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

Haiyin Huang, Peilan Yang, Jie Wang, Yingen Wu, Suna Zi, Jie Tang, Zhenwei Wang, Ying Ma, Yuqing Zhang, Haiyin Huang, Peilan Yang, Jie Wang, Yingen Wu, Suna Zi, Jie Tang, Zhenwei Wang, Ying Ma, Yuqing Zhang

Abstract

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.

Figures

Figure 1
Figure 1
The flow chart of the N-of-1 trials in the treatment of stable bronchiectasis by traditional Chinese medicine based on syndrome differentiation.
Figure 2
Figure 2
The flowchart of the whole process including recruitment, enrollment, and completion of the study.
Figure 3
Figure 3
The comparison of the mean symptom scores between the individualized decoction and control decoction in the first, second, and third pairs of a series (14 cases) of N-of-1 trials.

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Source: PubMed

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