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. 2015 May 13;2015(5):CD003448. doi: 10.1002/14651858.CD003448.pub4

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
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
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