Acupmed2394.indd

Acupuncture reduces crying in infants with
infantile colic: a randomised, controlled, blind
clinical study
Kajsa Landgren, Nina Kvorning and Inger Hallström Acupunct Meddoi: 10.1136/aim.2010.002394 Updated information and services can be found at: References
This article cites 52 articles, 10 of which can be accessed free at: Open Access
This paper is freely available online under the BMJ Journals unlockedscheme, see http://ard.bmj.com/info/unlocked.dtl Published online October 18, 2010 in advance of the print journal.
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Acupuncture reduces crying in infants with infantile colic: a randomised, controlled, blind clinical study Kajsa Landgren,1 Nina Kvorning,2 Inger Hallström1 ABSTRACT
outcomes after acupuncture in children with night Objective To investigate whether acupuncture reduces
crying.13 14 One qualitative study15 and one ran- the duration and intensity of crying in infants with colic.
domised controlled study16 also indicate that acu- Patients and methods 90 otherwise healthy infants,
puncture has an effect on infants’ crying. The 2–8 weeks old, with infantile colic were randomised in objective of this study was to further investigate this controlled blind study. 81 completed a structured whether minimal acupuncture reduces the duration Correspondence to
programme consisting of six visits during 3 weeks to an and intensity of crying in infants with colic.
acupuncture clinic in Sweden. Parents blinded to the allocation of their children met a blinded nurse. The infant MATERIAL AND METHODS
was subsequently given to another nurse in a separate A prospective, randomised, controlled, blinded clin- room, who handled all infants similarly except that infants ical trial was performed at a private acupuncture allocated to receive acupuncture were given minimal, clinic in Sweden, from November 2005 to February standardised acupuncture for 2 s in LI4.
2007. For the past 15 years this acupuncture clinic Results There was a difference (p=0.034) favouring the
has offered acupuncture treatment for adult patients acupuncture group in the time which passed from with different symptoms and for infants with colic.
inclusion until the infant no longer met the criteria for colic. The duration of fussing was lower in the acupunc- Patients
ture group the fi rst (74 vs 129 min; p=0.029) and second Infants with colic, 2–8 weeks old, whose parents week (71 vs 102 min; p=0.047) as well as the duration sought help at either a child health centre, the regional of colicky crying in the second intervention week (9 vs 13 hospital’s paediatric clinic or at the acupuncture clinic min; p=0.046) was lower in the acupuncture group. The where the trial was performed, were consecutively total duration of fussing, crying and colicky crying (TC) preselected by health professionals who were was lower in the acupuncture group during the fi rst (193 informed of the inclusion criteria: healthy infants, vs 225 min; p=0.025) and the second intervention week born after gestational week 36, not treated with dicy- (164 vs 188 min; p=0.016). The relative difference from clomine and fulfi lling the modifi ed Wessel criteria for baseline throughout the intervention weeks showed colic: ‘crying/fussing for at least 3 h a day, occurring 3 differences between groups for fussing in the fi rst week days or more in the same week’.1 Parents with eligi- (22 vs 6 min; p=0.028), for colicky crying in the second ble infants and who were willing to participate week (92 vs 73 min; p=0.041) and for TC in the second reported the extent and degree of their infant’s crying week (44 vs 29 min; p=0.024), demonstrating favour and fussing in a diary for at least 3 days. Exclusion of cow’s milk from the infant’s diet was recommended Conclusions Minimal acupuncture shortened the
during the registration period if it had not already duration and reduced the intensity of crying in infants been tried. If meeting the criteria, the infant was with colic. Further research using different acupuncture included in the study and started the structured pro- points, needle techniques and intervals between gramme 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 contin- INTRODUCTION
ued the regular programme at their ordinary child Ten per cent of newborn children in the Western health centre throughout the duration of the study.
world experience colic.1 2 The aetiology is unclear but gastrointestinal factors and allergy to cow’s milk Randomisation and blinding
protein have been suggested as possible causes.3 A registered nurse skilled in acupuncture, nurse A, Another suggestion is that colic is a behavioural was hired specifi cally to perform the randomisa-condition resulting from unfavourable parent–infant tion, administer the intervention and be the sole interaction.3 In three meta-analyses current medical person aware of allocation and with access to the treatments are evaluated as either ineffi cient (sime- records during the study. Nurse A met the infants thicone) or as having serious side effects like sei- alone in the treatment room and was only informed zures, asphyxia and death3–5 (dicyclomine, presently of their age and study number. The randomisation withheld by the manufacturer). In spite of the good procedure divided the infants into an intervention prognosis of infantile colic with full spontaneous group with a structured programme including acu-recovery,6 colic inhibits optimal family relations7–9 puncture (acupuncture group) or to the same struc- and increases the risk of child abuse.10–12 Acupuncture tured programme not including acupuncture is widely used and discussed in infantile colic. (control group). As we proposed that age was a online under the BMJ Journals unlocked scheme, see http:// However, few articles have been published on this prognostic variable that might interfere with the subject. Two uncontrolled studies report positive result, restricted randomisation was used to achieve Landgren K, Kvorning N, Hallström I. Acupunct Med (2010). doi:10.1136/aim.2010.002394 Copyright 2010 by British Medical Journal Publishing Group.
Original paper
a balance between 2–5 weeks old and 6–8 weeks old infants, database. Reports were made on at least 3 days during the base- respectively, in the groups. Two sets of sealed opaque envelopes, line week preceding possible inclusion and daily during the three marked ‘2–5 weeks old’ and ‘6–8 weeks old’, respectively, had intervention weeks, directly following the baseline week. Twice been prepared by nurse A before the study started. The enve- weekly, parents completed a questionnaire modifi ed from lopes contained a card with either ‘control group’ or ‘interven- Reinthal et al,16 in which they described any adverse effects they tion group’, each in equal amounts. The card in the upper considered to be caused by treatment. Duration of crying in the envelope in the pile appropriate to the infant’s age determined treatment room and bleeding were noted by nurse A. The pri- the group to which each infant was assigned. Consequently, all mary end point was the number of infants who fulfi lled the colic infants had an equal probability of assignment to either group. criteria during each of the intervention weeks. The secondary Each infant remained in the initially allocated group throughout end point was the total duration of fussing, crying and colicky crying (TC) during the three intervention weeks as reported by The study was double blind as neither the parents who regis- tered the infants crying nor the nurse who met the parents (nurse B, the fi rst author) knew to which group the infant belonged. Statistical analyses
Nurse B enrolled parents of potential patients, informed them of Based on the assumption that 50% of the infants would go into the trial, assessed the infant’s eligibility, obtained informed con- spontaneous remission without treatment and 75% with acu- sent and met the parents at the acupuncture clinic. Two closed puncture, 40 patients per group were needed in order to have a doors separated the parents from the treatment room and music 90% chance of detecting a signifi cant difference in remission at a was always played. Parents were informed that the needle was two-sided 5% level. The statistical software SPSS version 17 very thin, usually caused no bleeding or visible marks and that (SPSS, Chicago, Illinois, USA) was used for calculations. As two acupuncture does not necessarily provoke crying.
parameters were not normally distributed all data were analysed with non-parametric statistics. Kaplan–Meier analysis was per- Intervention
formed to assess the time for each infant’s crying to fall below The structured programme consisted of a total of six biweekly 180 min, indicating that the infant no longer fullfi lled the criteria visits to the acupuncture clinic. The fi rst visit lasted for 30 min, for colic. To evaluate differences between intervention and con- during which the parents met nurse B who repeated informa- trol groups the log rank test was performed. Mann–Whitney U tion on the study and collected baseline demographic data. test was used to analyse crying and fussing times, and the rela- During the following fi ve visits, parents met nurse B for 15 min tive difference in crying and fussing between the baseline and appointments, and were asked standardised questions such as the intervention weeks was measured as a percentage. p Values ‘How is it going?’, received standardised oral support such as <0.05 were considered statistically signifi cant.
‘Hopefully it will be better soon’ and were given time for questions.
At each visit, the infant was carried to the treatment room by Participants and progress throughout the trial
nurse B and left there with nurse A. The initial handling of the Of the 210 infants who between November 2005 and February infants in the treatment room was identical. Nurse A held each 2007 were suspected to have colic, 90 fulfi lled the colic criteria infant’s hand and spoke soothingly. If starting to cry, the infant after completing the diary. Three infants randomised to the con- was comforted by the nurse in her arms. The infants allocated to trol group did not meet the criteria and were excluded, and the have acupuncture subsequently received minimal, standardised procedures for analysing the diaries before randomisation were acupuncture with a sterilised, disposable acupuncture needle, changed (fi gure 1). Two infants in the acupuncture group who Vinco MicroClean, 0.20 × 13 mm. The needle was inserted unilat- only came to the clinic fi ve times as the symptoms disappeared erally and left in place for 2 s at an approximate depth of 2 mm at are counted as fulfi llers as their parents continued to complete point LI4 of the hand’s fi rst dorsal interossal muscle, a point often the diary. Background data were analysed for infants starting the used in clinical practice when treating infants with colic and, also structured programme (n=86) and for infants who completed the used in an earlier randomised controlled trial (RCT) studying acu- three intervention weeks (n=81) (table 1). Outcomes from the puncture treatment for colic and known for the generalised anal- intervention weeks are based on the infants’ remaining in the getic effect.16 Left and right hands were used alternately. After a study each week and drop outs are reported as missing values. maximum of 5 min in the treatment room, nurse A carried infants Infants were stratifi ed by age and age at inclusion was similar in back to their parents. Infants allocated to the two groups went both groups (table 1). However, owing to small numbers in the through exactly the same procedure except for the insertion of an subgroups, age groups were analysed together.
acupuncture needle in the acupuncture group.
Baseline data
Assessments and outcomes
There were no signifi cant differences between the groups for Defi nitions of ‘fussing’ (showing dissatisfaction and whimpering background characteristics such as parents being born in Sweden, despite being carried), ‘crying’ (screaming loudly) and ‘colicky educational level, smoking and mother’s complications during crying’ (crying hysterically and unconsolably) were communi- pregnancy or delivery; nor were there differences between their cated to the parents both verbally and in writing. Parents reported baseline levels of fussing and crying (tables 1 and 2).
infants’ fussing, crying and colicky crying in a standardised diary form originally developed and validated by Barr et al17 and modi-fi ed and tested by Canivet et al.18 The diary form consisted of Outcome measures
sheets, each covering 24 h. Parents fi lled in boxes, each repre- Rate of infants fulfi lling the colic criterion in each of the senting 5 min, to indicate when their infant was fussing (marked as F), crying (marked as C) and colicky crying (marked as CC). There was a difference (p=0.034) between groups in the time All marked boxes were counted manually and transferred into a which passed from inclusion until the infant had a mean value Landgren K, Kvorning N, Hallström I. Acupunct Med (2010). doi:10.1136/aim.2010.002394 Original paper
Figure 1 Flow chart of infants through the trial.
Table 1 Baseline data for infants
Infants starting the intervention (N=86)
Infants completing 3 weeks (N=81)
Acupuncture group
Control group (n=40)
Acupuncture group
Control group (n=38)
Background characteristics
Having a parent and/or sibling with food intolerance/allergy, n (%) Having a parent and/or sibling who had had infantile colic, n (%) Table 2 Baseline data for fussing, crying, colicky crying and the total duration of fussing, crying and colicky crying (TC)
Infants starting the intervention (N=86)
Infants completing 3 weeks (N=81)
Categories of fussing
and crying, min/day
Acupuncture group (n=46)
Control group (n= 40)
Acupuncture group (n=43)
Control group (n= 38)
Landgren K, Kvorning N, Hallström I. Acupunct Med (2010). doi:10.1136/aim.2010.002394 Original paper
for TC of <180 min/day for the fi rst time, indicating that the the acupuncture group during the second intervention week. infant no longer met the criteria for colic. Figure 2 demonstrates However, TC was lower in the acupuncture group than in the this difference by showing the proportion of infants with a control group as early as the fi rst intervention week (p=0.025) mean TC <180 min/day for each of the six treatment periods and in the following intervention week (p=0.016) (table 3). A consisting of 3 or 4 days depending on whether treatment was subanalysis showed TC to already be lower (p=0.005) in the acu- given on a Monday or a Thursday. Median time until criteria for puncture group after the fi rst treatment. The relative difference colic were no longer fulfi lled was 7 days in both groups.
between groups, measured as the percentage decrease of crying and fussing from baseline to intervention weeks 1, 2 and 3 Duration of fussing, crying and colicky crying showed differences between groups for fussing the fi rst week The duration of fussing was shorter in the acupuncture group (p=0.028), for colicky crying the second week (p=0.041) and for during the fi rst (p=0.029) and second (p=0.047) intervention TC the second week (p=0.024) (table 4).
weeks. The duration of colicky crying was shorter (p=0.046) in Adverse events
Slight bleeding (one drop) was detected after needling in one of
the 256 acupuncture treatments administered. Thirty-two infants
(74%) in the acupuncture group cried for more than 10 s during
one to four interventions in the treatment room compared with
14 infants (37%) in the control group (p = 0.009) (table 5). Crying
lasted more than a minute in 37 out of 256 needling occasions
(14%). No infant cried for more than 2 min. No other adverse
events were reported.
DISCUSSION
In this study where both acupuncture and control groups were
allotted six visits with support and counselling as an interven-
tion beside their ordinary child health centre visits, there was
an expected decrease in TC in both groups.19 However, the
decrease was slightly faster in the acupuncture group as shown
by measuring both absolute and relative differences between
groups. There was a small but signifi cant difference between
groups already after the fi rst treatment and in the duration until
the infants no longer fullfi lled the colic criterion. Spontaneous
Figure 2 Proportion of infants with a mean total duration of fussing,
healing might explain the lack of difference between groups crying and colicky crying (TC) under 180 min/day for each of the six during the third intervention week. The results of this study are Table 3 Fussing, crying, colicky crying and total duration of fussing, crying and colicky crying (TC) during the three intervention weeks for the
infants still remaining in the trial at each of the intervention weeks
First intervention week
Second intervention week
Third intervention week
Categories of fussing and
Acupuncture
Control group p Value
Acupuncture group Control group
Acupuncture group Control group p Value
crying, min/day
group (n=46)
Table 4 Relative difference in fussing, crying, colicky crying and total duration of fussing, crying and colicky crying (TC) between the baseline
week and the fi rst, second and third intervention weeks, respectively
Difference baseline – fi rst intervention week
Difference baseline – second intervention week
Difference baseline – third intervention week
Categories of crying
and fussing, median
Acupuncture
Control group
Acupuncture group
Control group
Acupuncture group Control group
group (n=46)
Landgren K, Kvorning N, Hallström I. Acupunct Med (2010). doi:10.1136/aim.2010.002394 Original paper
Table 5 Infants who cried more than 10 s in the treatment room during the intervention
Infants who cried more than 10 s during …
Acupuncture group (n=43)
Control group (n=38)
in agreement with the only RCT on acupuncture in infantile effect on the autonomous system.25–27 39–44 Stimulating LI4 colic published,16 in which 40 infants were included, of whom bilaterally resulted in more immediate effect than unilateral 20 were needled in LI4 bilaterally for 20 s. Spontaneous remis- stimulation.39 The motility in the intestinal tract and the gastric sion was more likely to occur in that study as some of the acid secretion increased or decreased depending on which infants were older than 8 weeks. Furthermore, the parents were points were needled.29 30 32 45 46 In human adults47–49 and children50 blinded but not the nurse meeting the parents and administer- acupuncture had a benefi cial effect on visceral symptoms like nausea. Acupuncture increased bowel movement in children,51 altered gastric motility52 and affected gastric emptying in adults Strengths and limitations of this study
with motility disorders53 but caused no effect on gastric motility The strengths of our study are the randomisation, the blinding of in healthy individuals.54 Manual acupuncture applied to LI4 the parents, the small number of drop-outs and strict protocol, induced an increase in the sympathetic and parasympathetic including an extensive diary validated in several studies.18 20 21 nervous systems in 12 healthy individuals.55 Furthermore, the infants were included before their eighth week It is possible that infantile colic derives from distension of the in order to minimise the risk of spontaneous healing during the intestines and activation of the autonomic nervous system and study period, and infants recovering after a 5-day period exclud- that acupuncture can infl uence both visceral pain and the auto- nomic nervous system. Thus it is plausible that even modest Blinding patient and practitioner and fi nding an inert control stimulation of LI4, as performed in this study, can infl uence are considerable methodological problems in acupuncture either or both mechanisms and thereby alleviate infantile colic.
research.22–27 As parents could easily be infl uenced by the acupuncturist’s enthusiasm, an advantage of this study was that Generalisability
the nurse they met was blinded to the infants’ allocation. The This study includes infants with eczema, a rash from a Von Rosen structured programme, ensuring equal support and advice to all splint, a temperature, a hand burned by boiling water and infants participating families infl uenced both groups equally, is a whose mothers had a high level of anxiety or depression. In this strength. Infants in both groups lacked expectations and had lim- aspect the participants represent clinical reality, and these affl ic- ited communication skills, thereby eliminating any difference in tions were equally distributed among the groups. Parents who placebo effect in them and in their blinded parents.
were negative about exposing their children to acupuncture or No test of blinding was done after the three intervention weeks, who lacked the ability to complete the diaries did not participate which is a limitation. More infants in the acupuncture group than and infants born prematurely were excluded. This leaves the in the control group started to cry in the treatment room. Parents included sample and the results of this study as reasonably rep- might have heard the infants cry and thus suspected that the resentative of the general population.
infant had received acupuncture. However the fussing/crying lasted for <10 s in most cases. On one occasion one infant cried for more than a minute after the acupuncture treatment but none Clinical implications
cried for more than 2 min, indicating that this light acupuncture Parents have described colic as a strain on the family.7–9 As no treatment was well tolerated by the infants.
safe and effective cure is known we assume that even a short The safety of acupuncture is a major concern, particularly dur- reduction of the colicky period can make a difference. Of the ing early infancy when responses are diffi cult to evaluate. In a 210 infants estimated by the parents to have colic, only 90 ful- review, acupuncture was considered a safe modality for paediat- fi lled the criteria after registration of their symptoms in the diary. ric patients, but the authors advised that fewer needles should be This indicates that parents have a tendency to overestimate the used when treating children.28 In accordance with this our study crying, and a diary in which parents note their infant’s crying used one single point with light stimulation. As different acu- could be a valuable diagnostic tool. Another explanation may be puncture points result in different effects29–32 55 the option of that the defi nition of colic does not refl ect the parent’s experi- choosing points individually after analysing all symptoms pre- ence of what they consider to be colic.
sented in an ordinary clinical setting may increase effi cacy of future acupuncture treatment of colic. The six treatments in this CONCLUSION
Standardised, light stimulation of the acupuncture point LI4 twice a week for 3 weeks reduced the duration and intensity of Possible mechanisms and explanations
crying more quickly in the acupuncture group than in the control Most basic acupuncture research is conducted with electroacu- group. No serious side effects were reported. Future research is puncture on animals, and cannot be generalised to manual acu- needed to validate the results and to investigate the effi cacy of puncture in infants. However, it is known that acupuncture in other acupuncture points and modes of stimulation for the treat- animals inhibits somatic33–36 and visceral pain37 38 and has an Landgren K, Kvorning N, Hallström I. Acupunct Med (2010). doi:10.1136/aim.2010.002394 Original paper
25. Birch S. A review and analysis of placebo treatments, placebo effects, and placebo Summary points
controls in trials of medical procedures when sham is not inert. J Altern Complement Med 2006;12:303–10.
▶ Previous reports suggested acupuncture might reduce infantile 26. Birch S, Hesselink JK, Jonkman FA, et al. Clinical research on acupuncture. Part 1. What have reviews of the effi cacy and safety of acupuncture told us so far? ▶ We conducted a randomised controlled trial in 90 infants.
J Altern Complement Med 2004;10:468–80.
▶ Acupuncture showed a small but signifi cant effect on some 27. Madsen MV, Gøtzsche PC, Hróbjartsson A. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ 2009;338:a3115.
28. Jindal V, Ge A, Mansky PJ. Safety and effi cacy of acupuncture in children: a review of the evidence. J Pediatr Hematol Oncol 2008;30:431–42.
29. Noguchi E, Ohsawa H, Tanaka H, et al. Electro-acupuncture stimulation effects on Acknowledgements Thanks to Margareta Normark for providing acupuncture, to
duodenal motility in anesthetized rats. Jpn J Physiol 2003;53:1–7.
30. Sato A, Sato Y, Suzuki A, et al. Neural mechanisms of the refl ex inhibition and excitation of gastric motility elicited by acupuncture-like stimulation in anesthetized rats. Neurosci Funding The authors thank Ekhagastiftelsen, Magn Bergvalls Stiftelse, General Mater-
nity Hospital Foundation, Pampers and Baby Bag for funding.
31. Li YQ, Zhu B, Rong PJ, et al. Effective regularity in modulation on gastric motility induced Competing interests None.
by different acupoint stimulation. World J Gastroenterol 2006;12:7642–8.
Ethics approval This study was conducted with the approval of the Lund University,
32. Li YQ, Zhu B, Rong PJ, et al. Neural mechanism of acupuncture-modulated gastric Research Ethics Committee (Dnr 583/2005).
motility. World J Gastroenterol 2007;13:709–16.
33. Rong PJ, Zhu B, Huang QF, et al. Acupuncture inhibition on neuronal activity of spinal Provenance and peer review Not commissioned; externally peer reviewed.
dorsal horn induced by noxious colorectal distention in rat. World J Gastroenterol 2005;11:1011–17.
34. Newberg AB, Lariccia PJ, Lee BY, et al. Cerebral blood fl ow effects of pain and REFERENCES
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Landgren K, Kvorning N, Hallström I. Acupunct Med (2010). doi:10.1136/aim.2010.002394

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