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Bu-Fei Yi-Shen granule combined with acupoint sticking therapy in patients with stable chronic obstructive pulmonary disease: a randomized, double-blind, double-dummy, active-controlled, 4-center study.
J Ethnopharmacol. 2012 Jun 01; 141(2):584-91.JE

Abstract

ETHNOPHARMACOLOGICAL RELEVANCE

Bu-Fei Yi-Shen granule combined with acupoint sticking therapy has been used in the patients with stable chronic obstructive pulmonary disease (COPD) as major traditional interventions for the treatment of the disease.

AIM OF THE STUDY

The objective of this study was to evaluate the efficacy and safety of traditional Chinese herbal medicine, the Bu-Fei Yi-Shen granule combined with acupoint sticking therapy in patients with stable COPD.

METHODS

A 4-center, double-blinded, double-dummy and randomized controlled method was conducted. 244 patients who were divided into the trial group (n=122, treated with Bu-Fei Yi-Shen granule combined with Shu-Fei Tie acupoint sticking therapy and oral placebo sustained-release theophylline) and the control group (n=122, treated with oral sustained-release theophylline and placebo Bu-Fei Yi-Shen granule combined with placebo Shu-Fei Tie acupoint sticking therapy). The frequency and duration of acute exacerbation, lung function, clinical symptoms, six-minute walking distance, dyspnea grade and quality of life were observed during the 4-month treatment period, and for a further 6 months follow-up.

RESULTS

Two hundred and twenty one patients fully completed the study, intent-to-treat (ITT) population was 234 and per-protocol (PP) population was 221. After treatment for 4 months and follow-up for 6 months, there were differences between the experimental and control group in frequency of acute exacerbation (ITT: P=0.007, P=0.013; PP: P=0.045, P=0.046); duration of acute exacerbation (ITT: P=0.030, P=0.005; PP: P=0.048, P=0.006); scores of symptoms (ITT: P=0.000, P=0.000; PP: P=0.000, P=0.000); six-minute walking distance (ITT: P=0.002, P=0.001; PP: P=0.002, P=0.001); dyspnea grade (ITT: P=0.014, P=0.009; PP: P=0.018, P=0.012); physiological aspects (ITT: P=0.003, P=0.000; PP: P=0.001, P=0.000); psychological aspects (ITT: P=0.007, P=0.001; PP: P=0.001, P=0.000) and environment aspects (ITT: P=0.003, P=0.000; PP: P=0.001, P=0.000) of the WHOQOL-BREF questionnaire. There were no differences between the experimental and control group in FVC, FEV1 and FEV1% and adverse events.

CONCLUSIONS

Bu-Fei Yi-Shen granule combined with acupoint sticking therapy showed beneficial effects for patients with stable COPD in the measured parameters over the 4-month treatment period and 6 months follow-up, with no relevant between-group differences in adverse events.

Authors+Show Affiliations

The Geriatric Department of Henan University of Traditional Chinese Medicine, Jinshui District, Zhengzhou, PR China. li_js8@163.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21911051

Citation

Li, Jian-Sheng, et al. "Bu-Fei Yi-Shen Granule Combined With Acupoint Sticking Therapy in Patients With Stable Chronic Obstructive Pulmonary Disease: a Randomized, Double-blind, Double-dummy, Active-controlled, 4-center Study." Journal of Ethnopharmacology, vol. 141, no. 2, 2012, pp. 584-91.
Li JS, Li SY, Yu XQ, et al. Bu-Fei Yi-Shen granule combined with acupoint sticking therapy in patients with stable chronic obstructive pulmonary disease: a randomized, double-blind, double-dummy, active-controlled, 4-center study. J Ethnopharmacol. 2012;141(2):584-91.
Li, J. S., Li, S. Y., Yu, X. Q., Xie, Y., Wang, M. H., Li, Z. G., Zhang, N. Z., Shao, S. J., Zhang, Y. J., Zhu, L., Guo, L. X., Bai, Y. P., & Wang, Y. F. (2012). Bu-Fei Yi-Shen granule combined with acupoint sticking therapy in patients with stable chronic obstructive pulmonary disease: a randomized, double-blind, double-dummy, active-controlled, 4-center study. Journal of Ethnopharmacology, 141(2), 584-91. https://doi.org/10.1016/j.jep.2011.08.060
Li JS, et al. Bu-Fei Yi-Shen Granule Combined With Acupoint Sticking Therapy in Patients With Stable Chronic Obstructive Pulmonary Disease: a Randomized, Double-blind, Double-dummy, Active-controlled, 4-center Study. J Ethnopharmacol. 2012 Jun 1;141(2):584-91. PubMed PMID: 21911051.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bu-Fei Yi-Shen granule combined with acupoint sticking therapy in patients with stable chronic obstructive pulmonary disease: a randomized, double-blind, double-dummy, active-controlled, 4-center study. AU - Li,Jian-Sheng, AU - Li,Su-Yun, AU - Yu,Xue-Qing, AU - Xie,Yang, AU - Wang,Ming-Hang, AU - Li,Ze-Geng, AU - Zhang,Nian-Zhi, AU - Shao,Su-Ju, AU - Zhang,Yi-Jie, AU - Zhu,Lin, AU - Guo,Lian-Xiang, AU - Bai,Yun-Ping, AU - Wang,Yan-Fang, Y1 - 2011/09/05/ PY - 2011/03/28/received PY - 2011/08/23/revised PY - 2011/08/25/accepted PY - 2011/9/14/entrez PY - 2011/9/14/pubmed PY - 2012/9/29/medline SP - 584 EP - 91 JF - Journal of ethnopharmacology JO - J Ethnopharmacol VL - 141 IS - 2 N2 - ETHNOPHARMACOLOGICAL RELEVANCE: Bu-Fei Yi-Shen granule combined with acupoint sticking therapy has been used in the patients with stable chronic obstructive pulmonary disease (COPD) as major traditional interventions for the treatment of the disease. AIM OF THE STUDY: The objective of this study was to evaluate the efficacy and safety of traditional Chinese herbal medicine, the Bu-Fei Yi-Shen granule combined with acupoint sticking therapy in patients with stable COPD. METHODS: A 4-center, double-blinded, double-dummy and randomized controlled method was conducted. 244 patients who were divided into the trial group (n=122, treated with Bu-Fei Yi-Shen granule combined with Shu-Fei Tie acupoint sticking therapy and oral placebo sustained-release theophylline) and the control group (n=122, treated with oral sustained-release theophylline and placebo Bu-Fei Yi-Shen granule combined with placebo Shu-Fei Tie acupoint sticking therapy). The frequency and duration of acute exacerbation, lung function, clinical symptoms, six-minute walking distance, dyspnea grade and quality of life were observed during the 4-month treatment period, and for a further 6 months follow-up. RESULTS: Two hundred and twenty one patients fully completed the study, intent-to-treat (ITT) population was 234 and per-protocol (PP) population was 221. After treatment for 4 months and follow-up for 6 months, there were differences between the experimental and control group in frequency of acute exacerbation (ITT: P=0.007, P=0.013; PP: P=0.045, P=0.046); duration of acute exacerbation (ITT: P=0.030, P=0.005; PP: P=0.048, P=0.006); scores of symptoms (ITT: P=0.000, P=0.000; PP: P=0.000, P=0.000); six-minute walking distance (ITT: P=0.002, P=0.001; PP: P=0.002, P=0.001); dyspnea grade (ITT: P=0.014, P=0.009; PP: P=0.018, P=0.012); physiological aspects (ITT: P=0.003, P=0.000; PP: P=0.001, P=0.000); psychological aspects (ITT: P=0.007, P=0.001; PP: P=0.001, P=0.000) and environment aspects (ITT: P=0.003, P=0.000; PP: P=0.001, P=0.000) of the WHOQOL-BREF questionnaire. There were no differences between the experimental and control group in FVC, FEV1 and FEV1% and adverse events. CONCLUSIONS: Bu-Fei Yi-Shen granule combined with acupoint sticking therapy showed beneficial effects for patients with stable COPD in the measured parameters over the 4-month treatment period and 6 months follow-up, with no relevant between-group differences in adverse events. SN - 1872-7573 UR - https://www.unboundmedicine.com/medline/citation/21911051/Bu_Fei_Yi_Shen_granule_combined_with_acupoint_sticking_therapy_in_patients_with_stable_chronic_obstructive_pulmonary_disease:_a_randomized_double_blind_double_dummy_active_controlled_4_center_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-8741(11)00633-7 DB - PRIME DP - Unbound Medicine ER -