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New negative study on saw palmetto fruit extract (e.g. PROSTA URGENIN UNO) for prostatic hyperplasia: There are numerous non-prescription herbal preparations on the market for the relief of micturition disorders in mild to moderate benign prostatic hyperplasia. The favourites are products containing saw palmetto fruit extract (serenoa repens; e.g. PROSTA URGENIN UNO), 1.3 million packs of the single or combined preparations of which were sold in German pharmacies in 2010. However, in a meta-analysis of 30 randomised studies with over 5,000 patients, no benefit was documented for the herbal preparation over placebo (TACKLIND, J. et al.: Serenoa repens for benign prostatic hyperplasia. The Cochrane Database of Systematic Reviews, as at Dec. 2007, access Nov. 2011). There is no effect either at a higher dose: In a randomised study recently published, 369 patients in the USA and Canada first took the usual dose of 320 mg daily or placebo. After 24 weeks the daily dose of the active study drug was increased to 640 mg and after 48 weeks to 960 mg. After a total of 78 weeks, the primarily determined AUASI* (American Urological Association Symptom Index) score had fallen for the active study drug by, on average, 2.20 points compared with the initial value, consequently numerically less than for placebo (2.99 points). Nor was there was any detectable benefit as regards the secondary endpoints (BARRY, M.J. et al.: JAMA 2011; 306: 1344-51). Rottapharm, the supplier of the saw palmetto fruit extract preparation PROSTA URGENIN UNO, said when asked that they were "very pleased" with the "meaningful result" of the study that no particular undesirable effects occurred with saw palmetto extract, even with a three times higher dose (Rottapharm: statement dated 28. Oct. 2011). The drugs of choice for symptomatic treatment of benign prostatic hyperplasia are alpha-1 receptor blockers such as doxazosin (CARDULAR PP URO, generics). 5-alpha reductase inhibitors such as finasteride (PROSCAR, generics) are reserved for particular situations (cf. a-t 2011; 42: 69-70). We advise against herbal preparations with no confirmed benefit, - Ed.
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