针刺治疗慢性严重功能性便秘：一项随机试验。

Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial.

机构信息

From Guang'anmen Hospital, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing Traditional Chinese Medicine Hospital of Capital Medical University, Dongzhimen Hospital of Beijing University of Chinese Medicine, Huguosi Hospital of Chinese Medicine of Beijing University of Chinese Medicine, Beijing; West China Hospital of Sichuan University, Chengdu, Sichuan; Yueyang Hospital of Integrated Traditional Chinese and Western Medicine of Shanghai University of Traditional Chinese Medicine, Shanghai; The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang; Guangdong Province Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong; The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin; Jiangsu Province Hospital of Traditional Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, Jiangsu; Heilongjiang Province Academy of Chinese Medical Science, Ha'erbin, Heilongjiang; The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui; Wuhan Integrated Traditional Chinese Medicine and Western Medical Hospital, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, Hubei, China; and Daemen College, Physical Therapy Wound Care Clinic, Amherst, New York.

出版信息

Ann Intern Med. 2016 Dec 6;165(11):761-769. doi: 10.7326/M15-3118. Epub 2016 Sep 13.

DOI:10.7326/M15-3118

PMID:27618593

Abstract

BACKGROUND

Acupuncture has been used for chronic constipation, but evidence for its effectiveness remains scarce.

OBJECTIVE

To determine the efficacy of electroacupuncture (EA) for chronic severe functional constipation (CSFC).

DESIGN

Randomized, parallel, sham-controlled trial. (ClinicalTrials.gov: NCT01726504).

SETTING

15 hospitals in China.

PARTICIPANTS

Patients with CSFC and no serious underlying pathologic cause for constipation.

INTERVENTION

28 sessions of EA at traditional acupoints or sham EA (SA) at nonacupoints over 8 weeks.

MEASUREMENTS

The primary outcome was the change from baseline in mean weekly complete spontaneous bowel movements (CSBMs) during weeks 1 to 8. Participants were followed until week 20.

RESULTS

1075 patients (536 and 539 in the EA and SA groups, respectively) were enrolled. The increase from baseline in mean weekly CSBMs during weeks 1 to 8 was 1.76 (95% CI, 1.61 to 1.89) in the EA group and 0.87 (CI, 0.73 to 0.97) in the SA group (between-group difference, 0.90 [CI, 0.74 to 1.10]; P < 0.001). The change from baseline in mean weekly CSBMs during weeks 9 to 20 was 1.96 (CI, 1.78 to 2.11) in the EA group and 0.89 (CI, 0.69 to 0.95) in the SA group (between-group difference, 1.09 [CI, 0.94 to 1.31]; P < 0.001). The proportion of patients having 3 or more mean weekly CSBMs in the EA group was 31.3% and 37.7% over the treatment and follow-up periods, respectively, compared with 12.1% and 14.1% in the SA group (P < 0.001). Acupuncture-related adverse events during treatment were infrequent in both groups, and all were mild or transient.

LIMITATIONS

Longer-term follow-up was not assessed. Acupuncturists could not be blinded.

CONCLUSION

Eight weeks of EA increases CSBMs and is safe for the treatment of CSFC. Additional study is warranted to evaluate a longer-term treatment and follow-up.

PRIMARY FUNDING SOURCE

Ministry of Science and Technology of the People's Republic of China through the Twelfth Five-Year National Science and Technology Pillar Program.

摘要

背景

针灸已被用于治疗慢性便秘，但其实效证据仍然不足。

目的

确定电针对慢性严重功能性便秘（CSFC）的疗效。

设计

随机、平行、假对照试验。（ClinicalTrials.gov：NCT01726504）。

地点

中国的 15 家医院。

参与者

患有 CSFC 且无严重潜在病理原因导致便秘的患者。

干预措施

8 周内，28 次在传统穴位进行电针（EA）或在非穴位进行假电针（SA）。

测量

主要结局是从基线到第 1 周到第 8 周每周完全自发性排便次数（CSBMs）的变化。参与者随访至第 20 周。

结果

共纳入 1075 名患者（EA 组和 SA 组各 536 名和 539 名）。在第 1 周到第 8 周期间，每周 CSBMs 的平均增加量为 EA 组 1.76（95%CI，1.61 至 1.89），SA 组 0.87（CI，0.73 至 0.97）（组间差异，0.90 [CI，0.74 至 1.10]；P<0.001）。在第 9 周到第 20 周期间，每周 CSBMs 的平均增加量为 EA 组 1.96（CI，1.78 至 2.11），SA 组 0.89（CI，0.69 至 0.95）（组间差异，1.09 [CI，0.94 至 1.31]；P<0.001）。EA 组在治疗和随访期间每周有 3 次或更多 CSBMs 的患者比例分别为 31.3%和 37.7%，而 SA 组分别为 12.1%和 14.1%（P<0.001）。两组在治疗期间针灸相关不良事件均不常见，且均为轻度或一过性。