School of Primary Care, Population Sciences and Medical Education, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, SO16 5ST, UK.
Southampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.
BMC Complement Med Ther. 2021 Jan 29;21(1):48. doi: 10.1186/s12906-021-03206-4.
Pelargonium sidoides DC (Geraniaceae) root extract, EPs®7630 or "Kaloba®", is a widely used herbal remedy for respiratory infections, with some evidence of effectiveness for acute bronchitis. However, it is not yet widely recommended by medical professionals in the UK. There is a need to undertake appropriately designed randomised trials to test its use as an alternative to antibiotics. The aim was to assess the feasibility of conducting a double-blind randomised controlled trial of Pelargonium sidoides root extract for treatment of acute bronchitis in UK primary care, investigating intervention compliance, patient preference for dosage form and acceptability of patient diaries.
Feasibility double-blind randomised placebo-controlled clinical trial.
We aimed to recruit 160 patients with cough (≤ 21 days) caused by acute bronchitis from UK general practices. Practices were cluster-randomised to liquid or tablet preparations and patients were individually randomised to Kaloba® or placebo. We followed participants up for 28 days through self-reported patient diaries with telephone support and reviewed medical records at one month. Outcomes included recruitment, withdrawal, safety, reconsultation and symptom diary completion rates. We also assessed treatment adherence, antibiotic prescribing and consumption, mean symptom severity (at days 2-4 after randomisation) and time to symptom resolution. We interviewed 29 patients and 11 health professionals to identify barriers and facilitators to running such a randomised trial.
Of 543 patients screened, 261 were eligible, of whom 134 (51%) were recruited and 103 (77%) returned a completed diary. Overall, 41% (41/100) of patients took antibiotics (Kaloba® liquid group: 48% [15/31]; placebo liquid group: 23% [6/26]; Kaloba® tablet group: 48% [9/21]; placebo tablet group: 50% [11/22]). Most patients adhered to the study medication (median 19 out of 21 doses taken in week 1, IQR 18-21 - all arms combined). There were no serious adverse events relating to treatment. Most patients interviewed found study recruitment to be straightforward, but some found the diary too complex.
It was feasible and acceptable to recruit patients from UK primary care to a double-blind placebo-controlled trial of herbal medicine (Kaloba®) for the treatment of acute bronchitis, with good retention and low data attrition.
HATRIC was registered on the ISRCTN registry ( ISRCTN17672884 ) on 16 August 2018, retrospectively registered. The record can be found at http://www.isrctn.com/ISRCTN17672884 .
Pelargonium sidoides DC（Geraniaceae）根提取物，EPs®7630 或“Kaloba®”，是一种广泛用于治疗呼吸道感染的草药疗法，有一些证据表明对急性支气管炎有效。然而，在英国，它尚未得到医学专业人员的广泛推荐。有必要进行适当设计的随机试验，以测试其作为抗生素替代品的用途。目的是评估在英国初级保健中进行 Pelargonium sidoides 根提取物治疗急性支气管炎的双盲随机对照试验的可行性，调查干预措施的依从性、患者对剂型的偏好以及患者日记的可接受性。
可行性双盲随机安慰剂对照临床试验。
我们旨在从英国全科医生那里招募 160 名因急性支气管炎而咳嗽（≤21 天）的患者。将实践按群组随机分配为液体或片剂制剂，患者按个体随机分配为 Kaloba®或安慰剂。我们通过自我报告的患者日记、电话支持和一个月时的医疗记录，对参与者进行了 28 天的随访。结果包括招募、退出、安全性、重新咨询和症状日记完成率。我们还评估了治疗依从性、抗生素处方和消耗、平均症状严重程度（随机分组后第 2-4 天）和症状缓解时间。我们采访了 29 名患者和 11 名卫生专业人员，以确定开展此类随机试验的障碍和促进因素。
在筛选的 543 名患者中，有 261 名符合条件，其中 134 名（51%）被招募，103 名（77%）完成了日记。总体而言，41%（41/100）的患者服用了抗生素（Kaloba®液体组：48%[15/31]；安慰剂液体组：23%[6/26]；Kaloba®片剂组：48%[9/21]；安慰剂片剂组：50%[11/22]）。大多数患者坚持使用研究药物（第 1 周中位数为 21 剂中的 19 剂，IQR 18-21-所有臂合并）。没有与治疗相关的严重不良事件。大多数接受采访的患者发现招募患者参加英国初级保健的双盲安慰剂对照试验非常简单，但有些患者发现日记过于复杂。
从英国初级保健中招募患者参加双盲安慰剂对照试验，使用草药（Kaloba®）治疗急性支气管炎是可行且可接受的，保留率高，数据丢失率低。
HATRIC 于 2018 年 8 月 16 日在 ISRCTN 注册处（ISRCTN17672884）注册，是事后注册。记录可在 http://www.isrctn.com/ISRCTN17672884 上找到。
