Cost-utility of cognitive behavioral therapy versus U.S. Food and Drug Administration recommended drugs and usual care in the treatment of patients with fibromyalgia: an economic evaluation alongside a 6-month randomized controlled trial
Open accessAbstract
Introduction: Cognitive behavioral therapy (CBT) and U.S. Food and Drug Administration (FDA)-recommended pharmacologic treatments (RPTs; pregabalin, duloxetine, and milnacipran) are effective treatment options for fibromyalgia (FM) syndrome and are currently recommended by clinical guidelines. We compared the cost-utility from the healthcare and societal perspectives of CBT versus RPT (combination of pregabalin + duloxetine) and usual care (TAU) groups in the treatment of FM. Methods: The economic evaluation was conducted alongside a 6-month, multicenter, randomized, blinded, parallel group, controlled trial. In total, 168 FM patients from 41 general practices in Zaragoza (Spain) were randomized to CBT (n = 57), RPT (n = 56), or TAU (n = 55). The main outcome measures were Quality-Adjusted Life Years (QALYs, assessed by using the EuroQoL-5D questionnaire) and improvements in health-related quality of life (HRQoL, assessed by using EuroQoL-5D visual analogue scale, EQ-VAS). The costs of healthcare use were estimated from patient self-reports (Client Service Receipt Inventory). Cost-utility was assessed by using the net-benefit approach and cost-effectiveness acceptability curves (CEACs). Results: On average, the total costs per patient in the CBT group (1,847€) were significantly lower than those in patients receiving RPT (3,664€) or TAU (3,124€). Patients receiving CBT reported a higher quality of life (QALYs and EQ-VAS scores); the differences between groups were significant only for EQ-VAS. From a complete case-analysis approach (base case), the point estimates of the cost-effectiveness ratios resulted in dominance for the CBT group in all of the comparisons performed, by using both QALYs and EQ-VAS as outcomes. These findings were confirmed by bootstrap analyses, net-benefit curves, and CEACs. Two additional sensitivity analyses (intention-to-treat analysis and per-protocol analysis) indicated that the results were robust. The comparison of RPT with TAU yielded no clear preference for either treatment when using QALYs, although RPT was determined to be more cost-effective than TAU when evaluating EQ-VAS. Conclusions: Because of lower costs, CBT is the most cost-effective treatment for adult FM patients. Implementation in routine medical care would require policymakers to develop more-widespread public access to trained and experienced therapists in group-based forms of CBT. Trial registration: Current Controlled Trials ISRCTN10804772. Registered 29 September 2008.
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In Luciano 2014, ACT compared to AC and treatment as usual (TAU) reported no serious adverse events.
“The second study compared ACT to AC and TAU and reported no serious AEs (Luciano 2014).”
From Psychological therapies for the management of chronic pain (excluding headache) in adults (2020) · cites this paper as Luciano 2014
The Methods > Interventions section (page unavailable) identifies the study groups as cognitive behavioral therapy (CBT), recommended pharmacological treatment (RPT), and treatment as usual (TAU)—not ACT, AC, and TAU. The passages examined also do not report whether serious adverse events occurred. (LLM, conf=0.88)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredFor Luciano 2014, selective reporting was judged unclear risk because the trial protocol was not published.
“Unclear risk Trial protocol not published”
From Psychological therapies for the management of chronic pain (excluding headache) in adults (2020) · cites this paper as Luciano 2014
The Methods section (page unavailable) says a detailed description of the RCT protocol can be reviewed elsewhere, citing references 23 and 25. The References section identifies reference 25 as a published article in Trials (2009), contrary to the claim that the protocol was not published. The paper does not itself assign a selective-reporting risk rating. (LLM, conf=0.86)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredFor Luciano 2014, random sequence generation was judged low risk because a random allocation of participants into 3 conditions used a computer-generated randomization list.
“Low risk”
From Psychological therapies for the management of chronic pain (excluding headache) in adults (2020) · cites this paper as Luciano 2014
The Methods > Design section (page unavailable) says participants were randomly assigned to three groups in a 1:1:1 ratio. It does not describe a computer-generated randomization list or establish a low-risk judgment for random sequence generation; searches for those details found no supporting passage. (LLM, conf=0.83)
Experimental — accuracy not yet measuredFor Luciano 2014, incomplete outcome data was judged low risk because ITT analysis with multiple imputation of missing data was used and attrition was less than 10%.
“Low risk ITT analysis with multiple imputation of missing data; attrition < 10%”
From Psychological therapies for the management of chronic pain (excluding headache) in adults (2020) · cites this paper as Luciano 2014
For Luciano 2014, treatment expectations was judged unclear risk because it was not assessed.
“Unclear risk Not assessed”
From Psychological therapies for the management of chronic pain (excluding headache) in adults (2020) · cites this paper as Luciano 2014
For Luciano 2014, blinding of outcome assessment was judged low risk because study personnel who conducted the interviews and assessed the outcomes were blinded to treatment allocation.
“Low risk”
From Psychological therapies for the management of chronic pain (excluding headache) in adults (2020) · cites this paper as Luciano 2014
In the Luciano 2014 control arm (recommended pharmacological treatment), adverse events included nausea (25%), dry mouth (23.1%), drowsiness (21.2%), constipation (19.2%), headache (21.2%), and fatigue (21.2%).
“In the control arm (recommended pharmacological treatment), however, they noted AEs including nausea (25%), dry mouth (23.1%), drowsiness (21.2%), constipation (19.2%), headache (21.2%), and fatigue (21.2%).”
From Psychological therapies for the management of chronic pain (excluding headache) in adults (2020) · cites this paper as Luciano 2014
The Methods > Interventions section identifies a recommended pharmacological treatment group receiving pregabalin and, for patients with comorbid major depression, duloxetine. Our copy does not report the claimed adverse events or their percentages for that group; searches for the event names and the specific percentages found no matching passage. Page numbers were not available in the indexed copy. (LLM, conf=0.77)
Experimental — accuracy not yet measuredNo adverse events were noted in the psychological condition in Luciano 2014.
“No AEs were noted in the psychological condition.”
From Psychological therapies for the management of chronic pain (excluding headache) in adults (2020) · cites this paper as Luciano 2014
The Methods > Interventions section identifies the psychological condition as group CBT, but does not describe adverse-event monitoring. Searches for adverse events, side effects, harms, and safety found no passage reporting whether adverse events occurred in that group; the claim cannot be verified from our copy. (LLM, conf=0.72)
Experimental — accuracy not yet measuredFive participants withdrew from the Luciano 2014 control arm due to adverse events.
“Further, five participants withdrew from the study in the control arm due to AEs (Luciano 2014).”
From Psychological therapies for the management of chronic pain (excluding headache) in adults (2020) · cites this paper as Luciano 2014
The Methods (Design) identify a usual-care control arm, and the Discussion says 49 of its 55 patients were followed up for the economic evaluation. The copy does not say that five participants withdrew from that arm or attribute any withdrawals to adverse events (searched for adverse events, withdrawals, and reasons for loss to follow-up). (LLM, conf=0.73)
Experimental — accuracy not yet measuredFor Luciano 2014, allocation concealment was judged low risk because it was done by a research assistant not involved in the study.
“Low risk By research assistant not involved in the study”
From Psychological therapies for the management of chronic pain (excluding headache) in adults (2020) · cites this paper as Luciano 2014
The Methods > Design passage (page unavailable) says participants were randomly assigned and two evaluators were blinded, but it does not describe allocation concealment or who carried it out. Searches for “research assistant” and “allocation concealment” found no passage supporting the stated reason for the low-risk judgment. (LLM, conf=0.72)
Experimental — accuracy not yet measured
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- Authors
- Luciano, J. V., D’Amico, F., Cerdà-Lafont, M., Peñarrubia-María, M. T., Knapp, M., Cuesta-Vargas, A. I., Serrano-Blanco, A., & García-Campayo, J.
- Affiliations
- Universitat Oberta de Catalunya (ES)
- London School of Economics and Political Science (GB)
- Parc Sanitari Sant Joan de Déu (ES)
- Instituto de Salud Carlos III (ES)
- Corresponding author
- Luciano, Juan V
- Venue
- Arthritis Research & Therapy
- Published
- 2014-10-01
- Volume
- 16
- Issue
- 5
- Pages
- 451-451
- ISSN
- 1478-6354 (ISSN-L)
- PMC
- PMC4203881
- OpenAlex
- W2106193295
- Cited by
- 48
- References
- 62
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 2 · 2023: 2 · 2022: 3 · 2021: 8 · 2020: 5 · 2019: 4 · 2018: 3 · 2017: 4 · 2016: 8 · 2015: 5
- FWCI
- 4.33
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Arthritis Research & Therapy (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- O2 - Repositori Institucional (Universitat Oberta de Catalunya) (publishedVersion, cc-by)
- London School of Economics and Political Science Theses Online (London School of Economics and Political Science) (acceptedVersion)
- London School of Economics and Political Science Research Online (London School of Economics and Political Science) (acceptedVersion)
- QUT ePrints (Queensland University of Technology) (submittedVersion, cc-by)
- RePEc: Research Papers in Economics (submittedVersion)
- LSE Research Online Documents on Economics (submittedVersion)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, cc-by)
- Repositorio Institucional de la Universidad de Málaga (University of Málaga) (submittedVersion, other-oa)
- Funders
- Instituto de Salud Carlos III
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Keywords
- fibromyalgia, cognitive behavioral therapy, pregabalin, duloxetine, milnacipran, pharmacotherapy, cost-utility analysis, cost-effectiveness, quality-adjusted life years, health-related quality of life, usual care, health care costs, societal perspective, net benefit analysis, cost-effectiveness acceptability curves, general practice, Zaragoza
- MeSH terms
- Duloxetine Hydrochloride, Pregabalin, Adult, Analgesics, Cost-Benefit Analysis, Drug Therapy, Combination, Female, Fibromyalgia, gamma-Aminobutyric Acid, Humans, Male, Middle Aged, Quality of Life, Surveys and Questionnaires, Thiophenes, Time Factors, United States, United States Food and Drug Administration, Cognitive Behavioral Therapy, Treatment Outcome, Health Care Costs, Quality-Adjusted Life Years
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