Primary studies included in this systematic review

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Primary study

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A multi-centre, randomised, double-blind, placebo-controlled clinical trial on the efficacy and tolerability of GeloMyrtol® forte in acute bronchitis

Tijdschrift Drug research
Year 2013
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GeloMyrtol® forte (Myrtol®) is a phytomedicine obtained by distillation from essential oils. The trial was conducted to confirm the efficacy of Myrtol® in the treatment of acute bronchitis. Methods: Patients with acute bronchitis and without confounding co-morbidity or co-medication were randomly assigned to treatment with either Myrtol® 300 mg 4 times daily or matched placebo in double-blind, parallel-group fashion. Signs and symptoms were evaluated by the investigator at baseline and after 7, 10 and 14 days of treatment; intake of medication, wellbeing and symptoms were recorded daily by the patient in the patients' diaries. Findings: 413 patients were enrolled and randomised (Myrtol®: 202; Placebo: 211); 398 had at least one on-treatment efficacy evaluation (Myrtol®: 196; Placebo: 202). The mean change in coughing fits from D01 (baseline) to D07-D09 (after about one week treatment) was 62.1% (95% CI: 57.6-66.6%) and 49.8% (95% CI: 44.6-55.0%) for treatment with Myrtol® and placebo, respectively (p<0.0001). With Myrtol®, the median time to 50% reduction in coughing fits was statistically significantly shorter and there were more patients without day-time coughing fits; there also were statistically significantly less day-time coughing fits, less difficulty coughing up, less sleep disturbance due to night-time coughing; with Myrtol® there was less symptomatic impairment (composite bronchitis severity score and subscores) and significant more patients had a clinically satisfying response to the investigational treatment. Both treatments were generally well tolerated. Conclusions: Myrtol® is statistically significantly superior to placebo in treating acute bronchitis. © Georg Thieme Verlag KG Stuttgart · New York.

Primary study

Unclassified

Treatment of acute bronchitis with EPs 7630: Randomized, controlled trial in children and adolescents.

Auteurs Kamin W , Ilyenko LI , Malek FA , Kieser M
Tijdschrift Pediatrics international : official journal of the Japan Pediatric Society
Year 2012
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BACKGROUND: The aim of this trial was to investigate the efficacy and tolerability of EPs 7630, a herbal drug preparation from Pelargonium sidoides, in children and adolescents suffering from acute bronchitis, outside the strict indication for antibiotics. METHODS: A total of 220 patients with acute bronchitis were randomized and given either verum containing EPs 7630 (1-6 years/>6-12 years/>12-18 years: 3 × 10/3 × 20/3 × 30 drops/day) or matching placebo for 7 days. The main outcome measure was the change in the total score of bronchitis-specific symptoms (BSS) from day 0 to day 7. RESULTS: The decrease in the BSS total score was significantly higher for EPs 7630 compared to placebo (change day 0-day 7: 4.4 ± 1.6 vs 2.9 ± 1.4 points; P < 0.0001). Improvements were most pronounced for 'coughing' and 'rales at auscultation'. Tolerability was similarly good in both groups. CONCLUSIONS: EPs 7630 proved to be an efficacious and well-tolerated option for the treatment of acute bronchitis in children and adolescents outside the strict indication for antibiotics.

Primary study

Unclassified

Acute bronchitis therapy with ivy leaves extracts in a two-arm study. A double-blind, randomised study vs. an other ivy leaves extract.

Tijdschrift Phytomedicine : international journal of phytotherapy and phytopharmacology
Year 2011
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Ivy leaves extracts are authorised in medicinal products for the treatment of acute bronchitis. Different studies and the long experience on the market show safety and efficacy of this drug. A double-blind, randomised study was conducted to assess the efficacy and tolerability of ivy leaves soft extract with an other ivy leaves extract. 590 patients with acute bronchitis participated in this study. They were treated with test or comparator for 7 days (±1). The Bronchitis Severity Score (BSS) decreased gradually and to a similar extent from Day 1 to Day 7 in both treatment groups. Starting from values of 6.2-6.3±1.2, the BSS decreased by approximately 4.7-4.9 points until Day 7, so that patients left the study with a mean BSS of 1.4-1.6. The BSS subscales cough, sputum, rhales/rhonchi, chest pain during coughing, and dyspnoea improved to a similar extent in both treatment groups. Overall, 2.7% of patients (per group and overall) experienced an adverse event, all of which were non-serious. Fewer patients younger than ten years had adverse events than would have been expected from their share of the study population (p=0.015; Fisher's exact test). As a conclusion, the test product with ivy leaves soft extract proved to be non-inferior to the comparator ivy leaves extract in improving symptoms of acute bronchitis.

Primary study

Unclassified

Antitussive effect of bakumondoto a fixed kampo medicine (six herbal components) for treatment of post-infectious prolonged cough: controlled clinical pilot study with 19 patients.

Tijdschrift Phytomedicine : international journal of phytotherapy and phytopharmacology
Year 2011
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Bakumondoto (TJ-29) is a traditional herbal medicine that has been used in Japan for the treatment of bronchitis, bronchial asthma, and cough. This study investigated the effect of TJ-29 for the treatment of post-infectious prolonged cough. We performed a multicenter randomized controlled trial treating patients without (group A, n=11) or with TJ-29 (group B, n=8) for a total of 2 weeks using a beta 2 stimulant as the basal agent. Efficacy and safety were compared by a cough diary, VAS and sleeping questionnaire. At 4 and 5 days after treatment, the cough score of group B showed significant improvement compared with group A, demonstrating an early antitussive effect. At the assessment 2 weeks after treatment start, both groups showed similar levels of improvement in the cough score. No significant difference was observed in the VAS and the sleeping questionnaire items. In conclusion, oral TJ-29 administration could be useful and safe for the treatment of post-infectious prolonged cough.

Primary study

Unclassified

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

Tijdschrift International journal of clinical pharmacology and therapeutics
Year 2010
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Objective: The study aim was to demonstrate the efficacy and to investigate the tolerability of EPs 7630, a herbal drug preparation from Pelargonium sidoides roots, in the treatment of patients (1 - 18 years) with acute bronchitis outside the strict indication for antibiotics. Materials and methods: A total of 200 patients were randomized to receive either active drug containing EPs 7630 (1 - 6 years: 3 × 10 drops/d; > 6 - 12 years: 3 × 20 drops/d; > 12 - 18 years: 3 × 30 drops/d) or placebo for 7 consecutive days. Primary outcome measure: change in the total score of bronchitis-specific symptoms (BSS) from Day 0 toDay 7. Main secondary outcomemeasures: treatment outcome, patients' satisfaction with treatment, onset of effect, bed rest. Results: From baseline to Day 7, the mean BSS score improved significantly more for EPs 7630 compared with placebo (3.4 ± 1.8 vs. 1.2 ± 1.8 points, p < 0.0001). On Day 7, treatment outcome was significantly better (p < 0.0001), satisfaction with treatment more pronounced (77.6% vs. 25.8%, p < 0.0001), onset of effect faster, and time of bed rest shorter as compared with placebo. Tolerability was similarly good in both groups. All adverse events were assessed as non-serious. Conclusion: EPs 7630 was shown to be efficacious and safe in the treatment of acute bronchitis in children and adolescents outside the strict indication for antibiotics with patients treated with EPs 7630 perceiving a more favorable course of the disease and a good tolerability as compared with placebo. ©2010 Dustri-Verlag Dr. K. Feistle.

Primary study

Unclassified

A randomized double blind placebo controlled clinical evaluation of extract of Andrographis paniculata (KalmCold) in patients with uncomplicated upper respiratory tract infection.

Tijdschrift Phytomedicine : international journal of phytotherapy and phytopharmacology
Year 2010
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A randomized, double blind placebo controlled clinical study was conducted to evaluate the efficacy of KalmCold, an extract of Andrographis paniculata, in patients with uncomplicated upper respiratory tract infection (URTI). The assessment involved quantification of symptom scores by Visual Analogue Scale. Nine self evaluated symptoms of cough, expectoration, nasal discharge, headache, fever, sore throat, earache, malaise/fatigue and sleep disturbance were scored. A total of 223 patients of both sexes were randomized in two groups which received either KalmCold (200 mg/day) or placebo in a double blind manner. In both the treatments, mean scores of all symptoms showed a decreasing trend from day 1 to day 3 but from day 3 to day 5 most of the symptoms in placebo treated group either remained unchanged (cough, headache and earache) or got aggravated (sore throat and sleep disturbance) whereas in KalmCold treated group all symptoms showed a decreasing trend. Within groups, mean scores of symptoms in both the groups decreased significantly (p &lt; or = 0.05) from day 1 to day 3 and day 5 while from day 3 to day 5 all symptoms except expectoration in placebo group did not improve significantly whereas in KalmCold treated group all symptoms improved significantly (p &lt; or = 0.05) except earache. Comparing mean between both groups, all symptoms at day 1 and day 3 were found to be the same while at day 5 all symptoms except earache in KalmCold treated group improved significantly (p &lt; or = 0.05) than placebo group. Similarly, within groups, overall scores of all symptoms in both the groups decreased significantly (p &lt; or = 0.05) from day 1 to day 3 and day 5 while from day 3 to day 5 placebo group did not improve significantly whereas KalmCold treated group showed significant improvement (p &lt; or = 0.05). On between groups analysis, KalmCold group showed significant reduction (p &lt; or = 0.05) in overall symptom scores as compared to placebo group. In both placebo and KalmCold treated groups, there were only a few minor adverse effects with no significant difference in occurrence (Z = 0.63; p &gt; 0.05). The comparison of overall efficacy of KalmCold over placebo was found to be significant (p &lt; or = 0.05) and it was 2.1 times (52.7%) higher than placebo. The findings of this study revealed that KalmCold was effective in reducing symptoms of upper respiratory tract infection.

Primary study

Unclassified

Vapor rub, petrolatum, and no treatment for children with nocturnal cough and cold symptoms

Tijdschrift Pediatrics
Year 2010
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OBJECTIVE: To determine if a single application of a vapor rub (VR) or petrolatum is superior to no treatment for nocturnal cough, congestion, and sleep difficulty caused by upper respiratory tract infection. METHODS: Surveys were administered to parents on 2 consecutive days - on the day of presentation when no medication had been given the previous evening, and the next day when VR ointment, petrolatum ointment, or no treatment had been applied to their child's chest and neck before bedtime according to a partially double-blinded randomization scheme. RESULTS: There were 138 children aged 2 to 11 years who completed the trial. Within each study group, symptoms were improved on the second night. Between treatment groups, significant differences in improvement were detected for outcomes related to cough, congestion, and sleep difficulty; VR consistently scored the best, and no treatment scored the worst. Pairwise comparisons demonstrated the superiority of VR over no treatment for all outcomes except rhinorrhea and over petrolatum for cough severity, child and parent sleep difficulty, and combined symptom score. Petrolatum was not significantly better than no treatment for any outcome. Irritant adverse effects were more common among VR-treated participants. CONCLUSIONS: In a comparison of VR, petrolatum, and no treatment, parents rated VR most favorably for symptomatic relief of their child's nocturnal cough, congestion, and sleep difficulty caused by upper respiratory tract infection. Despite mild irritant adverse effects, VR provided symptomatic relief for children and allowed them and their parents to have a more restful night than those in the other study groups. Copyright © 2010 by the American Academy of Pediatrics.

Primary study

Unclassified

Efficacy and tolerability of EPs 7630 tablets in patients with acute bronchitis: A randomised, double-blind, placebo-controlled dose-finding study with a herbal drug preparation from Pelargonium sidoides

Tijdschrift Current medical research and opinion
Year 2010
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Objective: Acute bronchitis is one of the most frequent health complaints for which patients seek medical advice. Although viral infections prevail, antibiotics are commonly prescribed. In this study, the efficacy and tolerability of EPs 7630 tablets, a herbal drug preparation from the roots of Pelargonium sidoides, were investigated in adults with acute bronchitis outside the strict indication for antibiotics. Research design and methods: In this randomised, double-blind, placebo-controlled, multicentre dose-finding trial using an adaptive group-sequential design, 406 patients were randomly assigned to one of four parallel treatment groups (10mg EPs 7630 tablets three times a day (30-mg group), 20mg EPs 7630 tablets three times a day (60-mg group), 30mg EPs 7630 tablets three times a day (90-mg group) or placebo three times a day) for a treatment period of 7 days. Primary endpoint was the change in the total score of bronchitis-specific symptoms (BSS) from baseline to day 7. Results: Between day 0 and day 7, the mean BSS score decreased by 2.7±2.3 (placebo), 4.3±1.9 (30-mg group), 6.1±2.1 (60-mg group), and 6.3±2.0 points (90-mg group), respectively. The differences between the EPs 7630 groups and placebo were statistically significant (p<0.0001, each). The secondary endpoints showed comparable results. EPs 7630 was well-tolerated. All documented adverse events were of mild to moderate intensity; their frequency was dose-dependent. No serious adverse events were reported. Conclusion: This study demonstrated statistically significant and clinically relevant superiority of all three tested dosages of EPs 7630 over placebo. All dosages of EPs 7630 were well-tolerated. Taking into account both efficacy and safety, the results of this study indicate that the 20mg tablets of EPs 7630 taken three times daily constitute the optimal dose with respect to the benefit-risk ratio. © 2010 Informa UK Ltd All rights reserved.

Primary study

Unclassified

Pelargonium sidoides in acute bronchitis - Health-related quality of life and patient-reported outcome in adults receiving EPs 7630 treatment

Auteurs Matthys H , Lizogub VG , Funk P , Malek FA
Tijdschrift Wiener medizinische Wochenschrift (1946)
Year 2010
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Health-related quality of life (HRQL) and patient-reported outcome (PRO) have become important outcome parameters for the evaluation of medical treatment within clinical trials and, furthermore, to evaluate efficiency in clinical practice. We therefore report further exploratory results of an already reported dose-finding study with EPs 7630 tablets, now focussing on HRQL and PRO. A total of 406 adults with acute bronchitis were randomly assigned to one of four parallel treatment groups (placebo, 30 mg, 60 mg or 90 mg EPs 7630 daily). HRQL and PRO were assessed by questionnaires as secondary outcome measures at each study visit or daily in the patient's diary. At day 7, the patient-reported outcome measures were significantly more improved in all the three EPs 7630 groups compared to placebo (EQ-5D and EQ VAS, SF-12: physical score, impact of patient's sickness, duration of activity limitation, patient-reported treatment outcome, satisfaction with treatment). In conclusion, a statistically significant and clinically relevant improvement of HRQL/PRO compared to placebo was shown in all the three EPs 7630 groups. © 2010 Springer-Verlag Zusammenfassung.

Primary study

Unclassified

Efficacy and tolerability of EPs 7630 in patients (aged 6-18 years old) with acute bronchitis: A randomized, double-blind, placebo-controlled clinical dose-finding study.

Tijdschrift Acta paediatrica (Oslo, Norway : 1992)
Year 2010
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AIM: For EPs 7630, a herbal drug preparation from <i>Pelargonium sidoides</i> roots, therapeutic effects in respiratory tract infections outside the strict indication for antibiotics have already been demonstrated in adults. Now, a dose-finding study for EPs 7630 was performed in children and adolescents. METHODS: A total of 400 patients (aged 6–18 years) were randomized to receive either 30 mg, 60 mg or 90 mg EPs 7630 or placebo daily. Primary outcome criterion was the change in the bronchitis- specific symptoms (BSS) total score from day 0 to day 7. RESULTS: After 7 days of treatment, the change in the BSS total score was significantly better in the 60 mg and 90 mg groups compared with placebo without relevant differences between these two dosages. Especially ‘coughing’, ‘sputum’ and ‘rales at auscultation’ improved under EPs 7630. Onset of effect was faster, time of bed rest shorter and treatment outcome and satisfaction with treatment were rated better. Tolerability was comparable with placebo in all treatment groups. CONCLUSION: EPs 7630 is effective in acute bronchitis outside the strict indication for antibiotics in 6–18 years old patients, with a dose of 60 mg or 90 mg daily offering the best benefit/risk ratio. EPs 7630 significantly reduces the severity of symptoms, leads to a more favourable course of the disease and a faster recovery from acute bronchitis compared with the placebo, and is well tolerated. (PsycINFO Database Record (c) 2016 APA, all rights reserved)