Comparing the Efficacy and Safety of Pregabalin Monotherapy With Pregabalin Combined Other Neuromodulatory Drugs (Venlafaxine) in the Treatment of Fibromyalgia: A Multicenter Clinical Study
Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread pain, fatigue, and emotional disorders. Its onset is related to factors such as central sensitization and imbalance of neurotransmitters. The current mainstream treatments include pregabalin, but the efficacy of pregabalin is limited, with only 25%-40% pain relief rate, and adverse reactions are common. Selective serotonin and norepinephrine reuptake inhibitors (SNRIs), such as duloxetine, has demonstrated efficacy in FM by modulating pain pathways through increased serotonin and norepinephrine availability. Several studies have highlighted benefits of venlafaxine in FM. We hypothesize that the combination of pregabalin with venlafaxine may offer greater pain relief compared pregabalin monotherapy, without a significant increase in adverse effects for patients with FM.
• Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;
• Aged 18 years or older;
• Experiencing moderate to severe FM that have not been effectively alleviated by non-pharmacological treatments and has not received currently recommended pharmacological treatment for FM;
• Numeric rating scale (NRS) score ≥ 4 at baseline;
• Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;
• Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher;
• Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.