Gotzen 1994.
Methods | Prospective, randomized, double‐blind, placebo‐controlled study | |
Participants | 39 participants with mild to moderate hypertension Mean age = 60 years; male (53.3%) Baseline SBP was 143.9 ± 10.3 mmHg and DBP was 85.5 ± 8.9 mmHg in placebo group Baseline SBP was 149.9 ± 15.5 mmHg and DBP was 91.1 ± 13.8 mmHg in cicletanine 100 mg group |
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Interventions | cicletanine 100 mg per day or placebo for 8 weeks duration cicletanine 100 mg = 20 and placebo = 19 |
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Outcomes | Systolic blood pressure, diastolic blood pressure at end of treatment Also daytime (6.00am to 22.00pm) and nighttime (22.00pm to 6.00am) measurements |
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Notes | Article in German translated by Ciprian Jauca. Table II: End‐of‐treatment week 8 SBP in cicletanine 100 mg was 139.3 ± 13.5 mmHg and DBP was 85.0 ± 9.9 mmHg End‐of‐treatment week 8 SBP in placebo group was 140.3 ± 15.6 mmHg and DBP was 82.7 ± 9.8 mmHg All 39 participants completed the study (no withdrawals). Biochemical parameters were either not measured or not reported. |
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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) | Low risk | "optically identical placebo was administered double‐blind at 8:00 AM." |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not described in the publication. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants completed the study and their blood pressure measurements were reported. |
Selective reporting (reporting bias) | High risk | Adverse events and biochemical markers were not reported. |
Other bias | Unclear risk | The authors did not declare sponsorship or funding of this study and conflicts of interest in the publication. |