Cost–utility analysis of antibiotic treatment in patients with chronic low back pain and Modic changes: results from a randomised, placebo-controlled trial in Norway (the AIM study). Issue 6 (15th June 2020)

• Record Type: Journal Article
• Authors: Grotle, Margreth; Bråten, Lars Christian; Brox, Jens Ivar; Espeland, Ansgar; Zolic-Karlsson, Zinajda; Munk Killingmo, Rikke; Tingulstad, Alexander; Grøvle, Lars; Froholdt, Anne; Kristoffersen, Per Martin; Wigemyr, Monica; van Tulder, Maurits W; Storheim, Kjersti; Zwart, John-Anker
• Other Names: author non-byline.; Anke Audny author non-byline.; Fors Terese author non-byline.; Wilhelmsen Maja author non-byline.; Kjos Guro author non-byline.; Østhus Ida Beate author non-byline.; Marchand Gunn Hege author non-byline.; Lurud Britt Elin author non-byline.; Granviken Fredrik author non-byline.; Andersen Hege author non-byline.; Rao Vidar author non-byline.; Skouen Jan Sture author non-byline.; Kadar Thomas Istvan author non-byline.; Claussen Siv Krüger author non-byline.; Vetti Nils author non-byline.; Andersen Erling author non-byline.; Randen Sigrun author non-byline.; Presberg Hilde author non-byline.; Pedersen Linda Margareth author non-byline.; Winsvold Bendik Slagsvold author non-byline.; Schistad Elina Iordanova author non-byline.; Gammelsrud Karianne Wiger author non-byline.; Lie Benedicte Alexandra author non-byline.; Vigeland Maria Dehli author non-byline.; Flåm Siri Tennebø author non-byline.; Rolfsen Mads Peder author non-byline.; Hellum Christian author non-byline.; Haugen Anne Julsrud author non-byline.; Sørensen Veronica author non-byline.; Thorsø Marianne author non-byline.; Huneide Knut Morten author non-byline.; Lutro Olav author non-byline.; Aßmus Jörg author non-byline.; Einar Thor author non-byline.;
• Is Part Of: BMJ open. Volume 10:Issue 6(2020)
• Publication Date: 2020-06-15
• Subjects: health economics -- back pain -- pain management -- pain management -- clinical trials; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2019-035461
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Objective: To evaluate the cost–utility of 100 days of antibiotics in patients with chronic low back pain (LBP) and type I or II Modic changes included in the Antibiotic treatment In patients with chronic low back pain and Modic changes (AIM) study. Design: A cost–utility analysis from a societal and healthcare perspective alongside a double-blinded, parallel group, placebo, multicentre trial. Setting: Hospital outpatient clinics at six hospitals in Norway. The main results from the AIM study showed a small effect in back-related disability in favour of the antibiotics group, and slightly larger in those with type I Modic changes, but this effect was below the pre-defined threshold for clinically relevant effect. Participants: 180 patients with chronic LBP, previous disc herniation and Modic changes type I (n=118) or type II (n=62) were randomised to antibiotic treatment (n=89) or placebo-control (n=91). Interventions: Oral treatment with either 750 mg amoxicillin or placebo three times daily for 100 days. Main outcome measures: Quality-adjusted life years (QALYs) by EuroQoL-5D over 12 months and costs for healthcare and productivity loss measured in Euro (€1=NOK 10), in the intention-to-treat population. Cost–utility was expressed in incremental cost-effectiveness ratio (ICER). Results: Mean (SD) total cost was €21 046 (20 105) in the amoxicillin group and €19 076 (19 356) in the placebo group, mean difference €1970 (95% CI; −3835 to 7774). Cost per QALY gained was €24 625. In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained. Given these ICERs and a willingness-to-pay threshold of €27 500 (NOK 275 000), the probability of amoxicillin being cost-effective was 51%. Even when the willingness-to-pay threshold increased to €55 000, the probability of amoxicillin being cost-effective was never higher than 53%. Conclusions: Amoxicillin treatment showed no evidence of being cost-effective for people with chronic LBP and Modic changes during 1-year follow-up. Trial registration number: ClinicalTrials.gov NCT02323412 .