Background: There is some evidence that cognitive behaviour therapy (CBT) is efficacious in chronic fatigue syndrome (CFS), but little data on its cost-effectiveness. Design: Prospective economic analysis alongside a randomized clinical trial. Methods: CFS patients were randomly assigned to CBT, guided support groups (SG), or the 'natural course' (NC, no protocol-based interventions). Patients were treated for 8 months and followed-up for another 6 months. Costs per patient showing clinically significant improvement, based on the CIS fatigue scale, and costs per quality-adjusted life year, were determined for a time period of 14 months. Results: Data were available for 171 patients at 8 months and for 128 at 14 months. At 8 and 14 months, the percentages of improved patients were 31% and 27% for CBT, 9% and 11% for SG, and 12% and 20% for NC. Mean QALYs gained at 14 months were, for CBT, SG and NC, respectively, 0.0737, -0.0018 and 0.0458. CBT and SG mean treatment costs were EUD1490 and EUD424. Other medical costs for CBT, SG, and NC, respectively, were EUD324, EUD623 and EUD412 for the first period, and EUD232, EUD561 and EUD378 for the second period. Non-medical costs for these periods for CBT, SG and NC were EUD262, EUD550, EUD427 and EUD226, EUD439, EUD287, respectively. Productivity costs were considerable, but not significantly different between groups. Discussion: CBT was less costly and more effective than SG. Compared to NC, the baseline incremental cost-effectiveness of CBT was EUD20516 per CFS patient showing clinically significant improvement, and EUD21 375 per QALY. The bootstrap ratios showed considerable uncertainty regarding the results. Future research should focus on productivity costs, and follow patients prospectively over a longer period.
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