Table 3. Summary of findings for the secondary comparison: phytotherapy with Serenoa repens versus placebo.
| Outcomes | No. of participants (studies) Follow-up | Certainty of the evidence (GRADEa) | Relative effect (95% CI)b | Anticipated absolute effects | ||
|---|---|---|---|---|---|---|
| Risk with placebo/no treatment | Risk difference with phytotherapy with S. repens | |||||
| Urologic symptom score | 416 (3 RCTs) | ⨁◯◯◯ VERY LOWc,d,e |
- | The mean urologic symptom score was 11.1 | MD 2.94 lower (5.55 lower to 0.32 lower) | |
| Measured by IPSS scores (range 0–35) | ||||||
| Higher scores indicate worse symptoms | ||||||
| Follow-up: 12 to 48 weeks | ||||||
| Quality of life | 265 (2 RCTs) | ⨁◯◯◯ VERY LOWc,f,g |
One study reported improvements (p<0.05) while the other did not. | |||
| Measured by IPSS-QoL score (range 0–6) | ||||||
| Follow-up: 6 to 12 months | ||||||
| Adverse events | 437 (3 RCTs) | ⨁⨁◯◯ LOWc,e |
RR 0.87 (0.56–1.36) | 158 per 1,000 | 21 fewer per 1,000 (70 fewer to 57 more) | |
| Cumulative incidence | ||||||
| Follow-up: 12 to 48 weeks | ||||||
Patient or population: lower urinary symptoms due to benign prostatic hyperplasia. Setting: Sweden, Australia, Italy, Russia, Germany, USA. Intervention: S. repens with other phytotherapy. Comparison: placebo/no treatment.
GRADE, Grading of Recommendations Assessment, Development, and Evaluation; CI, confidence interval; IPSS, International Prostate Symptom Score; -, not available; MD, mean difference; QoL, quality of life; RR, risk ratio.
a:GRADE Working Group grades of evidence: (1) High certainty: We are very confident that the true effect lies close to that of the estimate of the effect. (2) 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. (3) Low certainty: Our confidence in the effect estimate is limited. The true effect may be substantially different from the estimate of the effect. (4) 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.
b: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).
c:Downgraded one level due to concerns about bias: all studies did not have a pre-specified analysis plan or protocol (some concerns of selective outcome reporting).
d:Downgraded one level due to concerns about inconsistency: high statistical inconsistency (I2=77%).
e:Downgraded one level due to imprecision: wide confidence interval.
f:Downgraded one levels due to imprecision: the included studies reported p-values and we are uncertain about effect sizes.
g:Downgraded one level due to inconsistency: the included studies reported different effects.