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Natural Treatment of BPH
A practical experience report on Sabalasan®
by EUGEN RIEDI, ROLAND SCHOOP, ANDY SUTER
Urination problems, the frequent urge to urinate, and the tiresome need to get up during the night often affect men still in the “prime of life”. Nowadays, benign prostatic hyperplasia (BPH) can be considered a widespread disease. Half of all 50-year-old men have prostate problems – a proportion that increases substantially with increasing patient age(1). Sufferers often interpret the symptoms as “normal signs of ageing” and accept them. The family doctor can do a great deal to improve their quality of life.
Introduction
The treatment options range from phytopharmaceuticals to synthetic alpha-1 blockers and 5 α-reductase inhibitors. However, phytotherapy, in particular, enjoys a good standing in the treatment of BPH. In the past, several studies proving that phytopharmaceuticals are highly effective in BPH have been published (2). One of the most important phytopharmaceuticals is without doubt saw palmetto extract, as contained in Sabalasan®. The different substances in the lipophilic fraction of saw palmetto extract allow the various symptoms of BPH to be treated at two levels: firstly, Sabalasan® produces a specific antiandrogenic effect by inhibition of 5α -reductase (3) and by inhibition of dihydrotestosterone (DHT) receptor binding (4). Secondly, Sabalasan® brings about dose-dependent inhibition of cyclo-oxygenase and 5-lipoxygenase, which leads to a consistent lowering of their metabolite levels, achieving an anti-oedematous and anti-inflammatory effect (5). A practical experience survey documenting experience and the value of BPH treatment with Sabalasan® was carried out recently among Swiss general practitioners and internal specialists in independent practice. This report summarises the most important results.
Observation of experience
The interviews for this practical experience report were carried out between May 2003 and June 2004 among 85 doctors in independent
practice in Switzerland. 364 men with a mean age of 65 years, and with previously untreated Alken stage I and II benign
prostatic hyperplasia, were followed up and documented. As is usual in practical surveys, the rhythm of observations,
the treatment and the intervals between appointments followed the normal routine of the practice or were left at the doctors’
discretion. Sabalasan® was prescribed and dosed in accordance with the recommendations in the summary of product
characteristics. At the start of treatment and after eight weeks, the severity of the prostatic hyperplasia was recorded using
the IPS score (Table), and further information collected related to the index measuring quality of life due to urinary problems as
well as an assessment of Sabalasan® in terms of effectiveness, tolerability and onset of effect. Naturally,
all adverse events were documented.
Table: IPS Score (International Prostate Symptom score)
How often during the last 4 weeks...
Not at all
Less than one in 5 times
In less than half of cases
In about half of cases
In more than half of cases
Nearly all the time
1-did you feel as if you were not able to empty your bladder completely?
0
1
2
3
4
5
2-did you have to pass water again within 2 hours of your last urination?
0
1
2
3
4
5
3-did you notice that the urine stream was interrupted several times?
0
1
2
3
4
5
4-did you have difficulty making urination last longer?
0
1
2
3
4
5
5-did you notice a weak urine stream?
0
1
2
3
4
5
6-did you have to press down or strain to be able to urinate?
0
1
2
3
4
5
How many times...
Never
Once
Twice
3 times
4 times
5 or more
7-did you have to get up to urinate each night, on average?
0
1
2
3
4
5
Total IPS score = ____________ Sum of points from questions 1-7
Results
Effectiveness
At the start of treatment, the mean IPS score for all patients was 16.2, corresponding to moderate benign prostatic hyperplasia symptoms. After only eight weeks, a statistically significant 35% reduction in the score was achieved. It is interesting that the symptomatic improvement took place regardless of the baseline score. A subanalysis examined the effect of Sabalasan® as a function of symptom severity (Figure 1). For this purpose, the patients were subdivided into three groups – 0 to 7 points corresponded to mild symptoms, 8 to 19 to moderate symptoms and 20 to 35 to severe symptoms. The symptoms in all three patient groups underwent a statistically significant reduction - by 42%, 38% and 30% respectively. The good effect even in patients with severe symptoms is interesting. It was possible to reduce their IPS score from an average of 23 points to 16 points.
Due to the onset of effect within four weeks in 82.7% of patients and the effective reduction in the IPS score, the investigators involved rated the effectiveness of Sabalasan® as very positive overall – 35% considered the effect very good, 53% good and only 12% inadequate. It was also possible to significantly improve the index measuring quality of life due to urinary problems (Figure 2). At the start of the treatment, the patients felt somewhat dissatisfied with their urinary problems,
whereas after eight weeks they were overwhelmingly satisfied.
Tolerability
A single adverse reaction was reported during the observation – occasional belching. Otherwise, the treatment was rated as very good by the doctors and patients alike (Figure 3), and 86.5% of patients wished to continue the treatment.
Discussion
The objective of the practical experience report was to gather data on the effectiveness and tolerability of Sabalasan® in everyday practice. It goes without saying that the validity of a practical experience report is limited and that it cannot replace a well-founded study in which the use of the treatment is laid down by a trial protocol. Compared with the results from clinical trials, the results of this practical observation provide an important starting point for the use of Sabalasan®in everyday practice.
With the 30% reduction in irritative and obstructive symptoms, measured using the IPS score, and the significant improvement in the quality of life index, the results obtained with Sabalasan® meet the requirements of a modern BPH treatment. They also concord with current studies of saw palmetto extract, which show a similar reduction in the IPS score (2). Even in comparison with other conventional treatment options such as finasteride, a 5α- reductase inhibitor, Sabalasan® demonstrates comparable effectiveness, with a low side effect rate (6). It is interesting that eight weeks of treatment with Sabalasan® brought about a mean therapeutic success equivalent to that achieved with six months of treatment (7) or one year of treatment (6) in long-term studies. Most of the results discussed here, from the largest study of saw palmetto extract conducted to date in Switzerland, are therefore in harmony with the results of controlled clinical trials. This also shows that compliance is ensured in practical observations. Sabalasan® is therefore suitable for the effective treatment of mild and moderate BPH, with a low side effect rate.
The most important results
This practical observation included 364 patients with an average IPS score of 16.2. On treatment with Sabalasan®, their score fell significantly (p < 0.05) by 35% to 10.5. The effectiveness of Sabalasan® was rated as good to very good by both patients and doctors, and 82.7% of patients reported an onset of effect after only four weeks. Tolerability proved to be very good. Throughout the observation period, only one adverse event connected with the test medication was reported – occasional belching.
Dr. med. Eugen Riedi Medical Director for Urology Kantonsspital Chur
Roland Schoop Andy Suter Bioforce AG, Roggwil
References 1-Madersbacher S., Studer U.E.; Benigne Prostatahyperplasie. Schweiz Med Forum. Nov 2002; 45: 1058-73. 2-Wilt T. Ishani A., Mac Donald R.; Serenoa repens for benign prostatic hyperplasia (Cochrane Review) In: The Cochrane Library 2003; 1. Oxford: Update Software. 3-Koch E., Biber A.: Pharmakologische Wirkungen von Sabal und Urtikaextrakten als Grundlage für eine rationale medikamentöse Therapie der benignen Prostatahyperplasie. Urologie 1994; 34; 90-95. 4-Briley M. et al.: Permixon, a new treatment for prostatic benign hyperplasia, acts directly at the cytosolic androgen receptor in rat prostate. Br J Pharmacol 1983; 79:327. 5-Wagner H. et al.: Über ein neues antiphlogistisches Wirkprinzip aus Sabal serrulata I. Planta Med. 1981; 41:244-251. 6-Carraro J. et al.: Comparison of phytotherapy (Permixon) with finasteride in the treatment of benign prostate hyperplasia. A randomized international study of 1098 patients. The Prostate 1996; 29: 231-240. 7-Debruyne F. et al.: Comparison of a phytotherapeutic agent with an alpha-blocker (tamsulosin) in the treatment of benign prostate hyperplasia: a 1-year randomized international study. Prog Urol 2002 Jun; 12 (3): 384-92.
Declaration of interest: The practical survey was financed by Bioforce AG.
