Table 1.

Overall quality score of reporting using items from the CONSORT statement (n = 63)

Item	Criteria	Description	Number of positive trials	%	Cohen’s к coefficient	95% CI
1	‘Randomized’ in The title or abstract	Study identified as a randomized controlled in the title or abstract	63	100	1.00	1.00
2	Background	Adequate description of the scientific background and explanation of rationale	17	27	0.82	0.66 to 0.97
3	Trial design	Description of trial design (such as parallel, factorial) including allocation ratio	4	6	1.00	1.00
4	Participants	Description of the eligibility criteria for participants	50	79	0.58	0.28 to 0.87
5	Interventions	Details of the interventions intended for each group	54	86	0.77	0.52 to 1.02
6	Outcomes	Definition of primary (and secondary when appropriate) outcome measures	49	78	0.79	0.60 to 0.99
7	Sample size	Description of sample size calculation	1	2	1.00	1.00
12	Statistical methods	Description of the statistical methods used to compare groups for primary outcomes, subgroup analyses, or adjusted analyses	49	78	0.85	0.69 to 1.02
13	Flow chart	Details on the flow of participants through each stage of the trials (number of patients randomly assigned, receiving intended treatment, completing the protocol and analyzed)	59	84	0.85	0.56 to 1.14
14	Recruitment	Dates defining the periods of recruitment and follow-up	38	60	0.59	0.37 to 0.81
17	Outcomes and estimation	For each primary and secondary outcome, a summary of results for each group is given, and the estimated effect size and its precision (for example, 95% CI)	53	84	0.71	0.44 to 0.99
18	Ancillary analyses	Clear statement of whether subgroup/adjusted analyses were prespecified or exploratory	0	0	1.00	1.00
19	Harms	Description of all important adverse events in each group	2	3	1.00	1.00