Lifestyle Factors in Hypertension Drug Research: Systematic Analysis of Articles in a Leading Cochrane Report

Table 2

(a) Details of source studies that mention lifestyle modifications (𝑛=34). (b) Detailed description of source articles cited in a leading selected Cochrane review (Wright and Musini [8]) that made mention of lifestyle modifications (continued).

(a)

Trial title	Publication date	Journal	Study design of publication	Lifestyle intervention mentioned (yes/no)	Diet	Alcohol restriction	Exercise
Carter	1970** [9]	The Lancet	Randomized to treatment or not	YES	“…treatment combined with restriction of salt intake…”	—	—
MRC-TMH	1992 [10]	British Medical Journal	Randomized single blind comparing 2 treatments and placebo (Final results)	NO	—	—	—
	1985** [11]	British Medical Journal	Randomized single blind comparing 2 treatments and placebo (Preliminary results)	YES	Doctors judgment for advising on salt intake	—	Doctors judgment for advising on exercise
OSLO	1986** [12]	Drugs	Open randomized to treatment or not	NO	—	—	—
	1980 [13]	American Journal of Medicine	Open randomized to treatment or not	YES	“General advice on salt consumption”	—	—
SHEP	1991** [14]	JAMA	Randomized, double blind, placebo controlled	NO	—	—	—
	1991 [15]	Hypertension: Supplemental Edition	Supplemental edition publication	YES	“Standardized general information on nutrition. Moderation of salt intake and emphasis on foods high in potassium are to be recommended”	—	Standardized general information regular gradual exercise
SHEP-P	1989** [16]	Stroke	Randomized double blind, placebo-controlled trial	NO	—	—	—
	1970 [17]	JAMA	Epidemiologic assessment of the role of blood pressure in stroke	NO	—	—	—
	1986 [18]	Controlled Clinical Trials	Recruitment experience review for SHEP-P publication	NO	—	—	—
	1982 [19]	Current Medical Research Opinion	Proposal/review of SHEP-P protocol publication	YES	Information on diet and exercise: “Moderation of salt intake to 3 to 4 g sodium daily in favour of foods high in potassium will be recommended”	—	Regular and graded exercise for muscular tone and skeletal mobility will be advised
SYST-EUR	1980** [20]	Lancet	Randomized, double blind, placebo controlled	NO	—	—	—
	1991 [21]	Aging	Objectives and protocol publication	YES	Individual investigators’ judgment to prescribe diet changes	—	—
TEST	1995** [22]	Cerebrovascular Disease	Randomized, double blind, placebo controlled	YES	—	—	—
UKPDS 39	1991 [23]	Diabetologia	Study design publication	YES	“3 month trial of diet control after initial recruitment. All patients continued to receive dietary advice throughout the study and were encouraged to give up smoking…Centers were notified if the total cholesterol or triglyceride values were greater than 8.5 or 4.0 mmol/L respectively and could institute hypolipidemic therapy if dietary advice failed to lower these values satisfactorily” Initial diet therapy: “At the initial visit all patients were advised to take a “prudent” diet, containing approximately 50 % carbohydrate, low saturated fat and moderately high fiber with a reduced energy content if obese, aiming to attain ideal body weight. For the first 3 months they were seen at monthly intervals, usually by a dietitian as well as a doctor”	—	—
	1998** [24]	British Medical Journal	Randomized controlled (Open label)	YES		—	—
USPHSHCSG	1977** [25]	Circulation Research	Randomized, double blind, placebo controlled	YES	“There was no intervention on diet or smoking or other behavioral factors.” In conclusion, Moderate salt restriction may be appropriate	—	In conclusion, as a supplement, a reasonable exercise program may be an appropriate management
VA-II	1970** [26]	JAMA	Randomized, double blind, placebo controlled	YES	Low salt diet for congestive heart failure patients only	—	Restricted activity for congestive heart failure patients only
VA-NHLBI	1978** [27]	Circulation Research	Randomized, double blind, placebo controlled	YES	“Subjects were also advised if lipid abnormalities were present and a diet was recommended but not further emphasized”	—	At the discretion of the physician, nonhypertensive conditions warranting ambulatory therapy were treated or were referred to appropriate local facilities for evaluation and treatment

∗∗indicates the major publication for the study as defined by Wright and Musini [8].

(b)

Publication title	Smoking cessation	Relaxation/stress management	Weight loss	Other or undefined “lifestyle”	Description included in publication
Carter			“…treatment combined with …weight reduction.”
MRC-TMH	Doctors’ judgment for advising on smoking cessation		Doctors’ judgment for managing obesity
OSLO	“General advice regarding smoking”		“General advice regarding weight loss”
SHEP	Standardized general information on smoking		Avoidance or reduction of obesity was to be advised	“Potassium supplements were given to all participants who had serum potassium concentrations below 3.5 mmol/L at two consecutive visits”
SHEP-P			Avoidance or reduction of obesity will be advised		(On the third clinical visit)…A complete orientation to the trial is given, including information on diet and exercise…; “Moderation of salt intake to 3 to 4 g sodium daily in favour of foods high in potassium will be recommended”
SYST-EUR				Individual investigators’ judgment to prescribe lifestyle changes	“Diet and lifestyle changes have been recommended for the treatment of hypertension in the elderly, as they might be sufficient to reduce the blood pressure. However, few studies have specifically described the effects of such changes on blood pressure in the elderly and often no controls were included. In addition, aging may alter the relationships between the incidence of cardiovascular complications and indicators of cardiovascular risk, such as body weight and serum cholesterol”; “…diet and lifestyle changes should not be obligatorily recommended to all patients. Individual investigators conserve the decision to prescribe diet and lifestyle measures to their patients in keeping with local treatment policies, provided that such measures are equally reinforced in all patients at a particular centre, independent of the level of blood pressure”
TEST	Only mentioned in introduction
UKPDS 39	“Encouraged to give up smoking”				“3 month trial of diet control after initial recruitment. All patients continued to receive dietary advice throughout the study and were encouraged to give up smoking…Centers were notified if the total cholesterol or triglyceride values were greater than 8.5 or 4.0 mmol/L respectively and could institute hypolipidemic therapy if dietary advice failed to lower these values satisfactorily.” Initial diet therapy: “At the initial visit all patients were advised to take a “prudent” diet, containing approximately 50 % carbohydrate, low saturated fat and moderately high fibre with a reduced energy content if obese, aiming to attain ideal body weight. For the first 3 months they were seen at monthly intervals, usually by a dietitian as well as a doctor”; “Type 2 diabetic patients aged 25–65 years inclusive, median age 53 years, median body mass index 28 kg/m^2and median fasting plasma glucose 11.3 mmol/L, were recruited and treated initially by diet. Ninety five percent remained hyperglycaemic (fasting plasma glucose > 6 mmol/L) and were randomly allocated to different therapies”
USPHSHCSG	In conclusion, as a supplement, smoking cessation may be an appropriate management		In conclusion, as a supplement, weight control may be an appropriate management		Recommendations in conclusion: “Such careful follow-up supplemented by other hygienic intervention, such as weight control, moderate salt restriction, smoking cessation, and a reasonable exercise program, may be appropriate management for many mild, uncomplicated hypertensives, and avoids the potential hazards, inconvenience, and expense of long-term drug use”
VA-II					Recommendations in conclusion: “Such careful follow-up supplemented by other hygienic intervention, such as weight control, moderate salt restriction, smoking cessation, and a reasonable exercise program, may be appropriate management for many mild, uncomplicated hypertensives, and avoids the potential hazards, inconvenience, and expense of long-term drug use”
VA-NHLBI	All subjects were advised of the risks of smoking and obesity and, where indicated, were encouraged to eliminate these additional risk factors. Their responses were noted, but no further action was taken		All subjects were advised of the risks of smoking and obesity and, where indicated, were encouraged to eliminate these additional risk factors. Their responses were noted, but no further action was taken