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An n-of-1 Trial Service in Clinical Practice: Testing the Effectiveness of Liuwei Dihuang Decoction for Kidney-Yin Deficiency Syndrome.

Yuhong H, Qian L, Yu L, Yingqiang Z, Yanfen L, Shujing Y, Shufang Q, Lanjun S, Shuxuan Z, Baohe W - Evid Based Complement Alternat Med (2013)

Bottom Line: Results.Among the whole group, neither the individual Likert score nor the SF-36 showed any statistical differences between LDD and placebo.Discussion.

View Article: PubMed Central - PubMed

Affiliation: Second Affiliated Hospital, Tianjin University of Traditional Chinese Medicine, Tianjin, China.

ABSTRACT
Objective. To describe the clinical use of n-of-1 RCTs for kidney-Yin deficiency syndrome that is a traditional Chinese medicine syndrome in publicly clinical practice in China. Methods. Our study included patients with kidney-Yin deficiency syndrome, using a within-patient, randomized, double-blind, crossover comparison of Liuwei Dihuang decoction versus placebo. Outcome Measures. Primary outcome measures included number of individual completion rates, response rate, and post-n-of-1 RCTs decisions. Secondary measures were the whole group score of individual Likert scale, SF-36 questionnaire. Results. Fifty patients were recruited and 3 were not completed. Forty-seven patients completed 3 pairs of periods, 3 (6.38%) were responders, 28 (59.57%) were nonresponders, and 16 (34.05%) were possible responders. Doctors and patients used the trial results to making decision. Three responders stayed on the medication management, 28 nonresponders ceased the LDD, 7 patients of the 16 possible responders could not give clear decision, and the others kept the same medication station. Among the whole group, neither the individual Likert score nor the SF-36 showed any statistical differences between LDD and placebo. Discussion. More attention should be paid to choose experienced TCM doctor as investigator and keep the simulant same with test medication in n-of-1 RCTs of TCM and sufficiently biological half-life period of Chinese medicine compound.

No MeSH data available.


Meta-analysis of SF-36 total score between LDD and placebo.
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Related In: Results  -  Collection


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fig4: Meta-analysis of SF-36 total score between LDD and placebo.

Mentions: Patients show same level of individual Likert score between LDD and placebo in meta-analysis. The standardized mean difference in the Likert score between LDD and placebo was −0.09 (95% CI −0.36 to 0.17), using a weighted mean difference technique. Because of no heterogeneity in results across the patients (test for heterogeneity, P = 0.07), fixed model was used (Figure 3). Similarly, patients show no difference of SF-36 total score between LDD and placebo. Overall, the standardized mean difference SF-36 total score between LDD and placebo was 2.41 (95% CI −0.95 to 5.76), using a weighted mean difference technique. Because of no heterogeneity in results across the patients (test for heterogeneity, P = 0.76), fixed model was used (Figure 4).


An n-of-1 Trial Service in Clinical Practice: Testing the Effectiveness of Liuwei Dihuang Decoction for Kidney-Yin Deficiency Syndrome.

Yuhong H, Qian L, Yu L, Yingqiang Z, Yanfen L, Shujing Y, Shufang Q, Lanjun S, Shuxuan Z, Baohe W - Evid Based Complement Alternat Med (2013)

Meta-analysis of SF-36 total score between LDD and placebo.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3794636&req=5

fig4: Meta-analysis of SF-36 total score between LDD and placebo.
Mentions: Patients show same level of individual Likert score between LDD and placebo in meta-analysis. The standardized mean difference in the Likert score between LDD and placebo was −0.09 (95% CI −0.36 to 0.17), using a weighted mean difference technique. Because of no heterogeneity in results across the patients (test for heterogeneity, P = 0.07), fixed model was used (Figure 3). Similarly, patients show no difference of SF-36 total score between LDD and placebo. Overall, the standardized mean difference SF-36 total score between LDD and placebo was 2.41 (95% CI −0.95 to 5.76), using a weighted mean difference technique. Because of no heterogeneity in results across the patients (test for heterogeneity, P = 0.76), fixed model was used (Figure 4).

Bottom Line: Results.Among the whole group, neither the individual Likert score nor the SF-36 showed any statistical differences between LDD and placebo.Discussion.

View Article: PubMed Central - PubMed

Affiliation: Second Affiliated Hospital, Tianjin University of Traditional Chinese Medicine, Tianjin, China.

ABSTRACT
Objective. To describe the clinical use of n-of-1 RCTs for kidney-Yin deficiency syndrome that is a traditional Chinese medicine syndrome in publicly clinical practice in China. Methods. Our study included patients with kidney-Yin deficiency syndrome, using a within-patient, randomized, double-blind, crossover comparison of Liuwei Dihuang decoction versus placebo. Outcome Measures. Primary outcome measures included number of individual completion rates, response rate, and post-n-of-1 RCTs decisions. Secondary measures were the whole group score of individual Likert scale, SF-36 questionnaire. Results. Fifty patients were recruited and 3 were not completed. Forty-seven patients completed 3 pairs of periods, 3 (6.38%) were responders, 28 (59.57%) were nonresponders, and 16 (34.05%) were possible responders. Doctors and patients used the trial results to making decision. Three responders stayed on the medication management, 28 nonresponders ceased the LDD, 7 patients of the 16 possible responders could not give clear decision, and the others kept the same medication station. Among the whole group, neither the individual Likert score nor the SF-36 showed any statistical differences between LDD and placebo. Discussion. More attention should be paid to choose experienced TCM doctor as investigator and keep the simulant same with test medication in n-of-1 RCTs of TCM and sufficiently biological half-life period of Chinese medicine compound.

No MeSH data available.