From BioForce the maker of Sabalasan

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Study objective
The slowly progressive enlargement of the prostate in elderly men, called benign prostatic hyperplasia (BPH), constricts the urethra, causing discomfort and lower urinary tract symptoms (LUTS). This also significantly increases the risk of sexual dysfunction (SDys), even more than in diabetes, hypertension, heart disease or hyperlipidemia. Existing synthetic medications for BPH like alpha-blockers or 5-alphareductase inhibitors cause additional SDys. Saw palmetto extract (Serenoa repens) is a well-established treatment for mild to moderate BPH. In a first-ever clinical trial, the therapeutic effects of a saw palmetto preparation (Sabalasan® Prostate 1) on both LUTS and SDys in patients with BPH were studied.
Authors
Andreas Suter, Medical department, A.Vogel Bioforce AG, Roggwil, Switzerland; Prof. Dr. Reinhard Saller, Institute of Natural Medicine, Zurich University Hospital, Switzerland; Dr. Eugen Riedi, Urological practice, Chur, Switzerland; Prof. Dr. Michael Heinrich, School of Pharmacy, University of London, University College London, United Kingdom.
Plant extract used
The study preparation was a lipophilic saw palmetto berry extract with a daily dosage of one capsule,
containing 320 mg extract (Sabalasan® Prostate 1, drug extraction ratio 9-12:1, ethanol 96% V/V), organically grown and manufactured by A.Vogel Bioforce (Roggwil, Switzerland).
Study design
Patients experiencing at least moderate BPH symptoms
(both obstructive and irritative) and sexual problems (like erectile dysfunction or lack of libido) for at least two months were recruited from two urological and four general practices in Switzerland to participate in this pilot trial. The open, multicentre, clinical study had a total duration of 9 weeks per patient, which consisted of a 1-week untreated run-in phase and a subsequent treatment period of 8 weeks. Patients with diseases, medications or other medical conditions with possible impact on BPH and sexual function were not included. Validated questionnaires evaluated changes in BPH (IPSS) and sexual dysfunction (bSFI, Urolife QoL-9). Additional questions covered the global assessment of efficacy, safety and general ratings.

• IPSS The International Prostate Symptom Score is a validated 7-item questionnaire to screen for, rapidly diagnose and track the symptoms of BPH. The symptoms questions correlate to mildly (0-7), moderately (8-19) and severely symptomatic (20-35). Inclusion criteria for all patients was an IPSS score > 7.
• bSFI The brief Sexual Function Inventory is a validated instrument with two questions on sexual drive, three on erections, two on ejaculation, four on problem assessment and one question on overall sexual satisfaction. Each question is rated on a corresponding scale from 0 (most severe problem) to 4 (no problem). Inclusion criteria for all patients was a score < 5 for the sexual drive component of bFSI (2 questions, score 0-8).
• Urolife QoL-9 The Urolife BPH Quality of Life-9 questionnaire is also a validated score with one question each on sexual desire, erection and sexual satisfaction; each is rated on a 100-mm visual analogue scale, ranging from 0 (most severe problem) to 100 (no problem at all).

Study results

• Participants A total of 82 patients were recruited (intention-to-treat group), with 69 patients evaluated in the end (per-protocol population). No significant differences existed between both groups, all following results refer to the per-protocol group. The mean age of the BPH patients was 57.3 ± 11.1 years (median 60.0 years). With the exception of BPH and sexual dysfunction, the study group had no other pathological findings. The symptoms did not change between the first two visits (run-in phase), so only result changes from visit 2 and visit 3 will be shown.
• IPSS After 8 weeks of treatment the total IPSS score was highly significantly reduced by 51%, from 14.4 ± 4.7 to 6.9 ± 5.2 (p<0.0001). Also, each single test item itself improved to a similarly significant degree covering both the obstructive and the irritative symptom scale (Figure 1).
• bSFI The total bSFI score improved by 40%, from 22.4 ± 7.2 to 31.4 ± 9.2 (p<0.0001). The single item scores for sexual drive, erectile function, ejaculatory function, problem assessment and sexual satisfaction were also each significantly improved (p<0.0001). The biggest relative improvements in single questions were seen in the problem assessment domain, where ‘getting and keeping an erection’ improved by 64%, and ‘having problems with lack of drive’ and ‘ejaculation’ each improved by 54% (Figure 2).
• Urolife QoL-9 The Urolife QoL-9 total score saw an improvement of 36%, from 162.7 ± 47.9 to 105.0 ± 56.3 (p<0.0001).
• Assessments by investigators and patients 76% of all patients rated the overall efficacy of the saw palmetto treatment with ‘very good’ or ‘good.’ The investigators rated these aspects even better with 82% ‘very good’ or ‘good.’ When asked for the best effect, 8% of the patients indicated ‘erectile function,’ 26% ‘libido’ and 66% ‘erectile function and libido together.’ About 90% of patients and investigators would take or recommend medication again.
• Safety 96.1% of the patients and investigators rated the tolerability of the product as ‘very good’ or ‘good.’

Conclusion
This study has shown for the first time that a saw palmetto intervention in patients with BPH and SDys had a beneficial effect on both BPH symptoms and on SDys. The saw palmetto preparation was as effective in reducing BPH symptoms as an alpha blocker or a 5-alpha-reductase inhibitor, both often used as standard BPH treatment. But in contrast to those drug classes, saw palmetto was associated with a significant improvement in sexual dysfunction. Compared with clinical studies using alpha blockers in combination with PDE-5-inhibitors like Viagra (to alleviate disease- and drug-related sexual dysfunction), the saw palmetto treatment yielded efficacy results similar to this combination but without the adverse effects of such combination therapies.

If you are interested in the Original Libido Study, click here to download PDF.

1 Suter A, Saller R, Riedi E, Heinrich M: Improving BPH symptoms and sexual dysfunctions with a saw palmetto preparation? Results from a pilot trial. Phytother Res. 2012
Apr 23 (DOI: 10.1002/ptr.4696).