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- Saw Palmetto (Serenoa repens, Arecaceae)
- Prostate Cancer
- Serum Prostate-specific Antigen (PSA)
- Lower Urinary Tract Symptoms (LUTS)
- Radiation Therapy
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Date:
03-15-2017 | HC# 081662-564
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Re: Saw Palmetto's Safety and Efficacy in Treating LUTS in Patients with Prostate Cancer Undergoing Radiation
Wyatt
GK, Sikorskii A, Safikhani A, McVary KT, Herman J. Saw palmetto for symptom
management during radiation therapy for prostate cancer. J Pain Symptom Manage. June 2016;51(6):1046-1054.
Prostate cancer affects many men across the
world, and lower urinary tract symptoms (LUTS) are prevalent in men treated
with radiation therapy (a standard cancer treatment). Studies with saw palmetto
(Serenoa repens, Arecaceae) have
suggested its use in treating benign prostatic hyperplasia (enlarged prostate)1;
however, its safety and efficacy in the treatment of LUTS in those undergoing
radiation is unclear. As other treatments for this condition, namely
alpha-adrenergic blockers, can cause adverse side effects (ASEs), saw palmetto
may be an alternative. This clinical study tested increasing doses for safety. The
maximum tolerated dose of saw palmetto was then used to test efficacy for LUTS
treatment in a randomized, double-blinded, controlled trial in those suffering
from prostate cancer.
This study took place in the United States from
2011-2014, and men with early-stage prostate cancer and eligible for radiation
therapy were included. Patients were 21 years or older with a Karnofsky
Performance Status score of ≥ 70% (this assesses quality of life in patients
with cancer, with 100% indicating cancer-free status and 0% indicating death),
a Gleason score of ≤ 8 (this measures tumor differentiation, with a score of 10
meaning less differentiated tumors and 1 indicating highly differentiated
tumors), and a serum prostate-specific antigen (PSA) of ≤ 40 ng/ml (elevated
concentrations are indicative of disease).
Those who had T4 or M1 (certain types of prostate
cancer), were using other botanicals, had undergone radiation in the area
previously, had liver or kidney function problems, or had systemic conditions
were excluded. Radiation therapy was done for 5 days per week for 8 weeks. Saw
palmetto treatment was begun 2 weeks prior to radiation and continued 2 weeks
after radiation was ended, for a total of 12 weeks of treatment. Follow up was
conducted up to 22 weeks. There were no restrictions on the use of other drugs
for LUTS.
Patients took a health-related quality of life (HRQOL)
assessment at baseline and weeks 12, 14, and 22. It is unclear how this was
measured, and no details were given regarding a questionnaire. At baseline and from
weeks 3-22, LUTS assessment was made using the International Prostate Symptom
Score (IPSS). This consists of 6 symptoms rated from 0 (indicating no symptom) to
5 (always present). Assessed at baseline and from weeks 2-22, the Common
Terminology Criteria for Adverse Events (CTCAE) data were obtained. The CTCAE
is a questionnaire of certain symptoms such as fatigue, nausea, and
hemorrhoids, among other factors. It ranges from 0-4 for each symptom, where
higher numbers indicate increased severity. The Functional Assessment of Cancer
Therapy-Prostate (FACT-P; weeks assessed not given) also was used to measure
factors such as emotional and social well-being. This scale ranged from 0 for
"not at all" to 4 for "very much."
Blood parameters (nitrogen, white blood cell
count, etc.) were measured at baseline and 6 weeks, and serum PSA was assessed
at baseline and week 22. The initial part of the study was a dose-finding
phase, where the first 3 patients were given the dosage of 320 mg daily of saw
palmetto. Since no ASEs were noted during the 12-week treatment, the dosage of
the next 4 patients for the same time period was 640 mg daily, after which 20
men took the highest dose of 960 mg daily for 12 weeks. The parameter for ASEs
(particularly nausea, gastritis, and anorexia, based on previously reported
ASEs and assessed as scoring 2 or higher using the CTCAE) was a prevalence of
10%. [Note: It is not specified whether the prevalence refers to ASEs or
patients.] Saw palmetto was distributed in gel capsules (320 mg), with
instructions to take 1 at a time with food in accordance with a patient's prescribed
dose. No information on the source, preparation, or plant part used was given.
Placebo is also not defined.
For the dose-finding phase, 27 patients
participated, with 3 taking 320 mg saw palmetto daily, 4 taking 640 mg daily,
and 20 patients taking 960 mg daily. With the exception of 1 patient dropping
out due to gastritis, no ASEs were observed during this phase; 17 patients
finished the 12-week dose-finding phase—dropout reasons other than gastritis were
delay in receiving saw palmetto, scheduling conflicts, and too many
medications. In total, 5 patients took alpha-adrenergic (antitumor) drugs.
For the randomized controlled trial (RCT), patients
were randomly assigned into either a saw palmetto (960 mg) group (10 patients)
or a placebo group (11 patients). None of the patients in the saw palmetto
group took alpha-adrenergic drugs, but 2 patients in the placebo group did.
Blood parameters and PSA levels were not significantly different between the
herb-supplemented and placebo groups at baseline or week 6 or 22.
At baseline of the exploratory RCT phase, the
functional well-being section of the FACT-P questionnaire was significantly
higher in the saw palmetto group as compared with the placebo group (23.60 ±
4.12 vs. 19.33 ± 4.59, P = 0.04), indicating a more healthy status in the saw
palmetto group. [Note: It is mentioned that this was adjusted statistically
when analyzing final results.] At the end of the study, the FACT-P
prostate-specific concerns part of the questionnaire reflected a significantly
higher score in the saw palmetto group as compared with the placebo group
(35.13 ± 1.92 vs. 33.81 ± 1.82, P = 0.03). No other significant differences
were observed.
In summary, this study suggests that the final dosage
of saw palmetto used here (960 mg) may be well tolerated. Discussed limitations
include a modest sample size. It is mentioned that those in the saw palmetto
group in the trial did not use standard medication for LUTS, suggesting that
further work may be necessary in establishing the potential efficacy of this
treatment for remediating symptoms.
—Amy C.
Keller, PhD
Reference
1Blumenthal M,
Goldberg A, Brinckmann J, eds. Herbal
Medicine: Expanded Commission E Monographs. Austin, TX: American Botanical
Council; Newton, MA: Integrative Medicine Communications; 2000.
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