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Persistence. Integration and Patience are Key to Treatment

Over the last several months I have been implementing what I call the "P-I-P" theory in my efforts to help patients live with fi­bromyalgia. The theory revolves around creating a triad of care that includes the physician, the individual and the pharmacist, with treatment protocols based on persistence, integration and patience.
 
A patient called the pharmacy sometime back looking for help and had heard that I was an expert on fibromyalgia. The irony of such a statement was very amusing as well as humbling. To be thought of as an expert in something that we know so very little about brought a smile to my face. It also made me realise that spending time with patients with special needs and working dili­gently with them and their physicians will make anyone some­what of an "expert."

Background
 
Fibromyalgia, or what is more properly referred to as fibromyal­gia syndrome, is a collection of symptoms with an unknown cause. It is a disorder that has been known for centuries.

Hippocrates once described fibromyalgia syndrome, which was known as neurasthenia in Victorian times. More recently it was known as fibrositis or polymyalgia, and in the mid 1800s it was thought to be a type of rheumatism that afflicted patients with "painful hard places." These individuals were often thought to be neurotic, and even today are sometimes deemed attention-seek­ing hypochondriacs.

This can be attributed to the multitude of symptoms that ac­company the disease and the rapidity with which they come and go, which can leave the patient frustrated and confused.

Today fibromyalgia is accepted as a distinct illness that affects about 5 % of the population, with diagnosed women outnumber­ing men by about eight to one.

Symptoms

Fibromyalgia syndrome is a syndrome involving muscular (myo-) pain (-algia) characterized by chronic aching of the mus­cles, multiple tender points, fatigue, morning stiffness and non-restorative sleep. Other symptoms associated with fibromyalgia syndrome include irritability, depression, impaired memory, headaches, dizziness and blurred vision, sensations to heat, unex­plained anxieties, gas, bloating, constipation and/or diarrhea, ir­ritable bowel or spastic colon, urinary urgency, and numbness or tingling sensations usually of the hands and feet. Restless legs and cramps are frequent, as are nonspecific patches of itching with or without a rash or dermatitis.

There are 18 trigger points of pain that include the shoulder muscles, neck, area between the shoul­der blades, lower back, elbow, wrists, chest, hips and knees.

Treatment Regimen

It is because the cause of fibromyalgia syndrome is unknown that we see so many types of treatments and medications pre­scribed from several categories. Patients become extremely frustrated and turn to all kinds of fad treatments. In many instances these programs will offer some patients re­lief, but none seems to be the defmitive an­swer. Anti-inflammatories (both steroidal and nonsteroidal) are used extensively, even though we are quite sure that fibromyalgia syndrome is not an inflammatory disease like lupus and rheumatism.

Fibromyalgia may be a disorder of brain chemicals that has a direct effect on pain and stiffness but also seems to leave these patients depressed.

Depression does not cause fibromyalgia syndrome, but the use of tricyclic antide­pressants and selective serotonin reuptake inhibitors to increase the availability of serotonin will often offer the patient some relief from the discomfort and accompa­nying depression. It is felt that these pa­tients suffer muscle pain because the mus­cle fibres do not properly heal. Muscle relaxants and tranquilisers are widely used to allow these muscles to rest and, hope­fully, give them a better chance to heal.

Sleep deprivation is a major problem for most people suffering from fibromyalgia. Again, the inability for these fibers to rest and heal during the night is a problem; therefore, the use of sleeping aids is quite common. Most experts agree that diet is a big issue, as well as proper nutritional sup­plementation. Exercise may be one of the most single important factors in a fi­bromyalgia patient's well-being.

It is because of all the mystery about the causes of and treatments for fibromyalgia that the patient must be treated on an individual basis. Pharmacists are in a great position to help these patients cus­tomise their treatment plan and work with their health-care provider to help them feel better.  

Dietary Recommendations

A well-balanced diet of about 50% raw foods and "live" juices should consist most­ly of fruits and vegetables, whole grains, raw nuts and seeds, skinless poultry and deep-water fish. Meals should be split up into four to five servings throughout the day, and each meal should contain like foods, i.e., all fruits or all grains. It is ex­tremely important that patients eliminate all caffeine, sugar and alcohol from their diets. They should try to reduce or stop consumption of meats, dairy products and other foods high in saturated fats. They should drink plenty of water, a minimum of eight large glasses daily.

Exercise

It is vital to maintain a good exercise pro­gram. I think it is extremely important for patients to prop­erly stretch before and after exercise, and they should never exercise to the point when they experience pain. If they are in pain when they are finished with their phys­ical workout, they may be doing themselves more harm than good.

Remember that we are dealing with muscles that do not heal properly. Other areas that these patients should explore are yoga and massage ther­apy. Both will help to stretch the muscles and increase blood flow, leaving the fibers energized but relaxed.

Sleep

Regular sleep is both very important and very difficult. Convey to patients the need to establish a bedtime and a time to arise and the need to adhere to these times as closely as possible. It will help to establish a sleep pattern that is in place so that they will sleep better when they begin to feel better.

Stress

Patients should try to avoid physical and emotional stress. They should try to break up necessary physical activities such as house and yard work into several separate episodes. They should work extremely hard on the mind and spirit to cope with emo­tional stress which, if unmanaged, will only worsen fibromyalgia symptoms.

Nutritional Support

Nutritional support has become a large part of our recommended protocols. Again, it is important to educate yourself about the nutritional needs of the fibromyalgic, re­membering that each patient needs to be treated on an individual basis. In my stud­ies I have come to believe that a majority of fibromyalgia syndrome patients are deal­ing with an immune-system issue.

I feel that nutritional support should address the im­mune system, and part of that is to target the food-immune complexes created not only by the foods eaten, but by improper digestion and absorption of the nutrients. The analogy I use is that we need to build a solid foundation before we put that man­sion on it. I think one of the shortfalls of many nutritional protocols is that these pa­tients have many gastrointestinal (GI) prob­lems that are not addressed. I think it is im­portant to go back to "square one" with these individuals and support their GI sys­tems before you offer them the essential nutrition that they need.

I recommend a program with probiotics, digestive enzyme support and colon-cleansing fibres before any vitamins, minerals or herbs are used. Once this is completed, the nutritional needs can be addressed. This can be diffi­cult because there are many formulas for fibromyalgia syndrome, but you must work with your patient to identify these needs. These formulas will usually include total vitamin and mineral supplementation and will address some of the specific deficien­cies that these patients have.

Other con­siderations are amino acids, additional mag­nesium, malic acid and calcium and antioxidants, to name a few.

Topical Treatments

Initially, topical treatments will start with one or two ingredients applied for a period of seven to ten days. If little or no relief is obtained, we will gradually titrate the dosage upward or begin to add additional ingredients.

An example would be to start with ketoprofen 10% cyclobenzaprine 2% PLO gel applied to the trigger points three to four times a day. Titration may involve increasing the ketoprofen to 15 % and adding lidocaine 5 %. In fact, one of the preparations that has become a standard in our fibromyalgia formulary is ketoprofen 15 % cyclobenzaprine 3 %/lidocaine 5 % PLO gel. Other options are to try ibupro­fen or diclofenac along with baclofen and bupivacaine.

I also like to use amitriptyline extensively in these patients, mostly in combination with carbamazepine and lidocaine. Another very effective for­mula for any of our patients suffering from any neuropathic pain is lidocaine 10%, amitriptyline 7% and carbamazepine 7%.

It is possible to customize a formulation that will best serve a particular individual. The first transdermal formulation that is prescribed will more than likely not be the gel that will be used several months later. To find the most effective gel, keep in mind that it is an ongoing process. 

As an example, we took an individual from a prescription for ketoprofen 15 %, carbamazepine 6% and amitriptyline 6% to a preparation of amitriptyline 7%, baclofen 2% and ketamine 5%. This took place over about a period of three months, but she was patient and her physician was willing to work with us to customise that gel until we met her individual needs.