Comparing 22 fibromyalgia patients with 22 age and gender-matched healthy control subjects, Kaufmann found a significant reduction in two immune system markers. The markers in question, CD62L and CD11b/CD18, are called adhesion molecules because they stick to the surface of the white blood cells that circulate as part of the immune system. These adhesion molecules work as communication “flags” in the immune system to get white blood cells to travel to places in the body where they need them, such as tissue injury sites. They also are involved in recognizing and destroying infectious organisms, as well as removing toxic substances and debris from the body.

A reduced number of adhesion molecules on the surface of your white blood cells would likely lead to a compromised immune system, one that lags in its ability to get rid of infections and clear up inflammation in the tissues. As a consequence, you may have a more difficult time getting over colds or flu-bugs that commonly occur during the winter months. So if you find yourself trapped with a head cold, flu, or other infection that lingers on and on, try increasing your sleep time to help power up your immune system.

Besides lowering your ability to fend off infections, a decline in adhesion molecules on your white blood cells may also compound your painful symptoms. These molecules also play a role in triggering your white blood cells to release powerful opioid-like pain relievers in the muscles and other tissues where local injury may easily occur.

While the reduction in adhesion molecules may explain why you have trouble getting rid of infections and why the slightest injury produces more pain than it should for you, these defects in immune function cannot identify people specifically with fibromyalgia. Kaufmann’s team has reported similar findings in people with complex regional pain syndrome.² This means that additional studies are needed to determine the relationship between the immune system changes and the development and persistence of painful conditions. For now, your best defense is a good night’s sleep, and anything else you can do to minimize the stress of your chronic illness.

1. Kaufmann I, et al. Rheumatol Int [epub ahead of print] December 4, 2008.
2. Kaufmann I, et al. Clin Immunol 125:103-111, 2007.

Healthy people under hypnosis who are given the suggestion of heat pain (even though they do not receive any stimulus) show changes in their brain activity using functional magnetic resonance imaging (fMRI).¹

These changes are consistent with what would be expected for people experiencing pain. However, do people need to be hypnotized for the suggestion to produce pain, or in the case of fibromyalgia, relieve pain? Stuart W. G. Derbyshire, Ph.D., and his colleagues at the University of Birmingham in England, attempted to answer this question using fMRI in a group of patients with fibromyalgia.²

Only patients who were able to increase or decrease their pain by visualizing a “pain dial” in an experimental setting were included in the study. Researchers selected these volunteers because they were more likely able to respond to hypnosis and suggestion using the same pain-altering technique. Fibromyalgia patients who used distraction or other techniques to reduce pain were excluded.

To image changes in brain activity, all subjects had to be in the fMRI scanner during the sessions. After a few practice sessions, verbal suggestions were replaced by non-verbal signals in the form of a simple sequence of taps to the patient’s left foot (one tap to dial the pain down as close to zero as possible, two taps to bring the pain to mid-range, and three taps to dial it up to the maximum pain of 10).

Seven fibromyalgia patients in the hypnosis group were evaluated under hypnosis with the suggestion for controlling their pain dial. Six patients were given only the suggestions without any hypnosis (the suggestion-only group). After each session of low, medium, and high pain suggestion states, patients were asked to rate their pain on a scale of 0 to 10, and how hypnotized they felt on a 0-10 scale (zero being not at all hypnotized). Each patient also rated how much control they felt in the hypnosis group and the suggestion-only group on a 0-10 scale (zero being no control).

Based solely on patient pain ratings:

• hypnosis alone had no effect,
• suggestion-alone was significantly effective for altering the person’s pain, and,
• hypnosis plus suggestion was the most effective.

Is there something about hypnosis that makes it easier for patients to incorporate the suggestion of turning the pain dial up or down? “That was one of the puzzles of the study,” says Derbyshire. “Going in, we expected a fairly good difference from the hypnosis, but we found that behaviorally (i.e., the patient’s pain ratings) the hypnotic induction made very little difference. This is in line with arguments that suggestion is independent of any hypnotic induction.”

Unlike each patient’s high and low pain ratings, significant changes in brain activity were visible on the fMRI for all conditions, including the hypnosis-only situation. Still, hypnosis plus suggestion produced the greatest changes in key brain centers responsible for processing pain. Derbyshire believes that there may be something happening in the brain that cannot be detected by a simple pain rating scale.

“One possibility,” says Derbyshire, “is that the pain was moving more in general after hypnosis, but the peak shifts remained the same. Patients reported the peaks (high and low pain from 0-10) because that is what we asked them to do. I’m not sure that the induction provides for more relaxation or a better ‘focus’ but that is consistent with what we found. More studies are needed to determine this.” It should also be added that patients felt more in control of their pain when hypnotized.

Do the results of this study mean that you can just suggest to yourself that your pain is less to ease your discomfort? “Positive self-talk might be helpful,” says Derbyshire, but he cautions against interpreting his study in such simplistic terms.

“The hypnotic suggestion technique is very good for acute pain control in highly regular environments, such as a dentist’s chair. There is no reason why that cannot be adapted to the more messy, outside world but, in reality, life is not lived under controlled dental or laboratory conditions.”

“I would not want to overstate what we did. We chose people who could bring to mind a dial controlling their pain and then asked them to move the dial up and down, allowing their pain to move with the dial. That’s really it and there is no reason why one has to use a dial. Sean Mackey, M.D., Ph.D., at Stanford does a similar trick using a fireplace, whereby as the fire is dulled the pain goes with it. And there is no reason why a patient can’t stop when their pain gets really bad, drag up the dial, and dial their pain down. No reason except life can’t always be stopped like that and, once the effort of dialing down the pain is relinquished, the pain comes back, which is probably demoralizing.”

Positive self-talk and being optimistic is bound to be helpful, but Derbyshire is being realistic about fibromyalgia patients being able to mentally tune down their pain. “Fibromyalgia is a tough illness, and it won’t yield to suggestion on an everyday basis. If it was that easy, you could argue that anything that helps is a good thing. Of course, our study was fundamentally based upon the premise that pain can be controlled under some circumstances. But it is a heck of a reach from there to suggestions of everyday control in the messy, real-world setting.”

Mindfulness techniques that involve positive suggestion may plausibly help with your pain and are certainly worth a try. However, keep your expectations realistic. Derbyshire says these techniques he used were simple to learn and should not require a therapist to learn them, although this could be useful. Check the self-help section of your local library or bookstore for assistance.

1. Derbyshire SWG, et al. Neurology 23:392-401, 2004.

2. Derbyshire SWG, et al. Eur J Pain [Epub ahead of print] 2008.

And the primary reason that the survey respondents gave for using placebos (a sugar pill or substitute for a proven medication) was to enhance patient expectations. Sadly, only 20 percent of the 334 internists and 345 rheumatologists who responded indicated that they would never resort to the use of placebos.

Given the many medications on the market, you may wonder: Is it ethical for a doctor to prescribe you a placebo without your knowledge or informed consent? Although the results of this survey indicate just how controversial this issue is (at least when dealing with fibromyalgia patients), two large medical societies clearly oppose the deceptive use of placebos.

In 2004, the American Society of Pain Management Nurses and the American Pain Society issued a statement saying they “adamantly oppose the use of placebos in the assessment and treatment of pain in all patients.” The American Medical Association (AMA) issued a position statement in 2006, which says, “Physicians may use placebos for diagnosis or treatment only if the patient is informed of and agrees to its use … a placebo must not be given merely to mollify a difficult patient, because doing so serves the convenience of the physician more than it promotes the patient’s welfare.”

When a physician prescribes a medication and tells you that it should help reduce your pain, studies have shown that people will usually feel much better, even if the medication is a sugar pill or placebo. Your “enhanced expectations” lead to a sense of hopefulness and this causes temporary alterations in the pain processing centers of the brain that can be objectively measured by brain imaging techniques.² So in reality, a placebo may only be beneficial if your doctor uses words to persuade you that the medication will ease your painful suffering. It’s commonly referred to as the “white coat effect” and it is strongly influenced by what your doctor (who wears the white coat) actually says when he or she gives you the prescription.

The point is, enhancing expectations does not have to be done through the deceptive use of placebos. “Physicians can avoid using a placebo, yet produce a placebo-like effect through the skillful use of reassurance and encouragement,” states the AMA. Perhaps in today’s managed care environment, doctors do not feel that they have the time to talk to their patients. Or maybe it is easier to whip out the prescription pad and recommend something that the physician knows is worthless. Whatever the reason, the patient is short-changed.

One of the most disturbing survey findings pertained to the frequent use of “active” placebos, which are agents with no known benefit but they may exert side effects. Only 2 percent of the physicians actually prescribed a sugar pill, while the most common active placebos were over-the-counter analgesics (45 percent), vitamins (38 percent), antibiotics (13 percent), and sedatives (13 percent).

Analgesics can be detrimental to the stomach (e.g., aspirin, ibuprofen, ketoprofen, etc.) or the liver (e.g., acetaminophen). Vitamins may not cause side effects, but are typically expensive and not covered by health insurance. Particularly disturbing is the use of antibiotics because it leads to the development of drug-resistant bacterial strains (e.g., MRSA). As for sedatives, they can be addicting, enhance the odds of traffic accidents, and magnify the memory fog.

Now don’t rush off and assume your physician is prescribing placebos to you. As a patient, you can protect yourself from receiving a placebo in place of known effective therapies for chronic pain and your other symptoms. The majority of physicians who prescribed placebos were vague about what they were giving their patients. As an example, a physician might say, “This medicine is not typically used for your condition but might benefit you.” So whenever a physician hands you a prescription slip or makes a recommendation for a supplement, you should always ask:

1. What exactly is this medication/supplement and how will it work to reduce my pain (or whatever symptom is being treated)?
2. Are you aware of any published studies that document the effectiveness of this medication over that of a placebo for treating fibromyalgia or a chronic pain?
   • If your doctor answers yes, then ask:
     What percentage of the patients in the study received significant symptom improvement with the agent?
   • If your doctor answers no, then ask:
     What makes you think this will work for me if it did not work for other fibromyalgia or chronic pain patients?

If your doctor is rushed for time or provides a vague and difficult-to-interpret response, keep your cool and remain considerate (doctors do run on tight schedules). Ask if you may speak to the nurse or the physician assistant (if your doctor has one) to receive literature or a patient resource on the medication. If this does not work or if all of your questions have been answered but you still feel confused about the purpose of the prescribed medication, you can always look it up on the government’s Consumer Health MedlinePlus website. Unfortunately, so many medications prescribed for fibromyalgia are actually indicated for nonpainful conditions. Before you fill the prescription, you can also consult your pharmacist, although he or she will not know your physician’s rationale for prescribing a given medication.

1. Tilburt JC, et al. BMJ [Epub ahead of print] Oct. 24, 2008.
2. Benedetti F. Eval Health Professions 25:369-386, 2002.

Symptoms include a depressed mood, loss of interest, low energy, social withdrawal, anxiety, feelings of guilt, cravings for starchy or sweet food, increased appetite, weight gain, and insomnia.¹ Patients say that their worst month is either January or February.

Many people who experience the winter blues are not aware that they have SAD. They may simply view this seasonal lull in mood as a normal stage that everyone goes through when the days are shorter and the body gets less sunshine. Because SAD is often overlooked, most patients endure roughly 13 seasonal episodes of this condition before getting treated for it.

If you experience repeated bouts with depression during the winter and suspect that you have SAD, don’t assume it’s your fibromyalgia and don’t let it compound your symptoms. Effective therapies are available.

Because the nights are longer in the winter, the body’s internal clock and its natural sleep/wake cycle shift.² The body’s clock and sleep/wake cycle are controlled by the pineal gland at the base of the brain. It secretes melatonin when it is dark at night. When the eyes are exposed to light, melatonin production is shut off. Because the sun rises later in the winter, melatonin is secreted longer in the morning. In genetically predisposed individuals, it is suspected to be responsible for the common symptom of morning tiredness or sluggishness that is associated with SAD.³

Two other pieces of evidence that point to a malfunction in the body’s internal clock mechanism have to do with the effective treatment results obtained by using exposure to bright light in the early morning, or a small micro-dose of melatonin taken in the late afternoon to bring the melatonin “cycle” forward in an effort to reduce morning fatigue.

Light Box Therapy

Using a bright light box for 30 minutes each morning has been shown in studies to be just as effective as taking an antidepressant, such as Prozac.⁴ In fact, light therapy tends to work slightly faster and produce fewer side effects than Prozac, a selective serotonin re-uptake inhibitor (SSRI) medication that may cause agitation, sleep disturbance, and palpitations. Analysis of light therapy for treating SAD indicates that patients need to use a high intensity box that emits 10,000 lux; “lux” is the light intensity rating of the box. For a 10,000 lux box, 30 minutes of exposure with your eyes open (but not looking directly at the light) each morning is sufficient.⁵ Boxes with lower “lux” ratings may be cheaper, but more time is needed to get the same effect. Light boxes are not covered by insurance and can be costly. Shop online at superstores like Costco, or a local health products distributor. Prices start around $200. Light therapy may not be as convenient as taking medication, but the side effects are fewer, despite speculation that these devices may cause an increase in eye strain and headaches.

Supplements

Research is ongoing on the use of a tiny dose of melatonin (0.1 mg) taken in the late afternoon, but so far it appears to work synergistically with light therapy to treat SAD.³ This small dosage does not produce sedation, but it has enough of a physiological impact to signal the pineal gland to reset the body’s clock. The typical over-the-counter doses of melatonin are much higher (e.g., 3 mg), so you would need to seek the help of a compounding pharmacist to prepare the smaller dose formula. This would also require a doctor’s prescription.

When the days are shorter, people are at an increased risk of developing vitamin D deficiency. Talk to your doctor. A vitamin D deficiency is easy to identify and inexpensive to correct. Another option might be to visit a tanning salon a couple of days a week for a limited amount of time to make up for the loss of sun exposure and the ultraviolet (UV) rays that help your skin make vitamin D. A small study showed that UV light helped produce natural substances in the body that made people feel better, experience less pain, and improve mood.⁶

Medication

What about preventing SAD episodes from occurring each winter? First, all other medical reasons for depressed mood need to be checked (such as thyroid problems, sleep disorders, lung difficulties, chronic sinus infections, etc.) One study using long-acting Wellbutrin (buproprion) showed that initiating treatment in November and tapering off the dose at the end of March prevented SAD in 50% of patients.¹ The starting dose of buproprion XL was 150 mg/day, and if tolerated or needed, was increased to 300 mg/day. Buproprion is less likely than Prozac to cause side effects, with its primary side effect being dry mouth. In fact, if you have restless legs syndrome (RLS), buproprion is the one antidepressant that will not aggravate this sleep disorder.

Self-Help Strategies

• Avoid becoming “house bound” by going outside each day.
• Make a point of keeping your house or apartment well-lit.
• If you have a fireplace, try lighting it on cold days; there are certain comforts associated with warm fires.
• Be careful not to unintentionally compensate for increased sluggishness by eating lots of sweets. Weight gain will not lift your mood.
• Loosely structure your days to have a blend of time spent on yourself, with others, and doing something productive. Lack of structure is a major contributor to feeling down or blue.
• If you are not working outside the house, try getting dressed and leaving the house at the same time each day, say, 10:00 a.m. (just like going to work). This is a good opportunity to run errands, shop, and accomplish other duties early. It can help you feel more productive and stave off some guilty feelings.

As you get into the heart of winter, create a plan. Everyone thrives on a mixture of people, activities, stimulation, rest, structure, alone time, and time with others.

1. Modell JG, et al. Biol Psychiatry 58:658-667, 2005.
2. Lewy AJ, et al. PNAS 103(19):7414-7419, 2006.
3. Srinivasan V, et al. World J Biol Psychiatry 7(3):138-151, 2006.
4. Lam RW, et al. Am J Psychiatry 163:805-812, 2006.
5. Golden RN, et al. Am J Psychiatry 162:656-662, 2005.
6. Feldman SR, et al. J Am Acad Dermatol 51:45-51, 2004.

The hippocampus plays an essential role in memory and learning, pain regulation, and toning down the body’s response to stress. Given that fibromyalgia patients have cognitive difficulties, severe pain, and a hyperactive stress response, Wood hypothesized that he would find abnormalities in the hippocampus using magnetic resonance spectroscopy (MRS) imaging.

MRS is a technology that enables researchers to measure the concentrations of various brain chemicals or metabolites being produced. One such metabolite, N-acetylaspartate (NAA), is the substance that Wood found to be significantly low in the hippocampus of people with fibromyalgia. NAA is only produced by neurons (not other types of cells), and a reduced level may represent loss of neurons or metabolic dysfunction of the neurons in the hippocampus. Either way, it implies a reduced hippocampal function.

While many abnormalities have been reported in fibromyalgia, only those that can be tied to the symptoms or disease severity are likely to provide treatment insight. Wood found a link that correlates lower NAA values and the person’s level of impairment based on the core features of physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well being. As such, he says his findings lend credence to the idea that a functional or structural defect in the hippocampus contributes to the development of fibromyalgia.

In a previously published study by Wood, he found that fibromyalgia patients did not release dopamine in response to a painful stimulus.² The healthy control group of subjects released plenty of dopamine and experienced much less pain than the group of fibromyalgia patients. The current finding that the hippocampus is not operating properly offers an explanation because it plays a critical role in controlling the amount of dopamine released by other centers of the brain in response to pain. In addition, it further highlights why medications that increase dopamine in the central nervous system are being evaluated for the treatment of fibromyalgia.

What’s next? A 2007 report by M. Catherine Bushnell, Ph.D., of McGill University in Montreal, showed an accelerated gray matter loss in the hippocampus and many other brain structures involved in pain processing.³ In August of this year, Bushnell was funded by AFSA to replicate these findings using a larger group of subjects and to determine if the results correlate with a variety of measures pertaining to cognitive function and pain.

AFSA is a 501 (c)3, all-volunteer, nonprofit organization dedicated to funding research on the causes and treatments of fibromyalgia. For more information, visit AFSA’s website.

1. Wood PB, et al. J Pain [Epub ahead of print] Sept. 2, 2008.
2. Wood PB, et al. Eur J Neurosci 25:3576-3582, 2007.
3. Kuchinad A, et al. J Neurosci 27:4004-4007, 2007.

Quite often, fibromyalgia is triggered by muscle pain in one area (due to an injury or fall) that eventually spreads, or refers, to the whole body. In addition, once symptoms of fibromyalgia are present, it is common for the regional pain caused by myofascial trigger points to produce a referral of pain. Myofascial trigger points (MTPs) are regions in a muscle with tense, ropey bands that feel like firm knots. Pressing on an MTP hurts, and it also refers pain to other muscle areas. This spreading pain is a common phenomenon, but it is not known if it varies between men and women.

A research study presented at the 2008 American Pain Society meeting investigated whether local and referred pain is different between women and men.* A University of Iowa research team recruited 69 healthy volunteers (35 female, 34 male) and injected a painful acidic solution into the mid-belly of their back calf muscle to determine if the spread or referral of pain was different between the sexes.

The average pain ratings at the site of the acidic injection was the same for the two groups (women and men) … an important observation because it means that women do not simply complain more about their pain. Of the participants, 62 percent experienced a referral or spreading of pain from the middle of the calf down to the back ankle region. Looking specifically at the group of volunteers who referred pain, women outnumbered the men two to one. Ironically, this is the same distribution ratio of reported widespread pain in the general population.

The study authors state that the referral or spread of pain likely occurs by a central nervous system mechanism when the pain at a regional muscle site exceeds a certain threshold. Given that women do have lower pain thresholds, this could partially explain why women are more likely to experience the spreading of pain and may be why more women develop fibromyalgia. And although a smaller portion of male volunteers in this study developed referred pain, these findings also support the fact that there is a subgroup of men that may be more susceptible to getting fibromyalgia.

Aside from helping to explain the higher prevalence of fibromyalgia in women, this study offers insight on the importance of treating MTPs—for both women and men. Not only do MTPs refer pain to other areas (which provides a strong case to get them treated post haste), they also increase the number of pain signals going to the central nervous system. This, in turn, can cause a magnification of the “whole body” pain of fibromyalgia.

Many treatments may help relieve or reduce the pain of MTPs, such as massage, injecting the MTP with an anesthetic, ultrasound-omit, frequency specific microcurrent, low level laser therapy, application of moist heat or coolant spray and then gently stretching the affected muscles, and various hands-on physical therapy techniques. In addition, factors that may enhance the development of MTPs should be addressed. This may include getting quality sleep, improving the way you use your muscles to avoid straining them, and eating healthy so that your muscles are adequately nourished.

* Frey Law L, et al. J Pain 9(4 suppl 2):P9 Abs #134, 2008.

Frank Leavitt, Ph.D., and Robert Katz, M.D., of Rush Medical College in Chicago, IL, just published a study showing that the speed of information processing was significantly impaired in 50 percent of the 67 fibromyalgia patients tested.* Putting their findings into perspective, the authors state, “People with fibromyalgia are essentially doing the same job at roughly half the speed.”

If you require more time to process the same amount of stimulus information, how does this relate to the symptom of feeling like you are in a brain fog, or what is often referred to as fibro fog? According to Leavitt and Katz, “Time delays in processing information alter the timing of other cognitive operations. For example, delays in processing can affect what you remember, because time governs the decay of information.” So the quicker you can process information, the sooner it can be stored in permanent memory and the greater likelihood that the data actually gets stored. Faster processing speeds also translate into improved accuracy of the details being retained. This occurs because of the reduced odds that the information “fades” or becomes “blurred” before it has a chance to be stored in memory.

Yet, you may be wondering: If fibromyalgia patients have a reduced mental processing speed, why wasn’t this identified years ago? A person’s processing speed cannot be determined by a single test. One must measure all factors that influence the overall processing speed, which includes mental speed (i.e., how fast the brain processes info), auditory speed, quickness of pattern recognition, pace of visual scanning, speed of decision making, inspection time, and motor (muscle movement) speed. A deficit in one area could have serious ramifications, but may not be picked up unless all of the aspects that contribute to processing speed are measured.

Leavitt and Katz used a battery of ten tests to evaluate all factors that may influence a person’s processing speed. This approach is more extensive than previous studies, and it produces a complete picture of every step involved in the speed of processing all types of information. Sixty-seven fibromyalgia patients (recruited consecutively and not based on whether they complained of brain fog) were compared to 51 non-fibromyalgia subjects with memory complaints (e.g., they had a history of seizures, head trauma, stroke, etc.). The results for both groups were also compared to the standardized norms for each test.

In the reading and color naming tasks, fibromyalgia patients scored substantially poorer than the group of controls that complained of cognitive difficulties. The reading test consisted of asking subjects to read the names of colors printed in black ink (e.g., red, blue or green). The color naming test required subjects to state the color of a row of Xs printed in either red, blue or green ink. In general, people have the ability to read words automatically faster than their ability to name colors. All tests were timed.

Despite how annoyed you may be with your fibro fog, there is an upside to this finding. More than 70 percent of fibromyalgia patients scored in the normal range on at least seven of the ten tests. This means that most of the steps involved in processing information is done in a timely manner, and only the brain areas involved in reading and color naming are affected. So the processing speed deficit in fibromyalgia is selective, but the downside is that researchers do not know what is causing the dysfunction.

The findings by Leavitt and Katz are somewhat paradoxical because fibromyalgia patients performed the worst on the tests that were the easiest. “Unlike the other timed tests in the battery, naming words and colors are relatively mindless tasks that are executed with a minimum of personal effort. In tasks that require a greater demand on taxing process capabilities, the speed in fibromyalgia patients is either similar to or better than the control sample.”

While this selective glitch in mental processing speed of reading and color naming may be an oddity, this study shows that for half of the fibromyalgia patient population, fibro fog is definitely a reality! If your doctor refers you for cognitive testing, make sure that the Word and Color naming tasks of the Stroop Test are included. Inquire about the tests to be used before you even set up an appointment. Otherwise, your cognitive complaints may go undetected and your doctor will falsely assume that you are just another complainer.

The University of Washington has an Interactive Stroop Test available for you to take online.

* Leavitt F, Katz RS. J Clin Rheumatology 14(4):214-218, August 2008.

The Fibromyalgia Network has been reporting on the progress of Cymbalta through clinical trials since the spring of 2004.

SNRI drugs, such as Cymbalta, are thought to relieve pain by increasing the availability of serotonin and norepinephrine (NE) in the central nervous system. These two neurotransmitters help filter out pain signals in the spinal cord so that fewer make it up to the brain. When serotonin and NE are released at the nerve endings, SNRIs latch onto these two neurotransmitters and carry them back across the nerve junction so that both can be reused to fight pain. In a way, SNRIs “recycle” the two neurotransmitters that are low in many patients with fibromyalgia.

In the most recent double-blind, randomized, phase III clinical trial of 520 men and women with fibromyalgia, researchers compared Cymbalta at 20 mg, 60 mg, and 120 mg doses taken once daily for six months versus placebo. People taking the two higher doses (but not 20 mg/day) reported pain reduction after the first week. After three and six months, patients taking either 60 or 120 mg daily reported a significant reduction in pain compared to patients taking the placebo. Aside from measures of pain, the two higher doses of Cymbalta also reduced mental fatigue, which might possibly relate to improvements in mental clarity.

Cymbalta was shown to be equally effective in men and women with and without mood disorders. Even people over 65 years of age reaped similar improvements in pain as those in the younger age groups.

Nausea, dry mouth, constipation, and sleepiness were the most common side effects of the medication. The side effects increased at the higher dose. Weight gain or blood pressure elevations may occur in a subgroup of patients taking Cymbalta.

Overcoming the side effects may include monitoring blood pressure (if it goes up, you may need to reduce dose), making adjustments for daytime sleepiness, and not taking it close to bedtime if it disrupts your sleep. “The key message is to not give up too soon: try different doses and try taking it at different times during the day. Patients usually find the right approach for them,” said Lesley Arnold, M.D. of the University of Cincinnati College of Medicine, in Ohio, and lead investigator for the clinical trials on Cymbalta.

Cymbalta has already been FDA-approved to treat diabetic peripheral neuropathic pain (DPNP), major depressive disorder, and generalized anxiety disorder, all in adults older than 18 years of age.

The FDA also added important warnings and precautions to the Cymbalta prescription information including who should not take this medication.

Many chronic, painful conditions tend to increase with age, such as rheumatoid arthritis, diabetes, cancer, and fibromyalgia. “Important to understanding these conditions is the question of how advancing age changes the processing and ultimately the perception of pain,” comments Yezierski in his study presented at the May 2008 American Pain Society (APS) meeting.

Rats of varying ages were injected in the hind paws with a substance that causes a temporary state of inflamation and discomfort. Next they were evaluated for changes in thermal sensitivity as a function of advancing age using four different age groups: 8 months, 16 months, 24 months and 32 months. In rat time, 8-10 months of age is considered mature, while 37 months is considered “very old.” The rats were tested to determine their relative degree of thermal preference and the speed at which they escaped cold and hot environments (50 degrees F and 112 degrees F).

Yezierski found that the older the rat, the greater their preference to heat (i.e., aversion to cold), implying an increased cold sensitivity as animals age. He also found that the speed at which the 32-month old rats escaped from the cold and hot environments was faster than for any of the other age groups. In fact, the 8- and 16-month old rats were not bothered by exposure to the hot/cold climates.

Although this study was done in rats, not humans, it lends support to the common phenomena expressed by retirement-aged people who can no longer stand the cold and also tend to develop an aversion to extremely hot climates.

The study, conducted in Great Britain, looked at the medical costs per year of patients not diagnosed with fibromyalgia and compared it to their costs per year after they were diagnosed. In a way, patients served as their own control because it looked at each person’s change in medical expenditures before and after the fibromyalgia diagnosis.

Information about the cost of four categories was obtained: 1) diagnostic tests, 2) medications, 3) referrals to specialists, and 4) visits to the general practitioner (similar to the primary care provider in the United States). Between the years 1998 and 2003, 2,260 new diagnoses of fibromyalgia were recorded. The average age of the patients was 49 years, and 81 percent of the cases were women.

Following diagnosis, study results demonstrated substantial reductions in health care costs. In fact, the overall cost savings per patient, per year was $265. Looking at how this breaks down into the various health resource categories, the savings were as follows: $96 on tests, $89 on medications, $62 on referrals to specialists, and $18 on visits to general practitioners. Understandably, the cost savings would be less for doctor visits because fibromyalgia is a chronic condition and patients still need to regularly see a physician for their fibromyalgia-related health care.

While $265 per patient per year may not sound like a lot of savings, keep in mind the high prevalence rate of fibromyalgia (3-5 percent of the general population). In the United States, if just 10 percent of people with fibromyalgia were currently undiagnosed, the added medical burden would be $2 million per year using the cost valued from the Great Britain study. However, medical costs are considered to be much higher in the United States, so the cost burden of not diagnosing people with fibromyalgia would be substantially more.

The January 14th front page article in the New York Times called into question whether the diagnosis of fibromyalgia was real. The report also stated that diagnosing fibromyalgia placed a financial burden on the health care system. Clearly, these statements were merely opinions that were deceptively promoted as fact. This research paper provides the scientific proof that diagnosing people with fibromyalgia not only reduces unnecessary suffering, but it saves on health care costs too.

* Annemans L, et al. Arthritis Rheum 58(3):895-902, 2008.