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Posted by Phillipa on August 26, 2011, at 20:53:45
Especially for Floatingbridge Phillipa
From Medscape Medical News > Neurology
Vagus Nerve Stimulation Shows Early Promise in Fibromyalgia
Pauline AndersonAuthors and Disclosures
August 26, 2011 An open-label phase 1/2 trial of patients with treatment-resistant fibromyalgia shows that the therapy is safe and effective and may be a useful treatment addition.The aim of the uncontrolled single-center pilot study was to determine whether periodic but continuous stimulation of the left vagus nerve is a safe, tolerable, and useful adjunct treatment for patients reporting continued severe pain despite receiving current best medical management.
The research was led by Gudrun Lange, PhD, from the Department of Radiology, New Jersey Medical School, Newark, and carried out at the Pain and Fatigue Study Center, Department of Pain Medicine and Palliative Care, Beth Israel Medical Centre, New York City.
The results were published online August 3 in the journal Pain Medicine.
The study included 14 adult women who had physician-diagnosed fibromyalgia for at least 2 years and were refractory to conventional pharmacological treatment (ie, nonsteroidal anti-inflammatories, tricyclic antidepressants, and anticonvulsants).
The women were surgically implanted with a vagus nerve stimulation (VNS) device. After 2 weeks of recovery, they began a 2-week stimulation adjustment period during which VNS intensity was increased to deliver as high a current as could be comfortably tolerated.
All study participants tolerated the implantation. Of these, 12 patients completed the initial 3-month study, and 11 participated in a longitudinal study lasting an additional 8 months.
Same Adverse Effects
In general, the patients had the same types of adverse effects to VNS as those reported in patients with treatment-resistant epilepsy and depression, including stimulus-bound voice alteration, neck pain, nausea, and dyspnea. In addition, patients reported dry mouth and fatigue. During the study, there were 4 unanticipated/serious adverse events occurring in 4 patients.
The primary efficacy outcome was minimal clinically important difference (MCID+) that includes pain, overall wellness, and physical function. At 3 months, 5 of the14 participants became MCID+, and 2 no longer fulfilled fibromyalgia diagnostic criteria for pain and tenderness.
In addition, the therapeutic effect seemed to increase beyond the acute trial. At the end of 11 months, 7 patients were MCID+, and there was parallel improvement in fibromyalgia caseness, defined as widespread pain and at least 11 tender points, which was added as a secondary outcome.
"[W]e realized that using loss of [fibromyalgia] caseness as an outcome variable might be useful for clinicians in judging the potential efficacy of VNS," the authors write.
The researchers were "surprised" by the robustness and ubiquity of response to the VNS treatment, they note. Although improvement in tender point threshold appears to be a difficult outcome to achieve, "our results suggest that [fibromyalgia] treatment can reduce tender point threshold to the degree that the point treated is no longer tender," they write.
However, they add, tender point count was not a reliable predictor for continued therapeutic success.
An "obvious question" is whether the results represented a placebo effect "related to being in a treatment trial necessitating surgery, feeling a sensory stimulus throughout the day and having high hopes for a good therapeutic outcome," said the authors. The continued improvement shown by some patients and the fact that more patients attained outcome criteria over time argues against a nonspecific or placebo explanation for the therapeutic benefit, they write.
The authors conclude that a controlled trial is needed to better understand the role of VNS in fibromyalgia.
This work was supported by a grant from the National Institutes of Health. Dr. Lange reports a US patent pending in her name for the use of VNS in fibromyalgia.
Pain Med. Published online August 3, 2011
Posted by floatingbridge on August 26, 2011, at 21:44:37
In reply to Vegas Nerve Stimulation For Fibromyalgia, posted by Phillipa on August 26, 2011, at 20:53:45
Thanks Phillipa. This sounds vaguely familiar, like I bumped into it somewher in my chaotic googling, this idea of nerve stimulation, but don't remember if it was VNS or not.
I admit the idea of an implant doesn't appeal to me. But this is interesting nonetheless. I can reread to see if the subjects were dealing with depression as well.
Thanks!
Posted by floatingbridge on August 26, 2011, at 21:49:17
In reply to Vegas Nerve Stimulation For Fibromyalgia, posted by Phillipa on August 26, 2011, at 20:53:45
P.S. Seems more studies are being conducting on these odd syndromes. Or is it more press? Whatever, I at least take comfort knowing there are people out there asking these questions and taking these ailments 'seriously'. Because I have found some treatment resistant syndromes provoke either disinterest or, yikes(!), some hostility :-/ in day to day practical medicine.
Posted by Phillipa on August 26, 2011, at 23:53:55
In reply to Re: Vegas Nerve Stimulation For Fibromyalgia » Phillipa, posted by floatingbridge on August 26, 2011, at 21:49:17
Of course thought of you first and thought you might like to read. I find the article on alchohol interesting as when drank felt better than better and was working. So now it's good for you. Love Phillipa
Posted by zatar on August 27, 2011, at 21:34:20
In reply to Vegas Nerve Stimulation For Fibromyalgia, posted by Phillipa on August 26, 2011, at 20:53:45
I believe that Fibromyalgia will be found to have sub-types which will determine which treatments are effective. There are also people labelled "Fibromyalgia" who have other undiagnosed disorders with somatic components.
Vagal nerve stimulation may indeed be effective for those susceptible to vasovagal reflex, but probably won't be effective for all.
Does vEgas nerve stimulation involve watching dancing girls??? :-)
-Zatar
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