Hu Yanhong Jessika, Zhou Xudong, Wang Shanjuan, Willcox Merlin, Garner Colin, Brown David, Becque Taeko, Stuart Beth, Han Zongru, Chang Qin, Moore Michael, Little Paul
Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, Victoria, Australia.
Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia.
Pilot Feasibility Stud. 2021 Jun 15;7(1):126. doi: 10.1186/s40814-021-00850-y.
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.
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.
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.
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.
ChiCTR-IPR-17014107.
尽管抗生素在中国急性腹泻的治疗中很少被推荐使用，但却被广泛应用。我们开展了一项关于洛哌丁胺、黄连素和姜黄治疗急性腹泻的随机、双盲探索性临床试验。
将年龄在18至70岁之间、患有急性非复杂性腹泻的成年人随机分为4组：（A）洛哌丁胺组；（B）洛哌丁胺与黄连素组；（C）洛哌丁胺与姜黄组；（D）洛哌丁胺、黄连素与姜黄组。若症状在48小时后恶化或未改善，所有参与者均可使用急救环丙沙星。主要终点为2周随访期内的可行性及环丙沙星的使用情况。招募后进行了半结构化访谈，并进行了主题分析。招募医生、发药药师和研究助理对治疗分配情况不知情。
在筛选的患者中，仅有21.5%（278/1295）被认为符合条件，其中49%（136/278）同意并进入最终分析。大多数参与者症状较轻，因为大多数中重度症状患者希望使用抗生素。随访情况良好（2周时为94%）。与招募期间医院中67%的急性腹泻患者相比，只有3名参与者使用了急救抗生素。B组症状持续时间中位数为14小时（四分位间距（IQR）10 - 22），D组为16小时（IQR 10 - 22），A组为18小时（IQR 10 - 33），C组为20小时（IQR 16 - 54）。再次咨询率较低。未发生严重的治疗相关不良事件。大多数接受访谈的参与者表示，尽管他们曾认为抗生素对腹泻有效，但在本试验中他们在未使用抗生素的情况下快速康复，这让他们感到惊讶。
尽管由于对抗生素的广泛预期，招募工作具有挑战性，但轻度腹泻患者愿意尝试替代疗法。这三种营养保健品疗法需要在更大样本的充分有力的随机对照试验中进一步评估。
ChiCTR - IPR - 17014107。
