PMID- 31812351 OWN - NLM STAT- MEDLINE DCOM- 20210427 LR - 20210427 IS - 1532-866X (Electronic) IS - 0049-0172 (Linking) VI - 50 IP - 3 DP - 2020 Jun TI - The safety of pulse corticosteroid therapy- Systematic review and meta-analysis. PG - 534-545 LID - S0049-0172(19)30687-0 [pii] LID - 10.1016/j.semarthrit.2019.11.006 [doi] AB - OBJECTIVE: To amass all available evidence from randomized controlled trials regarding the safety of pulse corticosteroids therapy, in order to establish its safety. PATIENTS AND METHODS: All electronic databases from 1/1966 up to 02/2019 were reviewed to find all randomized controlled trials comparing pulse corticosteroids to oral corticosteroids or to placebo/no treatment. Two reviewers independently extracted and recorded data regarding type of corticosteroid treatment, dosages, length of treatment and follow-up. Risk ratios (RR) with 95% (CI) for differences between pulse corticosteroids and comparator were pooled 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. RESULTS: A total of 64 trials were included: 18 trials which compared pulse corticosteroids to oral corticosteroids and 46 trials which compared pulse corticosteroids to placebo/no intervention. Pulse corticosteroids 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 corticosteroids compared to oral corticosteroids. CONCLUSION: Pulse corticosteroids was not associated with an increase risk of SAEs and should be regarded as safe. CI - Copyright (c) 2019 Elsevier Inc. All rights reserved. FAU - Edel, Yonatan AU - Edel Y AD - Rheumatology unit Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel; Department of Medicine C, Beilinson Hospital, Rabin Medical Center, Petah Tikva 49100, Israel; Sackler Faculty of Medicine, Tel Aviv University, Israel. Electronic address: yonatanad@clalit.org.il. FAU - Avni, Tomer AU - Avni T AD - Department of Medicine E, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Israel. FAU - Shepshelovich, Daniel AU - Shepshelovich D AD - Department of Medicine A, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Israel. FAU - Reich, Shelley AU - Reich S AD - Department of Medicine A, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel. FAU - Rozen-Zvi, Benaya AU - Rozen-Zvi B AD - Nephrology unit Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Israel. FAU - Elbaz, Michal AU - Elbaz M AD - Department of Medicine E, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Israel. FAU - Leibovici, Leonard AU - Leibovici L AD - Department of Medicine E, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Israel. FAU - Molad, Yair AU - Molad Y AD - Rheumatology unit Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Israel. FAU - Gafter-Gvili, Anat AU - Gafter-Gvili A AD - Department of Medicine A, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Israel. LA - eng PT - Journal Article PT - Meta-Analysis PT - Systematic Review DEP - 20191114 PL - United States TA - Semin Arthritis Rheum JT - Seminars in arthritis and rheumatism JID - 1306053 RN - 0 (Adrenal Cortex Hormones) SB - IM MH - Adrenal Cortex Hormones/*administration & dosage/adverse effects MH - Adult MH - Aged MH - Aged, 80 and over MH - Humans MH - Middle Aged MH - Pulse Therapy, Drug MH - Randomized Controlled Trials as Topic COIS- Declaration of Competing Interest None. EDAT- 2019/12/10 06:00 MHDA- 2021/04/28 06:00 CRDT- 2019/12/09 06:00 PHST- 2019/06/24 00:00 [received] PHST- 2019/09/05 00:00 [revised] PHST- 2019/11/08 00:00 [accepted] PHST- 2019/12/10 06:00 [pubmed] PHST- 2021/04/28 06:00 [medline] PHST- 2019/12/09 06:00 [entrez] AID - S0049-0172(19)30687-0 [pii] AID - 10.1016/j.semarthrit.2019.11.006 [doi] PST - ppublish SO - Semin Arthritis Rheum. 2020 Jun;50(3):534-545. doi: 10.1016/j.semarthrit.2019.11.006. Epub 2019 Nov 14.