Skip to main content
. 2020 Aug 5;2020(8):CD011625. doi: 10.1002/14651858.CD011625.pub3

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
Participants 200 normal postpartum women
Intervention group: 100 primiparous and multiparous women
Control group: 100 primiparous and multiparous women
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
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
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
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.