Evidence map›Paper›PMID 32546490›Full record

Trial reportBMJ open2020

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).

Margreth Grotle, Lars Christian Bråten, Jens Ivar Brox, Ansgar Espeland, Zinajda Zolic-Karlsson, Rikke Munk Killingmo, Alexander Tingulstad, Lars Grøvle, Anne Froholdt, Per Martin Kristoffersen and 5 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02323412 (Antibiotic Treatment in Patients With Chronic Low Back Pain and Modic Changes), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.1field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02323412 phase3completednot on this map

Antibiotic Treatment in Patients With Chronic Low Back Pain and Modic Changes: a Randomized Double-blind Placebo Controlled Trial

TypeinterventionalSponsorOslo University HospitalRan2015 to 2018Enrolled180ConditionsLow Back Pain, Modic Changes Type I or II Seen on MRIArmsAmoxicillin (Amoksicillintrihydrat), Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 5 institutions in 1 country.

Margreth GrotleDepartment of Research and Innovation, Oslo University Hospital, Oslo, Norway mgrotle@oslomet.no.ORCID 0000-0001-8243-1143
Lars Christian BråtenFORMI, Oslo University Hospital Ullevaal, Oslo, OSLO, Norway.ORCID 0000-0002-2560-2556
Jens Ivar BroxPhysical Medicine and rehabilitation, Oslo University Hospital, Oslo, Norway.ORCID 0000-0002-2507-1812
Ansgar EspelandDepartment of Radiology, Haukeland University Hospital, Bergen, Norway.
Zinajda Zolic-KarlssonRegional Research Support Services, Oslo University Hospital Ullevaal, Oslo, Norway.
Rikke Munk KillingmoDepartment of Physiotherapy, Oslo Metropolitan University Faculty of Health Sciences, Oslo, Oslo, Norway.
Alexander TingulstadDepartment of Physiotherapy, Oslo Metropolitan University Faculty of Health Sciences, Oslo, Norway.
Lars GrøvleDepartment of Rheumatology, Østfold Hospital Trust, Oslo, Oslo, Norway.
Anne FroholdtDepartment of Physical Medicine and Rehabilitation, Vestre Viken Hospital Trust, Drammen, Norway.
Per Martin KristoffersenDepartment of Radiology, Haukeland University Hospital, Bergen, Norway.
Monica WigemyrFORMI, Oslo University Hospital Ullevaal, Oslo, OSLO, Norway.
Maurits W van TulderDepartment of Health Sciences, VU University, Amsterdam, Netherlands.ORCID 0000-0002-7589-8471
Kjersti StorheimClinic for Surgery and Neurology, FORMI, Oslo, Norway.
John-Anker ZwartDepartment of Neurology and FORMI, Oslo University Hospital, Oslo, Norway.
AIM-study group
Oslo University Hospital · NOHaukeland University Hospital · NOOsloMet – Oslo Metropolitan University · NOØstfold Hospital Trust · NOVestre Viken Hospital Trust · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo 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.

designA cost-utility analysis from a societal and healthcare perspective alongside a double-blinded, parallel group, placebo, multicentre trial.

settingHospital 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.

participants180 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).

interventionsOral treatment with either 750 mg amoxicillin or placebo three times daily for 100 days.

main outcome measuresQuality-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).

resultsMean (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%.

conclusionsAmoxicillin 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.

Indexed as

Cost-Benefit AnalysisAmoxicillinAnti-Bacterial AgentsBone Marrow DiseasesChronic DiseaseDouble-Blind MethodEdemaHumansIntention to Treat AnalysisLow Back PainMiddle AgedNorwayPain MeasurementQuality-Adjusted Life YearsAmoxicillinAnti-Bacterial Agentsback painclinical trialshealth economicspain management

Identifiers

PMID32546490
PMCPMC7299049
OpenAlexW3034798731

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.