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Mud-bath therapy plus usual care found cost-effective for patients with OA
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In patients with knee osteoarthritis, mud-bath therapy appears to be cost-effective as a temporary, midterm complementary treatment, according to recent findings.
In an economic evaluation performed alongside a previous prospective, single-blinded randomized clinical trial, researchers enrolled 103 patients aged 40 years to 80 years who had primary, symptomatic, bilateral knee osteoarthritis (OA). Bilateral knee OA was defined by the American College of Rheumatology criteria, Eligible patients also had a Kellgren Lawrence radiologic score between 1 and 3.
After baseline evaluation, an independent investigator conducted non-stratified individual randomization. Patients were randomized 1:1 to one of two treatment regimens: usual care plus a 12-session cycle of mud-bath therapy [(MBT) n=53]; or usual care alone (n=50). Patients in the MBT group underwent a combination of daily local mud-packs (12 applications) during the course of approximately 2 weeks. Control group patients continued with their usual regimen of exercise, symptomatic drugs, intermittent treatment with symptomatic slow-acting drugs for OA or intra-articular hyaluronic acid. Global pain assessed by VAS was the primary outcome. Health-related quality of life (HRQoL) was determined through the EuroQol 5-domain (EQ-5D).
Patients were clinically evaluated 7 days prior to enrollment, at the time of enrollment (baseline), after 2 weeks, and after 3 months, 6 months, 9 months and 12 months after randomization. Each patient reported data about direct health care resource use through a daily diary, which was returned at follow-up visits. The diary tracked all drugs, laboratory and imaging tests, general practitioner and specialists’ visits, physical therapies, and devices used for treatment of knee OA. These data were collected at baseline, 2 weeks, 30 days, and monthly thereafter for 1 year.
The researchers found a statistically significant difference between the two groups in HRQoL as measured through the EQ-5D questionnaire at 2-weeks and 6-months follow-up. Of the dimensions evaluated in the EQ-5D questionnaire, pain and anxiety were revealed to be the most burdensome dimensions, with the highest rate of “extreme problem” reported by patients in the two groups.
During the study period overall, patients in the MBT group accumulated a mean 0.835 ± 0.10 quality-adjusted life years (QALYs), while the average QALY accumulation in the control group was 0.753±0.11. Therefore, the QALY gain of the MBT patients was equal to 0.08.
The control group was found to have higher average direct costs per patient (€303 vs. €975) largely due to hospitalization for total knee replacement and the use of intraarticular hyaluronic acid. MBT therapy combined with routine care was consistently found to be a dominant therapy vs. standard therapy alone in bootstrapping replications of costs and QALY sample distribution. A one-way sensitivity analysis found a 100% probability of MBT being cost-effective at standard thresholds.
“This study reports on the cost-effectiveness of MBT in addition to usual care vs. usual care alone based on economic evaluation performed alongside a randomized controlled trial,” the researchers wrote. “This cost-effectiveness analysis shows a favorable economic profile of a 12-session cycle of MBT in addition to usual care vs. usual care alone, with costs savings of about €672 per patient and 0.08 quality-adjusted life years gained over a 12-month follow-up period.” – by Jennifer Byrne
Disclosures: Galeazzi reports speaking fees from Federterme (less than $10,000). Fioravanti reports speaking fees from Federterme (less than $10,000).
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