- Email: [email protected]
Use of Complementary and Alternative Medical Therapies by Patients Referred to a Fibromyalgia Treatment Program at a Tertiary Care Center
ORIGINAL ARTICLE
CAM THERAPIES FOR PATIENTS WITH FIBROMYALGIA
Use of Complementary and Alternative Medical Therapies by Patients Referred to a Fibromyalgia Treatment Program at a Tertiary Care Center DIETLIND L. WAHNER-ROEDLER, MD; PETER L. ELKIN, MD; ANN VINCENT, MBBS, MD; JEFFREY M. THOMPSON, MD; TERRY H. OH, MD; LAURA L. LOEHRER; JAYAWANT N. MANDREKAR, PHD; AND BRENT A. BAUER, MD OBJECTIVE: To evaluate the frequency and pattern of complementary and alternative medicine (CAM) use in patients referred to a fibromyalgia treatment program at a tertiary care center. PATIENTS AND METHODS: Patients referred to the Mayo Fibromyalgia Treatment Program between February 2003 and July 2003 were invited on their initial visit to participate in a survey regarding CAM use during the previous 6 months. An 85-question survey that addressed different CAM domains was used. RESULTS: Of the 304 patients invited to participate, 289 (95%) completed the survey (263 women and 26 men). Ninety-eight percent of the patients had used some type of CAM therapy during the previous 6 months. The 10 most frequently used CAM treatments were exercise for a specific medical problem (48%), spiritual healing (prayers) (45%), massage therapy (44%), chiropractic treatments (37%), vitamin C (35%), vitamin E (31%), magnesium (29%), vitamin B complex (25%), green tea (24%), and weightloss programs (20%). CONCLUSION: CAM use is common in patients referred to a fibromyalgia treatment program.
distress. Single-modality treatments (eg, medications or physical therapy) for this syndrome have been of limited benefit,3 and many investigators have advocated multimodality treatment programs.4,5 The Mayo Fibromyalgia Treatment Program offers a 11/2-day multidisciplinary treatment program.6 Patients referred to a fibromyalgia treatment program at a tertiary care center are usually adversely affected by their symptoms, have been receiving care from various primary care physicians and rheumatologists, and can be expected to have a high rate of CAM use, as has been documented in patients with chronic rheumatologic diseases.7 The goal of this study was to evaluate the frequency and pattern of CAM use in patients referred to a fibromyalgia treatment program at a tertiary care center.
Mayo Clin Proc. 2005;80(1):55-60
PATIENTS AND METHODS
T
he use of complementary and alternative medicine (CAM) continues to increase in the United States. In a telephone survey conducted in 1991, 34% of respondents indicated using at least 1 CAM therapy during the past year1; in a similar survey conducted in 1997, the percentage of users had increased to 42%.2 Surveys have shown that CAM is used for the prevention of disease and the treatment of specific diseases.1 Physicians can anticipate frequent use of CAM for medical conditions that respond poorly or do not respond at all to conventional medicine. One such condition is fibromyalgia, a syndrome of unknown origin, characterized by chronic widespread pain, multiple tender points, and additional symptoms such as disturbed sleep, stiffness, fatigue, and psychological From the Department of Internal Medicine and Division of General Internal Medicine (D.L.W.-R., P.L.E., A.V., L.L.L., B.A.B.), Department of Physical Medicine and Rehabilitation (J.M.T., T.H.O.), and Department of Health Sciences Research (J.N.M.), Mayo Clinic College of Medicine, Rochester, Minn. Presented in part at the 27th World Congress of Internal Medicine, Granada, Spain, September 2004. Address reprint requests and correspondence to Dietlind L. Wahner-Roedler, MD, Division of General Internal Medicine, Mayo Clinic College of Medicine, 200 First St SW, Rochester, MN 55905 (e-mail: wahnerroedler.dietlind @mayo.edu). © 2005 Mayo Foundation for Medical Education and Research
Mayo Clin Proc.
•
This study was approved by the Mayo Foundation Institutional Review Board. Consecutive patients referred to the Mayo Fibromyalgia Treatment Program between February 2003 and July 2003 were approached in person and asked to complete a survey about their use of CAM therapies. The Mayo Fibromyalgia Treatment Program is staffed parttime by 3 physicians of the Department of Physical Medicine and Rehabilitation and 2 rheumatologists (approximately 0.1 full-time equivalent each). Access to this program is limited to Mayo physician–referred patients with a presumed diagnosis of fibromyalgia. Details regarding this multidisciplinary program have been described previously.6 After informed consent was obtained at the time of the initial Mayo Fibromyalgia Treatment Program appointment, the survey was administered by a registered nurse who remained available for questions. The nurse collected the completed surveys. SURVEY INSTRUMENT A survey was designed to determine the use of CAM therapies during the previous 6 months. The questions addressed the 5 domains outlined by the National Center for Complementary and Alternative Medicine (alternative medical systems, mind-body interventions, biologically
January 2005;80(1):55-60
•
www.mayoclinicproceedings.com
55
CAM THERAPIES FOR PATIENTS WITH FIBROMYALGIA
TABLE 1. Treatments and Techniques Used by Patients Referred to a Fibromyalgia Treatment Program, by Age Group* Age group (y) Treatments and techniques
18-24 (n=14)
25-34 (n=19)
35-44 (n=71)
45-54 (n=103)
55-64 (n=44)
65-74 (n=24)
≥75 (n=14)
All ages (N=289)
Exercise for a specific problem Spiritual healing (prayers) Massage therapy Chiropractic treatment Weight-loss programs Relaxation therapy Aromatherapy Music therapy Acupuncture Self-help (support groups) Homeopathy Acupressure Magnet or magnetic therapies Reflexology Energy healing Biofeedback Art therapy Others At least 1 treatment or technique
50 43 64 64 14 14 21 0 7 0 0 14 7 7 0 29 0 0 93
42 37 47 37 21 21 5 5 16 5 16 11 0 5 5 5 0 5 84
42 54 52 48 25 17 25 20 10 21 10 11 4 13 8 4 6 15 96
54 44 42 37 17 17 14 12 13 11 13 9 14 8 11 10 4 6 87
48 45 39 27 23 20 11 11 14 5 14 18 9 5 9 5 11 9 79
38 33 29 17 21 13 8 8 8 4 4 4 17 17 4 8 0 4 75
50 36 36 14 7 7 0 14 0 7 0 0 7 0 0 0 7 0 79
48 45 44 37 20 17 15 12 11 11 10 10 9 9 8 8 5 8 87
*Data are percentage of patients.
based therapies, manipulative and body-based therapies, and energy therapies) (http://nccam.nih.gov/health/whatiscam/). As per the National Center for Complementary and Alternative Medicines, we excluded the following dietary supplements that have been incorporated into conventional medicine: multiple vitamins with and without minerals, vitamin D, folic acid (folate), calcium, iron, and potassium. We included exercise, commercial diets, and self-help groups because these were included in the surveys by Eisenberg et al.1,2 For simplicity purposes, questions were arranged into the following 3 primary domains: treatments and techniques (21 questions), vitamins and minerals (12 questions), and herbs and other dietary supplements (52 questions). Space was provided after each category for patients to write in additional CAM therapies that they had used but were not listed. STATISTICAL ANALYSES Variables were described using summary statistics. Descriptive statistics (frequencies and proportions) were calculated to evaluate the frequency and pattern of CAM use in patients referred to a fibromyalgia treatment program at a tertiary care center. RESULTS TOTAL CAM USE Of the 304 patients invited to participate, 289 (95%) completed the survey. As expected from the prevalence of the disease (3.4% for women and 0.5% for men),8 most of the patients were women (263 women and 26 men). The mean 56
Mayo Clin Proc.
•
patient age was 48.8 years (range, 18-90 years). Ninetyeight percent of patients (97.7% of women and 100% of men) used some type of CAM therapy. The 10 most frequently used CAM therapies were exercise for a specific medical problem (48%), spiritual healing (prayers) (45%), massage therapy (44%), chiropractic treatments (37%), vitamin C (35%), vitamin E (31%), magnesium (29%), vitamin B complex (25%), green tea (24%), and weight-loss programs (20%). The total CAM use was 100% in all age groups except in the 45- to 54-year age group (95%) and the 75 years or older age group (93%). The median number of CAM modalities used was 8 (25th percentile, 5; 75th percentile, 13). CAM USE BY MODALITIES Treatments and Techniques. Eighty-seven percent of patients used 1 or more treatments and techniques. The median number of treatments and techniques used was 3 (25th percentile, 1; 75th percentile, 5). Treatments and techniques used by 5% or more of patients are given in Table 1. Treatments and techniques used by 1% to less than 5% of patients included craniosacral therapy, hypnosis, aquatic programs, and yoga. Exercise for a specific medical problem was the most frequently used modality, with its use being highest in the 45- to 54-year age group (54%). Vitamins and Minerals. Eighty-three percent of patients used 1 or more vitamins and minerals. The median number of vitamins and minerals used was 3 (25th percentile, 1; 75th percentile, 5). Vitamins and minerals used by 5% or more of patients are given in Table 2. Vitamin C was
January 2005;80(1):55-60
•
www.mayoclinicproceedings.com
CAM THERAPIES FOR PATIENTS WITH FIBROMYALGIA
TABLE 2. Vitamins and Minerals Used by Patients Referred to a Fibromyalgia Treatment Program, by Age Group* Age group (y) Vitamins and minerals
18-24 (n=14)
25-34 (n=19)
35-44 (n=71)
45-54 (n=103)
55-64 (n=44)
65-74 (n=24)
≥75 (n=14)
All ages (N=289)
Vitamin C Vitamin E Magnesium Vitamin B complex Zinc Megavitamin Chromium Selenium Vitamin A Beta carotene Others At least 1 vitamin or mineral
43 7 7 7 21 0 7 0 0 0 0 71
26 37 37 37 11 21 21 11 11 11 16 89
24 25 21 24 11 18 8 10 7 4 18 80
40 36 38 29 14 13 7 7 7 12 17 81
32 32 25 18 9 9 11 5 5 5 14 89
46 38 25 21 13 4 8 8 13 0 13 88
50 36 43 29 29 7 14 21 29 7 7 86
35 31 29 25 13 12 9 8 8 7 15 83
*Data are percentage of patients.
the most commonly used individual vitamin (35%) and magnesium the single most frequently used mineral (29%). The use of vitamin C was highest in patients in the 75 years or older age group (50%) and lowest in the 35- to 44-year age group (24%). The use of magnesium was highest in patients 75 years or older (43%) and lowest in patients 18 to 24 years (7%). Twelve percent of patients reported the use of megavitamins. Vitamins and minerals used by 1% to less than 5% of patients included choline, niacin, silver, and boron. Herbs and Other Dietary Supplements. Fifty-one percent of patients used 1 or more herbs and other dietary supplements. The median number of herbs and other dietary supplements used was 1 (25th percentile, 0; 75th percentile, 3). Supplements in this category used by 5% or more of patients are given in Table 3. The most frequently used herb and other dietary supplement was green tea (24%), which was used most frequently in the 35- to 44year age group (31%). Of note is the high use of echinacea (29%) in the 18- to 24-year age group. Supplements used by 1% to less than 5% of patients included black cohosh, lutein, St John’s wort, isoflavone, cayenne, bilberry, ephedra (ma huang), methylsulfonylmethane, goldenseal, senna, shark cartilage, feverfew, colostrum, cascara sagrada, malic acid, cat’s claw, pau d’arco, turmeric, creatine, hops, probiotics, kava, saw palmetto, 5-hydroxytryptophan, grape seed, burdock, don quai, stinging nettle, dandelion, flaxseed, kelp, melaleuca, and oregano. DISCUSSION Fibromyalgia represents an enigma to modern medicine, and the etiopathogenesis is far from elucidated. The treatment of patients with fibromyalgia is difficult, and no single treatment has been successful. Therefore, multimodality treatment programs have been developed. These Mayo Clin Proc.
•
programs usually include lifestyle modification and pharmacological interventions intended to relieve pain, improve sleep quality, and treat mood disorders.9 Because response to treatment is frequently poor, patients with fibromyalgia can be expected to be interested in a variety of CAM treatments. Patients seen in tertiary care centers are usually physician referred or have at least been evaluated by other physicians. By the nature of this type of practice, patients usually accept conventional medical treatments, and the use of CAM by these patients could be considered complementary rather than alternative. Therefore, in a strict sense, this study evaluated only the use of complementary therapies in patients referred to a fibromyalgia treatment program and not alternative therapies. Of note, the term CAM is in flux because therapies that have been proved to be safe and effective are often adopted into the armamentarium of conventional health care. Hence, a therapy that is considered CAM today may in fact be considered conventional once a sufficient degree of valid research is obtained. Because this is a dynamic process, differences exist regarding which therapies or treatments should be considered CAM at any point in time. In our survey, we included exercise for a specific problem, commercial diets, and self-help groups since these were included in surveys conducted by Eisenberg et al, although these modalities may be considered conventional at this time in most practices. We excluded the use of multiple vitamins with and without minerals, vitamin D, folic acid, calcium, iron, and potassium because these supplements are used frequently to address a conventional medical need or indication. Nonetheless, these supplements might be considered complementary in some practices. CAM therapies have become an important subject to rheumatologists and physiatrists because many patients try complementary treatments.10 Survey data have shown that
January 2005;80(1):55-60
•
www.mayoclinicproceedings.com
57
CAM THERAPIES FOR PATIENTS WITH FIBROMYALGIA
TABLE 3. Herbs and Other Dietary Supplements Used by Patients Referred to a Fibromyalgia Treatment Program, by Age Group* Age group (y) Herbs and dietary supplements
18-24 (n=14)
25-34 (n=19)
35-44 (n=71)
45-54 (n=103)
55-64 (n=44)
65-74 (n=24)
≥75 (n=14)
All ages (N=289)
Green tea Glucosamine Echinacea Chondroitin Flaxseed Acidophilus Coenzyme Q10 Fish oil (cod liver oil) Garlic Ginseng Psyllium Ginkgo biloba L-lysine Aloe Ginger Lecithin Valerian Melatonin Milk thistle Evening primrose oil Others At least 1 herb or other dietary supplement
14 7 29 0 0 7 7 14 0 14 14 0 7 0 7 0 14 14 0 7 21
11 16 11 11 16 21 16 5 11 11 5 11 11 5 11 11 11 11 5 0 16
31 11 17 13 14 14 8 13 13 11 8 10 3 11 8 4 7 6 6 7 27
27 17 14 12 11 14 15 11 8 7 7 5 7 6 3 5 4 4 4 4 20
20 23 9 14 23 11 11 11 7 7 9 5 2 0 5 5 2 2 5 2 14
8 33 13 29 17 8 13 4 4 4 8 8 8 4 0 4 4 0 8 4 8
21 29 14 21 0 7 7 14 21 0 0 14 7 0 7 7 0 7 0 7 14
24 18 14 13 13 13 12 11 9 8 8 7 6 6 5 5 5 5 5 5 19
64
37
54
50
52
50
43
51
*Data are percentage of patients.
many rehabilitation specialists endorse some form of CAM and believe in its usefulness11 and that most rheumatologists incorporate some CAM therapies into their professional practice through either direct patient care or referral to other providers.12 In a published survey mailed to a random sample of 2000 physician members of the American College of Rheumatologists, respondents were queried about their knowledge of 22 CAM therapies. Respondents reported knowing enough to discuss 10 of the therapies with patients, to consider 9 of the therapies to be part of legitimate medical practice, and to refer patients to someone else for 8 of the 22 therapies. When direct clinical use of the therapies was combined with referral, 9 of the 22 modalities had been used by more than 50% of the respondents, with counseling or psychotherapy (85%) and exercise (81%) at the top of the list. Alternatively, there were 9 therapies for which 75% of the sample reported no clinical use (meditation [24%], prayer and spiritual direction [23%], nonchiropractic manipulation [23%], hypnotherapy [19%], herbal medicine [14%], music therapy [9%], magnets [5%], energy healing [5%], and homeopathy [4%]). Interestingly, none of these modalities were considered part of legitimate medical practice by a substantial proportion of the sample, and as many as 50% of the respondents reported insufficient knowledge to discuss any of them with their patients. This is an important finding because 45% of our patients with fibromyalgia used spiritual heal58
Mayo Clin Proc.
•
ing, 12% used music therapy, 10% used homeopathy, 9% used magnets, and 8% used energy healing. The evidence for efficacy of nonherbal or supplement CAM treatments in patients with fibromyalgia was summarized recently.13 The systematic review concluded that the direction of evidence was “clearly positive” for the use of treatment with acupuncture and massage and “tentatively positive” for homeopathy. Exercise was the most frequently used modality by our patient population (48%). The evidence for use of exercise is mixed. Sim and Adams14 performed a systematic review of randomized controlled trials from 1980 to May 2000 of nonpharmacological interventions for fibromyalgia and concluded there was preliminary support of moderate benefit for aerobic xeercise. However, in a randomized trial performed in the Netherlands, no clear benefit from fitness training and biofeedback training was found compared with usual care.15 Magnetic therapies were used by 9% of our patients. A randomized, placebo-controlled, double-blind trial of static magnetic fields for fibromyalgia revealed no significant difference between groups that used real magnets and those that used sham magnets.16 In a review by Ernst13 regarding effectiveness of herbs and dietary supplements, the only herb or supplement mentioned for patients with fibromyalgia was capsaicin, with a tentatively positive direction of evidence.
January 2005;80(1):55-60
•
www.mayoclinicproceedings.com
CAM THERAPIES FOR PATIENTS WITH FIBROMYALGIA
In an open pilot study that evaluated the potential benefits of coenzyme Q10 (200 mg/d) combined with ginkgo biloba extract (200 mg/d) in patients with fibromyalgia, the authors reported a progressive improvement in quality-oflife scores and are now planning a controlled trial.17 Some beneficial effects have been reported with Sadenosylmethionine18 and 5-hydroxytryptophan19 in treating fibromyalgia. In reviewing the 10 top modalities used by our study population, it becomes apparent that many of these practices can be considered complementary to standard medical treatments. Use of exercise for a specific medical problem, spiritual healing (prayers), massage therapy, and chiropractic treatments are usually considered safe and helpful for several medical conditions, leading to improvement in quality of life. Many of the herbs and other dietary supplements used by our patients are known to have potential adverse effects and may pose a risk to the patient. Some of the concerns with the use of these supplements are adverse effects on coagulation (ginkgo biloba, garlic), cardiovascular function (ephedra), and cognition (valerian, kava, St John’s wort). Of particular concern to us was the use of ephedra by 9 patients and kava by 4 patients. Ephedra, also known as ma huang, is a sympathomimetic that has been associated with hypertension, palpitations, angina, myocardial infarction, cerebrovascular accidents, and seizures.20 Linked to more than 17 deaths, ephedra has pharmacokinetics similar to the anesthetic vasopressor ephedrine.21 Canada banned all sales of ephedra products in January 2002. In May 2003, legislation was signed that made Illinois the first state to ban the sale of ephedra. On February 6, 2004, the Food and Drug Administration published a final rule prohibiting the sale of dietary supplements that contained ephedra (the rule was effective 60 days after February 6, 2004). Our patients who used ephedra or kava had no documentation of such use in their medical records. Use of kava has been tentatively linked to liver damage, and the sale of kava has been banned from the market in Switzerland, Germany, Canada, Australia, and France. Several other countries are considering similar action.22 The Medicines Control Council of South Africa withdrew kava-containing products on the basis of accumulated worldwide evidence that such products pose a rare but serious risk of liver toxicity. Ginkgo biloba was used by 20 (7%) of our patients. Several reports of bleeding problems associated with longterm ginkgo use can be found in the literature, including postlaparoscopic cholecystectomy bleeding23 and spontaneous subdural hematoma.24 Intracerebral hemorrhage was noted when ginkgo biloba was combined with long-term use of warfarin.25 Mayo Clin Proc.
•
Twenty-five (9%) of our patients used garlic. Spontaneous epidural hematoma resulting in paraplegia26 and postoperative hemorrhage27 have been associated with excessive consumption of garlic. Barbiturates, hypnotics, benzodiazepines, and narcotics may have synergistic or unpredictable effects if combined with sedative herbal medicines that affect neurotransmitters.28 The long-term use of high-dose valerian has been linked to a possible postoperative benzodiazepine-like withdrawal reaction, resulting in cardiac failure and delirium during emergence from general anesthesia.29 A 54year-old man who combined the herb kava with cimetidine, terazosin hydrochloride, and alprazolam became semicomatose.30 The antidepressant botanical St John’s wort has been reported to cause excessive sedative effects if combined with narcotics.31 Botanical agents are often pharmacologically active, particularly with respect to liver metabolism. When a botanical decreases or increases the metabolism of a chemotherapeutic agent, increased toxicity or lowered efficacy may result. St John’s wort is the best known of several botanical treatments that induce enzymes in the cytochrome P-450 family,32 in particular CYP3A4. Thus, it is not surprising that several case reports have been published in which drug levels were significantly reduced by the coadministration of St John’s wort. These drugs include indinavir,33 digoxin,34 and cyclosporine.35 Although many of the potential adverse effects are based on isolated case reports, it is important to keep them in mind, particularly when there is no clear indication for using any of these supplements. An open patient-physician discussion about the potential usefulness and risks of CAM modalities is helpful. Because patients underreport the use of dietary supplements,36 they should be asked specifically about such use. Once physicians know their patients are using CAM therapies, they should relate which CAM modalities can be considered truly complementary and which modalities could possibly be harmful. CONCLUSION This study shows that CAM use is common among patients referred to a fibromyalgia treatment program at a tertiary care center. Because of the widespread and growing use of CAM, especially by patients with chronic illnesses, physicians and other health care practitioners must become familiar with the most frequently used CAM modalities in their patient population and openly discuss the risks and benefits of CAM practices with their patients. Truly complementary modalities should be integrated with mainstream medical therapies, whereas harmful or ineffective
January 2005;80(1):55-60
•
www.mayoclinicproceedings.com
59
CAM THERAPIES FOR PATIENTS WITH FIBROMYALGIA
treatments should become obsolete. More research is needed to determine the usefulness and potential adverse effects of many CAM modalities. We are grateful to Drs Mark C. Lee and Ralph E. Gay for their helpful suggestions in the preparation of the submitted manuscript.
REFERENCES 1. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR, Delbanco TL. Unconventional medicine in the United States: prevalence, costs, and patterns of use. N Engl J Med. 1993;328:246-252. 2. Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998;280:1569-1575. 3. White KP, Harth M. An analytical review of 24 controlled clinical trials for fibromyalgia syndrome (FMS). Pain. 1996;64:211-219. 4. Goldenberg DL. Fibromyalgia syndrome: an emerging but controversial condition. JAMA. 1987;257:2782-2787. 5. Bennett RM. Multidisciplinary group programs to treat fibromyalgia patients. Rheum Dis Clin North Am. 1996;22:351-367. 6. Pfeiffer A, Thompson JM, Nelson A, et al. Effects of a 1.5-day multidisciplinary outpatient treatment program for fibromyalgia: a pilot study. Am J Phys Med Rehabil. 2003;82:186-191. 7. Rao JK, Mihaliak K, Kroenke K, Bradley J, Tierney WM, Weinberger M. Use of complementary therapies for arthritis among patients of rheumatologists. Ann Intern Med. 1999;131:409-416. 8. Wolfe F, Ross K, Anderson J, Russell IJ, Hebert L. The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum. 1995;38:19-28. 9. Goldenberg DL. Fibromyalgia syndrome a decade later: what have we learned? Arch Intern Med. 1999;159:777-785. 10. Buchbinder R, Gingold M, Hall S, Cohen M. Non-prescription complementary treatments used by rheumatoid arthritis patients attending a community-based rheumatology practice. Intern Med J. 2002;32:208-214. 11. Schoenberger NE, Matheis RJ, Shiflett SC, Cotter AC. Opinions and practices of medical rehabilitation professionals regarding prayer and meditation. J Altern Complement Med. 2002;8:59-69. 12. Berman BM, Bausell RB, Lee WL. Use and referral patterns for 22 complementary and alternative medical therapies by members of the American College of Rheumatology: results of a national survey. Arch Intern Med. 2002; 162:766-770. 13. Ernst E. Complementary medicine. Curr Opin Rheumatol. 2003;15:151155. 14. Sim J, Adams N. Systematic review of randomized controlled trials of nonpharmacological interventions for fibromyalgia. Clin J Pain. 2002;18:324336. 15. van Santen M, Bolwijn P, Verstappen F, et al. A randomized clinical trial comparing fitness and biofeedback training versus basic treatment in patients with fibromyalgia. J Rheumatol. 2002;29:575-581. 16. Alfano AP, Taylor AG, Foresman PA, et al. Static magnetic fields for treatment of fibromyalgia: a randomized controlled trial. J Altern Complement Med. 2001;7:53-64.
60
Mayo Clin Proc.
•
17. Lister RE. An open, pilot study to evaluate the potential benefits of coenzyme Q10 combined with Ginkgo biloba extract in fibromyalgia syndrome. J Int Med Res. 2002;30:195-199. 18. Jacobsen S, Danneskiold-Samsoe B, Andersen RB. Oral S-adenosylmethionine in primary fibromyalgia: double-blind clinical evaluation. Scand J Rheumatol. 1991;20:294-302. 19. Caruso I, Sarzi Puttini P, Cazzola M, Azzolini V. Double-blind study of 5-hydroxytryptophan versus placebo in the treatment of primary fibromyalgia syndrome. J Int Med Res. 1990;18:201-209. 20. Haller CA, Benowitz NL. Adverse cardiovascular and central nervous system events associated with dietary supplements containing ephedra alkaloids. N Engl J Med. 2000;343:1833-1838. 21. Gurley BJ, Wang P, Gardner SF. Ephedrine-type alkaloid content of nutritional supplements containing Ephedra sinica (Ma-huang) as determined by high performance liquid chromatography. J Pharm Sci. 1998;87:15471553. 22. Shaver K. Liver toxicity with kava. Prescrib Lett. January 2001;18:1-3. Available at: http://www.naturaldatabase.com. Accessibility verified December 1, 2004. 23. Fessenden JM, Wittenborn W, Clarke L. Gingko biloba: a case report of herbal medicine and bleeding postoperatively from a laparoscopic cholecystectomy. Am Surg. 2001;67:33-35. 24. Rowin J, Lewis SL. Spontaneous bilateral subdural hematomas associated with chronic Gingko biloba ingestion. Neurology. 1996;46:1775-1776. 25. Matthews MK Jr. Association of Gingko biloba with intracerebral hemorrhage [letter]. Neurology. 1998;50:1933-1934. 26. Rose KD, Croissant PD, Parliament CF, Levin MB. Spontaneous spinal epidural hematoma with associated platelet dysfunction from excessive garlic ingestion: a case report. Neurosurgery. 1990;26:880-882. 27. Burnham BE. Garlic as a possible risk for postoperative bleeding [letter]. Plast Reconstr Surg. 1995;95:213. 28. Norred CL, Zamudio S, Palmer SK. Use of complementary and alternative medicines by surgical patients. AANA J. 2000;68:13-18. 29. Garges HP, Varia I, Doraiswamy PM. Cardiac complications and delirium associated with valerian root withdrawal. JAMA. 1998;280:1566-1567. 30. Almeida JC, Grimsley EW. Coma from the health food store: interaction between kava and alprazolam [letter]. Ann Intern Med. 1996;125:940-941. 31. Simmen U, Burkard W, Berger K, Schaffner W, Lundstrom K. Extracts and constituents of Hypericum perforatum inhibit the binding of various ligands to recombinant receptors expressed with the Semliki Forest virus system. J Recept Signal Transduct Res. 1999;19:59-74. 32. Budzinski JW, Foster BC, Vandenhoek S, Arnason JT. An in vitro evaluation of human cytochrome P450 3A4 inhibition by selected commercial herbal extracts and tinctures. Phytomedicine. 2000;7:273-282. 33. Piscitelli SC, Burstein AH, Chaitt D, Alfaro RM, Falloon J. Indinavir concentrations and St John’s wort [published correction appears in Lancet. 2001;357:1210]. Lancet. 2000;355:547-548. 34. Johne A, Brockmoller J, Bauer S, Maurer A, Langheinrich M, Roots I. Pharmacokinetic interaction of digoxin with an herbal extract from St John’s wort (Hypericum perforatum). Clin Pharmacol Ther. 1999;66:338-345. 35. Ruschitzka F, Meier PJ, Turina M, Lüscher TF, Noll G. Acute heart transplant rejection due to Saint John’s wort [letter]. Lancet. 2000;355:548549. 36. Hensrud DD, Engle DD, Scheitel SM. Underreporting the use of dietary supplements and nonprescription medications among patients undergoing a periodic health examination. Mayo Clin Proc. 1999;74:443-447.
January 2005;80(1):55-60
•
www.mayoclinicproceedings.com
CAM THERAPIES FOR PATIENTS WITH FIBROMYALGIA
Use of Complementary and Alternative Medical Therapies by Patients Referred to a Fibromyalgia Treatment Program at a Tertiary Care Center DIETLIND L. WAHNER-ROEDLER, MD; PETER L. ELKIN, MD; ANN VINCENT, MBBS, MD; JEFFREY M. THOMPSON, MD; TERRY H. OH, MD; LAURA L. LOEHRER; JAYAWANT N. MANDREKAR, PHD; AND BRENT A. BAUER, MD OBJECTIVE: To evaluate the frequency and pattern of complementary and alternative medicine (CAM) use in patients referred to a fibromyalgia treatment program at a tertiary care center. PATIENTS AND METHODS: Patients referred to the Mayo Fibromyalgia Treatment Program between February 2003 and July 2003 were invited on their initial visit to participate in a survey regarding CAM use during the previous 6 months. An 85-question survey that addressed different CAM domains was used. RESULTS: Of the 304 patients invited to participate, 289 (95%) completed the survey (263 women and 26 men). Ninety-eight percent of the patients had used some type of CAM therapy during the previous 6 months. The 10 most frequently used CAM treatments were exercise for a specific medical problem (48%), spiritual healing (prayers) (45%), massage therapy (44%), chiropractic treatments (37%), vitamin C (35%), vitamin E (31%), magnesium (29%), vitamin B complex (25%), green tea (24%), and weightloss programs (20%). CONCLUSION: CAM use is common in patients referred to a fibromyalgia treatment program.
distress. Single-modality treatments (eg, medications or physical therapy) for this syndrome have been of limited benefit,3 and many investigators have advocated multimodality treatment programs.4,5 The Mayo Fibromyalgia Treatment Program offers a 11/2-day multidisciplinary treatment program.6 Patients referred to a fibromyalgia treatment program at a tertiary care center are usually adversely affected by their symptoms, have been receiving care from various primary care physicians and rheumatologists, and can be expected to have a high rate of CAM use, as has been documented in patients with chronic rheumatologic diseases.7 The goal of this study was to evaluate the frequency and pattern of CAM use in patients referred to a fibromyalgia treatment program at a tertiary care center.
Mayo Clin Proc. 2005;80(1):55-60
PATIENTS AND METHODS
T
he use of complementary and alternative medicine (CAM) continues to increase in the United States. In a telephone survey conducted in 1991, 34% of respondents indicated using at least 1 CAM therapy during the past year1; in a similar survey conducted in 1997, the percentage of users had increased to 42%.2 Surveys have shown that CAM is used for the prevention of disease and the treatment of specific diseases.1 Physicians can anticipate frequent use of CAM for medical conditions that respond poorly or do not respond at all to conventional medicine. One such condition is fibromyalgia, a syndrome of unknown origin, characterized by chronic widespread pain, multiple tender points, and additional symptoms such as disturbed sleep, stiffness, fatigue, and psychological From the Department of Internal Medicine and Division of General Internal Medicine (D.L.W.-R., P.L.E., A.V., L.L.L., B.A.B.), Department of Physical Medicine and Rehabilitation (J.M.T., T.H.O.), and Department of Health Sciences Research (J.N.M.), Mayo Clinic College of Medicine, Rochester, Minn. Presented in part at the 27th World Congress of Internal Medicine, Granada, Spain, September 2004. Address reprint requests and correspondence to Dietlind L. Wahner-Roedler, MD, Division of General Internal Medicine, Mayo Clinic College of Medicine, 200 First St SW, Rochester, MN 55905 (e-mail: wahnerroedler.dietlind @mayo.edu). © 2005 Mayo Foundation for Medical Education and Research
Mayo Clin Proc.
•
This study was approved by the Mayo Foundation Institutional Review Board. Consecutive patients referred to the Mayo Fibromyalgia Treatment Program between February 2003 and July 2003 were approached in person and asked to complete a survey about their use of CAM therapies. The Mayo Fibromyalgia Treatment Program is staffed parttime by 3 physicians of the Department of Physical Medicine and Rehabilitation and 2 rheumatologists (approximately 0.1 full-time equivalent each). Access to this program is limited to Mayo physician–referred patients with a presumed diagnosis of fibromyalgia. Details regarding this multidisciplinary program have been described previously.6 After informed consent was obtained at the time of the initial Mayo Fibromyalgia Treatment Program appointment, the survey was administered by a registered nurse who remained available for questions. The nurse collected the completed surveys. SURVEY INSTRUMENT A survey was designed to determine the use of CAM therapies during the previous 6 months. The questions addressed the 5 domains outlined by the National Center for Complementary and Alternative Medicine (alternative medical systems, mind-body interventions, biologically
January 2005;80(1):55-60
•
www.mayoclinicproceedings.com
55
CAM THERAPIES FOR PATIENTS WITH FIBROMYALGIA
TABLE 1. Treatments and Techniques Used by Patients Referred to a Fibromyalgia Treatment Program, by Age Group* Age group (y) Treatments and techniques
18-24 (n=14)
25-34 (n=19)
35-44 (n=71)
45-54 (n=103)
55-64 (n=44)
65-74 (n=24)
≥75 (n=14)
All ages (N=289)
Exercise for a specific problem Spiritual healing (prayers) Massage therapy Chiropractic treatment Weight-loss programs Relaxation therapy Aromatherapy Music therapy Acupuncture Self-help (support groups) Homeopathy Acupressure Magnet or magnetic therapies Reflexology Energy healing Biofeedback Art therapy Others At least 1 treatment or technique
50 43 64 64 14 14 21 0 7 0 0 14 7 7 0 29 0 0 93
42 37 47 37 21 21 5 5 16 5 16 11 0 5 5 5 0 5 84
42 54 52 48 25 17 25 20 10 21 10 11 4 13 8 4 6 15 96
54 44 42 37 17 17 14 12 13 11 13 9 14 8 11 10 4 6 87
48 45 39 27 23 20 11 11 14 5 14 18 9 5 9 5 11 9 79
38 33 29 17 21 13 8 8 8 4 4 4 17 17 4 8 0 4 75
50 36 36 14 7 7 0 14 0 7 0 0 7 0 0 0 7 0 79
48 45 44 37 20 17 15 12 11 11 10 10 9 9 8 8 5 8 87
*Data are percentage of patients.
based therapies, manipulative and body-based therapies, and energy therapies) (http://nccam.nih.gov/health/whatiscam/). As per the National Center for Complementary and Alternative Medicines, we excluded the following dietary supplements that have been incorporated into conventional medicine: multiple vitamins with and without minerals, vitamin D, folic acid (folate), calcium, iron, and potassium. We included exercise, commercial diets, and self-help groups because these were included in the surveys by Eisenberg et al.1,2 For simplicity purposes, questions were arranged into the following 3 primary domains: treatments and techniques (21 questions), vitamins and minerals (12 questions), and herbs and other dietary supplements (52 questions). Space was provided after each category for patients to write in additional CAM therapies that they had used but were not listed. STATISTICAL ANALYSES Variables were described using summary statistics. Descriptive statistics (frequencies and proportions) were calculated to evaluate the frequency and pattern of CAM use in patients referred to a fibromyalgia treatment program at a tertiary care center. RESULTS TOTAL CAM USE Of the 304 patients invited to participate, 289 (95%) completed the survey. As expected from the prevalence of the disease (3.4% for women and 0.5% for men),8 most of the patients were women (263 women and 26 men). The mean 56
Mayo Clin Proc.
•
patient age was 48.8 years (range, 18-90 years). Ninetyeight percent of patients (97.7% of women and 100% of men) used some type of CAM therapy. The 10 most frequently used CAM therapies were exercise for a specific medical problem (48%), spiritual healing (prayers) (45%), massage therapy (44%), chiropractic treatments (37%), vitamin C (35%), vitamin E (31%), magnesium (29%), vitamin B complex (25%), green tea (24%), and weight-loss programs (20%). The total CAM use was 100% in all age groups except in the 45- to 54-year age group (95%) and the 75 years or older age group (93%). The median number of CAM modalities used was 8 (25th percentile, 5; 75th percentile, 13). CAM USE BY MODALITIES Treatments and Techniques. Eighty-seven percent of patients used 1 or more treatments and techniques. The median number of treatments and techniques used was 3 (25th percentile, 1; 75th percentile, 5). Treatments and techniques used by 5% or more of patients are given in Table 1. Treatments and techniques used by 1% to less than 5% of patients included craniosacral therapy, hypnosis, aquatic programs, and yoga. Exercise for a specific medical problem was the most frequently used modality, with its use being highest in the 45- to 54-year age group (54%). Vitamins and Minerals. Eighty-three percent of patients used 1 or more vitamins and minerals. The median number of vitamins and minerals used was 3 (25th percentile, 1; 75th percentile, 5). Vitamins and minerals used by 5% or more of patients are given in Table 2. Vitamin C was
January 2005;80(1):55-60
•
www.mayoclinicproceedings.com
CAM THERAPIES FOR PATIENTS WITH FIBROMYALGIA
TABLE 2. Vitamins and Minerals Used by Patients Referred to a Fibromyalgia Treatment Program, by Age Group* Age group (y) Vitamins and minerals
18-24 (n=14)
25-34 (n=19)
35-44 (n=71)
45-54 (n=103)
55-64 (n=44)
65-74 (n=24)
≥75 (n=14)
All ages (N=289)
Vitamin C Vitamin E Magnesium Vitamin B complex Zinc Megavitamin Chromium Selenium Vitamin A Beta carotene Others At least 1 vitamin or mineral
43 7 7 7 21 0 7 0 0 0 0 71
26 37 37 37 11 21 21 11 11 11 16 89
24 25 21 24 11 18 8 10 7 4 18 80
40 36 38 29 14 13 7 7 7 12 17 81
32 32 25 18 9 9 11 5 5 5 14 89
46 38 25 21 13 4 8 8 13 0 13 88
50 36 43 29 29 7 14 21 29 7 7 86
35 31 29 25 13 12 9 8 8 7 15 83
*Data are percentage of patients.
the most commonly used individual vitamin (35%) and magnesium the single most frequently used mineral (29%). The use of vitamin C was highest in patients in the 75 years or older age group (50%) and lowest in the 35- to 44-year age group (24%). The use of magnesium was highest in patients 75 years or older (43%) and lowest in patients 18 to 24 years (7%). Twelve percent of patients reported the use of megavitamins. Vitamins and minerals used by 1% to less than 5% of patients included choline, niacin, silver, and boron. Herbs and Other Dietary Supplements. Fifty-one percent of patients used 1 or more herbs and other dietary supplements. The median number of herbs and other dietary supplements used was 1 (25th percentile, 0; 75th percentile, 3). Supplements in this category used by 5% or more of patients are given in Table 3. The most frequently used herb and other dietary supplement was green tea (24%), which was used most frequently in the 35- to 44year age group (31%). Of note is the high use of echinacea (29%) in the 18- to 24-year age group. Supplements used by 1% to less than 5% of patients included black cohosh, lutein, St John’s wort, isoflavone, cayenne, bilberry, ephedra (ma huang), methylsulfonylmethane, goldenseal, senna, shark cartilage, feverfew, colostrum, cascara sagrada, malic acid, cat’s claw, pau d’arco, turmeric, creatine, hops, probiotics, kava, saw palmetto, 5-hydroxytryptophan, grape seed, burdock, don quai, stinging nettle, dandelion, flaxseed, kelp, melaleuca, and oregano. DISCUSSION Fibromyalgia represents an enigma to modern medicine, and the etiopathogenesis is far from elucidated. The treatment of patients with fibromyalgia is difficult, and no single treatment has been successful. Therefore, multimodality treatment programs have been developed. These Mayo Clin Proc.
•
programs usually include lifestyle modification and pharmacological interventions intended to relieve pain, improve sleep quality, and treat mood disorders.9 Because response to treatment is frequently poor, patients with fibromyalgia can be expected to be interested in a variety of CAM treatments. Patients seen in tertiary care centers are usually physician referred or have at least been evaluated by other physicians. By the nature of this type of practice, patients usually accept conventional medical treatments, and the use of CAM by these patients could be considered complementary rather than alternative. Therefore, in a strict sense, this study evaluated only the use of complementary therapies in patients referred to a fibromyalgia treatment program and not alternative therapies. Of note, the term CAM is in flux because therapies that have been proved to be safe and effective are often adopted into the armamentarium of conventional health care. Hence, a therapy that is considered CAM today may in fact be considered conventional once a sufficient degree of valid research is obtained. Because this is a dynamic process, differences exist regarding which therapies or treatments should be considered CAM at any point in time. In our survey, we included exercise for a specific problem, commercial diets, and self-help groups since these were included in surveys conducted by Eisenberg et al, although these modalities may be considered conventional at this time in most practices. We excluded the use of multiple vitamins with and without minerals, vitamin D, folic acid, calcium, iron, and potassium because these supplements are used frequently to address a conventional medical need or indication. Nonetheless, these supplements might be considered complementary in some practices. CAM therapies have become an important subject to rheumatologists and physiatrists because many patients try complementary treatments.10 Survey data have shown that
January 2005;80(1):55-60
•
www.mayoclinicproceedings.com
57
CAM THERAPIES FOR PATIENTS WITH FIBROMYALGIA
TABLE 3. Herbs and Other Dietary Supplements Used by Patients Referred to a Fibromyalgia Treatment Program, by Age Group* Age group (y) Herbs and dietary supplements
18-24 (n=14)
25-34 (n=19)
35-44 (n=71)
45-54 (n=103)
55-64 (n=44)
65-74 (n=24)
≥75 (n=14)
All ages (N=289)
Green tea Glucosamine Echinacea Chondroitin Flaxseed Acidophilus Coenzyme Q10 Fish oil (cod liver oil) Garlic Ginseng Psyllium Ginkgo biloba L-lysine Aloe Ginger Lecithin Valerian Melatonin Milk thistle Evening primrose oil Others At least 1 herb or other dietary supplement
14 7 29 0 0 7 7 14 0 14 14 0 7 0 7 0 14 14 0 7 21
11 16 11 11 16 21 16 5 11 11 5 11 11 5 11 11 11 11 5 0 16
31 11 17 13 14 14 8 13 13 11 8 10 3 11 8 4 7 6 6 7 27
27 17 14 12 11 14 15 11 8 7 7 5 7 6 3 5 4 4 4 4 20
20 23 9 14 23 11 11 11 7 7 9 5 2 0 5 5 2 2 5 2 14
8 33 13 29 17 8 13 4 4 4 8 8 8 4 0 4 4 0 8 4 8
21 29 14 21 0 7 7 14 21 0 0 14 7 0 7 7 0 7 0 7 14
24 18 14 13 13 13 12 11 9 8 8 7 6 6 5 5 5 5 5 5 19
64
37
54
50
52
50
43
51
*Data are percentage of patients.
many rehabilitation specialists endorse some form of CAM and believe in its usefulness11 and that most rheumatologists incorporate some CAM therapies into their professional practice through either direct patient care or referral to other providers.12 In a published survey mailed to a random sample of 2000 physician members of the American College of Rheumatologists, respondents were queried about their knowledge of 22 CAM therapies. Respondents reported knowing enough to discuss 10 of the therapies with patients, to consider 9 of the therapies to be part of legitimate medical practice, and to refer patients to someone else for 8 of the 22 therapies. When direct clinical use of the therapies was combined with referral, 9 of the 22 modalities had been used by more than 50% of the respondents, with counseling or psychotherapy (85%) and exercise (81%) at the top of the list. Alternatively, there were 9 therapies for which 75% of the sample reported no clinical use (meditation [24%], prayer and spiritual direction [23%], nonchiropractic manipulation [23%], hypnotherapy [19%], herbal medicine [14%], music therapy [9%], magnets [5%], energy healing [5%], and homeopathy [4%]). Interestingly, none of these modalities were considered part of legitimate medical practice by a substantial proportion of the sample, and as many as 50% of the respondents reported insufficient knowledge to discuss any of them with their patients. This is an important finding because 45% of our patients with fibromyalgia used spiritual heal58
Mayo Clin Proc.
•
ing, 12% used music therapy, 10% used homeopathy, 9% used magnets, and 8% used energy healing. The evidence for efficacy of nonherbal or supplement CAM treatments in patients with fibromyalgia was summarized recently.13 The systematic review concluded that the direction of evidence was “clearly positive” for the use of treatment with acupuncture and massage and “tentatively positive” for homeopathy. Exercise was the most frequently used modality by our patient population (48%). The evidence for use of exercise is mixed. Sim and Adams14 performed a systematic review of randomized controlled trials from 1980 to May 2000 of nonpharmacological interventions for fibromyalgia and concluded there was preliminary support of moderate benefit for aerobic xeercise. However, in a randomized trial performed in the Netherlands, no clear benefit from fitness training and biofeedback training was found compared with usual care.15 Magnetic therapies were used by 9% of our patients. A randomized, placebo-controlled, double-blind trial of static magnetic fields for fibromyalgia revealed no significant difference between groups that used real magnets and those that used sham magnets.16 In a review by Ernst13 regarding effectiveness of herbs and dietary supplements, the only herb or supplement mentioned for patients with fibromyalgia was capsaicin, with a tentatively positive direction of evidence.
January 2005;80(1):55-60
•
www.mayoclinicproceedings.com
CAM THERAPIES FOR PATIENTS WITH FIBROMYALGIA
In an open pilot study that evaluated the potential benefits of coenzyme Q10 (200 mg/d) combined with ginkgo biloba extract (200 mg/d) in patients with fibromyalgia, the authors reported a progressive improvement in quality-oflife scores and are now planning a controlled trial.17 Some beneficial effects have been reported with Sadenosylmethionine18 and 5-hydroxytryptophan19 in treating fibromyalgia. In reviewing the 10 top modalities used by our study population, it becomes apparent that many of these practices can be considered complementary to standard medical treatments. Use of exercise for a specific medical problem, spiritual healing (prayers), massage therapy, and chiropractic treatments are usually considered safe and helpful for several medical conditions, leading to improvement in quality of life. Many of the herbs and other dietary supplements used by our patients are known to have potential adverse effects and may pose a risk to the patient. Some of the concerns with the use of these supplements are adverse effects on coagulation (ginkgo biloba, garlic), cardiovascular function (ephedra), and cognition (valerian, kava, St John’s wort). Of particular concern to us was the use of ephedra by 9 patients and kava by 4 patients. Ephedra, also known as ma huang, is a sympathomimetic that has been associated with hypertension, palpitations, angina, myocardial infarction, cerebrovascular accidents, and seizures.20 Linked to more than 17 deaths, ephedra has pharmacokinetics similar to the anesthetic vasopressor ephedrine.21 Canada banned all sales of ephedra products in January 2002. In May 2003, legislation was signed that made Illinois the first state to ban the sale of ephedra. On February 6, 2004, the Food and Drug Administration published a final rule prohibiting the sale of dietary supplements that contained ephedra (the rule was effective 60 days after February 6, 2004). Our patients who used ephedra or kava had no documentation of such use in their medical records. Use of kava has been tentatively linked to liver damage, and the sale of kava has been banned from the market in Switzerland, Germany, Canada, Australia, and France. Several other countries are considering similar action.22 The Medicines Control Council of South Africa withdrew kava-containing products on the basis of accumulated worldwide evidence that such products pose a rare but serious risk of liver toxicity. Ginkgo biloba was used by 20 (7%) of our patients. Several reports of bleeding problems associated with longterm ginkgo use can be found in the literature, including postlaparoscopic cholecystectomy bleeding23 and spontaneous subdural hematoma.24 Intracerebral hemorrhage was noted when ginkgo biloba was combined with long-term use of warfarin.25 Mayo Clin Proc.
•
Twenty-five (9%) of our patients used garlic. Spontaneous epidural hematoma resulting in paraplegia26 and postoperative hemorrhage27 have been associated with excessive consumption of garlic. Barbiturates, hypnotics, benzodiazepines, and narcotics may have synergistic or unpredictable effects if combined with sedative herbal medicines that affect neurotransmitters.28 The long-term use of high-dose valerian has been linked to a possible postoperative benzodiazepine-like withdrawal reaction, resulting in cardiac failure and delirium during emergence from general anesthesia.29 A 54year-old man who combined the herb kava with cimetidine, terazosin hydrochloride, and alprazolam became semicomatose.30 The antidepressant botanical St John’s wort has been reported to cause excessive sedative effects if combined with narcotics.31 Botanical agents are often pharmacologically active, particularly with respect to liver metabolism. When a botanical decreases or increases the metabolism of a chemotherapeutic agent, increased toxicity or lowered efficacy may result. St John’s wort is the best known of several botanical treatments that induce enzymes in the cytochrome P-450 family,32 in particular CYP3A4. Thus, it is not surprising that several case reports have been published in which drug levels were significantly reduced by the coadministration of St John’s wort. These drugs include indinavir,33 digoxin,34 and cyclosporine.35 Although many of the potential adverse effects are based on isolated case reports, it is important to keep them in mind, particularly when there is no clear indication for using any of these supplements. An open patient-physician discussion about the potential usefulness and risks of CAM modalities is helpful. Because patients underreport the use of dietary supplements,36 they should be asked specifically about such use. Once physicians know their patients are using CAM therapies, they should relate which CAM modalities can be considered truly complementary and which modalities could possibly be harmful. CONCLUSION This study shows that CAM use is common among patients referred to a fibromyalgia treatment program at a tertiary care center. Because of the widespread and growing use of CAM, especially by patients with chronic illnesses, physicians and other health care practitioners must become familiar with the most frequently used CAM modalities in their patient population and openly discuss the risks and benefits of CAM practices with their patients. Truly complementary modalities should be integrated with mainstream medical therapies, whereas harmful or ineffective
January 2005;80(1):55-60
•
www.mayoclinicproceedings.com
59
CAM THERAPIES FOR PATIENTS WITH FIBROMYALGIA
treatments should become obsolete. More research is needed to determine the usefulness and potential adverse effects of many CAM modalities. We are grateful to Drs Mark C. Lee and Ralph E. Gay for their helpful suggestions in the preparation of the submitted manuscript.
REFERENCES 1. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR, Delbanco TL. Unconventional medicine in the United States: prevalence, costs, and patterns of use. N Engl J Med. 1993;328:246-252. 2. Eisenberg DM, Davis RB, Ettner SL, et al. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998;280:1569-1575. 3. White KP, Harth M. An analytical review of 24 controlled clinical trials for fibromyalgia syndrome (FMS). Pain. 1996;64:211-219. 4. Goldenberg DL. Fibromyalgia syndrome: an emerging but controversial condition. JAMA. 1987;257:2782-2787. 5. Bennett RM. Multidisciplinary group programs to treat fibromyalgia patients. Rheum Dis Clin North Am. 1996;22:351-367. 6. Pfeiffer A, Thompson JM, Nelson A, et al. Effects of a 1.5-day multidisciplinary outpatient treatment program for fibromyalgia: a pilot study. Am J Phys Med Rehabil. 2003;82:186-191. 7. Rao JK, Mihaliak K, Kroenke K, Bradley J, Tierney WM, Weinberger M. Use of complementary therapies for arthritis among patients of rheumatologists. Ann Intern Med. 1999;131:409-416. 8. Wolfe F, Ross K, Anderson J, Russell IJ, Hebert L. The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum. 1995;38:19-28. 9. Goldenberg DL. Fibromyalgia syndrome a decade later: what have we learned? Arch Intern Med. 1999;159:777-785. 10. Buchbinder R, Gingold M, Hall S, Cohen M. Non-prescription complementary treatments used by rheumatoid arthritis patients attending a community-based rheumatology practice. Intern Med J. 2002;32:208-214. 11. Schoenberger NE, Matheis RJ, Shiflett SC, Cotter AC. Opinions and practices of medical rehabilitation professionals regarding prayer and meditation. J Altern Complement Med. 2002;8:59-69. 12. Berman BM, Bausell RB, Lee WL. Use and referral patterns for 22 complementary and alternative medical therapies by members of the American College of Rheumatology: results of a national survey. Arch Intern Med. 2002; 162:766-770. 13. Ernst E. Complementary medicine. Curr Opin Rheumatol. 2003;15:151155. 14. Sim J, Adams N. Systematic review of randomized controlled trials of nonpharmacological interventions for fibromyalgia. Clin J Pain. 2002;18:324336. 15. van Santen M, Bolwijn P, Verstappen F, et al. A randomized clinical trial comparing fitness and biofeedback training versus basic treatment in patients with fibromyalgia. J Rheumatol. 2002;29:575-581. 16. Alfano AP, Taylor AG, Foresman PA, et al. Static magnetic fields for treatment of fibromyalgia: a randomized controlled trial. J Altern Complement Med. 2001;7:53-64.
60
Mayo Clin Proc.
•
17. Lister RE. An open, pilot study to evaluate the potential benefits of coenzyme Q10 combined with Ginkgo biloba extract in fibromyalgia syndrome. J Int Med Res. 2002;30:195-199. 18. Jacobsen S, Danneskiold-Samsoe B, Andersen RB. Oral S-adenosylmethionine in primary fibromyalgia: double-blind clinical evaluation. Scand J Rheumatol. 1991;20:294-302. 19. Caruso I, Sarzi Puttini P, Cazzola M, Azzolini V. Double-blind study of 5-hydroxytryptophan versus placebo in the treatment of primary fibromyalgia syndrome. J Int Med Res. 1990;18:201-209. 20. Haller CA, Benowitz NL. Adverse cardiovascular and central nervous system events associated with dietary supplements containing ephedra alkaloids. N Engl J Med. 2000;343:1833-1838. 21. Gurley BJ, Wang P, Gardner SF. Ephedrine-type alkaloid content of nutritional supplements containing Ephedra sinica (Ma-huang) as determined by high performance liquid chromatography. J Pharm Sci. 1998;87:15471553. 22. Shaver K. Liver toxicity with kava. Prescrib Lett. January 2001;18:1-3. Available at: http://www.naturaldatabase.com. Accessibility verified December 1, 2004. 23. Fessenden JM, Wittenborn W, Clarke L. Gingko biloba: a case report of herbal medicine and bleeding postoperatively from a laparoscopic cholecystectomy. Am Surg. 2001;67:33-35. 24. Rowin J, Lewis SL. Spontaneous bilateral subdural hematomas associated with chronic Gingko biloba ingestion. Neurology. 1996;46:1775-1776. 25. Matthews MK Jr. Association of Gingko biloba with intracerebral hemorrhage [letter]. Neurology. 1998;50:1933-1934. 26. Rose KD, Croissant PD, Parliament CF, Levin MB. Spontaneous spinal epidural hematoma with associated platelet dysfunction from excessive garlic ingestion: a case report. Neurosurgery. 1990;26:880-882. 27. Burnham BE. Garlic as a possible risk for postoperative bleeding [letter]. Plast Reconstr Surg. 1995;95:213. 28. Norred CL, Zamudio S, Palmer SK. Use of complementary and alternative medicines by surgical patients. AANA J. 2000;68:13-18. 29. Garges HP, Varia I, Doraiswamy PM. Cardiac complications and delirium associated with valerian root withdrawal. JAMA. 1998;280:1566-1567. 30. Almeida JC, Grimsley EW. Coma from the health food store: interaction between kava and alprazolam [letter]. Ann Intern Med. 1996;125:940-941. 31. Simmen U, Burkard W, Berger K, Schaffner W, Lundstrom K. Extracts and constituents of Hypericum perforatum inhibit the binding of various ligands to recombinant receptors expressed with the Semliki Forest virus system. J Recept Signal Transduct Res. 1999;19:59-74. 32. Budzinski JW, Foster BC, Vandenhoek S, Arnason JT. An in vitro evaluation of human cytochrome P450 3A4 inhibition by selected commercial herbal extracts and tinctures. Phytomedicine. 2000;7:273-282. 33. Piscitelli SC, Burstein AH, Chaitt D, Alfaro RM, Falloon J. Indinavir concentrations and St John’s wort [published correction appears in Lancet. 2001;357:1210]. Lancet. 2000;355:547-548. 34. Johne A, Brockmoller J, Bauer S, Maurer A, Langheinrich M, Roots I. Pharmacokinetic interaction of digoxin with an herbal extract from St John’s wort (Hypericum perforatum). Clin Pharmacol Ther. 1999;66:338-345. 35. Ruschitzka F, Meier PJ, Turina M, Lüscher TF, Noll G. Acute heart transplant rejection due to Saint John’s wort [letter]. Lancet. 2000;355:548549. 36. Hensrud DD, Engle DD, Scheitel SM. Underreporting the use of dietary supplements and nonprescription medications among patients undergoing a periodic health examination. Mayo Clin Proc. 1999;74:443-447.
January 2005;80(1):55-60
•
www.mayoclinicproceedings.com