Table 3.
Quality assessment of included studies according to the CONSORT checklist
Item | Asemi et al. [25] | Shargorodsky et al. [34] | Alizadeh et al. [24] | Murer et al. [32] | Jamilian et al. [30] | Faghihi et al. [27] | Farrokhian et al. [28, 40] | Bahmani [26] | Faure et al. [29] | Mohammad Hosseinzadeh et al. [35] | Mao [35] | Rayman et al. [33] |
---|---|---|---|---|---|---|---|---|---|---|---|---|
1a | Yes | No | Yes | Yes | Yes | Yes | Yes | No | No | Yes | No | Yes |
1b | Yes | Yes | Yes | No | Yes | No | Yes | Yes | Yes | Yes | Yes | Yes |
2a | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
2b | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
3a | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
3b | No | No | No | No | No | No | No | No | No | No | No | No |
4a | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
4b | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
5 | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
6a | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
6b | No | No | No | No | No | No | No | No | No | No | No | No |
7a | Yes | Yes | Yes | Yes | Yes | No | Yes | Yes | No | Yes | No | Yes |
7b | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
8a | Yes | No | Yes | Yes | Yes | Yes | Yes | Yes | No | No | Yes | Yes |
8b | No | No | Yes | Yes | Yes | Yes | Yes | Yes | No | No | Yes | Yes |
9 | Yes | No | Yes | Yes | Yes | No | Yes | Yes | No | No | Yes | Yes |
10 | Yes | No | No | No | Yes | No | Yes | Yes | No | Yes | No | Yes |
11a | No | No | No | No | Yes | No | Yes | Yes | No | No | No | Yes |
11b | No | No | No | No | No | No | No | No | No | No | No | No |
12a | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
12b | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
13a | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
13b | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
14a | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
14b | No | No | No | No | No | No | No | No | No | No | Yes | No |
15 | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes |
16 | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
17a | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes |
17b | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
18 | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
19 | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
20 | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
21 | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
22 | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
23 | Yes | No | Yes | Yes | Yes | No | Yes | Yes | No | Yes | Yes | Yes |
24 | No | No | No | No | No | No | No | No | No | No | No | Yes |
25 | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
Total | 30 | 25 | 30 | 29 | 32 | 26 | 32 | 31 | 23 | 28 | 29 | 33 |
(1a) Identification as a randomized trial in the title; (1b) Structured summary of trial design, methods, results, and conclusions; (2a) Scientific background and explanation of rationale; (2b) Specific objectives or hypotheses; (3a) Description of trial design (such as parallel, factorial) including allocation ratio; (3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons; (4a) Eligibility criteria for participants; (4b) Settings and locations where the data were collected; [5] The interventions for each group with sufficient details to allow replication, including how and when they were actually administered; (6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed; (6b) Any changes to trial outcomes after the trial commenced, with reasons; (7a) How sample size was determined; (7b) When applicable, explanation of any interim analyses and stopping guidelines; (8a) Method used to generate the random allocation sequence; (8b) Type of randomization; details of any restriction (such as blocking and block size); [9] Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned; [10] Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions; (11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how; (11b) If relevant, description of the similarity of interventions; (12a) Statistical methods used to compare groups for primary and secondary outcomes; (12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses; (13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome; (13b) For each group, losses and exclusions after randomization, together with reasons; (14a) Dates defining the periods of recruitment and follow-up; (14b) Why the trial ended or was stopped; [15] A table showing baseline demographic and clinical characteristics for each group; [16] For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups; 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval); 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended; [18] Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory; [19] All important harms or unintended effects in each group (for specific guidance see CONSORT for harms); [20] Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses; [21] Generalizability (external validity, applicability) of the trial findings; [22] Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence; [23] Registration number and name of trial registry; [24] Where the full trial protocol can be accessed, if available; [25] Sources of funding and other support (such as supply of drugs), role of funders