The United States Food and Drug Administration issued a Black Box warning in October 2004 after placebo-controlled trials of antidepressant medications found an increased risk of suicidal thoughts and behaviors among children and adolescents taking antidepressant medications relative to placebo. Subsequently, some researchers have concluded that the Black Box warning caused severe unintended consequences; specifically, they have argued that the warning led to reduced use of antidepressants among youth, which led to more suicides. In this paper, we critically examine research regarding the Black Box warning's alleged deleterious consequences. One study claimed that controlled trials did not actually find an increased risk of suicidality among youth taking fluoxetine relative to those taking placebo, but its measure of suicidality is likely invalid. We found that ecological time series studies claiming that decreasing antidepressant prescriptions are linked to higher rates of suicide attempts or actual suicides among youth were methodologically weak. These studies exhibited shortcomings including: selective use of time points, use of only a short-term time series, lack of performing statistical analysis, not examining level of severity/impairment among participants, inability to control confounding variables, and/or use of questionable measures of suicide attempts. Further, while some time-series studies claim that increased antidepressant prescriptions are related to fewer youth suicides, more recent data suggests that increasing antidepressant prescriptions are related to more youth suicide attempts and more completed suicides among American children and adolescents. We also note that case-control studies show increased risk of suicide attempts and suicide among youth taking antidepressants, even after controlling for some relevant confounds. As clinical trials have the greatest ability to control relevant confounds, it is important to remember such trials demonstrated increased risk of suicidality adverse events among youth taking antidepressants. The Black Box warning is firmly rooted in solid data whereas attempts to claim the warning has caused harm are based on quite weak evidence.
We published a meta-analysis of component trials of emotional freedom techniques (EFT) in this journal. EFT is an evidence-based method, validated in over 100 clinical trials, that uses fingertip tapping on acupressure points in conjunction with techniques from exposure and cognitive therapy. The meta-analysis examined six studies in which an active control, such as diaphragmatic breathing or sham acupoints, was used in place of tapping on actual acupoints. The purpose of the meta-analysis was to determine whether tapping was an inert or an active ingredient in EFTs observed treatment effects. Subsequent to publication, errors in the statistical analysis were identified, primarily incorrect standard deviation values, and our methodological approach was questioned by others. We therefore had the meta-analysis rerun by an independent senior statistician who compared pre- to follow-up results to determine the sustained effects of treatment. The cumulative fixed effects Hedge’s g-value was found to be 0.73 (95% confidence interval = 0.42–1.04, p < 0.0001). The corresponding random effects Hedge’s g-value is 0.74 (95% confidence interval = 0.34–1.13, p < 0.0001). We also reviewed and clarified our methodology. In conclusion, despite computational errors in our original publication, the present revised analysis supports the original conclusion that the acupressure component of the EFT protocol is an active ingredient that contributes to the method’s favorable health effects.
Church et al.'s meta-analysis of three studies claimed to support the specificity of acupoint tapping as a therapeutic technique in the treatment of mental health problems. However, our critical analysis found substantial methodological problems and inaccurate statistical analyses, which render their results invalid. Specifically, 1) two included studies did not include participants with documented mental health problems; 2) two included studies did not specifically isolate the effect of acupoint tapping; 3) clear rationales for selected measures were not provided; 4) comparison groups were not bona fide therapies; 5) researcher and therapist allegiances were not controlled; and 6) selection of included studies may have been biased. Further, our attempt to replicate their results failed; we found that acupoint tapping fared no better than comparison groups: k = 3 studies, d = −0.38 (95% confidence interval, 0.10 to −0.87), p = 0.12. We conclude that the Church et al.'s meta-analysis actually found no specific mental health benefits for acupoint tapping.
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