Patients and physicians are often too personally vested in their roles to recognize these potential pitfalls, and the result is an unpleasant and dissatisfactory encounter for both patient and provider. To understand how this happens, it is constructive to look at the differences in how each party perceives this sometimes contentious relationship.

Fibromyalgia patients are typically looking for two things when they first visit their doctor. They want someone to listen and understand, and they want to feel better. Reasonable desires, certainly, but not without the potential to create problems, either.

As modern citizens, we have been conditioned to think of our doctor as we would our auto mechanic. When something breaks we have it diagnosed, repaired, and continue as before, and this is actually a pretty good analogy most of the time. If we get a respiratory infection, we get it diagnosed, take our antibiotics, and in a week our metaphorical motors are running as smoothly as ever.

This is the expectation many fibromyalgia patients bring to their first office visit… and it is likely very different from the approach their physician will take. Of course, physicians are fond of the auto mechanic analogy, too. Given their choice, most would probably choose to see patients with definable, structural illnesses that can be treated with a high probability of success. Unfortunately, fibromyalgia syndrome does not fit this model. The fact that fibromyalgia symptoms are so diverse and the pain so generalized immediately presents treatment problems for the physician.

Providers tend to be cautious anytime a patient presents with idiopathic pain. Legal and ethical responsibilities require the provider to prescribe pain medications for medical purposes only, and subjective pain with no definable cause is a favorite ruse for individuals attempting to illegally divert drugs. It is unfortunate for suffering patients that fibromyalgia syndrome presents in this manner, leaving physicians immediately faced with a dilemma, especially when the patient is unfamiliar.

This is not intended as an indictment of physicians or their training. Quite the opposite, this cautious approach is exactly what should be expected from a competent physician. Suffering fibromyalgia patients are not likely to have this idea foremost in their minds, though.

By the time they reach the doctor’s office, most fibromyalgia patients have already dealt with a barrage of skepticism about their invisible illness. Spouses, employers, friends, and co-workers likely will have expressed some level of incredulity about their condition at some point, and it is natural for fibromyalgia patients to eventually assume a defensive attitude about their health. Combined with a provider’s professional skepticism, this defensiveness sets the stage for potential patient-provider conflicts.

Even when these initial difficulties are overcome, the nature of fibromyalgia creates other problems. The lack of quantifiable testing leaves the diagnosis of fibromyalgia open for debate, and inaccurate diagnosis of fibromyalgia is relatively common. Medically unexplained symptoms and bodily dysfunctions are common complaints in primary care settings, and differences in the assessment of these symptoms can create a relationship challenge between the provider and patient.⁽¹⁾

Patient reaction to a diagnosis of fibromyalgia syndrome can vary according to expectations, but often follows a predictable pattern which can act to undermine the physician’s treatment plan.⁽²⁾ The typical first reaction is one of denial. As discussed earlier, most fibromyalgia patients are expecting a definable illness that can be adequately controlled, if not completely cured. A diagnosis of fibromyalgia syndrome usually offers neither of these desired outcomes.

Even if the diagnosis is accepted, patients still tend to seek out second opinions, both medical and non-medical, in an attempt to find a more suitable outcome. Many times this is done without the diagnosing physician’s knowledge and may lead to non-compliance with prescribed therapy serving to further undermine the patient-provider relationship. Physicians tend to see this activity as subversive and may come to view their fibromyalgia patients as difficult, demanding or illness-focused.⁽³⁾ As a result of these attitudes, patients may have their pain and frustrations discounted by health care providers.

These tensions tend to be self-reinforcing as patients become more frustrated with redundant testing, poorly treated symptoms, and condescending attitudes. Health care providers may begin spending less time with these patients (viewing them as having unrealistically high expectations) or come to see their illness as primarily psychosomatic.⁽⁴⁾⁽⁵⁾ Obviously, this situation does nothing to improve patient outcomes, and leaves both patient and provider emotionally drained.

The good news is that solutions to this problem have been identified, but they require the commitment of both patient and provider in order to be effective. Shared decision-making, in which the patient plays an active role in selecting appropriate therapy, has been shown to make both a qualitative and quantitative difference in patient outcomes.⁽⁶⁾ Including family members in the treatment plan also tends to enhance improvement.

“One size fits all” therapy does not work well in treating fibromyalgia syndrome, and an interdisciplinary approach often achieves better results.⁽²⁾ Providers who consult with allied health team members report better results and less stressful patient interaction when treating fibromyalgia patients.

Above all, successful treatment of fibromyalgia requires a hopeful attitude from the patient. Patience, encouragement, and motivation are, then, necessary components of any treatment plan. Cultivating this cooperative partnership early in treatment helps avoid many of the pitfalls that can eventually poison the patient-provider relationship.

Learn more about fibromyalgia at: www.myalganex.com

1. Fitzcharles MA, Boulos P. Inaccuracy in the diagnosis of fibromyalgia syndrome: analysis of referrals. Rheumatology. 2003 Feb;42(2):263-7.
2. Alghalyini B. That sinking feeling: a patient-doctor dialogue about rescuing patients from fibromyalgia culture. Can Fam Physician. 2008 Nov;54(11):1576-7.
3. Asbring P, Närvänen AL. Ideal versus reality: physicians perspectives on patients with chronic fatigue syndrome (CFS) and fibromyalgia. Soc Sci Med. 2003 Aug;57(4):711-20.
4. Stutts LA, Robinson ME, McCulloch RC, Banou E, Waxenberg LB, Gremillion HA, Staud R. Patient-centered outcome criteria for successful treatment of facial pain and fibromyalgia. J Orofac Pain. 2009 Winter;23(1):47-53.
5. Robinson ME, Brown JL, George SZ, Edwards PS, Atchison JW, Hirsh AT, Waxenberg LB, Wittmer V, Fillingim RB. Multidimensional success criteria and expectations for treatment of chronic pain: the patient perspective. Pain Med. 2005 Sep-Oct;6(5):336-45.
6. Bieber C, Müller KG, Blumenstiel K, Schneider A, Richter A, Wilke S, Hartmann M, Eich W. Long-term effects of a shared decision-making intervention on physician-patient interaction and outcome in fibromyalgia. A qualitative and quantitative 1 year follow-up of a randomized controlled trial. Patient Educ Couns. 2006 Nov;63(3):357-66.

• similarities in clinical presentation/diagnosis
• possible common etiologies
• overlap of treatment modalities
• future trends

RLS Clinical Presentation/Diagnosis

Restless leg syndrome is a sensorimotor disorder causing unpleasant sensations and an almost irresistible urge to move the legs.⁽³⁾ The diagnostic criteria for RLS were established by the International Restless Legs Syndrome Study Group in 1995, and identify four essential components, along with several supportive and associated clinical features.⁽⁴⁾ The four essential components are:

1. Urge to move the legs
   -This is usually accompanied by uncomfortable or unpleasant sensations in the legs.
2. Onset or exacerbation with rest
   -The urge to move becomes more pronounced during periods of inactivity such as sitting or lying.
3. Relief with movement
   -The urge to move and unpleasant sensations are diminished by activity, for at least as long as the movement continues.
4. Circadian pattern
   -The urge to move is more pronounced in the evenings or night than during the day.

Disturbed sleep is the most common clinical manifestation of RLS and is often the primary reason patients seek medical attention. It should be noted, that while fibromyalgia patients also suffer from disturbed sleep patterns, RLS does not appear to be the root cause and sleep disturbances in fibromyalgia patients often occur in the absence of RLS.⁽⁵⁾ However, RLS sleep disturbances do appear to exacerbate the fatigue and cognitive impairment already present in many fibromyalgia patients.⁽²⁾

As with fibromyalgia syndrome, the vast majority of patients diagnosed with RLS are women, and there appears to be a strong hereditary component to both disorders.⁽²⁾ Additionally, some research indicates a genetic linkage between RLS, mood disorders and irritable bowel syndrome – three of the most common comorbidities of fibromyalgia syndrome.⁽⁶⁾⁽⁷⁾ Unfortunately, no laboratory test or physical exam can confirm the diagnosis of either fibromyalgia or restless leg syndrome, so timely and accurate diagnosis of each condition depends largely on the expertise of the health care provider.

Causes

The clinical study of RLS has mirrored that of fibromyalgia syndrome in the sense that researchers initially focused on possible peripheral causes but eventually concluded that CNS mechanisms were responsible for both syndromes. Current research suggests it is likely that both syndromes share a similar pathogenesis arising from dysfunction in the neuroendocrine system.⁽¹⁾ The exact mechanism of this CNS dysfunction is unclear, but it appears both pathologies involve increased spinal cord excitability and decreased regulation of sensory processing pathways.⁽⁸⁾⁽⁹⁾.

Much of the current fibromyalgia research is centered around the neurotransmitters, serotonin and norepinephrine, and the role they play in regulating pain.⁽⁸⁾ RLS research, meanwhile, has been primarily focused on dopamine, a neurotransmitter responsible for regulating motor control. Interestingly, recent evidence suggests that dopamine is also involved in pain modulation, indicating that, like restless leg syndrome, fibromyalgia may involve a disturbance of dopaminergic neurotransmission.⁽¹⁰⁾
.

Treatments

Fibromyalgia syndrome and RLS are treated with both pharmacologic and non-pharmacologic therapies. Non-pharmacologic therapies, like improved nutrition and better sleep hygiene, typically address functional symptoms of the disorders, while pharmacologic therapies usually act on neuroendocrine function in the central nervous system.⁽¹¹⁾

Drugs that increase levels of dopamine (i.e. ropinirole and pramipexole) are first-line treatments for restless leg syndrome.⁽³⁾ The majority of patients treated with these agents show improved symptoms, at least initially, but these medications can sometimes cause an augmentation, or rebound, effect and actually make symptoms worse between doses. This is especially likely to happen with older medications like levodopa. Attention should be paid to this possibility whenever initiating therapy or adjusting doses.⁽¹²⁾

It is also important to be aware that anti-depressant drugs used in the treatment of fibromyalgia can aggravate RLS symptoms in some patients, so a period of trial-and-error might be required to find appropriate therapies for an individual.⁽⁶⁾

Future

It appears that a combination of external environmental stressors and internal neuroendocrine dysfunction in genetically predisposed individuals leads to alterations in central nervous system function in both RLS and fibromyalgia syndrome.⁽³⁾⁽⁸⁾ Currently, the studies of both syndromes are directed primarily at neuroendocrine dysfunction and are likely to remain so for the foreseeable future. As the study of genetics continues to unravel the pathogenesis of fibromyalgia and RLS, the therapies should become more targeted toward specific, dysfunctional sensory pathways, leading to decreased symptoms and an improved quality of life.

Learn more about fibromyalgia at: www.myalganex.com

1. Yunus MB, Aldag JC. Restless legs syndrome and leg cramps in fibromyalgia syndrome: a controlled study. BMJ. 1996 May 25;312(7042):1339.
2. Stehlik R, Arvidsson L, Ulfberg J. Restless legs syndrome is common among female patients with fibromyalgia. Eur Neurol. 2009;61(2):107-11. Epub 2008 Dec 9.
3. Thomas K, Watson CB. Restless legs syndrome in women: a review. J Womens Health (Larchmt). 2008 Jun;17(5):859-68.
4. Walters AS. Toward a better definition of the restless legs syndrome. The International Restless Legs Syndrome Study Group. Mov Disord 1995;10(5):634-42.
5. Moldofsky H. The significance, assessment, and management of nonrestorative sleep in fibromyalgia syndrome. CNS Spectr. 2008 Mar;13(3 Suppl 5):22-6.
   
6. Hornyak M, Benes H, Eisensehr I, Haan J, Kassubek J, Peglau I, Stiasny-Kolster K, Trenkwalder C. Depression in restless legs syndrome : Pathogenesis, assessment, and implications for treatment. Nervenarzt. 2009 Apr 11. [Epub ahead of print]
7. Weinstock LB, Fern SE, Duntley SP. Restless legs syndrome in patients with irritable bowel syndrome: response to small intestinal bacterial overgrowth therapy. Dig Dis Sci. 2008 May;53(5):1252-6. Epub 2007 Oct 13.
8. Bradley LA, McKendree-Smith NL, Alarcón GS, Cianfrini LR. Is fibromyalgia a neurologic disease? Curr Pain Headache Rep. 2002 Apr;6(2):106-14.
9. Wood PB. Role of central dopamine in pain and analgesia. Expert Rev Neurother. 2008 May;8(5):781-97.
10. Wood PB, Schweinhardt P, Jaeger E, Dagher A, Hakyemez H, Rabiner EA, Bushnell MC, Chizh BA. Fibromyalgia patients show an abnormal dopamine response to pain. Eur J Neurosci. 2007 Jun;25(12):3576-82.
11. Paulson, G W. Restless legs syndrome. How to provide symptom relief with drug and nondrug therapies. Geriatrics. 2000 Apr; 55(4):35-8, 43-4, 47-8.
12. Ferini-Strambi L. Treatment options for restless legs syndrome. Expert Opin Pharmacother. 2009 Mar;10(4):545-54.

The study of pain pathways is an area of great interest for fibromyalgia researchers, and along with genetics, provides significant hope for advancement in the diagnosis and treatment of FMS. Current research indicates that dysfunctional sensory amplification can occur via several neurochemical pathways, and treatment modalities usually involve pharmacologic manipulation of these neurochemicals.

Recently, much of the focus has been centered on the serotonin-norepinephrine descending pain pathway.⁽²⁾ In this pain processing pathway, serotonin and norepinephrine are used by the brain as intermediaries to inhibit pain signals from the body. Deficiencies of serotonin or norepinephrine cause this feedback mechanism to misfire, and pain processing signals remain unregulated.

This has sparked interest among clinicians because some studies indicate that serum levels of serotonin and norepinephrine are diminished in fibromyalgia patients. Subsequent clinical trials with medications that modulate serotonin and norepinephrine (i.e. amitriptyline, duloxetine, venlafaxine) have proven beneficial to some subjects.⁽³⁾⁽⁴⁾

Another area of active research involves the voltage-dependant calcium channel which controls the release of excitatory neurotransmitters involved in pain processing, including glutamate and substance P. Inhibiting the release of these compounds decreases pain signal processing. Pregabalin and gabapentin are the two primary medications of this class used in fibromyalgia patients.

One of the more troubling aspects of developing effective treatments is the idea that fibromyalgia syndrome can affect more than one pain processing pathway, and further, the pathways involved may not be the same for each patient. So, a medication that works reasonably well in one patient may be completely ineffective (or detrimental) in another.

Genetic research into fibromyalgia even raises the possibility of multiple etiologies for FMS. Several different genetic markers are under study, and it is possible that not a single gene, but a variable combination of genes, is responsible for the expression of fibromyalgia syndrome.^(5)(6)(7)(8) Simply stated, the root cause of fibromyalgia may not be the same for all patients.

Because the currently available treatments for primary pain provide incomplete relief, attention also must be given to treating the functional symptoms of fibromyalgia syndrome. The treatment of pain amplification disorder is almost exclusively the domain of pharmacology, but the broad nature of related functional symptoms invites the use of many treatment modalities, both pharmacologic and non-pharmacologic.

It is easy to imagine how a pain amplification disorder like fibromyalgia syndrome could cause otherwise sub-clinical ailments to become symptomatic and require treatment. For instance, a headache in a hypersensitized fibromyalgia patient might be experienced as intolerably painful, while the same headache in a person with normal pain processing pathways might be perceived as only a nuisance.

Of course, this is an oversimplification. The connection between fibromyalgia and other conditions (like depression) involves both genetics and endocrinology, and is not just a result of heightened pain sensations, but the point is that fibromyalgia syndrome has the potential to adversely effect virtually any system in the body.

Treatment of these functional symptoms is primarily symptomatic or palliative in nature, and since not everyone has the same symptoms, the treatment must be individualized. This variability accounts, at least in part, for the numerous testimonials and miracle cures found online. It may be possible to virtually eliminate a particular functional symptom of fibromyalgia without correcting the underlying pathology. Confusion arises when this is mistaken as a “cure” for fibromyalgia syndrome.

Some of the more popular treatment modalities for these functional symptoms include:

• Pharmacologic agents
• Education
• Cognitive Behavioral Therapy
• Nutrition & Dietary Supplements
• Biofeedback
• Exercise Programs
• Therapeutic Yoga
• Massage Therapy
• Acupuncture
• Electro therapy

It is important to remember that the treatment must be individualized when addressing these symptoms. Therapies will not always have the same effect on individual fibromyalgia patients. The only way to arrive at a truly optimized treatment plan is through trial-and-error. Understanding this before treatment begins should help fibromyalgia patients keep a positive attitude while sorting through the broad collection of available treatments.

Due to the variable etiology and expression of fibromyalgia syndrome, finding effective treatments can be difficult. Dividing treatment goals into two categories- reduction of primary pain amplification, and reduction of resulting functional symptoms- can clarify the procedure, and allow for the individualized development of an optimal therapeutic plan.

Learn more about fibromyalgia at: www.myalganex.com

1. Lawson K. Treatment options and patient perspectives in the management of fibromyalgia: future trends. Neuropsychiatr Dis Treat. 2008 Dec;4(6):1059-71.
2. Senba E, Imbe H, Okamoto K. Descending facilitation in chronic stress and chronic pain state. Nihon Shinkei Seishin Yakurigaku Zasshi. 2008 Feb;28(1):29-35.
3. Russell IJ, Vaeroy H, Javors M, Nyberg F. Cerebrospinal fluid biogenic amine metabolites in fibromyalgia/fibrositis syndrome and rheumatoid arthritis. Arthritis Rheum. 1992 May;35(5):550-60.
4. Hauser W, Bernardy K, Uceyler N, Sommer C. Treatment of fibromyalgia syndrome with antidepressants: a meta-analysis. JAMA. 2009 Jan 14;301(2):198-209.
5. Bondy et al. The T102c polymorphism of the 5-HT2A-receptor gene in fibromyalgia. Neurobiol. Dis. 1999;6:433-439.
6. Offenbaecher et al. Possible association of fibromyalgia with a polymorphism in the seratonin transporter gene regulatory region. Arthritis Rheum. 1999;42:2482-2488.
7. Buskilla et al. An association between fibromyalgia and the dopamine D4 receptor exon III repeat polymorphism and relationship to novelty seeking behavior. Mol. Psychiatry 2004;9:73.
8. Gursoy et al. Significance of catecholamine o-methyl transferase gene polymorphism in fibromyalgia syndrome. Rheumatol. Int. 2003;23:104-107.

Of course, some of the design decisions are obvious, and it is a relatively simple matter for us make our selection based upon them. For instance, a manufacturer’s choice of ingredients is usually the first thing we would want to know in making our purchasing decision, and we shouldn’t have much difficulty determining this information. Unfortunately, other important design decisions aren’t listed on the label for us. In fact, without some diligence, we probably wouldn’t even be aware that many of these decisions have been made.

Wise product selection requires that we know a little about the design process. I’m not suggesting a course in pharmacokinetics, but we do need to understand the conceptual design process that occurs before production ever begins.

Product design usually begins with broad goals which are narrowed rather quickly as the process proceeds. For example, the goal in designing a fibromyalgia supplement might be to create a small, easily swallowed capsule of an odorless, tasteless, and completely safe ingredient requiring infrequent dosing while completely eliminating all symptoms of fibromyalgia. For many reasons, these goals need to narrowed, and from here the design process begins.

Dosage design is primarily a series of compromises made in getting from the ideal product to the marketable product. In our example, the elimination of all fibromyalgia symptoms isn’t a realistic goal, so every manufacturer must make the same compromise and use an ingredient that actually exists. Other choices, however, are not so clear, and different manufacturers will reach different conclusions.

For instance, the goal of creating an extremely small capsule may conflict with the goal of infrequent dosing. In fact, the goals may be mutually exclusive, and one manufacturer may subsequently choose to go with small capsules dosed multiple times daily, while another may choose large capsules with infrequent dosing. For fibromyalgia patients with dysphagia, this is not a trivial issue and may well be the determining factor in wise product selection. After all, if the capsule is too big to be swallowed, it isn’t very likely to be effective.

By the time the design process is over, many compromises will have been made, and products that began with similar design goals may wind up being quite distinct from one another. The importance placed on a particular design choice is often a matter of personal preference, but fibromyalgia patients should always be aware of several key design concepts.

1. Science Matters

When it comes to nutritional supplements, good research can be difficult to find. This makes it important to be faithful to the quality studies that do exist. For the fibromyalgia patient, this means following the protocols used in clinical research. Typical supplements aren’t designed this way. For instance, a magnesium supplement designed for the general populace would likely be sub-potent for a fibromyalgia patient.

2. The Dosing Schedule Should Be Simple

Fibromyalgia patients forget stuff; they misplace things; they get confused. If frequent dosing is required, or if the schedule varies, dosing mistakes are likely to be made. Pill boxes and timers may help, but dosing schedules should always be kept as simple as possible.

3. Keep It Small and Smooth

Dysphagia is a common symptom of fibromyalgia, so dosage sizes need to be kept to a minimum, and they should be encapsulated or film-coated so as to be as smooth as possible. Consideration should be given to how easily the dosage form can be divided or crushed. For some fibromyalgia patients, liquid dosage forms will be the only option, so these formulations should always be evaluated.

4. Taste And Smell Are Important, Too

Just as size and texture are unusually important to fibromyalgia patients, so are taste and smell. Fibromyalgia can heighten these senses to the point that tastes and smells barely noticed by healthy individuals can cause extreme discomfort in fibromyalgia patients.

5. Exile The Excipients

Sometimes, formulation decisions are made that aren’t necessarily in the patient’s best interest, such as when dyes are added to make a product more visually attractive. Excipients (non-active ingredients) are added to dosage forms for a number of reasons, and while many are essential, some are not. This is of particular concern to fibromyalgia patients who often have multiple chemical sensitivities. While a detailed examination of individual excipients is beyond the scope of this article, more information on this topic is available in the article, Fibromyalgia Supplements & Pharmaceutical Excipients.

6. Find A Good Source

It is a dirty secret of the vitamin and supplement industry that most ingredients are imported- usually from China or India. Many times, even products touted as “Made in the USA” are actually created using imported raw materials. The situation is so severe that, at times, it may be impossible to find domestic sources for a particular ingredient. Given the recent contamination cases involving imported food products, finding a reputable source is more important than ever and should not be overlooked.

7. More Isn’t Always Better

Some manufacturers seem to think that simply having the most ingredients is the goal of dosage formulation, and I must admit it makes for an impressive label as long as you don’t look at the numbers. Having all those ingredient comes at the cost of not being able to have very much of any one ingredient. In some formulations, the bulk of the ingredients are available only in token quantities. For fibromyalgia patients, in particular, this low-dose exposure would seem to be a bad design principle.

8. Sometimes New Is Just New

A similarly ineffective design principle (from the patient’s perspective) is the practice of putting the newest, trendiest, or most exotic ingredients in a product. While it can drive market share for the manufacturer, it usually does little good for the fibromyalgia patient. Sometimes new is just new, and waiting for the science to catch up is the wisest course of action.

9. Kill The Miracle Cures

Miracle cures for fibromyalgia do not exist- not through nutritional supplements, prescription medications, dietary modifications, psychotherapy, hypnosis or books. Fibromyalgia doesn’t have a switch that simply can be turned off. Instead, we are dealing with degrees of relief. I would personally be very skeptical of the design principles behind any product marketed as a miracle, cure, or secret. Remember, extraordinary claims should always require extraordinary evidence.

This list is not definitive by any means, but it does cover the basic design concepts that fibromyalgia patients should consider before purchasing vitamins or supplements. An informed decision should lead to proper product selection, and ultimately, a better quality of life.

Learn more about fibromyalgia at: www.myalganex.com

Lesson One: I Can’t Feel Sorry For Myself

As it slowly dawned on me that my wife’s condition would be permanent, and that our lives would not go back to how they had been pre-fibro, I began to feel cheated. My wife and I had always enjoyed being outdoors and active, and a large part of our relationship was based on these common interests (our first date had even been a canoe trip). It looked, now, like these things were gone for us, and that was just the beginning of the changes. Vacations, retirement plans, social engagements- everything had been thrown into a state of chaotic uncertainty.

At first, I think I was stunned by the sheer magnitude of changes that fibromyalgia meant for us, and I felt pretty sorry for myself. My wife’s fibromyalgia had been triggered by a rather serious illness, so for a long time afterward I kept hoping that she would “snap out of it” and be herself again. I know I brooded for quite a while before, finally, accepting the fact that there was no going back. Life had changed. All that was left was to decide what to do about it. This was probably the toughest, and most important, lesson I learned. Everything else I know about coping as a fibromyalgia spouse has flowed from the realization that I can’t afford to feel sorry for myself. I know that many spouses can’t manage to get to this point, and I can only say that for me, I really meant it when I said “for better or for worse.”

Lesson Two: We Need A Plan

Lesson two followed lesson one almost intuitively. Once I accepted that our lives had permanently changed, the next logical question was, “What do we do now?”

Had we not been able to establish new goals together as a couple, I’m sure our marriage would have fractured. Our relationship certainly couldn’t have grown, and in my experience, stagnant relationships don’t last long. We had to take a sober look at what was possible and adjust our long-term goals right along with our daily goals. Doing this brought an enormous about of stability back to our lives, but as I would learn, we still had a lot of adjusting to do.

Lesson Three: Appearances Can Be Deceiving

Some lessons I learned relatively easily, but not this one. I think it is because, unlike my wife, I could sometimes forget about fibromyalgia. For instance, I could go through a whole day of work scarcely thinking about it.

Eventually, though, I came home and if I didn’t quickly remember, I was setting myself up for another tough lesson. Many times, early in her illness, I made the mistake of assuming she felt fine, and she, having been suffering in silence for hours, directed the full force of her pain and frustration at me.

It probably took me longer than it should have, but eventually I learned that fibromyalgia doesn’t look like anything, and even though my wife might appear tranquil, she could be hurting and just barely keeping it together on the inside .

Lesson 4: It’s Not Personal

When, because of my insensitivity, these types of confrontations did occur, I almost always felt blind-sided, because I really didn’t anticipate them. I wasn’t living with fibromyalgia 24 hours a day, so to me her outbursts appeared excessive and irrational. I usually left these situations feeling hurt and more than a little confused.

I felt discounted in other ways, too. Sometimes, I would notice a blank look on her face when I would be talking to her, like she was deep in thought about something much more interesting than what I was saying. Other times, she would go to bed as soon as I got home from work, making me think she would have been happier if I had just stayed there.

I know, now, that these actions were not directed at me personally. The glazed look wasn’t because she was ignoring me; it was because she was having trouble focusing. She didn’t go to bed early to avoid me; she went to bed early to avoid lashing out at me. Knowing these things doesn’t fix everything, but it does help to keep them in mind, especially when I’m feeling neglected.

Lesson 5: Communication Makes Life Easier

One of the smartest things I’ve learned to do since my wife’s illness, whether it’s first thing in the morning or when I get home from work, is to ask her how she is feeling before I say anything else. Sharing this little bit of information has saved us much anguish. It is so much easier for her to tell me how she feels than it is for me to guess (I’m usually wrong). This goes back to the “Appearances Can Be Deceiving” lesson.

Lesson 6: Sometimes I Need to Leave

Sometimes her answer to, “How do you feel?” is a forced, “I hurt,” between clenched teeth. I’ve learned that during these times life is easier for both of us if I make myself scarce. I’m not saying I leave the county or anything, but I might find something to do in the garage for a while. I’ve learned that retreat can be a wise strategy.

Lesson 7: I Have To Slow Down

Learning to live at a pace that is comfortable for my wife has been surprisingly challenging. Slowing down means not only doing fewer things in a day, but also, doing those chosen things at a slower pace. I’m learning to walk slower, to talk slower, and to eat slower. I’ve learned that if we go at her pace, we get to enjoy a lot more of life together.

So, that’s it: seven hard won lessons. Of course, I still need to be reminded of these lessons myself periodically. I’m quite capable of falling into periods of self-pity, and I still can be dumbfoundingly insensitive to my wife’s condition. I don’t know if I’ll ever really be able to eat slower, but I do know I’m learning to be a better fibromyalgia spouse.

Learn more about fibromyalgia at: www.myalganex.com

When Pfizer’s Lyrica was approved by the FDA in June of 2007 it became the first prescription medication indicated for the treatment of fibromyalgia. It’s approval represented not only a hope for better individual treatment, but also a kind of validation for the fibromyalgia community at large. After years of struggling just to be heard by the medical establishment, fibromyalgia sufferers were suddenly watching Big Pharma recognize fibromyalgia as a treatable condition.

Not surprisingly, the drug has been a big winner for Pfizer. Lyrica’s fibromyalgia sales have been brisk from the start and are expected to grow to $641 million by 2016. In light of these numbers, it is easy to understand Pfizer’s motivation in pursuing the FDA approval. They fails to explain, however, exactly what fibromyalgia patients can expect from Lyrica.

Despite the hype, the approval of Lyrica for fibromyalgia has offered little in the way of novel treatment for fibromyalgia. In fact, Lyrica already has been available in the U.S. (with a neuropathic pain indication) since 2005, and of course, doctors have always been free to prescribe for off-label uses.

So, if the drug was already available, what was gained by the FDA’s approval of Lyrica for fibromyalgia? For the fibromyalgia patient, there were two main benefits. The first was that insurance companies were more likely to include Lyrica in their formularies, and the patient was less likely to be required to pay out-of-pocket for the medication. The second was that some doctors (primarily those unfamiliar with treating fibromyalgia) became more comfortable with prescribing Lyrica for fibromyalgia.

These are not small matters, to be sure, but they aren’t exactly the breakthrough for which some fibromyalgia patients had hoped. In contrast, Pfizer got exactly what they desired: a regulatory license to directly market Lyrica to fibromyalgia patients.

All of the subsequent largesse was not lost on Eli Lily and Company, and in a manner similar to Pfizer, they pursued a fibromyalgia indication for one of their existing drugs (the anti-depressant, Cymbalta). Upon receiving Cymbalta’s approval in June of 2008, they poured millions of dollars into a direct marketing campaign and once again sales boomed.

Both of these approvals caused quite a stir, but both were really more about market positioning for the manufacturers than about breakthroughs in fibromyalgia treatment. This is not to say these medications are ineffective. Quite the opposite, they help a number of fibromyalgia patients live better lives. It is actually somewhat intuitive to surmise that a medication originally approved for neuropathic pain and a medication originally approved for depression would be helpful in the treatment of fibromyalgia, but neither of these medications offers a true breakthrough in treatment.

This summer, Forest Pharmaceuticals plans to release Savella, the third FDA approved fibromyalgia medication. Right away, we should recognize that Savella is different from Lyrica and Cymbalta in that it is actually a new molecular entity not previously approved by the FDA for any indication.

Savella, like Cymbalta, is an anti-depressant categorized as a Serotonin-Norepinephrine Reuptake Inhibitor (SNRI). That is to say, it’s mechanism of action is the same as that of Cymbalta. Savella does differ from Cymbalta in that it is more selective for norepinephrine, while Cymbalta is more selective for serotonin. This gives reason to believe that Savella may provide a valuable alternative to Cymbalta for some patients, but we should also be aware that Savella does not represent a radical step forward in treatment.

For clarity, it is informative to examine the manner in which the FDA handled the New Drug Application (NDA) for Savella. Every NDA is classified during the drug review process according to it’s perceived importance to society. According to the FDA, “Fast Track, Accelerated Approval, and Priority Review are approaches that are intended to make therapeutically important drugs available at an earlier time.”⁽¹⁾

Drugs for previously untreatable conditions or drugs with a novel mechanism of action would likely qualify for these high priority reviews. For instance, Lyrica, by virtue of being the first drug with a fibromyalgia indication, was given a Priority Review even though it was not a new molecular entity. Savella, however, was not reviewed under any of these priority classifications, but rather, under the Standard Review process which according to the FDA, “is applied to a drug that offers at most, only minor improvement over existing marketed therapies.”⁽¹⁾ [emphasis added]

Keeping things balanced and in perspective is important for fibromyalgia patients, so as summer approaches and the hype for Savella shifts into high gear, remember those words, minor improvement, and set your expectations accordingly.

Learn more about fibromyalgia at: www.myalganex.com

1. US Food & Drug Administration, “Fast Track, Accelerated Approval & Priority Review,” May, 2006, http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm (March 20, 2009)

1. Take Back Your Sleep Cycle

Set up a regular routine for sleeping by going to bed and getting up at the same time each day, and make sure your bedroom has an atmosphere that is conducive to sleeping. This means not watching TV or spending time on the computer while in bed. Keep your bedroom dark, quite and cool. Try to avoid spicy foods or too many beverages before going to bed, and never underestimate the value of a good pillow.

2. Eat Right

This is a lot easier said than done, but it is possible. Look around the web and you’ll find a lot of advice about fibromyalgia and diet, but the advice is often contradictory and confusing. What works for one patient may not work for the next. Fibromyalgia is a perplexing syndrome. It’s a diverse disease that doesn’t present the same way in every patient. This doesn’t mean that you have to give up on eating right, though. You just have to do a little trial-and-error first.

Experience has shown that a few foods seem to cause problems for most fibromyalgia patients, so eliminating them is a good place to start. These include coffee, carbonated beverages, alcohol, and foods high in fat. It is important to realize that there is no “Fibromyalgia Diet” suitable for all patients. It will take time and effort discern the most appropriate diet for you. A journal of your dietary habits can really help speed this process.

3. Keep A Journal

 Journals aren’t just good for remembering what you had for dinner. Keeping a brief journal of your activities should become an important part of your daily routine. This doesn’t have to be extremely detailed or time-consuming, though detailed journals are usually more effective. As a minimum, list your day’s basic activities, any pain experienced and the approximate time of onset. Eventually, correlations between what you are doing and how you are feeling will become evident. This does require some diligence, but remember that greater effort will mean faster rewards.

4. Know Your Triggers

You may already know some of the factors that cause your fibromyalgia to flare, and your journal will help you discover more. Be cognizant of these triggers, even going so far as to write them down. Learn to recognize and avoid them even when you may be preoccupied. Fibromyalgia is different for everyone; it pays to know your fibromyalgia.

5. Educate Yourself

Fibromyalgia is personal, varying widely from individual to individual. No one knows your condition better than you (not even your doctor), so it is important that you empower yourself with knowledge. A standard treatment protocol does not exist for fibromyalgia. Because of it’s nature, your fibromyalgia must be managed by you.

6. Exercise

This goes against the natural tendencies of most fibromyalgia patients. After all, who wants to exercise while sleep deprived, with sore joints and a migraine headache? It may be counterintuitive, but exercise does benefit most fibromyalgia patients. The key to a successful exercise program is to start slowly, always being careful not to overexert yourself. Strength training, flexibility exercise, and aerobic activities are of particular value to fibromyalgia patients.

7. Start Cognitive Behavioral Therapy

This form of psychotherapy utilizes rational analysis to influence our thought processes and ultimately our behaviors. It has proved itself particularly useful for fibromyalgia patients, and best of all, you can do it all by yourself. A quick web search should point you in the right direction to get started.

8. Communicate

Let the people you care about know how you are feeling. Tell them in advance when you are in pain, stressed, or feel your patience waning. Do not hold your feelings inside until you feel compelled to release them in anger or frustration. Your family members want to help you. Remember to let them know important they are to you.

9. Accept Your Limitations

Fibromyalgia is a chronic disease and it is not likely to leave you. It may limit the quantity of what you can accomplish, but doesn’t have to limit the quality. Focus on those things that you can do, and pace yourself so as not to become exhausted or frustrated.

10. Congratulate Yourself

Fibromyalgia patients endure a lot, suffering in silence most of the time, but they also accomplish some amazing things in light of their condition. Raising a family, going to work, walking the dog… all of these things take extra effort for the fibromyalgia patient, yet everyday they get done. So, give yourself a pat on the back occasionally. You deserve it.

Learn more about fibromyalgia at: www.myalganex.com

It turns out that defining the purpose of a given excipient is a lot easier than determining whether or not it needs to be in your vitamins. This is due primarily to the broad range of purposes served by excipients. Some excipients, like disintegrants, are an essential part of a dosage form. Others, like sweeteners and shellacs, are intended solely to make a dosage form more palatable and the perceived value of these excipients likely would vary from patient to patient.

More controversial still are excipients such as lubricants and glidants whose lone purpose is to aid in the manufacturing process. These additives ensure the smooth functioning of the manufacturing machinery, ultimately leading to a lower market price, but they provide  no real health benefit. Many fibromyalgia patients, especially those who experience extreme chemical sensitivities, choose to minimize exposure to these “nonessential” excipients.

Finally, there are excipients that are used as marketing aids. These are things like artificial colors and printing inks which are intended to help the manufacturer sell more product. Most fibromyalgia patients try to avoid these types of excipients.

Let’s look in more detail at the major classifications of excipients, categorize them by how “essential” they are, and examine some of the more commonly used compounds.

 Essential: Excipients Integral to Dosage Formulation 

• Binders hold the tablet ingredients together in a stable form which makes them essential for obvious reasons.
• Disintegrants, conversely, are used to break apart tablets in the digestive tract thereby releasing the active ingredients for absorption into the blood stream.
• Fillers (diluents) are used to add volume to the dosage form so that it can be handled by the patient. Without fillers, some dosage forms would be too tiny to see!
• Suspensing/dispersing agents are used to prevent settling or clumping in suspensions and are necessary to ensure that each dose has the proper amount of active ingredient.

Cellulose, hydroxypropyl cellulose, methylcellulose, sodium starch glycolate, and crosscarmellose are commonly used examples of this category.

Optional: Excipients Based On Personal Preference

• Sweeteners are used to make ingredients more palatable, typically in liquid dosage forms.
• Preservatives are used to prolong the shelf life of the ingredients.
• Film formers/coatings are used to prolong shelf life and make large or unpleasant-tasting tablets easier to swallow.
• Flavors are used to mask unpleasant tasting active ingredients

Methyl paraben, propyl paraben, sugar and sodium citrate are typically used excipients in this category.

Questionable: Excipients Used To Improve The Manufacturing Process

• Lubricants are used to prevent powders from adhering to manufacturing machinery. They are usually used in conjunction with glidants.
• Glidants (flow enhancers) are also used to promote powder flow through manufacturing machinery, this time by reducing interparticle friction.
• Compression aids are used to compact ingredients prior to tableting.

Talc, magnesium stearate, and stearic acid are examples of this category of excipient.

Avoidable: Excipients Used For Marketing Purposes

• Printing inks are used for identification purposes as well as marketing. Since identifying marks are required on prescription medications, it may not always be possible to avoid ink.
• Colors, likewise, are used for identification and marketing purposes.

The FD&C dyes are the primary excipients in this category.

Because many fibromyalgia patients experience extreme chemical sensitivities they are understandably concerned about the effect pharmaceutical excipients may have on them. A rational strategy for these patients would be to exclude those excipients in the Questionable and Avoidable categories, select only those excipients necessary to ensure compliance from the Optional category, and accept that the excipients in the Essential category are required for the active ingredient to have the desired effect.

Learn more about fibromyalgia and nutritional supplementation at: www.myalganex.com

Over my years of practicing pharmacy, I have consistently noticed the disturbing relationship between the severity of the illness and the probability of a sub-optimal therapeutic outcome. Simply stated, sick people take more medicine and to ensure everything goes as intended special attention needs to be paid to when, and how, dosing is conducted.  Unlike with prescription drugs, however, definitive information about nutritional supplements can be difficult to find, especially for the supplements most preferred by fibromyalgia patients.

Some of these more common fibromyalgia supplements include:

• Malic acid
• Magnesium
• Vitamin D
• Sam-e
• Ginkgo Biloba
• Coenzyme Q10
• 5-HTP
• St. John’s Wort
• Glucosamine
• Chondroitin

So, let’s take a look at how to plan an effective regimen around these supplements.  Our first concern should be to determine if any need to be taken at a particular time of day, say upon waking or at bedtime.  In this case, we see that 5-HTP and, to a lesser extent, St. John’s Wort can cause drowsiness.  The St. John’s Wort dose is usually divided and taken three times daily, so drowsiness is minimized.  If sedation is the desired effect of the 5-HTP then a single large bedtime dose would be required, otherwise splitting the 5-HTP dose, as with the St. John’s Wort, would be advisable.

Next, we need to decide which supplements need to be taken with food and which on an empty stomach.  Our list contains only one item that needs to be taken on an empty stomach, Sam-e (for better absorption).  All the other supplements either need to be taken with food, or else food is irrelevant.

Our third concern, and one for which much research still needs to be conducted, is the potential for adverse interactions between the supplements. In this case, the Sam-e, the St. John’s Wort, and the 5-HTP all have the effect of raising the body’s level of the neurotransmitter, seratonin.  Taking these three together isn’t going to be advisable, so we’ll drop the Sam-e which had the empty stomach requirement, anyway.  By keeping the St. John’s Wort and 5-HTP split into three daily doses we lower to a safe level the potential for interaction between these two (while tidily avoiding our drowsiness side effect, too).

No matter the combination of supplements being taken, this three step process of determining what time of day to dose, whether to dose with or without food, and the potential for interactions, will give you a clear picture of how to achieve optimal outcomes with your nutritional supplementation.

Learn more about fibromyalgia and nutritional supplementation at: www.myalganex.com