Herbal ephedra/caffeine for Weight Loss: A 6-month Randomized Safety and Efficacy Trial

Int J Obes Relat Metab Disord. 2002 May;26(5):593-604. doi: 10.1038/sj.ijo.0802023.

Abstract

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/m(2)) 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 mm Hg, P< or =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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Blood Glucose / analysis
  • Blood Pressure / drug effects
  • Body Composition
  • Body Weight
  • Caffeine / administration & dosage
  • Caffeine / adverse effects
  • Caffeine / therapeutic use*
  • Cholesterol / blood
  • Cholesterol, HDL / blood
  • Cholesterol, LDL / blood
  • Cola / adverse effects
  • Dietary Supplements
  • Electrocardiography, Ambulatory
  • Ephedra sinica / adverse effects
  • Ephedra* / adverse effects
  • Ephedra* / chemistry
  • Ephedrine / administration & dosage
  • Ephedrine / adverse effects
  • Ephedrine / therapeutic use*
  • Heart Rate / drug effects
  • Humans
  • Patient Compliance
  • Placebos
  • Plant Preparations / administration & dosage
  • Plant Preparations / adverse effects
  • Plant Preparations / therapeutic use*
  • Prospective Studies
  • Triglycerides / blood
  • Weight Loss*

Substances

  • Blood Glucose
  • Cholesterol, HDL
  • Cholesterol, LDL
  • Placebos
  • Plant Preparations
  • Triglycerides
  • Caffeine
  • Cholesterol
  • Ephedrine