TY - JOUR
T1 - Pelargonium sidoides root extract for the treatment of acute cough due to lower respiratory tract infection in adults
T2 - a feasibility double-blind, placebo-controlled randomised trial
AU - Willcox, Merlin
AU - Simpson, Catherine
AU - Wilding, Sam
AU - Stuart, Beth
AU - Soilemezi, Dia
AU - Whitehead, Amy
AU - Morgan, Alannah
AU - Wrixon, Emma
AU - Zhu, Shihua
AU - Yao, Guiqing
AU - Webley, Fran
AU - Yan, Ruiyang
AU - Bostock, Jennifer
AU - Bell, Margaret
AU - Griffiths, Gareth
AU - Leydon, Geraldine
AU - Little, Paul
AU - Butler, Christopher
AU - Hay, Alastair D.
AU - Moore, Michael
N1 - Funding Information:
We would like to thank all the patients who participated, and all the GP practices who recruited patients to this study: Mulberry House Surgery and Lordshill Health Centre, Southampton; Homewell Curlew Practice, Havant; Liphook and Liss Surgery; Highcliffe Medical Centre; Wareham Surgery; Salisbury Medical Practice and Three Chequers Medical Practice, Salisbury; Vine Medical Group and Oaks Healthcare, Waterlooville; Chawton Park Surgery, Alton; Swanage Medical Centre; The Andover Health Centre; Abbeywell Surgery, Romsey; Friarsgate Practice, Winchester; The Adam Practice, Bournemouth; Park and St Francis Surgery, Eastleigh; Solent GP Practices; Swan Medical Group, Petersfield; The Cambridge Practice, Aldershot. We would also like to thank independent members of the independent Trial Steering Committee: Nick Francis, Julia Green, and David Gillespie. The NIHR Clinical Research Network in Wessex helped to identify participating practices.
Funding Information:
This work was supported by the National Institute of Health Research [grant numbers SPCR-2014-10043-336, CL-2016-26-005]. The funder had no role in the study.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/1/29
Y1 - 2021/1/29
N2 - Background: 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. Study design: Feasibility double-blind randomised placebo-controlled clinical trial. Methods: 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. Results: 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. Conclusions: 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. Trial registration: 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.
AB - Background: 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. Study design: Feasibility double-blind randomised placebo-controlled clinical trial. Methods: 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. Results: 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. Conclusions: 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. Trial registration: 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.
KW - Acute bronchitis
KW - Cluster-randomised
KW - Cough
KW - Double-blind randomised
KW - Feasibility clinical trial
KW - Herbal medicine
KW - Placebo-controlled
KW - Retention
UR - http://www.scopus.com/inward/record.url?scp=85100088137&partnerID=8YFLogxK
U2 - 10.1186/s12906-021-03206-4
DO - 10.1186/s12906-021-03206-4
M3 - Article
C2 - 33514367
AN - SCOPUS:85100088137
VL - 21
JO - BMC Complementary Medicine and Therapies
JF - BMC Complementary Medicine and Therapies
IS - 1
M1 - 48
ER -