New Avenues

Although not recommended by the EAU and AUA guidelines, phytotherapy has become a popular BPH treatment in parts of Europe. Recommendations from the 5th International Consultation on BPH regarding the use of plant extracts in the treatment of BPH suggest that every brand should be fully evaluated, and only extracts with proven clinical efficacy should be used.52 A lipido-sterolic extract of Serenoa repens (Saw palmetto) is one such option, and there is a growing database supporting the use of one form (LSESr Permixon), which is a complex mixture containing 90% free fatty acids and 7% esterified long-chain fatty acids, which mainly consists of oleic, lauric, myristic, and palmitic acid.53 In a recent meta-analysis of 14 randomized clinical trials involving over 4000 patients, with a maximum duration of 720 days, Permixon was associated with a mean decrease in IPSS of 4.78 and a mean improvement in Qmax of 1.02 mLs _ 1 above placebo.54 Although the exact mechanism of action is unknown, there is evidence to suggest that Permixon is a 5a-reductase inhibitor, which also inhibits DHT binding, and has anti-inflammatory effects relating to leukotriene production.53 Saw palmetto is also being explored in combination with nettle root, another herbal option, in a preparation known as Prostagutt forte. Other phytotherapeutic preparations also being assessed include red clover extracts, which contain high concentrations of isoflavones that have been shown to have symptomatic benefits.

In addition, luteinizing hormone-releasing hormone antagonists that inhibit the pituitary-gonadal axis, and vitamin D3 analogs that target receptors in the bladder are also in development. Botulinum A toxin (Botox) has also been explored in patients who were poor candidates for surgery. In a recent study of 10 patients with BPH and AUR, all patients given 200 U Botox injections into the transition zone of the prostate showed improvements in PVR, Qmax, and prostate volume, which were maintained during the 12-month follow-up period.55 Other areas being explored include de-sensitization of C-fibers, which are involved in nociception (pain perception), using intravesical resiniferatoxin solution56 and the effects of beta-radiation on key growth factors, including TGF^1 and bFGF. It is thought that betarays may shrink the hyperplastic cells and reawaken apoptosis.57

For existing products there is a trend toward new formulations such as extended-release doxazosin, which has the same clinical benefits as the standard preparation but with less need for dose-titration, and the use of these medications in comorbid conditions. In a recent study of BPH patients with comorbid sexual dysfunction, doxazosin extended-release 4 or 8 mg or doxazosin standard 1-8 mg were given to patients for 13 weeks. The study showed that sexual function improved after treatment with both formulations as shown by the International Index of Erectile Function questionnaire.58

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