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Journal of Chinese Integrative Medicine ›› 2010, Vol. 8 ›› Issue (5): 410-416.doi: 10.3736/jcim20100503

• Original Clinical Research • Previous Articles     Next Articles

Traditional Chinese versus integrative treatment in elderly patients with isolated systolic hypertension: A multicenter, randomized, double-blind controlled trial

Hao Li1, Long-tao Liu1, Wen-ming Zhao1, Jian-gang Liu1, Ming-jiang Yao1, Yong-xiang Han2, Yan-peng Shen2,Xing-dong Liu 3, Li Liu1, Xue-mei Wang1, Lin-lin Cai1 Jie Guan1    

  1. a Gerontology Medical Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China
    b Department of Gerontology, Yanqing County Hospital of Traditional Chinese Medicine, Beijing 102100, China
    c Community Health Service Centers of Yanqing County, Beijing 102100, China
  • Received:2009-08-10 Accepted:2010-02-01 Online:2010-05-20 Published:2010-05-15
  • Contact: Long-tao Liu E-mail:liulongtao1976@126.com

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Background

Isolated systolic hypertension (ISH) is a common disease in elderly people, threatening their health. Traditional Chinese medicine (TCM) treatment or integrative treatment had advantages in improving quality of life and protecting target organs, but need to be proved by large evidence-based researches.
Objective

To observe the effects of TCM treatment (Jiangya Capsule) or integrative treatment (combination of Jiangya Capsule and nimodipine) on blood pressure and vasoactive agents, and their safety in elderly ISH patients.Design, setting, participants and interventions: A multicenter, randomized, double-blind controlled trial was adopted. A total of 270 elderly ISH patients recruited from Xiyuan Hospital, and TCM Hospital and Community Health Service Centers of Yanqing County of Beijing were randomly divided into 3 groups: TCM group (Jiangya Capsule plus nimodipine simulation, 90 cases), integrative group (Jiangya Capsule plus nimodipine, 90 cases) and Western medicine (WM) group (nimodipine plus Jiangya Capsule simulation, 90 cases). They were all treated for 4 weeks.Main outcome measures: Before and after 4-week treatment, office blood pressure, 24-hour ambulatory blood pressure, serum nitric oxide (NO), and plasma endothelin-1 (ET-1), thromboxane B2 (TXB2) and 6-keto-prostaglandin 1α (6-keto-PGF1α) were detected, and safety evaluation was conducted.
Results

After 4-week treatment, 5 patients in TCM group were lost to follow-up and another 5 patients were excluded, and 80 patients finished the trial; 7 patients in integrative group were lost to follow-up and another 7 patients were excluded, and 76 patients finished the trial; 2 patients in WM group were lost to follow-up and another 3 patients were excluded, and 85 patients finished the trial. After treatment, systolic blood pressure (SBP) decreased in each group (P<0.05), and integrative treatment was superior to TCM or WM treatment in decreasing SBP (P<0.05). Twenty-four hour average SBP and day average SBP decreased significantly in each group, and night average SBP decreased in integrative group, and integrative treatment was superior to TCM or WM treatment in decreasing day average SBP. Serum NO and plasma 6-keto-PGF1α levels were elevated and plasma ET-1 and TXB2 levels were reduced after treatment, and integrative treatment was superior to TCM or WM treatment in reducing plasma TXB2 level.
Conclusion

TCM treatment or integrative treatment has affirmative effects and safety in treating elderly ISH patients, and integrative treatment has superiority in improving some indexes, and deserves further study.

Key words: Hypertension, Elderly, Traditional Chinese medicine therapy, Integrative traditional Chinese and Western medicine therapy, Multicenter trial, Double-blind method, Randomized Controlled trial

Figure 1

Flow diagram of this randomized trial"

"

Group n SBP DBP
TCM
Before treatment 80 157.83±12.69 80.91±7.51
After treatment 80 145.29±18.00* 79.69±7.06
Difference 80 12.66±4.22 2.2±1.23
WM
Before treatment 85 159.05±14.26 82.79±5.86
After treatment 85 146.35±15.97* 78.71±6.75
Difference 85 12.71±3.20 3.7±1.56
Integrative
Before treatment 76 159.87±12.09 82.08±6.75
After treatment 76 143.88±12.62* 77.84±8.23
Difference 76 15.99±5.48△▲ 2.56±1.37

"

Group n Twenty-four-hour average SBP Day average SBP Night average SBP
TCM
Before treatment 24 142.21±12.15 144.79±13.29 132.13±11.85
After treatment 24 131.87±10.56* 134.67±10.50* 124.58±10.04
Difference 24 10.51±5.32 10.05±6.57 7.96±5.43
WM
Before treatment 24 143.21±13.92 145.46±14.90 132.71±13.38
After treatment 24 131.92±11.34* 135.58±12.19* 123.38±12.42
Difference 11.85±5.39 9.85±7.12 9.21±6.45
Integrative
Before treatment 20 145.60±12.63 146.65±13.57 133.60±11.21
After treatment 20 126.00±11.65* 130.20±12.82* 122.60±10.64*
Difference 20 19.54±6.08△▲ 16.38±6.89△▲ 10.02±5.38

"

Group n NO (μmol/L) ET-1 (μg/L) TXB2 (μg/L) 6-keto-PGF1α (μg/L)
TCM
Before treatment 80 70.59±21.60 84.39±24.73 129.76±69.85 92.07±29.57
After treatment 80 86.14±24.49* 69.51±22.67* 113.48±63.45* 112.12±49.16*
Difference 80 15.48±9.63 –(15.23±9.62) –(16.21±10.24) 19.08±13.67
WM
Before treatment 85 72.49±23.85 84.73±27.47 129.24±76.49 86.04±25.60
After treatment 85 81.93±28.81* 71.86±25.42* 113.93±64.42* 104.48±37.28*
Difference 85 9.56±9.21 –(13.21±10.2) –(15.47±10.67)△ 18.47±13.21
Integrative
Before treatment 76 68.80±14.72 79.17±24.21 131.52±84.28 89.43±26.70
After treatment 76 87.71±20.71* 64.55±21.22* 104.58±62.75* 112.61±38.48*
Difference 76 18.32±10.14 –(15.37±9.87) –(27.12±12.38)△ 20.95±14.28
[1] Linderstrom E, Boysen G, Nyboe J . Influence of systolic and diastolic blood pressure on stroke risk: a prospective observational study[J]. Am J Epidemiol, 1995,142(12):1279-1290
doi: 10.1093/oxfordjournals.aje.a117595
[2] Li H, Liu LT . Considerations about treatment programs of elderly patients with hypertension[J]. J Chin Integr Med, 2009,7(7):607-610
李浩, 刘龙涛 . 基于老年高血压病临床治疗的思考[J]. 中西医结合学报, 2009,7(7):607-610
[3] Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report[J]. JAMA, 2003,289(19):2560-2572
doi: 10.1001/jama.289.19.2560
[4] The Revising Committee of Chinese Guidelines for Hypertension Prevention and Treatment. A revised version(2005) of Chinese guidelines for hypertension prevention and treatment[J]. Gao Xue Ya Za Zhi, 2005,13(Suppl):241
中国高血压防治指南修订委员会. 中国高血压防治指南(2005年修订版)[J]. 高血压杂志, 2005,13(Suppl):241
[5] Li H, Liu F, Cui L, Xu LR, Luo ZG . Clinical study of Jiangya Capsule on 24 cases of elderly patients with isolated systolic hypertension[J]. Zhong Yi Za Zhi, 2004,45(1):26-28
李浩, 刘芳, 崔玲, 徐立然, 罗增刚 . 降压胶囊治疗老年单纯收缩期高血压24例临床研究[J]. 中医杂志, 2004,45(1):26-28
[6] Tomassoni D, Lanari A, Silvestrelli G, Traini E, Amenta F . Nimodipine and its use in cerebrovascular disease: evidence from recent preclinical and controlled clinical studies[J]. Clin Exp Hypertens, 2008,30(8):744-766
doi: 10.1080/10641960802580232
[7] Bobrie G, Chatellier G, Genes N, Clerson P, Vaur L, Vaisse B, Menard J, Mallion JM . Cardiovascular prognosis of “masked hypertension” detected by blood pressure self-measurement in elderly treated hypertensive patients[J]. JAMA, 2004,291(11):1342-1349
doi: 10.1001/jama.291.11.1342
[8] Li SY, Xu KN, Huang JD, Fu YJ . Vascular endothelial function and its evaluation on elderly hypertensive patients[J]. Shandong Yi Yao, 2008,48(28):36-37
李施勇, 许开宁, 黄进弟, 符永健 . 老年高血压患者血管内皮功能的变化及评价方法[J]. 山东医药, 2008,48(28):36-37
[9] McEniery CM, Qasem A, Schmitt M, Avolio AP, Cockcroft JR, Wilkinson IB . Endothelin-1 regulates arterial pulse wave velocity in vivo[J]. J Am Coll Cardiol, 2003,42(11):1975-1981
doi: 10.1016/j.jacc.2003.06.016
[10] Wang CY, Ji NJ, Mei YB, Fan BF, Chen DH, Guan LH, Gao MY, Li JG . Detection of serum TXB2, 6-keto-PGF1α and insulin in primary hypertensive patients[J]. Xin Nao Xue Guan Bing Fang Zhi, 2001,1(2):27-28
王成尧, 季乃军, 梅益斌, 樊必夫, 陈东海, 管丽华, 高美英, 李建高 . 原发性高血压患者血清血栓素B2、6-酮-前列腺素F1α和胰岛素测定及其意义[J]. 心脑血管病防治, 2001,1(2):27-28
[11] Xia CX, Lu S . Progress of study on improvement of vascular endothelial function by Chinese herbal medicine in hypertensive patients[J]. Zhongguo Zhong Xi Yi Jie He Za Zhi, 2008,28(4):378-381
夏成霞, 陆曙 . 中药改善高血压病血管内皮功能的研究进展[J]. 中国中西医结合杂志, 2008,28(4):378-381
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