Clinical efficacy of farcosolvin syrup (ambroxol-theophylline-guaiphenesin mixture) in the treatment of acute exacerbation of chronic bronchitis.
BACKGROUND
Acute exacerbations of chronic bronchitis (AECB) are defined as recurrent attacks of worsening bronchial inflammation that are marked by an increase in the volume of daily sputum produced, a change in color of the expectorated sputum, and worsening dyspnea. Farcosolvin (Pharco Pharmaceuticals, Alexandria, Egypt) is a mixture of ambroxol (15 mg); theophylline (50 mg); and guaiphenesin (30 mg), per 5 mL syrup.


OBJECTIVE
To test the clinical efficacy of Farcosolvin in the treatment of AECB in a randomized, single-blinded, controlled study design.


METHODS
One hundred patients with AECB were randomized to either Farcosolvin or guaiphenesin treatment groups, in addition to the standard medical treatment for their cases. Baseline clinical symptomatolgy of breathlessness, cough, and sputum severity scoring were compared before and after 3 and 7 days of treatment in both groups and the differences compared between groups. Changes in perceived improvement were also compared between groups using the Clinical Global Impression of Improvement or Change Scale (CGIC).


RESULTS
There were statistically significant improvements in breathlessness and cough scores in both groups (pretreatment versus posttreatment at day 3 and at day 7; P < 0.05). There were highly statistically significant differences between groups in improvement in breathlessness and cough scores, after 3 and 7 days treatment, in favor of the Farcosolvin treatment group (P < 0.001). Out of 50 patients, 48 (96%) in the Farcosolvin-treated group rated their improvement on the CGIC scale as "much" and "very much" improved, while only 41 patients (82%) reported such a degree of improvement in the control group. The difference was statistically significant (P < 0.05).


CONCLUSIONS
We concluded from our study that Farcosolvin syrup might be safe and effective in improving symptoms in cases of acute exacerbation of chronic bronchitis.
Yakoot
Mostafa
M
Green Clinics and Research Center, Alexandria, Egypt. yakoot@yahoo.com
Salem
Amel
A
Omar
Abdel-Mohsen
AM
D000368:Aged; D000551:Ambroxol / Q000494:pharmacology / Q000627:therapeutic use*; D029481:Bronchitis, Chronic / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000494:pharmacology / Q000627:therapeutic use*; D003371:Cough / Q000188:drug therapy / Q000503:physiopathology; D004338:Drug Combinations; D004534:Egypt; D005100:Expectorants / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006140:Guaifenesin / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method; D013806:Theophylline / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
D001993:Bronchodilator Agents; D004338:Drug Combinations; D005100:Expectorants; D000551:Ambroxol; D006140:Guaifenesin; D013806:Theophylline