Brigida Barberio, Ilaria Marsilio, Andrea Buda, Luisa Bertin, Gianluca Semprucci, Annalisa Zanini, Martina Crepaldi, Fabiana Zingone, Edoardo Savarino
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We included all available randomized controlled trials (RCTs) comparing oral BDP or budesonide MMX with 5-ASAs or with placebo in induction of remission of mild-to-moderate UC. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated.</p><p><strong>Results: </strong>We identified two RCTs comparing BDP 5 mg with 5-ASA, one RCTs comparing BDP 10 mg with 5-ASA, two RCTs BDP 5 mg <i>versus</i> placebo, one RCT BDP 10 mg <i>versus</i> placebo, two RCTs budesonide MMX 9 mg <i>versus</i> 5-ASA, and six RCTs budesonide MMX 9 mg <i>versus</i> placebo. In terms of achieving clinical remission or improvement, BDP 5 mg, BDP 10 mg, and budesonide MMX 9 mg were more effective than placebo (OR 2.36, 95% CI 1.37-4.08; OR 2.23, 95% CI 1.02-4.87; and OR 2.03, 95% CI 1.45-2.85, respectively). The drugs were also more effective than placebo in achieving endoscopic remission. Regarding the comparisons with 5-ASA, we found no differences between 5-ASA and BDP 5 mg or BDP 10 mg or budesonide MMX 9 mg in achieving clinical remission or improvement (OR 0.90, 95% CI 0.51-1.57; OR 1.54, 95% CI 0.42-5.64; and OR 1.17, 95% CI 0.82-1.66). However, 5-ASA was more effective than budesonide MMX 9 mg in achieving histological remission (OR 0.33, 95% CI 0.16-0.70). Overall, all the drugs were safe and well tolerated.</p><p><strong>Conclusion: </strong>Low bioavailability steroids were more effective than placebo in achieving clinical remission, clinical and endoscopic remission, and histological remission. No differences were found between 5-ASA and BDP or budesonide MMX. Surely, more RCTs, also comparing BDP and budesonide MMX, are mandatory to confirm or not these results.</p>","PeriodicalId":23022,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":null,"pages":null},"PeriodicalIF":4.2000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/8f/2f/10.1177_17562848231188549.PMC10395162.pdf","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of oral beclomethasone dipropionate and budesonide MMX <i>versus</i> 5-aminosalicylates or placebo in ulcerative colitis: a systematic review and meta-analysis.\",\"authors\":\"Brigida Barberio, Ilaria Marsilio, Andrea Buda, Luisa Bertin, Gianluca Semprucci, Annalisa Zanini, Martina Crepaldi, Fabiana Zingone, Edoardo Savarino\",\"doi\":\"10.1177/17562848231188549\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Low bioavailability steroids, including beclomethasone dipropionate (BDP) and budesonide MMX, have been developed to ensure colonic targeting and low systemic activity than systematic corticosteroids in treating patients with ulcerative colitis (UC).</p><p><strong>Objectives: </strong>This systematic review and meta-analysis evaluated the efficacy and safety of BDP and budesonide MMX® compared with 5-aminosalicylic acid (5-ASAs) or placebo, in patients with mild-to-moderate UC.</p><p><strong>Design: </strong>Systematic review and meta-analysis.</p><p><strong>Methods: </strong>We searched MEDLINE, EMBASE, and the Cochrane central register of controlled trials from inception to December 2021. We included all available randomized controlled trials (RCTs) comparing oral BDP or budesonide MMX with 5-ASAs or with placebo in induction of remission of mild-to-moderate UC. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated.</p><p><strong>Results: </strong>We identified two RCTs comparing BDP 5 mg with 5-ASA, one RCTs comparing BDP 10 mg with 5-ASA, two RCTs BDP 5 mg <i>versus</i> placebo, one RCT BDP 10 mg <i>versus</i> placebo, two RCTs budesonide MMX 9 mg <i>versus</i> 5-ASA, and six RCTs budesonide MMX 9 mg <i>versus</i> placebo. In terms of achieving clinical remission or improvement, BDP 5 mg, BDP 10 mg, and budesonide MMX 9 mg were more effective than placebo (OR 2.36, 95% CI 1.37-4.08; OR 2.23, 95% CI 1.02-4.87; and OR 2.03, 95% CI 1.45-2.85, respectively). The drugs were also more effective than placebo in achieving endoscopic remission. Regarding the comparisons with 5-ASA, we found no differences between 5-ASA and BDP 5 mg or BDP 10 mg or budesonide MMX 9 mg in achieving clinical remission or improvement (OR 0.90, 95% CI 0.51-1.57; OR 1.54, 95% CI 0.42-5.64; and OR 1.17, 95% CI 0.82-1.66). However, 5-ASA was more effective than budesonide MMX 9 mg in achieving histological remission (OR 0.33, 95% CI 0.16-0.70). Overall, all the drugs were safe and well tolerated.</p><p><strong>Conclusion: </strong>Low bioavailability steroids were more effective than placebo in achieving clinical remission, clinical and endoscopic remission, and histological remission. No differences were found between 5-ASA and BDP or budesonide MMX. 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引用次数: 0
摘要
背景:低生物利用度类固醇，包括二丙酸倍氯米松(BDP)和布地奈德MMX，已被开发用于治疗溃疡性结肠炎(UC)患者，以确保结肠靶向性和较低的全身活性。目的:本系统回顾和荟萃分析评估了BDP和布地奈德MMX®在轻度至中度UC患者中的疗效和安全性，与5-氨基水杨酸(5-ASAs)或安慰剂相比。设计:系统回顾和荟萃分析。方法:我们检索了MEDLINE、EMBASE和Cochrane中央对照试验注册库，检索时间从建立到2021年12月。我们纳入了所有可用的随机对照试验(RCTs)，比较口服BDP或布地奈德MMX与5- asa或安慰剂在诱导轻度至中度UC缓解中的作用。计算比值比(ORs)和95%置信区间(ci)。结果:我们确定了两项比较BDP 5mg与5- asa的随机对照试验，一项比较BDP 10mg与5- asa的随机对照试验，两项BDP 5mg与安慰剂的随机对照试验，一项BDP 10mg与安慰剂的随机对照试验，两项布地奈德MMX 9mg与5- asa的随机对照试验，以及六项布地奈德MMX 9mg与安慰剂的随机对照试验。在实现临床缓解或改善方面，BDP 5 mg、BDP 10 mg和布地奈德MMX 9 mg比安慰剂更有效(or 2.36, 95% CI 1.37-4.08;或2.23,95% ci 1.02-4.87;OR为2.03,95% CI为1.45-2.85)。在实现内窥镜缓解方面，这些药物也比安慰剂更有效。关于与5- asa的比较，我们发现5- asa与BDP 5mg或BDP 10mg或布地奈德MMX 9mg在实现临床缓解或改善方面没有差异(or 0.90, 95% CI 0.51-1.57;Or 1.54, 95% ci 0.42-5.64;OR 1.17, 95% CI 0.82-1.66)。然而，在实现组织学缓解方面，5-ASA比布地奈德MMX 9mg更有效(OR 0.33, 95% CI 0.16-0.70)。总体而言，所有药物都是安全且耐受性良好的。结论:低生物利用度类固醇在实现临床缓解、临床和内镜缓解以及组织学缓解方面比安慰剂更有效。5-ASA与BDP或布地奈德MMX之间没有差异。当然，更多的随机对照试验，也比较BDP和布地奈德MMX，必须证实这些结果。
Efficacy and safety of oral beclomethasone dipropionate and budesonide MMX versus 5-aminosalicylates or placebo in ulcerative colitis: a systematic review and meta-analysis.
Background: Low bioavailability steroids, including beclomethasone dipropionate (BDP) and budesonide MMX, have been developed to ensure colonic targeting and low systemic activity than systematic corticosteroids in treating patients with ulcerative colitis (UC).
Objectives: This systematic review and meta-analysis evaluated the efficacy and safety of BDP and budesonide MMX® compared with 5-aminosalicylic acid (5-ASAs) or placebo, in patients with mild-to-moderate UC.
Design: Systematic review and meta-analysis.
Methods: We searched MEDLINE, EMBASE, and the Cochrane central register of controlled trials from inception to December 2021. We included all available randomized controlled trials (RCTs) comparing oral BDP or budesonide MMX with 5-ASAs or with placebo in induction of remission of mild-to-moderate UC. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated.
Results: We identified two RCTs comparing BDP 5 mg with 5-ASA, one RCTs comparing BDP 10 mg with 5-ASA, two RCTs BDP 5 mg versus placebo, one RCT BDP 10 mg versus placebo, two RCTs budesonide MMX 9 mg versus 5-ASA, and six RCTs budesonide MMX 9 mg versus placebo. In terms of achieving clinical remission or improvement, BDP 5 mg, BDP 10 mg, and budesonide MMX 9 mg were more effective than placebo (OR 2.36, 95% CI 1.37-4.08; OR 2.23, 95% CI 1.02-4.87; and OR 2.03, 95% CI 1.45-2.85, respectively). The drugs were also more effective than placebo in achieving endoscopic remission. Regarding the comparisons with 5-ASA, we found no differences between 5-ASA and BDP 5 mg or BDP 10 mg or budesonide MMX 9 mg in achieving clinical remission or improvement (OR 0.90, 95% CI 0.51-1.57; OR 1.54, 95% CI 0.42-5.64; and OR 1.17, 95% CI 0.82-1.66). However, 5-ASA was more effective than budesonide MMX 9 mg in achieving histological remission (OR 0.33, 95% CI 0.16-0.70). Overall, all the drugs were safe and well tolerated.
Conclusion: Low bioavailability steroids were more effective than placebo in achieving clinical remission, clinical and endoscopic remission, and histological remission. No differences were found between 5-ASA and BDP or budesonide MMX. Surely, more RCTs, also comparing BDP and budesonide MMX, are mandatory to confirm or not these results.
期刊介绍：
Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area.
The editors welcome original research articles across all areas of gastroenterology and hepatology.
The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.
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