Bodak 1989.
Methods | Prospective, randomized, double‐blind, placebo‐controlled study | |
Participants | 132 participants aged more than 60 years with diastolic arterial pressure over 95mmHg and systolic over 160 mmHg. 62.9% participants were aged over 75 years. Mean age was 73.6 years; male 32/60 (53.3%) Baseline SBP/DBP with SD1 Placebo = 173.2 ± 14.7/104.7 ± 6.9 mmHg Cicletanine 150 mg = 176.3 ± 10.7/103.2 ± 7.6 mmHg Heart rate: placebo = 75.8 ± 6.7 and cicletanine = 76.9 ± 9 |
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Interventions | Study A: cicletanine 150 mg per day and placebo for a duration of 180 days cicletanine 150 mg = 30 and placebo = 30 Study B: cicletanine 50 mg and cicletanine 100 mg with no parallel placebo arm, so this study was excluded from the review. |
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Outcomes | Systolic blood pressure, diastolic blood pressure Normalization of blood pressure Serum sodium, potassium, glucose, uric acid, creatinine, cholesterol, and triglycerides |
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Notes | Article in French translated by Ciprian Jauca. End‐of‐treatment SBP/DBP ± SD were reported in table III page 104. Withdrawal due to adverse events reported in Study A: 2 participants left in placebo group due to serious adverse events. Biochemical parameters at baseline and end of treatment with SD were reported in table V page 105. Change from baseline to end point in SBP, DBP, and biochemical values was calculated and SD at end of treatment was imputed for meta‐analysis. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described in the publication. |
Allocation concealment (selection bias) | Unclear risk | Not described in the publication. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not described in the publication. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "14 patients left the study early," 12 from the excluded Study B and 2 from the included Study A (both from the placebo group, both due to serious adverse events). |
Selective reporting (reporting bias) | Low risk | All outcome measures were reported. |
Other bias | Unclear risk | The authors did not declare sponsorship or funding of this study and conflicts of interest in the publication. |