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| Author | Reasons for conducting N-of-1 trials | n | Run-in period | Treatment | Control | Pairs | Observation period | Randomization and blinding | Primary outcome measures | Statistical methods | Conclusion |
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| Yuhong et al. 2013 [10] | Providing evidence for rational use of LDD. | 50 | No | LDD | Placebo | 3 | 4 weeks | Yes | Likert scale, individual completion rate, response rate, and posttrial decision-making | Individuals: the self-designed criteria; population: meta-analysis | Nonresponders ceased the LDD. The positive significance is to avoid the unreasonable drugs use. |
| Huang et al. 2018 [7] | Exploring the establishment of clinical efficacy evaluation methods in line with the characteristics of individualized diagnosis and treatment of TCM. | 17 | Yes | Individualized herbal decoction | Standard decoction for stable bronchiectasis | 3 | 4 weeks | Yes | 7-point Likert scale | Individuals: paired t test; population: mixed effects mode | Optimizing the combined analysis of individual and group data, the improvement of statistical models may make contribution in establishing a method of evaluating clinical efficacy in line with the characteristics of TCM. |
| Wang et al. 2010 [4] | To study the dose-effect relationship of Bezoar antihypertensive capsules and explore the individualized diagnosis, treatment, and evaluation of TCM. | 11 | No | High-dose Bezoar antihypertensive capsules | Low-dose Bezoar antihypertensive capsules | 3 | 4 weeks | Yes | Blood pressure, TCM symptom score | Paired t test, meta-analysis | Bezoar antihypertensive capsule can be used for mild to moderate hypertension particularly for lowering systolic blood pressure. |
| Chen et al. 2020 [11] | N-of-1 trials can provide more flexible clinical trial design for TCM and require a smaller sample size. | 10 | No | Modified SJZD with mesalazine placebo | Mesalazine with SJZD placebo | 3 | 8 weeks | Yes | Visual analogue scale (VAS) of symptom score | Mixed effects mode | This article is a protocol and there is no conclusion. |
| Liu et al. 2018 [15] | To evaluate the efficacy of TCM syndromes by N-of-1 trials. | 24 | Yes | Liuwei Dihuang capsule | Placebo | 2 | 2 weeks | Yes | 5-point Likert scale | t test, ANOVA for repeated measurement, and meta-analysis | N-of-1 trials can be used to evaluate the therapeutic effects of TCM syndromes. |
| Zhang et al. 2012 [21] | N-of-1 trials enable scientific evaluation of the individualized diagnosis and treatment of TCM. | 4 | No | Individualized herbal decoction and basic treatment | Basic treatment and Chinese medicinal decoction placebo | 3 | 4 weeks | Yes | TCM symptom score, serum IL-6 | t test | It is feasible to apply N-of-1 trials in clinical research of TCM. |
| Wang et al. 2016 [9] | To evaluate the feasibility of N-of-1 trails of TCM. | 1 | Yes | Individualized herbal decoction | Standard decoction for stable bronchiectasis | 3 | 4 weeks | Yes | 7-point Likert scale | Paired t test | N-of-1 trails reflected the advantage of TCM individualized treatment in this patient, providing with the highest rank of evidence for the patient. |
| Yu et al. 2012 [24] | Individualized treatment of TCM is the unique advantage. | 3 | No | Individualized herbal decoction | The basic treatment | 3 | 4 weeks | Randomization but no blinding | TCM symptom score, SCr, and Ccr | t test | N-of-1 trails for the clinical studies of TCM are useful and feasible. |
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