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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
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