Evidence map›Paper›PMID 27846307›Full record

SynthesisPloS one2016

Efficacy and Safety of Oral Beclomethasone Dipropionate in Ulcerative Colitis: A Systematic Review and Meta-Analysis.

Francesco Manguso, Raffaele Bennato, Giovanni Lombardi, Elisabetta Riccio, Giuseppe Costantino, Walter Fries

Open access · goldAbstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.4field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 38 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Francesco MangusoDepartment of Transplantation, UOSC of Gastroenterology and Endoscopy, AORN 'A. Cardarelli', Napoli, Italy.ORCID http://orcid.org/0000-0002-9617-7892
Raffaele BennatoDepartment of Transplantation, UOSC of Gastroenterology and Endoscopy, AORN 'A. Cardarelli', Napoli, Italy.
Giovanni LombardiDepartment of Transplantation, UOSC of Gastroenterology and Endoscopy, AORN 'A. Cardarelli', Napoli, Italy.
Elisabetta RiccioDepartment of Transplantation, UOSC of Gastroenterology and Endoscopy, AORN 'A. Cardarelli', Napoli, Italy.
Giuseppe CostantinoDepartment of Clinical and Experimental Medicine, Clinical Unit for Chronic Bowel Disorders, University of Messina, Messina, Italy.
Walter FriesDepartment of Clinical and Experimental Medicine, Clinical Unit for Chronic Bowel Disorders, University of Messina, Messina, Italy.
Ospedale Antonio Cardarelli · ITUniversity of Messina · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimWe performed a systematic review and meta-analysis of all the available evidence comparing efficacy and safety of oral prolonged released beclomethasone dipropionate (BDP) to active oral controls in patients with mild-to-moderate ulcerative colitis (UC). A subgroup-analysis compared the effectiveness of BDP and 5-ASA.

methodsLiterature research was performed in different databases, as well as manual search to identify abstracts from international meetings with data not included in extensive publications. Experts in the field and companies involved in BDP development and manufacture were contacted to identify unpublished studies used for registration purposes. Dichotomous data were pooled to obtain odds ratio meta-analysis.

resultsFive randomized controlled trials that compared oral BDP 5mg/day vs. all oral active controls in treating UC were identified as eligible. Efficacy and safety have been addressed after 4-week treatment period. One study evaluated efficacy and safety of BDP vs. prednisone and 4 of BDP vs. 5-ASA. Treatment with oral BDP 5 mg/day induces a significant better clinical response compared to oral 5-ASA (OR 1.86, 95% CI = 1.23-2.82, P = 0.003). The effect is detectable even when the comparison to prednisone is added (OR 1.41, 95% CI = 1.03-1.93, P = 0.03). Data on remission indicate that the potential clinical efficacy of BDP may be better than 5-ASA (OR 1.55, 95% CI = 1.00-2.40, P = 0.05). This difference is lost when the comparison with prednisone is added (OR 1.30, 95% CI = 0.76-2.23, P = 0.34). The safety analysis showed no differences between BDP and 5-ASA (OR 0.55, 95% CI = 0.24-1.27, P = 0.16). The lack of difference is maintained even when the study with prednisone is added (OR 0.67, 95% CI = 0.44-1.01, P = 0.06). However, the trend of difference is clear and indicates a more favourable safety profile of BDP compared to 5-ASA and PD.

conclusionsOral prolonged release BDP showed a superior efficacy vs. oral 5-ASA in inducing clinical improvement of mild-to-moderate UC with a similar safety profile.

Indexed as

Administration, OralAnti-Inflammatory Agents, Non-SteroidalBeclomethasoneColitis, UlcerativeDrug Administration ScheduleHumansMesalaminePatient SafetyPrednisoneRandomized Controlled Trials as TopicTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalBeclomethasoneMesalaminePrednisone

Identifiers

PMID27846307
PMCPMC5113024
OpenAlexW2551574118

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.