New research has raised questions about the effectiveness of the widely prescribed sedative, alprazolam, commonly known as Xanax XR. This study suggests that previous publications may have overstated its efficacy by more than 40%, potentially due to publication bias.
The research indicates that the most commonly prescribed type of sedative in the country may not be as effective as previously believed, based on information found in medical journals.
Published on October 19 in the journal Psychological Medicine, this study delved into both published and unpublished data from five randomized controlled clinical trials that had undergone review by the U.S. Food and Drug Administration (FDA) concerning alprazolam, which is marketed as Xanax XR. This medication belongs to the benzodiazepine class and has been widely used since the 1970s to address conditions like anxiety and insomnia.
Associated Risks and Implications in Clinical Practice
Recent years have seen a growing awareness of serious clinical risks associated with benzodiazepines, including issues such as dependence, withdrawal, falls, and cognitive impairment.
According to senior author Erick Turner, M.D., a professor of psychiatry at the Oregon Health & Science University School of Medicine and a former FDA reviewer, “Clinicians are well aware of these safety issues, but there’s been essentially no questioning of their effectiveness. Our study throws some cold water on the efficacy of this drug. It shows it may be less effective than people have assumed.”
Understanding Benzodiazepines
Benzodiazepines are a class of drugs primarily used to manage anxiety, insomnia, seizures, and muscle spasms. They operate by depressing the central nervous system, resulting in a calming effect on the brain. Some common types of benzodiazepines and their brand names include:
- Alprazolam (Xanax): Typically prescribed for anxiety and panic disorders.
- Diazepam (Valium): Used to treat anxiety, muscle spasms, and seizures.
- Lorazepam (Ativan): Commonly prescribed for anxiety disorders.
- Clonazepam (Klonopin): Used to address panic disorders and certain types of seizures.
- Temazepam (Restoril): Mainly prescribed for insomnia.
It is important to exercise caution when using benzodiazepines due to potential risks such as dependence and withdrawal.
Study Methodology and Key Findings
Turner and co-author Rosa Ahn-Horst, M.D., M.P.H., a psychiatry resident at Harvard University, examined publicly available FDA data from phase 2 and phase 3 clinical trials that investigated extended-release alprazolam for the treatment of panic disorder. While the extended-release version received FDA approval in 2003, the immediate-release formulation had been approved in 1981.
Their analysis revealed that although five trials were conducted, only three of them had been published in medical journals. Moreover, when the FDA assessed the trial results comparing the drug’s performance to a placebo, they determined that only one of the five trials had a clearly positive outcome.
Through a statistical method known as meta-analysis, which combines all study results, they found that while alprazolam extended-release was still superior to a placebo, its efficacy was not as pronounced as the published data had suggested. In particular, publication bias had inflated the drug’s effectiveness by more than 40%.
These findings may have significant implications, particularly for patients and clinicians who have not previously used benzodiazepines, as opposed to those who use the drug infrequently or have already developed physical dependence.
Reference: “Unpublished trials of alprazolam XR and their influence on its apparent efficacy for panic disorder” by Rosa Y. Ahn-Horst and Erick H. Turner, 19 October 2023, Psychological Medicine. DOI: 10.1017/S0033291723002830
Table of Contents
Frequently Asked Questions (FAQs) about Xanax Efficacy
What is the main finding of the study regarding Xanax (alprazolam)?
The study suggests that Xanax (alprazolam) may be less effective than previously believed, with publication bias potentially inflating its efficacy by over 40%.
What is publication bias, and how does it relate to the study?
Publication bias refers to the tendency of medical journals to publish studies with positive outcomes more frequently than those with neutral or negative results. In this study, publication bias may have led to an overestimation of Xanax’s effectiveness because only a subset of trials with positive outcomes was published.
How were the study’s findings obtained?
The researchers examined both published and unpublished data from five randomized controlled clinical trials reviewed by the FDA for Xanax XR. They used meta-analysis to combine the study results and assess the medication’s true efficacy.
What are the clinical implications of this study?
The study highlights potential concerns about the effectiveness of Xanax, especially for patients and clinicians who have not previously used benzodiazepines. It suggests the need for caution when considering Xanax prescriptions.
What are benzodiazepines, and what are their common uses?
Benzodiazepines are a class of drugs primarily used to treat conditions such as anxiety, insomnia, seizures, and muscle spasms. Some common examples include Xanax, Valium, Ativan, Klonopin, and Restoril.
Who conducted the study, and where was it published?
The study was conducted by Rosa Y. Ahn-Horst and Erick H. Turner. It was published in the journal Psychological Medicine on October 19, 2023.
What should individuals and healthcare professionals take away from this study?
Individuals and healthcare professionals should be aware of the potential overestimation of Xanax’s efficacy due to publication bias. This study emphasizes the importance of carefully considering the benefits and risks when prescribing or using Xanax.
More about Xanax Efficacy
- Psychological Medicine Journal – The journal where the study was published.
- FDA – The U.S. Food and Drug Administration, which reviewed the clinical trials related to Xanax XR.
- Benzodiazepines Overview – Information about benzodiazepines and their common uses.
- Oregon Health & Science University School of Medicine – The institution affiliated with senior author Erick Turner, M.D.
5 comments
so, they think xanax, that famous drug, ain’t as great as we thought, dang!
whoa, this is heavy stuff, so xanax may not be that good after all, crazy!
wonder how this affects doctors & patients, like, should we be worried bout taking xanax now, ya know?
gotta give props to those researchers for digging into this, big deal for healthcare, man!
benzodiazepines, that’s a mouthful, they use ’em for anxiety and stuff, but this study says watch out!