Jiang He, MD, PhD; Dongfeng Gu, MD, MS; Xigui Wu, MD; Jichun Chen, MSc; Xiufang Duan, MD; Jing Chen, MD, MSc; Paul K. Whelton, MD, MSc
This trial is registered as NCT00107744 on http://clinicaltrials.gov.
Note: Drs. He and Gu contributed equally to this work.
Grant Support: By a Career Development Award from the Tulane University Health Sciences Center (Dr. He); grant R01 HL68057 from the National Heart, Lung, and Blood Institute of the National Institutes of Health (Dr. He); and grant 96-906-02-02 of the National Ninth Five-Year Plan Key Program from the Ministry of Science and Technology of the People's Republic of China (Dr. Gu).
Potential Financial Conflicts of Interest: None disclosed.
Requests for Single Reprints: Jiang He, MD, PhD, Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, 1430 Tulane Avenue SL 18, New Orleans, LA 70112-2699; e-mail, email@example.com.
Current Author Addresses: Dr. He: Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, 1430 Tulane Avenue, SL 18, New Orleans, LA 70112-2699.
Drs. Gu, Wu, and Duan and Ms. Chen: Cardiovascular Institute and Fuwai Hospital, 167 Beilishi Road, Beijing, 100037 People's Republic of China.
Dr. Chen: Department of Medicine, Tulane University School of Medicine, 1430 Tulane Avenue, New Orleans, LA 70112.
Dr. Whelton: Office of Senior Vice President for Health Sciences, Tulane University Health Sciences Center, 1430 Tulane Avenue, New Orleans, LA 70112.
Author Contributions: Conception and design: J. He, D. Gu, X. Wu, Jing Chen, P.K. Whelton.
Analysis and interpretation of the data: J. He.
Drafting of the article: J. He.
Critical revision of the article for important intellectual content: J. He, D. Gu, X. Wu, Jing Chen, P.K. Whelton.
Final approval of the article: J. He, D. Gu, X. Wu, Jichun Chen, X. Duan, Jing Chen, P.K. Whelton.
Provision of study materials or patients: J. He, D. Gu, X. Wu, Jichun Chen, X. Duan.
Statistical expertise: J. He.
Obtaining of funding: J. He, D. Gu.
Administrative, technical, or logistic support: J. He.
Collection and assembly of data: J. He, D. Gu, X. Wu, Jichun Chen, X. Duan.
He J., Gu D., Wu X., Chen J., Duan X., Chen J., Whelton P.; Effect of Soybean Protein on Blood Pressure: A Randomized, Controlled Trial. Ann Intern Med. 2005;143:1-9. doi: 10.7326/0003-4819-143-1-200507050-00004
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Published: Ann Intern Med. 2005;143(1):1-9.
This double-blind trial from China randomly assigned 302 adults with high-normal or mildly elevated blood pressures (diastolic blood pressure of 80 to 99 mm Hg, systolic blood pressure of 130 to 159 mm Hg, or both) to daily cookies containing 40 g of either soybean protein or complex carbohydrates. At 12 weeks, soybean cookies reduced diastolic and systolic blood pressure values by about 3 to 4 mm Hg more than did the carbohydrate cookies.
The follow-up duration was short.
Soybean protein supplementation might help lower blood pressure in some people.
Hypertension has become a global public health challenge, affecting approximately 50 million individuals in the United States and 1 billion individuals worldwide (1, 2). The prevalence of hypertension has increased dramatically in developing countries during the past several decades (1, 3) and has increased slightly in the United States according to a recent national survey (4). Hypertension is not only very common but is also an important major modifiable risk factor for cardiovascular disease, stroke, and chronic kidney disease (5-7). Lifestyle modification, including nutritional intervention, provides an important approach for preventing and treating hypertension (2, 8). Clinical trials have documented that weight loss, exercise, alcohol restriction, sodium reduction, and potassium supplementation reduce blood pressure in both hypertensive and prehypertensive persons (2, 8). The effect of dietary macronutrients on blood pressure has not been well studied, although clinical trials indicate that diets rich in fruits, vegetables, and low-fat dairy products and with reduced saturated and total fat (Dietary Approaches to Stop Hypertension [DASH] diet) lower blood pressure (9).
Lincoln Medical & Mental Health Center, Affl. with Weill Medical College of Cornell University
July 22, 2005
Letter to Editor
In reference to the interesting study by He et al on the efficacy of soy protein in the reduction of blood pressure (BP) for patients with pre- hypertension and stage I hypertension (1), we would like to offer the following comments.
Firstly, participants in both study groups were given potassium supplements in one of the study sites. As potassium supplementation is associated with systolic blood pressure reduction (2, 3), we are interested to know how the investigators established a lack of effect modification between soy bean protein and potassium.
Secondly, Hawksley random-zero sphygmomanometers have been found to under-record up to 1.4 mm Hg in systolic and 2.5 mm Hg in diastolic BP measurements.(4) This bias, mainly attributed to overestimation of the final zero correction during BP measurement could potentially undermine the observed results.
Further, the level of physical activity is a confounding variable that needs careful evaluation in the study groups. Physical activity can lead to significant reduction in mean systolic and diastolic blood pressures of up to 3.84 and 2.58 mm Hg respectively. (5)
1. He J, Gu D, Wu X, Chen J, Duan X, Chen J, et al. Effect of soybean protein on blood pressure: a randomized, controlled trial. Ann Intern Med. 2005; 143:1-9.
2. Gu, Dongfong; He, Jiang; Wu, Xigui; Duan, Xiufang; Whelton, Paul K. Effect of potassium supplementation on blood pressure in Chinese: a randomized, placebo-controlled trial. Journal of Hypertension. 2001; 19(7):1325-1331.
3. Haddy FJ. Dietary sodium and potassium in the genesis, therapy, and prevention of hypertension. Journal of the American College of Nutrition. 1987; 6(3): 261-70.
4. McGurk C, Nugent A, McAuley D, Silke B. Sources of inaccuracy in the use of the Hawksley random-zero sphygmomanometers. Journal of Hypertension.1997;15:1379-84
5. Seamus P. Whelton; Ashley Chin, MPH, MA; Xue Xin, MD, MS; and Jiang He, MD, PhD. Effect of Aerobic Exercise on Blood Pressure: A Meta- Analysis of Randomized, Controlled Trials. 2002; 136 (7): 493-503.
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Cardiology, Nephrology, Hypertension, Coronary Risk Factors.
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