Clinical Question: Can Pelargonium sidoides extract decrease symptoms of acute bronchitis?
Setting: Outpatient (any)
Study Design: Randomized controlled trial (double-blinded)
Synopsis: Pelargonium sidoides, also known as kalwerbossie or the folk remedy Rabassam, is used in several countries. This study evaluated its effect in 468 adults with acute bronchitis of less than two days' duration. The diagnosis was based on clinical symptoms. Patients with asthma, previous treatment with antibiotics, or suspected pneumonia were excluded. Allocation to treatment group was concealed from the enrolling investigators.
Patients were given placebo drops or an extract of the roots of Pelargonium sidoides. The patients were instructed to take 30 drops three times daily 30 minutes before or after a meal for seven days. Acetaminophen also was allowed. Symptoms were evaluated using the Bronchitis Severity Score (BSS), for which the investigator evaluated patients for cough, sputum production, rales/rhonchi, chest pain while coughing, and dyspnea, each on a scale of zero to 4 (total possible score = 20). The minimum BSS for entry into the study was 5; the average score among the enrolled patients was 8. However, only about one half (n = 279 out of 468) had a BSS of at least 8.
The dropout rate in the placebo arm was significant; 44 percent of patients did not complete the study (compared with 13 percent of patients in the treatment group). Eighty-five percent of the dropouts occurred because of a lack of effectiveness. By three days, BSS had declined to an average of 4.8 in the treatment group and 6.2 in the placebo group (P < .001). At seven days, BSS was 2.5 in the treatment group and 4.8 in the placebo group. In a subset of patients with severe bronchitis (BSS of 8 or more at baseline), there also was a significant decrease in symptoms compared with placebo-treated patients (6.8-point drop in treated patients versus 4.5-point drop in the placebo group; P < .0001).
When evaluating individual symptoms, most of the improvement was seen after seven days in the complete resolution of rales/rhonchi (77 versus 44.4 percent in the placebo group; P < .0001) and chest pain during cough (84 versus 48 percent complete improvement in the placebo group; P < .0001). The rate of complete resolution of cough did not differ between the two groups, although the combined outcome of cure/improvement occurred more often in the treated patients (89 versus 57 percent in the placebo group; P < .0001). Fever was resolved in 97 percent of treated patients within seven days, but in only 60 percent of the patients receiving placebo. On average, treated patients were able to return to work two days earlier (4.7 versus 6.3 days in the placebo group; P < .0001).
Bottom Line: Use of the herbal product Pelargonium sidoides can decrease overall symptoms of acute bronchitis compared with placebo, and these symptom reductions occur within three to seven days. Although cough may linger in patients, they are able to return to work an average of two days earlier than patients treated with placebo. (Level of Evidence: 1c)