Skip to main content
Top
Published in: BMC Complementary Medicine and Therapies 1/2014

Open Access 01-12-2014 | Research article

Xuan Bai Cheng Qi formula as an adjuvant treatment of acute exacerbation of chronic obstructive pulmonary disease of the syndrome type phlegm-heat obstructing the lungs: a multicenter, randomized, double-blind, placebo-controlled clinical trial

Authors: Miao Liu, Xianggen Zhong, Yuhang Li, Fengjie Zheng, Ruohan Wu, Yan Sun, Jinchao Zhang

Published in: BMC Complementary Medicine and Therapies | Issue 1/2014

Login to get access

Abstract

Background

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is a common cause of morbidity and mortality. Traditional Chinese medicine (TCM) is used to treat AECOPD as adjunctive therapy. This study aimed to evaluate the efficacy and safety of the TCM formula Xuan Bai Cheng Qi as an adjuvant therapy for AECOPD patients with the syndrome type of phlegm-heat obstructing the lungs.

Methods

A multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted. A total of 244 patients were divided into the intervention group (n = 122, treated with conventional medicine and Xuan Bai Cheng Qi) and the control group (n = 122, treated with conventional medicine and placebo). Total symptom scores (cough, phlegm, wheezing, chest congestion) before treatment and at 3, 5, 7, 10 days post-treatment were recorded. Lung function, arterial blood gas, serum inflammatory cytokines, oxidation/anti-oxidation index were observed before treatment and at the end of the 10-day treatment.

Results

A total of 242 patients completed the study. The full analysis set (FAS) population was 244 and the per-protocol analysis set (PPS) population was 229. After the 10-day treatment, symptom scores of the Xuan Bai Cheng Qi group were significantly lower over time compared with the control group (FAS: mean difference -1.84, 95% CI -2.66 to -1.03, P < .001; PPS: mean difference -1.87, 95% CI -2.71 to -1.03, P < .001). FEV1, FVC, and FEV1%pred were significantly higher over time in the Xuan Bai Cheng Qi group compared with those in the control group (day 10, FAS and PPS: P < .05). PaO2 and PaCO2 were significantly improved in the Xuan Bai Cheng Qi group (day 10, FAS and PPS: P < .05). Xuan Bai Cheng Qi was also found to ameliorate cytokine levels and oxidation/antioxidant index compared with placebo. There were no differences in safety variables and adverse events between the two groups.

Conclusions

Xuan Bai Cheng Qi formula appears to be a safe and beneficial treatment for AECOPD of phlegm-heat obstructing the lungs syndrome type.
Appendix
Available only for authorised users
Literature
2.
go back to reference Bourbeau J, Ford G, Zackon H, Pinsky N, Lee J, Ruberto G: Impact on patients’ health status following early identification of a COPD exacerbation. Eur Respir J. 2007, 30: 907-913.CrossRefPubMed Bourbeau J, Ford G, Zackon H, Pinsky N, Lee J, Ruberto G: Impact on patients’ health status following early identification of a COPD exacerbation. Eur Respir J. 2007, 30: 907-913.CrossRefPubMed
3.
go back to reference Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA: Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax. 2002, 57: 847-852.CrossRefPubMedPubMedCentral Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA: Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax. 2002, 57: 847-852.CrossRefPubMedPubMedCentral
6.
go back to reference Xu WJ, Wang TF, Wang ZY, Jiao Y, Su HP, Yu LL, Lu JC, Zou XJ, Zhang N, Chen XH, Miao JY, Xu YL, Li SY, Wang MH, Wang QG: Comparison of traditional Chinese symptomatologies of acute and stable stages of chronic obstructive pulmonary disease. Acta Universitatis Traditionis Medicalis Sinensis Pharmacologiaeque Shanghai. 2010, 24 (6): 35-39. Chinese Xu WJ, Wang TF, Wang ZY, Jiao Y, Su HP, Yu LL, Lu JC, Zou XJ, Zhang N, Chen XH, Miao JY, Xu YL, Li SY, Wang MH, Wang QG: Comparison of traditional Chinese symptomatologies of acute and stable stages of chronic obstructive pulmonary disease. Acta Universitatis Traditionis Medicalis Sinensis Pharmacologiaeque Shanghai. 2010, 24 (6): 35-39. Chinese
7.
go back to reference Xin DY: Disseminating lung qi unblocking the bowels method in the treatment of acute exacerbation of chronic obstructive pulmonary disease: a randomized controlled observation. J Pract Tradit Chinese Intern Med. 2012, 26 (12): 25-28. Chinese Xin DY: Disseminating lung qi unblocking the bowels method in the treatment of acute exacerbation of chronic obstructive pulmonary disease: a randomized controlled observation. J Pract Tradit Chinese Intern Med. 2012, 26 (12): 25-28. Chinese
8.
go back to reference Li YH, Zhong XG, Jia X, Sun Y, Zheng FJ, Wang W, Zhou XW, Zhu XH, Tian Y, Liu XH: Effects of “catharsis large intestine”on oxidative stress in rats with COPD. Chin J Tradit Chin Med Pharm. 2010, 25: 1196-1198. Chinese Li YH, Zhong XG, Jia X, Sun Y, Zheng FJ, Wang W, Zhou XW, Zhu XH, Tian Y, Liu XH: Effects of “catharsis large intestine”on oxidative stress in rats with COPD. Chin J Tradit Chin Med Pharm. 2010, 25: 1196-1198. Chinese
9.
go back to reference Wang T, Zhang Q, Li YH, Xie H, Zhong XG, Jia X, Liu M, Liu XH: J Beijing Univ Tradit Chin Med. 2013, 36: 104-107. Chinese Wang T, Zhang Q, Li YH, Xie H, Zhong XG, Jia X, Liu M, Liu XH: J Beijing Univ Tradit Chin Med. 2013, 36: 104-107. Chinese
10.
go back to reference Meng FS: Clinical study on Xuan Bai Cheng Qi formula for acute exacerbation of chronic obstructive pulmonary disease. J New Chin Med. 2012, 44: 23-24. Chinese Meng FS: Clinical study on Xuan Bai Cheng Qi formula for acute exacerbation of chronic obstructive pulmonary disease. J New Chin Med. 2012, 44: 23-24. Chinese
11.
go back to reference Shi YJ, Wang H: Clinical observation of Tongfu treatment on treating 40 COPD patients with respiratory insufficiency. Med Innov China. 2013, 17: 39-40. Chinese Shi YJ, Wang H: Clinical observation of Tongfu treatment on treating 40 COPD patients with respiratory insufficiency. Med Innov China. 2013, 17: 39-40. Chinese
13.
go back to reference Chinese Society of Respiratory Diseases: Chronic obstructive pulmonary disease diagnostic and treatment guidelines (revised 2007). Chin J Tuberc Respir Dis. 2007, 30: 8-17. Chinese Chinese Society of Respiratory Diseases: Chronic obstructive pulmonary disease diagnostic and treatment guidelines (revised 2007). Chin J Tuberc Respir Dis. 2007, 30: 8-17. Chinese
14.
go back to reference State Administration of Traditional Chinese Medicine: Standards of Traditional Chinese Syndrome Diagnosis and Treatment. 1994, Beijing, China: China Press of Traditional Chinese Medicine, 2- State Administration of Traditional Chinese Medicine: Standards of Traditional Chinese Syndrome Diagnosis and Treatment. 1994, Beijing, China: China Press of Traditional Chinese Medicine, 2-
15.
go back to reference Wang YY, Lu ZL: Pulmonary disease. Internal Medicine of Traditional Chinese Medicine. 2002, Beijing: People’s Medical Publishing House, 200-Chinese, 2 Wang YY, Lu ZL: Pulmonary disease. Internal Medicine of Traditional Chinese Medicine. 2002, Beijing: People’s Medical Publishing House, 200-Chinese, 2
17.
go back to reference Zheng XY, Zheng XY: Guide to New Traditional Chinese Medicine Research (Trial). Edited by: Zheng XY. 2002, Beijing: China Medical Science Press, 53-58. Chinese, Respiratory disease , Volume 1, Zheng XY, Zheng XY: Guide to New Traditional Chinese Medicine Research (Trial). Edited by: Zheng XY. 2002, Beijing: China Medical Science Press, 53-58. Chinese, Respiratory disease , Volume 1,
18.
go back to reference Li W, Mao B, Wang G, Wang L, Chang J, Zhang Y, Wan MH, Guo J: A study of the mechanism of Qingre Huatan therapy in treatment of acute exacerbation of chronic obstructive pulmonary disease by improving airway inflammation and mucus hypersecretion. J Chin Integr Med. 2008, 6: 799-805. ChineseCrossRef Li W, Mao B, Wang G, Wang L, Chang J, Zhang Y, Wan MH, Guo J: A study of the mechanism of Qingre Huatan therapy in treatment of acute exacerbation of chronic obstructive pulmonary disease by improving airway inflammation and mucus hypersecretion. J Chin Integr Med. 2008, 6: 799-805. ChineseCrossRef
19.
go back to reference Peng WB, Li SF: Clinical observation of lung-purging, blood-activating and fu-unblocking herbs with western medicine in treating acute exacerbation of chronic obstructive pulmonary disease. Shanghai J Tradit Chin Med. 2009, 07: 28-30. Chinese Peng WB, Li SF: Clinical observation of lung-purging, blood-activating and fu-unblocking herbs with western medicine in treating acute exacerbation of chronic obstructive pulmonary disease. Shanghai J Tradit Chin Med. 2009, 07: 28-30. Chinese
20.
go back to reference Chen H, Zhi KY, Feng WJ: Clinical observation of fu-unblocking, clearing-heat in treating 128 patients with acute exacerbation of chronic obstructive pulmonary disease. Shanxi J Tradit Chin Med. 2008, 06: 29-30. Chinese Chen H, Zhi KY, Feng WJ: Clinical observation of fu-unblocking, clearing-heat in treating 128 patients with acute exacerbation of chronic obstructive pulmonary disease. Shanxi J Tradit Chin Med. 2008, 06: 29-30. Chinese
21.
go back to reference Papi A, Luppi F, Franco F, Fabbri LM: Pathophysiology of exacerbations of chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2006, 3: 245-251.CrossRefPubMed Papi A, Luppi F, Franco F, Fabbri LM: Pathophysiology of exacerbations of chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2006, 3: 245-251.CrossRefPubMed
22.
go back to reference Mallia P, Johnston SL: Mechanisms and experimental models of chronic obstructive pulmonary disease exacerbations. Proc Am Thorac Soc. 2005, 2: 361-366.CrossRefPubMed Mallia P, Johnston SL: Mechanisms and experimental models of chronic obstructive pulmonary disease exacerbations. Proc Am Thorac Soc. 2005, 2: 361-366.CrossRefPubMed
23.
go back to reference Ko FWS, Leung TF, Wong GWK, Ngai J, To KW, Ng S, Hui DSC: Measurement of tumor necrosis factor-alpha, leukotriene B4, and interleukin 8 in the exhaled breath condensate in patients with acute exacerbations of chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2009, 4: 79-86.PubMedPubMedCentral Ko FWS, Leung TF, Wong GWK, Ngai J, To KW, Ng S, Hui DSC: Measurement of tumor necrosis factor-alpha, leukotriene B4, and interleukin 8 in the exhaled breath condensate in patients with acute exacerbations of chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2009, 4: 79-86.PubMedPubMedCentral
24.
go back to reference Almansa R, Sanchez-Garcia M, Herrero A, Calzada S, Roig V, Barbado J, Rico L, Bobillo F, Eiros JM, Iglesias V, de Lejarazu RO, Bermejo-Martin JF: Host response cytokine signatures in viral and nonviral acute exacerbations of chronic obstructive pulmonary disease. J Interferon Cytokine Res. 2011, 31: 409-413.CrossRefPubMed Almansa R, Sanchez-Garcia M, Herrero A, Calzada S, Roig V, Barbado J, Rico L, Bobillo F, Eiros JM, Iglesias V, de Lejarazu RO, Bermejo-Martin JF: Host response cytokine signatures in viral and nonviral acute exacerbations of chronic obstructive pulmonary disease. J Interferon Cytokine Res. 2011, 31: 409-413.CrossRefPubMed
25.
go back to reference Liang R, Zhang W, Song YM: Levels of leptin and IL-6 in lungs and blood are associated with the severity of chronic obstructive pulmonary disease in patients and rat models. Mol Med Rep. 2013, 7: 1470-1476.PubMed Liang R, Zhang W, Song YM: Levels of leptin and IL-6 in lungs and blood are associated with the severity of chronic obstructive pulmonary disease in patients and rat models. Mol Med Rep. 2013, 7: 1470-1476.PubMed
26.
go back to reference Chu X, Wei M, Yang X, Cao Q, Xie X, Guan M, Wang D, Deng X: Effects of an anthraquinone derivative from Rheum officinale Baill, emodin, on airway responses in a murine model of asthma. Food Chem Toxicol. 2012, 50: 2368-2375.CrossRefPubMed Chu X, Wei M, Yang X, Cao Q, Xie X, Guan M, Wang D, Deng X: Effects of an anthraquinone derivative from Rheum officinale Baill, emodin, on airway responses in a murine model of asthma. Food Chem Toxicol. 2012, 50: 2368-2375.CrossRefPubMed
27.
go back to reference Zhou YX, Li M, Tang ZS, Wang B, Zhang B: Gypsum compounds and their antipyretic function and anti-inflammatory mechanisms. J Shaanxi Coll of Tradit Chin Med. 2012, 35 (5): 74-76. Zhou YX, Li M, Tang ZS, Wang B, Zhang B: Gypsum compounds and their antipyretic function and anti-inflammatory mechanisms. J Shaanxi Coll of Tradit Chin Med. 2012, 35 (5): 74-76.
28.
go back to reference Bhattacharya S, Haldar PK: Protective role of the triterpenoid-enriched extract of Trichosanthes dioica root against experimentally induced pain and inflammation in rodents. Nat Prod Res. 2012, 26: 2348-2352.CrossRefPubMed Bhattacharya S, Haldar PK: Protective role of the triterpenoid-enriched extract of Trichosanthes dioica root against experimentally induced pain and inflammation in rodents. Nat Prod Res. 2012, 26: 2348-2352.CrossRefPubMed
29.
go back to reference Yang HY, Chang HK, Lee JW, Kim YS, Kim H, Lee MH, Shin MS, Ham DH, Park HK, Lee H, Kim CJ: Amygdalin suppresses lipopolysaccharide-induced expressions of cyclooxygenase-2 and inducible nitric oxide synthase in mouse BV2 microglial cell. Neurol Res. 2007, 29 (11): 59-64.CrossRef Yang HY, Chang HK, Lee JW, Kim YS, Kim H, Lee MH, Shin MS, Ham DH, Park HK, Lee H, Kim CJ: Amygdalin suppresses lipopolysaccharide-induced expressions of cyclooxygenase-2 and inducible nitric oxide synthase in mouse BV2 microglial cell. Neurol Res. 2007, 29 (11): 59-64.CrossRef
30.
go back to reference Skyba P, Kluchova Z, Joppa P, Petrasova D, Tkacova R: Nutritional status in relation to respiratory impairment and systemic inflammation in patients with acute exacerbations of COPD. Med Sci Monit. 2009, 15 (10): CR528-CR533.PubMed Skyba P, Kluchova Z, Joppa P, Petrasova D, Tkacova R: Nutritional status in relation to respiratory impairment and systemic inflammation in patients with acute exacerbations of COPD. Med Sci Monit. 2009, 15 (10): CR528-CR533.PubMed
31.
go back to reference Zeng M, Li Y, Jiang Y, Lu G, Huang X, Guan K: Local and systemic oxidative stress status in chronic obstructive pulmonary disease patients. Can Respir J. 2013, 20 (1): 35-41.CrossRefPubMedPubMedCentral Zeng M, Li Y, Jiang Y, Lu G, Huang X, Guan K: Local and systemic oxidative stress status in chronic obstructive pulmonary disease patients. Can Respir J. 2013, 20 (1): 35-41.CrossRefPubMedPubMedCentral
32.
go back to reference Stanojkovic I, Kotur-Stevuljevic J, Milenkovic B, Spasic S, Vujic T, Stefanovic A, Llic A, Ivanisevic J: Pulmonary function, oxidative stress and inflammatory markers in severe COPD exacerbation. Respir Med. 2011, 105 (Suppl 1): S31-S37.CrossRefPubMed Stanojkovic I, Kotur-Stevuljevic J, Milenkovic B, Spasic S, Vujic T, Stefanovic A, Llic A, Ivanisevic J: Pulmonary function, oxidative stress and inflammatory markers in severe COPD exacerbation. Respir Med. 2011, 105 (Suppl 1): S31-S37.CrossRefPubMed
33.
go back to reference Yu CL, Huang TK, Ding ZZ, Gao XL, Zhang ZD: Traditional Chinese Medicine Thesauruses, Volume 1. 1993, Beijing: China Medical Science Press, 327-1 Yu CL, Huang TK, Ding ZZ, Gao XL, Zhang ZD: Traditional Chinese Medicine Thesauruses, Volume 1. 1993, Beijing: China Medical Science Press, 327-1
34.
go back to reference Yu CL, Huang TK, Ding ZZ, Gao XL, Zhang ZD: Traditional Chinese Medicine Thesauruses, Volume 2. 1993, Beijing: China Medical Science Press, 159-1 Yu CL, Huang TK, Ding ZZ, Gao XL, Zhang ZD: Traditional Chinese Medicine Thesauruses, Volume 2. 1993, Beijing: China Medical Science Press, 159-1
35.
go back to reference Yu CL, Huang TK, Ding ZZ, Gao XL, Zhang ZD: Traditional Chinese Medicine Thesauruses, Volume 2. 1993, Beijing: China Medical Science Press, 1985-1 Yu CL, Huang TK, Ding ZZ, Gao XL, Zhang ZD: Traditional Chinese Medicine Thesauruses, Volume 2. 1993, Beijing: China Medical Science Press, 1985-1
36.
go back to reference Yu CL, Huang TK, Ding ZZ, Gao XL, Zhang ZD: Traditional Chinese Medicine Thesauruses, Volume 1. 1993, Beijing: China Medical Science Press, 1482-1 Yu CL, Huang TK, Ding ZZ, Gao XL, Zhang ZD: Traditional Chinese Medicine Thesauruses, Volume 1. 1993, Beijing: China Medical Science Press, 1482-1
37.
go back to reference Chan K: Chinese herbal medicine concepts of herbs. Interactions Between Chinese Herbal Medicinal Products and Orthodox Drugs. Edited by: Chan K, Cheung L. 2000, London: Taylor and Francis, 36-41. Chan K: Chinese herbal medicine concepts of herbs. Interactions Between Chinese Herbal Medicinal Products and Orthodox Drugs. Edited by: Chan K, Cheung L. 2000, London: Taylor and Francis, 36-41.
Metadata
Title
Xuan Bai Cheng Qi formula as an adjuvant treatment of acute exacerbation of chronic obstructive pulmonary disease of the syndrome type phlegm-heat obstructing the lungs: a multicenter, randomized, double-blind, placebo-controlled clinical trial
Authors
Miao Liu
Xianggen Zhong
Yuhang Li
Fengjie Zheng
Ruohan Wu
Yan Sun
Jinchao Zhang
Publication date
01-12-2014
Publisher
BioMed Central
Published in
BMC Complementary Medicine and Therapies / Issue 1/2014
Electronic ISSN: 2662-7671
DOI
https://doi.org/10.1186/1472-6882-14-239

Other articles of this Issue 1/2014

BMC Complementary Medicine and Therapies 1/2014 Go to the issue