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

BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: The study will provide information about the efficacy and safety of acupuncture as a complement to usual care in infants with colic. TRIAL REGISTRATION: December 29, 2012: ClinicalTrials.gov NCT01761331