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RCT · 2020 · n=76

Efficacy of Intra-Articular Hypertonic Dextrose (Prolotherapy) for Knee Osteoarthritis: A Randomized Controlled Trial

Sit RWS, Wu RWK, Rabago D, et al. · Annals of Family Medicine

Promisingcounts toward this tier

WOMAC pain, the primary outcome, gave a difference-in-difference against saline of -10.34 (95% CI -19.20 to -1.49, P=0.022) at 52 weeks, with an overall trend of -8.26 (95% CI -14.83 to -1.69, P=0.014). Self-reported function (-9.55, P=0.022), WOMAC composite (-9.65, P=0.020), VAS pain (-10.98, P=0.038) and EuroQol-5D VAS (8.64, P=0.020) moved with it, while the objectively assessed physical function tests showed no difference between the groups, and neither did medication use (P=0.350). Within-group WOMAC composite improvement was 20.9 on dextrose against 9.4 on saline. The abstract states that no adverse events were reported; the results section counts eight serious adverse events across the 52 weeks, two on dextrose and six on saline, none judged related to the injections, with one knee replacement in each group.

Population
76 adults with knee OA in Hong Kong primary care
Intervention
Intra-articular hypertonic dextrose at weeks 0, 4, 8, 16
Comparator
Normal saline on the same schedule (blinded)
Limitations
Thirty-eight patients per arm at a single Hong Kong primary care clinic, two lost to follow-up; blinding was assessed and held. The benefit rests on patient-reported scores, because the trial's own objective function measures did not separate. Funded by a Chinese University of Hong Kong Direct Grant for Research of HKD 40,000, with no conflicts declared. The abstract prints the EuroQol confidence interval as 1.36 to 5.92, which does not contain its own point estimate; the results section gives 1.36 to 15.92. Saline may itself have a mild lavage effect, and this trial shares an author with the 2013 US trial.

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