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

Blomquist 1983.

Methods Randomised, double‐blind, placebo‐controlled, cross‐over trial
Participants Sample size: 18 infants. No withdrawals from the study
Setting: recruited from 9 child health centres (CHCs) in Umeå and the surrounding area
Sex: boys (44%)
Mean age: not reported (SD not reported). Range 2 to 14 weeks
Mean weight: not reported
Mean duration of colic: not reported
Mean crying: not reported
Feeding: not reported
Birth order: not reported
Inclusion criteria:
  • Parents must have sought help for the child at the CHC for colic problems.

  • The CHC nurse and/or CHC doctor then determined if the child’s problems were to be considered infantile colic.


Exclusion criteria: not reported
Interventions Intervention (18 infants): dicyclomine hydrochloride 100 mg in 100 mL of solution. As the mixture has a sweet and sour flavour, sugar and lemon lime were added.
Control (18 infants): placebo. Dosage was 5 mL of the respective solution, given 20 minutes before afternoon and evening meals. Parents were asked to refrain from changing the infant’s diet during treatment.
Administration: After 1 week, parents returned to the CHC for follow‐up, which included a weight check. At this time, parents made an overall assessment of the treatment week. Parents returned the first bottle and were given the new code‐labelled bottle. After an additional week, parents made a new overall assessment in connection with a new visit to the CHC.
Duration of study: 2 weeks
Washout period: no washout period planned
Outcomes The CHC distributed a diary containing data entry pages for 15 days of treatment. In the diary, parents recorded, for each day, times of meals, colic attacks, bowel movements and colic medications. Parents also commented on how severe they considered the child’s colic attacks to have been during the past 24‐hour period (none, mild, moderate, severe, very severe). In addition, parents assessed during which week treatment showed the highest efficacy.
Notes Country: Sweden
Funding source: Study authors did not specify whether they received financial support.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: Information was insufficient to permit a judgement of low risk. Order of use between the 2 treatment alternatives was randomly assigned.
Allocation concealment (selection bias) Unclear risk Comment: No information was reported.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Comment: Two code‐labelled bottles ‐ 1 of which contained dicyclomine hydrochloride, and the other, the solution without dicyclomine hydrochloride ‐ were given to each infant.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: Two code‐labelled bottles ‐ 1 of which contained dicyclomine hydrochloride, and the other, the solution without dicyclomine hydrochloride ‐ were given to each infant.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: Study authors reported study results for all randomised infants.
Selective reporting (reporting bias) High risk Comment: Outcomes were not clearly prespecified, and details of results were not reported by study period.
Other bias High risk Comment: No washout period was planned.