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Standardized minimal acupuncture, individualized acupuncture, and no acupuncture for infantile colic: study protocol for a multicenter randomized controlled trial - ACU-COL.

ABSTRACT: Despite 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.a 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.The study will provide information about the efficacy and safety of acupuncture as a complement to usual care in infants with colic.December 29, 2012: ClinicalTrials.gov NCT01761331.

SUBMITTER: Landgren K

PROVIDER: S-EPMC4570710 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Standardized minimal acupuncture, individualized acupuncture, and no acupuncture for infantile colic: study protocol for a multicenter randomized controlled trial - ACU-COL.

Landgren Kajsa K Tiberg Iren I Hallström Inger I

BMC complementary and alternative medicine 20150914

<h4>Background</h4>Despite 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 acupunctu ...[more]

PMID: 26370560

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Project description:BackgroundThe aim was to describe the feeding- and stooling patterns of infants with colic and evaluate the influence of minimal acupuncture.MethodsA prospective, randomized, controlled, blind clinical study was conducted at a private acupuncture clinic in Sweden. 90 otherwise healthy 2-8 weeks old infants, born after gestational week 36, fulfilling the criteria for infantile colic and not medicated with dicyclomine, were included. 81 infants went through a structured program consisting of six visits to the clinic, twice weekly. Infants randomized to receive acupuncture were given minimal, standardized acupuncture for two seconds in LI4. Frequency and size of stooling, as well as duration of, and intervals between, feeding sessions were reported by parents in a diary. Parental assessment of sleep and comments on stooling and side effects were collected in a questionnaire.ResultsAt baseline when the mean age was five weeks, infants in both groups were fed a median of eight times/day, 148 min/day, with considerable variations. No differences were found between groups in the frequency and duration of feeding during the intervention weeks. Furthermore there were no significant differences between the groups regarding the frequency of stooling, neither at baseline, at which point the infants of both groups had bowel movements 4.2 times/day, nor during the intervention weeks. There was an expected decrease in frequency of stooling in both groups, reaching 2.1 (p = 0.001) in the acupuncture group and 3.1 (p < 0.001) in the control group. The groups differed regarding large bowel movements which decreased linearly in the control group (p = 0.011) but not in the acupuncture group (p = 0.787). More parents in the acupuncture group than in the control group (28% and 15% respectively, p = 0.006) experienced the infant's sleep to be "better" or "much better." No other significant differences were found. However, parents described a normalized stooling and experienced an improvement in colic in their infants more frequently in the acupuncture group than in the control group.ConclusionsInfants with colic in the present study had a higher frequency of stooling than reported internationally in healthy infants. Minimal acupuncture had no major effect on feeding, stooling and sleep, although a minor effect of minimal acupuncture on stooling and sleep cannot be ruled out.Trial registrationClinicalTrials.govID NCT00860301.

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Standardized minimal acupuncture, individualized acupuncture, and no acupuncture for infantile colic: study protocol for a multicenter randomized controlled trial - ACU-COL.

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Standardized minimal acupuncture, individualized acupuncture, and no acupuncture for infantile colic: study protocol for a multicenter randomized controlled trial - ACU-COL.

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