Table 1 The quality scale This table lists the criteria of quality that were used to score the RCT manuscripts. Abbreviated definitions for the presence (1 point) or absence (0 points) of each criterion are provided.
1) assessment of the distribution of patient characteristics and prognostic factors between groups | |
   present | distribution of patient characteristics and prognostic factors assessed without asymmetry between groups |
   absent | not mentioned; distribution of patient characteristics and prognostic factors assessed with asymmetry noted between groups |
2) prevention of the movement of patients between groups after allocation, and the use of intention-to-treat analysis | |
   present | use of intention-to-treat analysis; no movement of patients between groups confirmed |
   absent | not mentioned; patients known to change groups before analysis |
3) the blinding of the patients to the treatment they received | |
   present | statements of double-blind present; use of a placebo; statements of the treatments being indistinguishable present; patients not aware of study due to clinical condition |
   absent | not mentioned; lack of placebo use in control group; readily-distinguishable treatments; blinding breakdown confirmed |
4) the blinding of the health care providers to the treatments received by the patients | |
   present | third-party dispensation of treatments; statements of health care provider blinding present; health care provider identical to outcome observer, and outcome observer is blinded |
   absent | not mentioned; health care team aware of patient allocation; lack of placebo in control condition; readily-distinguishable treatments; blinding breakdown confirmed |
5) the blinding of the outcome observer to the treatment received by the patient | |
   present | statements of double blind present; objective outcome; use of standardized tests or questionnaires that do not require an outcome observer; subjective principle outcome but outcome observer blinded to treatment; blinded health care providers performing outcome assessment |
   absent | not mentioned; subjective outcome without blinding of the outcome observer; blinding breakdown confirmed |
6) completeness of follow-up | |
   present | no patients lost to follow-up; acute experimental design does not permit loss of patients; analysis of lost patients provided according to randomization groups, with reason for loss |
   absent | not mentioned; no analysis of lost patients provided; effect of patient loss to follow-up confirmed |
7) allocation concealment | |
   present | use of consecutive opaque envelopes or pre-ordered treatments; third party assignment of allocation |
   absent | not mentioned; repeatable pattern of allocation; use of obvious identifiers for allocation (e.g., birth date, record number); assignment of treatment by treating physician |