A prospective, randomised, controlled, blinded clinical trial was performed at a private acupuncture clinic in Sweden, from November 2005 to February 2007. For the past 15 years this acupuncture clinic has offered acupuncture treatment for adult patients with different symptoms and for infants with colic.
Infants with colic, 2–8 weeks old, whose parents sought help at either a child health centre, the regional hospital's paediatric clinic or at the acupuncture clinic where the trial was performed, were consecutively preselected by health professionals who were informed of the inclusion criteria: healthy infants, born after gestational week 36, not treated with dicyclomine and fulfilling the modified Wessel criteria for colic: ‘crying/fussing for at least 3 h a day, occurring 3 days or more in the same week’.1
Parents with eligible infants and who were willing to participate reported the extent and degree of their infant's crying and fussing in a diary for at least 3 days. Exclusion of cow's milk from the infant's diet was recommended during the registration period if it had not already been tried. If meeting the criteria, the infant was included in the study and started the structured programme the following Monday or Thursday. Written informed consent was obtained from the parents, and the study was approved by the local research ethics committee (Dnr 583/2005). All infants continued the regular programme at their ordinary child health centre throughout the duration of the study.
Randomisation and blinding
A registered nurse skilled in acupuncture, nurse A, was hired specifically to perform the randomisation, administer the intervention and be the sole person aware of allocation and with access to the records during the study. Nurse A met the infants alone in the treatment room and was only informed of their age and study number. The randomisation procedure divided the infants into an intervention group with a structured programme including acupuncture (acupuncture group) or to the same structured programme not including acupuncture (control group). As we proposed that age was a prognostic variable that might interfere with the result, restricted randomisation was used to achieve a balance between 2–5 weeks old and 6–8 weeks old infants, respectively, in the groups. Two sets of sealed opaque envelopes, marked ‘2–5 weeks old’ and ‘6–8 weeks old’, respectively, had been prepared by nurse A before the study started. The envelopes contained a card with either ‘control group’ or ‘intervention group’, each in equal amounts. The card in the upper envelope in the pile appropriate to the infant's age determined the group to which each infant was assigned. Consequently, all infants had an equal probability of assignment to either group. Each infant remained in the initially allocated group throughout the study.
The study was double blind as neither the parents who registered the infants crying nor the nurse who met the parents (nurse B, the first author) knew to which group the infant belonged. Nurse B enrolled parents of potential patients, informed them of the trial, assessed the infant's eligibility, obtained informed consent and met the parents at the acupuncture clinic. Two closed doors separated the parents from the treatment room and music was always played. Parents were informed that the needle was very thin, usually caused no bleeding or visible marks and that acupuncture does not necessarily provoke crying.
The structured programme consisted of a total of six biweekly visits to the acupuncture clinic. The first visit lasted for 30 min, during which the parents met nurse B who repeated information on the study and collected baseline demographic data. During the following five visits, parents met nurse B for 15 min appointments, and were asked standardised questions such as ‘How is it going?’, received standardised oral support such as ‘Hopefully it will be better soon’ and were given time for questions.
At each visit, the infant was carried to the treatment room by nurse B and left there with nurse A. The initial handling of the infants in the treatment room was identical. Nurse A held each infant's hand and spoke soothingly. If starting to cry, the infant was comforted by the nurse in her arms. The infants allocated to have acupuncture subsequently received minimal, standardised acupuncture with a sterilised, disposable acupuncture needle, Vinco MicroClean, 0.20 × 13 mm. The needle was inserted unilaterally and left in place for 2 s at an approximate depth of 2 mm at point LI4 of the hand's first dorsal interossal muscle, a point often used in clinical practice when treating infants with colic and, also used in an earlier randomised controlled trial (RCT) studying acupuncture treatment for colic and known for the generalised analgetic effect.16
Left and right hands were used alternately. After a maximum of 5 min in the treatment room, nurse A carried infants back to their parents. Infants allocated to the two groups went through exactly the same procedure except for the insertion of an acupuncture needle in the acupuncture group.
Assessments and outcomes
Definitions of ‘fussing’ (showing dissatisfaction and whimpering despite being carried), ‘crying’ (screaming loudly) and ‘colicky crying’ (crying hysterically and unconsolably) were communicated to the parents both verbally and in writing. Parents reported infants' fussing, crying and colicky crying in a standardised diary form originally developed and validated by Barr et al17
and modified and tested by Canivet et al
The diary form consisted of sheets, each covering 24 h. Parents filled in boxes, each representing 5 min, to indicate when their infant was fussing (marked as F), crying (marked as C) and colicky crying (marked as CC). All marked boxes were counted manually and transferred into a database. Reports were made on at least 3 days during the baseline week preceding possible inclusion and daily during the three intervention weeks, directly following the baseline week. Twice weekly, parents completed a questionnaire modified from Reinthal et al
in which they described any adverse effects they considered to be caused by treatment. Duration of crying in the treatment room and bleeding were noted by nurse A. The primary end point was the number of infants who fulfilled the colic criteria during each of the intervention weeks. The secondary end point was the total duration of fussing, crying and colicky crying (TC) during the three intervention weeks as reported by parents in the diary.
Based on the assumption that 50% of the infants would go into spontaneous remission without treatment and 75% with acupuncture, 40 patients per group were needed in order to have a 90% chance of detecting a significant difference in remission at a two-sided 5% level. The statistical software SPSS version 17 (SPSS, Chicago, Illinois, USA) was used for calculations. As two parameters were not normally distributed all data were analysed with non-parametric statistics. Kaplan–Meier analysis was performed to assess the time for each infant's crying to fall below 180 min, indicating that the infant no longer fullfilled the criteria for colic. To evaluate differences between intervention and control groups the log rank test was performed. Mann–Whitney U test was used to analyse crying and fussing times, and the relative difference in crying and fussing between the baseline and the intervention weeks was measured as a percentage. p Values <0.05 were considered statistically significant.