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2642
Alternative Medicine Use in Patients with Localized
Prostate Carcinoma Treated with Curative Intent
Marguerite C. Lippert, M.D.1
Rebecca McClain, R.N., M.S.N.1
James C. Boyd, M.D.2
Dan Theodorescu, M.D., Ph.D.1,3
1
Department of Urology, University of Virginia
Health Sciences Center, Charlottesville, Virginia.
2
Department of Pathology, University of Virginia
Health Sciences Center, Charlottesville, Virginia.
3
Department of Molecular Physiology and Biological Physics, University of Virginia Health Sciences
Center, Charlottesville, Virginia.
Dan Theodorescu, M.D., Ph.D., is the recipient of a
career development award from the American
Cancer Society.
This work was supported in part by Grant 97-64
from the Milheim Foundation.
Address for reprints: Dan Theodorescu, M.D.,
Ph.D., Department of Urology, Box 422, University
of Virginia Health Sciences Center, Charlottesville,
VA 22908.
Received April 1, 1999; revision received July 26,
1999; accepted August 31, 1999.
© 1999 American Cancer Society
BACKGROUND. Alternative medicine therapies are estimated to be used by 7– 64% of
cancer patients but up to 72% do not inform their physician. To the authors’
knowledge little useful information is available regarding the prevalence of alternative medicine use by patients with prostate carcinoma. Thus, the authors attempted to evaluate the prevalence of alternative medicine use by prostate carcinoma patients treated with curative intent by either radical prostatectomy,
brachytherapy alone, or a combination of brachytherapy and external radiation
therapy.
METHODS. Between January 1997 and May 1998, 234 men with clinically localized
prostate carcinoma underwent radical prostatectomy (54 patients) or brachytherapy (180 patients) with (74 patients) or without (106 patients) external beam
radiation therapy. In July 1998 a questionnaire was mailed to all patients comprised of multiple questions regarding alternative medicine use to which 190
patients (81%) responded. The overall prevalence and types of alternative medicine
therapies used were assessed and the relation between age at procedure, pretreatment prostate specific antigen level, clinical stage, pretreatment Gleason score,
and type of treatment with the use of alternative medicine therapies was evaluated
using univariate and multivariate analysis.
RESULTS. The prevalence of alternative medicine use by prostate carcinoma patients responding to the survey was 43% (81 of 190 patients). No significant
differences in alternative medicine use were observed between the patients who
received brachytherapy alone (38%), those who underwent radical prostatectomy
(40%), and those treated with combined brachytherapy and external beam radiation therapy (51%). Vitamins, prayer or other religious practices, and herbal medicines were the most commonly used therapies in these patients. Higher pretreatment Gleason scores were associated with a greater use of alternative medicine
therapies on both multivariate and univariate analyses. Finally, using multivariate
analysis, younger prostate carcinoma patients were more likely to use alternative
medicine therapies than older patients.
CONCLUSIONS. Alternative medicine use is very prevalent among patients treated
for localized prostate carcinoma. Because some of these treatments may have a
potential biologic impact on tumor behavior and, consequently, on definitive or
surrogate therapeutic endpoints, patients should be questioned carefully regarding
alternative medicine use during routine tumor follow-up. Cancer 1999;86:2642– 8.
© 1999 American Cancer Society.
KEYWORDS: prostate neoplasms, alternative medicine, health surveys, prostatectomy, brachytherapy.
P
atients with other chronic diseases are increasingly seeking alternative medicine therapies. Thirty-four percent of Americans surveyed by phone in 1991 and 42% surveyed in 1997 reported using at
least 1 type of alternative medicine. In addition, in 1991 33% of
Alternative Medicine Use in Prostate Carcinoma/Lippert et al.
alternative medicine users reported consulting a provider of alternative medicine, whereas in 1997 this
figure rose to 46%.1,2 Extrapolation to the U.S. population suggested that the 629 million visits to providers
of alternative medicine exceeded the 386 million visits
to all U.S. primary care physicians in 1997.2 Of the
$13.7 billion spent on alternative medicine in 1990,
75% was paid out of pocket1 whereas of the $21.2
billion spent in 1997, $12.2 billion was paid out of
pocket.2 Increasing health insurance coverage of alternative therapies also supports increasing patient use.3
Because of such consumer demand, the U.S. Congress
targeted 0.02% ($2 million) of the 1992 National Institutes of Health (NIH) budget to evaluate alternative
medicine by creating the NIH Office of Alternative
Medicine (OAM). The OAM defines “alternative medicine” as therapies that are unproven. If these popular
unproven therapies are found to be effective, they
could become accepted as conventional medicine and
no longer be considered “alternative.”
The use of alternative medicine therapies for cancer patients varies from 7– 64% in published studies,
with an average prevalence of 31.4%.4 It is interesting
to note that it appears that up to 72% of those patients
using alternative therapies do not inform their physicians.1 Because alternative therapies may alter the
results of standard cancer therapies,5 produce side
effects, and confound results of clinical trials, new
patient evaluations should include questions concerning any herbal preparations or the practice of any
alternative methods of cancer treatment. The potential confounding effects due to alternative medicine
use are particularly relevant in diseases such as prostate carcinoma, in which status is assessed by biochemical markers. Unfortunately, to our knowledge,
little information is available regarding the prevalence
of alternative medicine in prostate carcinoma patients
and this limits our ability to understand the magnitude of the issue.
To address this important gap in the current literature, we sought to compare the prevalence of alternative medicine use in patients with localized prostate carcinoma treated with curative intent. In
addition, we studied the patterns of use as a function
of the treatment modality employed, such as radical
prostatectomy, brachytherapy alone, or a combination of brachytherapy and external beam radiation
therapy (EBRT).
METHODS
Study Population
Between January 1997 and May 1998, 234 men with
clinically localized prostate carcinoma underwent either radical prostatectomy (54 patients) or brachyther-
2643
apy (180 patients) with (74 patients) or without (106
patients) EBRT at 1 university medical center. These
patients were undergoing routine management of
their localized prostate carcinoma and were not enrolled in any clinical trials. Clinical stage of the prostate tumor was assessed retrospectively by review of
the medical records using the 1992 TNM system.6
Serum prostate specific antigen (PSA) levels also were
obtained for all patients prior to any treatment. The
grade of each neoplasm was determined using the
Gleason scoring system7 on pretreatment core needle
biopsies. Our pathologists reviewed all biopsy materials not generated at our hospital.
Selection of Patients for Therapeutic Procedure
Patients underwent either radical prostatectomy (perineal or retropubic approach) or brachytherapy after
thorough discussion of options and description of the
advantages and disadvantages of each approach by
the attending urologist. Radical prostatectomy patients did not undergo any pretreatment androgendeprivation therapy. Those patients who underwent
brachytherapy were recommended for additional
EBRT if their pretreatment PSA level was $ 10 ng/mL,
clinical T classification was $ T2c, or pretreatment
Gleason score was $ 7. Patients who underwent
brachytherapy alone received either flutamide, 250
mg, three times daily or bicalutamide, 50 mg daily,
and finasteride, 10 mg daily, beginning 2 months prior
to brachytherapy and continuing for a total of 8
months from the initiation of therapy. Patients who
underwent both brachytherapy and EBRT received
leuprolide instead of finasteride for the same duration.
No firm criteria or guidelines were used to assign
patients to the three treatment groups, instead, this
decision was made by the patient and physicians involved.
Questionnaire
In July 1998, a questionnaire was mailed first class
with a cover letter stating the goals of the project. No
financial reimbursement was given to the patients for
filling out the questionnaire. Our institutional review
board provided us with an exemption and did not
require individual informed consent to be obtained
because completion of the survey was considered as
providing informed consent. Within 30 days of the
initial mailing a reminder letter was sent to patients
who did not respond. The questionnaire was comprised of an extensive survey regarding alternative
therapy use (Fig. 1). Patients indicated whether they
used alternative medicine and could chose from 18
types of alternative medicine treatments. More than
one treatment could be chosen.
2644
CANCER December 15, 1999 / Volume 86 / Number 12
FIGURE 1.
Questionnaire comprised
of an extensive survey regarding use of
alternative therapies.
The effects of age at procedure, pretreatment PSA
level, clinical stage, pretreatment Gleason score, and
type of treatment on the prevalence of use of alternative medical therapies and types of therapies were
evaluated univariately using the Mann–Whitney U test
for quantitative and semiquantitative variables and
chi-square tests of association for the categoric variables. The SAS program CATMOD (SAS Institute, Cary,
NC) was used to evaluate these variables multivariately in a logistic model using maximum likelihood
estimation. The relative importance of each variable in
influencing the use of alternative medical therapies
was evaluated using chi-square values derived by the
Wald test based on the information matrix from the
likelihood calculations. The overall goodness-of-fit of
the multivariate logistic model was evaluated using a
likelihood ratio statistic comparing the specified
model with the unrestricted model. P values , 0.05
were considered significant. All mean values shown
are 6 the standard deviation.
tients at 7.8 6 1.5 ng/mL and 7.5 6 1.3 ng/mL, respectively, was lower than that of patients undergoing
combination radiation, who had a mean PSA level of
13.4 6 2.7 ng/mL. Mean Gleason scores ranged from
5.7 6 0.5 for brachytherapy patients to 6.4 6 0.6 for the
radical prostatectomy patients to 7.1 6 0.8 for combination radiation patients. The distribution based on
clinical T classification was very similar for the 40
radical prostatectomy patients and the 77 brachytherapy patients with approximately 50% of the patients
classified as T1 and 50% as T2. However, in the combination radiation patients, 14 (29%) were classified as
T1, 32 (65%) were T2, and 3 (6%) were classified as T3.
The 190 patients surveyed had a median follow-up of
6 months (range, 2–17 months). We detected 3 biochemical failures (PSA . 0.2 ng/mL) in patients
treated by radical surgery and 5 in the radiotherapy
group, defined as 3 consecutive increases in PSA after
achieving a nadir as recommended by the American
Society of Therapeutic Radiology and Oncology Consensus Panel.8
RESULTS
Prevalence and Types of Alternative Medicine Used
Patient Demographics and Tumor Characteristics
In the survey, 81 patients (42.6%) reported use of
alternative medicine therapies. Differences in the
rates of use of alternative medicine were not statistically significant between the treatment groups, with a
rate of use in the brachytherapy patients of 38% (35
patients), 40% in the radical prostatectomy patients
(16 patients), and 51% in the combination radiation
patients (30 patients). The three most commonly used
therapies were vitamins (34% rate of use), prayer or
religious practices (25%), and herbal medicines (13%).
Statistical Methods
Of the 190 patients responding to the survey, 40 (21%)
underwent radical prostatectomy, 91 (48%) underwent brachytherapy alone, and 59 (31%) underwent a
combination of EBRT and brachytherapy (Table 1).
The mean patient age was 60 6 6 years for the radical
prostatectomy patients, 67 6 7 years for the brachytherapy alone patients, and 69 6 7 years for the combination radiation group. The mean PSA level for both
the radical prostatectomy and the brachytherapy pa-
Alternative Medicine Use in Prostate Carcinoma/Lippert et al.
2645
TABLE 1
Patient and Tumor Demographics
Radical prostatectomy
Brachytherapy
Brachytherapy and EBRT
Parameter
Mean
SD
No.
Mean
SD
No.
Mean
SD
No.
Gleason score
PSA
Age
6.35
7.78
60.1
1.1
5.46
6.27
40
40
40
5.71
7.48
66.5
1.04
7.08
7.1
87
85
91
7.09
13.4
68.7
1.07
11.4
6.6
55
55
59
Tumor classification
T1
T2
T3
Total
Alternative medicine use
No
Yes
Total
Count
Percent
Count
Percent
Count
Percent
20
20
50
50
42
35
55
45
40
100
77
100
14
32
3
49
29
65
6
100
24
16
40
60
40
100
56
35
91
62
38
100
29
30
59
49
51
100
EBRT: external beam radiotherapy; SD: standard deviation; PSA: prostate specific antigen.
TABLE 2
Univariate Analysis of Alternative Medicine Use and Patient and Tumor Variables
Users of alternative treatments
Nonusers of alternative treatments
Parameter
Mean
SD
No.
Mean
SD
No.
P value
Age
PSA
Gleason score
64.6
9.75
6.5
7.5
9.95
1.3
81
79
80
66.7
9.05
6.1
7.3
7.69
1.1
109
101
102
NSa
NSa
, 0.02a
Radical prostatectomy
Brachytherapy
Brachytherapy and EBRT
Tumor classification
T1
T2
T3
Count
Percentage
Count
Percentage
16
35
30
19.8
43.2
37.0
24
56
29
22.0
51.4
26.6
NSb
30
42
0
41.7
58.3
0
46
45
3
48.9
47.9
3.19
NSb
SD: standard deviation; NS: not significant; PSA: prostate specific antigen; EBRT: external beam radiotherapy.
a
Mann–Whitney U test.
b
Chi-square test.
The use of vitamins and herbal medicines was very
similar in all treatment groups. However, only 17% of
the patients treated with brachytherapy used prayer or
religious practices compared with 30% of patients
who underwent radical prostatectomy or received
combination radiotherapy. Finally, 21% of the patients
(40 patients) reported using more than 1 type of alternative therapy at the time the questionnaire was
mailed.
Variables Associated with Alternative Medicine Use
Univariate analysis revealed a relation between increasing Gleason score and greater use of alternative
medicine therapies in prostate carcinoma patients
(P 5 0.02) (Table 2) (Fig. 2). The 80 patients who used
alternative medicine therapies had a mean Gleason
score of 6.5 6 1.3 compared with a mean Gleason
score of 6.1 6 1.1 in the 109 patients who did not use
alternative medicine therapies. However, patient age,
2646
CANCER December 15, 1999 / Volume 86 / Number 12
FIGURE 2. Variables related to the use
and type of alternative medicine therapies in prostate carcinoma patients. Histograms depicting the relation between
patient age at treatment and Gleason
score and the overall use and specific
type (prayer and religious practices) of
alternative medicine therapies.
TABLE 3
Multivariate Analysis of Alternative Medicine Use and Patient and
Tumor Variables
Parameter
Degrees of
freedom
Chi-squarea
P value
Gleason score
Age
Procedure
PSA
T classification
Likelihood ratiob
1
1
2
1
1
153
6.11
4.71
2.72
0.47
0.1
201.2
0.01
0.03
0.26
0.49
0.76
0.005
PSA: prostate specific antigen.
a
Chi-square values and associated P values were derived by the Wald test from the information matrix
of the likelihood calculations.
b
Likelihood ratio statistic compared the specified model with the unrestricted model and provided a
goodness-of-fit test for the model.
type of treatment, higher pretreatment PSA level, and
higher clinical T classification were not related to use
of alternative medicine therapies. Use of multivariate
analysis revealed an association between pretreatment Gleason score (P 5 0.0135) and younger patient
age (P 5 0.03) (Table 3) and use of alternative medicine therapies. No association with alternative medicine use was observed with type of treatment, clinical
stage, and pretreatment PSA level.
Variables Associated with Specific Forms of Alternative
Medicine Used
Of the three most commonly used alternative medicine therapies, only the use of prayer and religious
practices was associated with a higher Gleason score
(P 5 0.0019) and younger patient age (P 5 0.066) by
univariate analysis (Fig. 1). Patient age, type of treatment, higher pretreatment PSA level, and higher clinical stage were not related to the type of alternative
medicine used.
DISCUSSION
An increasing proportion of the U.S. population is
seeking alternative medicine therapies, with an increase from 34% in 1990 to 42% in 1997.1 Approximately 7– 64% of cancer patients in published studies
used alternative medical therapies.4 Alternative medicine therapies offer hope to cancer patients who wish
to leave no stone unturned and may enhance their
sense of control over an illness that makes them feel
helpless.9 In the study by Spiegel and Moore, 30 – 44%
of newly diagnosed cancer patients were distressed
enough to qualify for diagnosis of a psychiatric disorder.9 Although the significantly increased stress associated with initial cancer treatment decreases with
time, 20% of cancer patients have been reported to
remain psychiatrically distressed 6 months after initial
cancer therapy.9 A longitudinal questionnaire-based
study of cancer patients in Norway revealed that the
majority of users started their use of alternative therapies , 3 months after becoming aware of their cancer.10 In this same study, only 17–27% of patients
admitted to use of alternative therapies when questioned at a single point in time, whereas 40% of 252
patients used alternative medicine therapies during
the entire 5-year study period.10 In view of the data
presented earlier, because our study was of a crosssectional design, the 43% rate of use of alternative
Alternative Medicine Use in Prostate Carcinoma/Lippert et al.
medicine therapies by prostate carcinoma patients in
our current study may be an underestimate of the
actual prevalence. In addition, despite a very high
response rate of 81%, our study may not be a completely accurate reflection of alternative medical therapy use in prostate carcinoma patients because our
patients’ response to the questionnaire was voluntary
and no follow-up was undertaken of patients who did
not return the questionnaire.
To our knowledge little published information exists regarding the prevalence of alternative medicine
use in prostate carcinoma patients alone. Of the prostate carcinoma patients responding to our questionnaire, 43% noted using alternative medicine therapies.
Prostate carcinoma patients in combination with patients with testicular carcinoma have been found to
have an 8.8% rate of use of alternative therapies in 1
study11 compared with a rate of 28% when prostate
carcinoma patients were combined with testicular
carcinoma and lung carcinoma patients.10 However,
due to grouping of patients, such studies do not yield
useful and practical information given the great differences between the ages of patients with prostate
carcinoma and those with testicular carcinoma. Many
studies have revealed a higher prevalence of alternative medicine use in younger cancer patients.2,3,12,13
Indeed, younger patient age was associated significantly with an increased use of alternative therapies in
our study when evaluated with a multivariate logistic
model. In addition, although we did not collect such
data, other studies have shown that those patients
using complementary therapies are more likely to be
of higher socioeconomic status, female, and better
educated than patients who did not try alternative
therapies.2,11,13–16
A higher Gleason score was associated with
greater use of alternative medicine therapies in our
study by both multivariate and univariate analysis.
However, other predictors of worse prognosis such as
a higher pretreatment PSA level and clinical stage did
not appear to be associated with a higher rate of use.
In agreement with this finding, some studies have
shown greater use of alternative medicine therapies in
patients with more advanced disease,17 in patients
receiving palliative treatment only,15,17 and in patients
with prolonged illness11 whereas other studies revealed an equal rate of use in patients with advanced
and early stage cancer.10,18 In further contrast, a recent
study indicated that alternative medicine use was
highest among men who were clinically disease free
after radical therapy for localized prostate carcinoma.19 Although the clinical relevance of a difference of
0.4 in mean Gleason score between patients using
alternative medicine and those who do not is debat-
2647
able, it nevertheless is interesting to speculate why
this correlation exists. One possibility may be that
physicians communicated less hope to those patients
with higher Gleason scores, resulting in patients turning to alternative therapies to enhance their sense of
control over an illness that makes them feel helpless.
Although unlikely in our patient cohorts in view of
their relatively low PSA levels, tumors with a Gleason
score may be bulkier and as such could cause more
local symptoms, which in turn would influence the
patient’s interest in alternative medicine use.
Not surprisingly, the prevalence of prayer and religious practices as an alternative therapy for cancer
patients varies between countries and between geographic regions within a country.10,18 Approximately
34% of cancer patients have been found to become
more religious after being diagnosed with cancer.20 In
our study and those of others,20 there was a trend
toward younger patients being more likely to use
prayer and other religious practices, but the age difference between users and nonusers of prayer was not
statistically significant.
In the current study 13% of the prostate carcinoma patients responding indicated that they used
herbal medicines. Because herbal medicines used to
treat prostate carcinoma, such as PC-SPES, can reduce
serum PSA levels and reduce serum testosterone levels, results of standard or experimental therapies can
be confounded.5 Herbal medicines labeled to “promote prostate health” have been reported to have
antiandrogenic and antiestrogenic activities such as
saw palmetto21,22 or to inhibit in vitro growth of human prostate carcinoma cells such as a rye pollen
extract, cernilton.23,24 In addition, herbal medications
can cause side effects such as breast tenderness, decreased libido, and superficial venous thrombosis.5
Because up to 72% of patients using alternative medicine therapies do not inform their physicians,1 physicians who are not aware of a patient’s use of herbal
therapies may terminate a concomitant effective conventional therapy because of such clinical or biochemical (i.e., PSA) effects. Hence it is important for
physicians treating prostate carcinoma patients to
clearly ask their patients about alternative medicine
use.
The results of the current study document a significant use of alternative therapies in patients with
localized prostate carcinoma and gives some idea of
the current range of therapies. Physicians must be
informed of alternative medicine therapies used by
their prostate carcinoma patients so that possible interactions and complications can be avoided and outcomes of therapies interpreted correctly.
2648
CANCER December 15, 1999 / Volume 86 / Number 12
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