Bairui granules versus Reyanning granules in adults with acute bronchitis: a multicenter, randomized, double-blind, double-dummy, comparative trial

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Abstract
Background: Bairui granules, a monotherapy derived from Thesium chinense Turcz., are widely used in respiratory tract infections, yet high-quality clinical evidence for their effectiveness in acute bronchitis is lacking. Purpose: To evaluate the effectiveness and safety of Bairui granules in patients with acute bronchitis (Wind-heat invading lung syndrome). Study Design: The study (ChiCTR2200063906) was a multicenter, randomized, double-blind, double-dummy, comparative trial. Methods: Eligible participants from seven hospitals were randomized 2:1 to receive either Bairui granules plus placebo matching Reyanning Granules (experimental group) or Reyanning granules plus placebo matching Bairui Granules (control group) orally for 7 days. The primary endpoint was cough resolution rate after treatment. Secondary endpoints included time to cough and sputum resolution, area under the curve (AUC) for cough and sputum severity, bronchitis severity score (BSS), and traditional Chinese medicine (TCM) symptom scores. Results: Of 162 randomized patients, 161 completed the trial (107 experimental, 54 control). The cough resolution rate was higher in the experimental group than in the control group (72.22% vs. 35.19%; P < 0.0001). The time to cough resolution was 144 h (120,156) versus 168 h (138, 168) ( P = 0.001). AUC for cough severity was 184.3 versus 214.3 score·h ( P = 0.023). The BSS improvement at Day 9 was −4.82 (3.54) versus −4.30 (0.71) ( P = 0.068). The daytime cough TCM score improved by −6 (−6, −6) versus −6 (−6, −3) ( P = 0.003), and the sputum score improved by −3 (−6, −3) versus −3 (−3, −3) ( P = 0.031). Greater improvements were also observed in aversion to wind symptoms (Day 4) and sore throat symptoms (Day 9) in the experimental group. Adverse-event rates were similar between the two groups. All events were mild to moderate in severity and reversible. Conclusion: Bairui granules resulted in a higher cough-resolution rate and faster cough resolution than Reyanning granules in adults with acute bronchitis. The treatment was well tolerated. Clinical Trial Registration: https://www.chictr.org.cn/hvshowproject.html?id=193073&v=1.0 , identifier ChiCTR2200063906.

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