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EPs[R] 7630-solution--an effective therapeutic option in acute and exacerbating bronchitis.

Abstract

Acute bronchitis is one of the most common diagnoses in ambulatory care medicine. Although the benefit of antibiotics for acute bronchitis, which is mostly virally induced, is disputed, they are often prescribed. A therapeutic option for respiratory tract infections that do not fall within the strict indication range for antibiotic administration is the liquid herbal drug preparation from the roots of Pelargonium sidoides, EPs[R] 7630 (Umckaloabo[R]), which has been tested against placebo in double-blind clinical trials. EPs[R] 7630 has both antibacterial and immuno-modulating properties. The efficacy and tolerability of EPs[R] 7630 was investigated in a prospective, open, multicentric outcomes study with 205 patients suffering from acute bronchitis or acute exacerbation of chronic bronchitis. The main outcome measure was the change in the total score of five symptoms typical for bronchitis (cough, expectoration, wheezing/whistling on expiration, chest pain during coughing, and dyspnoea), which were each rated using a 5-point scale (from 0 = not present to 4 = extremely pronounced). Further symptoms (hoarseness, headache, aching limbs and fatigue) were assessed using a four-point scale (from 0 = not present to 3 = very pronounced). The total score of the typical bronchitis symptoms amounted to 6.1[+ or -]2.8 points on average at the start of treatment and decreased by 3.3[+ or -]3.8 points to 2.8[+ or -]2.6 points by the final examination on day 7. About 60.5% of the patients assessed their health condition at the end of the study as much improved or free from symptoms. The onset of action appeared after two days on average. Adverse events occurred in a total of 16 patients. There were no serious adverse events. Altogether, 78% of the patients were satisfied or very satisfied with the treatment.

[c] 2006 Elsevier GmbH. All rights reserved.

Keywords: Acute and exacerbating bronchitis; Herbal medicine; EPs[R] 7630; Umckaloabo[R]; Pelargonium sidoides

Introduction

Acute bronchitis is one of the most frequent diagnoses in medical practice. It is defined as an acute inflammation of the not chronically damaged lower respiratory tract and is mostly caused by viral infections. It is characterized by productive coughing (Hueston and Mainous, 1998). Although the benefit of antibiotic therapy for acute bronchitis is limited, particularly in cases of viral origin, they are prescribed in 60-80% of cases (Smucny et al., 2004). A current study shows that immediate or delayed antibiotic treatment has no influence on e.g. the duration of coughing--coughing continues for 3 weeks on average with or without antibiotics (Ebell, 2005; Little et al., 2005). Apart from the risk of side effects, the development of resistant bacteria is a disadvantage of non-indicated antibiotic therapy (Knutson and Braun, 2002).

Bronchitis is considered to be chronic if productive coughing persists for at least 3 months in two consecutive years (Flaherty et al., 2001). In these patients, an infection leads to acute exacerbation of the chronic bronchitis and is in 50-70% of these cases bacterial. Here too, therapy with antibiotics is only recommended for patients with increasing dyspnoea, sputum production or purulent expectoration and additional risk factors (Brunton et al., 2004).

The liquid herbal drug preparation EPs[R] 7630 from the roots of Pelargonium sidoides (exclusively contained in Umckaloabo[R]) (1) offers an effective therapeutic first line option for respiratory tract infections that do not fall within the strict indication for antibiotic treatment. EPs[R] 7630 is produced from the roots of a Geranium species native to South Africa and has antibacterial and immuno-modulating properties (Kayser and Kolodziej, 1997; Kayser et al., 2001). A shortening of the duration of illness and a reduction in symptoms in acute bronchitis has been demonstrated in several trials (Blochin et al., 1999; Chuchalin et al., 2005; Dome and Schuster, 1996). EPs[R] 7630 has also been shown to be very well tolerated.

A promising concept for understanding the results of particular health-care practices and interventions is the so-called outcomes research (e.g. Stucki, 1997). By linking the care patients get to the well-being they experience, outcomes research helps to develop better ways to monitor and improve quality of life. In particular for patients with chronic conditions, quality of life is of increasing importance for any therapeutic intervention (Wegener et al., 2003; Stucki, 1997).

In order to investigate the outcome of treatment with EPs[R] 7630 as well as to confirm the findings of former clinical trials under medical practice conditions, data on treatment with EPs[R] 7630 in patients with acute bronchitis or acute exacerbation of chronic bronchitis were collected in a prospective, open, multicentric outcomes study under routine clinical conditions.

Patients and methods

A total of 205 patients with acute bronchitis or acute exacerbation of chronic or recurrent bronchitis were enrolled in the multicenter, prospective, open outcomes study. The symptoms should have started not more than 7 days prior to inclusion into the study. The patients gave their written informed consent and were older than 18 years. The exclusion criteria comprised of an indication for imperative initial antibiotic treatment or antibiotic treatment within the past 4 weeks, a known or suspected hypersensitivity to the investigational medication, severe cardiac, renal or hepatic diseases and known alcohol or drug abuse. The study duration for each patient was seven days from the first consultation. During this period, 3 x 30 drops EPs[R] -solution/day were to be taken (EPs[R] -solution contains 80g EPs[R] 7630 per 100 ml solution). In addition to demographic data, information about concomitant diseases, concomitant medication, clinical findings and supportive measures were collected at baseline. Seven days after the consultation, the patient was interviewed by telephone and questioned about his health status, study medication intake, and use of other measures. Moreover, the Integrative Medicine Outcome Scale (IMOS) was used to assess the success of therapy and the Integrative Medicine Patient Satisfaction Scale (IMPSS) to assess satisfaction with the treatment.

The main outcome measure for the assessment of treatment efficacy was the change in intensity of the five typical bronchitis symptoms: Coughing, wheezing/whistling on expiration, expectoration, pain in the breast on coughing, and dyspnoea. These were assessed on a five-point scale (from 0 = not present to 4 = extremely pronounced) and added to produce a total score with a maximum of 20 points.

The data were evaluated descriptively in an Intention-to-treat and a Per-Protocol analysis. As the results of the two analyses did not differ significantly, only the results of Intention-to-treat analysis are given below.

Results

Demographic data

Approximately, two-thirds of the study participants were female (66.8%, 137/205), the mean age was 42[+ or -]16 (38) years (mean[+ or -]standard deviation (median)). In total, 120 patients (58.5%) reported to be non-smokers.

Diagnosis and therapy

Acute bronchitis was diagnosed in the majority of patients (87.8%, 180/205). A total of 9.3% (19/205) were suffering from acute exacerbation of their chronic bronchitis. Previous treatment for bronchitis was known in 22.4% (46/205) of the patients. Concomitant diseases were present in around half of the patients (51.7%, 106/205), usually in the form of acute sinusitis (21.5%, 44/205), laryngitis (12.7%, 26/205) or pharyngitis (11.7%, 24/205).

In total, 48.8% (100/205) of the patients reported the use of other therapy measures in addition to taking EPs[R] 7630. 22% (45/205) of the patients used inhalations, mostly with chamomile or saline solution. A total of 62 out of 205 (30.2%) patients reported the use of other supportive measures, such as antitussive or mucolytic agents, but also treatment with chest compresses or nasal douches.

According to the final examination, 87.8% (180/205) of the patients had taken EPs[R] 7630 as prescribed. Premature discontinuation of treatment was documented in eight cases. In one case, the patient withdrew consent, in two cases, adverse events occurred, and in two patients, discontinuation was the consequence of an exacerbation of the symptoms. Two patients could not be contacted for the final examination, and for one patient no exact details were available.

Efficacy analysis

The mean total score of the five typical bronchitis symptoms was 6.1[+ or -]2.8 (6) points at baseline; at the final examination on day 7 this was 2.8[+ or -]2.6 (2) points. The decrease therefore amounted to 3.3[+ or -]3.8 (3) points. In a sub-group analysis, in which only patients with a total score of more than 4 points at baseline were included (n = 128), the total score improved from 7.4[+ or -]2.3 (7) points at baseline to 2.8[+ or -]2.7 (2) points on day 7, which corresponds to a decrease of 4.6[+ or -]3.5 (5) points.

The improvement and remission rates for the individual symptoms were over 70% (Fig. 1) in each case.

Further symptoms, such as hoarseness, headache, aching limbs and fatigue, were assessed on a four-point scale (from 0 = not present to 3 = very pronounced). These symptoms showed improvement or remission rates of 66.9-88.2% (Fig. 2).

On average, the patients reported an improvement of their symptoms 2.3[+ or -]1.9 (2) days after the first consultation in the practice. At the final examination, 60.5% (124/205) of the patients assessed their health condition on the IMOS as clearly improved or were without symptoms (Fig. 3). They were also satisfied or very satisfied with the treatment in 78% (160/205) of cases. On the IMPSS, 92.7% (190/205) of the patients stated that they were satisfied or very satisfied with the doctor.

Safety analysis

Altogether, 18 adverse events in 16/205 (7.8%) of the patients were documented in this outcomes study. Eleven cases were adverse events involving the gastrointestinal tract. Of these, three were classified as suspected adverse drug reactions, although a relationship with the test medication was assessed as "unlikely". Serious adverse events did not occur. The study medication was therefore assessed as being safe and well tolerated for acute bronchitis or acute exacerbation of chronic bronchitis.

Discussion

Acute bronchitis is defined as a lower respiratory tract infection and is one of the most common diagnoses made by primary care physicians (Knutson and Braun, 2002). Although in up to 95% of cases the cause is viral, acute bronchitis has traditionally been treated with antibiotics (Hueston and Mainous, 1998). Because of increasing concern about antibiotic resistance and the scant evidence of benefit, this practice has been questioned (File and Hadley, 2002; Flaherty et al., 2001).

Focussing on the patients' quality-of-life, the results of this outcomes study confirm in a clinical practice setting that treatment of acute bronchitis or acute exacerbation of chronic bronchitis with EPs[R] 7630 (Umckaloabo[R]) is effective and well tolerated in the majority of cases.

The interval to the onset of action of the liquid herbal preparation was 2 days on average. The reduction in total score amounted to a median of 3 points and the remission and improvement rates of the typical bronchitis symptoms were consistently over 70%. This was associated with a clear clinical improvement. The satisfaction of the patients with the treatment and the physician in charge was high (78% and 92.7%, respectively).

Similar results were found in a multicentric, prospective, randomized, double-blind and placebo-controlled study of 124 patients with acute bronchitis reported recently (Chuchalin et al., 2005). In this study, the reduction in the total score of the five typical bronchitis symptoms was 7.2[+ or -]3.1 points in the active substance group compared to 4.9[+ or -]2.7 points in the placebo group. Rates of remission were much higher with EPs[R] 7630 than with placebo, although not as high as in the present study with regard to coughing and expectoration.

In the present study, adverse events occurred in only 16 out of 205 patients; serious adverse events were not reported. Thus, the tolerability of treatment with EPs[R] 7630 was shown to be very good, which is in line with previous trials in adults and also children (Blochin et al., 1999; Dome and Schuster, 1996; Haidvogl et al., 2006; Chuchalin et al., 2005). Bearing in mind the potential of antibiotics to produce serious toxicity and the hereby caused economic implications (Cunha, 2001; Gleckman and Czachor, 2000), EPs[R] 7630 therefore offers not only an effective but also a safe therapeutic first line option for respiratory tract infections that do not fall within the strict indication for antibiotic treatment.

The results reported in the literature and obtained by this multicenter outcomes study show that the liquid herbal drug preparation EPs[R] 7630 from the roots of P. sidoides is an effective and well tolerated therapeutic option for the treatment of acute bronchitis and acute exacerbation of chronic bronchitis, also under outcomes research criteria.

References

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Brunton, S., Carmichael, B.P., Colgan, R., Feeney, A.S., Fendrick, A.M., Quintiliani, R., Scott, G., 2004. Acute exacerbation of chronic bronchitis: a primary care consensus guideline. Am. J. Manage. Care 10, 689-696.

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Cunha, B.A., 2001. Antibiotic side effects. Med. Clin. North Am. 85, 149-185.

Dome, L., Schuster, R., 1996. Umckaloabo-eine phytother-apeutische Alternative bei akuter Bronchitis im Kindesalter? Arztezeitschrift fur Naturheilverfahren 37, 216-222.

Ebell, M.H., 2005. Antibiotic prescribing for cough and symptoms of respiratory tract infection. Do the right thing. J. Am. Med. Assoc. 293, 3062-3064.

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Haidvogl, M., Heger, M., 2006. Treatment effect and safety of EPs[R] 7630-solution in acute bronchitis in childhood: Report of a multicentre observational study. Phytomedicine 14 (2007) SVI 60-64.

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H. Matthys (a,*), M. Heger (b)

(a) Medical Dir. emeritus, Department of Pneumology, University Hospital Freiburg, Freiburg, Germany

(b) Clinical Research, ISO-Arzneimittel, Bunsenstrasse 6-10, Ettlingen, Germany

*Corresponding author. Lungs at Home, Hochruttestr. 17, D-79117 Freiburg i. Br. Tel.: +49(0) 761 62822; fax: +49(0) 761 6008580.

E-mail address: hmatthys@t-online.de (H. Matthys).

(1) Marketed by Spitzner Arzneimittel, Ettlingen, Germany.
Patients with remission or improvement [%]

Coughing 73.5
Wheezing/whistling on expiration 78.3
Expectoration 71.6
Chest pain during coughing 88.1
Dyspnoea 82.0

Fig. 1. Remission and improvement rates for the typical bronchitis
symptoms (n = 205).

Note: Table made from bar graph.

Patients with remission or improvement [%]

Hoarseness 66.9
Headache 87.0
Aching limbs 88.2
Fatigue 70.2
Fever 86.7

Fig. 2. Remission and improvement rates for the other symptoms
(n = 205).

Note: Table made from bar graph.

Slight to moderate improvement; 28.3
Unchanged; 5.4
Worse; 1.0
No data; 4.9
Free of symptoms; 12.7
Much better; 47.8

Fig. 3. Assessment of therapeutic success in patients [%] based in the
IMOS (n = 205).

Note: Table made from pie chart.
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Title Annotation:Pelargonium sidoides
Author:Matthys, H.; Heger, M.
Publication:Phytomedicine: International Journal of Phytotherapy & Phytopharmacology
Article Type:Clinical report
Geographic Code:4EUGE
Date:Feb 1, 2007
Words:2715
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