Clinical trial results show that vagus nerve stimulation may be a safe and effective treatment addition in patients with fibromylagia.
Results from a recent trial have shown that vagus nerve stimulation (VNS) may be a safe and effective treatment addition for patients with treatment-resistant fibromyalgia.
This trial focused on the cases of 14 adult women who suffered from physician-diagnosed fibromyalgia for at least two years and were unresponsive to conventional pharmacological treatments. Led by Gudrun Lange, PhD, Department of Radiology, New Jersey Medical School in Newark, each trial participant was surgically implanted with a VNS and required to report an improvement in pain, overall wellness, and physical function to assist in evaluating the efficacy of the treatment plan.
Upon evaluating the findings at the end of the three-month stimulation treatment, loss of both pain and tenderness criteria for the diagnosis of fibromyalgia was added as a secondary outcome measure. Of the 14 initial participants, five had achieved efficacy criteria, two of whom no longer met widespread pain or tenderness criteria for the diagnosis of fibromyalgia.
The researchers learned that the side effects suffered by the trial participants were comparable to those reported in patients treated with VNS for epilepsy or depression. In fact, by the 11 month checkup, they found that the effect of VNS appeared to increase over time as more participants attained both criteria.
The researchers concluded that the preliminary outcome measurements indicate that VNS may be a useful additional treatment for fibromyalgia patients whose pain does not respond to conventional therapeutic management. However, they agree that further research is required to better understand the role VNS plays in treating fibromyalgia.
The report, “Safety and Efficacy of Vagus Nerve Stimulation in Fibromyalgia: A Phase I/II Proof of Concept Trial,” was published in Pain Medicine.