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不同治疗频率的针刺治疗餐后不适综合征的随机临床试验:一项初步研究。

Acupuncture of different treatment frequency in postprandial distress syndrome: A pilot randomized clinical trial.

机构信息

Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China.

出版信息

Neurogastroenterol Motil. 2020 Jun;32(6):e13812. doi: 10.1111/nmo.13812. Epub 2020 Feb 12.

DOI:10.1111/nmo.13812
PMID:32048788
Abstract

BACKGROUND

The evidence for different frequencies of acupuncture treatment in postprandial distress syndrome (PDS) is insufficient. This study determined whether 3 sessions per week of acupuncture treatment are superior to 1 session per week for symptomatic outcomes in PDS.

METHODS

This 16-week randomized clinical pilot trial was conducted in an outpatient setting in China. Patients with PDS were randomly assigned to receive 3 sessions per week of acupuncture (group H) or 1 session per week of acupuncture (group L) for 4 weeks. The primary outcome was the complete elimination of core symptoms at week 4. Secondary outcomes included overall treatment efficacy, dyspepsia symptoms, quality of life, anxiety, and depression.

KEY RESULTS

Sixty patients were randomized of whom 53 (88.3%) completed this trial. The complete elimination rate of core symptoms was 26.7% (95% CI 12.3%-45.9%) in group H and 10.0% (95% CI 2.1%-26.5%) in group L at week 4 (P = .095). There was a significant difference between H and group L at weeks 8, 12, and 16 (P = .038, .02, and .02). All secondary outcomes were better in group H at all time points. No serious adverse events occurred in either groups.

CONCLUSIONS

This trial showed that acupuncture, at 3 sessions per week, tended to improve symptoms and the quality of life among patients with PDS as compared to once a week. Acupuncture treatment for 4 weeks was feasible and safe. A larger sample, multicenter, randomized controlled trial of acupuncture for PDS appears to be justified in the future.

摘要

背景

目前有关针灸治疗餐后不适综合征(PDS)的频率证据不足。本研究旨在探讨每周 3 次与每周 1 次的针灸治疗方案在 PDS 症状缓解方面的差异。

方法

本研究为 16 周的随机临床试点试验,在中国的门诊环境中进行。将 PDS 患者随机分为每周 3 次针灸组(H 组)和每周 1 次针灸组(L 组),分别接受 4 周治疗。主要结局是治疗 4 周时核心症状完全缓解的比例。次要结局包括总体治疗效果、消化不良症状、生活质量、焦虑和抑郁。

结果

共有 60 例患者被随机分组,其中 53 例(88.3%)完成了本试验。治疗 4 周时,H 组核心症状完全缓解率为 26.7%(95%CI 12.3%-45.9%),L 组为 10.0%(95%CI 2.1%-26.5%)(P=0.095)。H 组与 L 组在第 8、12、16 周时的差异均有统计学意义(P=0.038、0.02、0.02)。在所有时间点,H 组的所有次要结局均优于 L 组。两组均未发生严重不良事件。

结论

与每周 1 次相比,每周 3 次的针灸治疗方案更有助于改善 PDS 患者的症状和生活质量。4 周的针灸治疗方案是可行且安全的。未来有必要开展更大样本、多中心、随机对照试验,进一步评估针灸治疗 PDS 的疗效。

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