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An Assessment of the Utilization of Complementary and Alternative Medication in Women With Gynecologic or Breast Malignancies

From the College of Pharmacy, University of Houston; Division of Pharmacy, Division of Cancer Medicine, Division of Surgery, and the Division of Cancer Prevention, The University of Texas M.D. Anderson Cancer Center, Houston, TX

Address reprint requests to Judith A. Smith, Pharm D, BCOP, Department of Gynecologic Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Unit 401, Houston, TX 77030-4009; e-mail: jasmith{at}mdanderson.org.

	ABSTRACT

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION Authors' Disclosures of... REFERENCES

 
PURPOSE: To describe and assess the current utilization of complementary and alternative medicines (CAMs) in women with a diagnosis of either gynecologic or breast cancer and evaluate their reasons for use.

PATIENTS AND METHODS: This study included 250 female patients from the Multidisciplinary Breast Center and 250 patients from the Gynecologic Oncology Center of The University of Texas M.D. Anderson Cancer Center (Houston, TX). Patients were selected by having an odd-numbered medical record number, and they were contacted before their clinic visit. The goals of the study were explained, and verbal consent was obtained. Patients who agreed to participate were asked to bring a written list and the medication bottles of all over-the-counter prescriptions and CAMs with them to clinic. In clinic, the investigator obtained a written informed consent and administered the survey. All patients and surveys were assessable.

RESULTS: The most frequently used herbal products and megavitamins/minerals were identified from the patient medication histories. Overall, we found the proportion of patients using CAM to be 48% (95% CI, 44% to 53%; 241 of 500 patients). CAM use was related to patients' educational status: 62% had postgraduate degrees, 50% had college degrees, 56% had some college, and 33% had a high school education or less. Also, among patients using CAMs, only 53.5% had spoken to a healthcare provider regarding CAM therapy.

CONCLUSION: The use of CAM is common among women with cancer. Studies need to be conducted to establish if there are any potential drug interactions and/or therapeutic benefit of CAM products. Moreover, there is a need to educate patients and healthcare providers on appropriate and safe use of CAM products.

	INTRODUCTION

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The use of complementary and alternative medicine (CAM) such as herbal, vitamin, and nutritional supplements has increased over the past decade. An estimated 20% to 60% of patients in the United States use some form of CAM in various practice settings, with an estimated 16% to 20% using CAM along with prescription (RX) medication [1-3]. This is a major concern because the literature suggests that patients do not routinely report the use of CAM when providing a medication history [4,5]. Often this is an error of omission because the healthcare professional fails to ask specifically about these products, and patients do not classify these products as medications [6,7].

In the past, the use of CAM seemed somewhat innocuous. However, as with other medications, CAMs have pharmacologic activity that will cause biologic responses, adverse effects, and will contribute to drug-drug interactions [8,9]. Recent case reports regarding the drug interactions with St John's Wort have increased awareness of the need to evaluate the pharmacologic activity of each CAM [1,10]. Recently reported examples of adverse effects include renal failure and urothelial carcinoma with the Chinese herb Aristolochia fangchi, and severe liver dysfunction with kava [11-14]. In addition, there is currently no uniform standard on the herb content among different manufacturers; therefore increasing the difficulty of predicting the potential drug interactions, adverse effects, and efficacy of various CAMs.

There is increased concern about use of CAM by oncology patients because potential adverse drug interactions could cause patients to experience increased toxicity or decrease the efficacy of the conventional systemic therapy used to treat cancer. In our particular patient population, we were concerned about CAM therapies that have estrogenic or hormonal properties, such as derivatives of soy isoflavones or Chinese Licorice. The use of antioxidants is also concerning because of the free-radical sequestering ability of these agents, thus leading to potential drug interactions with chemotherapy agents that interrupt DNA replication through the formation of free-radicals, such as the platinum or nitrogen mustards agents.

The purpose of this study is to describe the current use of CAMs in women with a diagnosis of either gynecologic or breast cancer and to evaluate their reasons for use. Because of the infinite number of possible combinations of CAM with traditional chemotherapy, this study focused specifically on herbs, homeopathy, phytochemicals, minerals, and megavitamins. Data has shown that various CAM therapies, including mind and body interventions, was higher in women, persons with a higher level of education, and those between 35 and 54 years of age [15]. The data also shows that CAM use among varying ethnicities is similar [15]. In order to assess CAM use in our patient population, a survey instrument was developed based on previous literature in order to gather demographic data such as age, ethnicity, and level of education, as well as medication history and general opinion on CAM therapy.

	PATIENTS AND METHODS

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Patients with appointments in The University of Texas M.D. Anderson Cancer Center Multidisciplinary Breast Center (MBC) or Gynecologic Oncology Center (GOC) were screened to participate in this study. All patients with medical records ending in an odd number were asked to participate. The patient was contacted by telephone before her appointment to obtain verbal consent to participate in the study. Patients were asked to bring a written list of all the CAM, over-the-counter (OTC), and RX medications that they were currently using, along with all medication containers, to the clinic.

Eligible patients had to be female, over the age of 18 with a current or past diagnosis of a gynecologic or breast cancer, speak and understand the English language, and understand and sign the institutional informed consent. Patients with uncontrolled psychiatric illness or altered mental status interfering with their ability to answer survey questions were excluded. After written informed consent was obtained, the investigator conducted a one-on-one survey with each participant and verified the information on the medication list with the medication/product labels and instructions. CAM use was defined as the use of any formulation of herbs, homeopathy, phytochemicals, mineral supplements, or megavitamins to promote well-being or treat health conditions. A detailed medication history, including the dose, duration, and frequency of use of each medication was obtained. All medications were then classified by the investigator into one of four categories: 1) RX, 2) OTC, 3) herbal/alternative medication products, and 4) mega-vitamins and/or minerals. The term mega-vitamin and/or mineral was defined as 10 times the recommended daily allowance [16-18]. Combination multivitamin with herbals were classified as an herbal product. If only one component of a combination product was dosed in excess of 10 times the recommended daily allowance then only that component was listed as a mega-vitamin/mineral.

The survey instrument consisted of 20 questions. All patients completed five general demographic questions including age, birth and current hometown, education and ethnic background as well as two additional questions to describe disease status and treatment. A complete medication history was also obtained that included medication name, dosage, directions, indications for use, and the approximate duration of use. Also, eight questions were asked on medication usage that focused on compliance and CAM therapy safety and efficacy. Only patients actively taking CAM products were asked to complete the remaining four questions. These included questions to identify the sources of information, such as family, friends, internet, and media, that were used as guides by patients to select individual CAM therapies; which, if any, healthcare professionals were consulted about CAM use; patient impression of the healthcare professional's response to their inquiry about CAM therapy; and the primary indications of past or present CAM use. The estimated time for completion was approximately 15 minutes. Initially, a pilot study was completed with 10 to 15 patients to assess the functionality of the patient medication assessment survey to identify and clarify any problem questions. Proper adjustments were made to the survey instrument based on the pilot study.

The study planned to accrue 500 women with gynecologic cancer or breast cancer (250 from each center) who may or may not use complementary and alternative medicine, to allow for an estimation of the proportion of patients who currently use CAMs to be within a maximum 95% CI of ± 5%. Prospectively, two study groups were defined for this study: CAM users or nonusers. A descriptive analysis of all data was accomplished. ² tests evaluated differences between patients in the MBC and GOC and between other categoric variables. In addition, a stepwise multivariate logistic regression was employed to determine if the participant demographic variables, such as age, ethnicity, education, disease type, and treatment history, could predict CAM use. Initially, variables that were significant at the 0.20 level were considered, and in the final model, only those variables significant at the 0.05 level were included. The independent variables of age, clinic, disease status, ethnicity, and education were entered into the model. CAM use was coded as "zero" if there was no CAM use and "one" if CAM was used. Variables other than age were analyzed as categoric variables. The Logistic procedure in SAS software (Version 6, SAS Institute, Cary, NC, 1990) automatically created a dummy variable for each distinct value of the original variable. The Cochran-Armitage Trend Test was used to statistically test the trend in education for both the MBC and GOC patients. We estimated the maximum likelihood estimate of each parameter in the final model, as well as the significance of each parameter, evaluated by the Wald ² statistic. Odds ratio estimates and 95% CIs were calculated for different levels of significant variables as compared to each variable's corresponding reference level.

	RESULTS

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A total of 500 patients were accrued and completed the study. Of the 635 patients originally called before clinic visit, 539 (85%) agreed to participate in the study, while 96 (15%) declined because of time constraints in their schedule. Of the 539 patients who agreed to participate, two patients declined at their visit and 37 patients were either missed by the investigator or did not show up for their appointment. The baseline demographics of all patients surveyed are shown in Table 1. A total of 48% of patients had a medication history involving the use of CAM. Fifty-two percent (129 of 250) of patients in the MBC and 45% (112 of 250) in the GOC reported CAM use. (² = 2.32; P = .13). The most commonly used herbal preparation reported was the combination product glucosamine sulfate and chondroitin; among the megavitamins and/or minerals, the most commonly used was vitamin E. (Table 2 represents data from all patients.) When medication histories were divided into categories defining the use of RX, OTC products, herbal/alternative medication products, and mega-vitamins and/or minerals, the largest portion of patients were taking RX medications alone (32%) or RX medications in combination with OTC products (16%). There were no patients using CAM alone. More often patients were using a combination of RX and OTC medications in combination with either herbs (11%), megavitamins/minerals (13%), or both categories (14%).

CAM Use by Ethnicity
We used four categories of ethnicity in statistical analyses: white, black, Hispanic, and "other." There were no significant differences found between CAM use among these four ethnic groups in either clinic or the combined population. Fifty-one percent of white patients and 48% of "other" patients reported using CAM, but differences were not statistically significant (² = 6.26; P = .10; Table 1 represents data from all patients).

CAM Use by Level of Education
For statistical comparisons we used four education categories: high school or less, some college, college graduate, and postgraduate education. In both clinics there were significant differences in CAM use by these categories of education. In the MBC, among patients with some college education, 64% reported CAM use. The remaining portions were: 62% of postgraduates, 49% of college graduates, and 34% of high school graduates or less (² = 14.00; P = .003). Patients in the GOC had a similar trend, although in this group of patients the ordering was more consistent with a trend of increasing CAM use at each higher education level. In the GOC, the proportions of patients who reported CAM use were: 61% of postgraduates, 51% of college graduates, 47% of those with some college education, and 33% of high school graduates or less (² = 10.10; P = .02). For the MBC, although the proportions of CAM use did not strictly increase with increased education, the trend test was significant (Z = 2.49; P = .01). Patients in the GOC had a more significant trend for increased CAM use with increased education (Z = 3.16; P = .002). When information from the two clinics was combined, associations found using the ² table (² = 22.12) and the trend test (Z = 4.12) were highly significant in both cases (P < .0001; Table 1 represents data from all patients).

CAM Use by Age
The mean and median age of CAM users was slightly higher for users versus nonusers; 57.7 and 56.5 versus 55.0 and 54.0, respectively. The standard deviations of the two groups were approximately equal at 11.8 and 12.9. A t test comparing these differences was statistically significant with a significance level of 0.018. The range of ages of the two groups was 26 to 87 for CAM users and 22 to 91 for CAM nonusers.

Medication Safety
In the GOC, 151 patients (60%) felt that CAM therapies were both safe and effective. However, in the MBC, 121 patients (48%) felt that CAM therapies were safe and only 112 (45%) felt that they were effective. Lastly, only 142 patients (28%) out of the total number of patients surveyed considered CAM supplements as a type of medication.

Participants Taking CAM
The sources of information about CAM therapies were classified into five categories: health professional, alternative care specialist, internet/media, formal education, and friends and family. Some patients had used multiple resources. Over half (52.2%; 126 of 241) of CAM users had learned about CAM from the internet or media. The next most common resource was friends and family (37%), followed by a healthcare professional (21.6%). Fewer patients than expected, only 11.2% (27 of 241), had sought out information from an alternative care specialist.

Unlike previous reports, the majority (53.5%, 129 of 241) of CAM users in our study reported that they had discussed using CAM therapies with a healthcare professional, most commonly their oncologist (56%). Seventy-four percent of patients in the MBC and 63% of patients in the GOC felt positive about discussing CAM therapies with a healthcare professional. A higher proportion of patients in the GOC were unsure (28%) compared to patients in the MBC (10%), and more patients in the MBC answered that they felt negative about discussing CAM therapies (16%) than patients in the GOC (9%).

Of those who did not speak with a healthcare professional, the most common reason was that they were not asked and that it just never came up during their appointment. The distribution of the reasons provided by participants for taking CAM were significantly different in the two clinics (² = 31.1; P < .0001). Briefly, one major difference appeared to be that many more CAM users in the MBC stated their reason was to "reduce adverse drug reactions" and/or to "improve quality of life" as compared to GOC (30% v 10%). However, more CAM users in the GOC when compared to the MBC reported "treatment of cancer" (15% v 4%) as their reason for taking CAM. Yet despite these differences, the number one reason for use among both the GOC and MBC was stated to be to "improve overall health" (61% and 55%, respectively).

Multivariate Analyses of CAM Use and Demographic Variables
The three variables that remained significant in the multivariate logistic regression model were education (P < .0001), age (P = .0079), and status (P = .0080). We found that older patients were more likely to use CAM. For the categoric variables, these significance levels refer to the null hypothesis that all the coefficients in the set were equal to zero. In addition, in Table 3 (represents data from all patients), we present estimated odds ratios for each comparison of the distinct value of the categoric variables of education and status to their reference value as shown in the table. The significance levels in the last column refer to the null hypothesis that the individual coefficients are equal to zero.

	DISCUSSION

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Because it has been reported that CAM use is frequent among cancer patients [19] and women [2], this study was initiated to evaluate the use of CAM therapy in patients being seen in the MBC and GOC. As anticipated, a large proportion of our patients (48%) were current users of CAM. However, only approximately half of these patients have discussed CAM use with a healthcare professional. Although we found a high prevalence of use, the CAM use in the MBC at our institution was slightly less than what was previously reported. In a study by Richardson et al [20] conducted in 1997, 453 male and female patients from eight different cancer outpatient clinics, including the MBC, completed a questionnaire regarding use of a variety of CAM approaches; 62.6% of these cancer patients reported use of herb and vitamin products. The difference could have occurred because we focused only on women or because our survey instrument was a one-on-one interview rather than a self-administered questionnaire. Other survey articles have used a broader definition of CAM that encompasses other therapies such as mind and body interventions; however, we compared our results to the herb and vitamin use in these studies. A different interpretation of these results is that the use of CAM might be declining in our referral population. However, the prevalence of CAM use by gynecologic oncology patients at our institution was similar to the prevalence reported in other studies ranging from 49.6% to 56.3% [4,21].

In this study as in many others, patients who used CAM were typically taking other RX or OTC medications. These data, along with the increasing number of reports of interactions and adverse effects, reveal the importance of exploring the pharmacology of CAM to elucidate potential drug interactions and therapeutic outcomes. Of the patients defined as CAM users, most gathered information about CAM on their own by using resources such as the internet or the media. CAM users also seemed to look to their social support like friends and family for their opinion. Not surprisingly, healthcare professionals were third in line when listed as a likely resource for patients. This information demonstrates that patients are making an effort to take an active role in their own healthcare. Also, less than a third of all patients considered CAM a type of medication, which may contribute to the low incidence of reporting of CAM use to healthcare professionals when giving a medication history. The majority of patients who spoke to any healthcare professional felt positive about their conversation. Of those who had not discussed CAM with a professional, the most common reason was that it was never brought up during their visit. This emphasizes the importance of multiple health care professionals repeatedly asking patients about their knowledge and use of CAM in an open dialogue during a clinic visit. It is important for all health-care professionals to be receptive, to learn from the patient about CAM therapy options, and to provide the patient with any medical literature that may support or refute the therapeutic use or safety of a particular CAM. Since there is considerable variation in the dose and components of the CAM products, the patient should also be asked to bring the container to their next visit in order to obtain accurate dosing information for their medical record.

A higher proportion of patients in the MBC stated their reasons for CAM use to be to improve quality of life and to decrease the adverse effects of other medications that they may be using. Also, 15% of patients in the GOC stated that their reason for use was to treat their cancer. We found a wide variety of CAM in various formulations and doses being used for multiple indications. Identifying the most frequently used CAM was just one approach to prioritize the agents to evaluate first in the laboratory for drug interactions.

There were a few limitations of this study. Common to many surveys, there is potential for investigator and patient bias. Some patients may have been hesitant to disclose use of CAM. Also, because of language barriers, the survey could only be done with English-speaking patients, which excluded some ethnic influences. However, among the patients surveyed, there was not a statistically significant relationship between ethnicity and CAM use. There may have also been emotional distractions, such as anxiety, associated with a visit to see the physician regarding their cancer that could have influenced patient responses to the survey questions. Because patients needed to be called ahead of time in order to receive consent and to specify the requirements of the study, there were some geographical limitations for accrual to this study. Lastly, education in the area of the definition of CAM was a limitation for some patients. Although the definition of CAM was explained to all participants, only verbal confirmation of comprehension of definition was obtained. However, there was a breach between comprehension and application of the definition when patients were asked to provide a medication history to the investigator. This was evident when patients would self-report no CAM use but when their medication histories were reviewed, in fact they were using agents that by definition were types of CAM.

It is common knowledge that many patients are using CAM. Both patients and healthcare professionals need to be educated on the appropriate use of CAM during conventional treatment. However, before we can define the role of CAMs in conventional treatment of cancer, we need to learn more about the complex pharmacology of CAMs in appropriate preclinical studies and to design and initiate prospective clinical studies to establish the role of CAM therapy in modern medicine. Based on our findings in this study, further in vitro studies are being initiated to specifically evaluate alteration of cytochrome P450 metabolism and plasma protein binding displacement interactions when CAM therapies are coadministered with commonly used antineoplastic agents used in the treatment of gynecologic and breast malignancies. In addition, the potential cytotoxic activity of each CAM agent will be evaluated alone and in combination with commonly used antineoplastic agents, in human ovarian or breast cancer cell lines. The determination of interactions between CAM and other traditional chemotherapy agents will provide information for clinicians to guide their cancer patients in use of these CAM products in order to avoid unnecessary toxicities and optimize therapeutic outcomes.

	Authors' Disclosures of Potential Conflicts of Interest

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The authors indicated no potential conflicts of interest.

	NOTES

 
Authors' disclosures of potential conflicts of interest are found at the end of this article.

	REFERENCES

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION Authors' Disclosures of... REFERENCES

 
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6. Margolis ML: A survey of the use of herbal agents among Philadelphia veterans affairs medical center pulmonary outpatients. Chest 119:1981–1982, 2001[Free Full Text]

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Submitted April 23, 2003; accepted December 4, 2003.

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This Article Abstract Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Navo, M. A. Articles by Smith, J. A. Search for Related Content PubMed PubMed Citation Articles by Navo, M. A. Articles by Smith, J. A.