Quality assessment of included studies.

Y, yes; U, unclear; Randomisation:the study described as randomized; Random sequence generation: the correct method for generation of random numbers computer random numbers table, shuffled cards or tossed coins, and minimization; Allocation concealment: Adequate concealment was that up to the point of treatment (eg, central randomisation); Double-blinding: masking to both researchers and patients; Reporting of withdrawals: The numbers and reasons for withdrawal in each group had to be stated for a point to be awarded.