2013
DOI: 10.1016/j.rmed.2013.02.011
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Randomised, double-blind, placebo-controlled trial of EPs 7630 in adults with COPD

Abstract: The results demonstrate a statistically significant and clinically relevant superiority of add-on therapy with EPs 7630 over placebo and a good long-term tolerability in the treatment of moderate to severe COPD. EPs 7630 prolonged time to exacerbations and reduced exacerbation frequency and antibiotic use. Trial Registration No.: ISRCTN01681733.

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Cited by 23 publications
(15 citation statements)
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References 34 publications
(33 reference statements)
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“…As an add-on therapy for patients with chronic obstructive pulmonary disease, EPs 7630 led to postponement of exacerbations, reduced exacerbation frequency and antibiotic use (23).…”
Section: Objectivesmentioning
confidence: 99%
“…As an add-on therapy for patients with chronic obstructive pulmonary disease, EPs 7630 led to postponement of exacerbations, reduced exacerbation frequency and antibiotic use (23).…”
Section: Objectivesmentioning
confidence: 99%
“…Based on clinical data, the tolerability of treatment with EPs s 7630 has been shown to be good in both adults and children (Table 3). Nevertheless, some of the commonly reported adverse events included gastrointestinal complaints such as diarrhoea (Matthys et al, 2003(Matthys et al, , 2007(Matthys et al, , 2013Haidvogl and Heger, 2007;Matthys and Heger, 2007a;Bachert et al, 2009;Kamin et al, 2010Kamin et al, , 2012, nervous system complaints (Matthys et al, 2003), respiratory and mediastinal ailments (Matthys et al, 2003), ear and labyrinth complaints (Matthys et al, 2003), exanthema (Haidvogl and Heger, 2007), tracheitis and epistaxis (Lizogub et al, 2007) and allergic skin reactions (Bachert et al, 2009). Recently, a clinical study by Teschke et al (2012) concluded that Pelargonium sidoides did not reveal evidence of hepatotoxicity.…”
Section: Safety Evaluationmentioning
confidence: 99%
“…Eleven high quality studies [26–31, 33, 34, 37, 39, 40] reported FEV% and showed that HM as an adjunct therapy had no advantage on improving FEV% compared with WM (overall effect: P = 0.10, heterogeneity: I 2 = 32%) as shown in Figure 4(b), whereas the baseline of two groups had no significant difference in FEV% (overall effect: P = 0.26, heterogeneity: I 2 = 0%, Table S2). Seven studies [14, 27, 29, 31, 34, 35, 37] reported the forced vital capacity (FVC); pooled data showed that HM as an adjunct therapy had no advantage on improving FVC compared to WM (overall effect: P = 0.35, heterogeneity: I 2 = 0%, Figure 4(c)), whereas the baseline of two groups had no significant difference in FVC (overall effect: P = 0.42, heterogeneity: I 2 = 0%) as shown in Table S2.…”
Section: Resultsmentioning
confidence: 99%