All About Multiple Sclerosis

More MS news articles for September 2003

The use of complementary and alternative therapies by people with multiple sclerosis

http://www.hc-sc.gc.ca/pphb-dgspsp/publicat/cdic-mcc/24-2/e_e.html

Chronic Dis Can. 2003;24(2/3):75-79
Stacey A Page, Marja J Verhoef, Robert A Stebbins, Luanne M Metz and J Christopher Levy
Room 93, HMRB, Office of Medical Bioethics, University of Calgary, 3330 Hospital Drive NW, Calgary, Alberta, Canada, T2N 4N1; Fax: (403) 283-8524

Abstract

Complementary and alternative medicine (CAM) refers to therapeutic approaches not considered part of conventional medicine. A survey was mailed to sample of patients with multiple sclerosis (MS). The response rate was 440/673 (65%). Mean sample age was 48 years; 75% were female. Respondents ranged from mildly to severely impaired. Seventy percent used CAM primarily to improve health and manage the symptoms of MS. Most consumers reported positive effects. Lack of knowledge was the most common reason given for not using CAM. Patient education, physician-patient dialogue, and continued research and regulation of CAM are important to the well being of CAM consumers.

Introduction

Complementary and alternative medicine (CAM) refers to a broad range of health care products and practices that fall outside the Western biomedical paradigm. The popularity of CAM has been well documented, driven by such factors as the need for personal control, an increased interest in holism and an increasing prevalence of chronic disease.[1,2] Despite such widespread acceptance, the safety and efficacy of most CAM has not been clearly established. Nor is the practice of CAM uniformly regulated, leaving consumers with inconsistent standards of care.[3,4]

Multiple sclerosis is a recurrent inflammation of central nervous system white matter leading to myelin destruction and progressive neurological impairment. Conventional therapeutic approaches in multiple sclerosis (MS) focus on slowing disease progression and alleviating symptom experience. Although numerous pharmacological interventions are available, their effectiveness and tolerability vary across patients.[5]

Very few studies have described CAM use in MS and several among them are limited by small sample sizes and low response rates.[6–8] A broad range of therapies have been identified with the consumption of vitamins, herbs and special diets being more commonly used products, while chiropractic, acupuncture and massage are among the more commonly used practices.[6–9]

The present study describes CAM used by a large sample of adults with MS in southern Alberta, Canada.

Methods

Sample size determination: Calculations were based on estimating the proportion of MS patients who used complementary therapies to +/–5% with 95% confidence. Based on previous research, we conservatively estimated that CAM is used by 50% of MS patients.[7,8] To obtain our desired level of precision, a sample of approximately 390 people was needed. Allowing for a 50% response rate, 780 people were required for the survey.

Study population. The Calgary MS Clinic is the only source of neurological care for patients with MS in Southern Alberta (i.e., south of Red Deer). The MS clinic database was set up in 1993 and has captured all patients referred to the clinic since then. Referrals are made by physicians on the basis of known or suspected MS. At the time of sample selection, the clinic database contained information, including Expanded Disability Status Scale scores,[10] on 2,600 people. Based on a reported prevalence of MS in Alberta of 217/100,000[11] and a 1999 population of approximately 1.3 million in southern Alberta,[12] the expected number of cases is 2,821. The database therefore captured about 93% of all expected cases.

Patients for whom an address was not known, those known to be deceased, and those who had not given blanket consent to be approached for research projects were dropped from the database. Exclusion criteria defined by the researchers were people under 18 years of age and those whose diagnosis was possible or probable MS (vs. clinically definite and lab-supported MS). After these exclusions, a sampling frame of 1,335 remained. The database was then stratified by impairment level derived from the EDSS score yielding the distribution shown in Table 1. All people described as very severely impaired were included in the final sample as were the nine people for whom a score was not recorded. The remaining 742 subjects required were systematically and equally drawn from the remaining three impairment levels resulting in a total sample of 780. The distribution of the study sample is also illustrated in Table 1.

Procedure. A covering letter, questionnaire and postage-paid return envelope were distributed by mail in June 2000. A postcard reminder was sent out four weeks later.

Questionnaire. Complementary therapies were defined both in the covering letter and within the questionnaire as “those therapies or remedies not part of mainstream or regular medicine”. Data pertaining to CAM use were collected using a self-report questionnaire developed for the purpose of the study.

The development of the questionnaire was guided by other investigations that examined the use of CAM generally[13–15] and those that examined the use of CAM by people with MS.[7,9] The Expanded Disability Status Scale was included within the questionnaire.[10]

Experts in the respective areas of questionnaire construction, CAM and MS, reviewed the questionnaire at different stages of development. In addition, five outpatients from the MS Clinic volunteered to review the questionnaire in response to a poster requesting assistance. These individuals were asked if they found that the questions were clear and easy to answer. They were also asked for their opinion on the structure and content of the questionnaire. The comments provided by these reviewers were all different, revealing no systematic problem with the questionnaire. Their suggestions were useful and enhanced certain items by expanding response options and clarifying wording. Finally, the revised questionnaire was pilot-tested on a small sample of people drawn from the clinic database (n = 20). These people were asked both to complete the questionnaire and to answer a one-page form evaluating the questionnaire itself. Eight people completed the questionnaire review. No problems were identified with respect to the length of time required to complete the questionnaire or the clarity of the questions. No items were identified as causing difficulty in responding.

The final questionnaire contained 70 items. The response format included a combination of closed-ended and short answer options. Questions addressed demographic factors, disease factors and CAM use. To assess CAM use, people were asked to study a list containing the names of therapies and place checkmarks against any they had used specifically for their MS within the past two years. This list contained a broad range of CAMs identified in the literature and through questioning staff in the MS clinic. In addition, subjects were asked to describe therapies they used that were not identified within the list. People were given the opportunity to provide general comments on CAM. A subsection of the questionnaire dealt specifically with cannabis use. These results are reported elsewhere.[16]

Analyses. Data were entered into STATA 6.[17] Descriptive statistics were used to summarize responses. Multiple logistic regression was used to identify factors associated with CAM use (alpha = 0.05). Variables considered in this model were standard demographic characteristics (age, marital status, education, income) as well as characteristics related to MS (pattern of MS, disability level, time since diagnosis, use of conventional medication, comorbidities). As sex can act as an effect modifier, interaction terms were created between this variable and age, income, education, disability, medication use, comorbidities and pattern of MS. All variables and interaction terms were entered into the model. Backwards, stepwise regression was performed with the resulting models evaluated using the likelihood ratio chi-square test. The interaction terms were evaluated first followed by the predictor variables in order of decreasing magnitude of the p-value.

The study was approved by the Conjoint Health Research Ethics Board at the University of Calgary.

Results

Sample: Of the 780 surveys mailed, 107 were undeliverable (e.g., subjects moved, deceased). Four hundred and forty completed questionnaires were received (response rate 440/673 = 65%). Seventy-five percent of respondents were female, a slightly greater proportion than in the general MS population. Mean age was 48 years (standard deviation [SD] = 10.9). Most people were married or in common-law relationships (73%). The majority had at least high school education (94%). Close to one-third were working either full- (22%) or part-time (8%). Median family income was in the range of $40–$49,000.00.
 
TABLE 1
Distribution of sampling frame and study sample 
Impairment level 
(EDSS scores) 
Sampling frame (n
Study sample (n
No recorded score 
    9 
  9 
None-mild impairment
(EDSS 0–2.5) 
  545 
240 
Moderate impairment
(EDSS 3.0–5.5) 
  367 
241 
Severe impairment
(EDSS 6.0–8.0) 
  365 
241 
Very severe impairment
(EDSS 8.5–9.5) 
   49 
 49 
Total 
1,335 
780

Disease characteristics: Mean age of disease onset was 31 (SD = 9.5), with mean age at diagnosis 36 (SD = 9.4). Forty-four percent described their pattern of MS as relapsing-remitting, 23% as secondary progressive, 10% as primary progressive and 4% as progressive relapsing (19% unknown). The degree of disability experienced ranged from mild (8%), through moderate (47%), severe (38%) and very severe (7%). One third of the sample reported having a comorbidity. Conventional medications were used by 60% of respondents for treatment of MS-related symptoms.

CAM use: Seventy percent of respondents had used CAM within the past two years (n = 309/440: 95% CI = 66–75%). Over 100 different practices and products were described. Just over one third of respondents (n = 110, 37%) reported visiting a complementary practitioner and 11 different types of practitioners were accessed.

Twenty therapies and three types of practitioners were used by at least 10% of CAM consumers (Table 2). The median number of therapies an individual consumer reported using was 7 (inter-quartile range [IQR] = 5–12).

Vitamins and minerals were the most frequently reported category of products used with 79% of CAM consumers taking some combination of them. It could be argued that these products are not necessarily complementary or alternative. Excluding people who only used vitamins and minerals reduced the proportion reporting CAM use marginally from 70% to 68%. This difference was not statistically significant. Similarly, the use of traditional medical systems may overlap with individual practices and products (e.g., Traditional Chinese Medicine and acupuncture, herbal remedies) and could inflate the estimate of CAM use. Excluding those people who only used traditional medical systems reduced the number reporting CAM use from 309 to 308. This difference was not statistically significant. Vitamins/minerals and traditional medical systems were therefore retained in subsequent analyses.

Although a small number of people reported experiencing negative effects from CAM (5%), the vast majority perceived positive effects (72%). Therapies most often cited as beneficial were massage therapy, acupuncture and cannabis. The most common reasons for using CAM were to improve health (68%), to lessen the symptoms of MS (61%) and a belief that it couldn’t hurt (55%). Reasons most frequently endorsed for not using CAM were lack of knowledge about these therapies (42%) and satisfaction with the care provided by conventional practitioners (20%).

Information on CAM was obtained most commonly from the media (50%), or from family/friends (50%). The median amount of money spent on CAM in the past three months was $100.00 (IQR = 45.00–$300.00).

The majority of people indicated that their general practitioners and neurologists knew of their CAM use (77% and 62% respectively). Most indicated they had volunteered this information to their physicians, rather than being asked about it.

CAM consumers were not distinguished by age, marital status, education, income, disability level, pattern of MS, time since diagnosis or use of conventional medication. However, sex and income interacted to predict CAM use. Specifically, men with higher income were less likely to use CAM (OR = 0.19; CI = 0.065–0.54: p = 0.002). Among women, income was unrelated to CAM use (OR = 0.69; CI = 0.39–1.21: p = 0.20).

Discussion

The proportion of respondents with MS indicating they had used CAM within the past two years (70%) was higher that those found in two earlier surveys (64% and 55%) that examined CAM use by this group.[7,8] This variation could be due to a number of factors including the increasing popularity of CAM, differences in the definition and measurement of CAM or differences in the populations surveyed.

The use of CAM by the general public has increased steadily since the 1950s and the evidence suggests this trend will continue in the foreseeable future.[18] This has been illustrated by a number of surveys conducted in Canada. Studies conducted in the early 1990s suggested that 20–22% of Canadians had used CAM.[19,20] An Angus Reid Group survey, conducted in 1997, reported that 42% of its respondents had used alternative medicines and practices. In 1999, the Fraser Institute reported 50% had used CAM.[21] Focusing specifically on CAM practitioner use, data from the Canadian National Population Health Surveys conducted in 1994/95, 1996/97 and 1998/99 demonstrated steady increases in the proportion of Canadians consulting CAM practitioners (15%, 16% and 17% respectively).[2]

In addition to the passage of time, the relatively high prevalence of CAM use by this study sample likely reflects the fact that the participants have a chronic illness. CAM usage among the chronically ill tends to be higher than in the general population.[22,23]

Problems comparing the results of utilization surveys have been recognized. In particular, differing definitions of CAM (e.g., named therapies vs. open-ended questions) and differences in the time periods of use addressed (e.g., used in last six months vs. lifetime use) contribute to considerable variation in the prevalence of use reported.[24]

The sampling frame for this study consisted of those who had already given blanket consent to be approached for research. This group of patients may therefore be more open to trying new therapies or seeking out other therapeutic options, which may have resulted in an inflated estimate of CAM use for this patient group.

Although a substantial proportion of people in this survey reported their physicians knew of their CAM use, this tended to be due to the patient having volunteered the information. Conventional practitioners should be aware that many people with MS are using CAM and should initiate dialogue with their patients about CAM use. Where possible, health care professionals should be conversant with therapies commonly accessed by this patient group to help patients make informed, safe and appropriate choices, and to monitor patients using CAM. The current practice of the MS Clinic at Foothills hospital, for example, is to discourage people receiving interferon beta (Betaseron®) from consuming CAM products that could potentially affect the liver as interferon beta has been associated with serious liver dysfunction. While it is impractical to expect health professionals to be knowledgeable about all forms of CAM, the principles of evidence-based medicine can be applied to CAM as in any other area of practice.

Slightly over one third of respondents had visited a complementary practitioner; this is consistent with previous research.[9] It is interesting to note that while 30% of CAM users indicated they had received chiropractic treatment, only 20% reported seeing a chiropractor. Similar discrepancies are evident with CAM users receiving massage (43% vs. visiting a massage therapist 19%) and acupuncture (22% vs. visiting an acupuncturist 12%). This discrepancy raises two issues. First, it emphasizes the need for researchers to be clear in how they measure and report the use of CAM. Second, it suggests that chiropractic, massage and acupuncture services are being provided by a variety of practitioners. Some practitioners may be trained in a variety of disciplines — for example, Doctors of Traditional Chinese Medicine practice acupuncture and naturopaths may provide massage therapy. This discrepancy does, however raise the possibility that interventions are being provided by those whose scope of practice does not include the given treatment. Chiropractors, for example, are regulated by statute across Canada and the practice of this discipline is limited by law to those licensed by the profession.[25] Health care professionals and consumers need to be aware of practice standards to guide their use of CAM practitioners. Public interests will be further safeguarded by the continued development of regulatory bodies for CAM practitioners in disciplines of proven efficacy. Although some are well regulated by professional member organizations either by statute or voluntarily (e.g., chiropractors, naturopaths, massage therapists), others lack coordinated forms of representation. The establishment of regulatory bodies for CAM practitioners will help to ensure educational consistency and professional practice standards.

Many people appeared to operate under the assumption that CAM is not harmful and the belief that CAMs "couldn't hurt" was a factor motivating use for a substantial proportion of respondents. Moreover, as indicated by respondents, information on CAMs is obtained primarily from the media or from family/friends. Public education initiatives on the known risks and benefits of therapies and products available will help consumers to make informed decisions.

CAM has frequently been criticized for a lack of evidence on its safety and efficacy. The conclusions of most utilization studies of CAM include calls for rigorous research of these approaches and the current study is no exception. There are very few studies assessing the safety and efficacy of any CAM in MS.[26] This study has identified specific CAM practices and products used most often by respondents and this information may be used to set research priorities for evaluation of CAMs in this patient group.

The results of this study demonstrate that people with MS are likely to be using some type of CAM. The interests of CAM consumers with MS will be well served by dialogue between conventional health care practitioners and patients, public education and continued research and regulation of these products and practices.
 
TABLE 2
Products, practices and practitioners used by >10% of CAM consumers 
CAM product/practice 
n (%) 
Vitamins/minerals   
Multivitamins 
187 (61%) 
Vitamin C 
148 (48%) 
Vitamin E 
122 (40%) 
B vitamins 
118 (38%) 
Magnesium 
 73 (24%) 
Selenium 
 57 (19%) 
Zinc 
 55 (18%) 
Vitamin A 
 49 (16%) 
Body therapies   
Massage 
133 (43%) 
Chiropractic 
 92 (30%) 
Reflexology 
 44 (14%) 
Natural/herbal therapies   
Garlic 
 51 (17%) 
Gingko biloba 
 47 (15%) 
Ginseng 
 46 (15%) 
Cannabis 
 45 (15%) 
Aroma therapy 
 30 (10%) 
Mind/body therapies   
Relaxation/meditation 
 74 (24%) 
Yoga 
 51 (17%) 
Music therapy 
 30 (10%) 
Imagery/visualization 
 31 (10%) 
Spiritual therapies   
Prayer 
112 (36%) 
Nutritional therapies   
Evening primrose oil 
130 (42%) 
Nutritional supplements (e.g., Matol®, Shaklee®, Mannatech® 
 56 (18%) 
Energy therapies   
Acupuncture 
 68 (22%) 
Magnetic therapy 
 37 (12%) 
Other therapies   
Removal of mercury amalgams 
 43 (14%) 
Traditional medical system 
Traditional Chinese Medicine 
 37 (12%) 
Practitioners   
Chiropractor 
 61 (20%) 
Massage therapist 
 59 (19%) 
Acupuncturist 
 36 (12%) 

Acknowledgements

The time and effort of all respondents is gratefully acknowledged. The Multiple Sclerosis Society of Canada provided funding for this study

References

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Author References 

Stacey A Page, Office of Medical Bioethics, University of Calgary, Alberta, Canada

Marja J Verhoef, Department of Community Health Sciences, University of Calgary, Alberta, Canada

Robert A Stebbins, Department of Sociology, University of Calgary, Alberta, Canada

Luanne M Metz, Department of Clinical Neurosciences, University of Calgary, Alberta, Canada

J Christopher Levy, Faculty of Law, University of Calgary, Alberta, Canada

Correspondence: Stacey A Page, Room 93, HMRB, Office of Medical Bioethics, University of Calgary, 3330 Hospital Drive NW, Calgary, Alberta, Canada, T2N 4N1 Fax: (403) 283-8524;
 

Copyright © 2003, Health Canada