Intended for healthcare professionals


Effectiveness of treatments for infantile colic: systematic review

BMJ 1998; 316 doi: (Published 23 May 1998) Cite this as: BMJ 1998;316:1563
  1. P L B J Lucassen, general practitionera,
  2. W J J Assendelft, general practitionera,
  3. J W Gubbels, statisticianb,
  4. J T M van Eijk, professor of general practicea,
  5. W J van Geldrop, general practitionerc,
  6. A Knuistingh Neven, general practitionerd
  1. a Institute for Research in Extramural Medicine, Free University, Amsterdam, Netherlands
  2. b Organisation for Research and Policy Advice, Grave, Netherlands
  3. c Scientific Committee of the Dutch College of General Practitioners, Utrecht, Netherlands
  4. d Department of General Practice, University of Leiden, Leiden, Netherlands
  1. Correspondence to: Dr Assendelft
  • Accepted 2 February 1998


Objective: To evaluate the effectiveness of diets, drug treatment, and behavioural interventions on infantile colic in trials with crying or the presence of colic as the primary outcome measure.

Data sources: Controlled clinical trials identified by a highly sensitive search strategy in Medline (1966–96), Embase (1986–95), and the Cochrane Controlled Trials Register, in combination with reference checking for further relevant publications. Keywords were crying and colic.

Study selection: Two independent assessors selected controlled trials with interventions lasting at least 3 days that included infants younger than 6 months who cried excessively.

Data synthesis: Methodological quality was assessed by two assessors independently with a quality assessment scale (range 0-5). Effect sizes were calculated as percentage success. Effect sizes of trials using identical interventions were pooled using a random effects model.

Results: 27 controlled trials were identified. Elimination of cows' milk protein was effective when substituted by hypoallergenic formula milks (effect size 0.22 (95% confidence interval 0.09 to 0.34)). The effectiveness of substitution by soy formula milks was unclear when only trials of good methodological quality were considered. The benefit of eliminating cows' milk protein was not restricted to highly selected populations. Dicyclomine was effective (effect size 0.46 (0.33 to 0.60)), but serious side effects have been reported. The advice to reduce stimulation was beneficial (effect size 0.48 (0.23 to 0.74)), whereas the advice to increase carrying and holding seemed not to reduce crying. No benefit was shown for simethicone. Uncertainty remained about the effectiveness of low lactose formula milks.

Conclusions: Infantile colic should preferably be treated by advising carers to reduce stimulation and with a one week trial of a hypoallergenic formula milk.

Key messages

  • Infantile colic is common during the first months of life, but its cause is unknown

  • A definite diagnosis of infantile colic should be followed by a one week trial of substituting cows' milk with hypoallergenic formula milk

  • Dietary intervention should be combined with behavioural interventions: general advice, reassurance, reduction in stimuli, and sensitive differential responding (teaching parents to be more appropriately responsive to their infants with less overstimulation and more effective soothing)

  • Anticholinergic drugs are not recommended because of their serious side effects


    • Accepted 2 February 1998
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