Psychological Treatment Trials for Hypoactive Sexual Desire Disorder: A Sexual Medicine Critique and Perspective

Abstract

Introduction Publications claim efficacy for treatment of hypoactive sexual desire disorder (HSDD) in women with cognitive behavior therapy (CBT) and mindfulness meditation training (MMT). However, no review has evaluated the evidence for these therapies from the rigorous perspective of sexual medicine. Aims The aim of this study was to evaluate the published controlled trials of CBT and MMT for disorders of sexual desire from the perspective of sexual medicine standards of control paradigms, risk/benefit ratios, and clinical significance. Methods MEDLINE was reviewed from the last 10 years. Evaluated study quality via 10 metrics and efficacy as mean change, and proportion of responders and remitters. Results Three controlled trials support CBT and two controlled trials support MMT. The reports of the trials each lacked several scientific requirements: a hierarchy of endpoints with a planned primary endpoint, sufficient information on the intervention to reproduce it, randomization, adequate control, accepted measures of benefits and harms, compliance data, and/or outcomes of clinical relevance. Conclusions Psychological treatments for HSDD are not yet supported by adequate clinical trials. The current scientific and regulatory standards for drug treatment trials should also be applicable to psychological treatment trials.

Challenges in Designing Psychological Treatment Studies for Sexual Dysfunction

“…Though the findings of this meta-analysis challenge the conclusions by Pyke and Clayton (2015) On the basis of the Frühauf meta-analysis, and another systematic review (Günzler & Berner, 2012), neither of which were cited in the Pyke & Clayton (2015) critique, the International Consultation on Sexual Medicine, Committee on Psychological and Interpersonal Dimensions of Sexual function and Dysfunction recommended that clinicians consider CBT in the treatment of women with low sexual desire with a Grade A recommendation i.e., a strong recommendation based on high quality evidence (Brotto et al, 2016). We believe that these reviews demonstrating the efficacy of CBT for HSDD should not be taken as -proof‖, or rather in this case lack of proof, for the therapy's benefit.…”

“…The 10 standards included: (1) clear goals, (2) sufficient information on the therapy to duplicate it, (3) randomization to treatments, (4) equality of treatment groups, (5) adequate controls, (6) measure of compliance, (7) employ validated measures, (8) demonstrate clinical relevance, (9) clinically relevant duration, and (10) positive benefit-risk ratio. As noted by McCabe and Connaughton (2015) in their accompanying editorial, the paper by Pyke and Clayton (2015) provides a good point of discussion for future psychological treatment outcome studies in sexual dysfunction (for women and men); however, we believe that a number of the conclusions reached in this paper are not sufficiently supported by existing research, and/or do not advance our knowledge of effective treatments for sexual dysfunction. We hope that our remarks will continue the dialogue among clinicians and researchers to attain the highest possible standards, within what is achievable, when designing psychological treatment outcome studies.…”

“…The standard approach to evaluating efficacy (i.e., improves relevant outcomes to a greater degree than a relevant control condition in a tightly controlled study to maximize internal 1 Of note, the reviewed literature and critique by Pyke and Clayton (2015) focus on the diagnosis of HSDD (DSM-IV-TR, American Psychiatric Association, 2000 . This meta-analysis also found that effect sizes for the increases in sexual satisfaction and reductions in symptom severity for treatment of HSDD using cognitive-behavioral therapy (CBT) and CBT plus skills training, were in the moderate to large effect size range, as compared to a wait-list control (Frühauf et al, 2013).…”

“…We hope that our remarks will continue the dialogue among clinicians and researchers to attain the highest possible standards, within what is achievable, when designing psychological treatment outcome studies. Our comments are organized around three assumptions that we believe underlie Pyke and Clayton's (2015) conclusions regarding the efficacy of psychological treatments for HSDD.…”

“…We end with some specific suggestions for researchers to consider as they design future psychological trials for low desire. Pyke and Clayton (2015) provided a thoughtful critique of available controlled outcome studies focused on the treatment of women with low sexual desire (namely, hypoactive sexual desire Downloaded by [2.97.114.37] at 04:59 21 July 2016 disorder; HSDD).…”