Pygeum (Prunus africana) and Urinary support: evidence and sources

Benign prostatic hyperplasia (BPH) is a common chronic condition in older men. The aim of this overview of systematic reviews (SRs) is to summarise the current evidence on the efficacy and adverse effects of dietary supplements for treating BPH with lower urinary tract symptoms. We searched 5 electronic databases and relevant overviews without limitations on language or publication status. Six SRs of 195 articles were included in this overview. Serenoa repens was reviewed in 3 studies and no specific effect on BPH symptoms and urinary flow measures was observed. However, β-sitosterol, Pygeum africannum and Cernilton were reviewed in one study each, and significant improvement was observed for all three. All the included compounds have mild and infrequent adverse effects. SRs on β-sitosterol, Pygeum africannum and Cernilton have not been updated since 2000, thus an update of reviews on these compounds will be necessary in the future.

Purpose We examined the available data from clinical trials for certain botanicals used for lower urinary tract symptoms secondary to benign prostatic hyperplasia, including Serenoa repens (saw palmetto), Pygeum africanum (African plum), Secale cereale (rye pollen) and Hypoxis rooperi (South African star grass). Materials and methods MEDLINE and The Cochrane Library searches were done in June 2007 using the terms benign prostatic hyperplasia, lower urinary tract symptoms, phytotherapy, saw palmetto, Serenoa, Permixon, Pygeum africanum, Tadenan, Cernilton, Cernitin and Hypoxis. Search results were assessed for relevance and the inclusion of placebo controlled trials. Results Two systematic reviews and 3 clinical trials were examined in the evaluation of Serenoa repens. Data from the systematic reviews showed an improvement in flow rates and symptoms. The results of 1 clinical trial were equivocal and the remaining 2 trials clearly showed equivalence to placebo. Systematic reviews were used in the evaluation of P. africanum, Secale cereale and Hypoxis rooperi. P. africanum and H. rooperi showed an improvement in flow rates and symptoms compared to placebo, while S. cereale showed an improvement in symptoms but not flow rates compared to placebo. Conclusions Most clinical trials of investigating the efficacy of botanicals suffer from well documented methodological flaws. Saw palmetto has been clearly shown as comparable to placebo in a trial of sound methodology. While preliminary results appear promising, to our knowledge the remaining botanicals have yet to be evaluated in a trial of similar quality.

Background Benign prostatic hyperplasia (BPH), nonmalignant enlargement of the prostate, can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH has been growing steadily. The extract of the African prune tree, Pygeum africanum, is one of the several phytotherapeutic agents available for the treatment of BPH. Objectives To investigate the evidence whether extracts of Pygeum africanum (1) are more effective than placebo in the treatment of Benign Prostatic Hyperplasia (BPH), (2) are as effective as standard pharmacologic BPH treatments, and (3) have less side effects compared to standard BPH drugs. Search strategy Trials were searched in computerized general and specialized databases (MEDLINE (1966-2000), EMBASE, Cochrane Library, Phytodok), by checking bibliographies, and by contacting relevant manufacturers and researchers. Selection criteria Trials were eligible if they (1) were randomized (2) included men with BPH (3) compared preparations of Pygeum africanum (alone or in combination) with placebo or other BPH medications (4) included clinical outcomes such as urologic symptom scales, symptoms, or urodynamic measurements. Eligibility was assessed by at least two independent observers. Data collection and analysis Information on patients, interventions, and outcomes were extracted by at least two independent reviewers using a standard form. The main outcome measure for comparing the effectiveness of Pygeum africanum with placebo and standard BPH medications was the change in urologic symptoms scale scores. Secondary outcomes included change in urologic symptoms including nocturia and urodynamic measures (peak and mean urine flow, prostate size). The main outcome measure for adverse effects was the number of men reporting adverse effects. Main results A total of 18 randomized controlled trials involving 1562 men met inclusion criteria and were analyzed. Only one of the studies reported a method of treatment allocation concealment, though 17 were double-blinded. There were no studies comparing Pygeum africanum to standard pharmacologic interventions such as alpha-adrenergic blockers or 5-alpha reductase inhibitors. The mean study duration was 64 days (range, 30-122 days). Many studies did not report results in a method that permitted meta-analysis. Compared to men receiving placebo, Pygeum africanum provided a moderately large improvement in the combined outcome of urologic symptoms and flow measures as assessed by an effect size defined by the difference of the mean change for each outcome divided by the pooled standard deviation for each outcome (-0.8 SD [95% confidence interval (CI), -1.4, -0.3 (n=6 studies)]). Men using Pygeum africanum were more than twice as likely to report an improvement in overall symptoms (RR=2.1, 95% CI = 1.4, 3.1). Nocturia was reduced by 19%, residual urine volume by 24% and peak urine flow was increased by 23%. Adverse effects due to Pygeum Africanum were mild and comparable to placebo. The overall dropout rate was 12% and was similar between Pygeum Africanum (13%), placebo (11%) and other controls (8%). Reviewer's conclusions A standardized preparation of Pygeum africanum may be a useful treatment option for men with lower urinary symptoms consistent with benign prostatic hyperplasia. However, the reviewed studies were small in size, were of short duration, used varied doses and preparations and rarely reported outcomes using standardized validated measures of efficacy. Additional placebo-controlled trials are needed as well as studies that compare Pygeum africanum to active controls that have been convincingly demonstrated to have beneficial effects on lower urinary tract symptoms related to BPH. These trials should be of sufficient size and duration to detect important differences in clinically relevant endpoints and use standardized urologic symptom scale scores.

Objective To review and evaluate the literature relative to the use of herbal therapies in the treatment of benign prostatic hyperplasia. Data sources Literature was identified by MEDLINE, Embase, International Pharmaceutical Abstracts, and the International Bibliographic Information on Dietary Supplements searches and through cross-referencing of selected articles. Study selection/data extraction All articles identified from the data sources were evaluated and all information deemed relevant was included in this review. Data synthesis A large percentage of men >50 years old begin to experience signs and symptoms of benign prostatic hyperplasia (BPH). Herbs hold promise in the treatment of BPH. Serenoa repens, Pygeum africanum, Urtica dioica radix, and Cucurbita peponis semen are some of the botanical therapies used in the treatment of BPH. Conclusions There are many European studies examining efficacy, dose, and adverse effects of these plants in the treatment of BPH. However, numerous questions remain. These include issues concerning long-term beneficial and adverse effects of herbal therapy, prevention of complications, standardization of extracts, and concomitant use with "mainstream" medications. Based on the information available today, these botanical therapies can be used for treatment of a number of objective and subjective symptoms in patients with BPH, stages I and II.

Objectives To assess the effectivenessand tolerability of treatment with P africanum(P. africanum) in patients with lower urinary tractsymptoms (LUTS) associated with benign prostatichyperplasia (BPH) in routine clinical practice. Material and methods Cross-sectional observationalstudy in which 115 patients with LUTS/BPHtreated for 6 months with P. africanum (Tebetane® compuesto)in real-world clinical practice conditions wereincluded. The primary objective was to assess thequality of life (QoL) according to changes in the scoresof item 8 of the International Prostate Symptom Score(IPSS) questionnaire (a score ≥ 4 indicates a significantimpairment of QoL). Secondary objectives includedimprovement of urinary symptoms, urinary flow, satisfactionand compliance with treatment as well astolerability. Data were collected in a single scheduledvisit at 6 months of treatment with P. africanum andwere compared with data registered in the medicalrecords at the beginning of treatment. Results After 6 months of treatment withP. africanum, the percentage of patient with significantimpairment of QoL was 22.6% as compared with45.2% at the initiation of treatment (P 0,-001). Theoverall IPSS score showed a mean decreas of -4,-5points (median -4,0, interquartile range [IQR] -7,-0 to-2,0) and 69 patients (60%) showed a clinically significantimprovement (reduction of ≥ 4 points). Therewere significant decreases in IPSS subscales of storage(mean -1,-8; median -2,-0, IQR -3,-0 to 0 (P 0,-001)and voiding (mean -1,-9; median -2,-0, IQR -3,-0 to 0)(P 0,-001) symptoms. The degree of satisfaction and compliance with treatment was high with mean scores(median) of 6,9 (7,0) and 9,2 (10), respectively in the1-10 visual analogue scale. Treatment-related adverseeffects did not occur. Conclusions Treatment with P. africanum during6 months improved significantly QoL and LUTS inpatients with BPH, with a high level of satisfaction andcompliance with treatment, without adverse events.

Introduction The use of complementary and alternative medications has become a multi-million dollar business in the United States and comprises more than half of all filled prescriptions for benign prostatic hyperplasia (BPH) in Europe. For the practicing urologist, understanding the phytotherapeutic agents available, their proposed mechanism of action, the research supporting their use, and their safety profiles has become increasingly important as more patients inquire into their use. Materials and methods A comprehensive literature search was conducted to identify pertinent articles pertaining to alternative and complementary treatment options for the management of BPH. Treatments demonstrating adequate clinical data, including Serona repens, Pygeum africanum, and Secale cereal, were selected for in depth review. Results Small clinical trials for each of the agents demonstrated mixed results while larger more soundly constructed studies found no significant benefit for the use of phytotherapy in the treatment of BPH. Conclusions Based on the available literature, there is no evidence that phytotherapy significantly improves symptoms of BPH against placebo, despite being largely safe for ingestion. In patients with mild BPH symptoms who are reluctant to take standard pharmaceutical medications may try these agents provided that the patient understands their current limitations. Those with moderate or severe BPH should be discouraged from alternative and complementary treatments.