Clinical Use

The most studied saw palmetto preparation is a commercial product known as Permixon (Pierre Fabre Médicament, Castres, France), which is a liposterolic extract consisting of 80% free (e.g. 94 g/100 g extract) and 7% esterified fatty acids, as well as small amounts of sterols (beta-sitosterol, campesterol, stigmasterol, cycloartenol), and a minimum percentage of polyprenic compounds, arabinose, glucose, galactose, uronic acid, and flavonoids. BENIGN PROSTATIC HYPERTROPHY

Saw palmetto extracts are extremely popular in Europe where herbal preparations represent approximately one-third of total sales of all therapeutic agents sold for the treatment of BPH (Levin & Das 2000). Saw palmetto 1066

Substantial evidence suggests that saw palmetto is an effective treatment for stages 1 and 2 of BPH. A 2002 Cochrane review assessing the results from 21 randomised trials involving 3139 men concluded that saw palmetto improves urinary scores, symptoms and urinary flow measures compared with placebo, with effects on symptoms scores and peak urine flow similar to the pharmaceutical drug finasteride (Wilt et al 2002). Additionally, its use is associated with fewer adverse effects compared with finasteride and typically, symptomatic relief is reported more quickly.

In 2004, an updated meta-analysis of 14 randomised studies and three open-label studies was published (Boyle et al 2004). The analysis used data from 4280 patients derived from clinical studies that had used Permixon. Peak urinary flow rate and nocturia were the two common end-points. Active treatment was associated with a mean reduction in the International Prostate Symptom Score (IPSS) of 4.78 (0.41). A significant improvement in peak flow rate and reduction in nocturia was also reported.

Since then, a double-blind study of 1 year of continuous treatment with saw palmetto extract (160 mg twice daily) failed to produce significant differences compared with placebo for the American Urological Association Symptom Index, maximal urinary flow rate, prostate size, residual volume after voiding, quality of life, or serum PSA levels (Bent et al 2006). A closer look at the study reveals that some subjects with moderate to severe BPH were also included in the sample, which may have contributed to the results observed; however, this is speculative. Comparisons with alpha-adrenoreceptor antagonists Although several comparative trials have been undertaken with finasteride, only a few have compared it with alpha-adrenoreceptor antagonist drugs, which are also commonly used in BPH (Adriazola et al 1992, Debruyne et al 2002). The most recent was a large, randomised, double-blind study involving 811 men with symptomatic BPH, who were recruited from 11 European countries, which showed that Permixon 320 mg/day produced similar results to tamsulosin 0.4 mg/day (Omnic) (Debruyne et al 2002). More specifically, both treatments reduced the IPSS by an average of 4.4 in 80% of subjects. Those patients with the most severe disease experienced the greatest improvement in IPSS total score, with mean changes greater in the Permixon group than in the tamsulosin group (-8.0 and -6.8, respectively). In regard to safety, both treatments were considered well tolerated; however, ejaculation disorders were significantly more frequent with tamsulosin (4.2%) than with Permixon (0.6%). Although these results are promising, this study has been criticised for not including a placebo group as a comparator. Saw palmetto 1067

In a short 3-week study, Grasso et al (1995) compared the effects of alfuzosln (7.5 mg/day) with saw palmetto (320 mg/day) In 63 BPH subjects under double-blind test conditions. Both treatments were found to be as effective in regard to improving irritative score; with maximum and mean urine flow, however, alfuzosin was shown to more rapidly reduce symptoms of obstruction. Considering most studies have shown that 4-8 weeks' treatment with the herb is required to produce maximal effects, the effect seen at 3 weeks is encouraging.

An earlier study compared the effects of prazosin with saw palmetto in 45 patients with BPH over a 12-week period (Adriazola et al 1992). This study found that although both treatments reduced symptoms, prazosin was slightly more effective. Changes to prostate size It is still open to speculation as to whether saw palmetto affects prostate size, because studies have produced contradictory results (Aliaev et al 2002, Bent et al 2006, Pytel et al 2002). One open study of 1 55 men tested the effectiveness and tolerability of Permixon (160 mg twice daily) over 2 years (Pytel et al 2002), and not only detected a significant improvement in the IPSS and QOL marker, but also a decrease in prostate size and significant improvement in sexual function after the first year of treatment.

A longer 5-year study using Permixon in 26 subjects with BPH showed that a total daily dose of 320 mg twice daily also significantly reduced disease symptoms and improved QOL, while reducing prostate size by an average of 30% (Aliaev et al 2002). In 2003, results from two animal studies showed that saw palmetto (whole berry and extract) significantly diminished prostatic hyperplasia (Talpur et al 2003). In contrast, the 2006 study discussed earlier failed to find a significant effect on prostate size (Bent et al 2006).

Commission E approves the use of saw palmetto for stages 1 and 2 of BPH (Blumenthal etal 2000).

Clinical note— Benign prostatic hypertrophy

BPH occurs in more than 50% of men over the age of 50 years. It is a slow, progressive enlargement of the fibromuscular and epithelial structures of the prostate gland, which can lead to obstruction of the ureter and urine retention. Symptoms such as frequent and/or painful urination, painful perineal stress, and a decrease in urine volume and flow can develop. The condition has four stages, with stage 1 considered mild, stages 2 and 3 considered more severe and often requiring pharmacological treatment, and stage 4 as severe and necessitating surgery.

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