Efficacy and tolerability of EPs 7630 in children and adolescents with acute bronchitis – A randomized, double-blind, placebo-controlled multicenter trial with a herbal drug preparation from Pelargonium sidoides roots

2010 ◽  
Vol 48 (03) ◽  
pp. 184-191 ◽  
Author(s):  
W. Kamin ◽  
V. Maydannik ◽  
F.A. Malek ◽  
M. Kieser
Keyword(s):  
Children And Adolescents ◽  
Acute Bronchitis ◽  
Multicenter Trial ◽  
Drug Preparation ◽  
Herbal Drug ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Pelargonium Sidoides

scholarly journals Pelargonium sidoides root extract for the treatment of acute cough due to lower respiratory tract infection in adults: a feasibility double-blind, placebo-controlled randomised trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Merlin Willcox ◽  
Catherine Simpson ◽  
Sam Wilding ◽  
Beth Stuart ◽  
Dia Soilemezi ◽  
...  
Keyword(s):  
Primary Care ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Acute Bronchitis ◽  
Antibiotic Prescribing ◽  
Root Extract ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Link Type ◽  
Pelargonium Sidoides

Abstract 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.

scholarly journals Treatment of acute bronchitis in adults with extract of Pelargonium Sidoides: a randomised, double-blind, placebo controlled trial

2007 ◽  
pp. 49-55
Author(s):  
A. G. Chuchalin ◽  
B. Berman ◽  
V. Lemakher
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Controlled Trial ◽  
Alternative Therapy ◽  
Acute Bronchitis ◽  
Complete Recovery ◽  
Primary Outcome Measure ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Pelargonium Sidoides

Acute bronchitis is a wide-spread disease. Although it is generally caused by viruses, antibiotics are used for its treatment too much often. So it is very important to evaluate alternative therapy of acute bronchitis. The aim of the trial was to assess efficacy and safety of Pelargonium Sidoides (EPs 7630 is a registered trademark of Dr. Willmar Schwabe GmbH & Co, Karlsruhe, Germany) compared to placebo in patients with acute bronchitis. Study design: randomised, double-blind, placebo controlled trial with planned interim analysis. The trial centres: 6 outpatient medical centres. Patients: 124 adult patients with acute bronchitis, onset of the disease ≤ 48 h, and severity of symptoms ≥ 5 according to BSS scale gave written informed concert. EPs 7630 or placebo were administered in the dose of 30 drops t.i.d. during 7 days. The primary outcome measure was BSS scoring at the 7th day of the treatment. BSS scoring decreased by 7.2 ± 3.1 in the EPs 7630 group (n = 64) vs 4.9 ± 2.7 in the placebo group (n = 60). 95 % confidence interval (CI, 1.21, 3.56) for difference of the effects between two groups demonstrated significant improvement in the EPs 7630 in 7 days of the treatment compared to the placebo group (p < 0.0001). The EPs 7630 patients had parameters of complete recovery for every of 5 individual symptoms reliably higher compared to placebo patients. During the first 4 days of the treatment therapeutic effect was noted in 68.8 % of the EPs 7630 group vs 33.3 % of the placebo group (p < 0.0001). Health-related quality of life improved better in the EPs 7630 patients compared to the placebo group. Adverse events were found in 25 of 124 patients: 15 / 64 in the EPs 7630 group and 10 / 60 in the placebo group. All the adverse events were considered as non-serious. The efficacy of EPs 7630 in treatment of adults with acute bronchitis was higher compared to placebo. It could be an efficient alternative drug in therapy of acute bronchitis at the absence of indications for antibiotics administration.

Oral budenosid is highly effective in the treatment of collagenous colitis: A randomized, double-blind, placebo-controlled, multicenter trial

2001 ◽  
Vol 120 (5) ◽  
pp. A40-A40 ◽  
Author(s):  
S MIEHLKE ◽  
P HEYMER ◽  
T OCHSENKUEHN ◽  
E BAESTLEIN ◽  
G YARIAN ◽  
...  
Keyword(s):  
Collagenous Colitis ◽  
Multicenter Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Highly Effective

DGAVP (Org 5667) in early Alzheimer??s disease patients: an international double-blind, placebo-controlled multicenter trial

1991 ◽  
Vol 5 (3) ◽  
pp. 205
Author(s):  
ECh Wolters ◽  
P Riekkinen ◽  
A Lowenthal ◽  
JJ Van der Plaats ◽  
JMT Zwart ◽  
...  
Keyword(s):  
Multicenter Trial ◽  
Double Blind ◽  
Double Blind Placebo

Simethicone in the Treatment of Infant Colic: A Randomized, Placebo-Controlled, Multicenter Trial

PEDIATRICS ◽  
1994 ◽  
Vol 94 (1) ◽  
pp. 29-34
Author(s):  
Thomas J. Metcalf ◽  
Thomas G. Irons ◽  
Lawrence D. Sher ◽  
Paul C. Young
Keyword(s):  
Treatment Period ◽  
Multicenter Trial ◽  
Crossover Fashion ◽  
Infantile Colic ◽  
Parental Report ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Infant Colic ◽  
Geographic Regions

Objective. To determine the efficacy of simethicone in the treatment of infant colic. Design. Randomized, double blind, placebo-controlled. Setting. Three general pediatric practices in distinct geographic regions. Patients. Eighty-three infants between 2 and 8 weeks of age with infant colic. Interventions. Treatment with simethicone and placebo in double blind crossover fashion. Results. A total of 166 treatment periods, ranging from 3 to 10 days, were evaluated in the 83 infants. Compared to baseline, improvement in symptoms was reported for 54% of the treatment periods, worsening was reported for 22%, and, for 24%, there was no change. The likelihood of the treatment period being rated as showing improvement, worsening, or no change was the same whether the infant was receiving placebo or simethicone. Twenty-eight percent of he infants responded only to simethicone, 37% only to placebo, and 20% responded to both. No statistically significant differences were noted among these three groups of responders. No difference could be shown even when infants with "gas-related symptoms" (by parental report) were separated out as a group. Conclusion. Although both produced perceived improvements in symptoms, simethicone is no more effective than placebo in the treatment of infantile colic.

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