NEW YORK (Reuters Health) - In a cautionary tale about the use of unproven medicine, a new study shows an antipsychotic given to thousands of U.S. veterans with post-traumatic stress disorder has a negligible impact on the common condition.
However, veterans who got the drug, called risperidone, experienced significant side effects, including weight gain and sleepiness.
"We know there are large numbers of veterans who have been getting risperidone for a long time, and our study suggests that is not helpful," said Dr. John H. Krystal of the Veterans Affairs (VA) Connecticut Healthcare System in West Haven, who led the study.
While talk therapy and antidepressants are both effective against post-traumatic stress disorder, or PTSD, a considerable proportion of patients still have troubling symptoms.
Those include flashbacks and nightmares, being revved up and looking for signs of dangers everywhere, as well as feeling numb toward other people and positive emotions.
Many vets end up with disabilities due to their mental breakdown, Krystal told Reuters Health, noting that PTSD is the most common psychiatric disorder treated at the VA.
So when proven treatments fail, doctors often try a variety of drugs not proven to help the condition. For example, close to 87,000 PTSD-stricken vets were prescribed an antipsychotic in 2009, despite those drugs not being FDA-approved to treat the condition.
"The average patient was on almost three psychotropic medications," said Krystal. "It is a huge problem for patients that we don't have validated treatment to address this effectiveness gap."
To test whether antipsychotics actually have an impact on PTSD, Krystal's team randomly assigned 267 Vietnam, Iraq and Afghanistan vets already on antidepressants to take either an inactive placebo pill or risperidone. The drug was donated by Ortho-McNeil Janssen Scientific Affairs.
After six months, the PTSD symptoms had retreated considerably in both groups of patients, but there was no difference between them.
Risperidone didn't alleviate depression or anxiety either, or boost the vets' quality of life.
However, 15 percent of the vets on risperidone said they'd gained weight over the study, compared to only two percent of those on placebo. Fatigue, sleepiness and increased amounts of saliva were also common with the antipsychotic.
The study, published in the Journal of the American Medical Association, is the first large trial of antipsychotics in PTSD.
Krystal said that unless PTSD patients also have psychotic symptoms, like paranoia and delusions, the findings suggest doctors should stay away from antipsychotics.
Another study appearing along with Krystal's findings brought some good news, however.
In that report, German researchers found that a few weeks' worth of talk therapy effectively improved PTSD symptoms in a group of former child soldiers from Uganda.
Currently, some 250,000 children worldwide serve as child soldiers, according to the researchers.
"Child soldiering is one of the worst forms of psychological traumatization, children being abducted, kept for weeks, months or years, undergoing slavery, torture and sexual violence, and all of this during sensitive periods of their development," Frank Neuner of Bielefeld University told Reuters Health in an email.
"We could show that, when living under peaceful conditions, the majority of them can be successfully treated with limited efforts," he added.
Youths who told their stories to trained local lay counselors on average cut their symptoms by about 14 points more than those who took a catch-up English course (on a severity scale of 148).
Neuner said that while some organizations are providing trauma treatment in Uganda, there is still a lot of unmet need in the rural parts of the war-torn African country.
"Part of what happens when you tell your story is that those experiences become more linear," Dr. Charles Hoge, a PTSD expert at the Walter Reed Army Medical Center, told Reuters Health.
Hoge, who wrote an editorial about the new studies, said that process helps extinguish the irrational gut-level fear reactions that plague those with PTSD.
As for the U.S., he said, one major problem facing service members and vets is that many are reluctant to seek help.
"Around half of service members and veterans who need PTSD treatment are not coming in to get it," Hoge explained.
Although the military has placed a bigger emphasis on mental health and PTSD in recent years, Hoge said those services need to become a more-integrated part of routine primary care.
"It's fair to say that those efforts have had an effect in improving stigma and access, but I think it is also fair to say that we have a ways to go," he said.