Different Dose For Different Folks

Marketed under various names, for instance Revia, Depade, and Vivitrol, naltrexone is an opioid receptor antagonist and is used to treat alcohol and opioid dependence.  This FDA-approved drug is no longer under patent and is available in pharmacies in tablet form in 50 mg. strength. At this dose, the drug serves to inhibit the analgesic action of opioids.

Experimental Use

There is some proof that a much lower dose of naltrexone, less than 5 mg., acts as an analgesic, but in order to achieve this effect, the medication requires some fine-tuning of its compounds. The use of naltrexone as an analgesic would be considered an off-label use of the medication. There has been some experimental use of low dose naltrexone (LDN) to treat pain in diseases with an immune system association, for instance: fibromyalgia, HIV/AIDS, multiple sclerosis, Parkinson’s disease, certain cancers, rheumatoid arthritis, Crohn’s Disease, Ulcerative Colitis, Hashimoto’s Thyroiditis, and central nervous system conditions.

Now, a team is working toward definitive proof that LDN might reduce the symptoms of fibromyalgia, for instance, chronic pain, weakness, fatigue, sleep disturbances, and fibro fog. These scientists think that LDN may resolve imbalances in the nervous and immune systems.

Thorough Investigation

While doctors have experimented with treating fibromyalgia patients with LDN for several years, no studies have ever been done to determine how well it works for this condition. In order for the drug to lose its experimental status and become a mainstream drug for this condition, a thorough investigation of the drug must be undertaken.

Studies performed on animals showed that LDN was useful as a treatment for neuropathic pain, or pain incurred by nerve injury. There are also small trials in progress to determine if LDN might be effective in treating chronic pain in people. This most recent study, undertaken by Stanford researchers, concentrates on the specific effects of LDN on fibromyalgia patients.

Glial Cells

Scientists aren’t sure how LDN works to alleviate pain, but believe the treatment may serve to quiet glial cells in the central nervous system. When glial cells become excited, they create substances that produce pain and sleep disturbances. When glial cells are quiet, they manufacture substances that boost the body’s pain-fighting abilities.

The normal doses of naltrexone, from 50-100 mg. serve as an obstacle to the effects of pain-killing opioids. At doses 1 tenth to 1 20th of the normal dose, the drug seems to have the exact opposite effect and works to alleviate pain.

The Sleep-Pain Connection

Many fibromyalgia sufferers experience sleep disturbances and insomnia, but never make the connection between lack of sleep and fibromyalgia pain. Even thirty years ago, some researchers concluded that fibromyalgia symptoms may be due to chronic lack of restful sleep. But the scientists weren’t able to demonstrate how disturbed sleep might exacerbate fibromyalgia pain. Today, the researchers are taking a second look at the connection between sleep and pain, and their discoveries may help you find the key to reducing the main symptom of fibromyalgia: pain.

A German researcher, Bernd Kundermann, Ph.D. spoke about the sleep-pain connection for an article on the topic. After examining the findings of his own research and that of others, he commented, “The pain-relieving action of the body’s natural opioid system relies upon undisturbed sleep…this points to a detrimental effect of sleep disruption on the ability of the opioid system to provide pain relief.”

Kundermann feels that by resolving disturbed sleep, the body’s natural pain relievers can be freed to resolve the pain accompanying fibromyalgia syndrome.

Induced Sleep Loss

It can be difficult to spot the effects of sleep disturbances. To illustrate the insidious nature of sleep deprivation, Martha Lentz, Ph.D., R.N. of Seattle, WA, chose several middle-aged women in good health and subjected them to an induced loss of deep sleep, also known as slow wave sleep (SWS). While the subjected were permitted to sleep the night through, as they entered the SWS stage, they were roused with the help of a buzzer set at a high volume. The process caused the participants to enter a lighter stage of sleep without actually awakening them.

Sleep efficiency is measured according to the percentage of time spent asleep. The sleep efficiency of the women in this study appeared to remain the same, but the quality of their sleep underwent a drastic change. After three nights of having their deep sleep interrupted, the women began to experience muscle aches. The pain threshold of the women appeared to have been lowered, too. This was demonstrated by increased tenderness experienced in response to applied pressure.

Another scientist, S. Hakki Onen, M.D., Ph.D., applied Lentz’s methods to his own healthy research subjects and then allowed them to have one night of recovery in which the subjects were allowed undisturbed sleep. Onen discovered that a higher than average amount of sleep time was devoted to SWS during the recovery night. He also discovered that the threshold for pressure pain made a vast increase after only one night of good sound sleep. The scientist found that an increase in time spent in SWS gave greater pain relief than the subjects would have received from a high dose of ibuprofen.

Sleep-Enhancing Medications

The conclusion of this study leads to the theory that fibromyalgia patients may be able to alleviate their pain by increasing the amount of time they spend in slow wave sleep. There are some medications available than can enhance your sleep. Talk to your doctor if you suspect your pain may stem from sleep disturbances.

A Long Slow Process

The newest data tells us that doctors are taking too long to diagnose fibromyalgia. A recent survey suggests that the reasons for the delayed diagnoses are many. Meanwhile, the very same survey suggests that fibromyalgia leads to missed workdays, loss of employment, and lost income.

The Fibromyalgia Global Impact Survey was undertaken by the European Network of Fibromyalgia Associations (ENFA). ENFA is a coalition of organizations dedicated to patient advocacy and partnered by Pfizer, Inc. The survey polled 1,622 doctors as well as 800 confirmed fibromyalgia patients from eight countries including South Korea, Mexico, the Netherlands, Spain, Italy, Germany, France, and the UK. For every country represented by the survey, there were 100 subjects with confirmed diagnoses for fibromyalgia, along with around 100 primary care doctors and another 100 specialists such as psychiatrists, pain specialists, neurologists, and rheumatologists.

On analyzing the results generated by the survey, the researchers discovered that there was a time lag between the time a patient reported fibromyalgia-suggestive symptoms to a physician and the attainment of a firm diagnosis. The delay was demonstrated to be anywhere from 1.9 to 2.7 years from the first visit until a positive diagnosis was obtained. In addition to the diagnostic delay, it was seen that between two to four doctors were required to end up at a confirmed diagnosis for fibromyalgia.

No Confidence

The researchers posit that one element causing the delay in diagnosis is the paucity of confidence felt by the doctors who must rule on the presence of the condition. Between 16% and 71% of the physicians reported they were either “not very” or “not at all” confident as regards their competence in differentiating symptoms as stemming from fibromyalgia. Another important factor for the delay in diagnosis related to insufficient physician education on the subject of fibromyalgia syndrome.

As for the patients, the results of the study indicated that patients don’t see their physicians as soon as they experience symptoms, but rather wait from anywhere between 5 months to two years after the onset of fibromyalgia symptoms to see their doctors. Patients tend to think they can wait out the symptoms or cope without seeking treatment.

Missed Workdays

One interesting statistic generated by the survey is the fact that patients tend to experience between 6 to 11 fibromyalgia symptoms, among these sensitivity to touch, fatigue, sleep disturbances, and widespread pain. Twenty percent of the patient participants reported illness-related unemployment and around fifty percent reported missing at least 10 days of work during the previous year because of fibromyalgia.

Narcotics And Low Vitamin D Levels

Research performed under the auspices of the Mayo Clinic has shown a direct link between low vitamin D levels and amounts of narcotic medication taken by chronic pain patients. Researchers feel this is an important discovery since it may lead to greater motivation to find other means of treating the chronic pain of illnesses like fibromyalgia. The Centers for Disease Control and Prevention (CDC) report that chronic pain is the primary cause of disability within the United States. Most patients come to the point where they use narcotic medications such as oxycodone, fentanyl, or morphine.

Vitamin Deficiency

In this study, it was discovered that those patients taking the higher doses of these pain medications, in many cases double the amount of those on the lowest doses, had the greatest deficiencies for vitamin D while those on the lower amounts of narcotic medications had adequate levels of the vitamin. The vitamin-deficient patients described a lower degree of physical functioning and a perception of being in poor overall health. There was also a correlation between an increase in body mass index (BMI) and sinking levels of vitamin D. The results have been published in Pain Medicine.

Physical medicine and rehabilitation physician at the Mayo Clinic and lead author of the study Michael Turner, M.D., explains that vitamin D aids in developing bone and muscle strength. Many people, including those in the medical profession, tend not to realize that widespread pain and poor neuromuscular function can be the result of a vitamin D deficiency. Once doctors recognize vitamin D deficiency as the possible root of chronic pain, another avenue of treatment becomes available to suffering patients.

Chronic Pain

Turner and his team examined 267 patients from the Mayo Comprehensive Pain Rehabilitation Center in Rochester between February and December of 2006. The vitamin D levels of these chronic pain patients were analyzed at the time of their admission after which other parameters were assessed, such as pain levels, physical functioning, emotional distress, and health perception. Along with these parameters, other factors such as gender, diagnosis, age, and BMI were also recorded.

The researchers would like to see the results of this study followed by further research to assess how correcting the levels of vitamin D affects the quality of life of these patients. “Though preliminary, these results suggest that patients who suffer from chronic, diffuse pain and are on narcotics should consider getting their vitamin D levels checked. Inadequate levels may play a role in creating or sustaining their pain,” explains Dr. Turner.

Turner advises doctors to check the vitamin D levels of patients with chronic widespread pain that seems to be musculoskeletal in nature and responds with tenderness when palpated. “For example, many patients who have been labeled with fibromyalgia are, in fact, suffering from symptomatic vitamin D inadequacy.”

Treatment During Pregnancy

Fibromyalgia is a disorder that causes intense generalized fatigue, muscle pain, joint stiffness, anxiety, irritability, heightened sensitivity to external stimuli and sleep disturbances. There is no known cause for the condition. It cannot be cured and can only be moderately treated with medications. The medications don’t prevent the condition but can treat many of the symptoms. Sometimes fibromyalgia is overlooked during pregnancy and is often misdiagnosed as regular symptoms of pregnancy if the woman gets it for the first time while she is pregnant.

This is partly due to the highly generalized criteria for diagnosing the condition. Researchers are currently working on more accurate ways to diagnose fibromyalgia so that it can more easily be diagnosed in pregnant women as well as other individuals.

Fibromyalgia During Pregnancy

Women who have diagnosed or undiagnosed fibromyalgia before pregnancy tend to have worse symptoms during their pregnancy, according to the few studies that have been done on pregnant women and fibromyalgia. Symptoms tend to worsen in the third trimester. Researchers suspect the reason for this may be due to the higher amounts of the hormone relaxin produced during pregnancy as well as the physical and emotional stress placed on the body during pregnancy.

Treatments

There are very few to no medical pain relievers accepted as entirely safe for use during pregnancy. This means that pregnant women have limited options for treating the symptoms of the condition and must find other ways to manage the pain. If a woman is pregnant, most doctors will recommend against the pain relievers and antidepressants commonly used for treatment.

Is It Dangerous for the Baby?

Medications used to treat fibromyalgia can be dangerous for the baby but the condition itself isn’t. It doesn’t cut blood flow to the developing fetus and babies born of mothers with fibromyalgia don’t have more health problems than the general public and they don’t experience growth restrictions. Since there is no threat to the baby, it isn’t necessary to see a high-risk obstetrician unless your regular obstetrician suggests it.

Non-Medical Ways to Manage

Pregnant women with fibromyalgia have the challenging task of trying to manage the condition with no medication. Limited amounts of fibromyalgia medications will be prescribed if the symptoms are so severe that there is no other option, but there’s always concern that the drugs could damage the developing child.

Doctors recommend plenty of rest during pregnancy especially if a woman has fibromyalgia. The suggested amount of rest is at least two to three times during the day for about 20 to 30 minutes. The use of moist heat is encouraged to help manage the pain and this includes warm showers or baths.

Exercise like yoga is also encouraged. Exercise increases serotonin levels which can help with fibromyalgia symptoms like irritability and depression. Experts also suggest that women have a strong support system to help them when the symptoms of fibromyalgia become worse. Strong emotional support goes a long way towards helping women manage with the condition when there is no other option.

Waxing Lyrical Over Lyrica

Pfizer’s Lyrica (pregabalin) was the first medication ever approved by the USFDA for fibromyalgia. The anticonvulsant drug was developed to treat both partial seizures as are seen in temporal lobe epilepsy and neuropathic pain. The drug is also useful for spinal cord injuries. In Europe, doctors prescribe pregabalin as a medication for treating generalized anxiety disorder. The drug received first approval in Europe in the year 2004 and in the States in 2005.

In the United States, Lyrica has received approval as a medication that may be prescribed to treat epilepsy, diabetic nerve pain (neuropathy), and painful shingles (post-herpetic neuralgia). The FDA decided to approve the drug as a treatment for fibromyalgia as well, in 2007. Fibromyalgia manifests as widespread joint and muscle pain. The merest touch can cause excruciating pain in fibromyalgia sufferers.

In 2009, a subsidiary of Pfizer pleaded guilty to the charge of mischaracterizing Lyrica and three other drugs, with intent to mislead consumers. By illegal promotion of the drugs, false claims were submitted to government healthcare programs for use of the drugs in ways not medically sanctioned. Pfizer made a settlement of $2.3 billion and signed a corporate integrity agreement.

Side Effects?

No drug is free of side effects, and Lyrica is no exception. About 10% of patients treated with the drug experience dizziness or drowsiness. A somewhat smaller number of patients report problems with vision, coordination, speech, tremors, memory, lethargy, weight gain, constipation, euphoria, erectile dysfunction, swelling of the ankles, legs, and feet, and loss of libido. Fewer than 1% of those on pregabalin experience kidney stones, urinary problems, joint and muscle pain, cramped muscles, rashes, reddened skin, sweating, excessive salivation, an increase in heart rate, change in sensitivity response to touch, twitching muscles, hallucinations, agitation, confusion, or depression.

A smaller number of patients on the medication, fewer than 0.1%, find themselves with low neutrophil counts—these are a type of white blood cell, changes in blood pressure, pancreatic inflammation, heart block, cessation of urine production, skeletal muscle tissue breakdown, and difficulty swallowing.

There is a very low likelihood of developing a dependence of pregabalin. Those who experience withdrawal symptoms, often do so after having been treated with the drug for a lengthy period of time. Symptoms of withdrawal include anxiety, insomnia, and restlessness. While it is rare for a patient to experience dependence on Lyrica, it’s best to reduce the dosage of pregabalin on a gradual basis. 

Drug Interactions

Pfizer says there are some dangerous drug interactions that can occur with Lyrica, in particular with these drugs and substances:

*Drugs that serve to depress the central nervous system

*Alcohol

*Barbiturates

*Benzodiazepines

*Opioids