Ramesh 1998.
Methods | RCT, single‐centre, parallel‐group design | |
Participants | 36 male (n = 11) and female (n = 25) participants with advanced cancer in an Indian palliative care unit aged ≥ 15 years who were started on oral morphine for the first time and had opioid‐induced constipation Exclusion criteria: were infants and children aged < 15 years, people with intestinal obstruction, people already taking laxatives, people who were constipated even before the intake of morphine, people already undergoing Ayurvedic therapy as some medicines may have a laxative action Most common cancers were lung, tongue, breast, oesophagus or cervix. Majority of the participants were aged 51‐70 years |
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Interventions | Oral tablet Drug 1: misrakasneham (an Ayurvedic preparation; starting at 2.5 mL) Drug 2: senna (starting at 24 mg) in 3 steps of doses if previous level failed Maximum doses: senna 72 mg, misrakasneham 10 mL Duration of treatment: 2 weeks Given as a prophylactic when opioids started |
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Outcomes | Bowel movement | |
Notes | Trial authors recommended use of misrakasneham based on favourable toxicity profile and cost advantage. This preparation may be difficult to obtain for use in the UK | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomly allocated to the 2 study groups (25 each) by drawing lots (sampling with replacement) |
Allocation concealment (selection bias) | Unclear risk | No details provided |
Blinding (performance bias and detection bias) All outcomes | High risk | The difference between the physical forms of the 2 drugs necessitated an open trial rather than a double‐blind study |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 20 (80%) participants in misrakasneham group and 16 (64%) participants in senna group completed the trial. 1 participant from misrakasneham group and 4 participants from senna group dropped out because of irregular laxative administration. 0 dropped out because of inefficacy Unclear if used intention‐to‐treat analysis |
Selective reporting (reporting bias) | Unclear risk | No details provided |