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(Hypertension. 1995;26:820.)
© 1995 American Heart Association, Inc.

Articles

A Randomized Controlled Trial of Stress Reduction for Hypertension in Older African Americans

Robert H. Schneider; Frank Staggers; Charles N. Alexander; William Sheppard; Maxwell Rainforth; Kofi Kondwani; Sandra Smith; Carolyn Gaylord King

From the Center for Health and Aging Studies, Department of Physiological and Biological Sciences (R.H.S.) and Department of Psychology (C.N.A., M.R., K.K., C.G.K.), Maharishi University of Management, Fairfield, Iowa; the Hypertension and Stress Management Research Clinic, West Oakland Health Center, Oakland, Calif (F.S., W.S., K.K., S.S.); the Department of Social and Behavioral Sciences, University of Arkansas, Pine Bluff (C.G.K.); and the Haight-Ashbury Free Medical Clinic, San Francisco, Calif (F.S.).

Correspondence to Robert H. Schneider, MD, Center for Health and Aging Studies, Maharishi University of Management FB 1028, Fairfield, IA 52557-1028.

	Abstract

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Abstract We tested the short-term efficacy and feasibility of two stress education approaches to the treatment of mild hypertension in older African Americans. This was a randomized, controlled, single-blind trial with 3 months of follow-up in a primary care, inner-city health center. Of 213 African American men and women screened, 127 individuals (aged 55 to 85 years with initial diastolic pressure of 90 to 109 mm Hg, systolic pressure of 189 mm Hg, and final baseline blood pressure of 179/104 mm Hg) were selected. Of these, 16 did not complete follow-up blood pressure measurements. Mental and physical stress-reduction approaches (Transcendental Meditation and progressive muscle relaxation) were compared with a lifestyle modification education control program and with each other. The primary outcome measures were changes in clinic diastolic and systolic pressures from baseline to final follow-up, measured by blinded observers. The secondary measures were linear blood pressure trends, changes in home blood pressure, and intervention compliance. Adjusted for significant baseline differences and compared with control, Transcendental Meditation reduced systolic pressure by 10.7 mm Hg (P<.0003) and diastolic pressure by 6.4 mm Hg (P<.00005). Progressive muscle relaxation lowered systolic pressure by 4.7 mm Hg (P=.054) and diastolic pressure by 3.3 mm Hg (P<.02). The reductions in the Transcendental Meditation group were significantly greater than in the progressive muscle relaxation group for both systolic blood pressure (P=.02) and diastolic blood pressure (P=.03). Linear trend analysis confirmed these patterns. Compliance was high in both stress-reduction groups. Home systolic but not diastolic pressure changes were similar to clinic changes. Selected mental and physical stress-reduction techniques demonstrated efficacy in reducing mild hypertension in this sample of older African Americans. Of the two techniques Transcendental Meditation was approximately twice as effective as progressive muscle relaxation. Long-term effects and generalizability to other populations require further evaluation.

Key Words: hypertension, stress • relaxation • blacks • aged

	Introduction

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Age- and gender-specific mortality rates for African Americans are 50% higher than for white Americans.^{1 2} Disproportionately high rates of hypertension contribute to the excess rates of mortality and morbidity from cardiovascular and renal disease in this group.² Hypertension in African Americans has a higher prevalence, incidence, and severity; earlier onset; more target-organ damage; and is generally treated later and less adequately than in white Americans.³ Furthermore, more than 70% of elderly African Americans are hypertensive, and hypertensive diseases cause four to seven times more mortality than in older white Americans.^{4 5} For these reasons hypertension has been considered the number one health problem among adult African Americans.^{5 6}

Numerous controlled clinical trials have demonstrated that lowering blood pressure (BP) reduces morbidity and mortality in the general population⁷ and in African Americans in particular.⁸ However, the efficacy of conventional drug therapy in preventing the most frequent complication of hypertension—coronary heart disease—is substantially less than predicted.⁹ This may be due to adverse side effects of antihypertensive drug therapy.^{10 11} In addition, antihypertensive pharmacotherapy has been associated with impaired quality of life,¹² low compliance,¹³ and high cost.^{14 15} These limitations of conventional drug therapy have been noted in the elderly¹⁶ and African American¹⁷ patient populations. For these and other reasons the Fifth Joint National Committee (JNC V), National High Blood Pressure Education Program, and the Working Group on Hypertension in the Elderly recommended that nondrug lifestyle modification approaches be used as first-line definitive or adjunctive treatment for hypertension, particularly in African Americans with high BP.

Chronic psychosocial stress has been implicated in the etiology of hypertension.^{6 18 19} In African Americans socioenvironmental and psychosocial stress have been associated with higher BP.²⁰ Increasing social and economic disparities in later life may further increase psychosocial stress and the risk for hypertension in older African Americans.⁵ Heightened cardiovascular and sympathetic nervous system reactivity may be a mechanism for the stress-hypertension link in this population.^{20 21} Therefore, stress reduction may be useful for treating hypertension in older African Americans, yet there has been a lack of controlled clinical trials of stress reduction for hypertension in this group.²² However, there have been numerous clinical studies of stress-reduction approaches for hypertension in nonminority populations, with inconsistent results.^{23 24} These studies have generally suffered from serious methodological weaknesses, including inadequate sample sizes and baseline determinations; absence of appropriate control groups; possible confounding by expectancy or other cointerventions, such as changes in antihypertensive medication; and lack of comparison or differentiation of distinct approaches to stress reduction.^{24 25}

The question of heterogeneity of effects of different approaches to stress management has been investigated in several quantitative meta-analyses which suggest that the Transcendental Meditation (TM) technique, a mental technique for stress reduction,²⁶ may be particularly effective in reducing physiological arousal,²⁷ anxiety,²⁸ and smoking, alcohol, and drug abuse²⁹ and improving psychological health.³⁰ Previous studies on TM and BP in nonminority samples have suggested significant antihypertensive effects of the program.^{31 32 33} Progressive muscle relaxation (PMR),³⁴ a widely used physical-based approach, has also been used for reducing psychological stress²⁸ and BP.^{23 24 25} Both TM and PMR have been previously studied in young adult, normotensive African Americans.³⁵

Therefore, the objectives of the present study were to conduct a well-controlled clinical trial comparing mental (TM) and physical-based (PMR) techniques for stress reduction in the treatment of mild hypertension in a community-based sample of older African Americans to assess the short-term efficacy of these techniques in reducing hypertension and determine the feasibility of longer-term implementation of these stress-reduction programs in primary care settings with this patient population.

	Methods

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Overall Design
The design consisted of a randomized, controlled, single-blind, primary care center–based trial that included three study groups: the TM program, PMR, and a lifestyle modification education control (EC) program. The two active stress-management conditions (TM and PMR) were closely matched for external characteristics. The EC group partially controlled for treatment attention, time, and monitoring. Eligible participants underwent a baseline period of monitoring and then were randomly assigned to one of the study groups for 3 months of intervention. The primary outcome variables were changes in clinic systolic and diastolic BP values measured blindly. The secondary outcomes were changes in self-monitored home BP and compliance. Psychological and behavioral characteristics were assessed at baseline to determine the equivalence of groups. The study was carried out between January 1989 and June 1991 at the West Oakland Health Center, a primary care community health center in Oakland, Calif.

Eligibility and Randomization
The target population consisted of men and women, self-identified as African American, aged 55 years or older, with a history of mild hypertension. Subjects were recruited from local community clinics, senior citizen centers, and other community organizations and were reimbursed $6 per visit for travel expenses to the clinic. Initial BP eligibility criteria were 90 to 109 mm Hg diastolic BP and less than or equal to 189 mm Hg systolic BP based on three successive measurements at the initial screening visit. Subjects were eligible for entry into the trial whether or not they were taking antihypertensive medications as long as they met the BP eligibility criteria noted above. If potential subjects were taking BP medications and agreed to discontinue them, they were tapered off BP drugs by their primary physicians with a washout period of 4 to 8 weeks before entry into the baseline. BP medication dosages during the baseline and treatment periods were kept stable by participant and physician consent. Candidates were excluded if they had medical evidence of life-threatening or disabling diseases. All subjects participated with the approval of their primary physicians and gave informed consent. The study was approved by institutional review boards at the West Oakland Health Center and Maharishi University of Management and followed institutional guidelines at the collaborating centers.

After the initial screening visit and verification of eligibility, subjects returned to the study clinic every 1 to 2 weeks for an average of four baseline visits. At these subsequent baseline visits BP measurement and psychometric testing were performed. Final baseline BP level was based on three measurements at each of the last two baseline visits. After completion of baseline, subjects were randomly assigned to one of the treatment groups according to a number adaptive allocation model.^{36 37} This procedure was used because it allowed for adaptation of the ratio of experimental to control subjects based on the availability of eligible participants while maintaining randomization to the three study groups. If participants’ BP exceeded 104 mm Hg diastolic or 179 mm Hg systolic at any two successive visits, they were excluded from the trial and referred for standard care.

Follow-up Assessment
Data for all participants were subsequently collected monthly for 3 months. The final 3-month follow-up determinations were measured at a series of two visits 1 week apart. Clinic BP was measured by a research technician who was blinded to the treatment status of the subjects. All clinic BPs were measured with a stationary automated BP monitor with digital readout (model 300S, Vitastat Medical Services) that was calibrated against a mercury sphygmomanometer at regular intervals.³⁸ Readings were taken with subjects in the seated position after they had sat for 5 minutes at rest while not practicing any stylized relaxation technique. Three readings using the first and fifth Korotkoff sounds were recorded at each visit, with the last two averaged to give the final reading for that visit.

For the home BP determinations a standard self-monitoring procedure was used that had been previously studied for validity and reliability.^{18 39} Subjects were taught to record their own BP by a trained research technician using a semiautomatic, auscultatory device (model UA 731, Takeda Medical, Inc). A subject was considered proficient when his or her readings were within 5 mm Hg of the technician’s readings. The home BP monitoring equipment was periodically checked by the study staff for accuracy and proper operation. Participants recorded their home BP twice a day (in the morning and afternoon or evening) for 1 week at the end of the baseline and intervention phases.

A battery of psychosocial and behavioral assessments was administered verbally to each participant individually by a trained interviewer. These measures included (1) the National Survey of Black Americans subscales on personal efficacy, stress impact, and social support⁴⁰ ; (2) State-Trait Personality Inventory for trait anxiety and anger subscales⁴¹ ; (3) Multidimensional Health Locus of Control Scale for the internal control subscale⁴² ; (4) self-esteem⁴⁰ ; (5) well-being⁴³ ; (6) Nottingham Health Profile⁴⁴ ; (7) Generalized Outcome Expectancy⁴⁵ ; (8) expectancy of outcome for these specific treatments³¹ ; and (9) health habit questionnaires for exercise and diet.⁴⁶ Compliance with the active interventions was determined by a regularity questionnaire assessing frequency of practice of the stress-reduction technique, which the participants completed at monthly intervals during the treatment phase.⁴⁷ Perceived efficacy of the treatments was determined by questionnaire during the final posttest session.⁴⁸

Interventions
The two active stress-reduction conditions, TM and PMR, were matched to each other for teaching format, instructional time, home practice requirements, and expectancy of beneficial outcomes based on the standard TM course format.²⁶ Neither active stress-management intervention required any change in personal beliefs, philosophy, or lifestyle other than daily practice. Instruction in both active interventions included an introductory presentation and discussion, brief personal interview, personal instruction meeting, and three follow-up small group seminars. The instructional meetings lasted about 1.5 hours each and took place over the course of 1 week. Thereafter, each stress-reduction group met for a 1.5-hour session every month. Each of the instructors for the active interventions was African American and professionally qualified and experienced in teaching either PMR or TM. Participants were instructed to practice their respective techniques for 20 minutes twice daily (morning and evening) while seated comfortably with eyes closed. They were also requested not to reveal details of their program to individuals outside their treatment group.

The distinctive features of the three treatments were as follows: The TM program is the principal approach for stress management and self-development of Maharishi Ayur-Veda, a system of natural health care derived from the ancient Vedic approach to health by Maharishi Mahesh Yogi.^{49 50} The TM technique has been described as a simple yet precise mental technique whereby the ordinary thinking process becomes quiescent and a distinctive psychophysiological state of restful alertness appears to be gained.^{50 51} Details of the instructional protocol and practice have been previously described.²⁶

The PMR technique followed the previously published procedure of Bernstein and Borkovic³⁴ that is based on Jacobson’s classic muscle relaxation program.⁵² This physical relaxation technique involves directing the participants’ attention to tensing and relaxing the various muscle groups throughout the body systematically to achieve deep relaxation.

The partial attention control, termed lifestyle modification EC, included a set of educational instructions and materials modeled after the usual community practice recommendations for the nondrug management of mild hypertension. These included specific guidelines for reduction of dietary sodium and caloric intake as well as aerobic exercise based on the lifestyle modification recommendations of the Joint National Committee.⁶ Participants in this group met with the treatment provider for individual or small group sessions once every month for 0.5 to 1 hour during the treatment phase. Participants in this group were given expectations that their BP could be reduced by adoption of these lifestyle modifications.

Data Analysis
Baseline characteristics of the three groups were compared by MANOVA and univariate ANOVA. The baseline factors included age, sex, weight, BP, medication status, and psychological and behavioral/lifestyle characteristics.

Treatment outcomes were assessed by ANCOVA, with BP change as the outcome variable and baseline BP and other baseline characteristics that significantly differed between the groups as covariates. Change in BP was defined as 3-month posttreatment BP minus baseline BP. Significance was set at a value of P<.05.

Planned contrasts allowed pairwise comparisons of the three treatment groups on BP outcomes. These contrasts were one tailed because of the directionality of predictions.⁵³ On the basis of previous research discussed above, it was hypothesized that both active interventions would be superior to the EC program and that the TM group would show greater reductions in BP than the comparison relaxation program.^{29 31 32 33} For analysis of clinic BP trends over time, each of the three monthly follow-up visits was included in a repeated-measures ANCOVA (linear trend analysis). In addition, analyses by intention-to-treat³⁷ were performed by two methods. First, missing BP change scores were treated as missing at random, and the BMDP 5V routine was applied for estimation of their values.⁵⁴ Second, a more conservative approach was applied by assignment of the maximal increase in BP observed in any subject to all the missing values for all subjects. Effects of the interventions on psychological and behavioral variables will be reported in a future publication on quality of life.

	Results

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Recruitment and Attrition
Over an 18-month period 213 people were screened for eligibility for the study. Of these, 127 were randomized to treatment. The most common reason for exclusion of candidates during the baseline period was BP outside the study range. Of the 127 participants, 16 attrited over the course of the 3-month intervention period. Of those who attrited, 11 (2 TM, 3 PMR, 6 EC) were eliminated because of changes in their antihypertensive medication by their primary care physician. The remaining 5 subjects (2 TM, 2 PMR, 1 EC) withdrew for a variety of personal reasons, most commonly change of residence. Thus, 111 subjects completed the study.

Baseline Characteristics
Table 1 presents baseline demographic and BP characteristics of participants across randomized groups. The mean age was 67 years; 57% were female and 43% male. Fifty percent were not taking antihypertensive medications. Mean weight was 82 kg. Mean BP was 147/92 mm Hg. MANOVA indicated no significant difference between groups on baseline characteristics. Among the 19 baseline physiological and psychological characteristics assessed by univariate analysis, only age was significantly different between groups (TM, 64 years; PMR, 69 years; and EC, 67 years; P<.01).

View this table: [in this window] [in a new window]   Table 1. Baseline Characteristics for Stress-Reduction and Control Groups

Compliance Rates and Expectancy
Compliance with the active stress-reduction interventions was high. Monthly reports by the participants indicated that 97.1% of the TM group and 81.1% of the PMR group practiced their techniques "twice a day" or "almost twice every day." There was no significant difference between the active groups on compliance rates by a test of proportion. Participants in both the TM and PMR groups rated their instructors "excellent" (mean was 3.9 and 3.92, respectively, for TM and PMR instructors, with 4=excellent and 3=good). There were no differences between the active groups on the measures of outcome expectancy.

Clinic BP Results
Table 2 presents for each group (total n=111) adjusted change scores, with age and baseline BP as covariates. Both active intervention groups showed significant reductions in systolic and diastolic BP values compared with the lifestyle modification EC group. Compared with the EC group, the TM group showed an adjusted reduction of 10.7 mm Hg in systolic BP (P=.0002) and 6.4 mm Hg diastolic BP (P=.00005). Compared with the EC group, the PMR group showed adjusted reductions of 4.7 mm Hg in systolic BP (P=.054) and 3.3 mm Hg in diastolic BP (P=.02). The reductions in the TM group were significantly larger than in the PMR group for systolic BP (P=.02) and diastolic BP (P=.03). Clinic heart rates did not change significantly in any of the groups.

View this table: [in this window] [in a new window]   Table 2. Change From Baseline in Clinic BP for Stress-Reduction and Control Groups

The results of the intention-to-treat analyses did not substantially differ from the primary analyses above. Moreover, when dropouts from the study were compared with the continuing participants, there were no significant differences in baseline BP or demographic, lifestyle, or psychological characteristics.

Figs 1 and 2 display the systolic and diastolic BP changes adjusted for baseline BP and age for the 104 participants, with complete data for each of the three monthly follow-up visits. Repeated-measures ANCOVA confirmed significant reductions in both the TM and PMR groups compared with the EC group in systolic and diastolic BP values (TM, P<.0005 for systolic BP and P<.0001 for diastolic BP; PMR, P<.025 for both systolic BP and diastolic BP). Linear trend analysis for the repeated-measures ANCOVA showed there was a consistently greater downward linear trend over the 3 months in the TM group compared with the EC group for both systolic BP (P<.005) and diastolic BP (P<.01) but no significant trend differences for the PMR group compared with the EC group.

View larger version (18K): [in this window] [in a new window]   Figure 1. Line graph shows mean changes in clinic systolic pressure over 3 months (follow-up minus baseline) with SEM. Probability values are for repeated-measures ANCOVA comparing each experimental group (TM and PMR) with control (EC). TM indicates Transcendental Meditation (n=36); PMR, progressive muscle relaxation (n=33); and EC, lifestyle modification education control (n=35).

View larger version (16K): [in this window] [in a new window]   Figure 2. Line graph shows mean changes in clinic diastolic pressure over 3 months (follow-up minus baseline) with SEM. Probability values are for repeated-measures ANCOVA comparing each experimental group (TM and PMR) with control (EC). TM indicates Transcendental Meditation (n=36); PMR, progressive muscle relaxation (n=33); and EC, lifestyle modification education control (n=35).

Home BP Results
The results of home BP monitoring were calculated from an average of 14 readings during 7 days for the 92 participants with home BP data. Nineteen subjects did not comply with home BP recording and thus were not included in this analysis. Both active treatment groups demonstrated reductions in systolic BP compared with the lifestyle modification EC group. The TM group showed an adjusted reduction of 9.6 mm Hg (P=.0004) and the PMR group a reduction of 4.3 mm Hg (P=NS). The reduction in the TM group was significantly greater than in the PMR group (P<.05). Neither active intervention group demonstrated significant reductions in home diastolic BP.

BP Results in Medicated and Nonmedicated Subgroups
Although age was the only baseline characteristic that significantly differed between groups, inspection of baseline characteristics in Table 1 suggested the potential for other confounding differences between groups (eg, medication status, sex, and weight). Sex, weight, and medication status were then evaluated as additional covariates to the primary analysis, with no appreciable change in the results. We also examined whether baseline characteristics interacted with the BP outcomes. The only significant interaction was between medication status and diastolic BP (P=.02). To further evaluate the effects of medication status on BP change, we analyzed post hoc the medication and nonmedication subgroups for baseline characteristics and responses to treatment. Baseline BP values did not differ significantly between the medicated and nonmedicated subgroups. Within the nonmedicated subgroups the TM participants showed a reduction in systolic BP of 13.0 mm Hg, the PMR participants showed a reduction of 3.8 mm Hg, and the EC group showed an increase of 5.2 mm Hg. Within the medicated subgroups the TM participants showed a reduction in systolic BP of 7.9 mm Hg, the PMR participants showed a reduction of 6.0 mm Hg, and the EC group showed a decrease of 3.0 mm Hg. Regarding diastolic BP, in the nonmedicated subgroups there were reductions of 6.6 mm Hg in the TM group and 2.3 mm Hg in the PMR group and an increase of 4.7 mm Hg in the EC group. In the subgroup continuing to take antihypertensive medications, clinic diastolic BP was reduced 4.1 mm Hg in the TM group, 2.5 mm Hg in the PMR group, and 1.2 mm Hg in the EC group. Also, there were no significant changes in weight, self-reported exercise, or self-reported diet when the groups were compared.

	Discussion

Top Abstract Introduction Methods Results Discussion References

 
This trial demonstrated the feasibility and short-term efficacy of using selected stress-reduction approaches in the treatment of mild hypertension in older African Americans in an inner-city primary care health center setting. After 3 months of follow-up both TM and PMR significantly reduced systolic and diastolic BP values compared with a control program. Furthermore, TM practice was associated with BP reductions that were approximately twice as large as those with PMR. Compliance with both active interventions was relatively high. These effects were clinically and statistically significant, as discussed below.

This study met the design characteristics demanded for a well-controlled trial of behavioral stress-reduction approaches for hypertension^{24 25} : (1) The baseline period of four visits minimized reductions in BP during the treatment period caused by regression to the mean or habituation effects. (2) Randomization minimized, although it did not entirely eliminate, initial differences between the groups. (3) BP and other study data were collected in a single-blind design. Although the study participants were aware of the treatment they received, there were no differences between the groups in expectancy of beneficial outcome from the study. (4) Assessment at multiple follow-up visits (ie, monthly) demonstrated a consistent pattern of BP reductions. (5) The power was large enough to detect clinically significant BP differences between the groups. (6) The project was conducted in a primary care health center in an urban African American community, which enhances generalizability of findings to community settings. (7) Potential confounders or cointerventions such as changes in weight, self-reported exercise, diet, or antihypertensive medications were methodologically or statistically controlled.

This was one of the few randomized controlled trials to compare the relative efficacy of mental and physical-based techniques for stress reduction in hypertensive individuals within the same experimental setting^{25 55} and to our knowledge the only one with older African Americans. In addition, the utilization of two behavioral interventions in the same trial allowed each to serve as an active control for the other. Both TM and PMR engendered similar expectancies of positive outcome and required the same frequency and duration of instructional attention and daily home practice. Both interventions were taught by African American instructors from the community who were professionally trained and enthusiastic about their programs. Each was well received by the participants, as evidenced by high teacher ratings and compliance rates. Thus, the differences in BP-lowering effects between the two stress-reduction groups observed in this study were likely due to differences in efficacy between the two approaches rather than to nonspecific factors such as a placebo effect.

Therefore, these findings support the suggestion of heterogeneity of stress-reduction approaches; that is, different techniques produce different results.^{25 29} These findings do not support the conclusion of a recent trial that stress-reduction approaches in general lack efficacy in reducing BP.²³ The Trial of Hypertension Prevention (TOHP),²³ which used a multimodality stress-management program (including progressive relaxation) with high normal BP subjects, found no significant changes in BP compared with controls. Interestingly, in TOHP the stress-management intervention was associated with increased self-reported stress, which may explain its lack of efficacy in reducing BP. Also, two recent quantitative meta-analyses^{24 25} and the qualitative review of JNC V⁶ concluded that when clinical trials were well controlled, stress-reduction therapies generally showed little or no effect on lowering BP. However, none of the trials reported in these reviews included the TM program. In contrast, the current well-controlled trial, specifically comparing the efficacy of the TM technique with that of a widely used physical approach to relaxation, clearly showed their differential effectiveness in BP reduction over the short term.

The differential effectiveness of TM compared with PMR is consistent with the findings of prior meta-analyses in which the effects of TM practice on health-related outcomes, including mental and behavioral health (eg, arousal, anxiety, and smoking), were on average twice as large as other stress-reduction techniques, including PMR,^{28 30 56} and with a previous study of TM and relaxation in young adult African Americans.³⁵ The results found with the TM program in this trial with hypertensive African Americans were similar in magnitude to results of other trials of TM in predominantly white samples.³³ For example, in a randomized controlled trial in an elderly white sample, similar differential effects between TM and relaxation on systolic BP were observed.³¹

The reduction of 11/6 mm Hg with the TM program in this relatively short-term trial is also similar to the average reduction in BP reported in a meta-analysis of controlled trials of antihypertensive drug therapy of several years’ duration.⁹ If the results seen in this short-term feasibility study were maintained over at least 2 to 3 years, reductions in associated morbidity and mortality might be observed. For example, a meta-analysis of randomized trials of antihypertensive treatment in the elderly, with BP reductions similar to the present trial, found that cardiovascular mortality decreased 22%, stroke mortality 33%, and coronary mortality 26%.⁵⁷

The finding of similar reductions in the clinic and at home for systolic BP in both active intervention groups suggests that TM and PMR produced effects that generalized to the participants’ natural environment.^{58 59} The lack of significant change in home diastolic BP may have been due to the relative insensitivity of the electronic home monitoring device to diastolic BP or other limitations of the procedure. Home BP monitoring has been reported to systematically underestimate changes compared with clinic BP, especially diastolic BP.³⁹ Further investigation into out-of-clinic BP patterns with ambulatory BP monitoring may clarify this question.

Baseline differences between groups did not appear to account for the primary results of the study. First, all results were adjusted for age, the only statistically significant baseline difference between the groups. A second analysis also adjusted for the nonsignificant differences in weight, sex, and medication status, with no appreciable change in the results. Third, although there was a slightly larger proportion of medicated subjects in the control group, this could not account for the response differences between the groups because post hoc analysis indicated that medicated control participants’ BP decreased more during the trial than their nonmedicated counterparts. Therefore, the overrepresentation of medicated subjects in the EC group would have tended to decrease the differences in BP reduction between the active and control groups. Thus, the primary results may actually be more conservative than otherwise. Further studies comparing the antihypertensive responses of medicated and nonmedicated groups with larger sample sizes designed for this purpose may help to further clarify this question.⁶⁰ Finally, the two active treatment groups were generally similar to each other in baseline and demand characteristics of the intervention. Yet comparison of these active groups to each other on outcomes indicated that the TM subjects showed BP reductions about twice the magnitude of those of the PMR group despite their close matching.

The results with the active interventions of this trial, particularly TM, compare favorably with those of other lifestyle modification approaches in average BP reductions reported for weight loss, dietary sodium restriction, and aerobic exercise. For example, MacMahon et al⁶¹ summarized five randomized trials of weight reduction in hypertensive patients and reported that a mean weight loss of 9.2 kg (20 lb) was associated with a 6.3/3.1 mm Hg reduction in BP. In an overview of sodium reduction trials and BP, Cutler et al⁶² pooled results of 18 trials and found a weighted average decrease of 4.9/2.6 mm Hg in hypertensive subjects. Exercise training in hypertensive individuals has been associated with an average reduction of 5 to 6 mm Hg in systolic BP.⁶³

Regarding the potential mechanisms for the effects observed in this study, cross-sectional, case-control, and prospective studies in a variety of populations provide evidence for a role of chronic stress in the development, maintenance, and progression of hypertension that persists after controlling for age, weight, sodium and alcohol intakes; physical activity; and family history of hypertension.^{18 19 64} Proposed physiological mechanisms for the etiologic link between stress and hypertension include excessive sympathetic nervous system activation and cardiovascular reactivity.^{65 66} These may be coupled with other neuroendocrine alterations involving the hypothalamic-pituitary axis. In African Americans there is evidence that disproportionately high levels of psychosocial and environmental stress are associated with increased sympathetic tone, cardiovascular reactivity, peripheral vasoconstriction, and renally mediated sodium retention.⁶⁷ It may be that the cumulative effects of stress also contribute to the age-related increases in BP in African Americans that are not observed in traditional African societies.^{5 68} Although there is evidence for reduced sympathetic activation in TM practitioners,^{33 69} it has been proposed that the practice of TM may lower high BP through an integrated set of adaptive responses involving cortical, autonomic, neuroendocrine, and cardiovascular systems. These mechanisms may be part of an integrated neurophysiological homeostatic response.^{29 33 51}

Although JNC V acknowledged that stress may contribute to the etiology of hypertension and that stress management is an "appealing concept," it concluded that the role of stress-reduction techniques in the treatment of hypertension has not yet been adequately demonstrated.⁶ However, the JNC did not report findings from previous studies including the TM program,^{31 32 33} nor did they have access to the results of the present trial. Furthermore, as discussed above, recent findings do not support the homogeneity assumption of earlier reviews but instead indicate heterogeneous responses for different stress-reduction techniques.^{28 29 30 31 56}

The use of an effective stress-reduction technique such as that described in this report either alone or in combination with other lifestyle modifications suggested by JNC could contribute several distinct advantages for clinical care. These might include reduced adverse side effects, improved quality of life, enhanced compliance, reduced health-care costs over the long term, and potential improvements in morbidity and mortality from cardiovascular diseases.^{29 31 70} The latter hypothesis is supported by reports that TM has been associated with substantially lower morbidity from heart disease and lower all-cause mortality.^{31 70} This may be related in part to simultaneous improvements in other cardiovascular risk factors, such as smoking, serum cholesterol, and alcohol abuse.^{29 56 71}

The approach of prevention and health promotion with behavioral stress reduction is concordant with cultural theories in African American psychology⁷² and recommendations for health empowerment in African American individuals and communities.⁷³ This approach is also consistent with current recommendations for cost-effective prevention and health promotion.^{74 75}

In conclusion, the results from the present short-term study suggest that stress reduction, particularly with the TM program, may be feasible and efficacious in treating mild hypertension in older African Americans. The findings of the current trial require confirmation from future controlled trials with longer-term intervention periods, larger subgroup sizes (for evaluation of the interaction of medication and treatment effects), and diverse ethnic samples to determine generalizability to other populations.

	Acknowledgments

 
This work was supported by grants from the Retirement Research Foundation (No. 88-95 and No. 88-96), Chicago, Ill, and the Lancaster Foundation, Bethesda, Md. Preparation of this manuscript was supported in part by National Institutes of Health grant 5R01HL-48107. The authors are grateful to the following individuals for their helpful advice and/or editorial comments: Brian Hofland, PhD; Paul Gelderloos, PhD; Norman Anderson, PhD; R. Keith Wallace, PhD; David Orme-Johnson, PhD; Robert Cooper, MD; and for technical assistance, Bruce Smith, Linda Heaton, and John Salerno, PhD.

	Footnotes

 
Preliminary portions of this study were presented at the Third International Conference on Race, Ethnicity and Health, Salvador, Bahia, Brazil, July 1991, and at the 52nd Annual Scientific Meeting of the American Psychosomatic Society, Boston, Mass, April 13-16, 1994.

Received December 21, 1994; first decision January 20, 1995; accepted July 10, 1995.

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