Clinical study of individualized treatment of stable phase bronchiectasis by N-of-1 RCT
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Clinical study of individualized treatment of stable phase bronchiectasis by N-of-1 RCT
Shanghai Journal of Traditional Chinese MedicineVol. 50, Issue 3, Pages: 39-43(2016)
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WANG Jie, HUANG Hai-yin, YANG Pei-lan, et al. Clinical study of individualized treatment of stable phase bronchiectasis by N-of-1 RCT. [J]. Shanghai Journal of Traditional Chinese Medicine 50(3):39-43(2016)
DOI:
WANG Jie, HUANG Hai-yin, YANG Pei-lan, et al. Clinical study of individualized treatment of stable phase bronchiectasis by N-of-1 RCT. [J]. Shanghai Journal of Traditional Chinese Medicine 50(3):39-43(2016)DOI:
Clinical study of individualized treatment of stable phase bronchiectasis by N-of-1 RCT
Objective:To compare the efficacy of individualized herbal decoction with Bronchiectasis Stabilization Decoction within a patient with stable bronchiectasis through N-of-1 RCT (Single case randomized controlled trial). MethodsThe lengths of observation period and washout period of a patient with stable bronchiectasis were determined by preliminary test, and then We conducted N-of-1 RCT (single-patient, double-blind, randomized, multiple crossover design) with 3cycles in 1 patient with stable bronchiectasis. The primary outcome was patient self-reported symptom scores on a visual analogue scale (VAS), 24-hour sputum volume and CAT (The COPD Assessment Test) scores were observed. Results:①After three rounds of trial, the symptom scores of the trial periods diminished significantly more than control periods (P<0.05),and the lower limit of the 95% confidence interval of the mean change was 1.53 (>0.5), indicating that the individualized herbal decoction has clinical superiority over the controlled decoction. ②After three rounds of trial, 24-hour sputum volume of the trial periods diminished significantly more than control periods (P<0.05). ③After three rounds of trial, the scores of CAT scale of the trial periods diminished significantly more than control periods (P<0.05),indicating better quality of life in the trial periods. Conclusion:N-of-1 RCT reflected the advantage of TCM individualized treatment in this patient with stable bronchiectasis, it also provided with the highest rank of evidence of evidence-based medicine for this patient.
关键词
支气管扩张症单病例随机对照试验个体化治疗中医药
Keywords
bronchiectasisN-of-1 RCTindividualized treatmenttraditional Chinese medicine