Paul Little1, Beth Stuart2, Zoe Wingrove2, Mark Mullee2, Tammy Thomas2, Sophie Johnson2, Gerry Leydon2, Samantha Richards-Hall2, Ian Williamson2, Lily Yao2, Shihua Zhu2, Michael Moore2. 1. Primary Care Group (Little, Stuart, Wingrove, Mullee, Thomas, Johnson, Leydon, Williamson, Moore); Health Economic Analyses Team (Yao, Zhu), Primary Care and Population Sciences Unit, University of Southampton; Patient and Public Involvement Collaborator (Richards-Hall), Southampton, UK P.Little@soton.ac.uk. 2. Primary Care Group (Little, Stuart, Wingrove, Mullee, Thomas, Johnson, Leydon, Williamson, Moore); Health Economic Analyses Team (Yao, Zhu), Primary Care and Population Sciences Unit, University of Southampton; Patient and Public Involvement Collaborator (Richards-Hall), Southampton, UK.
Abstract
BACKGROUND: Reducing the use of antibiotics for upper respiratory tract infections is needed to limit the global threat of antibiotic resistance. We estimated the effectiveness of probiotics and xylitol for the management of pharyngitis. METHODS: In this parallel-group factorial randomized controlled trial, participants in primary care (aged 3 years or older) with pharyngitis underwent randomization by nurses who provided sequential intervention packs. Pack contents for 3 kinds of material and advice were previously determined by computer-generated random numbers: no chewing gum, xylitol-based chewing gum (15% xylitol; 5 pieces daily) and sorbitol gum (5 pieces daily). Half of each group were also randomly assigned to receive either probiotic capsules (containing 24 × 109 colony-forming units of lactobacilli and bifidobacteria) or placebo. The primary outcome was mean self-reported severity of sore throat and difficulty swallowing (scale 0-6) in the first 3 days. We used multiple imputation to avoid the assumption that data were missing completely at random. RESULTS: A total of 1009 individuals consented, 934 completed the baseline assessment, and 689 provided complete data for the primary outcome. Probiotics were not effective in reducing the severity of symptoms: mean severity scores 2.75 with no probiotic and 2.78 with probiotic (adjusted difference -0.001, 95% confidence interval [CI] -0.24 to 0.24). Chewing gum was also ineffective: mean severity scores 2.73 without gum, 2.72 with sorbitol gum (adjusted difference 0.07, 95% CI -0.23 to 0.37) and 2.73 with xylitol gum (adjusted difference 0.01, 95% CI -0.29 to 0.30). None of the secondary outcomes differed significantly between groups, and no harms were reported. INTERPRETATION: Neither probiotics nor advice to chew xylitol-based chewing gum was effective for managing pharyngitis. Trial registration: ISRCTN, no. ISRCTN51472596.
BACKGROUND: Reducing the use of antibiotics for upper respiratory tract infections is needed to limit the global threat of antibiotic resistance. We estimated the effectiveness of probiotics and xylitol for the management of pharyngitis. METHODS: In this parallel-group factorial randomized controlled trial, participants in primary care (aged 3 years or older) with pharyngitis underwent randomization by nurses who provided sequential intervention packs. Pack contents for 3 kinds of material and advice were previously determined by computer-generated random numbers: no chewing gum, xylitol-based chewing gum (15% xylitol; 5 pieces daily) and sorbitol gum (5 pieces daily). Half of each group were also randomly assigned to receive either probiotic capsules (containing 24 × 109 colony-forming units of lactobacilli and bifidobacteria) or placebo. The primary outcome was mean self-reported severity of sore throat and difficulty swallowing (scale 0-6) in the first 3 days. We used multiple imputation to avoid the assumption that data were missing completely at random. RESULTS: A total of 1009 individuals consented, 934 completed the baseline assessment, and 689 provided complete data for the primary outcome. Probiotics were not effective in reducing the severity of symptoms: mean severity scores 2.75 with no probiotic and 2.78 with probiotic (adjusted difference -0.001, 95% confidence interval [CI] -0.24 to 0.24). Chewing gum was also ineffective: mean severity scores 2.73 without gum, 2.72 with sorbitol gum (adjusted difference 0.07, 95% CI -0.23 to 0.37) and 2.73 with xylitol gum (adjusted difference 0.01, 95% CI -0.29 to 0.30). None of the secondary outcomes differed significantly between groups, and no harms were reported. INTERPRETATION: Neither probiotics nor advice to chew xylitol-based chewing gum was effective for managing pharyngitis. Trial registration: ISRCTN, no. ISRCTN51472596.
Authors: Paul Little; Kate Rumsby; Joanne Kelly; Louise Watson; Michael Moore; Gregory Warner; Tom Fahey; Ian Williamson Journal: JAMA Date: 2005-06-22 Impact factor: 56.272
Authors: Martin C Gulliford; Alex Dregan; Michael V Moore; Mark Ashworth; Tjeerd van Staa; Gerard McCann; Judith Charlton; Lucy Yardley; Paul Little; Lisa McDermott Journal: BMJ Open Date: 2014-10-27 Impact factor: 2.692
Authors: Paul Little; F D Richard Hobbs; Michael Moore; David Mant; Ian Williamson; Cliodna McNulty; Gemma Lasseter; M Y Edith Cheng; Geraldine Leydon; Lisa McDermott; David Turner; Rafael Pinedo-Villanueva; James Raftery; Paul Glasziou; Mark Mullee Journal: Health Technol Assess Date: 2014-01 Impact factor: 4.014
Authors: David Schnadower; Phillip I Tarr; T Charles Casper; Marc H Gorelick; J Michael Dean; Karen J O'Connell; Prashant Mahajan; Adam C Levine; Seema R Bhatt; Cindy G Roskind; Elizabeth C Powell; Alexander J Rogers; Cheryl Vance; Robert E Sapien; Cody S Olsen; Melissa Metheney; Viani P Dickey; Carla Hall-Moore; Stephen B Freedman Journal: N Engl J Med Date: 2018-11-22 Impact factor: 91.245