The Korean Journal of Pain

The Korean Pain Society (대한통증학회)
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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 (Department of Radiology, Chung-Ang University Gwangmyeong Hospital) ;
  • Lee, Joon Woo (Department of Radiology, Seoul National University Bundang Hospital) ;
  • Lee, Eugene (Department of Radiology, Seoul National University Bundang Hospital) ;
  • Yeom, Jin S. (Department of Orthopedic Surgery, Seoul National University Bundang Hospital) ;
  • Kim, Ki-Jeong (Department of Neurosurgery, Seoul National University Bundang Hospital) ;
  • Shin, Hyung-Ik (Department of Rehabilitation Medicine, Seoul National University Hospital, Seoul National University College of Medicine) ;
  • Kang, Heung Sik (Department of Radiology, Seoul National University Bundang Hospital)
  • Received : 2021.12.14
  • Accepted : 2022.04.04
  • Published : 2022.07.01
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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.

Keywords

Acknowledgement

We are grateful to An-joo Lee (A.J.L), Hye-Sun Shin (H.S.S.), Ji Young Yoon (J.Y.Y.), Jungmin Choi (J.M.C.), and Jin Sun Kwan (J.S.K) for their contributions to our study and to Soyeon Ahn and Young Mi Park for statistical analyses.

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