[Treatment of upper respiratory infection by fangfeng tongsheng granule: a randomized controlled study].

ABSTRACT

OBJECTIVE: To evaluate the clinical effectiveness and safety of Fangfeng Tongsheng Granule (FTG) in the treatment of upper respiratory infection (superficial cold and interior heat syndrome, exterior and interior excess syndrome). METHODS: A randomized, double-blinded, multi-centered, placebo-parallel-controlled clinical trial was adopted. Totally 324 patients were enrolled and assigned to two groups, 216 patients in the treatment group and 108 patients in the control group. Those in the treatment group took FTG at the daily dose of 3 g, twice per day, the therapeutic course being 3 days. Those with axillary temperature more than 37 degrees C took one more time before medication. Those in the control group took simulated agent granules the same dose and dosage as the treatment group. The effect of Chinese medical syndrome (ECMS), the rate of temperature-dropping-to-normal (RT), the time of temperature-dropping-to-normal (TT), the curative effect of single symptom (CESS) and adverse reactions were observed. RESULTS: Totally 203 completed the trial in the treatment group and 101 in the control group. In the treatment group, the cured-effective rate was 55.67% (113/ 101), the total effective rate was 93.10% (189/101), the ECMS score decreased by 9.24 +/- 4.46, while they were 5.94% (6/101), 36.63% (37/101), and 3.27 +/- 3.29, respectively in the control group (P < 0.01). The RT was 87.50% (98/112) in the treatment group and 58.49% (31/53) in the control group (P < 0.01). The TT in the treatment group was superior to that of the control group (P < 0.01). As for CESS, all of the three primary symptoms and nine secondary symptoms were improved more obviously in the treatment group than in the control group. The integral decreased obviously, showing statistical difference (P < 0.01). The decrease was more obvious in the treatment group than in the control group (P < 0.01). There was no adverse event related to FTG. CONCLUSION: FTG was effective and safe in treating upper respiratory infection (superficial cold and interior heat syndrome, exterior and interior excess syndrome).