Objective: To examine long-term safety and efficacy for weight loss of an herbal Ma Huang and Kola nut supplement (90/192 mg/day ephedrine alkaloids/caffeine).
Design: Six-month randomized, double-blind placebo controlled trial.
Subjects: A total of 167 subjects (body mass index (BMI) 31.8±4.1 kg/m2) randomized to placebo (n=84) or herbal treatment (n=83) at two outpatient weight control research units.
Measurements: Primary outcome measurements were changes in blood pressure, heart function and body weight. Secondary variables included body composition and metabolic changes.
Results: By last observation carried forward analysis, herbal vs placebo treatment decreased body weight (−5.3±5.0 vs −2.6±3.2 kg, P<0.001), body fat (−4.3±3.3 vs −2.7±2.8 kg, P=0.020) and LDL-cholesterol (−8±20 vs 0±17 mg/dl, P=0.013), and increased HDL-cholesterol (+2.7±5.7 vs −0.3±6.7 mg/dl, P=0.004). Herbal treatment produced small changes in blood pressure variables (+3 to −5 mmHg, P≤0.05), and increased heart rate (4±9 vs −3±9 bpm, P<0.001), but cardiac arrhythmias were not increased (P>0.05). By self-report, dry mouth (P<0.01), heartburn (P<0.05), and insomnia (P<0.01) were increased and diarrhea decreased (P<0.05). Irritability, nausea, chest pain and palpitations did not differ, nor did numbers of subjects who withdrew.
Conclusions: In this 6-month placebo-controlled trial, herbal ephedra/caffeine (90/192 mg/day) promoted body weight and body fat reduction and improved blood lipids without significant adverse events.
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The authors gratefully acknowledge the help of the following individuals: Wayne Snodgrass, MD, PhD, for contributing to protocol design; Stanley Heshka, PhD, for the randomization procedure; Sheila Dawling, PhD, for supervising urine toxicologic screening, Steven B Heymsfield, MD, for EKG evaluations and for supervision of physical evaluations. Research support was provided by: Science Toxicology and Technology Consulting, San Francisco, CA, USA and National Institutes of Health grant P30DK 26687.
Appendix I: medical exclusions from the study
Active heart disease, a positive history of palpitations, hypertension (office measurement ≥140 systolic BP or diastolic BP ≥90 or ABPM mean 24 h systolic BP ≥139 mmHg or diastolic BP ≥87 mmHg), epilepsy, history of mental illness, hyperthyroidism, chronic use of any drug (by self-report or by presence in urine toxicology screen) except oral contraceptives, hormone replacement therapy or synthetic thyroid hormone, active bulimia, known prostatic hypertrophy, pregnancy (reported or detected by HCG testing), glaucoma, active cancer or cancer in remission for ≤5 y, renal dysfunction, liver dysfunction (ALT, alkaline phosphatase>2×upper limit of normal), acute or chronic active hepatitis, AIDS, any acute illness within the past 4 weeks, any other chronic illness that might be adversely impacted by concurrent use of the herbal compound, concurrent participation in another research protocol involving diet or any drug use, concurrent participation in a diet program involving severe calorie restriction (800 or fewer calories per day), caffeine intake of 500 mg per day or greater, use of appetite suppressant drugs or ephedra-containing herbal supplements within the last 6 months and weight change of 5 kg or more within the past 3 months.
Appendix II: urine toxicology screen
Amphetamine metabolites, salicylates, phenothiazines, amphetamine class, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates, methadone, phencyclidine, tricyclics, methanol, ethanol, acetone, iso-propanol, ethchlorvynol.
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Boozer, C., Daly, P., Homel, P. et al. Herbal ephedra/caffeine for weight loss: a 6-month randomized safety and efficacy trial. Int J Obes 26, 593–604 (2002). https://doi.org/10.1038/sj.ijo.0802023
- Ma Huang
- Kola nut
- ephedra alkaloids
- weight loss
- clinical trial
- herbal medicine
- alternative medicine
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