Item	Authors’ judgement	Support for judgement
Adequate sequence generation?	Yes	Randomisation by random number table
Allocation concealment?	Yes	As a placebo controlled study it is likely that allocation was concealed.
Blinding?	Yes	Participants were blinded (placebo controlled), outcome assessors blinded.
Incomplete outcome data addressed?	Yes	All withdrawals are explained and all participant data included. Four withdrawals; 3 from treatment group for non-compliance because of loose bowels; 1 withdrew from control for non-compliance. The data of these subjects was excluded from the analysis. The baseline data of all 85 subjects was not significantly different from those of the 81 women.
Free of selective reporting?	Unclear	No protocol provided but all nominated and expected outcomes are reported.
Free of other bias?	Yes	None identified.