WEDNESDAY, Dec. 12 (HealthDay News) -- A cannabis-based prescription drug called Sativex, used to treat debilitating muscle spasms in multiple sclerosis (MS) patients, is the subject of a large new evidence review. Whether the drug -- licensed for use in the United Kingdom -- actually gets the job done remains uncertain.
Cannabinoids are active ingredients in marijuana. Sativex is not currently approved by the U.S. Food and Drug Administration, which considers it an investigational drug as clinical trials are under way.
In Britain, Sativex mouth spray is prescribed for patients only as an alternative treatment when standard therapies fail to provide adequate symptom relief.
And now a British team's review of previous studies upon which its initial U.K. approval had been granted suggests that although Sativex appeared to offer some benefit, the studies themselves contain design flaws or insufficiencies that may make the conclusions unreliable.
"Our findings were that the medicine has a small beneficial effect," said David Phizackerley, the London-based deputy editor of the journal Drug and Therapeutics Bulletin, which published the study Dec. 12.
"However, we identified problems with the clinical trials of the drug," he added. "The trials compared the drug against placebo rather than against another drug, some of the trials were short, some included small numbers of patients; some trials didn't show a benefit from using the drug and some trials used a dose greater than the recommended dose," Phizackerley said.
"[So] at the moment there is limited evidence that this particular formulation of cannabis extract has a small beneficial effect in relieving the symptoms of spasticity in patients with MS," he explained.
The authors stressed that their review focused solely on investigations of the Sativex formulation. None of the studies explored the use of
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