The two most common treatments for musculoskeletal pain used by physical therapists are ultrasound and transcutaneous electrical nerve stimulation (TENS). Ultrasound works by emitting sound waves from a hand-held wand that penetrates between 1 and 2 inches deep into soft tissue, such as your muscles. These sound waves can increase heat and improve circulation in the region, relax muscles, and heal tissues. TENS units work by applying two pads placed on the skin across a painful area. The small unit emits an electric signal believed to ease discomfort by activating the natural opioid pain-relieving system in the spinal cord.

A research team led by Felipe Azevendo Moretti, P.T., of the Universidade Federal in Sao Paulo, has found the combination of both therapies have been somewhat successful at reducing the muscle aches and disturbed sleep of fibromyalgia.* However, that is based on using this combination therapy during 12 sessions over a one month period. Each of the treatments was applied for two minutes at each painful tender point (typically averaging 14 per patient), making this approach very time-consuming. Whereas insurance companies may not approve such frequent visits.

But the real question answered by the Moretti’s recent study is whether there was any difference in effectiveness if sessions were once or twice weekly over a duration of 12 weeks. This means one group of 25 fibromyalgia patients received 12 treatments while the other group received 24 treatments. Moretti looked at their pain, sleep and physical function measures before and after the 12 weeks, and found the effects of combined ultrasound plus TENS was the same regardless of whether it was given once or twice weekly.

Before the current study, patients were asked to rate their level of pain on the first day of the study and over the previous week, as well as their sleep, and overall quality of life. They also noted their number of tender points (one group averaged 15 while the other averaged 14).

After 12 weeks of treatment to tender points, patients’ scores in all areas dropped dramatically. Those receiving treatment once a week reported pain in half as many tender points, and pain scores fell from 7.6 (on 10 a point scale where 10 represents worst possible pain) to 3.1. Pain experienced over the first seven days compared to the last seven days of the study dropped from 9.5 to 3.3. Sleep problems and quality of life scores also improved at least 35%. Similar changes in scores were obtained by the twice weekly study group.

“Based on these results, we can observe that the combined therapy was effective not just in the improvement of the musculoskeletal symptoms, but also helped the patients with sleep and quality of life,” said Moretti. “Once the patients have a reduction in the number of tender points, the subjective feeling of pain is diminished.”

A greater than 50% drop in painful symptoms of fibromyalgia for patients not taking any medications or using other treatments is substantial. In addition, none of the patients experienced intolerable side effects, which can be a turnoff when trying a new drug or other approaches.

Moretti believes this combination therapy along with medications and other forms of treatment, such as water exercise or walking, can be added to each patient’s care to create more substantial benefits. How long the combo ultrasound plus TENS therapy lasts beyond the three-month treatment was not determined by this study. Regardless of its lasting effects, this approach can certainly help patients increase activity levels while minimizing the potential for added discomfort.

“This study helps professionals who work with fibromyalgia patients know that it is possible to obtain symptom improvement with only one weekly application of the ultrasound and TENS therapies,” said the physical therapist. “Clearly, it is important to offer the most efficient treatment solution for the least amount of money.”

* Moretti FA, et al. Physiother Res Int Nov 24, 2011, doi: 10.1002/pri.525. [Epub ahead of print]

(Keep in mind this is a research study to show the effectiveness of TENS. Understandably, 12 PT treatments could be costly, but a therapist can help you with the proper use of a TENS unit that can be purchased and applied as needed. Units range from $40 to $70.)

Milunovic points out there is a major problem with the definition of pain as “an unpleasant sensory and emotional experience.” Adding to this vague definition that is largely useless to the practicing physician is the 1990 fibromyalgia criteria put forth by the American College of Rheumatology (ACR). It says fibromyalgia is present in a person who has tenderness in at least 11 of the 18 defined tender point areas. That definition is all about pain and says nothing about the other baffling symptoms you have such as fatigue, sleep disorder, or trouble concentrating (e.g., fibro fog).

“The new 2010 ACR criteria somewhat reduce the importance of tender points while concentrating more on other features,” says Milunovic. “The primary aspects newly introduced are fatigue, cognitive problems and waking without feeling rested. Secondary aspects include symptoms varying from irritable bowel disease to dizziness and nervousness.”

On the surface, this new criteria may seem more likely to pick up the specific types of symptoms you have besides the pain, but it falls short as well because it just generates a number ranging from 0 to 12. “This approach attempts to collapse symptoms into a globally perceived measure of dysfunction,” says Milunovic. Condensing your symptoms and their severity to just a number may be useful for following your progress in a clinical trial, but doesn’t help your doctor pinpoint specific symptoms that deserve priority treatment.

“Being able to identify key symptom clusters may reflect significant individual variability,” says Milunovic. In other words, not all fibromyalgia patients are alike, nor should they be treated that way. He goes on to suggest, “Measurement of this variability may allow for more individualized therapeutic strategies.” After all, when you go to the doctor, don’t you want to be treated for your individual complaints, rather than a number or score obtained through tender point counts or a symptom tally?

“We may be missing or mixing subpopulations of fibromyalgia patients with distinct neurobiological or behavioral characteristics,” notes Milunovic. By ignoring the subgroups of fibromyalgia patients and applying cookbook treatment guidelines by various professional pain associations, he adds that “the use of personalized medicine in research and clinical practice remains only a remote possibility.”

While most researchers in the field of fibromyalgia acknowledge many subgroups or varieties of this disease, patients with highly variable characteristics are excluded from clinical trials. So the published trials your doctor may be relying upon for treatment guidance might not apply specifically to you. Milunovic suggests various scientifically sound yet cheaper assessment tools, such as multi-probe brain electroencephalograms, be used in place of the expensive functional MRI tests to better define the various subgroups of fibromyalgia patients.

Implementing a uniform set of objective test measures to all patients and entering the findings into a massive database used by multiple countries is how Milunovic believes subgroups of fibromyalgia may be identified. He adds that the end goal is to enhance the effectiveness of treatments by enabling physicians to offer more personalized care specific to your particular set of symptoms.

* Bras M, et al. Psychiatria Danubina 23:246-250, 2001.

Using 44 women with fibromyalgia and 122 healthy controls, the researchers snipped hairs from the tops of heads, very close to the roots, to perform their analysis. Like crime scene investigators, the research team led by Nam-Seok Joo, M.D., carefully selected patients and controls with similar characteristics related to age, body mass, and lifestyle habits. Women with other illnesses that could possibly influence their hair sample were excluded from the study. All the participants, averaging 44 years of age, had to refrain from using hair gels, or applying any type of chemical processing (such as coloring or perms) for at least two weeks before the snip.

The clean hair analysis showed fibromyalgia patients had significantly lower levels of calcium, magnesium, copper, iron, and manganese. Many other minerals, such as chromium, selenium, potassium, phosphorous, sodium, and zinc, did not differ between the patients and controls.

Previous reports looking at mineral status in fibromyalgia patients have been mixed and often conflicting. Joo points to the inherent problem of these prior studies, which sampled blood or urine. The body is made to adapt to changing demands, such that many minerals are robbed from the bones to maintain sufficient blood levels. And alterations in the urine may not say much about the level of mineral storage in the bones or other tissues. However, hair analysis should provide a more accurate picture of the body’s overall mineral status.

“Several studies have explored the relationship between fibromyalgia patients and oxidative stress. Still other studies investigated elemental composition of patients, but they surveyed only blood and urine samples,” reported Joo. “The latter studies, while potentially useful, overlooked the mineral content of hair. The hair mineral assay is a good method to explore the mineral status at the cellular level.”

So what exactly does it mean to be low in the five minerals identified by Joo? More studies are needed, but Joo points out that several reports have shown that fibromyalgia patients lack the necessary antioxidants to neutralize reactive chemicals that can interfere with cellular functions. This, in turn, leads to an oxidative stress environment and could account for symptoms involving muscles spasms and cramps, fatigue, neuromuscular weakness, and insomnia.

While it is not practical to start taking a whole barrage of expensive mineral supplements, fibromyalgia patients should consider taking a daily broad-spectrum multivitamin and mineral supplement that contains 100 percent of the essential nutrients including iron.

* Kim YS, et al. J Korean Med Sci 26(10):1253-7, 2011.

Low-intensity exercise is often recommended to people with fibromyalgia to help maintain mobility. But the thought of starting an activity, overdoing it, stopping, and starting all over again is a frustrating and discouraging cycle.

Two researchers in Spain have come up with a therapeutic exercise program that fibromyalgia patients seem to be able to stick with while improving their overall health.* The study included 44 fibromyalgia patients divided into two groups. One formed the control group that received educational literature on fibromyalgia health and simply resumed their normal lifestyle. The actual study group received an exercise program that included deep water running in a warm water pool with the aid of a floatation device.

The eight-week program consisted of five minutes of gentle stretching, 15 minutes of mobility and flexibility exercises, 15 minutes of moderate muscle strengthening, 20 minutes of deep water running with a flotation device, followed by a five-minute relaxing, cool-down period. In total, the participants did this one-hour routine three times a week.

Before and after the eight-week program, both groups were given a fibromyalgia symptom questionnaire to evaluate the treatment effects. In addition, the study group was given a heart-rate activity test to determine at what point they were pushing themselves beyond a moderate threshold. This information was used to individualize each study participant’s exercise treatment program.

During the first two weeks, patients in the deep water running group were instructed to keep a fairly low heart rate. Then they should attempt to exercise with an increased heart rate that produced a moderate water running pace based on their prior testing. This part of the study was done in six feet of 81-degree water (the deep end of a pool). Participants wore a floatation belt that kept their head above water, and they were instructed to mimic a running motion. No participants dropped out of the study.

The test group reported a 20% reduction in most of their fibromyalgia symptoms. Significantly noted was less pain, fatigue, and morning stiffness. Improvements were also made in physical function, anxiety, depression, sleep, and overall quality of life. The control group showed no improvement.

“It is difficult to separate the effectiveness of the deep water running from the other activities,” said Antonio I. Cuesta-Vargas, Ph.D. “But previous studies of exercise show worsening of symptoms and high drop-out levels. Here, there were no reported adverse effects confirming that patients with fibromyalgia can undergo physical training without damage and increased muscle soreness, and the deep water running may be a useful addition to treatment.”

A 20% improvement is relatively small, but keep in mind that this is just one aspect of treatment. Cuesta-Vargas is now seeking to incorporate this combination of physical activity into a complete program for fibromyalgia patients that includes diagnosis, activity and counseling, and pain management.

* Cuesta-Vargas AI, Adams N. Clin Rheumatol [Epub ahead of print] Aug 25, 2011.

Note: Looking for a flotation device that’s easy to use? See a variety available online at the following locations:

• Aqua jogger and water running flotation devices: Amazon.com, $28.74 and up.
• Flotation belt by WaterGym, Watergym.com, $33.95
• Water jogging belts: SwimOutlet.com, starting at $25.95.

Sustained muscle contractions are known to trigger the release of pain-relievers into the spinal cord to reduce feelings of achiness in those muscles that are getting the workout. It’s a natural process that soothes pain, at least in healthy subjects. But this system that provides analgesia after exercise appears to be working the wrong way in fibromyalgia patients.

Study participants were asked to contract the large shoulder muscles in their upper back until their muscles gave away to fatigue. Twenty-two fibro patients were compared to the same number of healthy control subjects. Everyone in the study was middle-aged, so age was not a factor.

The upper shoulder muscles’ sensitivity to pressure pain was measured before and immediately after the contraction, as well as 20 minutes later. Pain sensitivity was also checked in a lower leg muscle that was relaxed the entire time. The research team predicted that the spinal cord was misinterpreting the messages from the contracting muscles and making pain worse throughout the body in people with fibromyalgia.

The brief muscle contraction in the healthy group produced less pain in the shoulder area right after the exercise and 20 minutes later. This is what should happen when taxing one’s muscles, so that waste products like lactic acid don’t leave people hurting. If this did not happen, people would learn to avoid exercise whenever possible and that wouldn’t be healthy. Pain sensitivity in the lower leg was unaffected. The results were quite the opposite for those with fibro.

Pain levels started out much higher in the group of fibromyalgia patients (as expected). In addition, the spinal cord did not kick in to relieve post-exercise soreness in the shoulders. Worse yet, pain sensitivity increased significantly in the leg muscles that were relaxed throughout the study.

What does this mean? The system in the spinal cord that people rely upon to ease post-exercise discomfort seems to be responding to workouts by increasing the pain in fibro. So, if you are a fibro patient on your feet all day long, your activity can cause sore leg muscles and also make other muscles hurt, such as those in your arms.

Exercise is an essential part of staying fit and healthy, but it is hard to do if it increases your pain, as this study demonstrates. The trick is to not overwork any of your muscles. This explains why fibromyalgia patients state that keeping their pain under control requires frequent rest breaks and changing positions to avoid straining any muscle group.

Increasing physical function has to be done extraordinarily slow in fibromyalgia patients just to keep the pain levels stable. As your muscles get bigger and stronger, your body will be able to sustain more activity before the spinal cord decides to amplify your pain. Improving fitness has to be done very carefully and gradually, or increased muscle aches will constantly trip you up (unlike those healthy folks who feel great after a heavy workout).

* Ge HY, et al. Descending pain modulation and its interaction with peripheral sensitization following sustained isometric muscle contraction in fibromyalgia. Eur J Pain 16(2):196-203, 2012. (Available online ahead of print June 28, 2011.)

]]> http://www.fmnetnews.com/latest-news/keeping-your-body-aches-under-control/feed 57 http://www.fmnetnews.com/latest-news/disease-severity-markers http://www.fmnetnews.com/latest-news/disease-severity-markers#comments Fri, 29 Jul 2011 21:20:16 +0000 joshua@fmnetnews http://newsite.fmnetnews.com/?p=1934 Wouldn’t it be wonderful if doctors could order a blood test to see how well a therapy is doing, or document that a drug is not working? Better yet, you could have objective proof of your pain severity instead of your lab work making you look perfectly fine. Several blood markers have been identified in fibromyalgia patients, and the results are being refined by Alan Light, Ph.D., of the University of Utah, in hopes that they will produce a diagnostic blood test. Light also suspects he will be able to identify many subgroups of fibromyalgia.

The work by Light is absolutely exciting, but a diagnostic blood test could take years. In the meantime, Dennis Ang, M.D., and his team at Indiana University, are looking at the potential for a quick, rather simple lab test for objectively measuring disease severity. In particular, his goal is to document the pain levels in people with fibromyalgia.*

Part of the difficulty with developing blood markers for fibro is that most of the action is occurring within the nervous system and the blood often does not reflect these changes. So Ang is looking for surrogate markers in the blood that might tell doctors how the central nervous system is working in people with fibromyalgia.

Plenty of research evidence shows that painful inputs from all over your body and multiple muscles place your central nervous system on high alert. This bombardment of inputs leads to a system where the concentration of pain transmitting chemicals builds up, such as substance P (SP) and corticotrophin-releasing hormone (CRH). In fact, both SP and CRH are elevated in the spinal fluid of people with fibromyalgia. As a result, the nervous system becomes sensitized to future painful inputs. Instead of toning down the pain signals, the nervous system magnifies them (e.g., making you feel worse, not better).

So why don’t researchers and treating physicians just order a blood test to measure your levels of SP and CRH? While these chemicals are at least double what they should be in the spinal fluid of people with fibromyalgia, their values in the blood are normal. This is the hurdle that researchers have been stumbling over because many factors are clearly abnormal in the nervous system in people with fibro. Yet, spinal fluid measurements are only done in research studies and such techniques are simply not available for treating physicians.

Ang’s team is testing a method to take a peak at what is happening inside the nervous system by testing two substances in the blood that may be caused by elevations in SP and CRH (both elevated in fibromyalgia). A simple diagram of how this new test might work is shown below. Basically, elevated SP and CRH causes an activation of mast cells that are located all over your body, leading to enhanced release into the blood of two immune system chemicals or chemokines: IL-8 and MCP-1.

Exactly what IL-8 and MCP-1 do in the body is not nearly as important as just knowing that previous research has shown them to be elevated in the blood of fibromyalgia patients. If these two substances correspond to how well you are doing, then their concentration should decrease with improvements in pain ratings. On the other hand, if pain scores get worse, then their levels ought to increase. At least, this is how markers for measuring your disease severity should work.

One way to check if these two markers are able to pick up changes in fibro pain is to measure them before and after a treatment trial (i.e., the longitudinal measurement of treatment effects over time). Ang put a small group of fibro patients through a six-week course in pain and stress management while not changing any medications used.

Improvements in fibro pain corresponded to reductions in both IL-8 and MCP-1. The results are only preliminary, but offer hope that objective disease severity markers can be developed for fibromyalgia.

“While our study does not implicate a cause-and-effect relationship, the longitudinal associations of fibromyalgia pain severity with blood concentration of IL-8 and MCP-1 raise the question that these two chemokines may be involved in the pathogenesis of fibromyalgia,” writes Ang. “If our findings are replicated in a larger group of patients, IL-8 and MCP-1 may facilitate the prediction of prognosis and monitoring of treatment response in the future.”

* Ang DC, et al. Pain Med [epub ahead of print] June 30, 2011.

With primary care facing a shortage crisis in the U.S., the need for more healthcare options is crucial. In research by Thomas Bodenheimer, M.D., M.P.H., today’s medical students are more reluctant to go into primary care because of higher workloads and lower incomes compared to specialty medicine.¹ And with healthcare reform expected to increase access to primary care for 32 million more Americans in the next few years, only 7% of fourth-year medical students in a 2010 survey plan to go into this field.

“NPs are well positioned to be part of the solution to issues of access to primary care,” said Joanne M. Pohl, Ph.D. and Board Certified NP, in an article written by Laura A. Stokowski, R.N., M.S., for Medscape News.² “Forty years of evidence confirm that NPs provide high-quality, cost-effective care and can contribute significantly to narrowing the primary care gap. There is no place for limitations on practice or other regulations that are not based on evidence.”

Research led by Marielle E. Kroese, M.Sc., provides evidence that supports specialized nurses in primary care.³ Her team in the Netherlands did a study of 193 patients suspected of having fibromyalgia who were referred for diagnosis and treatment to a rheumatology clinic. Patients in the study were randomly divided and assigned to see either specialized rheumatology nurses or a rheumatologists (M.D.). The researchers wanted to compare patient satisfaction and costs between the care providers.

Initially, patients were able to get an appointment with the nurses within three weeks compared to three months for the rheumatologists. Actually, eight patients assigned to the rheumatologists dropped out of the study because of the long wait time.

Patients were seen one week after their first consultation, at three weeks, six weeks, and nine months later. About 75% of patients seen by a rheumatologist and 92% of those seen by the nurses were diagnosed with fibro. (All patients confirmed by the nurses with fibro were seen and received further confirmation from a rheumatologist.) Regardless of diagnosis, all the patients filled out questionnaires every two weeks during the study concerning their health, treatments, satisfaction with their care provider, and ability to function. Patients were also required to maintain a record of medical expenses.

After nine months, both patient groups reported to be in similar heath. However, the patients seeing the nurses were more satisfied and had better functionality with less cost throughout the study. Specifically, patients rated the nurses better in all nine patient-satisfaction categories including: taken seriously, understanding, time spent with nurse, paying attention to the social aspects of the illness, and giving clear information and advice. The research estimates that the average costs including medical and loss of productivity at work and home amounted to $5,595 per patient seen by a nurse compared to $7,690 per rheumatology patient. Some of this difference is accounted for by the patients who reported not being productive in the three months they had to wait for their initial appointment with the rheumatologist.

“The nurse-led diagnostic process can be recommended from a healthcare and societal perspective,” said Kroese. “Patients in the nurse group were significantly more satisfied. Total healthcare costs and patient and family costs were significantly lower in the nurse group. Also costs from a societal perspective including absenteeism from work were lower.”

Where do you go from here? Check your insurance list of providers for nurse practitioners. If none are listed, don’t dismay. You may need to print the list of nearby primary care providers and call around to find out if an NP works in the doctor’s office. The M.D.’s name may be on the door (and on the billing paperwork), but research shows that an NP may be your best option for fibromyalgia care.

1. Bodenheimer T, Hoangmai PH. Health Aff 29(5) 799-805, 2010.
2. Stokowski L. Medscape Ask the Experts The Nurse Practitioner Will See you Now, June 29, 2010.
3. Kroese ME, et al. J Rheumatol [Epub ahead of print] April 2011.

Regular sun exposure causes your skin to produce vitamin D, which does more than maintain healthy bones and build strong muscles. This essential vitamin is known for its immune system effects on relieving pain and inflammation. Making sure you get adequate sun exposure should lead to greater vitamin D levels and less fibromyalgia pain … at least in theory.

A team in Israel put this theory to the test. Their study included 60 chronic pain patients, primarily those with fibromyalgia, but also patients with osteoarthritis and rheumatoid arthritis. All subjects sun-bathed briefly each day for three weeks under medical supervision. Pain levels, disease severity, and serum vitamin D were measured before and after the three-week period.

Vitamin D increased by 25%, regardless of whether the patient had fibromyalgia or arthritis. Greater changes in vitamin levels correlated with the degree of improvements in pain and disease severity. The research team comments that their findings “support the hypothesis that increased serum vitamin D may reduce musculoskeletal pain.”

Minimize Risks

Exposure to sun places people at risk for skin cancer.³ Dermatologists Steven Feldman, M.D., Ph.D., and Sarah Taylor, M.D., at Wake Forest University, offer the following advice for FM patients who find the sun helpful:

• Short, controlled increments (less than 15 minutes), 2-3 times a week, are best.
• Cover your neck with a cloth and wear a hat that shades your face. These are the most common areas for skin cancer.
• Wear a cover-up if the warmth of the sun reduces your pain, and wear sun screen.

1. Taylor SL, et al. J Alt Complement Med 15:15-23, 2009.
2. Harari M, et al. Isr Med Assoc J 13:12-15, 2011.
3. Feldman SR, et al. Pediatric Derm 22(6):501-12, 2005.

A new study by a Canadian team helps substantiate this escalating pain experience.* It also documents that movement-related pain is more severe for people with fibromyalgia compared to patients with chronic low back pain. And better yet, these differences between fibro and low back pain are not related to depression or fear of movement.

The repetitive task study required patients to lift 18 canisters off a table in front of them (just hold it for a second, then place it back down). The canisters were waist high and arranged in three rows. Those in the front row could be lifted without reaching or bending forward. Lifting the canisters in the second and third rows required additional stretching and strain on the arms and back when reaching for them. With each successive canister lift, the subjects rated their pain level and how heavy they perceived the canister to be (some were filled with more sand than others but they all looked identical).

Fibromyalgia patients reported more intense pain than the back pain patients after lifting the sixth through 18th canister. As the number of canisters lifted increased, so did the pain caused by the repetitive activity, and more so for the fibro group of patients. These differences were not due to lifting the canisters longer or faster, as both patient groups performed the lifting task with the same speed.

The study found that 28% of the 50 fibromyalgia patients experienced at least a one-third increase in pain levels going from the first to the 18th canister. Only 6% of the 50 back pain patients experienced a similar increase in pain with the repetitive lifting task.

“There were no indications that the fear of movement accounted for diagnosis-related differences in repetition-induced pain,” state the authors. Indeed, fear of movement was the same for both the fibro and back pain patients, so the greater pain in the fibromyalgia group could not be attributed to fear. However, the escalation of pain with repeat movement could offer an explanation for why fibro patients struggle during the early phases of a fitness program that necessitates using the same muscles over and over again.

“The results of the present study show that individuals with fibromyalgia are more susceptible to repetitive-induced activity related pain than individuals with chronic low back pain,” conclude the study authors. “The findings are consistent with anecdotal accounts of the difficulties that individuals with fibromyalgia experience in the context of repeated physical activity.”

* Lambin DL, et al. Pain 2011 Jun;152(6):1424-30.

An effective treatment for sleep can be challenging to find, particularly one that does not leave you feeling hung over in the morning. Medications may help by sedating you, but after you wake up, their effects may persist. Rather than a therapy that works by sedation, it would be better to find a treatment that actually improves the quality and restorative nature of your sleep. Of course, long-term safety is also a concern because the sleep disorder of fibromyalgia is most often persistent and chronic.

A research team in Italy tested a more natural route to treating insomnia.* Using only melatonin, zinc, and magnesium supplements, they enrolled a group of residents in a long-term care facility for the study.

Each of the three supplements selected are substances the body needs and uses every day. While there are no set quantities for melatonin use, science knows this naturally produced hormone in the brain is closely associated with sleep-wake cycles and diminishes in quantity as we age. Zinc and magnesium are both trace minerals that are needed by the body to make melatonin. In addition, zinc may improve mood, and magnesium is relaxing and calming. Combined, all three of these elements seem to strengthen each other’s properties and should lead to better quality of sleep.

Forty-three men and women with insomnia were carefully selected to participate. Since they were elderly, the researchers were meticulous in screening out people with dementia, depression, other sleep disorders, or those on any medication that might alter sleep.

Researchers administered a series of commonly used questionnaires for assessing sleep. In addition, everyone wore armband sensors that measured how much they slept and moved during the day and night. The greater the activity picked up by the sensors during the night, the more the disturbed sleep. The questionnaires were given before and after the eight-week study, while the armbands were worn for 72 hours before the study and the last two weeks of the week study.

Twenty-two participants were given 5 mg of melatonin, 225 mg of magnesium, and 11 mg of zinc in a pear sauce each night before bed for eight weeks. The dose of the magnesium and zinc is just shy of the standard recommended daily allowance as established by the U.S. Department of Agriculture.

The other 21 participants were part of the control group that received only the pear sauce. None of the participants knew whether they were in the test group or the placebo control group.

Patients in the test group reported a 45% improvement in their sleep quality, compared to the control group. In addition, benefits were reported in not only quality of sleep, but also mood, ease in getting to sleep, morning alertness, and overall feeling better during the day. The sensor on the armband also measured significant improvements in total sleep time and daytime movement. In contrast, control group members reported no differences in sleep or health at all. Overall, side effects were minimal and none of the participants in either group dropped out of the study.

“These study findings are of great relevance from a clinical point of view,” says Mariangela Rondanelli, Ph.D., of the University of Pavia, Italy, the study’s lead researcher. “The concept of quality of life is defined as perceived global achievement and satisfaction within a number of key domains, with special emphasis on well-being.” Rondanelli notes that a larger study will need to be done before more conclusions can be drawn.

While it may seem expected that melatonin could help with sleep, the other benefits may not be as clear, she says. “It is possible that better nighttime sleep quality made participants more alert during the day. Furthermore, improved mood and well-being may have positively influenced the subjective evaluation of daytime sleepiness in the participants.”

More information on supplements and health is reported in the article, “Covering the Bases on Nutrition,” that appears in the April 2011 issue of the Fibromyalgia Network Journal. A feature article “Setting the Clock Straight on Melatonin” is offered as a free bonus to those receiving the Journal. Join the Fibromyalgia Network to stay abreast with the latest in research, treatments, and coping tips.”

* Rondanelli M, et al. JAGS 59:82-90, 2011.