Sandhiya 2015.
Methods | Study design: parallel‐group trial Total study duration: from 1 January 2012 to 11 April 2013 Duration of follow‐up: no follow‐up beyond treatment phase Method of randomisation: not described, performed in a 1:1 ratio Method of concealment of allocation: drugs distributed using sequentially numbered opaque sealed envelopes Blinding: not mentioned Power calculation: not mentioned Phases of the study: 1 (treatment phase) Number of patients randomised: 47 (24/23 for trimetazidine/ranolazine group) Exclusions post‐randomisation: not reported Withdrawals (and reasons): not reported |
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Participants | Total number: 40 Country of enrolment: Greece Setting/location: outpatient Diagnostic criteria (stable angina pectoris): history of exertional angina and CAD documented by coronary angiography (macrovascular angina) Comorbidities: diabetes mellitus Age (mean): 57.4 ± 9.1 / 58 ± 8.1 years for trimetazidine/ranolazine group Gender (male %): 83% (87.5/78.3 for trimetazidine/ranolazine group) Inclusion criteria:
Exclusion criteria:
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Interventions | Number of intervention groups: 2 Concomitant medications: statins Excluded medications: those mentioned in exclusion criteria Trimetazidine group
Ranolazine group
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Outcomes | Total number of outcomes: 1
Angina episodes frequency
RESULTS Angina episodes frequency
Adverse events The adverse events reported for the ranolazine group included angina, constipation, postural hypotension, headache, dizziness, nausea and weakness; for the trimetazidine group were constipation, weakness, palpitations, angina, dizziness, nausea, dyspepsia, headache, gastric discomfort and joint pain. |
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Notes | Relevant observations for the data provided before: none Source of funding: no external source of funding Notable conflicts of interest: the authors declare that they have no conflict of interest |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation is stated but described only as "in a 1:1 ratio" |
Allocation concealment (selection bias) | Low risk | Study drugs were provided in sequentially numbered opaque sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Study declared to be double‐blinded, but no description is provided. However, it can be presumed that participants and personnel were blinded since drugs were provided in sealed envelopes |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Study declared to be double‐blinded, but no description is provided |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No exclusion or withdrawal is reported, we assume that all patients completed the study |
Selective reporting (reporting bias) | Unclear risk | There is no published protocol. Results for all the outcomes stated in the "Methods" section of the paper are reported |
Other bias | Low risk | The authors declare that the study was not supported by external source of funding. Also, they declared that they had no conflict of interest. |