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Effects of a lifestyle programme on ambulatory blood pressure and drug dosage in treated hypertensive patients: a randomized controlled trial
Burke V, Beilin LJ, Cutt HE, Mansour J, Wilson A, Mori TA
Journal of Hypertension 2005 Jun;23(6):1241-1249
clinical trial
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To assess effects of multifactorial lifestyle modification on antihypertensive drug needs in treated hypertensive individuals. DESIGN: Randomized controlled trial. SETTING: Research studies unit. PARTICIPANTS: 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). INTERVENTION: 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 After 4 months, if mean 24-h ambulatory blood pressure (ABP) was less than 135/85 mmHg, antihypertensive drugs were withdrawn over 4 weeks and long-term home blood pressure monitoring was begun. MAIN OUTCOME MEASURES: Antihypertensive drug requirements, ABP, weight, waist girth at 4 months and 1-year follow-up. RESULTS: 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 drugwithdrawal 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). CONCLUSIONS: 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.
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