Effects of a lifestyle programme on ambulatory blood pressure and drug dosage in treated hypertensive patients: a randomized controlled trial. Oat ingestion reduces systolic and diastolic blood pressure in patients with mild or borderline hypertension: a pilot trial. Lack of effect of short-term changes in sodium intake on blood pressure in adolescent schoolchildren. Effect of low vs. high dietary sodium on blood pressure levels in a normotensive Indo-Asian population. Appropriate Blood Pressure Control in NIDDM (ABCD) Trial. Do whole-grain oat cereals reduce the need for antihypertensive medications and improve blood pressure control? Sodium manipulation in the management of hypertension. The view against its general use. Physiologic and related behavioral outcomes from the Women's Lifestyle Heart Trial. Randomised controlled factorial trial of dietary advice for patients with a single high blood pressure reading in primary care. Antihypertensive activity of verapamil: impact of dietary sodium. The VERSAL Study Group.
To assess effects of multifactorial lifestyle modification on antihypertensive drug needs in treated hypertensive individuals.
                Randomized controlled trial.
                Research studies unit.
                Overweight hypertensive patients, receiving one or two antihypertensive drugs, were recruited by advertising, and allocated randomly to a usual care group (controls; n = 118) or a lifestyle modification group (programme group; n = 123).
                A 4-month programme of weight loss, a low-sodium 'Dietary Approaches to Stop Hypertension'-type diet with added fish, physical activity and moderation of alcohol intake. After 4 months, if mean 24-h ambulatory blood pressure (ABP) was less than 135/85 mmHg, antihypertensive drugs were withdrawn over 4 weeks and long-term home blood pressure monitoring was begun.
                Antihypertensive drug requirements, ABP, weight, waist girth at 4 months and 1-year follow-up.
                Ninety control group and 102 programme group participants completed the study. Mean 24-h ABP changed after 4 months by -1.0/-0.3 +/- 0.5/0.4 mmHg in controls and -4.1/-2.1 +/- 0.7/0.5 mmHg with the lifestyle programme (P < 0.01). At follow-up, changes in the two groups were not significantly different (4.1/1.3 +/- 1.1/1.0 mmHg in controls; 2.5/-0.1 +/- 1.1/0.8 mmHg in the programme group; P = 0.73). At 4 months, drug withdrawal differed significantly between the groups (P = 0.038) in men (control 44%; programme 66%) but not in women (65 and 64%, respectively; P = 0.964). At follow-up, sex-related differences were not significant, and 41% in the control group and 43% in the programme group maintained drug-withdrawal status. With the programme, net weight loss was 3.3 kg (P < 0.001) at 4 months and 3.0 kg (P < 0.001) at follow-up; respective net decreases in waist girth were 3.3 cm (P < 0.001) and 3.5 cm (P < 0.001).
                A 4-month multifactorial lifestyle modification in patients with treated hypertension reduced blood pressure in the short-term. Decreased central obesity persisted 1 year later and could reduce overall cardiovascular risk. We assessed the short-term antihypertensive effects of soluble fiber-rich whole oat cereals when added to a standard American diet. In addition, multiple assessments of insulin sensitivity were conducted.
                This was a randomized, controlled, parallel-group pilot study designed to compare an oat cereal group (standardized to 5.52 g/day beta-glucan) to a low-fiber cereal control group (less than 1.0 g/day total fiber) over 6 weeks.
                A total of 18 hypertensive and hyperinsulinemic (= 10 U/mL or more) men and women completed the trial.
                Primary study outcomes were changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP). Secondary outcomes included blood lipid, fasting glucose, and insulin levels and side effects related to elevated blood pressure and increased dietary fiber intake.
                The oat cereal group experienced a 7.5 mm Hg reduction in SBP (P &lt.01) and a 5.5 mm Hg reduction in DBP (P &lt.02), while there was virtually no change in either SBP or DBP in the control group. In the oat cereal group, a trend was observed for a lower total insulin response to a glucose load, suggesting improved insulin sensitivity. However, this could not be confirmed using estimates from the Bergman Minimal Model, perhaps because of our small sample size. The oats group experienced a significant reduction in both total cholesterol (9%) and low-density lipoprotein cholesterol (14%).
                The addition of oat cereals to the normal diet of patients with hypertension significantly reduces both SBP and DBP. Soluble fiber-rich whole oats may be an effective dietary therapy in the prevention and adjunct treatment of hypertension. The relationship between sodium intake and blood pressure in adolescents was examined in a dietary intervention study. One hundred schoolchildren aged 11-14 years and representing the top, middle and bottom deciles of the blood pressure range completed a crossover protocol requiring them to raise and lower their sodium intake for alternate periods of 4 weeks. Blood pressure and urinary sodium excretion were assessed weekly and diet diaries were recorded at the end of each 4-week diet period. Diet-diary analysis confirmed that sodium intake was selectively affected by the intervention. Estimates of average urinary sodium excretion at the end of each diet period differed by more than 80 mmol/day. However, there was no significant change of either systolic or diastolic blood pressure, measured supine in the whole study group, in either sex or in any of the sub-groups, even in those children representing the highest blood pressure decile. Furthermore, the blood pressure changes seen in individuals during the crossover did not correlate with their changes in sodium excretion. This lack of effect of sodium on blood pressure is consistent with other dietary intervention studies in children and supports the hypothesis that the sodium sensitivity of blood pressure is age-related. We conclude that dietary sodium restriction alone has little potential for lowering blood pressure at an early age, even in children with higher than average blood pressure. Hypertension is a major modifiable risk factor, and while sodium restriction in hypertensive patients appears effective, its role in normotensive individuals remains unclear. We assessed the effect of a low vs. high-sodium diet on blood pressure in normotensive Indo-Asian adults.
                A randomized, controlled, crossover trial was conducted on 200 normotensive subjects randomly selected from the general population in Karachi, Pakistan. Participants were randomized to either a low (20 mEq/day) or a high-sodium diet (220 mEq/day) for 1 week, followed by 1 week of washout, then the alternate diet for 1 week. The primary outcome was difference in systolic blood pressure (SBP) measured at the end of each phase in the overall population.
                Mean (95% confidence interval) decline in 24-h urinary sodium excretion was 81.0 (69.6-92.4) mEq/day (P < 0.001), and in SBP was 1 (0-3)mm Hg (P = 0.17) between high and low-sodium phase. A significant interaction was detected (P = 0.001) between dietary sodium and baseline SBP with a greater adjusted mean (95% confidence interval) decline in SBP (6 (2-9)mm Hg) among participants with high-normal SBP (130-139 mm Hg) and no significant change (-1(-2 to 1)) in those with normal baseline SBP (<130 mm Hg), respectively.
                Reducing sodium intake has a beneficial effect on blood pressure in Indo-Asians with high-normal SBP, at least in the short term. Given the ubiquity of high-normal blood pressure (BP), and frank hypertension in this population, we argue that primary prevention strategies, targeted at use of discretionary sodium, should now be designed and evaluated. The ABCD (Appropriate Blood Pressure Control in Diabetes) Trial is a large, prospective, randomized clinical trial of 950 patients with non-insulin-dependent diabetes mellitus (NIDDM) designed to compare the effects of intensive blood pressure control with moderate control on the prevention and progression of diabetic nephropathy, retinopathy, cardiovascular disease, and neuropathy in NIDDM. The secondary objective is to determine equivalency of the effects of a calcium channel blocker (nisoldipine) and an angiotensin-converting-enzyme inhibitor (enalapril) as a first-line antihypertensive agent in the prevention and/or progression of these diabetic vascular complications. The study consists of two study populations aged 40-74 years, 470 hypertensive patients (diastolic blood pressure of > or = 90.0 mmHg at time of randomization) and 480 normotensive patients (diastolic blood pressure of 80.0 mmHg at time of randomization). The study duration is 5 years and is scheduled to end in May of 1998. Patients are randomized to receive either intensive antihypertensive drug therapy or moderate antihypertensive drug therapy. Patients are also randomized to nisoldipine or enalapril, with open-label medications added if further blood pressure control is necessary. The primary outcome measure is glomerular filtration rate as assessed by 24-h creatinine clearance. Secondary outcome measures are urinary albumin excretion, left ventricular hypertrophy, retinopathy, and neuropathy. Cardiovascular morbidity and mortality will also be evaluated. Given the data showing the impact of hypertension on complications in NIDDM, the ABCD Trial is designed to determine if intensive antihypertensive therapy will be more efficacious than moderate antihypertensive therapy on the outcome of diabetic complications in NIDDM. Our study compared 2 whole grain oat-based cereals with 2 refined grain wheat-based cereals to determine their effects on the need for antihypertensive medications in people with high blood pressure (BP).
                This 12-week, randomized controlled parallel-group trial with = 6 weeks of voluntary follow-up was designed to investigate the antihypertensive effects of oats. After 4 weeks of baseline feeding, medication dose was maintained or reduced by half or completely throughout the middle 4 weeks of the study. In the final 4 weeks, participants continued cereal consumption; medication was adjusted according to the protocol.
                Men and women (n = 88) being treated for hypertension with a mean baseline BP below 160/100.
                Primary study outcomes included change in SBP and DBP as well as antihypertensive medication reduction. Secondary measures included blood lipid, fasting glucose, and insulin levels and side effects related to elevated BP and increased dietary fiber intake.
                Seventy-three percent of participants in the oats group versus 42% in the control group were able to stop or reduce their medication by half. Treatment group participants whose medication was not reduced had substantial decreases in BP. The oats group experienced a 24.2-mg/dL reduction in total cholesterol levels, a 16.2-mg/dL decrease in low-density lipoprotein cholesterol levels, and a 15.03-mg/dL drop in plasma glucose levels vs controls.
                Results suggest that a diet containing soluble fiber-rich whole oats can significantly reduce the need for antihypertensive medication and improve BP control. Considering the lipid and glucose improvements as well, increased consumption of whole oats may significantly reduce cardiovascular disease risk. Extreme changes in sodium intake do have an effect on blood pressure of both normotensive and hypertensive individuals. Cross-population correlates of average sodium intake and mean population blood pressure are discordant with the results of studies within single populations and cannot be used as sufficient evidence to justify a reduction of dietary sodium intake in the general population to prevent hypertension. Both explanatory and management trials of sodium restriction have yielded contradictory results, and convincing evidence on the nature and size of subgroups of hypertensives with enhanced sodium sensitivity is lacking. The proportion of patients who will follow a moderately restricted sodium diet is low, unless expensive and time-consuming programs of instruction and monitoring are introduced. In light of this evidence, it is premature to recommend diets that are low in sodium as a public health measure and as initial and sole treatment of hypertension. The Women's Lifestyle Heart Trial was a small (N = 28) randomized controlled trial to evaluate the effects of a comprehensive lifestyle self-management program (very low-fat vegetarian diet, stress-management training, exercise, group support, and smoking cessation) on reduction of cardiovascular risk factors in postmenopausal women with coronary heart disease (CHD). Women assigned to the treatment condition (Prime Time) participated in a week-long retreat followed by twice-weekly 4-hour meetings. Endpoints were program adherence; changes in lipid profiles, body mass, blood pressure, hypolipidemic and antihypertensive medications; and quality of life. Risk factor and psychosocial evaluations were conducted at baseline and at 4, 12, and 24 months. Repeated measures analyses of covariance revealed that the dietary, stress management, and physical activity changes made by intervention women were dramatic and lasting. There were significantly greater improvements in the Prime Time condition compared to the usual care control group on body mass, angina symptoms, and quality of life, and a tendency for a greater reduction in blood pressure-lowering medications. Similar patterns were seen in lipids, blood pressure, and lipid-lowering medications, but did not reach significance. These results demonstrate that postmenopausal CHD women can make lasting lifestyle changes, and that these changes may reduce the need for cardiac medications and improve CHD risk factors and quality of life. To assess the effect of brief interventions during the "watchful waiting" period for hypertension.
                Factorial trial.
                General practice.
                296 patients with blood pressure > 160/90 mm Hg were randomised to eight groups defined by three factors: an information booklet; low sodium, high potassium salt; prompt sheets for high fruit, vegetable, fibre; and low fat.
                Blood pressure (primary outcome); secondary outcomes of diet, weight, and dietary biomarkers (urinary sodium:potassium (Na:K) ratio; carotenoid concentrations).
                Blood pressure was not affected by the booklet (mean difference (diastolic blood pressure) at one month 0.2, 95% confidence interval 1.6 to 2.0), salt (0.13; 1.7 to 2.0), or prompts (0.52; 1.3 to 2.4). The salt decreased Na:K ratio (difference 0.32; 0.08 to 0.56, P = 0.01), and the prompts helped control weight (difference 0.39 (0.85 to 0.05) kg at one month, P = 0.085; 1.2 (0.1 to 2.25) kg at six months, P = 0.03). Among those with lower fruit and vegetable consumption (< 300 g per day), prompts increased fruit and vegetable consumption and also carotenoid concentrations (difference 143 (16 to 269) mmol/l, P < 0.03) but did not decrease blood pressure.
                During watchful waiting, over and above the effect of brief advice and monitoring, an information booklet, lifestyle prompts, and low sodium salt do not reduce blood pressure. Secondary analysis suggests that brief interventions-particularly lifestyle prompts-can make useful changes in diet and help control weight, which previous research indicates are likely to reduce the long term risk of stroke. To define the influence of dietary salt intake on the antihypertensive effect of slow-release verapamil 240 mg once a day in a population with mild-to-moderate essential hypertension.
                Parallel, randomized, multicentre study.
                Patients were advised to follow a moderately low salt diet (Low-salt group). After a 2-week run-in period, those patients with 24-h urinary sodium excretion (UNa) < or = 120 mmol/day and a diastolic blood pressure (DBP) between 90 and 114 mmHg were randomly assigned to verapamil + Low-salt or verapamil + unrestricted-salt diet (High-salt group) for 28 days. Compliance with diets was defined as Low-salt UNa < or = 120 mmol/day and High-salt UNa > 120 mmol/day with UNa increased by > or = 60 mmol/day over the level attained at the end of the run-in period.
                Significant reductions in mean systolic blood pressure (SBP) and DBP were found in both the Low-salt (n = 235) and High-salt (n = 183) groups. The therapeutic goal (DBP < 90 mmHg) was achieved in 38.3% of patients in the Low-salt and 44.8% of patients in the High-salt group. Office blood pressure results were confirmed by ambulatory 24-h blood pressure monitoring in a subsample of patients. Verapamil reduced mean blood pressure throughout the nycthemeral cycle without any significant difference between the two groups.
                The restriction in sodium intake does not have an additive effect on the antihypertensive effect of the slow-channel calcium antagonist verapamil.
Intensive interventions, unsuited to primary care or population prevention programmes, provide only minimal reductions in blood pressure during long-term trials. Further evaluations to assess effects on morbidity and mortality outcomes are needed for populations as a whole and for patients with elevated blood pressure.
A low sodium diet may help in maintenance of lower blood pressure following withdrawal of antihypertensives. If this is confirmed, with no increase in cardiovascular events, then targeting of comprehensive dietary and behavioural programmes in patients with elevated blood pressure requiring drug treatment would be justified.