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KMID : 0363120220350030336
Korean Journal of Pain
2022 Volume.35 No. 3 p.336 ~ p.344
Evaluation of the efficacy and safety of epidural steroid injection using a nonparticulate steroid, dexamethasone or betamethasone: a double-blind, randomized, crossover, clinical trial
Lee Guen-Young

Lee Joon-Woo
Lee Eugene
Yeom Jin-S.
Kim Ki-Jeong
Shin Hyung-Ik
Kang Heung-Sik
Abstract
Background: The U.S. Food and Drug Administration has prohibited epidural steroid injection (ESI) with particulate steroids. Thus, this study aimed to compare the efficacy and safety of ESI with two nonparticulate steroids, dexamethasone and betamethasone.

Methods: The eligible patients (n = 600) who received ESI (0 week) with dexamethasone (ESI-dexa) or betamethasone (ESI-beta) had follow-up visits at 2, 4, and 8 weeks with a phone interview at 12 weeks. The primary endpoint was the proportion of effective responders without pain or who were much improved at 2 weeks. The secondary endpoints were the proportion of crossover injections at 2 weeks; changes in the visual analog scale (VAS) and disability index scores at 2, 4, and 8 weeks; the number of additional ESIs in 12 weeks; the number of participants having spinal surgery, as well as the incidence of adverse events over the 12 weeks.

Results: The proportion of effective responders at 2 weeks was not different between ESI-beta (72/216, 33.3%) and ESI-dexa (63/200, 31.5%; P = 0.670). Adverse events were more common with ESI-dexa (40/200, 20.0%) than with ESI-beta (24/216, 11.1%; P = 0.012). VAS scores decreased more with ESI-beta than with ESI-dexa at 2 weeks (difference, 0.35; P = 0.023) and 4 weeks (difference, 0.42; P = 0.011). The disability score improved significantly more with ESI-beta compared with ESI-dexa at 2 weeks (difference, 3.37; P = 0.009), 4 weeks (difference, 4.01; P = 0.002), and 8 weeks (difference, 3.54; P = 0.007).

Conclusions: Betamethasone would be more appropriate for ESI.
KEYWORD
Betamethasone, Comparative Study, Dexamethasone, Incidence, Injections, Epidural, Pain, Spine, Steroids
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