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. 2016 Sep 16;2016(9):CD009999. doi: 10.1002/14651858.CD009999.pub2

Akçam 2006.

Methods Randomised, double‐blind, cross‐over, placebo‐controlled trial with 2 treatments groups
Participants Sample size: 30 infants with typical infantile colic (minimum of 3 hours of crying per day, 3 days per week for the last 3 weeks). 5 dropped out (2 for urinary infections, 1 for otitis and 2 because of loss of contact)
Setting: recruited from public healthcare clinics, general practitioners and the paediatric outpatient clinic at the Maternity Hospital
Sex: boys (40%)
Mean age: 9 (SD 5.9) weeks; range not reported
Mean weight: 5046 (SD 1296) grams
Mean duration of colic: 7.1 (SD 5.4) weeks
Mean crying: 3.9 (SD 0.8) hours per day
Feeding: breast fed (10 purely breast fed; 25 partially breast fed)
Birth order: not reported
Inclusion criteria:
  • Complete physical examination

  • Complete blood count and urine analysis performed on all infants at the beginning of the study to exclude other possible reason for crying


Exclusion criteria: not reported
Interventions Intervention (25 infants): glucose solution (30%) prepared for intravenous usage
Placebo (25 infants): distilled water
Administration: Parents received oral and written instructions to give 1 mL of the distributed solution by medicine dropper over 15 to 20 minutes, while holding the infants in their arms, when the infant continued to cry after attempts of consoling by feeding, changing the nappy or carrying had failed. Repeat visits were scheduled for the fourth and eighth days after the first visit. Same patients used 1 drug for 4 days, and then used other drug for another 4 days.
Duration of the study: 8 days
Washout period: not planned. Same patients used 1 drug for 4 days, then used other drug for another 4 days.
Outcomes At each visit, parents described the effect of the last treatment using a 6‐point scale: 0 = 'getting worse', 1 = ' no improvement', 2 = 'mild improvement', 3 = 'moderate improvement', 4 = 'marked improvement', 5 = 'completely well after each dose'. Study authors considered infants with an improvement of 2, 3 or 4 as responders.
Notes Country: Turkey
Funding source: Study authors did not report whether the study received funding.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: No information was reported about the method used to generate randomisation.
Allocation concealment (selection bias) Unclear risk Comment: 1 bottle containing glucose solution and 1 containing distilled water were prepared by a pharmacist, who also arranged and kept the coding and distributed the bottles; they were arranged in numbered pairs, and within the pairs, glucose and placebo were randomly designated with the letters A and B. Each infant was randomised to a number, and to the pair of bottles to be tried first, by 2 separate draws through the sealed envelope technique. Not specified whether the envelopes were opaque.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Comment: Glucose as 30% solution and placebo as distilled water were arranged in identical coloured glass bottles. No information was given to parents regarding the contents of either bottle. The study was conducted as double‐blind ‐ only pharmacist knew the bottle coding.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Comment: No information was given to parents regarding the contents of either bottle.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Comment: A total of 25 of 30 infants (83.3%) completed the study. 5 infants were excluded (2 for urinary infections, 1 for otitis and 2 because of loss of contact) for reasons that seemed not related to the outcome. Not reported during which period they dropped out.
Selective reporting (reporting bias) High risk Comment: Study authors reported data about the outcome declared in the Methods section for all 25 infants who completed the study, but they did not report results for each treatment by study period, neither the number of infants who improved with both treatments.
Other bias High risk Comment: Same infants used 1 drug for 4 days, then used other drug for another 4 days. Washout period was not planned.