Diarrhoea Management using Over-the-counter Nutraceuticals in Daily practice (DIAMOND): a feasibility RCT on alternative therapy to reduce antibiotic use
Diarrhoea Management using Over-the-counter Nutraceuticals in Daily practice (DIAMOND): a feasibility RCT on alternative therapy to reduce antibiotic use
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
Alternative therapy, Antibiotic management, Diarrhoea, Feasibility RCT, Nutraceuticals, Over-the-counter, Turmeric (curcumin-active ingredient)
126
Hu, Yanhong Jessika
db339d28-c6e8-4daf-8983-0ef773dbb4f4
Zhou, Xudong
83b8512a-f3cf-45a8-bc09-94bd7c09c9fe
Wang, Shanjuan
92901717-b62f-4995-ad95-acc4526e993b
Willcox, Merlin
dad5b622-9ac2-417d-9b2e-aad41b64ffea
Garner, Colin
1415a8c4-8b31-460e-8630-1b653c736afc
Brown, David
820012d2-d25b-49f3-a82b-6ccfeb1f4774
Becque, Taeko
ecd1b4d5-4db8-4442-81c2-04aa291cf2fd
Stuart, Beth
626862fc-892b-4f6d-9cbb-7a8d7172b209
Han, Zongru
2eb0fa6a-42c6-4502-b173-fce96f242e05
Chang, Qin
a7aea7d6-deb8-46a7-a81e-c13a85afc781
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
15 June 2021
Hu, Yanhong Jessika
db339d28-c6e8-4daf-8983-0ef773dbb4f4
Zhou, Xudong
83b8512a-f3cf-45a8-bc09-94bd7c09c9fe
Wang, Shanjuan
92901717-b62f-4995-ad95-acc4526e993b
Willcox, Merlin
dad5b622-9ac2-417d-9b2e-aad41b64ffea
Garner, Colin
1415a8c4-8b31-460e-8630-1b653c736afc
Brown, David
820012d2-d25b-49f3-a82b-6ccfeb1f4774
Becque, Taeko
ecd1b4d5-4db8-4442-81c2-04aa291cf2fd
Stuart, Beth
626862fc-892b-4f6d-9cbb-7a8d7172b209
Han, Zongru
2eb0fa6a-42c6-4502-b173-fce96f242e05
Chang, Qin
a7aea7d6-deb8-46a7-a81e-c13a85afc781
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Hu, Yanhong Jessika, Zhou, Xudong, Wang, Shanjuan, Willcox, Merlin, Garner, Colin, Brown, David, Becque, Taeko, Stuart, Beth, Han, Zongru, Chang, Qin, Moore, Michael and Little, Paul
(2021)
Diarrhoea Management using Over-the-counter Nutraceuticals in Daily practice (DIAMOND): a feasibility RCT on alternative therapy to reduce antibiotic use.
Pilot and Feasibility Studies, 7 (1), , [126].
(doi:10.1186/s40814-021-00850-y).
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
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More information
Accepted/In Press date: 3 May 2021
Published date: 15 June 2021
Additional Information:
Funding Information:
This project was supported by a grant from Antibiotic Research UK and Prof David Brown personally. The salary of MLW was funded by the National Institute of Health Research (NIHR), under grant CL-2016-26-005. The funders had no role in study design, data collection and interpretation, or the decision to submit the work for publication.
Funding Information:
We thank all the patients to take part in this study. Shanghai Jiading District Central Hospital leaders support. The doctors from Jiading District Central Hospital for the recruitment. The research team from Zhejiang University and Diamond study group. The turmeric capsules used in the study were kindly donated by Nu U Nutrition, York, UK. We would like to acknowledge the early contributions from Professor George Lewith, we remember and are grateful for his lifetime of contributions to medical research.
Publisher Copyright:
© 2021, The Author(s).
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
Keywords:
Alternative therapy, Antibiotic management, Diarrhoea, Feasibility RCT, Nutraceuticals, Over-the-counter, Turmeric (curcumin-active ingredient)
Identifiers
Local EPrints ID: 450867
URI: http://eprints.soton.ac.uk/id/eprint/450867
ISSN: 2055-5784
PURE UUID: bbd31b3d-1b92-424d-9513-b08e3a427cbb
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Date deposited: 17 Aug 2021 16:32
Last modified: 18 Mar 2024 03:39
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Contributors
Author:
Yanhong Jessika Hu
Author:
Xudong Zhou
Author:
Shanjuan Wang
Author:
Colin Garner
Author:
David Brown
Author:
Zongru Han
Author:
Qin Chang
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