Yanhong Jessika Hu1,2, Xudong Zhou3, Shanjuan Wang4, Merlin Willcox5, Colin Garner6, David Brown7, Taeko Becque5, Beth Stuart5, Zongru Han4, Qin Chang4, Michael Moore5, Paul Little5. 1. Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, Victoria, Australia. jessika.hu@mcri.edu.au. 2. Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia. jessika.hu@mcri.edu.au. 3. School of Public Health, Zhejiang University, 866 Yuhangtang Road, Zhejiang, 310058, Hangzhou, China. 4. Affiliated Hospital of Jiading District Centre, Shanghai Institute of Health Science, No. 1 Chengbei Rd, Jiading Qu, Shanghai Shi, 201800, China. 5. Primary Care Research Centre, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, SO16 5ST, United Kingdom. 6. Antibiotic Research UK, Genesis 5, York Science Park, Heslington, York, YO10 5DQ, United Kingdom. 7. Alchemy Biomedical Consulting, St Johns Innovation Centre, Cowley Road, Cambridge, CB4 0WS, United Kingdom.
Abstract
BACKGROUND: Although rarely indicated, antibiotics are commonly used for acute diarrhoea in China. We conducted a randomised, double blind exploratory clinical trial of loperamide, berberine and turmeric for treatment of acute diarrhoea. METHODS:Adults with acute uncomplicated diarrhoea aged 18 to 70 were randomised to 4 groups: (A) loperamide; (B) loperamide and berberine; (C) loperamide and turmeric; (D) loperamide, berberine and turmeric. All participants were given rescue ciprofloxacin for use after 48 h if symptoms worsened or were unimproved. Primary endpoints were feasibility and ciprofloxacin use during the 2-week follow-up period. Semi-structured interviews were conducted following recruitment and were analysed thematically. Recruiting doctors, delivery pharmacists and research assistants were blinded to treatment allocation. RESULTS:Only 21.5% (278/1295) of patients screened were deemed eligible, and 49% (136/278) of these consented and were entered into the final analysis. Most participants had mild symptoms, because most patients with moderate or severe symptoms wanted to be given antibiotics. Follow-up was good (94% at 2 weeks). Only three participants used rescue antibiotics compared to 67% of acute diarrhoea patients in the hospital during the recruitment period. The median symptom duration was 14 h in group B (interquartile range (IQR) 10-22), 16 h in group D (IQR 10-22), 18 h in group A (IQR 10-33) and 20 h in group C (IQR 16-54). Re-consultation rates were low. There were no serious treatment-related adverse events. Most interviewed participants said that although they had believed antibiotics to be effective for diarrhoea, they were surprised by their quick recovery without antibiotics in this trial. CONCLUSION: Although recruitment was challenging because of widespread expectations for antibiotics, patients with mild diarrhoea accepted trying an alternative. The three nutraceuticals therapy require further evaluation in a fully powered, randomised controlled trial among a broader sample. TRIAL REGISTRATION: ChiCTR-IPR-17014107.
RCT Entities:
BACKGROUND: Although rarely indicated, antibiotics are commonly used for acute diarrhoea in China. We conducted a randomised, double blind exploratory clinical trial of loperamide, berberine and turmeric for treatment of acute diarrhoea. METHODS: Adults with acute uncomplicated diarrhoea aged 18 to 70 were randomised to 4 groups: (A) loperamide; (B) loperamide and berberine; (C) loperamide and turmeric; (D) loperamide, berberine and turmeric. All participants were given rescue ciprofloxacin for use after 48 h if symptoms worsened or were unimproved. Primary endpoints were feasibility and ciprofloxacin use during the 2-week follow-up period. Semi-structured interviews were conducted following recruitment and were analysed thematically. Recruiting doctors, delivery pharmacists and research assistants were blinded to treatment allocation. RESULTS: Only 21.5% (278/1295) of patients screened were deemed eligible, and 49% (136/278) of these consented and were entered into the final analysis. Most participants had mild symptoms, because most patients with moderate or severe symptoms wanted to be given antibiotics. Follow-up was good (94% at 2 weeks). Only three participants used rescue antibiotics compared to 67% of acute diarrhoeapatients in the hospital during the recruitment period. The median symptom duration was 14 h in group B (interquartile range (IQR) 10-22), 16 h in group D (IQR 10-22), 18 h in group A (IQR 10-33) and 20 h in group C (IQR 16-54). Re-consultation rates were low. There were no serious treatment-related adverse events. Most interviewed participants said that although they had believed antibiotics to be effective for diarrhoea, they were surprised by their quick recovery without antibiotics in this trial. CONCLUSION: Although recruitment was challenging because of widespread expectations for antibiotics, patients with mild diarrhoea accepted trying an alternative. The three nutraceuticals therapy require further evaluation in a fully powered, randomised controlled trial among a broader sample. TRIAL REGISTRATION: ChiCTR-IPR-17014107.
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