Clinical Question:
In adults with acute bronchitis symptoms of short duration, is an extract of
pelargonium sidoides more effective than placebo in reducing symptoms?
Bottom Line:
The pelargonium sidoides extract (Umckaloabo in Germany) produced a
significantly greater reduction in symptoms of acute bronchitis than
placebo, and more patients were satisfied with treatment. As with all herbal
products, results may be different with pelargonium products other than this
extract.
Reference:
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 2005;1:437-45.
Study Design:
Randomized controlled trial (double-blinded)
Synopsis:
Pelargonium sidoides is approved in several countries for the treatment of
acute respiratory tract infection based on a possible antimicrobial or
immune modulation action. Russian, German, and US researchers conducted this
study using a root preparation available in Germany (Umckaloabo). They
recruited 124 patients from outpatient clinics in Russia who'd had acute
bronchitis symptoms for less than 48 hours, defined clinically and by a
bronchitis severity score (BSS) greater than 4 of a possible 20 (average
score = 9). The BSS rates cough, sputum, rales/rhonchi, chest pain during
coughing, and dyspnea on a score from 0 to 4. Approximately 25% of the
patients were current smokers and another 31% had the odd designation of "no
remark or classification not possible." The patients were randomized, using
concealed allocation, to receive taste- and color-matched placebo or the
pelargonium extract at a dose of 1.5 mL (30 drops) 3 times daily for 8 days.
The intention-to-treat analysis was performed with the statistician blinded
to treatment assignment. At the end of treatment, BSS scores had decreased
by an average of 7.2 points in the treatment group as compared with 4.9
points in the placebo-treated patients (absolute difference = 2.3 points;
95% CI, 1.2 - 3.6; P < .001). More than 90% of patients in the treated group
had a BSS greater than 5; the rate in the placebo group was 52% (P <.001).
Significantly more patients receiving treatment reported satisfaction than
did those receiving placebo (80% vs 43%; number needed to treat = 2.7). |