Is there a role for autologous conditioned serum injections in osteoarthritis? A systematic review and meta-analysis of randomised controlled trials.

ABSTRACT

OBJECTIVE: To assess whether patient reported outcome measures (PROMs) improve after autologous conditioned serum (ACS) administration in patients with osteoarthritis. METHODS: Databases and clinical trial registers were searched to March 2024 for randomised controlled trial (RCTs) comparing ACS vs comparators/controls. Primary outcomes were pain, function and stiffness measured with Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and visual analogue scale (VAS). Secondary outcome was complications. Risk of bias (RoB) and certainty of evidence were assessed using RoB 2 and the Grades of Recommendation, Assessment, Development and Evaluation Working Group (GRADE) respectively. Meta-analysis was undertaken using RevMan v5.4. Results are presented as standardised mean differences (SMD) or mean differences (MD) with 95% confidence intervals (CI). Sensitivity analysis compared all comparators and saline control. RESULTS: Five RCTs were identified (n = 741 participants); two (n = 529 participants) compared ACS against saline (placebo). Three studies were "some concern" and two studies "high risk" for bias. Analysis comparing ACS with all comparators significantly favoured ACS at 6 months for WOMAC SMD -0.61 (95% CI -1.01 to -0.21; p = 0.003); and VAS SMD -1.24 (95% CI -2.11 to -0.38; p = 0.005); with high heterogeneity. Comparing ACS with saline, there was no significant difference in WOMAC or VAS at 6 months SMD -0.40 (95% CI -0.93 to 0.12; p = 0.13) and MD -9.87 (95% CI -27.73 to 7.98, p = 0.28). Complications were similar ACS (24.8%) vs saline (24.4%), with serious complications rare. CONCLUSION: There is currently insufficient data to support the use of ACS in osteoarthritis with conflicting results when compared to alternative therapies and saline control, with high heterogeneity. Before consideration as a potential treatment, a high-quality multicentre RCT is required to assess the efficacy of ACS.