Department of Research and Innovation, Oslo University Hospital, Oslo, Norway
Department of Physiotherapy, Oslo Metropolitan University Faculty of Health Sciences, Oslo, Norway.
BMJ Open. 2020 Jun 15;10(6):e035461. doi: 10.1136/bmjopen-2019-035461.
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.
A cost-utility analysis from a societal and healthcare perspective alongside a double-blinded, parallel group, placebo, multicentre trial.
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.
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).
Oral treatment with either 750 mg amoxicillin or placebo three times daily for 100 days.
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).
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%.
Amoxicillin treatment showed no evidence of being cost-effective for people with chronic LBP and Modic changes during 1-year follow-up.
ClinicalTrials.gov NCT02323412.
评估慢性下腰痛（LBP）患者接受 100 天抗生素治疗的成本效用，这些患者纳入了抗生素治疗慢性下腰痛和 Modic 改变（AIM）研究中的 I 型或 II 型 Modic 改变。
一项来自社会和医疗保健视角的成本效用分析，以及一项双盲、平行组、安慰剂、多中心试验。
挪威六家医院的门诊。AIM 研究的主要结果显示，抗生素组在背部相关残疾方面有较小的效果，I 型 Modic 改变的效果稍大，但这一效果低于临床相关效果的预先定义阈值。
180 名慢性 LBP、先前椎间盘突出和 I 型（n=118）或 II 型（n=62）Modic 改变的患者被随机分配接受抗生素治疗（n=89）或安慰剂对照（n=91）。
口服治疗，每日三次，每次 750 毫克阿莫西林或安慰剂，共 100 天。
12 个月时 EuroQoL-5D 的质量调整生命年（QALYs）和以欧元（€1=NOK 10）衡量的医疗保健和生产力损失的成本，在意向治疗人群中。成本效用以增量成本效果比（ICER）表示。
阿莫西林组的总费用为€21046（20105），安慰剂组为€19076（19356），平均差异为€1970（95%CI：-3835 至 7774）。每获得一个 QALY 的成本为€24625。在 I 型 Modic 改变的患者中，阿莫西林组的医疗保健消费高于安慰剂组，导致每获得一个 QALY 的成本为€39425。鉴于这些 ICER 和 275000 欧元（NOK 275000）的意愿支付阈值，阿莫西林具有成本效益的概率为 51%。即使意愿支付阈值增加到 55000 欧元，阿莫西林具有成本效益的概率也从未高于 53%。
在 1 年随访期间，慢性 LBP 和 Modic 改变患者接受阿莫西林治疗没有证据表明具有成本效益。
ClinicalTrials.gov NCT02323412。
