A randomized double-blind placebo-controlled clinical trial of a product containing ephedrine

[Guest guest]

Here's a recent article, I will try to get the entire article in the future.

 

Brian

 

November 2004, Volume 28, Number 11, Pages 1411-1419

 

International Journal of Obesity (2004) 28, 1411-1419.

doi:10.1038/sj.ijo.0802784

Published online 31 August 2004

PaperA randomized double-blind placebo-controlled clinical trial of a product

containing ephedrine, caffeine, and other ingredients from herbal sources for

treatment of overweight and obesity in the absence of lifestyle treatmentC S

Coffey1, D Steiner2, B A Baker1 and D B Allison1,3,4

1Department of Biostatistics, University of Alabama at Birmingham, AL, USA

 

2Research Testing Laboratories, Great Neck, NY, USA

 

3Section on Statistical Genetics, University of Alabama at Birmingham,

Birmingham, AL, USA

 

4Clinical Nutrition Research Unit, University of Alabama at Birmingham,

Birmingham, AL, USA

 

Correspondence to: Dr DB Allison, Department of Biostatistics, Ryals Public

Health Bldg 327, 1665 University Blvd, University of Alabama at Birmingham,

Birmingham, AL 35294-0022, USA. E-mail: Dallison

Abstract

OBJECTIVE: To evaluate the efficacy and side effects of an herbal formulation to

promote weight loss, as compared to placebo.

 

DESIGN: 12-week multicenter double-blind, placebo-controlled, randomized

parallel groups design. Study conducted at three clinical sites in New York

State. Subjects were randomized to receive either the 'active' product or a

'placebo' supplement for 12 weeks. Minimal steps were taken to influence

lifestyle changes with regard to diet or exercise.

 

SUBJECTS: 102 overweight/obese (30<BMI39.9 kg/m2) volunteers between the ages of

18 and 65 y.

 

MAIN OUTCOME MEASURES: Weight, percent body fat, fat mass, waist circumference,

BMI, blood pressure, and pulse measured at 2 days, 1 week, 2 weeks, 4 weeks, 8

weeks, and 12 weeks postrandomization.

 

RESULTS: Subjects receiving the 'active' treatment experienced, on average, an

additional 1.5 kg of weight loss compared with subjects receiving the placebo.

In addition, subjects receiving the 'active' treatment experienced greater

reductions in BMI and waist circumference over the 12-week period. No

differences were observed with respect to percent body fat, fat mass, diastolic

or systolic blood pressure, pulse, the occurrence of any adverse event, or the

occurrence of any presumed treatment-related adverse event. Testing of the study

product by two independent laboratories indicated that it had only approximately

half of the intended amount of ephedrine alkaloids and caffeine.

 

CONCLUSIONS: Over the 12-week trial, subjects on the active treatment

experienced significantly greater weight loss than subjects on placebo, without

an increase in blood pressure, pulse, or the rate of adverse events. These

benefits were achieved in the absence of any lifestyle treatment to change

dietary or exercise behavior and with lower doses of ephedrine alkaloids and

caffeine than those commonly utilized.

 

 

kampo36 <kampo36 wrote:

 

related story:

http://www.acupuncturetoday.com/archives2004/oct/10danwen.html

 

rh

 

Chinese Medicine , acudoc11@a... wrote:

> More negative propaganda 'stories' as usual.

> The FDA has to make have someone create support for them for if attacked

> properly they WILL lose.

>

 

 

 

 

 

 

 

 

 

http://babel.altavista.com/

 

 

and adjust

accordingly.

 

If you , it takes a few days for the messages to stop being

delivered.

 

 

 

 

 

[Guest guest]

Chinese Medicine , Brian Hardy

<mischievous00> wrote:

>

> >Testing of the study product by two independent laboratories indicated that

it had

only approximately half of the intended amount of ephedrine alkaloids and

caffeine.

>

> CONCLUSIONS: Over the 12-week trial, subjects on the active treatment

experienced

significantly greater weight loss than subjects on placebo, without an increase

in blood

pressure, pulse, or the rate of adverse events. These benefits were achieved in

the absence

of any lifestyle treatment to change dietary or exercise behavior and with lower

doses of

ephedrine alkaloids and caffeine than those commonly utilized.

>

>

 

kind of makes you wonder who came up with the recommended dosages for the

weight-

loss products that got yanked and what their criteria was. i seem to remember a

listserv

discussion on the dosage of ephedrine in a popular supplement vs what we were

taught in

school and the supplement's daily recommended dosage was in some cases something

like 3 or more times the upper limit of the CHM dose. now the baby is out with

the

bathwater with the FDA zero-tolerance policy.