Abstract
BackgroundAlthough 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.MethodsAdults 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.ResultsOnly 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.ConclusionAlthough 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 registrationChiCTR-IPR-17014107
Highlights
Acute diarrheal disease is still a major global burden [1,2,3]
Despite the limited benefit and potential harm from antibiotic use, acute diarrhoea is commonly treated with antibiotics in low- and middle-income countries (LMICs) [4,5,6]
An effective non-antibiotic treatment for acute diarrhoea could relieve the pressure on Chinese doctors to prescribe antibiotics
Summary
Acute diarrheal disease is still a major global burden [1,2,3]. Despite the limited benefit and potential harm from antibiotic use, acute diarrhoea is commonly treated with antibiotics in low- and middle-income countries (LMICs) [4,5,6]. Patients in primary care are often frustrated with the lack of effective interventions for self-limiting illnesses and a majority (72%) report that they expect to receive a prescription for something to help their symptoms [11], especially when they are poor and have spent precious resources to travel to see a doctor. Telling them that their problem will resolve spontaneously may lead to conflicts [12]. Double blind exploratory clinical trial of loperamide, berberine and turmeric for treatment of acute diarrhoea
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