Summary of findings 1. Roselle extract compared to placebo for hypertension in adults.
| Roselle extract compared to placebo for hypertension in adults | ||||||
| Patient or population: hypertension in adults with type 2 diabetes mellitus Setting: 5 public health centres in Yogyakarta, Indonesia Duration of follow‐up periods: 8 weeks of treatment Intervention: Roselle extract Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with Roselle extract | |||||
| Change** in SBP at week 8 (mmHg) | The mean change in SBP at week 8 was −5.69 mmHg. at baseline mean 146.8 (SD 20), at week 8 mean 141.11 (SD 20.63) |
MD 1.65 higher (7.89 lower to 11.19 higher) | Not applicable | 52 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1, 2, 3 | Change in SBP is highly skewed for both groups. |
| Change** in DBP at week 8 (mmHg) | The mean change in DBP at week 8 was 0.13 mmHg. at baseline mean 81.47 (SD 9.71), at week 8 mean 81.61 (SD 8.29) |
MD 4.6 higher (1.38 lower to 10.58 higher) | Not applicable | 52 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1, 2, 3 | Change in DBP is highly skewed for both groups. |
| Withdrawals due to adverse effects | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Change** in pulse pressure (mmHg) | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| Change** in heart rate (beats/min) | ‐ | ‐ | ‐ | ‐ | ‐ | Not reported |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). **Change‐from‐baseline outcomes calculated by end measurement minus baseline measurement. CI: confidence interval; DBP: diastolic blood pressure; MD: mean difference; RCT: randomised controlled trial; SBP: systolic blood pressure; SD: standard deviation | ||||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
1Downgraded three levels due to methodological limitations: attrition bias (overall dropout rate 13.4%, reason for dropout not provided for one withdrawal in the intervention group, and unequal dropout rates between study arms (20% vs 6.6%)); selective outcome reporting; and imbalance in participant characteristics at baseline between groups. 2Downgraded two levels due to imprecision: few participants (total sample size included was 52 participants; less than 400 (rule of thumb)); for SBP, 95% CI included no effects and also appreciable benefit and harm (minimally important difference (MID) of 5 mmHg), for DBP 95% CI included no effects and appreciable harm (MID of 5 mmHg). 3Downgraded one level due to indirectness: the evidence was restricted to participants aged 50 and over.