Oct. 17, 2006 -- The weight loss drug Acomplia hasn't been approved by the FDA, but it's already drawing attention from the public and scientists.
The latest Acomplia headlines appear online in The Cochrane Library.
The researchers included graduate student Cintia Curioni, MSc, of Brazil's University of Rio de Janeiro.
For one or two years, participants either took Acomplia in higher or lower doses (20 milligrams or 5 milligrams daily) or pills containing no medicine (placebo).
But they didn't just pop pills. They also shaved about 600 calories off their daily diet.
Pounds Shed, Waists Slimmed
The studies' key question: Who lost the most weight?
The answer: Participants taking the higher dose of Acomplia.
In a year's time, they lost about 11 more pounds, on average, than those taking the placebo.
Dieters taking the lower Acomplia dose lost nearly 3 pounds more in a year than those taking the placebo, on average.
Both Acomplia groups trimmed their waists: by an inch and a half with the higher dose and half an inch with the lower dose.
But the higher Acomplia dose may have come with more risks.
People taking the higher Acomplia dose were more likely to have adverse effects, "especially of nervous system, psychiatric, and gastrointestinal origin," Curioni's team writes.
Reviewers: More Studies Needed
On the one hand, "even modest amounts of weight loss may be potentially beneficial," write Curioni and colleagues.
They note that people taking the higher dose of Acomplia had "modest weight loss of about 5%" of their body weight.
But on the other hand, the reviewers call for caution in interpreting the review's results.
They note that about 40% of the participants quit the studies early and none of the studies met the reviewers' highest standards.
Curioni's team calls for longer, more rigorous studies before making definitive recommendations about the drug's use in overweight and obese patients.
Meanwhile, the reviewers say drug-free methods "should remain the cornerstone oftherapy" in people who want to lose extra weight.
That may sound simple. But diet and exercise are often easier said than done.
If you're interested in losing weight, consult your doctor to start a healthy weight loss plan.
Acomplia, which has been approved in Europe, is made by the drug company Sanofi-Aventis. Sanofi-Aventis has not settled on the drug's U.S. name pending FDA approval. Sanofi-Aventis is a WebMD sponsor.