A]H
1990;3:425-427
CRITICAL C O M M E N T S O N C U R R E N T LITERATURE
The Potential Benefits of Nonpharmacological Therapy Norman M. Kaplan
sired weight loss average of — 7.6 kg versus + 0 . 9 kg for the drug treated, but reduced sodium intake (measured as urinary excretion) only from 169 mmol/day to 127 (those on drugs started at 183 and ended at 169) and had no increase in potas sium intake or decrease in the generally low levels of reported alcohol intake. As a group, they significantly increased the ratio of PS to S fat from 0.36 to 0.53, whereas the ratio in the drug treated patients remained at 0.34. The effects of the two regimens on blood pressure and serum lipids differed considerably (Table 1). Whereas the drug regimen was markedly more potent in lowering the blood pressure, it tended to adversely alter the levels of various serum lipids. The authors assume that their results are applicable to the treatment of "well motivated patients. The experimental de sign was close to everyday clinical practice in that the aim of treatment was to obtain normal blood pressure according to generally accepted recommendations and with access to all common antihypertensive drugs."
Critique Dietary programs are widely recommended as the first line of treatment for patients with mild, uncomplicated hypertension—a population numbering in the many millions and in whom therapy with diuretics and ^-blockers has not been found to offer protection against coronary disease. How Summary The subjects were 61 men aged 40 to 69 with ever, as the authors of this paper note: "The main shortcoming modest obesity (mean body weight of 99 kg, mean body mass of these recommendations is the lack of knowledge of whether index of 31 kg/m ) and mild hypertension (mean blood pres such dietary programmes have the same favourable effect on sure of 154/96 off therapy for 6 weeks). They were randomly morbidity associated with hypertension as do antihyperten allocated to either drugs (atenolol 50 to 100 mg once daily sive drugs. Long term studies comparing non-pharmacologi initially; bendrofluazide 2.5 mg daily and nifedipine 10 to cal programmes with conventional drug treatment are there 20 mg twice daily, if needed) or diet (aimed at reducing body fore necessary, and they must consider not only feasibility and weight by at least 5%, restricting sodium intake to below 95 antihypertensive measures but also effects on metabolic fac mmol/day, decreasing alcohol intake to less than an ounce a tors and structural changes in the cardiovascular system due to day, increasing the ratio of polyunsaturated (PS) to saturated hypertension/' (S) fat to greater than 0.5 and increasing potassium intake to at This study is one of a small number to carefully compare least 100 mmol/day). nondrug to drug therapy and of an even smaller number to go The patients were followed for one year after randomiza as long as a year. Although it provides no evidence of the tion. The 28 who remained on the diet accomplished the de- effects of either approach to "structural changes in the cardio vascular system due to hypertension," it does provide useful data about the feasibility, the antihypertensive efficacy, and the effect on metabolic factors of the two regimens. From t h e U n i v e r s i t y o f T e x a s S o u t h w e s t e r n M e d i c a l C e n t e r a t The diet program—other than for reduced calories and sat Dallas. urated fat—was poorly followed, despite fairly intensive Address c o r r e s p o n d e n c e a n d r e p r i n t r e q u e s t s t o N o r m a n M . K a p counseling and follow-up, beyond what would likely be pro lan, M D , P r o f e s s o r o f I n t e r n a l M e d i c i n e , T h e U n i v e r s i t y o f T e x a s vided by most practicing physicians, and the continued partic Southwestern M e d i c a l C e n t e r a t D a l l a s , 5 3 2 3 H a r r y H i n e s B o u l e v a r d , ipation of a highly motivated, selected population. Despite a Dallas, T e x a s 7 5 2 3 5 - 8 8 5 2 .
Antihypertensive effect of diet compared with drug treat ment in obese men with mild hypertension. Berglund A, Andersson OK, Berglund G, Fagerberg B. Br Med J 1989;299:480-485.
2
© 1990 by the American
Journal
of Hypertension,
Inc.
0895 -
7061/90/$3.50
Downloaded from http://ajh.oxfordjournals.org/ at University of Otago on July 18, 2015
Two recent papers have confirmed that nonpharmacological therapies are valuable both in the treatment of established hypertension and, perhaps even more importantly, in the pre vention of the disease. Their value in treatment has been fairly well documented although the ability of patients to follow the nondrug regimen and the degree of antihypertensive efficacy that can be achieved if they do follow the regimen continue to be debated. The first of these papers compares a dietary regimen (re duced calories, sodium and alcohol) to drug treatment and confirms that a diet can accomplish a modest antihypertensive effect, considerably less than provided by drugs but of addi tional value because of the concomitant improvement in blood lipids provided by the diet. On the other hand, the value of nondrug therapy in preven tion, though often espoused, has until now not been docu mented. The second paper is the first to demonstrate that the onset of hypertension can be at least postponed and perhaps prevented by a multifaceted nondrug program.
426
KAPLAN
AJH-MAY
TABLE 1. DIET VERSUS DRUGS IN OBESE HYPERTENSIVES Patients Diet Drug
3, NO. 5, PART 1
those who are predisposed to hypertension, as noted in the second study.
61 men, avg age = 54, avg BMI = 31, avg BP = 154/97 i 500 kcal/day —* 7.6 kg weight loss; 1 42 mmol Na+/day, avg = 1 2 7 mmol/day atenolol, 50 to 100 mg daily; plus diuretic or nifedipine as needed
Results
BP
DBP < 90
Cholesterol
HDL-C
Diet Drug
-4/3 -16/11
9/31 22/30
-13mg/dL + 2mg/dL
+ 4mg/dL — 5 mg/dL
From Berglund et al. Br Med J 1989; 299:480-485. BMI = body mass index; BP = blood pressure; HDL-C = high density lipoprotein choles terol; DBP = diastolic blood pressure.
2
Primary prevention of hypertension by nutritional-hy gienic means: Final report of a randomized, controlled trial. Stamler R, Stamler J, Gosch FC, et al. JAMA 1989;262:18011807. Summary A total of 201 men and women, aged 30 to 44 and considered to be "hypertensive-prone/' were enrolled in a 5 year trial comparing multiple-nondrug intervention to simple observation upon the incidence of hypertension (diastolic blood pressure > 90 mm Hg or institution of antihypertensive therapy by the patient's personal physician). The subjects were chosen as being "hypertension-prone" because they had a high to normal diastolic blood pressure (DBP) of 85 to 89 at a second screening or a DBP of 80 to 84 plus overweight (10% to 49% above desirable weight) and/or a rapid resting pulse rate > 80/min. The goals of the intervention program were: reduction in overweight by at least 4.5 kg or 5% of weight; reduction in sodium intake to 80 mmol/day; reduction of alco hol intake to no more than 2 drinks/day; and increase in iso tonic exercise to 70 to 75% of maximal heart rate for age for 30 min 3 times a week. Whereas the control group were simply monitored every 6 months, the intervention group had inten sive individualized counseling and follow-up to encourage adherence to the program. The subjects were enrolled and followed at their worksite, which likely contributed to the excellent 87% rate of participa tion for 4 years or more. At the end of 5 years, the measured changes between the 2 groups were relatively small (Table 2), though more of the intervention group exercised regularly. At the end of the trial the absolute differences in blood pressure between the 2 groups were only 1.3/1.2 mm Hg. Despite these relatively small differences, the incidence of hypertension was significantly lower in the intervention group than in the con trol group and the onset of hypertension was more delayed among those few who did become hypertensive. When the relationship between nutritional changes and changes in blood pressure were examined, weight loss had a greater effect than did sodium restriction. In addition, those who lost the most weight had greater falls in serum choles terol, triglyceride and fasting glucose levels. Comment The authors state that their trial is "thefirstlongterm trial on efficacy of multifactor nutritional-hygienic inter vention for primary prevention of hypertension." They recog nize the potential biases introduced by the more intensive care and follow-up given the intervention group. Nonetheless, these results do show apparent protection against or at least a delay in the development of hypertension by very modest changes in weight, sodium and alcohol intake along with in creased isotonic exercise. Furthermore, their population of "healthy, active people recruited by worksite population screening" is more typical of the overall population than those people usually studied in teaching hospital or clinic settings.
TABLE 2. FIVE YEAR INCIDENCE OF HYPERTENSION IN 201 YOUNG MEN AND WOMEN WITH BASELINE BLOOD PRESSURE AVERAGING 122/82 Urinary Alcohol Incidence of Weight sodium intake hypertension (kg) (mmol/day) (g/day) (DBP > 90) Intervention Monitor only
-2.0 +0.8
From Stamler et al. JAMA 1989;262:1801-1807.
-41 -11 DBP = diastolic blood pressure.
-9.9 -7.7
9/102(8.8%) 19/99(19.2%)
Downloaded from http://ajh.oxfordjournals.org/ at University of Otago on July 18, 2015
meaningful change only in body weight, the diet-treated pa tients did display a slight overall fall in blood pressure, at least enough to lower the diastolic pressure to below the goal of less than 90 mm Hg in almost one-third of the subjects, who likely would thereby no longer be considered in need of antihyper tensive therapy. The minimal fall in blood pressure is con trasted to the much larger fall with similar degrees of weight loss reported by Reisin et al and MacMahon et al, who fol lowed their patients for only 4 and 5 months, respectively. Nonetheless the diet-treated group definitely improved their serum lipid levels, to levels better than those seen in most diet-based trials. On the other hand, the antihypertensive drugs used in this study, a ^-blocker in 25 of 26 and a diuretic in 6 of 26, have clearly been shown to adversely alter serum lipids. If lipid-improving agents such as α-blockers or lipid-neutral agents such as angiotensin converting enzyme inhibitors or calcium entry blockers had been used, the differences between drugs and diet as to lipid changes likely would have been much less marked while an equally greater antihypertensive effect from the drugs would have been observed. Nonetheless, diuretics and ^-blockers remain the most widely used drugs both in the US and worldwide. Therefore, their simultaneously good and bad effects on the two major cardiovascular risk factors need to be remembered and further attention paid to the benefits to be gained from nondrug therapies. It is rational to use nondrug therapy first in those with mild uncomplicated hypertension. If it keeps the pressure within acceptable limits, probably below a diastolic of 95 mm Hg rather than the 90 used in this study, many patients can almost certainly be safely kept off of drugs, while remaining under surveillance in case their pressures begin to rise. If drugs are needed, the additional benefits to be gained from nondrug therapy, particularly by weight reduction for those who are obese, should be preserved. Nondrug therapies may have an even greater value in pre venting or at least slowing the development of hypertension in 1
1990-VOL
AJH-MAY
1990-VOL
3, NO. 5, PART 1
Therefore, I agree with their final conclusions that "the find ings in this group are generalizable to wider sections of the population" and that "implementation of a strategy of pri mary prevention of hypertension by safe nutritional-hygienic means would seem to be appropriate as a necessary comple ment to the ongoing effort of early detection and effective treatment for those with high blood pressure already estab lished."
NONPHARMACOLOGICAL THERAPY
427
REFERENCES 1.
R e i s i n E , A b e l R , M o d a n M , e t a l : Effect o f w e i g h t l o s s w i t h o u t s a l t restriction o n the reduction o f b l o o d pressure in o v e r w e i g h t h y pertensive patients. Ν Engl J M e d 1 9 7 8 ; 2 9 8 : 1 - 6 .
2.
M a c M a h o n S W , M a c D o n a l d G J , B e r n s t e i n L, et al: C o m p a r i s o n o f weight reduction with metoprolol in treatment o f hypertension in young overweight patients. Lancet 1 9 8 5 ; 1 : 1 2 3 3 - 1 2 3 6 .
Downloaded from http://ajh.oxfordjournals.org/ at University of Otago on July 18, 2015
1990;3:425-427
CRITICAL C O M M E N T S O N C U R R E N T LITERATURE
The Potential Benefits of Nonpharmacological Therapy Norman M. Kaplan
sired weight loss average of — 7.6 kg versus + 0 . 9 kg for the drug treated, but reduced sodium intake (measured as urinary excretion) only from 169 mmol/day to 127 (those on drugs started at 183 and ended at 169) and had no increase in potas sium intake or decrease in the generally low levels of reported alcohol intake. As a group, they significantly increased the ratio of PS to S fat from 0.36 to 0.53, whereas the ratio in the drug treated patients remained at 0.34. The effects of the two regimens on blood pressure and serum lipids differed considerably (Table 1). Whereas the drug regimen was markedly more potent in lowering the blood pressure, it tended to adversely alter the levels of various serum lipids. The authors assume that their results are applicable to the treatment of "well motivated patients. The experimental de sign was close to everyday clinical practice in that the aim of treatment was to obtain normal blood pressure according to generally accepted recommendations and with access to all common antihypertensive drugs."
Critique Dietary programs are widely recommended as the first line of treatment for patients with mild, uncomplicated hypertension—a population numbering in the many millions and in whom therapy with diuretics and ^-blockers has not been found to offer protection against coronary disease. How Summary The subjects were 61 men aged 40 to 69 with ever, as the authors of this paper note: "The main shortcoming modest obesity (mean body weight of 99 kg, mean body mass of these recommendations is the lack of knowledge of whether index of 31 kg/m ) and mild hypertension (mean blood pres such dietary programmes have the same favourable effect on sure of 154/96 off therapy for 6 weeks). They were randomly morbidity associated with hypertension as do antihyperten allocated to either drugs (atenolol 50 to 100 mg once daily sive drugs. Long term studies comparing non-pharmacologi initially; bendrofluazide 2.5 mg daily and nifedipine 10 to cal programmes with conventional drug treatment are there 20 mg twice daily, if needed) or diet (aimed at reducing body fore necessary, and they must consider not only feasibility and weight by at least 5%, restricting sodium intake to below 95 antihypertensive measures but also effects on metabolic fac mmol/day, decreasing alcohol intake to less than an ounce a tors and structural changes in the cardiovascular system due to day, increasing the ratio of polyunsaturated (PS) to saturated hypertension/' (S) fat to greater than 0.5 and increasing potassium intake to at This study is one of a small number to carefully compare least 100 mmol/day). nondrug to drug therapy and of an even smaller number to go The patients were followed for one year after randomiza as long as a year. Although it provides no evidence of the tion. The 28 who remained on the diet accomplished the de- effects of either approach to "structural changes in the cardio vascular system due to hypertension," it does provide useful data about the feasibility, the antihypertensive efficacy, and the effect on metabolic factors of the two regimens. From t h e U n i v e r s i t y o f T e x a s S o u t h w e s t e r n M e d i c a l C e n t e r a t The diet program—other than for reduced calories and sat Dallas. urated fat—was poorly followed, despite fairly intensive Address c o r r e s p o n d e n c e a n d r e p r i n t r e q u e s t s t o N o r m a n M . K a p counseling and follow-up, beyond what would likely be pro lan, M D , P r o f e s s o r o f I n t e r n a l M e d i c i n e , T h e U n i v e r s i t y o f T e x a s vided by most practicing physicians, and the continued partic Southwestern M e d i c a l C e n t e r a t D a l l a s , 5 3 2 3 H a r r y H i n e s B o u l e v a r d , ipation of a highly motivated, selected population. Despite a Dallas, T e x a s 7 5 2 3 5 - 8 8 5 2 .
Antihypertensive effect of diet compared with drug treat ment in obese men with mild hypertension. Berglund A, Andersson OK, Berglund G, Fagerberg B. Br Med J 1989;299:480-485.
2
© 1990 by the American
Journal
of Hypertension,
Inc.
0895 -
7061/90/$3.50
Downloaded from http://ajh.oxfordjournals.org/ at University of Otago on July 18, 2015
Two recent papers have confirmed that nonpharmacological therapies are valuable both in the treatment of established hypertension and, perhaps even more importantly, in the pre vention of the disease. Their value in treatment has been fairly well documented although the ability of patients to follow the nondrug regimen and the degree of antihypertensive efficacy that can be achieved if they do follow the regimen continue to be debated. The first of these papers compares a dietary regimen (re duced calories, sodium and alcohol) to drug treatment and confirms that a diet can accomplish a modest antihypertensive effect, considerably less than provided by drugs but of addi tional value because of the concomitant improvement in blood lipids provided by the diet. On the other hand, the value of nondrug therapy in preven tion, though often espoused, has until now not been docu mented. The second paper is the first to demonstrate that the onset of hypertension can be at least postponed and perhaps prevented by a multifaceted nondrug program.
426
KAPLAN
AJH-MAY
TABLE 1. DIET VERSUS DRUGS IN OBESE HYPERTENSIVES Patients Diet Drug
3, NO. 5, PART 1
those who are predisposed to hypertension, as noted in the second study.
61 men, avg age = 54, avg BMI = 31, avg BP = 154/97 i 500 kcal/day —* 7.6 kg weight loss; 1 42 mmol Na+/day, avg = 1 2 7 mmol/day atenolol, 50 to 100 mg daily; plus diuretic or nifedipine as needed
Results
BP
DBP < 90
Cholesterol
HDL-C
Diet Drug
-4/3 -16/11
9/31 22/30
-13mg/dL + 2mg/dL
+ 4mg/dL — 5 mg/dL
From Berglund et al. Br Med J 1989; 299:480-485. BMI = body mass index; BP = blood pressure; HDL-C = high density lipoprotein choles terol; DBP = diastolic blood pressure.
2
Primary prevention of hypertension by nutritional-hy gienic means: Final report of a randomized, controlled trial. Stamler R, Stamler J, Gosch FC, et al. JAMA 1989;262:18011807. Summary A total of 201 men and women, aged 30 to 44 and considered to be "hypertensive-prone/' were enrolled in a 5 year trial comparing multiple-nondrug intervention to simple observation upon the incidence of hypertension (diastolic blood pressure > 90 mm Hg or institution of antihypertensive therapy by the patient's personal physician). The subjects were chosen as being "hypertension-prone" because they had a high to normal diastolic blood pressure (DBP) of 85 to 89 at a second screening or a DBP of 80 to 84 plus overweight (10% to 49% above desirable weight) and/or a rapid resting pulse rate > 80/min. The goals of the intervention program were: reduction in overweight by at least 4.5 kg or 5% of weight; reduction in sodium intake to 80 mmol/day; reduction of alco hol intake to no more than 2 drinks/day; and increase in iso tonic exercise to 70 to 75% of maximal heart rate for age for 30 min 3 times a week. Whereas the control group were simply monitored every 6 months, the intervention group had inten sive individualized counseling and follow-up to encourage adherence to the program. The subjects were enrolled and followed at their worksite, which likely contributed to the excellent 87% rate of participa tion for 4 years or more. At the end of 5 years, the measured changes between the 2 groups were relatively small (Table 2), though more of the intervention group exercised regularly. At the end of the trial the absolute differences in blood pressure between the 2 groups were only 1.3/1.2 mm Hg. Despite these relatively small differences, the incidence of hypertension was significantly lower in the intervention group than in the con trol group and the onset of hypertension was more delayed among those few who did become hypertensive. When the relationship between nutritional changes and changes in blood pressure were examined, weight loss had a greater effect than did sodium restriction. In addition, those who lost the most weight had greater falls in serum choles terol, triglyceride and fasting glucose levels. Comment The authors state that their trial is "thefirstlongterm trial on efficacy of multifactor nutritional-hygienic inter vention for primary prevention of hypertension." They recog nize the potential biases introduced by the more intensive care and follow-up given the intervention group. Nonetheless, these results do show apparent protection against or at least a delay in the development of hypertension by very modest changes in weight, sodium and alcohol intake along with in creased isotonic exercise. Furthermore, their population of "healthy, active people recruited by worksite population screening" is more typical of the overall population than those people usually studied in teaching hospital or clinic settings.
TABLE 2. FIVE YEAR INCIDENCE OF HYPERTENSION IN 201 YOUNG MEN AND WOMEN WITH BASELINE BLOOD PRESSURE AVERAGING 122/82 Urinary Alcohol Incidence of Weight sodium intake hypertension (kg) (mmol/day) (g/day) (DBP > 90) Intervention Monitor only
-2.0 +0.8
From Stamler et al. JAMA 1989;262:1801-1807.
-41 -11 DBP = diastolic blood pressure.
-9.9 -7.7
9/102(8.8%) 19/99(19.2%)
Downloaded from http://ajh.oxfordjournals.org/ at University of Otago on July 18, 2015
meaningful change only in body weight, the diet-treated pa tients did display a slight overall fall in blood pressure, at least enough to lower the diastolic pressure to below the goal of less than 90 mm Hg in almost one-third of the subjects, who likely would thereby no longer be considered in need of antihyper tensive therapy. The minimal fall in blood pressure is con trasted to the much larger fall with similar degrees of weight loss reported by Reisin et al and MacMahon et al, who fol lowed their patients for only 4 and 5 months, respectively. Nonetheless the diet-treated group definitely improved their serum lipid levels, to levels better than those seen in most diet-based trials. On the other hand, the antihypertensive drugs used in this study, a ^-blocker in 25 of 26 and a diuretic in 6 of 26, have clearly been shown to adversely alter serum lipids. If lipid-improving agents such as α-blockers or lipid-neutral agents such as angiotensin converting enzyme inhibitors or calcium entry blockers had been used, the differences between drugs and diet as to lipid changes likely would have been much less marked while an equally greater antihypertensive effect from the drugs would have been observed. Nonetheless, diuretics and ^-blockers remain the most widely used drugs both in the US and worldwide. Therefore, their simultaneously good and bad effects on the two major cardiovascular risk factors need to be remembered and further attention paid to the benefits to be gained from nondrug therapies. It is rational to use nondrug therapy first in those with mild uncomplicated hypertension. If it keeps the pressure within acceptable limits, probably below a diastolic of 95 mm Hg rather than the 90 used in this study, many patients can almost certainly be safely kept off of drugs, while remaining under surveillance in case their pressures begin to rise. If drugs are needed, the additional benefits to be gained from nondrug therapy, particularly by weight reduction for those who are obese, should be preserved. Nondrug therapies may have an even greater value in pre venting or at least slowing the development of hypertension in 1
1990-VOL
AJH-MAY
1990-VOL
3, NO. 5, PART 1
Therefore, I agree with their final conclusions that "the find ings in this group are generalizable to wider sections of the population" and that "implementation of a strategy of pri mary prevention of hypertension by safe nutritional-hygienic means would seem to be appropriate as a necessary comple ment to the ongoing effort of early detection and effective treatment for those with high blood pressure already estab lished."
NONPHARMACOLOGICAL THERAPY
427
REFERENCES 1.
R e i s i n E , A b e l R , M o d a n M , e t a l : Effect o f w e i g h t l o s s w i t h o u t s a l t restriction o n the reduction o f b l o o d pressure in o v e r w e i g h t h y pertensive patients. Ν Engl J M e d 1 9 7 8 ; 2 9 8 : 1 - 6 .
2.
M a c M a h o n S W , M a c D o n a l d G J , B e r n s t e i n L, et al: C o m p a r i s o n o f weight reduction with metoprolol in treatment o f hypertension in young overweight patients. Lancet 1 9 8 5 ; 1 : 1 2 3 3 - 1 2 3 6 .
Downloaded from http://ajh.oxfordjournals.org/ at University of Otago on July 18, 2015
