Summary of findings 3. Pine bark extract compared to placebo for the treatment of CVD.
Pine bark extract compared to placebo for the treatment of CVD | ||||||
Patient or population: adults with CVD Setting: not reported Intervention: pine bark extract 1x 10 g pouch daily, taken orally once sachet contents dissolved in 180 mL water resulting in an isotonic solution Comparison: placebo 1x 10 g pouch daily, taken orally once sachet contents dissolved in 180 mL water resulting in an isotonic solution | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
Risk with placebo | Risk with pine bark extract | |||||
Participant‐reported | No studies reported this outcome. | |||||
Investigator‐reported | ||||||
Diastolic blood pressure (mm Hg) Follow‐up: 2 months |
The mean diastolic blood pressure was 92 mm Hg. | MD 3.00 mm Hg lower (4.51 lower to 1.49 lower). | ‐ | 61 (1 RCT) | ⊕⊝⊝⊝ VERY LOWa,b,c | It is not known whether pine bark extract supplements decrease diastolic blood pressure. |
HDL cholesterol (mmol/L) Follow‐up: 2 months |
The mean HDL cholesterol was 0.96 mmol/L. | MD 0.05 mmol/L higher (0.01 lower to 0.11 higher). | ‐ | 61 (1 RCT) | ⊕⊝⊝⊝ VERY LOWa,b,c | It is not known whether pine bark extract supplements increase HDL cholesterol. |
LDL cholesterol (mmol/L) Follow‐up: 2 months |
The mean LDL cholesterol was 1.01 mmol/L. | MD 0.03 mmol/L lower (0.05 lower to 0.00). | ‐ | 61 (1 RCT) | ⊕⊝⊝⊝ VERY LOWa,b,c | It is not known whether pine bark extract supplements decrease LDL cholesterol. |
All‐cause mortality | No studies reported this outcome. | |||||
Serious adverse events: hospitalisation | Hospitalisation of 1 participant occurred in the pine bark extract supplement group of each included study. | 176 (2 RCTs) | ⊕⊝⊝⊝ VERY LOWa,b,d | It is not known whether pine bark extract supplements increase hospitalisation. | ||
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; CVD: cardiovascular disease; HDL: high‐density lipoprotein; LDL: low‐density lipoprotein; RR: risk ratio. | ||||||
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. |
a Downgraded once for indirectness: single study only. b Downgraded once for risk of bias: concerns regarding selection bias. c Downgraded once for imprecision: optimal information size not met. d Downgraded twice for imprecision: optimal information size not met; very few events and the 95% CI is very wide.