The Lack of Effect of New Fibromyalgia Drugs

Written by

We now understand that fibromyalgia is a multifactorial illness with overlapping causes. Some of the potential contributors include underlying infections like Lyme disease and Epstein-barr (learn more about the underlying infections here), hormone imbalances, mitochondrial dysfunction, immune system dysfunction, and possibly even heavy metal toxicity for some individuals. Patients experience chronic widespread pain, fatigue, sleep disturbances, digestive issues, and other debilitating symptoms.

Most experts agree that an integrative approach to treatment is best. However, doctors and patients in the U.S. generally rely heavily on pharmaceutical treatments for fibromyalgia due to lack of insurance coverage for complementary and alternative therapies shown to be helpful in the context of a multimodal approach. These include therapies such as massage, acupuncture, cognitive behavioral therapy, biofeedback, dietary changes, and exercise.

As our understanding of FM has grown and changed over the course of the last few decades, the drugs prescribed for managing FM symptoms have also gone through a transformation.

In 2013, Wolfe and colleagues published their findings regarding the changes in drug therapies for FM between 2000 and 2010. They also examined the effectiveness of a new class of drugs that are now commonly prescribed for FM. The data from this community study raises the question of whether or not we are headed in the right direction with fibromyalgia drug treatment and re-emphasizes the need for integrative, effective, and affordable treatments.

A total of 3,123 adult fibromyalgia patients with a mean age of 54.1 (over 90% female) participated in online surveys over the course of 11 years. Pain, fatigue, and functionality were measured using visual analogue scales (for pain and fatigue) and a Health Assessment Questionnaire (HAQ) disability index to measure functional status. During the study period, opioid and NCAD use increased while nonsteroidal anti-inflammatory (NSAID) and tricyclic antidepressant use decreased. NCADs include analgesic and central acting drugs like anticonvulsants and serotonin-norepinephrine reuptake inhibitors. A few example of pharmaceuticals that are included in the NCAD group were pregabalin, duloxetine, and milnacipran.

NCADs saw the biggest increase, with 10% of patients having used one or more of them in 2000 compared to 40% by 2010. This increase was most likely due to clinical trials showing that NCADs resulted in statistically significant improvements in pain among FM patients when compared to placebo. While significant, however, improvements were still small and were not shown to extend to improvements in fatigue or functionality. Similar results were found in the Wolfe et al study. Overall, patients reported only what amounted to 2.8 – 4.3% decrease in pain outcomes with no effect on fatigue or functionality. Better outcomes could not be established despite the data being analyzed different ways. Clinically, this translates to very poor effectiveness of these drugs, making them no more beneficial than the other medications previously prescribed more commonly for FM. Most patients still reported poor quality of life and continued to experience high amounts of pain and fatigue.

Not only are these newer fibromyalgia drugs not very effective, they are also quite expensive. For example, a year supply of pregabalin (an anticonvulsant) costs $3000 per year, while amitriptyline (a tricyclic antidepressant) costs a mere $65 per year.

Additionally, the European Medicines Agency refused to approve the newer centrally acting drugs for fibromyalgia due to poor risk to benefit ratio. These factors taken together do not paint a positive picture of the current state of pharmaceutical options for fibromyalgia symptom management. And maybe that’s because symptom management is not where we need to be focused in the first place. Now that we know some of the mechanisms involved in fibromyalgia, there are better options – like addressing root causes in addition to symptom management using a variety of standard and non-standard approaches.

At Holtorf Medical Group, thousands of patients with chronic pain and fatigue have been helped through protocols based on a multimodal approach. In fact, one study showed that out of a group of 500 patients being treated at Holtorf Medical Group, energy level and sense of well-being among these individuals had doubled on average by only the fourth office visit.

It seems clear that it is time to look beyond ineffective and expensive drug treatment and put our time and money into truly untangling, once and for all, the complex web that is fibromyalgia. Patients have endured the physical and emotional suffering for far too long.


1. Wolf, F et al. Longitudinal patterns of analgesic and central acting drug use and associated effectiveness in fibromyalgia. Eur J Pain. 2013; 17: 581-86.