Clinical Versus Alternative Approaches to Treating Fibromyalgia
(Complete doctoral study with survey questionnaire)
by Daniel T. Wagner, R.Ph., MBA, Pharm.D.
Objectives: To help identify a potential protocol of treatment for fibromyalgia patients by accumulating and evaluating data on drugs, supplements, diet, stress level, allergies, and exercise, associated with the syndrome, to randomly enroll patients of all ages to complete an extensive questionnaire about their affliction, to compare the data scientifically as well as from a holistic approach, and to help the pharmacist identify these patients and give them more information and ability to elicit a more encompassing disease state management and cognitive services.
Design: An eleven-page questionnaire was sent to patients previously diagnosed with fibramyalgia or myofascial pain asking questions on all aspects of their syndrome.
Setting: The population was chosen from patients at the Back Institute at Allegheny General Hospital in Pittsburgh (where I was doing a clinical Pharm.D. rotation), and from my own consulting practice at Nutri-farmacy in Wildwood, PA.
Patients: The questionnaire was mailed to 101 persons known to suffer from FMS. 68 patients returned the questionnaire.
Main Outcomes Measured: Clinical and other professional outcomes were measured from analysis of the data collected which included opinions of the patients on the most effective and ineffective drugs and supplements commonly used by health care practitioners. Although this is not a scientific study per se, it was highly efficacious in assessing the multi-faceted aspects of this syndrome.
Results: Many results can be interpreted from the data collected, whether from a professional or a patient perspective. Most surprising was that only about 20% of any pharmaceutical intervention or dietary supplement were rated as being "effective." The only exception was magnesium, which was 30% effective. It appears that a wide variety of treatments and protocols for treatment are offered to FMS sufferers, and 25% of the people feel that their physician does not understand their disease at all.
Conclusions: It must be noted that interpretation and conclusions extracted from the data collected in this research are my own. Health professionals may interpret the data in any way their experience dictates. Perhaps an approach to treating FMS should be varied as to what drugs a physicians prescribes and what supplements should be recommended by a knowledgeable health professional, and see what combination is most effective for each individual patient.
Fibromyalgia (FMS) is considered more of a syndrome than a disease for it appears to have many causes. FMS is difficult to diagnose and has no known etiology. FMS affects nearly 10 million Americans between the ages of 25-60 and women account for more than 80% of cases. Also known as fibromyalisis, muscular rheumatism, neuropathic pain, or myofascial pain syndrome, FMS is characterized by widespread pain involving muscles, tendons and joints associated with chronic aches, pain and fatigue. There is evidence that FMS can be caused by physical as well as emotional trauma; chronic anxiety or depression; physical or sexual abuse; allergies; high levels of toxicity; Lyme's disease, and more. There is even documentation that links it to Gulf War Syndrome and the problems associated with breast implants. People who suffer with the constant pain and fatigue of this baffling phenomenon will testify that it affects their entire lives, their family, their job and their recreation time.
FMS might be a good example of a disease-like state that should be treated both conventionally and with holistic interventions. Every aspect of the patient's life must be analyzed including diet, relationships, past history, exercise, body mechanics, and relaxation techniques.
In order to evaluate a mechanism or protocol to improve the quality of life for people who have FMS which focuses on many aspects of their life, I initiated a comprehensive "Fibromyalgia/Myofascial Syndrome Questionnaire" (survey) that was done in cooperation with rheumatologists at Allegheny General Hospital in Pittsburgh, PA. The project on integrative approaches to treating FMS was a special research project as part of my Pharm.D. clerkship rotation.
The Questionnaire
Many rheumatologists and orthopedic surgeons do not see fibromyalgia as a distinct disease, indeed some think it is an "invisible" disease with symptoms stemming from the fact that they are fatigued from lack of sleep exacerbated by depression. In other words, it is mostly "all in the head." This prognosis is disconcerting in many ways, for in my many years as a clinical/natural pharmacist doing extensive counseling in patients who take both legend and alternative medicines, I have personally seen over 300 patients who claim to have FMS symptoms. I felt that it would be of importance to do research in this area. The survey concentrated on evaluating drug therapy, vitamin/herbal therapy, diet, exercise, allergies, and stress factors. Although there are a myriad of other effective and legitimized forms of treating FMS patients (including chiropractic, acupuncture, massage, trigger point injections, surgery, and biofeedback), these methods were not part of the questionnaire. It should be stated that even though the data clearly reflects certain patterns of treatment for FMS, it can be interpreted in many ways. The overall evaluations, interpretations and conclusions are my own based on the evidence, the data and my extensive experience in counseling patients with this affliction.
The Fibromyalgia/Myofascial Syndrome Questionnaire was mailed to 102 patients and 66 responded (64.7%). The sex ration was 64 females and 2 males. The average age of the patient was 50.7 years, with 27.6% of the patients being under 45 years and 72.4% being older than 45 years. The average number of years since they were first diagnosed with FMS was 7.2 years.
Identification of the 'Typical' Fibromyalgia Patient
When evaluating the data, much can be deduced about this enigma of a syndrome called fibromyalgia. Typically, without imparting personal bias or experience, the questionnaire gives us the following identification of the 'typical' FMS patient:
The typical FMS patient is a female between 45-50 years of age who has experienced symptoms for 5-8 years. Her most common symptoms (neck pain 98%, back pain 87%, joint pain 81%, hip pain 80%, and a high degree of other aches and pains) are moderate to moderately-severe in nature and have been chronic and severe for over six months. Her fatigue is also chronic and has lasted more than six months. She experiences gastro-intestinal symptoms 50% of the time, which includes irritable bowel, diarrhea, and/or constipation. She experiences many other health problems more than 2/3rds of the time. These include allergy symptoms, headaches, dry mouth/eyes, depression, and sleep disturbances. One-third of the time she will have hypothyroidism, clinical depression, and/or endometriosis, with osteoporosis and/or ovarian cysts occurring 25% of the time.
Although a plethora of prescription drugs are prescribed for FMS patients, only a few (non-steroidal anti-inflammatory drugs [NSAIDs], selective serotonin reuptake inhibitors [SSRIs], and pain pills) show effectiveness only 20% of the time. However, the same three groups of drugs show ineffectiveness 15% of the time. Generally, prescription (Rx) drugs show minimal effectiveness for a majority of FMS patients, and there is no most effective or accepted protocol to follow. Nearly two-thirds of FMS patients try taking vitamins, herbs or other alternative medicines. Consequently, and very similar to Rx drugs, the most effective supplements (Calcium, B-complex, and Multi-vitamin/mineral combinations) also show effectiveness only 13-20% of the time. Only one drug and/or supplement stood out as being 30% effective, and that was magnesium.
50% of women think their diet is good or excellent, but the data shows differently. Nearly 50% of the typical FMS woman's diet consists of fat, refined carbohydrates, dairy, meat, and sugar. Conversely, 50% consists of fruits, vegetables, and whole grains. This is unfortunately the standard American diet that is so lacking in balance. A more plausible diet ratio should probably be a 75/25% ratio of plant foods versus animal foods and sugar.
Although allergies are surprisingly evident (70%) in FMS sufferers, it is rarely taken into account or identified by the patient or physician. Food allergies are recognized by one-half of the participants, although their understanding of food allergies is lacking. Over one-third of the patients recognized a cow's milk/dairy allergy or sensitivity, but 50% still consume dairy foods at a moderate rate. More than 50% of the women have taken estrogens in the form of birth control pills or hormone replacement therapy. The amount of exercise (mainly walking) is only occasional, and two-thirds of the time pain and fatigue limit exercise activity. Massage appears effective two-thirds of the time, and about one-third have tried stretching exercises including yoga.
Unfortunately, 50% of the FMS women diagnose and treat themselves. Only one out of three women believes that her physician(s) understands her disease, and 22% think that their physician(s) doesn't understand fibromyalgia at all. Stress and anxiety is a factor recognized in the daily lives of 90% of the women, and two-thirds think it exacerbates their condition. Half of the women have experienced an extremely stressful childhood or adolescence.
Evaluation of FMS Therapy (Medications)
Listed below are some of the assessments and conclusions that can be postulated from the data derived from the questionnaire.
Evaluation of FMS Therapy (Supplements)
Diagnostic Considerations
In preparing the questionnaire for this study, many various health practitioners were interviewed regarding their professional approach to evaluating, diagnosing, and treating fibromyalgia. The patients were also extremely helpful in providing their own experiences with treatments and therapies that seemed to help, hinder, or be indifferent to their affliction. Since an actual diagnosis should always to left to a qualified physician, it can still be beneficial to list possible diagnostic considerations that either the patient or the practitioner can pursue. Some of the best recommendations in this area are listed:
General Dietary Recommendations
Diet recommendations should only be generalized, for although no health professional would deny that diet plays an important role in health and disease prevention, it would be prudent to conclude that not one diet fits everyone, and not one diet is 'right' or 'wrong.' The ancient Greek physicians wrote, "Let food be your medicine and medicine be your food." If these words of wisdom are to be heeded then perhaps the best and healthiest approach may be to attain a "balanced" diet. The survey showed a general lack of nutritional knowledge (something prevalent in the United States), propagated by the lack of nutritional training in our medical, pharmacy, nursing, and other school, of allopathic training. Although frequently regarded by nutritional experts and dieticians as the S.A.D. (Standard American Diet), over 55% of the patients regarded their diets as good or excellent. Many experts would consider a diet that is approximately 70-75% of fruits, vegetables and whole grains and 25-30% of meats, poultry, dairy and fats as balanced, there is still much debate about the healthiest approach. However, the fact that the diets of the survey's participants were more in the range of 50/50 shows a lack of knowledge of general nutrition and food intake.
Allergies are one of the most common health problems we face today. Statistics show that allergies (both environmental and food) have increased 300% in the last decade. A surprising 68% of the women surveyed stated that they have allergies of some sort. 46% of the patients reported that they experience food allergies. Food allergies are one of the most underreported problems in nutrition science today. Although allergies and sensitivities to foods can manifest symptoms that are modest and benign, the increase in occurrence of food allergies is staggering. The most common foods that most people are allergic to are: dairy products, wheat, eggs, nuts, citrus, sugar, and soy. By far, the most common food allergies are experienced with dairy and wheat intake. In our survey, 33% suspected a food allergy to cow's milk/dairy, 17% to sugar and 10% to wheat. Even though one-third of the survey's participants reported an allergy to dairy, nearly 50% still had a moderate to fair intake of dairy in their diets. Perhaps, if the general public better understood the ramifications of food allergies (increased post-nasal drip, rhinitis, phlegm, wheezing, and gastrointestinal upset), their intake would be more slight and moderate.
Some general recommendations regarding dietary approaches in the treatment of fibromyalgia are:
General Recommendation for Exercise
Few would argue that exercise is one of the key ingredients to health. It is imperative that the FMS patient exercise to tolerance, because too strenuous or excessive exercise can predicate a "flare-up" which will be followed by days or weeks of rest and possible drug therapy. In addition, exercise is one of the greatest relievers of stress- the greatest trigger of FMS symptoms. According to our survey the exercise most frequented by FMS patients included walking (43%), stretching (15%), water aerobics (13%), and biking and swimming (10%). Unfortunately, only 40% of our women surveyed got adequate or frequent exercise. Those who got little or none frequently blamed fatigue (67%), pain (59%), and physical limitations (31%) as the main reasons for their lack of physical exercise. Exercising to tolerance is a critical component in the overall treatment of the FMS sufferer. That means slowly but surely reaching a stage of better fitness and endurance. Swimming and walking are excellent exercise choices. Light weight training can be utilized to build muscle and strength. Yoga is an excellent stress reliever and medium to stretch muscles, tendons and ligaments. Physical therapy, under the direction of a qualified professional, is very helpful to many FMS women.
Alternative professional therapies are a useful aspect of the arsenal of treatments that can enable the FMS patient to live a better pain-free quality of life. Chiropractic services can be extremely helpful to patients who require alignments and supplemental and nutritional support. Massage therapy that is geared toward the special needs of the FMS patient can also be of extreme benefit. Other alternative therapies that are gaining stature in the treatment of FMS include: acupuncture, biofeedback, detoxification methods, psychiatric therapy, homeopathy, and aromatic therapy. Since FMS is such an enigma of a disease it is not unreasonable to look into other types of treatments and therapies to see which one works the best for YOU.
Conclusions
After much controversy, fibromyalgia has been accepted as a distinct diagnosis, albeit a syndrome and not specifically a disease. Since the etiology is still unknown, the mainstay of treatment is still symptom management. This survey has shown that patient education can be a valuable benefit in helping the patient have a higher quality of life, free from pain and fatigue. The data obtained from this questionnaire can be evaluated and interpreted in many ways. The most important use of this survey may be as a guide or tool to establishing a practical protocol for most FMS sufferers. Presently, many protocols exist, but it may be most beneficial for the physician, pharmacist, or health care practitioner to investigate which works the best for the individual patient, and not only the symptoms. Low-dose tricyclic antidepressants have been shown to improve sleep, tenderness and general pain. Magnesium, along with other supplements, help relax the muscles and reduce fatigue. Exercise is also recommended to provide natural relief. Psychological counseling may be required in some patients. Allergies and diet play a key role that is not well defined or understood.
The pharmacist can help the patient cope with the condition by educating the patient and the patient's family about the illness and medications, look at possible interventions with diet and supplements, refer the patient to support groups, and monitor progress and adverse effects. In assessing the pharmacist's role as a clinician in improving "disease state management," it is unconscionable to think that he or she should only evaluate drug therapy without looking at the entire gambit of health initiatives.
References
Bennett RM., "Fibromyalgia: The commonest cause of chronic widespread pain," Colorado Health Net, internet www.coloradohealthnet.org.
Dolby V., "Fibromyalgia: Is there hope for chronic pain?" Better Nutrition, Feb. 1998.
Krohn K, "Syndromes associated with fibromyalgia," Colorado Health Net, internet www.coloradohealthnet.org.
LaValle JB., "A contemporary look at fibromyalgia," Natural Pharmacy, Jan. 1999. Pp 6-8.
Lowe JC., "Resluts of an open trial of T3 therapy with 77 euthyroid female fibromylagia Patients," Clinical Bulletin of Myofascial therapy, 2(1) 1997, pp. 35-37.
McCoy KB., "Physical therapy for the fibromyalgia patient," Colorado Health Net, Internet www.coloradohealthnet.org.
Melvin JL., "Fibromyalgia syndrome," Am. Occupational Therapy Assoc. 1996.
Percival M., "Fibromyalgia: Nutritional support," Nutritional Pearls. Vol 17, 1996.
Respond RM, Spellman J., "Fibromyalgia and the role of the pharmacist," U.S. Pharmacist, Dec. 1997, pp. 41-52.
Saul D., "Newer treatments for fibromyalgia pain," Intl. Journal of Integrative Med., May/June 1999. Pp 27-34.
Schneider MJ., "Tender points/fibromyalgia vs. trigger points/myofascial pain Syndrome: A need for clarity in terminology and differential diagnosis," J. of Manipulative & Physiological Therapeutics, 18(6), July/Aug 1995, pp. 398-406.
Wagner DT., "Complementary treatments for fibromyalgia," Herb & Dietary Supplement Report, Sept. 1999. P. 6.
Dan Wagner is a natural pharmacist and herbalist from Gibsonia. He is owner of NutriFARMACY, Western Pennsylvania's only all natural pharmacy located in the North Hills on Wildwood Road. Dan has done extensive research on botanical medicines in the rainforests of Belize, Costa Rica, the Amazon, and Africa. He is president of The Student Rainforest Fund, a non-profit educational organization that takes college students studying the health sciences to Belize each year. As pharmacy specialist he is a board member of Global Links and The World Health Mission, two international voluntary organizations that send medicine, medical supplies, and equipment to hospital in the Third World. He has volunteered his services in Nigeria, Cuba, Ecuador, and Kenya. In April of 2000 he was awarded the American Pharmaceutical Association "Merit 2000 Award." Their highest award to an American pharmacist working freely on behalf of the profession and the world's needy. Visit Nutri-farmacy's website at www.nutrifarmacy.com for more articles and information, or call toll-free 1-877-289-7478.