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Cernitin for Benign Prostatic Hyperplasia
Wilt T, Mac Donald R, Ishani A, Rutks I, Stark G.
General Internal Medicine, Department of Veterans Affairs Coordinating
Center
of the, One Veterans Drive, Minneapolis, Minnesota 55417, USA.
BACKGROUND: Benign prostatic hyperplasia (BPH), nonmalignant
enlargement of the prostate, can lead to obstructive and irritative lower
urinary
tract symptoms (LUTS). The pharmacologic use of plants and herbs
(phytotherapy) for the treatment of LUTS associated with BPH has been
growing
steadily. Cernitin, prepared from the rye-grass pollen Secale cereale,
is one of
the several phytotherapeutic agents available for the treatment of BPH.
OBJECTIVES: This
systematic review aims to assess the effects of Cernitin 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 Cernitin 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 Cernitin 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.
Cernitin
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]. Cernitin
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]. Cernitin 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 Cernitin was 4.8% compared to 2.7% for placebo and 5.2% for
Paraprost.
REVIEWER'S CONCLUSIONS: The Cernitin 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 Cernitin is well
tolerated
and modestly improves overall urologic symptoms including nocturia.
Additional
randomized placebo and active-controlled trials are needed to evaluate the
longterm
clinical effectiveness and safety of Cernitin.
Publication Types:
• Review
• Review, Academic
PMID: 10796739 [PubMed - indexed for MEDLINE]
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