节律性按摩对比心率变异性生物反馈治疗痛经的疗效：一项随机对照试验。
Efficacy of rhythmical massage in comparison to heart rate variability biofeedback in patients with dysmenorrhea-A randomized, controlled trial.
机构信息
ARCIM Institute, Filderstadt, Germany; Tübingen University Children´s Hospital, Germany; Dept of Pediatrics, Filderklinik, Filderstadt, Germany.
ARCIM Institute, Filderstadt, Germany; Tübingen University Children´s Hospital, Germany.
出版信息
Complement Ther Med. 2019 Feb;42:438-444. doi: 10.1016/j.ctim.2018.11.009. Epub 2018 Nov 13.
BACKGROUND
20-90% 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 = .005). Bonferroni adjusted post-hoc tests revealed a significant difference between rhythmical massage and control group (mean difference: -1.61; 95 CI: -2.77/-0.44; p = .004; ES: -0.80). No significant differences were found between rhythmical massage and biofeedback (mean difference: -0.71; 95 CI: -1.82/ 0.40; p = .361; ES: -0.34) and between biofeedback and control group (mean difference: -0.90; 95 CI: -2.10/-0.30; p = .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.
背景
20-90%的女性患有痛经。原发性痛经（PD）的标准治疗方法是使用 NSAIDs 和口服避孕药，虽然有效，但并非没有可能的副作用。
目的
研究节奏按摩（人智学医学）和心率变异性生物反馈与常规护理（对照组）相比，对原发性痛经女性疼痛强度的疗效。
方法
这是一项三臂随机对照研究。两种干预措施（每周一次节奏按摩或每天 15 分钟心率变异性生物反馈）均在三个月内进行。第三组（对照组）采用常规护理。主要结局是三个月后（评估 2，t2）月经期间平均疼痛强度（通过数字评分量表，NRS）的组间差异。次要结局是使用镇痛药、生活质量（SF-12）和心率变异性。
结果
该研究共纳入 60 名女性，平均年龄 29.7 岁，标准差 8.0（节奏按摩组 n=23，生物反馈组 n=20，对照组 n=17）。三个月后，三组间主要结局有显著差异（p=0.005）。Bonferroni 事后检验显示，节奏按摩组与对照组间有显著差异（平均差异：-1.61；95%置信区间：-2.77/-0.44；p=0.004；ES：-0.80）。节奏按摩组与生物反馈组间无显著差异（平均差异：-0.71；95%置信区间：-1.82/0.40；p=0.361；ES：-0.34），生物反馈组与对照组间也无显著差异（平均差异：-0.90；95%置信区间：-2.10/-0.30；p=0.211；ES：-0.51）。次要结局在 t2 时三组间无显著差异。生物反馈组的脱落率（n=6）高于按摩组（n=2）或对照组（n=4）。
结论
初步证据表明，与常规护理相比，节奏按摩可能在 12 周后改善疼痛强度。
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