Issue: 71 Page: 32-33
Special Extract of Traditional African Herb Pelargonium Treats Bronchitis in Clinical Trial
by John Neustadt
HerbalGram. 2006; 71:32-33 American Botanical Council
Special Extract of Traditional African Herb Pelargonium Treats Bronchitis in Clinical Trial
Reviewed: Chuchalin AG, Berman B, Lehmacher W. Treatment of
acute bronchitis in adults with a Pelargonium sidoides preparation (EPs 7630): a randomized, double-blind,
placebo controlled trial. Explore!
November 2005;1(6):437-445.
Acute bronchitis is a common upper respiratory tract infection caused primarily
by the respiratory syncytial virus (RSV), but also by the coxsackie, influenza,
parainfluenza, and ECHO viruses or adenoviruses. Conventional medical treatment
is aimed primarily at reducing symptoms. Treatment with antibiotics does not
substantially decrease the duration of the illness; however 70% of the cases
of acute bronchitis continue to be treated in conventional medicine by prescribing
antibiotics. This clinical trial evaluated the potential of an herbal medicinal
preparation made of the roots of Pelargonium sidoides DC, Geraniaceae
for the treatment of acute bronchitis. P. sidoides is an herb used
traditionally in South Africa for its ability to treat various symptoms of
upper respiratory tract infections.
This randomized, double-blind, placebo controlled clinical
trial was conducted in Russia at 6 urban primary care outpatient clinics.
Included in the study were 124 subjects (37 men, 87 women, mean age
approximately 36 years) diagnosed with acute bronchitis and a Bronchitis
Severity Score (BSS) ? 5, and duration of symptoms of ? 48 hours. The BSS is a
5-point scale that scores bronchitis symptoms, namely cough, sputum,
rales/rhonchi (a crackling sound during respiration related to congestion in
the bronchi), chest pain during coughing, and dyspnea (difficult breathing).
Symptoms were assessed through interviews with the subjects,
in which a score of 0 = the absence of symptoms, 1 = mild symptoms, 2 =
moderate, 3 = severe, and 4 = very severe symptoms. Excluded from the study
were people who should be receiving antibiotics (e.g., those with suspected
pneumonia), people who had been treated with antibiotics within 4 weeks of the
study, people with allergic bronchial asthma, tendency to bleed,
hypersensitivity or possible hypersensitivity to the medication, severe heart,
renal, liver disease, and those on other medications that might impair the
validity of the study results (e.g., antibiotics).
The primary outcome measure was the change in BSS compared
to placebo. The secondary outcomes measured were BSS less than 5 at the conclusion
of the study, a decrease of BSS ? 5 points compared to baseline, consumption of
paracetamol (aka acetaminophen, a non-prescription analgesic), change in
individual subjects' symptoms of BSS, and the results of the SF-12 Health
Survey and EQ-5D quality of life questionnaires. An additional outcome measure
was the Integrative Medicine Outcome Scale (IMOS), which is a 5-point scale
that rates whether a subject has achieved "complete recovery," "major
improvement," "slight to moderate improvement," "no change," or
"deterioration." Subject satisfaction with the treatment was also assessed by
using the Integrative Medicine Patient Satisfaction Scale (IMPSS), a 5-point
scale with the ratings of "very satisfied," "satisfied," "neutral,"
"dissatisfied," and "very dissatisfied." Adverse events were recorded to
determine their frequency, nature, and severity using a 4-point rating scale.
Subjects in the EPs 7630 group were prescribed a proprietary
extract of P. sidoides, EPs 7630 (Dr.
Willmar Schwabe GmbH & Co., Karlsruhe, Germany; a corresponding product is
marketed in the US as Umcka¨ ColdCare by Nature's Way, Springville, UT ). The
dosage was 4.5 mL (30 drops) 3 times daily 30 minutes before or after meals for
7 days, or a matching placebo. (EPs 7630 is an ethanolic extract of the root of
P. sidoides with a drug-extract
ratio of 8-10:1. The commercial product is a solution, consisting of 80% EPs
7630 and 20% glycerol.)
BSS significantly decreased from 7.2 ± 3.1 points in the EPs
7630 group compared to 4.9 ± 2.7 points in the placebo group (P < 0.0001).
This showed "a highly significant superiority of EPs 7630 compared with placebo
on day seven." Clinical superiority of EPs 7630 was detected as early as 3
days, with a mean BSS at that time of 4.4 ± 2.2 for the EPs 7630 group compared
to 6.2 ± 2.5 points in the placebo group from baseline to day 7 of treatment (P
< 0.0001).
The results showed benefits in the EPs 7630 group based on
several measurements. BSS of less than 5 points was noted in 61 of 64 subjects
(95.3%) in the EPs 7630 group compared to 35 of 60 subjects (58.3%) in the
placebo group (P < 0.0001). Similarly, a decrease in BSS of at least 5
points occurred in 58 of 64 subjects (90.6%) in the EPs 7630 group compared to
31 of 60 subjects (51.7%) in the placebo group from baseline to day 7 of
treatment (P < 0.0001). These 2 criteria defined "rapid recovery," which was
detected in 58 of 64 subjects (90.6%) in the EPs 7630 group compared to 25 of
60 subjects (41.7%) in the placebo group (P < 0.0001). Symptomatic
improvement of rales/rhonchi, chest pain during coughing, and dyspnea after 7
days of EPs 7630 administration exceeded 90% of that group, whereas less than
60% of the placebo group experienced recovery of these symptoms. Rales/rhonchi
were absent in 55 of 60 subjects (91.7%) in the EPs 7630 group versus 29 of 59
subjects (49.2%) in the placebo group (P < 0.0001). Chest pain during
coughing was absent in 55 of 58 subjects in the EPs 7630 group (94.8%) compared
to 29 of 52 subjects (55.8%) in the placebo group (P < 0.0001). Cough was
the symptom that showed the slowest rate of recovery in both groups. Cough
disappeared in 20 of 64 subjects (31.3%) in the EPs 7630 group compared to 3 of
60 subjects (5.0%) in the placebo group (P < 0.0001). Similarly, hoarseness
disappeared in 45 of 58 subjects (77.6%) in the EPs 7630 group compared to 20
of 52 subjects (38.5%) in the placebo group (P < 0.0001).
At the end of the study period, 54 of 64 subjects (84.4%) in
the EPs 7630 group compared to 18 of 60 subjects (30.0%) of the placebo group
were assessed as "major improved or completely recovered" by the IMOS. This
assessment was given to 43 of 64 subjects (67.2%) in the EPs 7630 group
compared to 11 of 60 subjects (18.3%) of the placebo group by days 3-5 of
treatment. A noticeable effect of EPs 7630 treatment was described within 2-5
hours by 2 of 64 subjects (3.1%) and within 1-2 days by 14 of 64 subjects
(21.9%). The majority of subjects in the EPs 7630 group reported remission of
their acute bronchitis symptoms by day 7, whereas "many patients" in the
placebo group reported experiencing no change by day 7. Adverse events were not
significantly different between the EPs 7630 and placebo groups. No serious
adverse events were reported.
This clinical trial agrees with an earlier, larger study
showing the superiority of EPs 7630 over placebo for the treatment of acute
bronchitis in 468 subjects.1 A comprehensive review of the
traditional uses and modern research on P. sidoides was published in 2003,2 and another
recent paper reviews the clinical pharmacology of P. sidoides special extract.3 The safety and efficacy
of this formula provides an alternative to the ineffective conventional
treatments for acute bronchitis.
ÑJohn Neustadt, ND
References
1.' Matthys H, Eisebitt R, Seith B, Heger M. Efficacy and safety of an extract
of Pelargonium sidoides (EPs 7630) in adults with acute bronchitis.
A randomized, double-blind, placebo-controlled trial. Phytomed. 2003;10
Suppl 4:7-17. [Reviewed as HerbClip 110134.254. Available at:
http://www.herbalgram.org/herbclip/review.asp?i=43781. Accessed June 6,
2006.]
2. Kolodziej
H, Schulz V. Umckalaobo: From traditional application to modern phytodrug. Deutsche
Apotheke Zeitung. 2003;143(12):55-64.
3. Brown D. Extract of Pelargonium sidoides: South African Herbal
Remedy Successfully Treats Acute Bronchitis and Tonsillopharyngitis. HerbalGram.
2004;No. 63:17-19. Available at: http://www.herbalgram.org/herbalgram/articleview.asp?a=2703.
Accessed June 15, 2006.
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