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Effect of Herbal Ephedra Sinica and Evodia Rutaecarpa

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Effect of Herbal Ephedra Sinica and Evodia Rutaecarpa J Acupunct Meridian Stud 2008;1(2):128−138 RESEARCH ARTICLE 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 Ho-Jun Kim1, Jung-Mi Park2*, Jin-Ah Kim2, Byeong-Pyo Ko3 1Department of Oriental Rehabilitation Medicine, Dongguk University Ilsan Hospital, Korea 2Department of Oriental Internal Medicine (Cardiovascular and Neurology), East-West Neo Medical Center, KyungHee University, Korea 3Department of Oriental Rehabilitation Medicine, Bundang CHA Hospital, Pochon CHA University, Korea Received: May 31, 2008 Abstract Accepted: Oct 15, 2008 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 KEY WORDS: diet is commonly followed by a resting metabolic rate decrease and ultimate weight body composition; regain. Ephedra sinica and evodia rutaecarpa are known to have sympathomimetic ephedra; and anti-obesity effects. Design and Objective: This study was a prospective; double-blinded, randomized evodia; and placebo-controlled clinical trial to evaluate the effects of ephedra sinica and low-calorie diet; evodia rutaecarpa on resting metabolic rate (RMR), body composition and short- obesity; term safety in obese Korean premenopausal women on a low-calorie diet. resting metabolic rate Methods: One hundred and twenty-five otherwise healthy obese women (body mass index ≥ 25 kg/m2) were recruited and randomly assigned to three groups: ephedra group (n = 41), evodia group (n = 45) and placebo group (n = 39). Subjects were admin- istered 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 per- formed to evaluate the short-term safety and lipid-lowering effects of the herbs. Results: All three groups showed significant body mass index (BMI) decreases, proba- bly 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. Conclusion: 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. *Corresponding author. Department of Oriental Internal Medicine, East-West Neo Medical Center, KyungHee University, 149 Sang-il, Gangdong, Seoul, Korea. E-mail: [email protected] ©2008 Korean Pharmacopuncture Institute Effect of herbal Ephedra sinica and Evodia rutaecarpa 129 1. Introduction In the present study, the authors hypothesized that the RMR decline, which may be a major factor The rising prevalence of obesity in the last 20−30 for weight regain during a diet program, can be years has led to obesity being characterized as an minimized by the metabolism promotion effect of epidemic. The World Health Organization announced ephedra and evodia, and that both herbs have that obesity and its complications are the leading some effects on body composition. The short-term world-wide health threat [1]. Although numerous safety of using ephedra and evodia was also eval- weight loss programs have been developed in con- uated by the means of blood chemistry and ventional medicine, their effectiveness has proven self-questionnaire. to be quite limited [2]. Meanwhile, alternative agents, including herbs used in Chinese medicine, have been consumed extensively in the United States and 2. Methods European countries for weight loss purposes. Among these agents, preparations that include ephedra 2.1. Study design are the most popular [3]. Ephedra is the stem of ephedra sinica, also known The present study was a randomized, controlled, as ma-huang, and has been used in Chinese medi- double-blind clinical trial to assess the efficacy cine for over 5000 years as a treatment for the com- and safety of herbal extracts of ephedra sinica and mon cold, arthralgia, asthma and other ailments evodia rutaecarpa, and was conducted in Bundang [4,5]. Because of its sympathomimetic effect, var- CHA Hospital, South Korea for 8 weeks between ious herbal mixtures containing ephedra have been December 2004 and May 2005. used for obesity treatment in western countries as A total of 142 women volunteered for the study well as in Asia. by e-mail. Seventeen were not selected due to pos- The fruit of evodia rutaecarpa is regarded as a sible health hazards or incorrect body mass index ‘hot nature’ herb in Chinese literature. Evodiamine (BMI; under 25 kg/m2). The remaining 125 volunteers is a major component of the herb and manifests had blood exams in the main laboratory of CHA capsaicin-like vanilloid receptor agonist activity Hospital on the first visit. The subjects, healthy [6,7]. Some studies have reported that capsaicin Korean premenopausal women, were assigned to and evodia have anti-obesity effects [6]. three groups of ephedra, evodia and placebo by ran- Energy expenditure is commonly divided into domization. Randomization was conducted by choos- three components: resting metabolic rate (RMR), ing a number from 1 to 125 already randomly allotted physical activity and thermogenesis induced by to three groups by randomization computer soft- food intake, exposure to cold, and other stressors. ware. 41, 45 and 39 subjects were thus allotted to RMR accounts for the largest proportion (60−75%) the ephedra, evodia, placebo groups, respectively. of total daily energy needs in individuals, but the The study was blinded for all researchers involved. contribution of a low RMR to the etiology of obesity After assignment, subjects were educated on a is still controversial [1,8]. However, it is well estab- healthy low-calorie diet of 1200 kcal/day. A diet lished that energy restriction and weight loss may diary was encouraged during the whole study pe- cause a sustained suppression of the RMR for a given riod to check dietary compliance. Moderate exer- body composition [1]. The decreased RMR may be cise (40 minutes walk, five times in a week, 70% of important for weight regain in obese subjects after maximum heart rate) was indicated. All other med- weight loss during a diet program [9]. Therefore, icines, diet or exercise programs were prohibited clinicians involved in bariatric management have during the study. After instruction, subjects were a great interest in keeping or enhancing the RMR given a 4 week supply of herbal extract capsules of patients during a low-calorie diet. in an opaque bottle. Unconsumed capsules were Table 1 Evaluation progress 2nd visit 3rd visit 4th visit 1st visit Week 2 Week 6 Week 0 Week 4 Week 8 Body composition ✓ ✓ ✓ Metabolic rate ✓ Telephone ✓ Telephone ✓ WHR ✓ counsel ✓ counsel ✓ Blood sampling ✓ ✓ 130 H.J. Kim et al returned to the pharmacist after 4 and 8 weeks, 2.3. Preparation and subjects who had not taken 2/3 of their cap- sules were excluded from the study. On the second Evodia and ephedra used in the study were obtained visit, resting metabolic rate, body composition and from the Department of Oriental Pharmacology at basic anthropometric parameters were measured. Bundang CHA Hospital (Bundang, Korea). After wash- Between visits, a researcher contacted subjects by ing, each herb was hot water-extracted at 105°C telephone to check on the diet program and remind for 70 minutes. The herbal solution was concentrated them of the next scheduled visit. After 4 weeks in a decompressed condition at 60°C. To obtain the and 8 weeks, the third and fourth visits were made powder extract, the solution was spray-dried. The to reexamine the resting metabolic rate, body com- herb powder was contained in 250 mg capsules. position and basic anthropometric parameters. A Subjects were ordered to take four capsules 30 min- follow-up blood exam was only done at week 8 utes after each meal, three times a day, for a total (Table 1). Blood pressure was measured on the first of 12 capsules a day. The recommended maximum and last visits. To evaluate adverse effects of both daily doses of ephedra and evodia in natural herb herbs, symptoms and signs were self-reported before form are 12 g according to the Korean Oriental As- and after the experiment. sociation for the Study of Obesity. The effective Prior to the experiment, the basic purpose and acquisition rates of extraction in the study were principle of the study, potential adverse effects 17.4% and 24.9% in ephedra and evodia, respectively. of herbal extracts as well as their right of with- Therefore, roughly 3 g of evodia (evodiamine 6.75 mg, drawal from the study was thoroughly explained rutaecarpine 0.66 mg) extract powder and 2 g of to all subjects, and subjects were asked to sign a ephedra (pseudoephedrine 31.52 mg) extract powder personal consent form. The study was approved by were equivalent to 12 g of natural herbs. One gram the Institutional Review Board of Bundang CHA of corn starch was added to the ephedra powder Hospital. to make the amount identical to the evodia pow- der. The placebo contained 3 g of corn starch in a 2.2. Subjects capsule of identical appearance. Subjects were recruited by advertisements in local 2.4. HPLC analysis of standard materials to newspapers and on the webpage of Bundang CHA test samples Hospital. To qualify, subjects needed to be pre- menopausal Korean women between 21 and 50 The Laboratory of Oriental Pharmacology, Oriental years of age and have a BMI over 25 kg/m2 and Medical Hospital, KyungHee University, Seoul, Korea, must have been weight-stable within ± 3 kg during analyzed the samples of the herbal extracts by the previous 6 months.
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