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:
Exclusion criteria: not reported |
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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 |
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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. |
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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. |