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Q: enlarged prostate ( Answered,   0 Comments )
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Subject: enlarged prostate
Category: Health > Men's Health
Asked by: jeijei-ga
List Price: $100.00
Posted: 03 Feb 2003 19:45 PST
Expires: 05 Mar 2003 19:45 PST
Question ID: 157010
Which over-the-counter supplements for benign prostatic hypertrophy
have been scientifically tested between 2000 and 2002?
Answer  
Subject: Re: enlarged prostate
Answered By: kevinmd-ga on 04 Feb 2003 11:56 PST
 
Hello,
Thanks for asking your question.  There are have been a multitude of
herbal remedies that have been scientifically tested for benign
prostatic hypertrophy since 2000.   I will give you the various tests
and the abtracts from relevant studies.

There are a lot of supplements and studies that claim to help BPH. 
Here are systematic reviews and meta-analyses (studies of studies) for
4 supplements.  All data here is physician written and peer reviewed. 
It is what is accepted in the medical community.  Hopefully this will
help you seperate what's true or not.

Herbal therapies for BPH are commonly used in Europe; these remedies
comprised 70 percent of spending for drug treatment of prostatism in
Germany in 1997. Two herbal extracts have officially been approved for
the treatment of prostatism in France. No herbal therapies have been
approved by the United States Food and Drug Administration for this
purpose, although many men probably try these treatments. There is a
substantial placebo effect associated with herbal therapy, as there is
for most drugs used to treat BPH.

1) Beta-sitosterols
Many of the over-the-counter remedies contain Beta-sitosterols. The
pharmacologic use of plants and herbs (phytotherapy) for the treatment
of LUTS associated with BPH has been growing steadily.
Phytotherapeutic preparations containing beta-sitosterols, derived
from the South African star grass, Hypoxis rooperi, or from species of
Pinus and Picea, are available for the treatment of BPH.  Here is a
systematic review that summarizes all the studies using this extract.

"Objectives:
This systematic review aimed to assess the effects of beta-sitosterols
(B-sitosterol) on urinary symptoms and flow measures in men with of
benign prostatic hyperplasia (BPH).

Search strategy:
Trials were searched in computerized general and specialized databases
(MEDLINE, EMBASE, Cochrane Library, Phytodok), by checking
bibliographies, and by contacting manufacturers and researchers.

Selection criteria:
Trials were eligible for inclusion provided they (1) randomized men
with BPH to receive B-sitosterol preparations in comparison to placebo
or other BPH medications, and (2) included clinical outcomes such as
urologic symptom scales, symptoms, or urodynamic measurements.

Data collection and analysis:
Information on patients, interventions, and outcomes was extracted by
at least two independent reviewers using a standard form. Main outcome
measure for comparing the effectiveness of B-sitosterols with placebo
and standard BPH medications was the change in urologic symptom scale
scores. Secondary outcomes included changes in nocturia as well as
urodynamic measures (peak and mean urine flow, residual volume,
prostate size). Main outcome measure for side effects was the number
of men reporting side effects.

Main results:
519 men from 4 randomized, placebo-controlled, double-blind trials,
(lasting 4 to 26 weeks) were assessed. 3 trials used non-glucosidic
B-sitosterols and one utilized a preparation that contained 100%
B-sitosteryl-B-D-glucoside. B-Sitosterols improved urinary symptom
scores and flow measures. The weighted mean difference (WMD) for the
IPSS was -4.9 IPSS points (95%CI = -6.3 to -3.5, n = 2 studies). The
WMD for peak urine flow was 3.91 ml/sec (95%CI = 0.91 to 6.90, n = 4
studies) and the WMD for residual volume was -28.62 ml (95%CI = -41.42
to -15.83, n = 4 studies). The trial using 100%
B-sitosteryl-B-D-glucoside (WA184) show improvement in urinary flow
measures. B-sitosterols did not reduce prostate size. Withdrawal rates
for men assigned to B-sitosterol and placebo were 7.8% and 8.0%,
respectively.

Conclusions:
The evidence suggests non-glucosidic B-sitosterols improve urinary
symptoms and flow measures. Their long term effectiveness, safety and
ability to prevent BPH complications are not known." (1)

2) Cernilton
Cernilton, prepared from the rye-grass pollen Secale cereale, is
another one of the several phytotherapeutic agents available for the
treatment of BPH.
Here is a systematic review that summarizes all the studies using this
extract:
"Objectives:
This systematic review aims to assess the effects of Cernilton on
urinary symptoms and flow measures in men with benign prostatic
hyperplasia (BPH).

Search strategy:
Trials were searched in computerized general and specialized databases
(MEDLINE, EMBASE, Cochrane Library, Phytodok), by checking
bibliographies, and by contacting manufacturers and researchers.

Selection criteria:
Trials were eligible if they were: (1) randomized controlled trials or
controlled clinical trials comparing Cernilton with placebo or other
BPH medications in men with BPH; and (2) included clinical outcomes
such as urologic symptom scales, symptoms, or urodynamic measurements.

Data collection and analysis:
Information on patients, interventions, and outcomes was extracted by
at least two independent reviewers using a standard form. Main outcome
measure for comparing the effects of Cernilton with placebo and
standard BPH medications were the change in urologic symptoms scales.
Secondary outcomes included changes in nocturia as well as urodynamic
measures (peak and mean urine flow, residual volume, prostate size).
Main outcome measure for side effects was the number of men reporting
side effects.

Main results:
444 men were enrolled in 2 placebo-controlled and 2 comparative trials
lasting from 12 to 24 weeks. Three studies used a double-blind method
although treatment allocation concealment was unclear in all.
Cernilton improved "self rated urinary symptoms" (percent reporting
satisfactory or improving symptoms) versus placebo and Tadenan. The
weighted risk ratio (RR) for self-rated improvement versus placebo was
2.40 [95% CI = 1.21, 4.75], and the weighted RR versus Tadenan was
1.42 [95% CI = 1.21, 4.75]. Cernilton reduced nocturia compared with
placebo and Paraprost. Versus placebo, the weighted RR was 2.05 [95%
CI = 1.41, 3.00], and versus Paraprost, the WMD was -0.40 times per
evening [95% CI = -0.73, -0.07]. Cernilton did not improve urinary
flow rates, residual volume or prostate size compared to placebo or
the comparative study agents. Adverse events were rare and mild. The
withdrawal rate for Cernilton was 4.8% compared to 2.7% for placebo
and 5.2% for Paraprost.

Conclusions:
The Cernilton trials analyzed were limited by short duration, limited
number of enrollees, gaps in reported outcomes, and unknown quality of
the preparations utilized. The comparative trials lacked a proven
active control. The available evidence suggests Cernilton is well
tolerated and modestly improves overall urologic symptoms including
nocturia. Additional randomized placebo and active-controlled trials
are needed to evaluate the long-term clinical effectiveness and safety
of Cernilton." (2)

3) Pygeum africanum 
Another supplement used for BPH is pygeum africanum.  Here is a
meta-analysis from the American Journal of Medicine:
"METHODS: 
Studies were identified through the search of Medline (1966 to 2000),
Embase, Phytodok, the Cochrane Library, bibliographies of identified
trials and review articles, and contact with relevant authors and drug
companies. Randomized trials were included if participants had
symptomatic benign prostatic hyperplasia, the intervention was a
preparation of P. africanum alone or in combination with other
phytotherapeutic agents, a control group received placebo or other
pharmacologic therapies for benign prostatic hyperplasia, and
treatment duration was at least 30 days. Two investigators
independently extracted key data on design features, subject
characteristics, and therapy allocation.

RESULTS: 
A total of 18 randomized controlled trials involving 1,562 men met the
inclusion criteria and were analyzed. Many studies did not report
results in a method that permitted meta-analysis. Only 1 of the
studies reported a method of treatment allocation concealment,
although 17 were double-blinded. The mean study duration was 64 days
(range 30 to 122). Compared with placebo in 6 studies, P. africanum
provided a moderately large improvement in the combined outcome of
urologic symptoms and flow measures as assessed by an effect size
defined by the difference of the mean change for each outcome divided
by the pooled standard deviation for each outcome (-0.8 SD [95%
confidence interval (CI): -1.4 to -0.3]). Summary estimates of
individual outcomes were also improved by P. africanum. Men were more
than twice as likely to report an improvement in overall symptoms
(risk ratio = 2.1, 95% CI: 1.40 to 3.1). Nocturia was reduced by 19%
and residual urine volume by 24%; peak urine flow was increased by
23%. Adverse effects due to P. africanum were mild and similar to
placebo. The overall dropout rate was 12% and was similar for P.
africanum (13%), placebo (11%), and other controls (8%; P = 0.4 versus
placebo and P = 0.5 versus other controls).

CONCLUSIONS: 
The literature on P. africanum for the treatment of benign prostatic
hyperplasia is limited by the short duration of studies and the
variability in study design, the use of phytotherapeutic preparations,
and the types of reported outcomes. However, the evidence suggests
that P. africanum modestly, but significantly, improves urologic
symptoms and flow measures. Further research is needed using
standardized preparations of P. africanum to determine its long-term
effectiveness and ability to prevent complications associated with
benign prostatic hyperplasia." (3)

4) Saw pawmetto (permixon)
A more common supplemnent is saw palmetto.  Serenoa repens (permixon)
is the extract from the saw palmetto plant that is used in the studies
on BPH.  Boyle et al (2000) performed a meta-analysis with this
extract:
"METHODS: 
All published clinical trial data on Permixon (11 randomized clinical
trials and 2 open label trials), involving 2859 patients, were used.
These trials were disparate in size (from 22 to 592 patients) and
duration (from 21 to 180 days). Peak urinary flow rate and nocturia
were the two common end points. The statistical analysis was based on
a random effects meta-analysis.

RESULTS: The average +/- SE placebo effect on the peak urinary flow
rate was an increase of 0.51 +/- 0.51 mL/s. The estimated effect of
Permixon was a further increase of 2.20 +/- 0.51 mL/s (P <0.001).
Placebo was associated with a reduction in the mean number +/- SE of
nocturnal urinations of 0.69 +/- 0.15. A further reduction of 0.50 +/-
0.01 episodes of urination (P <0.001) occurred that was attributable
to Permixon. Some heterogeneity was found among the studies. Treatment
duration did not appear to impact either of these effects.

CONCLUSIONS: This meta-analysis of all available published trials of
Permixon in the treatment of men with benign prostatic hyperplasia
revealed a significant improvement in peak flow rate and reduction in
nocturia greater than with placebo." (4)

Again, these are the major studied extracts and herbal remedies used
in the treatment of BPH.  All data is peer-reviewed and physician
written - hopefully this will help you cut through all the hype that
is out there.

Please use the answer clarification to ask any questions before rating
this answer.  I will be happy to explain any issue.
 
Thanks, 
Kevin, M.D. 
 
Search strategy: 
No internet search engine was used in this answer.  All sources are
from objective, physician-written, peer-reviewed resources.
 
Bibliography:
1) Wilt, T. Ishani, A. Mac Donald, R. Stark, G. Mulrow, C. Lau, J.
Beta-sitosterols for benign prostatic hyperplasia. Cochrane Database
of Systematic Reviews. Issue 4, 2002.
2) Wilt, T. Mac Donald, R. Ishani, A. Rutks, I. Stark, G. Cernilton
for benign prostatic hyperplasia. Cochrane Database of Systematic
Reviews. Issue 4, 2002.
3) Ishani, A, MacDonald, R, Nelson, D, et al. Pygeum africanum for the
treatment of patients with benign prostatic hyperplasia: a systematic
review and quantitative meta-analysis. Am J Med 2000; 109:654.
4) Boyle, P, Robertson, C, Lowe, F, Roehrborn, C. Meta-analysis of
clinical trials of permixon in the treatment of symptomatic benign
prostatic hyperplasia. Urology 2000; 55:533.
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