title: Psychological Treatment Trials for Hypoactive Sexual Desire Disorder: A Sexual Medicine Critique and Perspective.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
authors.affiliation: Medical Department, S1 Biopharma, Inc., New Fairfield, CT, USA.
authors.forename: Robert E
authors.identifier: http://orcid.org/0000-0003-0764-2500
authors.initials: RE
authors.lastname: Pyke
authors.affiliation: Department of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine, Charlottesville, VA, USA.
authors.forename: Anita H
authors.initials: AH
authors.lastname: Clayton
mesh_terms: D000328:Adult; D015928:Cognitive Behavioral Therapy; D005260:Female; D006801:Humans; D007989:Libido; D012725:Sexual Behavior / Q000523:psychology*; D020018:Sexual Dysfunctions, Psychological / Q000523:psychology* / Q000628:therapy*
keywords: Clinical Significance; Cognitive Behavior Therapy; Control Treatment Paradigm; Female Sexual Dysfunction; Hypoactive Sexual Desire Disorder; Mindfulness Meditation