To estimate the effectiveness and harms of Serenoa repens monotherapy in In prova BPH treatment of lower urinary tract symptoms LUTS consistent with benign prostatic hyperplasia BPH. Trials were eligible if they randomised men with symptomatic BPH to receive Serenoa repens extract monotherapy for at least 4 weeks in comparison with placebo, and assessed clinical outcomes and urodynamic measurements.
Our primary outcome was improvement in LUTS, based on change in urological symptom-scale scores. Trial lengths ranged from 4 to 72 weeks. The mean age of all enrolees was The mean baseline total score was 14 points, indicating moderately severe symptoms.
In all, 16 trials were double blinded and adequate treatment allocation concealment was reported in six trials. Based on mostly short-term studies, Q max measured at study endpoint were also not significantly different between treatment groups WMD 1. Adverse events of Serenoa repens extracts were few and mild, and incidences were not statistically significantly different vs placebo. Phytotherapy is often used as a first-line treatment in Western countries [ 12 ].
In the USA use of phytotherapeutic agents has also markedly increased. In a survey, Serenoa repens was used by 2. One survey reported that one-third of men choosing non-surgical therapy for BPH were using herbal preparations In prova BPH or combined with prescription medications [ 4 ]. We have updated a previous a systematic review to address the effects and harms of monotherapeutic preparations of Serenoa repens In prova BPH the treatment of LUTS associated with BPH [ 5 ].
Systematic reviews, references, clinical-practice guidelines, and conference abstracts were also hand-searched. We included studies that were:. As a measure of overall In prova BPH study quality we used criteria developed by Schulz and The Cochrane Collaboration In prova BPH 67 ].
Analyses were performed using RevMan 5. To minimise the uncertainty of the pooled-effect estimate, we used an inverse variance method, which allows larger trials with a smaller standard error of the mean more weight over smaller trials with larger standard error of the mean. The combined search strategies identified 17 trials enrolling participants meeting inclusion criteria Table 1 [ 10 — 26 ]. Overall the mean age of the participants was The mean baseline values for Q max and nocturia were The standard daily dose was mg.
One trial used a mg dose of In prova BPH repens extract [ 20 ] and one trial increased the standard dose up to three times mg [ 10 ]. Only two trials were considered long-term, a minimum trial duration of 1 year [ 1012 ].
The most recent trials were conducted in In prova BPH USA [ 101219 ] and Australia [ 26 ]. Six trials reported adequate treatment allocation concealment [ 101214161920 ].
Most of the trials adequately addressed incomplete data indicating low risk for attrition bias. Two trials compared IPSS total scores at study endpoint [ 1126 ].
The moderate-term study 6 months by Bauer et al. The short-term trial of 12 weeks reported improved symptoms for both arms but the difference between groups was not statistically significant WMD 1. Long- or moderate-term Serenoa repens therapy did not improve Q max compared with placebo based on mean changes from baseline WMD 0.
An analysis of mostly short-term studies also found Q max values were not significantly different between treatment groups based on rates when measured at study endpoint WMD 1.
The percentages of study withdrawals were comparable for the Serenoa repens therapy and placebo groups, 9. Adverse events of Serenoa repens therapy were few and In prova BPH, and compared with placebo, not statistically significantly different. The most common adverse events reported included gastrointestinal discomfort, upper respiratory tract infections, diarrhoea, and headache.
The long-term trial by Barry et al. In previous In prova BPH reviews [ 527 ], first published inwe reported that Serenoa repens extracts provided mild improvement of urological symptoms. Method of allocation concealment was unclear In prova BPH most of these trials, which may have In prova BPH to selection bias. Thus we urged caution in concluding effectiveness. Beginning inwith the addition of rigorous, high quality, long-term trials, we reported that Serenoa repens therapy was no better than placebo in reducing LUTS in men with BPH.
In prova BPH high quality month trial enrolling participants In prova BPH that Serenoa repens therapy In prova BPH not improve symptoms or urinary flow and other objective measures [ 12 ].
The most recent trials included in this update have included at least men In prova BPH 1012 ] and these In prova BPH larger studies were longer term and of higher methodological quality.
Another problem in many studies was the use of unvalidated symptom scores. Lack of standardisation is a long-recognised problem of phytotherapeutic products, and that includes Serenoa repens [ 2930 ]. A systematic review reported improvements in the IPSS In prova BPH of Permixon and placebo but included only one direct comparison between the two arms [ 31 ].
In the present review, there was no difference in reported In prova BPH in the AUASI but none of the trials used Permixon. In conclusion, Serenoa repens In prova BPH are widely used to treat symptomatic BPH. During the last 4 years we have seen two very high quality trials comparing Serenoa repens to placebo and up to 6 years duration. These trials found Serenoa repens no better than placebo, even in one trial at escalating doses. Supported in part by a Grant no. National Center for Biotechnology InformationU.
BJU Int. Author manuscript; available in PMC Jun 1. James W. Timothy J. Author information Copyright and License information Disclaimer. Correspondence: Timothy J. Copyright notice. The publisher's final In prova BPH version of this article is available free at BJU Int. See other articles in PMC that cite the published article. Abstract Objective To estimate the effectiveness and harms of Serenoa repens monotherapy in the treatment of lower urinary tract symptoms LUTS consistent with benign prostatic hyperplasia BPH.
Adverse events were generally mild and comparable to placebo. Keywords: Serenoa repensbenign prostatic hyperplasia, phytotherapy, systematic review. Results Literature search and trial characteristics The combined search strategies identified 17 trials enrolling participants meeting inclusion criteria Table 1 [ 10 — 26 ].
Open in a separate window. Study quality Six trials reported adequate treatment allocation concealment [ 101214161920 ]. Q max and secondary outcomes Long- or moderate-term Serenoa repens therapy did not improve Q max compared with placebo based on mean changes from baseline WMD 0. Study withdrawals and adverse events The percentages of study withdrawals were comparable for the Serenoa repens therapy and placebo groups, 9.
Discussion In previous Cochrane reviews [ 527 ], first published inwe reported that Serenoa In prova BPH extracts provided mild improvement of urological symptoms.
Acknowledgments Supported in part by a Grant no. References 1. Plant extracts in benign prostatic hyperplasia.
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Serenoa repens for benign In prova BPH hyperplasia. Cochrane Database SystRev. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. Higgins JP, Green S, editors. Assessing risk of bias in included studies.
Version 5. The Cochrane Collaboration. Available at www. Review Manager RevMan [Computer program]. Measuring inconsistency in meta-analysis.
In prova BPH of increasing doses of Saw palmetto extract on lower urinary tract symptoms. Saw In prova BPH fruit extract for treatment of benign prostatic In prova BPH. Results of a placebo-controlled double-blind study. MMW Fortschr Med. Saw palmetto for benign prostatic hyperplasia. N Engl J Med. Boccafoschi C, In prova BPH S. Confronto fra estratto di Serenoa repens e placebo mediate prova clinica controllata in pazienti con adenomatosi prostatica. A double-blind, placebo-controlled study of the plant extract Serenoa repens in the treatment of benign hyperplasia of the prostate.