Effect Size in Efficacy Trials of Women With Decreased Sexual Desire

Pyke, Robert E.; Clayton, Anita H.

doi:10.1016/j.sxmr.2018.01.003

Cited by 11 publications

(8 citation statements)

References 21 publications

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“…Moreover, the statistical methodology did not consider the effect size, which measures the magnitude of a given intervention in comparison with placebo and other treatments, without confounding by sample size. The comparison of effect size for medications and placebo by using the main measures of sexual desire and distress indicated that the median differential effect size was almost double for medications (flibanserin,BMT, and transdermal testosterone) when compared to placebo [14]. These results are in line with patient-reported outcomes on meaningful clinical benefits with drugs over placebo and collectively suggest reconsidering study design, validated end points, and instruments to assess clinical significance.…”

Section: Introductionmentioning

confidence: 72%

What are the challenges in prescribing pharmacotherapy for female sexual dysfunctions?

Nappi

Gardella

2019

Expert Opinion on Pharmacotherapy

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Section: Introductionmentioning

confidence: 72%

What are the challenges in prescribing pharmacotherapy for female sexual dysfunctions?

Nappi

Gardella

2019

Expert Opinion on Pharmacotherapy

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“…Both treatments produced significant increases in sexual desire and arousal that corresponded with large effect sizes ( d > −1.29). By comparison, a recent review of the effect sizes of pharmaceutical trials for women with low desire revealed a mean effect size of 1.0 for flibanserin, 0.9 for bremelanotide, and 0.9 for transdermal testosterone (Pyke & Clayton, 2018). The effect sizes for SIDI scores in the present study were higher than both the effect sizes associated with sexual pharmaceuticals and those found in a pilot study of the same MBCT ( d = 0.94; Paterson et al, 2017).…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

“…The effect sizes from t1 to follow-up time points across the STEP and MBCT treatments ranged from d = 0.83 to 1.17, whereas effect sizes across the flibanserin trials were all less than d = .90, with most ranging between 0.40 and 0.70 (Pyke & Clayton, 2018). Even the 3-point mean difference between the two active treatment groups is notably larger than the largest difference across studies between active treatment and placebo on FSDS-R scores for flibanserin (Pyke & Clayton, 2018). The 12-month FSDS-R scores in the MBCT and STEP groups (18.92 and 21.6, respectively), although still in the clinical range, are appreciably lower than the lowest scores obtained in trials of flibanserin (23.4) and bremelanotide (22.0; Pyke & Clayton, 2018).…”

Section: Discussionmentioning

confidence: 99%

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A randomized trial comparing group mindfulness-based cognitive therapy with group supportive sex education and therapy for the treatment of female sexual interest/arousal disorder.

Brotto

Zdaniuk

Chivers³

et al. 2021

Journal of Consulting and Clinical Psychology

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Objective: Sexual interest/arousal disorder (SIAD) is the most prevalent sexual dysfunction in women. Our goal was to compare (a) group mindfulness-based cognitive therapy (MBCT) plus sex education with (b) group supportive sex education and therapy (STEP) for women with SIAD. Method: Eight-session treatments were delivered weekly and participants completed the measures of sexual desire and arousal, sexual distress, relationship satisfaction, rumination, and global impressions of change, at baseline, immediately posttreatment, and at 6-and 12-month posttreatment. Of 148 women who consented, 70 were randomized to MBCT (mean age 39.3 ± 13.2 years) and 78 were randomized to STEP (mean age 37.9 ± 12.2 years). Results: Sexual desire and arousal significantly improved at each time point relative to baseline, with large effect sizes (d = −1.29 to −1.60), and similarly for MBCT and STEP. Sexual distress also improved at each time point with large effect sizes (d = 0.83-1.17), and more so for MBCT relative to STEP. Relationship satisfaction significantly improved (d = −0.17 to −0.20), and rumination about sex improved significantly in both arms, with medium effect sizes (d = 0.42-0.69), with both outcomes responding more to MBCT. About half the participants across both treatments reported moderate or great improvements in global indicators of desire and overall sexuality. Conclusions: Results support the efficacy of both group MBCT and group supportive sex education for improving symptoms of SIAD with 12-month retention of improvements. What is the public health significance of this article?This study suggests that both mindfulness-based group therapy and supportive sex education are effective in improving the symptoms of sexual interest/arousal disorder in women, with greater improvements for mindfulness-based group therapy for sexual distress. Treatment effects from both therapies were strong to very strong and were maintained 12 months after treatment. Women reported a very high level of overall satisfaction with both treatments.

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“…Pyke and Clayton 7 examined the effect size (ES; Cohen’s d) of treatments for HSDD with specific reference to testosterone, flibanserin, and bremelanotide vs placebo controls as compared with psychotherapy vs wait-list controls. They found that the mean ES was 1.0 for pharmacological interventions vs 0.55 for drug placebo; and the mean ES was 1.0 for psychotherapies vs 0.05 for wait-list controls.…”

Section: Hsdd: How Large Is the Treatment Effect?mentioning

confidence: 99%