Benign prostatic hyperplasia (BPH), the non-malignant enlargement of the prostate, is traditionally treated by a series of medical or surgical methods, with extensive research currently in progress to develop new therapeutic techniques. In recent decades, the disease and consequent lower urinary tract symptoms (LUTS) is also being managed through the use of alternative medicines, both alone or as complementary to other medical grows. As this is a growing trend among patients opting out of surgical procedures, researchers at the Albert Einstein College of Medicine, Bronx, New York, have listed more than 30 phytotherapeutic compounds, describing in detail saw palmetto berry (SPB), Pygeum africanum and Secale cereal. The review, entitled “Complementary and alternative medications for benign prostatic hyperplasia”, was published in The Canadian Journal of Urology.

Saw palmetto berry (SPB), also called serona repens, has been one of the most studied compounds and the most commonly used phytotherapeutic agent for BPH. Several formulations of SPB are on the market under several brands, since phytotherapeutic agents are listed as food by the FDA and face an easier legislation on production and distribution. This results in different preparations, listing variations of extraction processes and drug content, especially in the presence of free fatty acids, the theorized source of most benefit. This information is important when evaluating clinical trials, as the product itself presents a great degree of variability. Several mechanisms of action for SPB have been proposed by researchers, but no consensus has been reached.

Two different large-scale clinical studies funded by the NIH have shown that SPB does not provide benefit in symptoms scores, such as prostate size, prostate-specific antigen (PSA) and score IPSS, when compared to placebo. More reviews on the efficacy of SPB have been published, but results report the same non significant difference between the compound and placebo. Researchers regard the null effect of SPB on PSA as a safety highlight, as this non-effect decreases the risk of undetected prostate cancer when PSA levels are screened. Results on safety and tolerability have been very positive, with a well tolerate SPB dose of 320mg per day. Reported side effects are mild headaches, gastrointestinal problems and reduced libido. Permixon (Pierre Fabre Medicament, Castres, France) is the most studied formulation of SPB.

Pygeum africanum has been prescribed for several decades in France for the management of BPH, under the trade name Tadenan (Fournier, Dijon, France).  Like SPB, several mechanisms of action have been proposed such as inactivation of androgen receptors, inhibition of cellular growth factors and anti-inflammatory properties. Results of clinical trials leave the question of P.africanum’s efficacy unanswered. Though in some studies there was a mild benefit over placebo, the design of such studies is not considered reliable, due to short duration, variation of dose, absence of IPSS scores and no information on side effects. The reported adverse effects include mild headaches and gastrointestinal problems.

Secale cereal, also named rye pollen, has been proposed to act on relaxation of urethral and bladder smooth muscles and induction of apoptosis of prostatic epithelial cells, for example. Cernilton (AB Cerlene, Engelholm, Sweden) is its most extensively studied formulation. In a clinical trial, Cernilton was reported to reduce nocturia (urination during the night), but had no advantageous effect over placebo in reducing prostate size and LUTS in general. Another clinical trial, with a Cernilton dose of 750 mg actually achieved some beneficial results in prostate size reduction and lowering IPSS scores, but confidence in these clinical trials is not abundant due to variation in study design. Reported side effects include gastrointestinal problems and allergic respiratory and skin reactions.

The phototherapeutic agents are still undergoing a series of single or combination trials, so a consensus on the efficacy and mechanisms of action has yet to be reached among researchers and clinicians. “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”, the authors conclude in their study.