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Reporting Bias Rife in Antidepressant Studies for Anxiety

Many studies evaluating antidepressant efficacy for your treatment for panic attacks that might be judged by the US Food and Drug Administration (FDA) as positive are published. However, it’s actually different story for nonsignificant studies, results of a brand new meta-analysis show.

Investigators with the University Clinic Groningen, the Netherlands, discovered that trials that this FDA deemed positive were five times most probably published compared with trials deemed not positive. Furthermore, they found evidence for study publication bias (P < .001), outcome reporting bias (P = .02), and spin (P = .02).

The findings, investigators say, give you a skewed view of antidepressant efficacy.

“Antidepressants have value in treating panic attacks, but they also are not ‘miracle drugs,’ and it’s possible there is less evidence to compliment their efficacy than what appears that are caused by the published studies,” Annelieke Roest, PhD, told Medscape Medical News in written correspondence.

“It is essential that physicians have a good realistic view of the efficacy of them drugs so they are able to have a well-justified decision when prescribing this family of drugs,” she told me.

The findings were published online March 25 in JAMA Psychiatry.

Skewed View?

The investigators observe that there is always “strong evidence that significant success with randomized research studies usually tend to be published than non-significant studies.

“Accordingly, published studies, including meta-analyses, may overestimate the advantages treatments while underestimating their harms, thus misinforming physicians, policy makers, and patients.”

The scientists examined reporting biases in double-blind, placebo-controlled trials toward the pharmacologic remedy for anxiety attacks and quantified the extent to which these biases inflate estimates of drug efficacy.

They identified phase 2 and three double-blind, placebo-controlled trials a member of the FDA and conducted in pursuit of marketing approval of second-generation antidepressants for your remedy for generalized depression, panic disorder, sad (social anxiety disorder), posttraumatic stress disorder, and obsessive-compulsive disorder.

Studies involving seven selective serotonin reuptake inhibitors and two serotonin norepinephrine reuptake inhibitors were evaluated.

Of the 57 trials identified by researchers, findings from 41 out of them (72%) were judged to be positive from the FDA.

However, 43 of 45 (96%) of this very articles published in the literature were positive (P < .001).

This suggests that trials the FDA deemed positive were five times most probably published in agreement with that determination when compared to trials determined to be not like positive from the FDA (risk ratio, 5.20; 95% confidence interval, 1.87 – 14.45; P < .001).

Sixteen of this very 57 trials identified by investigators (28%) have not been judged to be positive by the FDA, and seven of these trials (44%) have not been published.