Investigation into the Individualized Treatment of Traditional Chinese Medicine through a Series of N-of-1 Trials

Purpose. To compare the efficacy of individualized herbal decoction with standard decoction for patients with stable bronchiectasis through N-of-1 trials. Methods. We conducted a single center N-of-1 trials in 17 patients with stable bronchiectasis. Each N-of-1 trial contains three cycles. Each cycle is divided into two 4-week intervention including individualized decoction and fixed decoction (control). The primary outcome was patient self-reported symptoms scores on a 1-7 point Likert scale. Secondary outcomes were 24-hour sputum volume and CAT scores. Results. Among 14 completed trials, five showed that the individualized decoction was statistically better than the control decoction on symptom scores (P<0.05) but was not clinically significant. The group data of all the trials showed that individualized decoction was superior to control decoction on symptom scores (2.13±0.58 versus 2.30±0.65, P=0.002, mean difference and 95% CI: 0.18 (0.10, 0.25)), 24 h sputum volume (P=0.009), and CAT scores (9.69±4.89 versus 11.64±5.59, P=0.013, mean difference and 95% CI: 1.95 (1.04, 2.86)) but not clinically significant. Conclusion. Optimizing the combined analysis of individual and group data and the improvement of statistical models may make contribution in establishing a method of evaluating clinical efficacy in line with the characteristics of traditional Chinese medicine individual diagnosis and treatment.