1
456
EFFECTS OF SAW PALMETTO HERBAL BLEND ON BENIGN PROSTATIC HYPERPLASIA
Patient ability to provide informed consent
Exclusion criteria
Failure to meet the inclusion criteria
History of allergy to saw palmetto or to any component of
the proprietary herbal blend
History of any illness or condition that in the opinion of the
investigator may confound the results of the study or pose
additional risk to the patient
Significant abnormalities on pre-study clinical examina-
tion or laboratory measurements
Treatment with any investigational drug during the pre-
vious month
Drug or alcohol abuse or dependence
REFERENCES
1
. Marks, L. S. and Tyler, V. E.: Saw palmetto extract: newest (and
oldest) treatment alternative for men with symptomatic be-
nign prostatic hyperplasia. Urology, 53: 457, 1999
2. Wilt, T. J., Ishani, A., Stark, G. et al: Saw palmetto extracts for
treatment of benign prostatic hyperplasia: a systematic re-
view. JAMA, 280: 1604, 1998
3
4
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. Buck, A. C.: Phytotherapy for the prostate. Brit J Urol, 78: 325,
1996
. Lowe, F. C. and Ku, J. C.: Phytotherapy in treatment of benign
prostatic hyperplasia: a critical review. Urology, 48: 12, 1996
. Lowe, F. C. and Fagelman, E.: Phytotherapy in the treatment of
benign prostatic hyperplasia: an update. Urology, 53: 671,
1999
Concurrent use of ␣-adrenergic receptor antagonists (pra-
zosin, terazosin, doxazosin or tamsulosin) and/or any hor-
monal therapy that may affect the prostate (for example
gonadotropic releasing hormone agonists, testosterone an-
tagonists or anabolic steroids), and use of finasteride or pros-
tate phytotherapy within the last 18 months or ␣-blockers
within the last 1 month
6. Marks, L. S., Partin, A. W., Gormley, G. J. et al: Prostate tissue
composition and response to finasteride in men with symptom-
atic benign prostatic hyperplasia. J Urol, 157: 2171, 1997
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. Marks, L. S., Partin, A. W., Dorey, F. J. et al: Long-term effects
of finasteride on prostate tissue composition. Urology, 53: 574,
1999
. Hodge, K. K., McNeal, J. E., Terris, M. K. et al: Random system-
atic versus directed ultrasound guided transrectal core biop-
sies of the prostate. J Urol, 142: 71, 1989
. Kyprianou, N., Litvak, J. P., Borkowski, A. et al: Induction of
prostate apoptosis by doxazosin in benign prostatic hyperpla-
sia. J Urol, 159: 1810, 1998
Evidence of urethral stricture or radiotherapy to the pelvis
Diagnosis of chronic prostatitis or repeat urinary tract
infection (3 or more episodes in the last year) or active uri-
nary tract infection confirmed by a positive pre-study urine
culture, although patients may enter the study after the 10. Bostwick, D. G., Wheeler, T. M., Blute, M. et al: Optimized
microvessel density analysis improves prediction of cancer
successful resolution of an acute urinary tract infection
stage from prostate needle biopsies. Urology, 48: 47, 1996
1. Perry, K. T., Anthony C. T. and Steiner, M. S.: Immunohisto-
chemical localization of TGF beta 1, TGF beta 2, and TGF beta
Previous bladder surgery, prostatectomy or another inva-
1
1
1
sive procedure for BPH, including transurethral incision of
the prostate, balloon urethroplasty, microwave hyperther-
mia, urethral stenting and so forth
3 in normal and malignant human prostate. Prostate, 33: 133,
1997
Known or suspected neurogenic bladder, such as severe
diabetic neuropathy
History of recurrent acute urinary retention episodes
Patient inability to provide written informed consent for
any reason, including legal incompetence, language or com-
prehension difficulty and psychological, psychiatric or emo-
tional factors
2. Prins, G. S., Sklarew, R. J. and Pertschuk, L. P.: Image analysis
of androgen receptor immunostaining in prostate cancer accu-
rately predicts response to hormonal therapy. J Urol, 159: 641,
1998
3. Carraro, J.-C., Raynaud, J.-P., Koch, G. et al: Comparison of
phytotherapy (Permixon) with finasteride in the treatment of
benign prostate hyperplasia:
a randomized international
study of 1098 patients. Prostate, 29: 231, 1996
Patient inability to undergo transrectal ultrasonography
with biopsy for any reason
1
1
4. Eisenberg, D. M., Davis, R. B., Ettner, S. L. et al: Trends in
alternative medicine use in the United States, 1990–1997:
results of a follow-up national survey. JAMA, 280: 1569, 1998
5. Rhodes, L., Primka, R. L., Berman, C. et al: Comparison of
finasteride (Proscar), a 5 alpha reductase inhibitor, and vari-
ous commercial plant extracts in in vitro and in vivo 5 alpha
reductase inhibition. Prostate, 22: 43, 1993
APPENDIX 2: PANEL OF 26 STANDARD BLOOD TESTS
Hemoglobin
Hematocrit
White blood count with differential
Platelet count
Iron
Iron binding capacity
Glucose
1
6. Strauch, G., Perles, P., Vergult, G. et al: Comparison of finas-
teride (Proscar) and Serenoa repens (Permixon) in the inhibi-
tion of 5-alpha reductase in healthy male volunteers. Eur Urol,
2
6: 247, 1994
17. Weisser, H., Behnke, B., Helpap, B. et al: Enzyme activities in
tissue of human benign prostatic hyperplasia after three
months’ treatment with the Sabal serrulata extract IDS 89
Blood urea nitrogen
Creatinine
(
Strogen) or placebo. Eur Urol, 31: 97, 1997
1
8. Helpap, B., Oehler, U., Weisser, H. et al: Morphology of benign
prostatic hyperplasia after treatment with Sabal extract IDS
Phosphorus
Uric acid
8
9 or placebo J Urol Pathol, 3: 175, 1995
Total protein
1
9. Gerber, G. S., Bales, G., Kirsh, E. et al: Medicinal botanicals in
the treatment of lower urinary tract symptoms (LUTS): a
demographic analysis of awareness and use at the University
of Chicago. J Urol, suppl., 159: 334, abstract 1282, 1998
Albumin
Globulin
Bilirubin
Alkaline phosphatase
Serum glutamic-oxaloacetic transaminase
Serum glutamate pyruvate transaminase
Aspartate transaminase
Lactate dehydrogenase
Sodium
20. Nam, R. K., Fleshner, N., Rakovitch, E. et al: Prevalence and
patterns of the use of complementary therapies among pros-
tate cancer patients: an epidemiological analysis. J Urol, 161:
1521, 1999
2
1. Angell, M. and Kassirer, J. P.: Alternative medicine—the risks of
untested and unregulated remedies. N Engl J Med, 339: 839,
1998
Chloride
2
2
2. Dietary Supplement Health and Education Act of 1994. Public
Law 103–417.
3. Slifman, N. R., Obermeyer, W. R., Aloi, B. K. et al: Contamina-
tion of botanical dietary supplements by Digitalis lanata.
N Engl J Med, 339: 806, 1998
Magnesium
Potassium
Cholesterol
Triglycerides