TY - JOUR
T1 - Antibiotics versus placebo for acute bacterial conjunctivitis
AU - Chen, Yu Yen
AU - Liu, Su Hsun
AU - Nurmatov, Ulugbek
AU - van Schayck, Onno C.P.
AU - Kuo, Irene C.
N1 - Funding Information:
The work of Professor van Schayck is supported by Maastricht University, the Netherlands. National Eye Institute, National Institutes of Health, USA
Funding Information:
Funding source: Allergan, Inc. Declaration of interest: W.H., M.C., Y.R.B., and J.M.D. have no competing conflicts of interest; C.F., L.V., D.A.H., and H.J. are employees of Allergan, Inc. Writing and editorial assistance were provided to the authors by Kakuri Omari, PhD, and Gayle Scott, PharmD, of Evidence Scientific Solutions (Philadelphia, PA), and funded by Allergan, Inc. (Irvine, CA). Trial registry: NCT00518089 (clinicaltrials.gov) Publication language: English Comments: one of the two trials reported in Heller 2014; the other was NCT00509873.
Funding Information:
Yu-Yen Chen: declared no conflicts of interest. Su-Hsun Liu: reported a grant from the National Eye Institute, National Institutes of Health, USA; payment to institution. Onno CP van Schayck: no declaration of interest to be reported Ulugbek Nurmatov: no declaration of interest to be reported Irene C Kuo: reported partial salary support from the National Eye Institute, National Institutes of Health, for her editorial work for the Cochrane review.
Funding Information:
Funding source: "The study was sponsored by Bausch & Lomb Global Clinical Programs, Rochester, New York, which also designed and conducted the study. Publication was sponsored by Bausch & Lomb." Declaration of interest: "Dr. Karpecki is a consultant for Bausch & Lomb and has received consulting fees/payment for advisory board participation from Bausch & Lomb Advanced Medical Optics, Inc.; OCuSOFT, Inc.; Inspire Pharmaceuticals Inc.; OcuSense, Inc.; Odyssey Medical, Inc.; Rapid Pathogen Screening Inc.; and Allergan, Inc. Dr. DePaolis has received consulting fees/payment for advisory board participation and lecture fees from Bausch & Lomb; Advanced Medical Optics; and Alcon Laboratories, Inc.; he has also received lecture fees from CooperVision, Inc. Dr. White has received consulting fees/payment for advisory board participation from Primary Eyecare Network; Vistakon Pharmaceuticals, LLC; Alcon; and CooperVision; he has also received lecture fees from Alcon, Optos Eye Care, and Ciba Vision. Ms. Brunner and Drs. Usner, Paterno, and Comstock are employees of Bausch & Lomb." Trial registry:NCT00622908 (clinicaltrials.gov) Publication language: English
Funding Information:
More than two-thirds of the trials were funded by pharmaceutical companies; Leibowitz 1991 also reported funding from nonprofit organizations. Two trials were supported by an academic institution or government agency (Rietveld 2005; Rose 2005). Authors of four trials did not disclose funding information (Gigliotti 1984; Gross 2003; Miller 1992; Yang 2013).
Funding Information:
Funding source: Alcon Research, Ltd. Financial support for this publication was provided by Alcon Research, Ltd. (Fort Worth, TX, USA). Writing and editorial assistance was provided by Heather A. Edens, PhD, H EDENS, LLC, Marietta, GA, USA. Declaration of interest: "Shachar Tauber is a consultant for Allergan, Inc., Ista Pharmaceuticals, and Inspire Pharmaceuticals, and a founder and owner of Ocugenics which has received funding from the U.S. Department of Defense. Shachar Tauber’s wife is an employee of Alcon Laboratories, Inc. Gale Cupp, Richard Garber, Firoz Vohra, John Bartell and David Stroman are employees of Alcon Research, Ltd. Alcon Research, Ltd. designed the study and performed the data analysis." Trial registry:NCT00759148 (clinicaltrials.gov) Publication language: English
Funding Information:
Funding source: "This study was supported in part by a grant from Alcon Laboratories, Inc., Fort Worth, TX; by an unrestricted departmental grant from Research To Prevent Blindness, Inc., New York, NY; and by a grant from the Massachusetts Lion Eye Research Fund, Inc., Boston, MA." Declaration of interest: NR Trial registry:NR Publication language: English
Funding Information:
We would like to acknowledge the contributions of Aziz Sheikh (Uversity of Edinburgh), Brian Hurwitz (King's College London), James Cave (The Downland Practice, Newbury), and Susannah McLean (University of Edinburgh) on the previous versions of the review. CEV@US supported the authors in the development of this update. The following people conducted the editorial process for this update: Sign-off Editors (final editorial decision): Dr. Tianjing Li (University of Colorado Anschutz Medical Campus), Dr. Gianni Virgilli (Queen's University Belfast) Managing Editor and Assistant Managing Editors (selected peer reviewers, collated peer-reviewer comments): Anupa Shah (Queen's University Belfast); Louis Leslie (University of Colorado Anschutz Medical Campus), Genie Han (Johns Hopkins University) Methodologist (provided methodological and editorial guidance to authors, edited the article): Valerie Tsz Wing Yim (University of Colorado Anschutz Medical Campus) Information Specialist: Iris Gordon (CEV) Copy Editor: Anne Lethaby (Cochrane Central Editorial Service) Peer reviewers: Dr. Darren Ting (University of Nottingham) and an anonymous reviewer Sign-off Editors (final editorial decision): Dr. Tianjing Li (University of Colorado Anschutz Medical Campus), Dr. Gianni Virgilli (Queen's University Belfast) Managing Editor and Assistant Managing Editors (selected peer reviewers, collated peer-reviewer comments): Anupa Shah (Queen's University Belfast); Louis Leslie (University of Colorado Anschutz Medical Campus), Genie Han (Johns Hopkins University) Methodologist (provided methodological and editorial guidance to authors, edited the article): Valerie Tsz Wing Yim (University of Colorado Anschutz Medical Campus) Information Specialist: Iris Gordon (CEV) Copy Editor: Anne Lethaby (Cochrane Central Editorial Service) Peer reviewers: Dr. Darren Ting (University of Nottingham) and an anonymous reviewer
Funding Information:
Funding source: "The study was sponsored by Bausch & Lomb, Inc., who designed and managed the study." Declaration of interest: NR Trial registry:NCT00972777(clinicaltrials.gov) Publication language: English Comments: "Results of an interim study analysis were reported elsewhere (Silverstein et al. Clin Ther 2011;33(1)"13-26)"
Publisher Copyright:
Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
PY - 2023/3/13
Y1 - 2023/3/13
N2 - Background: Acute bacterial conjunctivitis is an infection of the conjunctiva and is one of the most common ocular disorders in primary care. Antibiotics are generally prescribed on the basis that they may speed recovery, reduce persistence, and prevent keratitis. However, many cases of acute bacterial conjunctivitis are self-limited, resolving without antibiotic therapy. This Cochrane Review was first published in The Cochrane Library in 1999, then updated in 2006, 2012, and 2022. Objectives: To assess the benefits and side effects of antibiotic therapy in the management of acute bacterial conjunctivitis. Search methods: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2022, Issue 5), MEDLINE (January 1950 to May 2022), Embase (January 1980 to May 2022), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov), and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases in May 2022. Selection criteria: We included randomized controlled trials (RCTs) in which any form of antibiotic treatment, with or without steroid, had been compared with placebo/vehicle in the management of acute bacterial conjunctivitis. This included topical and systemic antibiotic treatments. Data collection and analysis: Two authors independently reviewed the titles and abstracts of identified studies. We assessed the full text of all potentially relevant studies and determined the included RCTs, which were further assessed for risk of bias using Cochrane methodology. We performed data extraction in a standardized manner and conducted random-effects meta-analyses using RevMan Web. Main results: We included 21 eligible RCTs, 10 of which were newly identified in this update. A total of 8805 participants were randomized. All treatments were topical in the form of drops or ointment. The trials were heterogeneous in terms of their eligibility criteria, the nature of the intervention (antibiotic drug class, which included fluoroquinolones [FQs] and non-FQs; dosage frequency; duration of treatment), the outcomes assessed and the time points of assessment. We judged one trial to be of high risk of bias, four as low risk of bias, and the others as raising some concerns. Based on intention-to-treat (ITT) population, antibiotics likely improved clinical cure (resolution of clinical symptoms or signs) by 26% (RR 1.26, 95% CI 1.09 to 1.46; 5 trials, 1474 participants; moderate certainty) as compared with placebo. Subgroup analysis showed no differences by antibiotic class (P = 0.67) or treatment duration (P = 0.60). In the placebo group, 55.5% (408/735) of participants had spontaneous clinical resolution by days 4 to 9 versus 68.2% (504/739) of participants treated with an antibiotic. Based on modified ITT population, in which participants were analyzed after randomization on the basis of positive microbiological culture, antibiotics likely increased microbiological cure (RR 1.53, 95% CI 1.34 to 1.74; 10 trials, 2827 participants) compared with placebo at the end of therapy; there were no subgroup differences by drug class (P = 0.60). No study evaluated the cost-effectiveness of antibiotic treatment. Patients receiving antibiotics had a lower risk of treatment incompletion than those in the placebo group (RR 0.64, 95% CI 0.52 to 0.78; 13 trials, 5573 participants; moderate certainty) and were 27% less likely to have persistent clinical infection (RR 0.73, 95% CI 0.65 to 0.81; 19 trials, 5280 participants; moderate certainty). There was no evidence of serious systemic side effects reported in either the antibiotic or placebo group (very low certainty). When compared with placebo, FQs (RR 0.70, 95% CI 0.54 to 0.90) but not non-FQs (RR 4.05, 95% CI 1.36 to 12.00) may result in fewer participants with ocular side effects. However, the estimated effects were of very low certainty. Authors' conclusions: The findings of this update suggest that the use of topical antibiotics is associated with a modestly improved chance of resolution in comparison to the use of placebo. Since no evidence of serious side effects was reported, use of antibiotics may therefore be considered to achieve better clinical and microbiologic efficacy than placebo. Increasing the proportion of participants with clinical cure or increasing the speed of recovery or both are important for individual return to work or school, allowing people to regain quality of life. Future studies may examine antiseptic treatments with topical antibiotics for reasons of cost and growing antibiotic resistance.
AB - Background: Acute bacterial conjunctivitis is an infection of the conjunctiva and is one of the most common ocular disorders in primary care. Antibiotics are generally prescribed on the basis that they may speed recovery, reduce persistence, and prevent keratitis. However, many cases of acute bacterial conjunctivitis are self-limited, resolving without antibiotic therapy. This Cochrane Review was first published in The Cochrane Library in 1999, then updated in 2006, 2012, and 2022. Objectives: To assess the benefits and side effects of antibiotic therapy in the management of acute bacterial conjunctivitis. Search methods: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2022, Issue 5), MEDLINE (January 1950 to May 2022), Embase (January 1980 to May 2022), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov), and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases in May 2022. Selection criteria: We included randomized controlled trials (RCTs) in which any form of antibiotic treatment, with or without steroid, had been compared with placebo/vehicle in the management of acute bacterial conjunctivitis. This included topical and systemic antibiotic treatments. Data collection and analysis: Two authors independently reviewed the titles and abstracts of identified studies. We assessed the full text of all potentially relevant studies and determined the included RCTs, which were further assessed for risk of bias using Cochrane methodology. We performed data extraction in a standardized manner and conducted random-effects meta-analyses using RevMan Web. Main results: We included 21 eligible RCTs, 10 of which were newly identified in this update. A total of 8805 participants were randomized. All treatments were topical in the form of drops or ointment. The trials were heterogeneous in terms of their eligibility criteria, the nature of the intervention (antibiotic drug class, which included fluoroquinolones [FQs] and non-FQs; dosage frequency; duration of treatment), the outcomes assessed and the time points of assessment. We judged one trial to be of high risk of bias, four as low risk of bias, and the others as raising some concerns. Based on intention-to-treat (ITT) population, antibiotics likely improved clinical cure (resolution of clinical symptoms or signs) by 26% (RR 1.26, 95% CI 1.09 to 1.46; 5 trials, 1474 participants; moderate certainty) as compared with placebo. Subgroup analysis showed no differences by antibiotic class (P = 0.67) or treatment duration (P = 0.60). In the placebo group, 55.5% (408/735) of participants had spontaneous clinical resolution by days 4 to 9 versus 68.2% (504/739) of participants treated with an antibiotic. Based on modified ITT population, in which participants were analyzed after randomization on the basis of positive microbiological culture, antibiotics likely increased microbiological cure (RR 1.53, 95% CI 1.34 to 1.74; 10 trials, 2827 participants) compared with placebo at the end of therapy; there were no subgroup differences by drug class (P = 0.60). No study evaluated the cost-effectiveness of antibiotic treatment. Patients receiving antibiotics had a lower risk of treatment incompletion than those in the placebo group (RR 0.64, 95% CI 0.52 to 0.78; 13 trials, 5573 participants; moderate certainty) and were 27% less likely to have persistent clinical infection (RR 0.73, 95% CI 0.65 to 0.81; 19 trials, 5280 participants; moderate certainty). There was no evidence of serious systemic side effects reported in either the antibiotic or placebo group (very low certainty). When compared with placebo, FQs (RR 0.70, 95% CI 0.54 to 0.90) but not non-FQs (RR 4.05, 95% CI 1.36 to 12.00) may result in fewer participants with ocular side effects. However, the estimated effects were of very low certainty. Authors' conclusions: The findings of this update suggest that the use of topical antibiotics is associated with a modestly improved chance of resolution in comparison to the use of placebo. Since no evidence of serious side effects was reported, use of antibiotics may therefore be considered to achieve better clinical and microbiologic efficacy than placebo. Increasing the proportion of participants with clinical cure or increasing the speed of recovery or both are important for individual return to work or school, allowing people to regain quality of life. Future studies may examine antiseptic treatments with topical antibiotics for reasons of cost and growing antibiotic resistance.
U2 - 10.1002/14651858.CD001211.pub4
DO - 10.1002/14651858.CD001211.pub4
M3 - (Systematic) Review article
SN - 1469-493X
VL - 2023
JO - Cochrane Database of Systematic Reviews
JF - Cochrane Database of Systematic Reviews
IS - 3
M1 - CD001211
ER -