Mundow 1975.
Study characteristics | ||
Methods | Study design: quasi‐randomised trial Trial duration: 6 weeks (5 May 1974 to 11 June 1974) Trial location: St James' Hospital Dublin. Ireland |
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Participants | 200 normal postpartum women Intervention group: 100 primiparous and multiparous women Control group: 100 primiparous and multiparous women |
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Interventions | Intervention: Danthron/Poloxalkol (Dorbanex). Each patient was given 2 yellow capsules at 18:00 hour every evening, starting from the 3rd day of delivery, for the next 3 days (6 capsules). The capsules were taken from numbered bottles. Control: placebo ‐ author did not give name of placebo; it was stated that an identical code was used for both the placebo and experimental intervention |
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Outcomes |
Outcomes 1. Number of days to first bowel movement 2. Visible haemorrhoids 3. Abdominal pain Secondary outcomes 4. Diarrhoea 5. Nausea 6. Urine discolouration |
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Notes | There was no information on number of participants in each arm of intervention. Ethical approval not stated, and declaration of interest not provided. The funding organisation was not reported. Dates of study: study was conducted between 5 May 1974 to 11 June 1974 Funding sources: no information on how the study was funded Declarations of interest: not disclosed |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote ''Consecutive patients were enrolled into study" Randomisation component not explicitly stated, quasi‐randomised trial |
Allocation concealment (selection bias) | High risk | Quasi‐randomised trial |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote "The placebo and the active capsules were indistinguishable to the participant". No information on the personnel, or method used in blinding both participant and the personnel |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote "The code which identified the active from the placebo was held at Riker Laboratories at Loughborough, and was sent to the investigator only at the end of the study, the active and placebo were indistinguishable". |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The number of participants in each group was not stated explicitly and there was no flow diagram to illustrate this. |
Selective reporting (reporting bias) | Low risk | Study protocol was not available, but all outcomes specified in the method section were addressed. |
Other bias | Unclear risk | There was no information on conflicts of interest, how sample size was determined; no comment was made on ethical approval. The funding organisation was not reported. |