Dr Andrade considers the association between ondansetron use during pregnancy and major congenital malformations. Does confounding by indication explain the findings? And do the benefits conveyed by this medication outweigh the risks?
The fragility index is the smallest number of subjects whose status needs to change for a significant finding to lose its significance. Read this article to learn about the usefulness and the limitations of this statistic.
In this month's column, Dr Andrade discusses a recent study suggesting that angiotensin receptor blockers are associated with suicide risk. This critical examination of the study will help readers understand its design and limitations.
Are electronic prescribing alerts useful or simply annoying? A survey gathered the opinions of ASCP members on several aspects of these alerts, including how often they are inaccurate and how the clinician tended to proceed when presented with one. The authors also reflect on what these findings may mean.
A recent meta-analysis found substantial benefits of memantine in treating obsessive-compulsive disorder. Dr Andrade takes a closer look at the methods the authors used and the studies they included to weigh the merits of their conclusions.
Clobazam is widely used for seizure disorders and anxiety, but its potential teratogenicity has been little discussed in the literature. In this article, Dr Andrade reviews the evidence regarding clobazam and risk of congenital malformations.
Does benzodiazepine use during pregnancy increase the risk of major malformations? In this article, Dr Andrade takes a close look at the methodology of a recent meta-analysis and proposes conclusions that differ from those of the authors.
Do P values tell the whole story? Dr Andrade highlights the importance of statistical methods as he considers the findings of a study that evaluated risk of intellectual disability after gestational exposure to antidepressants.
According to a recent meta-analysis, anti-inflammatory drugs like NSAIDs and statins have an antidepressant effect as well. But do the flaws in the analysis undermine its findings? Dr Andrade takes a closer look at this intriguing study.
An elderly woman with treatment-resistant schizoaffective disorder finally finds a drug that works, but when the lurasidone dose increases, a rash occurs and her mental health destabilizes again. Is rash an omen for a worse side effect?
About one-third of those with schizophrenia show limited response to antipsychotic treatment. This ASCP Corner article provides an update on the role of clozapine, alternative treatment options, and augmentation options for management of these patients.
Baclofen, a French Exception, Seriously Harms Alcohol Use Disorder Patients Without Benefit
To the Editor: Dr Andrade’s analysis of the Bacloville trial in a recent Clinical and Practical Psychopharmacology column, in which he concluded that “individualized treatment with high-dose baclofen (30-300 mg/d) may be a useful second-line approach in heavy drinkers” and that “baclofen may be particularly useful in patients with liver disease,” deserves comment.1
First, Andrade failed to recall that the first pivotal trial of baclofen, ALPADIR (NCT01738282; 320 patients, as with Bacloville), was negative (see Braillon et al2).
Second, Dr Andrade should have warned readers that Bacloville’s results are most questionable, lacking robustness. Although he cited us,3 he overlooked the evidence we provided indicating that the Bacloville article4 was published without acknowledging major changes to the initial protocol, affecting the primary outcome. Coincidentally (although as skeptics, we do not believe in coincidence), the initial statistical team was changed when data were sold to the French pharmaceutical company applying for the marketing authorization in France. As Ronald H. Coase warned, “If you torture the data long enough, it will confess.”