and placebo-controlled clinical trial to evaluate the effects of ephedra sinica and evodia rutaecarpa on resting metabolic rate (RMR), body composition and short-term safety in obese Korean premenopausal women on a low-calorie diet.


METHODS
One hundred and twenty-five otherwise healthy obese women (body mass index > or =25 kg/m(2)) were recruited and randomly assigned to three groups: ephedra group (n = 41), evodia group (n = 45) and placebo group (n = 39). Subjects were administered ephedra extract in capsules (pseudo-ephedrine 31.52 mg) or evodia extract in capsules (evodiamine 6.75 mg, rutaecarpine 0.66 mg) or placebo capsules as well as participating in a low-calorie diet for 8 weeks. Resting metabolic rate and body composition were measured at baseline, 4 and 8 weeks. Basic serum tests were performed to evaluate the short-term safety and lipid-lowering effects of the herbs.


RESULTS
All three groups showed significant body mass index (BMI) decreases, probably due to the low-calorie diet. Among the groups, the most prominent BMI-reducing effect was seen in the ephedra group. In RMR, no significant change in any group or significant difference among the groups was found. No significant adverse effects were observed in serum tests or in the self-questionnaire.


CONCLUSIONS
Ephedra combined with a low-calorie diet was effective in reducing BMI. RMR change was not compensated for by the herbal medicines tried. RMR change seemed to be affected by constitution and body composition rather than by medicine. Ephedra and evodia were proven to be safe for short-term use in the herbal form.
Kim
Ho-Jun
HJ
Department of Oriental Rehabilitation Medicine, Dongguk University Ilsan Hospital, Korea.
Park
Jung-Mi
JM
Kim
Jin-Ah
JA
Ko
Byeong-Pyo
BP
D000328:Adult; D001481:Basal Metabolism / Q000187:drug effects*; D001823:Body Composition / Q000187:drug effects*; D004311:Double-Blind Method; D029789:Ephedra / Q000737:chemistry*; D029790:Ephedra sinica / Q000737:chemistry*; D005260:Female; D006801:Humans; D008875:Middle Aged; D010936:Plant Extracts / Q000008:administration & dosage*; D017697:Premenopause / Q000187:drug effects / Q000378:metabolism*; D011446:Prospective Studies; D055815:Young Adult
D010936:Plant Extracts