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:
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. |