Estudio observacional para conocer el perfil de los pacientes con dolor crónico musculoesquelético en tratamiento con la combinación de Tramadol 37,5 mg/Paracetamol 325 mg o Paracetamol 1 g o Metamizol 575 mg (estudio PROFILE)

摘要

Objectives: The main objective of the study was to learn whether there were differences in the sociodemographic and clinical profile of patients with chronic musculoskeletal pain of moderate intensity treated with fixed dose combination of Tramadol 37.5 mg/paracetamol 325 mg (TP) or Paracetamol (P) 1g or Metamizole (M) 575 mg. Secondary objectives were to ascertain the reasons for choosing different treatments, the relationship between affective state and pain and finally to determine the satisfaction of patients with analgesic treatment. Material and methods: A postmarketing, multicenter, cross-sectional study involving 151 researchers specialized in rheumatology, orthopedics, rehabilitation and pain units throughout all the Spanish territory was carried out. Patients ≥ 18 years with chronic musculoskeletal pain of any etiology of ≥ 3 months duration, moderate intensity and receiving one of the three treatments mentioned were included. The affective state of depression and anxiety was assessed using the Goldberg Scale. Additionally the relationship between pain and the affective state was evaluated as well as the patient satisfaction using a Likert scale. Results: 1,325 patients were evaluable for analysis, 62.9% were women with a mean age of 59.8 years (SD = 15.0) for all patients analyzed. The patients profile showed statistically significant differences between treatments only for employment status, being treated patients with TP more often occupationally active (37%). There were no significant differences for other sociodemographic characteristics. The mean intensity of pain assessed by VAS in the 24 hours prior to the study visit was 6.2 points (SD = 1.5) with no significant differences between groups. The most frequent etiology of pain was osteoarthritis in 64.1% of cases. 53.1% of patients were treated with TP, 24.5% with P and 22.4% with M. In 71.6% of those treated with TP the first reason of its choice by the specialists was its efficacy while for P patients was the tolerability (74.5%). The 27.5% and 31.1% of patients had probable anxiety and depression disorders respectively, being observed a significant difference only for depression, more frequent in patients with P and M (36.3 and 34.5% respectively) and lower (27.3%) with TP (p <0.05). Comparing between treatment groups regarding affective/pain state, 24.2% with P referred to feel fairly/much sadness, 23.3% for group M and 15.6% for the combination TP (p <0, 0001). More than half of the patients were fairly/very satisfied with the analgesic treatment, showing the highest level of satisfaction (78.3%) patients treated with TP (p < 0.0001). Conclusions: There were no significant differences in the clinical and sociodemographic profile of patients among the different treatment groups. However, in clinical variables, patients with moderate pain treated with TP showed, compared to the other two treatments, a lower presence of depressive disorder, a better relation with their affective/pain state and greater satisfaction with the analgesic treatment.