Patients with HIV may develop dementia as a result of the virus in the brain or inflammation as a result of the illness. The typical symptoms of HIV-associated dementia include short-term memory loss, slowing of thinking, difficulties with complex tasks, and social withdrawal. Neurological symptoms such as hand tremor and gait difficulties are also common. This story is about a study that tested an anti-seizure medication, valproic acid (Depakote), on cognitive functioning in 22 patients in over a 10-week period. 16 people in the study had HIV-related cognitive impairment, while 6 did not. Valproic acid is FDA approved to prevent seizures, but it is currently also used off-label for treatment of certain mental illnesses and in Alzheimer’s patients, as it is thought to prevent or reverse cognitive decline. The storyâ€™s description of study design and results is incomplete and there is no quantitative data presented on benefits or side effects. The study only lasted 10 weeks, and while there was a trend towards improvement, the story made no explanation of what â€œimprovementâ€ means or how it was measured or in how many people it was observed. It is important that the journalist mentions the need for a larger clinical trial to replicate results. 22 people is a very small sample to suggest generalizability of the results in terms of treating HIV dementia with valproic acid, so the headline is overzealous. There is still no “cure” for HIV-related dementia and current non-experimental options for treating this condition are not mentioned. The story doesnâ€™t mention side effects of taking valproic acid. The quote that it is “safe and well-tolerated by this population” does not provide enough information for a piece reporting the results of a published study. Also, 10 weeks is not enough time to assess long-term side effects for this medication in HIV patients. Anti-convulsant drugs like Depakote can have serious side effects when taken long term. These include weight gain, edema, sleepiness, gastrointestinal problems and liver toxicity.
The story doesn’t specifically mention the cost of treatment. However, this piece focuses on a very preliminary trial of an off-label use of an anti-seizure medication. Cost of drug would be useful, but not essential for this piece.
No mention of quantitative data from the study. The story says “Those who took the drug showed some improvement in mental function. Brain scans also showed positive changes in brain metabolism.” But it doesn’t tell readers how many people showed improvement or how much improvement or how improvement was measured. How many brain scans showed positive changes? How positive? How was positive measured?
The story doesn’t mention side effects of taking valproic acid, which may include liver toxicity. Other side effects include dizziness and upset stomach. One study participant developed acid reflux disease during the trial. The quote that it is “safe and well-tolerated by this population” does not provide enough information for a piece reporting on the results of a published study. Also, 10 weeks is not enough time to assess long-term side effects for this medication in HIV patients. Anti-convulsant drugs like Depakote can have bothersome side effects when taken long term. These include weight gain, edema, sleepiness, and gastrointestinal problems.
The story’s description of the study design is incomplete. Of 22 patients, 6 had no cognitive impairment while 16 did. The study only lasted 10 weeks, and while there was a trend towards improvement, measurements of cognitive improvement did not change significantly between the placebo and valproic acid groups. There was, however, an increase in frontal white matter in the treatment arm of cognitively impaired participants, which is viewed as evidence of the effectiveness of the drug. It is important that the story mentions the need for a larger clinical trial to replicate results. 22 people is a very small sample to suggest generalizability of the results for HIV patients with dementia, so the headline is overzealous. And the story allows an interviewee to say that the treatment is well-tolerated and safe. It’s difficult to make that judgment after a trial in just 22 patients. There is still no “cure” for HIV-related dementia.
No evidence of disease mongering. The story only discusses treatment limited to patients with HIV-related dementia. However, the story could have provided more explanation of the prevalence or progression to dementia in HIV.
The article says the study was funded by the National Institute of Mental Health and sources are named as the study investigators. The journal article upon which the story is based states that the researchers have no conflicts of interest, but we are not told this in the news story. Stories should include such information. Nonetheless, we give this a satisfactory score.
The story doesn’t mention other established or experimental options for treating HIV-related dementia.
Mentions study is preliminary to larger clinical trials of valproic acid in HIV-related dementia, so this is not currently a readily available treatment. However, since valproic acid is readily available for use in seizures, this new use would be an “off-label” use. No information on how to enroll in these trials. The story could have improved on these points, but we give it a satisfactory score.
By saying that researchers “may have found a new trick for an old anti-seizure drug,” the story is clear on this point. Valproic acid (trade name Depakote) for seizures is not new. Experimental use to improve cognitive function in HIV-related dementia is new. Not yet FDA approved for this use.
We can’t be sure if the story relied solely or largely on a news release. However, we can say that story includes no input from any independent sources – only from two co-investigators.