Effects of a Paracetamol and Tramadol Fixed-dose Combination on Pain, Asthenia, Cognitive Disorders and Sleep Quality in Fibromyalgia

Abstract

Objective: Fibromyalgia syndrome (FMS) is a chronic condition characterized by widespread musculoskeletal pain associated with a variety of other symptoms. In order to evaluate the effects of a multimodal analgesia approach to the treatment of FMS, a retrospective observational study was performed. Methods: Sixty-nine consecutive outpatients, seen for the first time and diagnosed with FMS, were identified in our registry between April 2011 and May 2012. All patients were prescribed a fixed combination of tramadol 37.5 mg + paracetamol 325 mg, either alone or combined with other treatments. The patient’s general details and FMSrelated signs and symptoms were recorded. In order to have a more objective evaluation of the severity of pain, we assigned a score (0-4) based on the reaction of the patient to the touch of tender points (Evoked Pain Score: EPS). Results: The study confirmed that the symptoms of FMS take on a number of forms and are treated using various therapeutic approaches; however, patients were still suffering pain at the time of their first visit. Significant reduction in pain and improvement in quality of life were observed at the second visit, with a statistically significant reduction in the VAS (8.1 vs. 5.5; p<0.001), EPS (2.7 vs. 2.0; p<0.001) and FMS-related symptoms. Conclusion: Multimodal analgesia with a tramadolo-paracetamol combination is a valid analgesia option in the treatment of FMS, as it exploits different mechanisms of action on pain and on the associated symptoms, such as asthenia, sleep disturbance, paraesthesia, headache and restless legs.