A medicine made from marijuana, without the stuff that gives a high, cut seizures in kids with a severe form of epilepsy in a study that strengthens the case for more research into pot's possible health benefits.
"This is the first solid, rigorously obtained scientific data" that a marijuana compound is safe and effective for this problem, said one study leader, Dr. Orrin Devinsky of NYU Langone Medical Center.
The study was published Wednesday by The New England Journal of Medicine.
For years, patients and their parents have argued for more research and wider access to marijuana, with only anecdotal stories and small, flawed studies on their side. The new study is the first large, rigorous test -- one group got the drug, another got a dummy version, and neither patients, parents nor doctors knew who took what until the study ended.
It tested a liquid form of cannabidiol, one of marijuana's more than 100 ingredients, called Epidiolex. It doesn't contain THC, the hallucinogenic compound in marijuana, and is not sold anywhere yet, although its maker, GW Pharmaceuticals of London, is seeking U.S. Food and Drug Administration approval.
The company paid for, designed and helped run the study, and another doctor involved in the study has related patents.
Patients in the study have Dravet syndrome, a type of epilepsy usually caused by a faulty gene. It starts in infancy and causes frequent seizures, some so long-lasting they require emergency care and can be fatal. Kids develop poorly, and their mental impairment seems related to the frequency of seizures -- from four to as many as 1,717 a month in this study.
It included 120 children and teens, ages 2 to 18, in the U.S. and Europe. They took about a teaspoon of a sweet-smelling oil twice a day (drug or placebo) plus their usual anti-seizure medicines for 14 weeks.
Serious seizures with convulsions dropped from around 12 a month to about six for those on the drug and did not change in the others. Three patients on the drug became seizure-free during the study.
A Section on 05/25/2017