- Panic is an acute type of anxiety disorder, and frequent panic attacks can be a sign of panic disorder, a type of anxiety disorder.
- Xanax is a drug commonly prescribed for panic disorder in the United States.
- Recent research suggests that Xanax may be less effective for panic disorder than previously thought.
Panic describes an acute episode of anxiety, and panic attacks describe intense panic experienced over a short period of time. If you have repeated panic attacks, you may be diagnosed with the following illnesses:
The most common treatment for panic disorder is a combination of psychotherapy and medications such as Xanax. Xanax (alprazolam) is
Now, a team of researchers from Oregon Health & Science University School of Medicine and Harvard Medical School has found that Xanax XR (an extended release version of Xanax) may be less effective against panic disorder than previously thought. did.
they are reporting it
Their findings were recently published in the journal psychiatry.
Dr. Eric Turnersaid the study’s co-author, a professor of psychiatry at Oregon Health & Science University School of Medicine, and a former U.S. FDA reviewer. Today’s medical news Over the years, he said, he and his colleagues have investigated several other types of psychoactive drugs, compared the results of U.S. Food and Drug Administration reviews to the findings in journal articles, and found evidence of publication bias. .
“Just recently, I was contacted by an OHSU medical student who was interested in working on a project with me,” he said.
“I suggested doing so because I knew that benzodiazepines had not been considered in this way. However, most of the benzodiazepines had been approved decades earlier (e.g. in 1963). (Valium), we did not have access to FDA review for most drugs,” he continued.
“Reviews of the original Xanax, which was approved in 1981, were also not available. However, since the extended-release (XR) formulation was approved relatively recently (2003), FDA review is now available. ” added Dr. Turner.
For this study, researchers examined published US FDA data from phase 2 and 3 clinical trials conducted on Xanax XR for the treatment of panic disorder.
The researchers reported that only five trials had been conducted and only three were published in medical journals. When the FDA looked at drug companies’ clinical trial results to see how well Xanax It was determined that there was only one case.
After conducting a statistical analysis of the combined results of all five studies, the scientists reported that Xanax XR was still better than a placebo, but not as good as the published data.
They say publication bias inflated Xanax XR’s efficacy by more than 40%.
“We had half-expected to find evidence of publication bias, as we had experienced this phenomenon with other drug classes, but we didn’t know how much to expect,” Dr. Turner said. “I have to say there were more negative studies than I expected.”
“However, the difference between the two ‘ways of looking’ at trial data – FDA and journal articles – is that using meta-analysis It wasn’t that dramatic. ” he added.
Medical journals publish the results of scientific studies that are peer-reviewed or peer-reviewed by other experts in the same field who did not participate in the research.
Publication bias occurs when research is not accepted for publication based on the direction or strength of the findings. For example, studies with positive results are more likely to be published than studies with negative or statistically non-significant results.
“Publication bias, also known as selective publication, is the process of selecting which research results are published and which are not, so that the drug looks better,” Dr. Turner explained.
“If the results are satisfactory in terms of the effectiveness or safety of a drug, then of course they will be published. On the other hand, if the results are not flattering, the results will either be kept private or a more flattering result will be published.” could be published using a different statistical analysis that yields ,” he continued.
After reviewing this research, Dr. Nathan A. CarrollThe associate chief psychiatrist at Hackensack Meridian Health said he was not surprised by the results.
“There’s always a concern that decisions are influenced by available data, which is a type of availability bias. There’s often an invisible hand when it comes to research and results. “The results of this study will pull back the curtain of that invisible hand,” he explained. MNT.
Dr. Carroll said it is essential that the public knows about publication bias.
“Readers should be aware that there is a strong tendency to publish only positive results and that available information often influences decision-making. If clinicians do not see the whole picture, “It can distort decision-making. But publication bias is difficult to identify because we don’t know what we don’t know,” he said.
Dr. David MerrillThese medical publications are used to persuade both doctors and patients, says Geriatric Psychiatrist and Director of the Pacific Neuroscience Institute Pacific Brain Health Center in Santa Monica, California. He agreed.
“Readers should be concerned that only the doctor and themselves are in the picture. [p]positive data supporting the use of the drug; [b]But when we look at the negative data, we say, wait a minute, this may not be as effective as we think,” he said.
“It can be misleading and impact the informed consent process, which requires a true risk-benefit analysis,” he added.
When asked how researchers and medical journals can help eliminate publication bias, Dr. Turner said that researchers conducting systematic reviews of medicines provide the truth, the whole truth, and nothing but the truth. said that one should not rely too much on published literature to
“If available, unpublished clinical trial data should be sought from regulatory agencies such as the FDA,” he continued.
“Another big thing they can do before starting a study is to see if they can use the new ‘registered report’ peer review model. “Unfortunately, although there are over 300 journals participating in this model, few, if any, publish in the field of clinical drug trials,” he said.
Dr. Merrill proposed clinical trials that commit to sharing data publicly in an open manner from the beginning.
“So we agreed in advance, or in advance, to do this trial and we’re going to publish the results and the data no matter what the results are,” he said.
“Publication bias exists not only in drug trials, but in science in general, where it is much easier to publish ‘positive results.’ If the results are negative (meaning no difference or benefit from a placebo), we often see those studies rejected for publication because of established scientific and medical systems. Masu. To reinforce positive outcomes. ”
— Dr. David Merrill
Three changes to limit bias
Dr. Carroll said the three changes will help eliminate publication bias, which requires support from both researchers and publishers.
“First, publishers can commission researchers willing to publish negative results. Second, a database must be created so that researchers can register their hypotheses. This “This would also be consistent with the study’s recommendations on the ‘value of regulatory data to the general public’,” he said.
“Finally, there is the issue of transparency and whether the industry has an ethical obligation to publish negative results,” added Dr. Carroll.