Glen I. Spielmans

Prayer and Health: Review, Meta-Analysis, and Research Agenda

This article reviews the empirical research on prayer and health and offers a research agenda to guide future studies. Though many people practice prayer and believe it affects their health, scientific evidence is limited. In keeping with a general increase in interest in spirituality and complementary and alternative treatments, prayer has garnered attention among a growing number of behavioral scientists. The effects of distant intercessory prayer are examined by meta-analysis and it is concluded that no discernable effects can be found. The literature regarding frequency of prayer, content of prayer, and prayer as a coping strategy is subsequently reviewed. Suggestions for future research include the conduct of experimental studies based on conceptual models that include precise operationally defined constructs, longitudinal investigations with proper measure of control variables, and increased use of ecological momentary assessment techniques.

Does type-D personality predict outcomes among patients with cardiovascular disease? A meta-analytic review

OBJECTIVE Research generally indicates that psychological variables are stronger predictors of cardiovascular outcomes in healthy populations than in those with preexisting illness. Studies of Type-D personality, however, suggest that it may also be predictive of negative health outcomes in cardiovascular patient populations. To date, no independent, comprehensive meta-analysis centered specifically on Type-D has integrated this literature and provided quantitative estimates of these relationships. The present meta-analysis investigated the associations between Type-D personality and (a) major adverse cardiac events (MACE), (b) health-related quality of life (HRQOL) and (c) biochemical markers of cardiovascular disease among cardiovascular patients. METHOD Two independent reviewers abstracted data from 15 separate studies. A random effects meta-analytic model was utilized to calculate omnibus effect sizes for each set of related studies, i.e., for the MACE (N of patients=2903), HRQOL (N of patients=1263) and biochemical marker (N of patients=305) measures. RESULTS A positive association was found between Type-D personality and MACE, whereas a negative association was observed between Type-D personality and HRQOL. There was a trend toward significance in the association between Type-D personality and cardiovascular disease biomarkers. CONCLUSION Type-D personality is a promising construct for understanding psychological relationships with important outcomes among cardiovascular patients. Subsequent investigations undertaken by a more diverse group of unaffiliated scientists are important for further development in this line of research.

The promotion of olanzapine in primary care: An examination of internal industry documents

Media reports have discussed how olanzapine was marketed off-label for dementia and subsyndromal bipolar disorder. Much of this marketing occurred in primary care settings. However, these reports have provided few details. In legal proceedings, Lilly disclosed internal documents that detail the strategies utilized to market olanzapine. The current paper addresses the marketing of olanzapine in detail based upon a review of these documents. All 358 documents released by Lilly are publicly available online. Documents were utilized for this review if they were relevant to the marketing of olanzapine in primary care settings in the United States. It was found that olanzapine was marketed off-label in primary care settings for relatively mild symptoms that were framed as bipolar disorder and schizophrenia. A key strategy in this campaign was the use of hypothetical patient profiles in detailing visits, most of which clearly failed to meet diagnostic criteria for any recognized mental disorder. Evidence emerged that olanzapine was also marketed off-label as a treatment for dementia.

Duloxetine Does Not Relieve Painful Physical Symptoms in Depression: A Meta-Analysis

Background:Duloxetine inhibits both serotonin and norepinephrine reuptake and is marketed as a treatment for both the core emotional symptoms and painful physical complaints that often accompany depression. Some studies have found that duloxetine is efficacious in treating painful symptoms associated with depression but these findings have been inconsistent. Several narrative review articles have reached positive conclusions about the efficacy of duloxetine as an analgesic in depression but there has been no quantitative systematic review regarding the impact of duloxetine on pain among this population. A meta-analysis of data pertaining to duloxetine’s purported analgesic effects on depressed patients was thus undertaken. Methods:Studies were selected through searching Medline and Cochrane Trial databases as well as examining Lilly’s public clinical trial database. A random effects model was used. Results: Across five trials, the results indicate a very small (d = 0.115) and statistically nonsignificant (p = 0.057) analgesic effect for duloxetine. Additionally, some of the relevant data on duloxetine’s effects have not been reported fully, making it likely that the obtained results reflect an overestimate of its true impact on painful physical symptoms in depression. Discussion:The current analysis is based on a small number of studies; further trials may yield significant results favoring duloxetine. Based upon the currently available evidence, the marketing of duloxetine as an antidepressant with analgesic properties for people with depression does not appear to be adequately supported.

Specificity of psychological treatments for bulimia nervosa and binge eating disorder? A meta-analysis of direct comparisons.

Treatment guidelines state that cognitive-behavioral therapy (CBT) and interpersonal therapy are the best-supported psychotherapies for bulimia nervosa (BN) and that CBT is the preferred psychological treatment for binge eating disorder (BED). However, no meta-analysis which both examined direct comparisons between psychological treatments for BN and BED and considered the role of moderating variables, such as the degree to which psychotherapy was bona fide, has previously been conducted Thus, such an analysis was undertaken. We included 77 comparisons reported in 53 studies. The results indicated that: (a) bona fide therapies outperformed non-bona fide treatments, (b) bona fide CBT outperformed bona fide non-CBT interventions by a statistically significant margin (only approaching statistical significance for BN and BED when examined individually), but many of these trials had confounds which limited their internal validity, (c) full CBT treatments offered no benefit over their components, and (d) the distribution of effect size differences between bona fide CBT treatments was homogeneously distributed around zero. These findings provide little support for treatment specificity in psychotherapy for BN and BED.

The efficacy of antidepressants on overall well-being and self-reported depression symptom severity in youth: a meta-analysis.

Background: Recent meta-analyses of the efficacy of second-generation antidepressants for youth have concluded that such drugs possess a statistically significant advantage over placebo in terms of clinician-rated depressive symptoms. However, no meta-analysis has included measures of quality of life, global mental health, self-esteem, or autonomy. Further, prior meta-analyses have not included self-reports of depressive symptoms. Methods: Studies were selected through searching Medline, PsycINFO, and the Cochrane Central Register for Controlled Trials databases as well as GlaxoSmithKlines online trial registry. We included self-reports of depressive symptoms and pooled measures of quality of life, global mental health, self-esteem, and autonomous functioning as a proxy for overall well-being. Results: We found a nonsignificant difference between second-generation antidepressants and placebo in terms of self-reported depressive symptoms (k = 6 trials, g = 0.06, p = 0.36). Further, pooled across measures of quality of life, global mental health, self-esteem, and autonomy, antidepressants yielded no significant advantage over placebo (k = 3 trials, g = 0.11, p = 0.13). Discussion: Though limited by a small number of trials, our analyses suggest that antidepressants offer little to no benefit in improving overall well-being among depressed children and adolescents.

Drug Approval and Drug Effectiveness

Data on the efficacy and safety of psychiatric medicines should form the foundation of evidence-based treatment practices. The US Food and Drug Administration (FDA) reviews such data in determining whether to approve new treatments, and the published literature serves as a repository for evidence on treatment benefits and harms. We describe the FDA review of clinical trials, examining the underlying logic and legal guidelines. Several FDA reviews provide evidence that the agency requires only minimal efficacy for psychiatric drugs. Further, in some instances, the FDA has relied on secondary rather than primary outcomes and has discounted the findings of negative studies in its review of antidepressant and antipsychotic medications. The published literature provides another lens into the safety and efficacy of treatments. We describe how treatment efficacy is systematically overstated and treatment-related harms are understated in the scientific literature. Suggestions are provided to improve public access to underlying safety and efficacy data and for the FDA to potentially improve its review process.

Moderators in psychotherapy meta-analysis

Abstract Psychotherapy meta-analyses sometimes generate heterogeneous results, partially due to key methodological characteristics which vary between studies (e.g., psychotherapy conditions are contrasted with structurally different control conditions). Examining these potential moderator variables can help explain heterogeneous results within and between psychotherapy meta-analyses. The present manuscript provides an overview of moderators that are highly relevant to test the generalizability of effects across psychotherapy trials. These moderators mainly fall into one of the following groups: (a) structural equivalence of interventions, (b) preferences/allegiances, (c) therapist effects, and (d) sample representativeness. Individual moderators include: Bona fide psychotherapy, proximity to psychological interventions, psychotherapy orientation, pre-training of therapists, supervision, caseload of therapists, dosage, homework, patient preferences, researcher and therapist allegiance, therapist effects in nested designs, aspects of sample representativeness, multiple outcomes, and time of assessment. Our analysis of 15 psychotherapy meta-analyses published in 2016 suggests that the structural equivalence of psychotherapeutic conditions, patient and therapist preferences/allegiances, therapist effects and nested data structures as well as sample representativeness were often neglected and little-discussed as potential moderators. The manuscript describes further conceptual and methodological challenges when conducting moderator analyses such as the categorization of psychological treatments and the importance of interrater coding. We encourage meta-analysts to consider moderators which have previously shown utility in explaining heterogeneous results in the psychotherapy literature. Clinical or methodological significance of this article: Relevant moderator variables help explain heterogeneous results in psychotherapy meta-analyses. Though these variables are often overlooked, they should be regularly incorporated in meta-analyses.

Concerns about data reporting and interpretation in “Efficacy and tolerability of the novel triple reuptake inhibitor amitifadine in the treatment of patients with major depressive disorder: A randomized, double-blind, placebo-controlled trial”

Tran et al. (2012) reported results from a proof-of-concept placebo-controlled study of amitifadine in major depressive disorder and made comparisons to other antidepressant drugs with respect to drug-placebo differences and effect size. We have concerns about how data were reported as well as the validity of these comparisons. Specifically, Tran et al.’s primary outcome measure was “the change in the total score on the Montgomery Asberg Depression Rating Scale (MADRS) from baseline to the end of treatment” (Section 2.3, “Outcome Measures”), and they assert that “the difference between amitifadine and placebo for mean change from baseline in MADRS score was 3.8” (Section 4, “Discussion”). However, according to Table 3, 3.8 is actually the group difference in adjusted mean MADRS scores at end of treatment (Week 6) as opposed to the difference in mean change from baseline. In actuality, the mean change from baseline to endpoint in the groups are as follows, using the baseline MADRS scores from Table 2 and the posttest scores from Table 3: amitifadine (30.6–18.2) 1⁄4 12.4; placebo (32.2– 22.0) 1⁄4 10.2. These results indicate that the difference between amitifadine and placebo for mean change from baseline in MADRS score was only 2.2. Indeed, placebo accounted for 82% of the effect of amitifadine. Tran et al. further asserted that the effect size associated with amitifadine (d 1⁄4 0.61) was “about double” the pooled effect size achieved in clinical trials of other antidepressants (d 1⁄4 0.32; Turner et al., 2008); however, the effect size generated in Tran et al. cannot reasonably be compared to the effect size found across a wide body of antidepressant clinical trials which likely differed substantially from Tran et al. in terms of multiple important variables such as initial severity, placebo response rate, duration of trial, etc (Shadish and Sweeney, 1991; Spielmans et al., 2007). Perhaps the most overt issue with claims by Tran et al. relates to the use of the Mixed Model Repeated Measures (MMRM) approach to data analysis and effect size calculation. Most (if not all) of the effect sizes reported in the Turner et al. meta-analysis were obtained using the Last Observation Carried Forward (LOCF) data analytic approach which yields different effect sizes than does MMRM, such that Tran et al. compare “apples to oranges”. This issue was the source of controversy when Thase et al., 2006 reported the results of the BOLDER II study of quetiapine monotherapy for bipolar I and II depression

Using the MMPI-2 to Predict Symptom Reduction during Psychotherapy in a Sample of Community Outpatients

In the present study, potential MMPI-2 predictors of psychotherapy outcome were examined in a community clinical sample of 51 patients seeking treatment at a university training clinic. Results indicated that particular MMPI-2 scales (L, F, Pd, Pa, Sc, Trt) were the most predictive of initial levels of patient distress, whereas three other clinical scales (Hs, D, Hy) were significantly associated with actual symptom reduction over time. The clinical implications of these data include the use of the MMPI-2 in clinical practice as a means to frame the provision of direct feedback to patients regarding the likelihood of treatment response, which in turn, might actually have therapeutic benefits. The limitations of the study are reviewed and suggestions for future research are offered, including the potential use of widely known and utilized instruments in helping to predict response to psychotherapy.