The effect of posthypnotic suggestion and task difficulty on adherence to health-related requests

The effects of posthypnotic suggestion on health-related behavior, using a behavioral measure of adherence were investigated. Three hundred twenty three students covering the full range of hypnotic suggestibility were prescribed an easy (mood rating) or a difficult (physical activity) task. Participants were randomly assigned to receive either a) hypnosis with posthypnotic suggestions to facilitate performance of the assigned task or b) a social request to perform the assigned task. There were significant effects for type of task and hypnosis, revealing that participants adhered significantly more to the easy task and that hypnosis decreased task adherence. Hypnotic suggestibility did not predict adherence, and its interaction with posthypnotic suggestion was not significant. These results suggest that posthypnotic suggestion may decrease adherence rates regardless of participants’ suggestibility level

A Systematic Review of Comparative Efficacy of Treatments and Controls for Depression

Background: Although previous meta-analyses have examined effects of antidepressants, psychotherapy, and alternative therapies for depression, the efficacy of these treatments alone and in combination has not been systematically compared. We hypothesized that the differences between approved depression treatments and controls would be small. Methods and Findings: The authors first reviewed data from Food and Drug Administration Summary Basis of Approval reports of 62 pivotal antidepressant trials consisting of data from 13,802 depressed patients. This was followed by a systematic review of data from 115 published trials evaluating efficacy of psychotherapies and alternative therapies for depression. The published depression trials consisted of 10,310 depressed patients. We assessed the percentage symptom reduction experienced by the patients based on treatment assignment. Overall, antidepressants led to greater symptom reduction compared to placebo among both unpublished FDA data and published trials (F = 38.5, df = 239, p<0.001). In the published trials we noted that the magnitude of symptom reduction with active depression treatments compared to controls was significantly larger when raters evaluating treatment effects were un-blinded compared to the trials with blinded raters (F = 2.17, df = 313, p<0.05). In the blinded trials, the combination of antidepressants and psychotherapy provided a slight advantage over antidepressants (p = 0.027) and psychotherapy (p = 0.022) alone. The magnitude of symptom reduction was greater with psychotherapies compared to placebo (p = 0.019), treatment-as-usual (p = 0.012) and waiting-list (p<0.001). Differences were not seen with psychotherapy compared to antidepressants, alternative therapies or active intervention controls. Conclusions: In conclusion, the combination of psychotherapy and antidepressants for depression may provide a slight advantage whereas antidepressants alone and psychotherapy alone are not significantly different from alternative therapies or active intervention controls. These data suggest that type of treatment offered is less important than getting depressed patients involved in an active therapeutic program. Future research should consider whether certain patient profiles might justify a specific treatment modality

How effective are Z-drug hypnotics for treatment of adult insomnia? Meta-analysis of data submitted to the Food and Drug Administration

The Problem: Z-drugs are the most commonly prescribed hypnotics worldwide. They are widely prescribed because general practitioners and patients believe that they are effective and superior to older hypnotics. Previous meta-analyses of Z-drugs suffer from publication or reporting bias and did not adequately examine study heterogeneity. We wanted to investigate the effectiveness of Z-drugs in adults using a data source that was less likely to be affected by publication bias. The approach: We examined clinical trials of currently approved Z-drugs submitted to the Food and Drug Administration (FDA) since pharmaceutical companies are required to provide information on all sponsored trials, whether published or not, when applying for new drug approvals. We included randomized double blind placebo controlled trials and excluded studies with a crossover design, those including healthy patients with normal sleep or single night studies with induced insomnia. We analysed drug efficacy as change score from baseline to posttest for drug and placebo groups, and the difference of both change scores for available outcomes. Weighted raw and standardized mean differences with their confidence intervals (CIs) under random-effects assumptions were calculated for polysomnographic (PSG) and subjective outcomes: wake after sleep onset, sleep latency, number of awakenings, total sleep time, sleep efficiency, subjective sleep quality, and morning sleepiness score. We performed weighted regression moderator analysis to explain heterogeneity of drug effects. Findings: We included 16 studies comprising 4973 subjects from different countries, varying drug dosages, treatment lengths and study years. Z-drugs showed significant but small improvements (reductions) only in PSG (d+ = -0.36, 95% CI = -0.57 to -0.16) and subjective sleep latency (d+ = -0.33, 95% CI = -0.62 to -0.041) compared with placebo. Analyses of weighted mean raw differences indicated that drugs decreased sleep latency by only 22 minutes (95% CI = -33 TO -11) with no evidence of change in other measures. Moderator analyses indicated that sleep latency was more likely to be reduced with larger drug doses, studies published earlier, including higher proportions of younger or women patients, and of longer treatment duration. Consequences: This study of FDA data shows that, despite being commonly prescribed, Z-drugs have limited benefit with small reductions in subjective and PSG sleep latency especially with larger dosages, but no improvement in other sleep measures compared to placebo. Placebo effects were moderate for sleep latency. Doctors and patients need to be aware of the relative benefits as well as harms of hypnotic drugs when deciding to use them in preference to psychological treatments

The Efficacy of Paroxetine and Placebo in Treating Anxiety and Depression: A Meta-Analysis of Change on the Hamilton Rating Scales

Background: Previous meta-analyses of published and unpublished trials indicate that antidepressants provide modest benefits compared to placebo in the treatment of depression; some have argued that these benefits are not clinically significant. However, these meta-analyses were based only on trials submitted for the initial FDA approval of the medication and were limited to those aimed at treating depression. Here, for the first time, we assess the efficacy of a selective serotonin reuptake inhibitor (SSRI) in the treatment of both anxiety and depression, using a complete data set of all published and unpublished trials sponsored by the manufacturer. Methods and Findings: GlaxoSmithKline has been required to post the results for all sponsored clinical trials online, providing an opportunity to assess the efficacy of an SSRI (paroxetine) with a complete data set of all trials conducted. We examined the data from all placebo-controlled, double-blind trials of paroxetine that included change scores on the Hamilton Rating Scale for Anxiety (HRSA) and/or the Hamilton Rating Scale for Depression (HRSD). For the treatment of anxiety (k = 12), the efficacy difference between paroxetine and placebo was modest (d = 0.27), and independent of baseline severity of anxiety. Overall change in placebo-treated individuals replicated 79% of the magnitude of paroxetine response. Efficacy was superior for the treatment of panic disorder (d = 0.36) than for generalized anxiety disorder (d = 0.20). Published trials showed significantly larger drug-placebo differences than unpublished trials (d’s = 0.32 and 0.17, respectively). In depression trials (k = 27), the benefit of paroxetine over placebo was consistent with previous meta-analyses of antidepressant efficacy (d = 0.32). Conclusions: The available empirical evidence indicates that paroxetine provides only a modest advantage over placebo in treatment of anxiety and depression. Treatment implications are discussed