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微针疗法治疗婴儿腹绞痛的效果:一项多中心、三臂、单盲随机对照试验(ACU-COL)

Effect of minimal acupuncture for infantile colic: a multicentre, three-armed, single-blind, randomised controlled trial (ACU-COL).

作者信息

Landgren Kajsa, Hallström Inger

机构信息

Faculty of Medicine, Department of Health Science, Lund University, Lund, Sweden.

出版信息

Acupunct Med. 2017 Jun;35(3):171-179. doi: 10.1136/acupmed-2016-011208. Epub 2017 Jan 16.

Abstract

BACKGROUND

Evidence for treating infantile colic with acupuncture is contradictory.

AIM

To evaluate and compare the effect of two types of acupuncture versus no acupuncture in infants with colic in public child health centres (CHCs).

METHODS

A multicentre, randomised controlled, single-blind, three-armed trial (ACU-COL) comparing two styles of acupuncture with no acupuncture, as an adjunct to standard care, was conducted. Among 426 infants whose parents sought help for colic and registered their child's fussing/crying in a diary, 157 fulfilled the criteria for colic and 147 started the intervention. All infants received usual care plus four extra visits to CHCs with advice/support (twice a week for 2 weeks), comprising gold standard care. The infants were randomly allocated to three groups: (A) standardised minimal acupuncture at LI4; (B) semi-standardised individual acupuncture inspired by Traditional Chinese Medicine; and (C) no acupuncture. The CHC nurses and parents were blinded. Acupuncture was given by nurses with extensive experience of acupuncture.

RESULTS

The effect of the two types of acupuncture was similar and both were superior to gold standard care alone. Relative to baseline, there was a greater relative reduction in time spent crying and colicky crying by the second intervention week (p=0.050) and follow-up period (p=0.031), respectively, in infants receiving either type of acupuncture. More infants receiving acupuncture cried <3 hours/day, and thereby no longer fulfilled criteria for colic, in the first (p=0.040) and second (p=0.006) intervention weeks. No serious adverse events were reported.

CONCLUSIONS

Acupuncture appears to reduce crying in infants with colic safely.

TRIAL REGISTRATION NUMBER

NCT01761331; Results.

摘要

背景

针刺治疗婴儿腹绞痛的证据相互矛盾。

目的

评估并比较两种针刺疗法与不进行针刺对公共儿童健康中心(CHC)腹绞痛婴儿的疗效。

方法

开展了一项多中心、随机对照、单盲、三臂试验(ACU-COL),比较两种针刺方式与不针刺作为标准护理辅助手段的效果。在426名因腹绞痛寻求帮助并在日记中记录孩子哭闹情况的婴儿中,157名符合腹绞痛标准,147名开始干预。所有婴儿均接受常规护理,并额外到CHC进行4次咨询/支持访视(每周两次,共2周),构成金标准护理。婴儿被随机分为三组:(A)在LI4进行标准化最小针刺;(B)受中医启发的半标准化个体化针刺;(C)不针刺。CHC护士和家长均不知情。针刺由有丰富针刺经验的护士进行。

结果

两种针刺疗法的效果相似,且均优于单纯的金标准护理。与基线相比,接受任何一种针刺疗法的婴儿在第二次干预周(p = 0.050)和随访期(p = 0.031)哭闹时间和腹绞痛哭闹时间的相对减少幅度更大。在第一次(p = 0.040)和第二次(p = 0.006)干预周,接受针刺治疗的婴儿中每天哭闹<3小时、因而不再符合腹绞痛标准的更多。未报告严重不良事件。

结论

针刺似乎能安全地减少腹绞痛婴儿的哭闹。

试验注册号

NCT01761331;结果

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2361/5466913/03ebc52049da/acupmed-2016-011208f01.jpg

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