Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Diarrhoea Antibiotic Management Using Over-the-Counter Nutraceuticals in Daily Practice (DIAMOND): A Feasibility RCT on Alternative Therapy to Reduce Antibiotic Use

Version 1 : Received: 12 October 2020 / Approved: 13 October 2020 / Online: 13 October 2020 (12:26:55 CEST)

How to cite: Hu, Y.J.; Zhou, X.; Wang, S.; Willcox, M.; Garner, C.; Brown, D.; Becque, T.; Stuart, B.; Han, Z.; Chang, Q.; Moore, M.; Little, P. Diarrhoea Antibiotic Management Using Over-the-Counter Nutraceuticals in Daily Practice (DIAMOND): A Feasibility RCT on Alternative Therapy to Reduce Antibiotic Use. Preprints 2020, 2020100280 (doi: 10.20944/preprints202010.0280.v1). Hu, Y.J.; Zhou, X.; Wang, S.; Willcox, M.; Garner, C.; Brown, D.; Becque, T.; Stuart, B.; Han, Z.; Chang, Q.; Moore, M.; Little, P. Diarrhoea Antibiotic Management Using Over-the-Counter Nutraceuticals in Daily Practice (DIAMOND): A Feasibility RCT on Alternative Therapy to Reduce Antibiotic Use. Preprints 2020, 2020100280 (doi: 10.20944/preprints202010.0280.v1).

Abstract

Background: Although rarely indicated, antibiotics are commonly used for acute diarrhoea in China. We conducted a randomized, double blind exploratory clinical trial of loperamide, berberine and turmeric for treatment of acute diarrhoea. Methods: Adults with acute uncomplicated diarrhoea were randomized 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 hours 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. Results: Only 21.5% (278/1295) of patients screened were deemed eligible, and 49% (136/278) of these consented and 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 two participants used rescue antibiotics compared to 65% of acute diarrhoea patients in the hospital during the recruitment period. The median symptom duration was: 14 hours in group B (IQR 10-22), 16 hours in group D (IQR 10-22), 18 hours in group A (IQR 10-33), 20 hours in group C (IQR 16-54). Re-consultation rates were low. There were no serious treatment-related adverse events. Most interviewed participants said the treatment was effective. Conclusion: Although recruitment was challenging because of widespread expectations for antibiotics, patients with mild diarrhoea accepted to try an alternative. This therapy requires further evaluation in a fully powered, randomised controlled trial among a broader sample.

Subject Areas

Diarrhoea; Antibiotic Management; Over-the-counter; Nutraceuticals; Feasibility RCT; Alternative therapy; Turmeric (curcumin -active ingredient)

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