Korean J Pain.  2022 Jul;35(3):336-344. 10.3344/kjp.2022.35.3.336.

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 GY
• Lee JW
• Lee E
• Yeom JS
• Kim KJ
• Shin HI
• Kang HS

• KMID: 2530989
• DOI: http://doi.org/10.3344/kjp.2022.35.3.336

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

Figure

• 

  Fig. 1 Trial profile: flow diagram of this study. ESI-dexa: epidural steroid injection with dexamethasone, ESI-beta: epidural steroid injection with betamethasone.

• 

  Fig. 2 Change of pain intensity (VAS) along follow-up period (0-, 2-, 4-, and 8-week) with 95% CI using linear mixed model. The error bars indicate 95% CIs. VAS: visual analog scale, CI: confidence interval, ESI-dexa: epidural steroid injection with dexamethasone, ESI-beta: epidural steroid injection with betamethasone.

• 

  Fig. 3 Change of disability score (ODI or NDI) along follow-up period (0-, 2-, 4-, and 8-week) with 95% CI using linear mixed model. The error bars indicate 95% CIs. ODI: Oswestry disability index, NDI: neck disability index, CI: confidence interval, ESI-dexa: epidural steroid injection with dexamethasone, ESI-beta: epidural steroid injection with betamethasone.

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