The treatment of fibromyalgia syndrome appears to be entering something of a golden age. Recently, after years of struggling just to be taken seriously, fibromyalgia patients have witnessed the release of a series of medications indicated for the treatment of fibromyalgia syndrome. While it is true that these medications are far from perfect and aren’t effective for everyone, they have provided a strong sense of direction for researchers and raised hopes for more efficacious treatments in the future.

Currently, the most promising areas of research center around central nervous system neurotransmittors and the role they play in pain modulation. In the United States, the drugs currently approved for the treatment of fibromyalgia syndrome affect either the neurotransmitters, serotonin and norepinephrine (duloxetine, milnacipran), or gamma-aminobutyric acid (pregabalin). These are not the only neurotransmitters that are involved in pain modulation, however, leading researchers to look at the role that dopamine may play in the pathology of fibromyalgia syndrome, too.

In fact, there are several good reasons to think that dopamine may play a key role in the etiology and clinical presentation of fibromyalgia syndrome:

1. A link has been identified between fibromyalgia syndrome and an abnormality in a gene responsible for proper dopaminergic expression.⁽¹⁾ This genetic link suggests that altered dopaminergic pathways may be at least partially responsible for the symptoms of fibromyalgia syndrome.

2. Studies utilizing positron emission topography (PET) to map brain response have empirically shown that fibromyalgia patients exhibit decreased dopaminergic activity in response to painful stimuli when compared to control groups.⁽²⁾⁽³⁾ These fibromyalgia patients also perceived the painful stimuli to be more severe than did the control group. Since dopamine has been implicated in both pain modulation and processing, these studies suggest dopamine may be at least partially responsible for the widespread pain experienced by fibromyalgia patients.

3. Anecdotal evidence shows that low dopamine levels are associated with stiff, achy muscles, cognitive impairment, and difficulty focusing. These symptoms are familiar to most fibromyalgia patients.

These are among the factors that have lead researchers to conduct clinical trials on the dopaminergic agent, pramipexole, with intriguing results. Compared with the control group, patients in this study experienced gradual, significant improvement in measurements of pain, fatigue, function, and overall well-being, suggesting that dopaminergic agents may be of value in the treatment of fibromyalgia syndrome.⁽⁴⁾

While these results are encouraging, pramipexole is not yet approved for the treatment of fibromyalgia syndrome, and in the absence of an approved prescription product, some fibromyalgia patients have turned to natural alternatives (dietary changes, natural supplements). Foods thought to affect dopamine levels include almonds, bananas, avocados, lima beans, pumpkin seeds and sesame seeds. Unfortunately, despite anecdotal evidence reporting positive results, no controlled studies exist to verify the efficacy of these efforts.

Though research into the role of central nervous system neurotransmission in the expression of fibromyalgia syndrome appears to hold great promise, the medications currently available are only marginally effective and the need for better therapies is acute. As research progresses, dopaminergic agents such as pramipexole are likely to be added to the growing arsenal of approved agents, hopefully leading to greater relief for a growing number of fibromyalgia patients.

Learn more about fibromyalgia at: www.myalganex.com

1. Dan B, Hagit C, Lily N, Ebstein RP. An association between fibromyalgia and the dopamine D4 receptor exon III repeat polymorphism and relationship to novelty seeking personality traits. Molecular Psychiatry, 2004 9, 730–731. [↩]
2. Wood PB, Schweinhardt P, Jaeger E, Dagher A, Hakyemez H, Rabiner E, Bushnell MC, Chizh BA. Fibromyalgia patients show an abnormal dopamine response to pain. European Journal of Neuroscience, 2007 June;25(12):3576-3582. [↩]
3. Wood P, Patterson II J, Sunderland J, Tainter K, Glabus M, Lilien D. Reduced presynaptic dopamine activity in fibromyalgia syndrome demonstrated with positron emission tomography: a pilot study. The Journal of Pain, 8(1):51-58. [↩]
4. Holman AJ, Myers RR. A Randomized, Double-Blind, Placebo-Controlled Trial of Pramipexole, a Dopamine Agonist, in Patients With Fibromyalgia Receiving Concomitant Medications. Arthritis & Rheumatism, 2005 Aug;52(8):2495-2505. [↩]

Each time you or I purchase a vitamin or nutritional supplement- whether at our local pharmacy, grocery, or favorite internet shop- we are validating the formulation and design decisions made by that particular manufacturer. The problem is that we usually aren’t aware of these design choices, making it impossible to accurately evaluate similar products.

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

Whether via prescription medications, dietary supplements, or even processed foods, most fibromyalgia patients regularly ingest the often misunderstood chemical compounds known as excipients. Excipients are substances other than the active ingredient which are included in the manufacturing process or are contained in a finished dosage form. Many of us have read the fine print on our vitamin label and having found ingredients like magnesium stearate, EDTA, and hydroxy-propyl-methylcellulose, wondered, “What are these things, really? And, do they really need to be in my fibromyalgia supplements?”

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

The nature of fibromyalgia syndrome is such that most patients eventually find themselves taking various nutritional supplements, vitamins, botanicals, and other dietary supplements. As the dosing becomes more frequent, the potential for problems increases and managing one’s therapy can, at times, seem overwhelming. The key to an effective dosing regimen, then, is to first inform yourself and follow up with a little advance planning. 

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