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Acupuncture treatments for infantile colic: a systematic review and individual patient data meta-analysis of blinding test validated randomised controlled trials.

ABSTRACT: Needle acupuncture in small children has gained some acceptance in Western medicine. It is controversial, as infants and toddlers are unable to consent to treatment. We aimed to assess its efficacy for treating infantile colic.A systematic review and a blinding-test validation based on individual patient data from randomised controlled trials. Primary end-points were crying time at mid-treatment, at the end of treatment and at a 1-month follow-up. A 30-min mean difference (MD) in crying time between acupuncture and control was predefined as a clinically important difference. Pearson's chi-squared test and the James and Bang indices were used to test the success of blinding of the outcome assessors [parents]. Eligibility criteria and data sources: We included randomised controlled trials of acupuncture treatments of infantile colic. Systematic searches were conducted in Cochrane CENTRAL, MEDLINE, EMBASE, CINAHL and AMED, and in the Chinese language databases CNKI, VIP, Wang fang, SinoMed and Chinese Clinical Trial Registry.We included three randomised controlled trials with data from 307 participants. Only one of the included trials obtained a successful blinding of the outcome assessors in both the acupuncture and control groups. The MD in crying time between acupuncture intervention and no acupuncture control was -24.9?min [95% confidence interval, CI -46.2 to -3.6; three trials] at mid-treatment, -11.4?min [95% CI -31.8 to 9.0; three trials] at the end of treatment and -11.8?min [95% CI -62.9 to 39.2; one trial] at the 4-week follow-up. The corresponding standardised mean differences [SMDs] were -0.23 [95% CI -0.42 to -0.06], -0.10 [95% CI -0.29 to 0.08] and -0.09 [95% CI -0.48 to 0.30]. The heterogeneity was negligible in all analyses. The statistically significant result at mid-treatment was lost when excluding the apparently unblinded study in a sensitivity analysis: MD -13.8?min [95%CI -37.5 to 9.9] and SMD -0.13 [95%CI -0.35 to 0.09]. The registration of crying during treatment suggested more crying during acupuncture [odds ratio 7.7; 95% CI 2.7-20.6; one trial]. GRADE-Moderate quality evidence.Percutaneous needle acupuncture treatments should not be recommended for infantile colic on a general basis. Systematic review registration: PROSPERO 2015:CRD42015023253 Key points The role of acupuncture in the treatment of infantile colic is controversial. Available trials are small and present conflicting results. There were no clinically important differences between infants receiving acupuncture and no acupuncture control in this IPD meta-analysis of randomised controlled trials. The data indicate that acupuncture induces some treatment pain in many of the children. The study results indicate that percutaneous needle acupuncture should not be recommended for treatment of infantile colic on a general basis.

SUBMITTER: Skjeie H

PROVIDER: S-EPMC5901442 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Acupuncture treatments for infantile colic: a systematic review and individual patient data meta-analysis of blinding test validated randomised controlled trials.

Skjeie Holgeir H Skonnord Trygve T Brekke Mette M Klovning Atle A Fetveit Arne A Landgren Kajsa K Hallström Inger Kristensson IK Brurberg Kjetil Gundro KG

Scandinavian journal of primary health care 20180117 1

<h4>Objective</h4>Needle acupuncture in small children has gained some acceptance in Western medicine. It is controversial, as infants and toddlers are unable to consent to treatment. We aimed to assess its efficacy for treating infantile colic.<h4>Design</h4>A systematic review and a blinding-test validation based on individual patient data from randomised controlled trials. Primary end-points were crying time at mid-treatment, at the end of treatment and at a 1-month follow-up. A 30-min mean d ...[more]

PMID: 29338487

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Project description:BackgroundDespite weak evidence, the use of acupuncture has increased in infantile colic. The only three randomized trials conducted evaluated standardized minimal acupuncture in one single point. Two showed effect but one did not so further research is necessary. The aims of the study are 1) to test if results in earlier trials conducted in private acupuncture clinics can be repeated at Child Health Centers (CHC) and 2) to compare the effect of two types of acupuncture and no acupuncture in infants with colic at CHC.Methods/designa multicenter randomized controlled three-armed trial for infantile colic conducted in four regions of Sweden. Alongside the standard program at their regular Child Health Center infants visit a study center twice a week for 2 weeks. The infants are randomly allocated into three groups. According to the power analysis, 144 otherwise healthy infants aged 2-9 weeks old, who - according to parents' registration in a diary - are crying and/or fussing more than three hours per day, more than 3 days per week will be included. Parents register daily in the diary during the baseline week, two intervention weeks, and one more week directly after the last study visit. At four study visits at the Child Health Center parents meet a nurse for 20-30 min to receive advice and support. The nurse and the parents are blinded for group allocation. Infants are carried to another room, where they spend five minutes with an acupuncturist. Infants randomized to group A receive standardized minimal acupuncture in LI4. Group B receive individualized acupuncture where, according to symptoms, the acupuncturist can choose between the points Sifeng, LI4, and ST36. Group C receives no acupuncture. The primary outcome is relative difference in crying, counted in minutes. Secondary outcomes are number of infants fulfilling the criteria for colic, and changes in sleep and stooling frequency. Adverse events and blinding are recorded. Recruitment started in January 2013. During the first 14 months 93 patients were included. Data collection continues until May 2015. No interim analyses have been conducted.DiscussionThe study will provide information about the efficacy and safety of acupuncture as a complement to usual care in infants with colic.Trial registrationDecember 29, 2012: ClinicalTrials.gov NCT01761331.

Project description:IntroductionAs the main manifestation of gallstone disease, biliary colic (BC) is an episodic attack that brings patients severe pain in the right upper abdominal quadrant. Although acupuncture has been documented with significance to lead to pain relief, the immediate analgesia of acupuncture for BC still needs to be verified, and the underlying mechanism has yet to be covered. Therefore, this trial aims first to verify the immediate pain-alleviation characteristic of acupuncture for BC, then to explore its influence on the peripheral sensitised acupoint and central brain activity.Methods and analysisThis is a randomised controlled, paralleled clinical trial, with patients and outcome assessors blinded. Seventy-two patients with gallbladder stone disease presenting with BC will be randomised into a verum acupuncture group and the sham acupuncture group. Both groups will receive one session of immediate acupuncture treatment. Improvements in patients' BC will be evaluated by the Numeric Rating Scale, and the pain threshold of acupoints will also be detected before and after treatment. During treatment, brain neural activity will be monitored with functional near-infrared spectroscopy (fNIRS), and the needle sensation will be rated. Clinical and fNIRS data will be analysed, respectively, to validate the acupuncture effect, and correlation analysis will be conducted to investigate the relationship between pain relief and peripheral-cerebral functional changes.Ethics and disseminationThis trial has been approved by the institutional review boards and ethics committees of the First Teaching Hospital of Chengdu University of Traditional Chinese Medicine, with the ethical approval identifier 2019 KL-029, and the institutional review boards and ethics committees of the First People's Hospital of Longquanyi District, with the ethical approval identifier AF-KY-2020071. The results of this trial will be disseminated through peer-reviewed publications and conference abstracts or posters.Trial registration numberCTR2000034432.

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Acupuncture treatments for infantile colic: a systematic review and individual patient data meta-analysis of blinding test validated randomised controlled trials.

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Acupuncture treatments for infantile colic: a systematic review and individual patient data meta-analysis of blinding test validated randomised controlled trials.

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