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Efficacy of rhythmical massage in comparison to heart rate variability biofeedback in patients with dysmenorrhea -- a randomized, controlled trial [with consumer summary]
Vagedes J, Fazeli A, Boening A, Helmert E, Berger B, Martin D
Complementary Therapies in Medicine 2019 Feb;42:438-444
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: 20 to 90% of all women suffer from dysmenorrhea. Standard therapy of primary dysmenorrhea (PD) are NSAIDs and oral contraceptives, effective but not without possible side effects. OBJECTIVE: To examine the efficacy of rhythmical massage (Anthroposophic Medicine) and heart rate variability biofeedback compared to usual care (control group) on pain intensity in women with primary dysmenorrhea. METHODS: This was a three-arm randomized controlled study. Both interventions (rhythmical massage once a week or HRV biofeedback 15 min daily) were carried out over a period of three months. The third group (control) applied usual care. The primary outcome were between-group differences in mean pain intensity (detected by a Numeric Rating Scale, NRS) during menstruation after three months (post-assessment, t2). Secondary outcomes were the use of analgesics, quality of life (SF-12) and heart rate variability. RESULTS: The study involved 60 women, mean age 29.7 years, SD 8.0 (n = 23 rhythmical massage, n = 20 biofeedback, n = 17 control). For the primary outcome there was a significant difference between the groups after three months (p = 0.005). Bonferroni adjusted post-hoc tests revealed a significant difference between rhythmical massage and control group (mean difference -1.61; 95 CI -2.77 to -0.44; p = 0.004; ES -0.80). No significant differences were found between rhythmical massage and biofeedback (mean difference -0.71; 95 CI -1.82 to 0.40; p = 0.361; ES -0.34) and between biofeedback and control group (mean difference -0.90; 95 CI -2.10 to -0.30; p = 0.211; ES -0.51). For the secondary outcomes no significant differences were found between the groups at t2. The drop-out rate was higher in the biofeedback group (n = 6) than in the massage (n = 2) or the control group (n = 4). CONCLUSION: Preliminary evidence suggests that rhythmical massage might improve pain intensity after 12 weeks compared to usual care.

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