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Journal of Chinese Integrative Medicine ›› 2012, Vol. 10 ›› Issue (8): 847-852.doi: 10.3736/jcim20120803

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Adequate application of quantitative and qualitative statistic analytic methods in acupuncture clinical trials

Ming T. Tan1, Jian-ping Liu2, Lixing Lao3,4()   

  1. 1. Division of Biostatistics and Bioinformatics, University of Maryland School of Medicine, Baltimore 21201, Maryland, USA
    2. Center for Evidence-based Medicine, Beijing University of Chinese Medicine, Beijing 100029, China
    3. Center for Integrative Medicine, University of Maryland School of Medicine, Baltimore 21201, Maryland, USA
    4. Institute of Acupuncture, Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, China
  • Received:2012-06-13 Accepted:2012-07-08 Online:2012-08-20 Published:2018-08-15
  • Contact: Lixing Lao

Recently, proper use of the statistical methods in traditional Chinese medicine (TCM) randomized controlled trials (RCTs) has received increased attention. Statistical inference based on hypothesis testing is the foundation of clinical trials and evidence-based medicine. In this article, the authors described the methodological differences between literature published in Chinese and Western journals in the design and analysis of acupuncture RCTs and the application of basic statistical principles. In China, qualitative analysis method has been widely used in acupuncture and TCM clinical trials, while the between-group quantitative analysis methods on clinical symptom scores are commonly used in the West. The evidence for and against these analytical differences were discussed based on the data of RCTs assessing acupuncture for pain relief. The authors concluded that although both methods have their unique advantages, quantitative analysis should be used as the primary analysis while qualitative analysis can be a secondary criterion for analysis. The purpose of this paper is to inspire further discussion of such special issues in clinical research design and thus contribute to the increased scientific rigor of TCM research.

Key words: acupuncture therapy, randomized controlled trial, statistics, medical, qualitative analysis, quantitative analysis

Table 1

Primary outcome measure for observed VAS scores and changes in VAS scores (cm) from baseline at each time point in ITT analyses (n=169)[7]"

Characteristic Acupuncture (n=56) Sham acupuncture 1 (n=56) Sham acupuncture 2 (n=57) Pvalue
Observed VAS scores (cm)
0.5 hour after treatment 5.0 (4.0, 5.5) 4.6 (3.0, 5.7) 5.5 (3.0, 6.0) 0.103
1 hour after treatment 4.9 (6.7, 5.1) 4.8 (4.0, 5.5) 5.2 (3.0, 6.0) 0.166
2 hours after treatment 4.0 (3.1, 5.0) 4.5 (4.0, 5.1) 5.0 (3.0, 6.0) 0.032*
4 hours after treatment 4.0 (2.0, 4.9) 4.2 (3.0, 5.3) 5.0 (3.0, 5.8) 0.028*
Changes in VAS scores from baseline (cm)
0.5 hour after treatment 0.0 (–0.3, 0.0) 0.0 (–0.2, 0.0) 0.0 (–0.1, 0.0) 0.471
1 hour after treatment –0.4 (–1.0, 0.0)? –0.2 (–0.5, 0.1) 0.0 (–0.5, 0.0) 0.063
2 hours after treatment –0.7 (–1.5, –0.1)? –0.3 (–0.8, 0.2)? –0.2 (–0.7, 0.0)? 0.006*
4 hours after treatment –1.0 (–2.1, 0.0)? –0.5 (–1.2, 0.1)?? –0.1 (1.0, 0.0)??a 0.012*

Table 2

Comparing effectiveness of acupuncture to a control in treating migraine"

组别 n 基本恢复 显效 有效 无效 有效率(%)
治疗组 20 5 (25) 10 (50) 3 (15) 2 (10) 901)
对照组 20 2 (10) 5 (25) 8 (40) 5 (25) 75
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