A randomised, double-blinded study comparing giving etoricoxib vs. placebo to female patients with fibromyalgia.

OBJECTIVES: Current therapeutic approaches to fibromyalgia syndrome (FMS) do not provide satisfactory pain control to a high percentage of patients. This unmet need constantly fuels the pursuit for new modalities for pain relief. This randomised, double-blind, controlled study assessed the efficacy and safety of adding etoricoxib vs. placebo to the current therapeutic regimen of female patients with FMS. METHODS: In this double-blind, placebo-controlled study, female patients were randomised to receive either 90 mg etoricoxib once daily or placebo for 6 weeks. Several physical and mental parameters were assessed throughout the study. The primary end-point was the response to treatment, defined as ≥ 30% reduction in the average Brief Pain Inventory score. Secondary outcomes were changes in the Fibromyalgia Impact Questionnaire, SF-36 Quality of Life assessment questionnaire and Hamilton rating scales for anxiety and depression. RESULTS: Overall, 73 patients were recruited. Although many outcome measures improved throughout the study, no difference was recorded between the etoricoxib- and placebo-treated groups. The Brief Pain Inventory, Fibromyalgia Impact Questionnaire, The Hamilton Anxiety and Depression scores did not differ between the two groups. CONCLUSIONS: This is the first randomised, double-blind study assessing the effect of adding etoricoxib to pre-existing medications for female patients with FMS. Although being mildly underpowered this study clearly has shown that etoricoxib did not improve pain scores and did not lead to any beneficial mental or physical effects.

Perioperative blood transfusion in cancer patients undergoing laparoscopic colorectal resection: risk factors and impact on survival.

BACKGROUND: Perioperative blood transfusion has been associated with a poor prognosis in patients undergoing surgery for colorectal cancer. The aim of this study was to evaluate risk factors for blood transfusion and its impact on long-term outcome exclusively in patients undergoing laparoscopic surgery for curable colorectal cancer. METHODS: Data were retrieved from a prospectively collected database of patients who underwent laparoscopic surgery for curable colorectal cancer over a 6-year period. Long-term data were collected from our outpatient clinic and personal contact when necessary. RESULTS: Two hundred and one patients underwent laparoscopic surgery for curable colorectal cancer (stage I-III). Sixty-eight (33.8 %) received blood transfusions during or after surgery. These patients were typically older, had lower preoperative hemoglobin levels, had a more advanced cancer, had a higher Charlson score, had a higher rate of complications and had a higher conversion rate. Kaplan-Meier overall survival analysis was significantly worse in patients who received blood transfusions (P = 0.004). Decreased disease-free survival was also observed in transfused patients; however, this did not reach statistical significance (P = 0.21). A multivariate analysis revealed that transfusion was not an independent risk factor for decreased overall and disease-free survival. The Charlson score was the only independent risk factor for overall survival (OR = 2.1, P = 0.002). Independent factors affecting disease-free survival were stage of disease, Charlson score and, to a lesser degree, age and body mass index. CONCLUSIONS: Perioperative blood transfusion is associated with decreased long-term survival in patients undergoing laparoscopic resection for colorectal cancer. However, this association apparently reflects the poorer medical condition of patients requiring surgery and not a causative relationship.