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*Departments of Anesthesia and Perioperative Care, University of California, San Francisco, California; and the
Department of Anesthesia at John Muir Medical Center, Walnut Creek, California, Kaiser Permanente Medical Center, San Francisco, California, and San Francisco General Hospital, San Francisco, California
Address correspondence and reprint requests to Dr. Leung, University of California, San Francisco, Mount Zion Medical Center, Department of Anesthesia and Perioperative Care, 1600 Divisadero St., San Francisco, CA 94143-1605. Address e-mail to jmleung{at}itsa.ucsf.edu
| Abstract |
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18 yr old awaiting elective noncardiac surgery at five San Francisco Bay Area Hospitals. A total of 2560 patients completed the study survey (60% response rate). Of these patients, 39.2% admitted to using some form of alternative medicine supplements, of which herbal medicine was the most common type (67.6%). Of those who admitted to taking alternative medicine supplements, 44.4% did not consult with their primary physicians, and 56.4% did not inform the anesthesiologists before surgery regarding their use of these products; 53% of the patients ceased the use of these products before surgery. Multivariate logistic regression analysis revealed the following variables to be associated with the preoperative use of herbal medicine: female sex (odds radio [OR] 1.42, confidence interval [CI] 1.171.72), age 3549 yr (OR 1.25, CI 1.021.53), higher income levels (OR 1.85, CI 1.502.27), Caucasian race (OR 1.34, CI 1.071.67), higher level of education (OR 1.35, CI 1.101.65), problems with sleep (OR 1.32, CI 1.051.66), problems with joints or back (OR 1.27, CI 1.041.56), allergies (OR 1.48, CI 1.211.82), problems with addiction (OR 1.90, CI 1.252.89), and a history of general surgery (OR 1.25, CI 1.031.52). In contrast, diabetes mellitus (OR 0.55, CI 0.360.86) and the use of antithrombotic medications (OR 0.57, CI 0.380.87) were associated with decreased odds of the use of herbal medicines. We concluded that the use of alternative medicine supplements by surgical patients is prevalent. Documentation of the use of these products is critical to determine the potential of drug or anesthetic interactions in the perioperative period. IMPLICATIONS: The use of alternative medicine supplements by presurgical patients is prevalent. Documentation of the use of these products is critical to determine the potential of drug or anesthetic interactions in the perioperative period.
| Introduction |
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The prevalence of the supplemental use of these products in the United States is largely unknown, although it is thought to be widespread. A previous study by Eisenberg et al. (6) showed that 34% of the population surveyed used some kind of unconventional therapy. Another study by Eliason et al. (7) showed that 51% of patients attending family practice clinics took at least one dietary supplement, including vitamins, minerals, or herbal products. A study by Astin (8) showed that 40% of studied subjects used some form of alternative health care products and services. In presurgical patients, two recent studies reported that half of the patients surveyed admitted to using herbs and other dietary supplements (9,10).
Some of the dietary supplements have been suggested to have unwanted side effects, such as bleeding when warfarin is combined with ginkgo, garlic, dong quai, or danshen (11); possible monoamine oxidase inhibition by St. Johns Wort (12); interaction with benzodiazepine by Kava, inducing coma (13); or the induction of mania in depressed patients who mix antidepressants and Panax ginseng (11). Other risks of alternative medicine that had been reported include contamination of the herbal preparations (14), inconsistencies and adulteration of the medications (15), excessive sedation (16), and lead poisoning (17). These potential adverse effects raise the concern of the safety of these alternative health care products in surgical patients requiring anesthesia. During routine preoperative history and physical examination, questions on medication use are typically confined to prescription medications. Our institutional experience suggests that patients rarely volunteer information on the use of alternative health care products, and health care providers also rarely ask about their usage. As a result, the use of alternative medicine in a large cross-section of presurgical patients and the epidemiology associated with its use by presurgical patients are unknown. Determining their frequency of use by surgical patients and ultimately whether there are potential interactions with anesthetics and medications are important public health concerns.
Because there is little information regarding the epidemiology of the use of alternative health care products in the surgical population, we designed a study to investigate the prevalence and predictors of the supplemental use of these products in patients awaiting surgery.
| Methods |
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18 yr old presenting for elective noncardiac surgery at five San Francisco Bay Area hospitals, and who were free of cognitive impairment that prevented the completion of the questionnaire, were eligible for the study. This multicenter study involved three University of California, San Francisco teaching hospitals (Mount Zion Medical Center, San Francisco General Hospital, and Moffitt-Long Hospitals), John Muir Medical Center (Walnut Creek, CA), and Kaiser Permanente Medical Center, San Francisco. The hospitals were chosen to represent the underlying population of diverse racial background, socioeconomic status, and age distribution of the San Francisco Bay Area. The initial sample size calculation was based on an estimated prevalence of use of alternative health care products between 10% and 50% (6,8,18), and 95% confidence intervals (CIs) of 2%3% were based on our pilot studies in presurgical patients. On the basis of a response rate of >60% from our pilot studies, a total study sample size of 2500 patients was initially planned. The survey was conducted between January and November 1999. Before surgery, each potential study subject was given a questionnaire (available from the corresponding author) regarding their use of over-the-counter alternative medicine products, which were defined as herbal medicine, minerals, vitamins, and other dietary supplements. A specific list of 11 commonly used herbal therapies was provided, in addition to the opportunity to write in any other remedies taken. To increase the response rate, those who did not have enough time to fill out the questionnaire before surgery were provided with the study questionnaire either in person or by mail to be completed at home and returned by mail. The survey was designed as a self-administered questionnaire, to be completed easily in 1015 min. To get a representative sample of the population residing in the San Francisco Bay Area, the questionnaire (in English) was translated also to Spanish, Russian, and Chinese. Patients with an inability to read or write were given assistance to complete the survey.
The types of data collected included the use of any alternative medicine supplements, which included herbal medications, vitamins, minerals, and other dietary supplements. Specific herbal medications named in the questionnaire included Dong Quai, saw palmetto, Echinacea, St. Johns Wort, garlic, valerian, ginkgo biloba, yohimbe, ginseng, and kava-kava, as well as other dietary supplements, such as melatonin. Potential predictor variables of the use of alternative medicine that were measured are listed in Table 1. This included 27 self-reported past or current medical problems, past surgical procedures, current prescription medications, and habits of tobacco or alcohol use. Health status was measured by self-rated overall health, presence of pain, and functional status. Demographic data measured included age, sex, ethnicity, education, and income levels. In addition, the reasons for the use of alternative medicine supplements, the perceived benefits from these products, consultation with the primary physicians and anesthesiologists regarding the products use, preoperative cessation of use, and the amount of money spent per month were also measured.
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2 or Fishers exact tests (Stata 5.0; Stata Corporation, College Station, TX). A multivariate logistic regression analysis was performed with an initial model that included as independent variables all factors found to be univariately significant (P < 0.10). The contribution of each factor was assessed by testing the regression coefficient against zero. Factors were removed from the model in a stepwise fashion: the factor showing the smallest contribution was deleted at each step. After a factor was removed, the contribution of each factor previously removed from the model was reassessed to determine whether any of them now added significantly (P < 0.05) to the model. The model-building was stopped when all factors remaining in the model had regression coefficients significantly different from zero and no other factors outside the model continued to add significantly at the 0.05 levels. Odds ratios (ORs), 95% CIs, and two-sided P values were reported.
For other general analysis,
2 analysis with continuity correction was applied to categorical data. Other comparisons, such as site differences for some specific variables, were evaluated by one-way analysis of variance with repeated measures. The agreement between patients who did not consult with their primary physician and anesthesiologist was measured by the
statistic.
| Results |
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The demographic characteristics of the study patients are shown in Table 2. The socioeconomic status of the patients was diverse, as was the age distribution. Overall, 1003 of 2560 patients (39.2%) admitted to using some form of alternative medicine supplements, of which herbal medicine was the most common type (67.6% of all alternative medicine supplements used) (Table 3). The range of alternative medicine use in the five sites varied from 22% to 44%. The reasons for using alternative medicine supplements were diverse (Table 4); the most common reasons were for improvement of general health (54.9%) and disease prevention (33.3%). The percentages of patients who used alternative medicine for improvement of general health versus disease prevention were different among the five sites (19.3%, 36.7%, 52.2%, 31.5%, and 54.4%; P < 0.0001). When evaluating the types of herbal medicine use between people who used alternative medicine for general health only and those who used them for specific disease indications, we found that the use of Echinacea, ginseng, and melatonin was significantly more in those subjects who reported using herbal medicines for general health promotion than for specific disease indications (Table 5). The benefits derived from taking alternative medicine supplements as perceived by patients were diverse (Table 6). Overall, 739 of 1003 (73.7%) of patients who used alternative medicine supplements felt some benefits from using them. The most common benefits perceived included increased energy level, decreased disease symptoms, disease prevention, and mood elevation.
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for those not informing their primary care physicians and their anesthesiologists was 0.57. Five-hundred-thirty-two patients (53%) ceased the use of these products before surgery. Of those who discontinued their medications before surgery, 36.8% ceased the use for <2 days, 28.2% for 27 days, 12.4% for 814 days, and 22.5% for >14 days before surgery. The amount of money spent monthly on alternative medicine products is shown in Table 7.
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| Discussion |
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The frequency of the use of alternative health care products and services by the general population is estimated to be between 34% and 42% via random household telephone surveys (6,8,19). These previous studies included not just alternative medications, but also lifestyle-related therapies such as massage, hypnosis, and other nonconventional therapies. Two recent studies in presurgical patients reported that half of the patients surveyed admitted to using herbs and other dietary supplements (9,10). These results are similar to our findings that 39% of the patients used some type of alternative medicine supplements. Furthermore, our finding that 26.4% of patients used herbal medicines is similar to the report by Tsen et al. (10), in which 22% of their patients reported using herbal medications.
Of those patients responding to the questionnaire, our findings that those with a higher level of education, who are middle aged, who have higher income levels, and who are Caucasian are more likely to take alternative medicine products are similar to those reported by previous population surveys (8,19). Our study is one of the first to further identify other predictors of alternative medicine use in presurgical patients; these include self-reported health problems such as sleep disturbance, joint or back problems, allergies and addiction, and a history of general surgical procedures. In contrast, patients who had diabetes mellitus or those who used antithrombotic medications were less likely to use alternative medicine products. Hospital site was not found to be a significant predictor of the use of alternative medicine. This result is probably because hospital site is really a surrogate measure of other more important variables (such as patient demographic factors and comorbidities) that contribute to the uniqueness of each site. The type of surgery that the patients were scheduled to undergo was not associated with the use of alternative medicine products. In our study, 14.4% of the patients reported that the alternative medicine use was to remedy the medical conditions leading to surgery. Whether this finding suggests that presurgical patients have an increased likelihood of using alternative medicine products than their nonsurgical cohort remains to be determined.
The true prevalence of drug and herbal medications interactions during anesthesia and surgery is unknown. Most clinical reports on drug-herb interactions in nonsurgical patients were case reports. Recently, several reviews provided a more comprehensive summary of the existing published data (11,2022). The problems identified included misidentification, adulteration, and contamination of these products. In contrast to prescription medications, labeling of herbal products may not accurately reflect their contents, and adverse effects attributed to these products may actually be caused by misidentified plants, other drugs, or heavy metals (23). For example, one report documented that some commercial ginseng preparations may contain large amounts of ephedrine, rather than the characteristic compound ginsenosides (24). Another reported that a Siberian ginseng product implicated in neonatal androgenization was caused by an unrelated species (25). Addition of pharmaceutical drugs to "herbal" products also has been reported (26); these additions included caffeine, paracetamol, indomethacin, hydrochlorothiazide, prednisolone, nonsteroidal antiinflammatory drugs, and benzodiazepines.
Drug-herb interactions typically involved synergistic or opposing effects between the herbs and the prescription medications (21). For example, antiplatelet drugs may be potentiated by the use of garlic, ginger, or ginkgo. In our current study, 17.4% of patients used ginkgo, garlic, or dong quai. It is not known whether the use of these herbs increases the hazards of epidural hematoma during epidural or spinal anesthetics, particularly in those patients who also take antiplatelet drugs such as aspirin. Although St. Johns Wort has monoamine oxidase inhibition effects and possibly serotonin reuptake inhibition (27), the clinical significance of such effects is unknown. In our study, only 4.5% of all patients surveyed admitted using this product. Whether these patients should refrain from taking St. Johns Wort for two weeks before surgery, as suggested for other medications containing monoamine oxidase inhibitors (28), is unclear. Further prospective studies will be necessary to document the relationship, if any, between preoperative use of herbal medications and intraoperative anesthetics and drugs.
The economic implications of the use of herbal preparations by presurgical patients are substantial. By using the results from our study, we can estimate that approximately one of every four presurgical patients uses herbal preparations. With a conservative estimate of $10 per month being spent per patient, of the 23 million adults undergoing surgery annually (29), approximately $690 million will be spent on herbal preparations alone by presurgical patients.
There are several potential limitations of this survey. First, our response rate of 60% may not be adequate to fully describe our study population. Specifically, bias in those who responded may skew the estimation of the prevalence of the use of alternative medicine. However, a further analysis of our data by sites suggests that the estimated prevalence of the use of alternative medicine is unlikely to be related to the response rate: the four sites with similar rates of alternative medicine supplement use (44%, 41%, 41%, and 44%) had varying response rates (42%72%). Second, our study pertains only to the epidemiology of the use of alternative medicine by surgical patients. We did not follow the clinical course of patients to determine whether there are drug-herb interactions. Further prospectively designed studies will be necessary to address this issue.
Because most patients do not inform their primary care physicians or their anesthesiologists about the use of alternative medicine, physicians involved in the perioperative care of surgical patients must solicit this information prospectively as part of routine preoperative evaluation. In addition, counseling of patients regarding herb-drug interactions is important because many patients often mistakenly think of herbs as natural alternatives to prescription medications, failing to recognize that herbs contain bioactive elements, some of which may be unsafe and may have interactions with anesthetics and drugs.
In summary, this study demonstrates that the use of alternative medicine supplements, in particular herbal preparations, by surgical patients is prevalent. The awareness of this practice is important for health care providers who participate in the care of these patients. Documentation of the use of these products is critical to determine the potential of drug or anesthetic interactions in the perioperative period.
| Acknowledgments |
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The authors thank all participating nurses at the five study sites for assistance in distributing the questionnaires and the physicians for the initial study administrative planning.
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