Herbal ephedra/caffeine for weight loss: a 6-month randomized safety and efficacy trial.
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).


METHODS
Six-month randomized, double-blind placebo controlled trial.


METHODS
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.


METHODS
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.
Boozer
C N
CN
New York Obesity Research Center, St Luke's-Roosevelt Hospital and Columbia University, New York 10025, USA.
Daly
P A
PA
Homel
P
P
Solomon
J L
JL
Blanchard
D
D
Nasser
J A
JA
Strauss
R
R
Meredith
T
T
D001786:Blood Glucose / Q000032:analysis; D001794:Blood Pressure / Q000187:drug effects; D001823:Body Composition; D001835:Body Weight; D002110:Caffeine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D030221:Cola / Q000009:adverse effects; D019587:Dietary Supplements; D015716:Electrocardiography, Ambulatory; D029789:Ephedra / Q000009:adverse effects / Q000737:chemistry; D029790:Ephedra sinica / Q000009:adverse effects; D004809:Ephedrine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D010349:Patient Compliance; D010919:Placebos; D028321:Plant Preparations / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D014280:Triglycerides / Q000097:blood; D015431:Weight Loss
D001786:Blood Glucose; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D010919:Placebos; D028321:Plant Preparations; D014280:Triglycerides; D002110:Caffeine; D002784:Cholesterol; D004809:Ephedrine