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Psychotherapy with somatosensory stimulation for endometriosis-associated pain: a randomized controlled trial
Meissner K, Schweizer-Arau A, Limmer A, Preibisch C, Popovici RM, Lange I, de Oriol B, Beissner F
Obstetrics and Gynecology 2016 Nov;128(5):1134-1142
clinical trial
5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To evaluate whether psychotherapy with somatosensory stimulation is effective for the treatment of pain and quality of life in patients with endometriosis-related pain. METHODS: Patients with a history of endometriosis and chronic pelvic pain were randomized to either psychotherapy with somatosensory stimulation (ie, different techniques of acupuncture point stimulation) or wait-list control for 3 months, after which all patients were treated. The primary outcome was brain connectivity assessed by functional magnetic resonance imaging. Prespecified secondary outcomes included pain on 11-point numeric rating scales (maximal and average global pain, pelvic pain, dyschezia, and dyspareunia) and physical and mental quality of life. A sample size of 30 per group was planned to compare outcomes in the treatment group and the wait-list control group. RESULTS: From March 2010 through March 2012, 67 women (mean age 35.6 years) were randomly allocated to intervention (n = 35) or wait-list control (n = 32). In comparison with wait-list controls, treated patients showed improvements after 3 months in maximal global pain (mean group difference -2.1, 95% confidence interval (CI) -3.4 to -0.8; p = 0.002), average global pain (-2.5, 95% CI -3.5 to -1.4; p < 0.001), pelvic pain (-1.4, 95% CI -2.7 to -0.1; p = 0.036), dyschezia (-3.5, 95% CI -5.8 to -1.3; p = 0.003), physical quality of life (3.8, 95% CI 0.5 to 7.1, p = 0.026), and mental quality of life (5.9, 95% CI 0.6 to 11.3; p = 0.031); dyspareunia improved nonsignificantly (-1.8, 95% CI -4.4 to 0.7; p = 0.150). Improvements in the intervention group remained stable at 6 and 24 months, and control patients showed comparable symptom relief after delayed intervention. CONCLUSION: Psychotherapy with somatosensory stimulation reduced global pain, pelvic pain, and dyschezia and improved quality of life in patients with endometriosis. After 6 and 24 months, when all patients were treated, both groups showed stable improvements. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, https://ClinicalTrials.gov, NCT01321840.
With permission from Excerpta Medica Inc.

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