Background/Purpose: Very high dose (or pulse) glucocorticoid treatment is widely used for autoimmune, inflammatory, infectious and other conditions. We aimed to amass all available evidence from randomized controlled trials regarding the safety of pulse steroids therapy, in order to establish its safety

Methods: Systematic review and meta-analysis of all randomized controlled trials comparing pulse steroids to oral steroids or to placebo/no treatment. All electronic databases up to 12/2018 were reviewed. Risk ratios (RR) with 95% (CI) for differences between pulse steroids and comparator were pooled (when RR < 1 denotes less risk with pulse steroids) using a fixed effect meta-analysis. The primary outcome was occurrence of severe adverse events (SAEs). Secondary outcomes included any adverse events (AEs), AEs requiring discontinuation, AEs per system involved and all-cause mortality. Sensitivity analysis was based on the methodology, design, and follow up time. Subgroup analysis was based on comparator, dosage of pulse steroids, treated condition and system involved

Results: A total of 64 trials were included: 18 trials which compared pulse steroids to oral steroids and 46 trials which compared pulse steroids to placebo / no intervention. Pulse steroids was not associated with increased risk for SAEs for both comparators: RR 0.77 (95% CI 0.52-1.14), and RR 0.99 (95% CI 0.93-1.06), respectively. Sensitivity analysis based on adequate allocation concealment and use of a valid AE grading did not alter the results. Subgroup analysis revealed no increased risk of specific SAEs or AEs with pulse steroids compared to oral steroids

Conclusion: Pulse steroids was not associated with an increase risk of SAEs and should be regarded as safe

Figure 1 abstarct

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-safety-of-pulse-therapy-systematic-review-and-meta-analysis/