Pharmacological treatments of fibromyalgia in adults; overview of phase IV clinical trials

Abstract

Background: Fibromyalgia is a chronic neurological condition characterized by widespread pain. The effectiveness of current pharmacological treatments is limited. However, several medications have been approved for phase IV trials in order to evaluate them.Aim: To identify and provide details of drugs that have been tested in completed phase IV clinical trials for fibromyalgia management in adults, including the primary endpoints and treatment outcomes. This article was submitted to Neuropharmacology, a section of the journal Frontiers in Pharmacology.Method: Publicly available and relevant phase IV trials registered at ClinicalTrials.gov were analyzed. The uses of the trialed drugs for fibromyalgia were reviewed.Results: As of 8 August 2022, a total of 1,263 phase IV clinical trials were identified, of which 121 were related to fibromyalgia. From these, 10 clinical trials met the inclusion criteria for the current study. The drugs used in phase IV trials are milnacipran, duloxetine, pregabalin, a combination of tramadol and acetaminophen, and armodafinil. The effectiveness of the current pharmacological treatments is apparently limited.Conclusion: Due to its complexity and association with other functional pain syndromes, treatment options for fibromyalgia only are limited and they are designed to alleviate the symptoms rather than to alter the pathological pathway of the condition itself. Pain management specialists have numerous pharmacologic options available for the management of fibromyalgia.

Sexuality in Women with Fibromyalgia Syndrome: A Metasynthesis of Qualitative Studies

“…Some studies report that the symptoms may even lead women to stop the sexual activity once it has started [24]. Pain appears to be associated with low mood and anxiety in women with FMS [44], and depression is common, related to problems with desire and arousal [19,45]. Our metasynthesis confirms that women suffering from FMS pain do not want to be with anyone [35], rejecting any contact with a partner.…”

Complex Chronic Diseases Program: Program Description & Health Outcomes Assessment from a Clinical Data Registry

“…The only exception was PSQI scoring which indicates that longer disease duration is related to reduced sleep quality at baseline. Though symptom improvement is probable over time and with treatment, there are no single curative treatments for CCDs, and the prognosis for recovery from ME/CFS and FM is low [18,[49][50][51], though more favourable in the initial stages of disease, especially, in the first year [52]. Studies have been inconsistent, but generally an increased disease duration for CCDs has been associated with poorer health outcomes [53][54][55][56].…”

Is fibromyalgia a neurological disorder?

“…V současnosti jsou pro léčbu fibromyalgie schváleny americkou FDA (ale ne EMA) tři přípravky: pregabalin, duloxetin a milnacipran. I když uvedené léky lze použít v prvním sledu a do jisté míry potlačí symptomatické projevy fibromyalgie, působí však necíleně, t.j. neovlivňují cílené patofyziologické pochody (32). Milnacipran zlepšuje bolest a únavu až u 70 % pacientů, na druhé straně může zhoršit kvalitu spánku nebo vyvolat deprese (35).…”