Treatment of Hypertension with Biofeedback and Relaxation ......Treatment of Hypertension with...

Treatment of Hypertension with Biofeedback andRelaxation Techniques

BERNARD L. FRANKEL.MD,* DALIJ. PATEL, MD, PHD, DAVIDHORWITZ,MD, WILLIAM T. FRIEDEWALD, MD, AND KENNETH R. GAARDER, MD,t

The present study describes a 16-week trial of the use of a combination of biofeedback andrelaxation techniques for the treatment of hypertension. Twenty-two hypertensive patientswere randomly allocated to one of three groups: (1) diastolic blood pressure feedback, elec-tromyographic feedback, and verbal relaxation; (2) sham blood pressure feedback; and (3) notreatment. For the 14 patients completing active treatment during an initial or crossover period,the average changes in blood pressure as measured outside the laboratory were minimal (0 / - Iand +1/0 mm Hg, supine and standing, respectively). Average blood pressure reduction in thelaboratory was no greater with active than with sham blood pressure feedback (-3/-2 vs.-51—2 mm Hg). One subject, however, after showing no change in blood pressure during shamfeedback, achieved pronounced and prolonged improvement following active treatment. Overallresults do not support the usefulness of these techniques as primary therapy in most hyperten-sives.

INTRODUCTION

Various behavioral and psycho-physiological techniques have been re-ported to reduce the blood pressure ofhypertensive patients, sometimes to animpressive degree. These techniques in-clude blood pressure feedback, transcen-dental meditation, relaxation training,

National Heart, Lung and Blood Institute, Na-tional Institutes of Health, Bethesda, Maryland20014.

*Present address: Department of Psychiatry,George Washington University School of Medicine,Washington, D.C. 20037.

tPresent address: Department of Psychiatry, Uni-versity of Texas Health Science Center, San Antonio,Texas 78205.

This research was presented in part at the Ameri-can Psychosomatic Society Annual Meeting, March25, 1977, Atlanta, Georgia, and the InternationalHypertension Congress, Bombay, October 8, 1977.

Address reprint requests to: Dali J. Patel, MD, PhD,National Institutes of Health, Building 10, Room5N204, Bethesda, Maryland 20014.

Received for publication August 8, 1977; revisionNovember 14, 1977.

and hypnosis, either alone or in combina-tion.

Benson et al. in 1971 (1), in the firstreport of the use of blood pressure feed-back in a study of essential hypertensives,found "meaningful" decreases of bloodpressure in five of the seven outpatientstreated with systolic blood pressure feed-back. In other studies of systolic bloodpressure feedback, Goldman et al. (2) andKleinman et al. (3) found significant de-creases in blood pressure between andduring laboratory sessions in outpatientsundergoing nine weekly training ses-sions; Kristt and Engel (4) were able toteach four of five hospitalized patients toboth raise and lower systolic pressureduring 3 weeks of daily training.

In studies with diastolic blood pressurefeedback, Miller (5) reported the reduc-tion of diastolic blood pressure from 97 to77 mm Hg in an intensively treated pa-tient with a cerebrovascular accident.Elder et al. (6, 7) significantly reduceddiastolic but not systolic blood pressure

276

0033-3174/78/0040-0276$01.75

Psychosomatic Medicine Vol. 40, No. 4 (June 1978)

Copyright * 1978 by the American PsychosoPublished by Elsevier North-Holland, Inc.

BIOFEEDBACK AND RELAXATION IN HYPERTENSION

in intensively treated hospitalized hyper-tensives, but were unable to achieve com-parable results with outpatients. Schwartzand Shapiro (8) found no reduction indiastolic blood pressure in six of sevenoutpatients. More recently, Surwit andShapiro (9) found no significant decreasesin blood pressure in any group when theycompared the antihypertensive effects ofcombined heart rate and systolic bloodpressure feedback with those of elec-tromyographic (EMG) feedback or ameditation-relaxation procedure.

In behavioral studies not employingblood pressure feedback, all investigatorsexcept Pollack et al. (10) reported en-couraging results. Patel and North (11),adding a combination of EMG and skinconductance feedback and yogic relaxa-tion exercises to ongoing drug treatment,impressively reduced blood pressure in17 outpatient hypertensives in compari-son with a matched control group. Taylpret al. (12), also working with patients re-ceiving antihypertensive drugs, showedthat a program of supplementary relaxa-tion training was more effective than sup-portive psychotherapy or drugs alone.Other studies have reported the bloodpressure lowering effectiveness of trans-cendental meditation (13-15), yoga (16),other kinds of relaxation (17-22), andverbal instructions (23) in patients withhypertension. However, most of thesestudies (Patel and North's being the out-standing exception) have lacked controlprocedures or other methodological fea-tures that would permit firm conclusionsto be drawn about the effectiveness of themethods of treatment.1

lSince the time this report was submitted for pub-lication a comprehensive review of this area hasbeen published by Shapiro et al. (34). This review ishighly recommended to the interested reader.

We present a study of the use of a com-bination of diastolic blood pressure feed-back and relaxation techniques for themanagement of hypertension. The studywas designed to give information aboutthe carryover of effects from practice ses-sions, the comparison of treatment withuntreated and sham-treated subjects,compliance with home practiceschedules, and the use of psychologicaltests to preselect responsive subjects.

METHODS

Subjects

Twenty-two outpatients with uncomplicated es-sential hypertension were studied. Characteristics ofthe patients are shown in Table 1. Each subject hadundergone a diagnostic evaluation of his hyperten-sion that included a urina'lysis, urine culture, in-travenous pyelogram, and serum electrolytes; addi-tional studies included plasma renin activity [12patients], aldosterone excretory rate [10], renogram[15], renal arteriogram [1], and vanilmandelic acidexcretion or plasma catecholamine levels [19]; noevidence of a primary etiology was found. Seven pa-tients continued preexisting diuretic therapythroughout, whereas 15 received no medications be-ginning at least 3 weeks before the study. All sub-jects were advised prior to giving written informedconsent that they might be randomized into a groupthat received no active therapy. Before beginning theexperimental period, each subject underwent the fol-lowing psychological tests; Minnesota MultiphasicPersonality Inventory, Zung Depression Scale,Eysenck Personality Inventory, Zuckerman MultipleAdjective Checklist, Jenkins Activity Scale, and theBarber Suggestibility Scale. The test results werelater correlated with responses to treatment.

Study Design

The sequence of study periods is shown in Fig.1A. Candidates for the study underwent an initialseries of eight blood pressure determinations over a6- to 8-week period. Those subjects showing aver-age diastolic blood pressure readings between 90and 105 mm Hg while they were supine were ran-

Psychosomatic Medicine Vol. 40, No. 4 (June 1978) 277

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-WEEKLY CLINIC BP's-

A. PROTOCOL I ' V///////A I V/M^/-•-BASELINE, 8 W K S - * - EXPERIMENTAL, 16 WKS

1. Active Ri (N=71,20 sessionsor 2. Sham DBP Fdbk IN=7>, 20 sessionsoi 3. No-Ri (N=SI, no sessions

* BP's used in calculating averages - 1 6 Wt tS—20 sessions

B. LAB SESSIONHOOKUP.

MONITOR10-15'

TALK10-15'

DBP FDBK30 Trials

20-25'

EMG FOBX15'

AUTOGENICTRAINING

10 15

PROGRESSIVERELAXATION

10-15'

UN-HOOK

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-BP's EVERY 2 MINUTES -

C. DBP FDBK TRIAL -30 HEARTBEATS- : & .

CUFF INFLATION2 SEC

\CUFF VERBAL

DEFLATION ENCOURAGE-1 SEC MENT

5 SEC

Fig. 1. Experimental protocol. A—sequence of base-line and experimental periods. B—events during atypical AT session. C—one of the trials of diastolic blood pressure feedback during a session of AT.

domly allocated to one of three protocols using a After completion of the 16-week period, seven pa-random number table with stratification based on tients in groups 2 and 3 elected to participate in thethe use or nonuse of diuretic therapy. The three AT protocol,protocols were:

1. Active Treatment (AT). Seven patients under-went a flexible combination of diastolic blood pres-sure feedback, frontalis EMG feedback, autogenictraining, and a progressive relaxation exercise dur-ing 20 laboratory sessions over 16 weeks. Individualtechniques were introduced in successive sessionsso that subjects were practicing all techniques by theseventh session (Fig. IB). They were also instructedto practice feedback, autogenic exercises, and relaxa-tion (via a tape) at home on a regular basis.

2. Sham Treatment (ST). Seven patients under-went 20 sessions over 16 weeks of sham or noncon-tingent blood pressure feedback arranged to conveya sense of success.

3. No Treatment (NT). Eight patients underwentweekly blood pressure determinations for 16 weekswithout other interventions or observations.

Laboratory Sessions

Each patient participating in the AT and ST pro-tocols was seated in a reclining chair in a quiet roomand was monitored as follows:

1. An arm cuff placed on one arm was used forautomatically monitoring blood pressure at 1- to2-min intervals via an Arteriosonde (Hoffman-LaRoche, Inc., Nutley, N. J.).

2. On the other arm, an arm cuff connected to theautomated system developed by Tursky et al. (24)was used for diastolic blood pressure feedback (Lex-ington Instrument Co., Waltham, Mass.).

3. Three disc electrodes taped to the clavicularareas and left forearm permitted electrocardiog-raphic monitoring.

4. Frontalis muscle EMG activity picked up by twoelectrodes taped to the forehead was conducted to a


BERNARD L. FRANKEL ET AL.

BIFS Model B-l EMG feedback system (Bio-Feedback Systems, Inc., Boulder, Colo.).

The sequence during a laboratory session of AT isshown in Fig. IB. Following a hookup period thesubject was left alone and monitored for 5 min. Theexperimenter then reentered, discussed the patient'scurrent life situation and progress, and in the case ofAT subjects, logged the daily home practice ques-tionnaires before leaving again. All subjects thenunderwent a blood pressure feedback procedure fol-lowed by EMG feedback and autogenic and relaxa-tion training. During a laboratory session of ST asimilar sequence for hookup and pretreatment dis-cussion was followed. Treatment consisted of simu-lated (noncontingent) feedback. EMG feedback andautogenic and relaxation training were omitted.

Blood Pressure Feedback. Diastolic blood pres-sure feedback (Fig. 1) was performed using the au-tomated blood pressure measuring device. The armcuff was automatically inflated to a constant pres-sure near the diastolic level for periods of 30 heart-beats. A microphone over the distal brachial arterypicked up Korotkoff sounds when diastolic bloodpressure was below cuff pressure.

In the AT session an electronic coincidence cir-cuit activated a sound and a light signal wheneverthe R wave of the EKG pickup was followed by aKorotkoff sound. These signals informed the patientof each heartbeat associated with a diastolic pressurebelow cuff pressure. He was encouraged to increasethe number of feedback signals and thereby to lowerhis blood pressure. This device was programmed toincrease the cuff pressure by 3 mm Hg on the nexttrial if the percentage of heartbeats followed by aKorotkoff sound was below 25% (i.e., the task wastoo difficult) and to decrease the cuff pressure by 2mm Hg if the preceding percentage exceeded 75%(i.e., the task was too easy). In addition to receivingbeat-by-beat information, the patient was informedat the end of each trial of the percentage of beats withdiastolic pressure below cuff pressure, was givenappropriate verbal reinforcement, and was informedwhether the next trial would be easier or more dif-ficult. During a typical session a subject underwent30 trials each of 30-beats duration and with an inter-trial interval of approximately 5-10 sec.

For the ST group, advantage was taken of the factthat disconnecting the microphone input jack fromthe console of the device resulted in a sound andflash of light with every heartbeat. During sham tri-als, the cuff was inflated to 10 mm Hg below the

base-line diastolic blood pressure and the mic-rophone input jack was repeatedly disconnected(sound and light on) and reconnected (sound andlight off) manually to give a predetermined percen-tage of feedback signals during the 30 heartbeats ineach of 20 trials. This percentage was varied fromtrial to trial but the patient was given an overallsense of success by causing signals for more thanhalf of the beats in approximately three-quarters ofthe trials. The actual scores and the sequence of theirpresentation were varied systematically from sessionto session in order to minimize the possibility of thepatient's discovering that he was in the sham feed-back group.

Frontalis EMG Feedback. AT patients receivedtraining in relaxation of the frontalis muscle viafrontalis EMG feedback, as described by Budzynskiand Stovya (25). The level of EMG activity of thismuscle was relayed to the patient as a continuoustone whose frequency varied directly with the levelof muscle tension. At the conclusion of each of ten64-sec trials (separated by 20-sec pauses), the patientwas given a score based on the integrated EMG out-put of the preceding trial. The patient was instructedto attempt to decrease the frequency of the soundand to lower the score and thus relax the frontalismuscle.

Autogenic and Relaxation Training. The AT pa-tients also received autogenic training as describedby Luthe (26); this is a form of autosuggestion inwhich the subject thinks repetitively of simple,standard phrases emphasizing bodily sensations as-sociated with relaxation (e.g., "my right arm isheavy"). These are introduced in a progressive se-quence allowing for growth in the subject's skillwith practice. AT patients practiced the autogenicexercises for about 10 to 15 min. After a 3- to 5-minpause, the therapist guided the patient through a10- to 15-min exercise utilizing the progressive re-laxation technique described by Pascal (27). Towardthe end of this, suggestions were given to the pa-tient about enhancing responses by practicing athome and applying the techniques during daily ac-tivities.

Home Practice. AT patients were asked to prac-tice the autogenic exercises for 5 to 8 min three timesdaily and the relaxation techniques of Wolpe andLazarus (28) for 15 to 20 min once every other dayusing a series of cassette tapes (available from In-

282 Psychosomatic Medicine Vol. 40, No. 4 (June 1978)


structional Dynamics, Inc., Chicago, II.). On the in-tervening days when not scheduled to listen to thetapes, they practiced frontalis muscle relaxation (viaa portable EMG feedback unit built at the NIH) oncedaily for 20 min for the first 4 weeks at the AT periodand diastolic BP feedback (utilizing the Parke DavisBPI 2200 sphygmomanometer) twice daily for 10min for the next 12 weeks. Each day, AT patientsfilled out a brief questionnaire designed to enhancemotivation and monitor home practice. The com-pleted questionnaires were brought to the laboratoryfor each session and discussed briefly. The ST pa-tients were not instructed in any home practicemaneuvers.

Therapists

The two therapists (B.L.F. and D.J.P.) saw approx-imately equal numbers of patients in the AT and STgroups. They monitored one another and followedset procedures to minimize differences in technique.Each therapist also filled out a standard form at eachAT session on which he rated average amount ofpractice, subjective reactions and attitudes of the pa-tient, and tension-inducing potential of externalevents in the patient's life.

Blood Pressure Monitoring

The means of the three blood pressure determina-tions taken by the Arteriosonde before and afterblood pressure feedback, EMG feedback, and the re-laxation exercises were used to assess the changes inpressure associated with each of these laboratoryprocedures.

The persistence of treatment effects were esti-mated from recordings of blood pressure and pulsethat were made weekly in a special room by the samenurse (who was blind to the patient's experimentalstatus); these recordings either preceded a laboratorysession or were on a different day. Blood pressurewas measured three times by the arm cuff methodafter subjects were supine for 8 min and once after 2min of standing. Subjects were instructed to relaxgenerally but not to specifically practice their tech-niques during these blood pressure observations. Foreach subject, the means of the last six visits in thebase-line and experimental periods were comparedand significance was computed using the t-test (seeTable 1).

RESULTS

Clinic Measurements

Average blood pressure of a group of 14hypertensive subjects (7 AT; 4 ST and 3NT after crossover to AT) did not changesignificantly during a 4-month programthat combined diastolic blood pressurefeedback, EMG feedback, and verbal re-laxation techniques; comparison of themean values during the last six visits ofthe pretreatment and treatment periodsrevealed a decrease of 0 / - 1 mm Hg(systolic/diastolic) while subjects weresupine and an increase of +1/0 mm Hgwhen subjects were standing. Mean val-ues for individuals and subgroups areshown in Tables 1 and 2. These valueswere obtained by an independent monitoroutside of the training laboratory andwere intended to measure the patient'sblood pressure independent of any possi-ble laboratory effects.

One patient (No. 10, Table 1) showed aclinically and statistically significant (P<0.05) drop in blood pressure during ac-tive treatment (16 /10 and 6 /4 mm Hg insupine and standing postures, respec-tively), whereas she showed inconsequen-tial changes during a prior period of shamblood pressure biofeedback. She achievedfurther blood pressure reduction during18 months of subsequent followup;weekly measurements in the final 6 ofthese months revealed further decreasesin blood pressure of 3 /4 and 8 /0 mm Hg tomean levels of 124 /81 and 119 /84 (supineand standing, respectively). Smaller de-creases (P> 0.05) in blood pressure werenoted for Subjects 6 and 7, but theseresembled the changes in Subjects 8and 12 who underwent sham blood pres-sure biofeedback and were comparable in


BERNARD L. FRANKEL ET AL

TABLE 2. Blood Pressure Measurements during the Final Six Weekly Visits to the Clinic in the Baseline

and Experimental Periods

Croup

AT Primary (N = 7)

AT Crossover (N=7)

ST(N = 7)

NT (N = 8)

Observation

period

Baseline

Active Rx

Sham or no Rxc

Active Rx

Baseline

Sham Rx

Baseline

No Rx

Supine

SBPb

148(4.9)

151 (6.4)

154(6.0)

151 (6.4)

150(7.6)

149 (6.8)

147(4.6)

152 (4.6)

DBP<>

95(1.9)

96 (3.0)

94(1.1)

91 (1.5)

95 (1.9)

93(1.9)

94 (0.7)

95(1.1)

Standin

SBP

147(6.0)

149(7.6)

156(7.9)

157 (7.9)

150(9.8)

149 (7.6)

154(7.1)

157 (4.9)

ga

DBP

102 (2.6)

103 (3.0)

103 (1.5)

102 (3.0)

102 (1.9)

101 (1.5)

103 (1.4)

105 (1.1)

a Mean (SEM); mm Hg.bSBP = systolic blood pressure; DBP = diastolic blood pressure.c Note that for AT crossover patients, the active treatment data are compared to the data of the immediately

preceding final 6 weeks of the sham- or no-treatment protocol rather than to that of the baseline period.

magnitude to the rises in pressure ex-perienced by Subjects 1, 2, and 4. Twosubjects (Nos. 12 and 19) in the crossoveractive treatment group were withdrawnand placed under drug therapy because ofrising levels of blood pressure.

Laboratory Training Sessions

Mean blood pressure levels in the train-ing laboratory at the start of sessionsshowed no significant trend during the4-month course of training (Table 3). Av-erage results in the laboratory were simi-lar to independent observations in theclinic (Table 2), although the correlationfor individual patients was often poor. Pa-tients differed in their ability to lowerdiastolic blood pressure during AT bloodpressure feedback sessions and could bedivided into two groups: those able to re-duce their average diastolic pressure (12patients) and those who increased theiraverage diastolic pressure (2 patients, Nos.2 and 4). Average changes during the lastsix sessions in pressures were —41-3mm Hg for the first group and -1 /5 mm

Hg for the second (-31-2 overall); theseeffects had usually receded by the timethe subjects left the laboratory. Subject10, who achieved the greatest averageblood pressure reduction ( - 6 / - 5 mmHg) during blood pressure feedback, alsohad the most convincing long-term ef-fects on blood pressure; however, shealso had the greatest response [—71—5mm Hg) during her earlier sessions ofsham blood pressure feedback. The sevenpatients who underwent sham bloodpressure feedback reduced blood pres-sure during the final six sessions (-51—2mm Hg) as effectively as subjects whounderwent authentic training. The use ofEMG feedback and relaxation exercises inthe AT patients yielded no blood pres-sure reduction on the average beyondthat associated with blood pressure feed-back.

Home Practice

Analyses of the daily logs of the 14 pa-tients who completed the program of ac-tive treatment revealed a 91% average



TABLE 3, Initial Blood Pressure Measurements in the Laboratory during the First Six and Final SixSessions

Croup

AT Primary (N = 7)AT Crossover (N = 7)ST(N = 7)

Sessions 1-6a

SBPb

154 (6)154(9)143 (11)

DBPb

101 (4)94(4)92(6)

Sessions 15-20a

SBP

150(7)151 (8)148(7)

DBP

98(4)94(3)93(4)

a Mean (SEM); mm Hg.b SBP = systolic blood pressure; DBP = diastolic blood pressure.

level of compliance, i.e.; they reportedcarrying out 91% of scheduled homepractice assignments. The compliancelevels of the three patients with the mostfavorable blood pressure levels in theclinic were similar to those of most otherpatients. The patients also generally re-ported consistently utilizing their de-veloping relaxation skills in environmen-tal situations that had been specified asstressful in previous discussions with thetherapists.

Additional Findings

Toward the end of the program of activetreatment most of the 14 patients reportedan increased ability to relax and to copemore effectively with stressful situations.Similarly, 5 of the 7 patients who under-went only sham blood pressure feedbackreported feeling more relaxed, but did notreport increased skills in coping withspecific stresses. Five of the 14 patientscompleting the program of active treat-ment had been noted to have recurrentheadaches diagnosed as the muscle con-traction or tension type during their initialevaluation (Patients 6,8,11,15, and 17); allfive reported moderate to marked reductionin the frequency and severity of the head-aches. They, as well as the other subjects,underwent frontalis EMG feedback trainingas part of the active treatment protocol.

Four of these 5 patients had previouslycompleted the sham or no-treatment pro-tocols but reported no change in theirheadaches. Prospective psychological test-ing revealed no correlation of test resultswith the outcome of the blood pressurestudies.

DISCUSSION

In this study, a combination of diastolicblood pressure feedback, EMG feedback,and verbal relaxation techniques usuallyfailed to effect a clinically meaningful re-duction in blood pressure in a group ofpatients with mild essential hypertension.The disappointing results applied both tolaboratory training sessions, where reduc-tion in blood pressure tended to be small inmagnitude and transitory; and to observa-tions in the clinic, where little prolongedbenefit was found. The results from onepatient do demonstrate, however, that anoccasional patient can achieve useful ef-fects on blood pressure with the techni-ques employed; Patient 10 showed sus-tained, pronounced reduction of bloodpressure to normal levels. Other patients,however, showed increase in blood pres-sure that in two cases required withdrawalfrom crossover studies.

These results resemble those of



Schwartz and Shapiro (8J and Surwit andShapiro (9) who found no reduction in theblood pressure of hypertensives undergo-ing diastolic and systolic blood pressurefeedback, respectively. Miller (29], al-though he achieved striking blood pres-sure reduction in an intensively trainedpatient with a cerebrovascular accident,had little success with 27 other hyperten-sive patients who underwent diastolicblood pressure feedback training; even inthe patient with pronounced blood pres-sure reduction, drug therapy had to be re-sumed when blood pressure rose in re-sponse to emotional stresses. In contrast tothese studies, Benson et al. (1) and Kristtand Engel ,(4) using systolic feedback andothers using relaxation techniques appearto have achieved favorable results (11-22).

The average decreases in blood pressureduring laboratory {paining sessions in thisstudy were 3 /2 mm Hg (systolic /diastolic)for blood pressure feedback and 5 /2 mmHg during sham feedback; these ap-proached the 4/4 mm Hg (sys-tolic/diastolic) obtained by Kleinman etal. (3) and the 5 mm Hg systolic of Ben-son etaL (1) but were less than the 7.0 mmHg systolic achieved by Goldman et al. (2)and the 9 mm Hg systolic of Kristt andEngel (4). The failure to find useful car-ryover of effects on blood pressure in thisstudy presumably reflected at least in partthe small reductions in pressure achievedduring laboratory sessions. It is possiblethat a more intensive training regimenwould have increased our success but sucha program would have made compliancemore uncertain and would have been im-practical for most of the subjects. The morefrequent use of antihypertehsive medica-tions concurrently with behavioraltherapies in other studies may be an addi-tional factor explaining differences fromthe presentstudy. Our efforts to design and

adhere to a protocol having strict controlprocedures may have interfered with max-imizing clinical efficacy and in retrospectmay have been important in some patients,failing to achieve meaningful blood pres-sure reductions For example, in the4-month active treatment period, proce-dures were introduced on a strict schedulewithout sufficiently specific criteria of pa-tient readiness for them. Tailoring the ex-posure to specific techniques to the effec-tiveness of their utilization and havingsessions as necessary devoted solely todiscussing and resolving difficulties inacquisition of skills might have facilitateda positive clinical response in some pa-tients. Incorporating such clinical flexibil-ity as part of a rigorously designed pro-tocol, however, appears to be a formidablechallenge but one worthy of careful con-sideration in future studies.

This study did incorporate several de-sirable elements of design that were com-monly absent in prior studies (Table 4).The practice of measuring blood pressurein a setting distinct in time, place, andpersonnel from the training laboratory andthe precaution of instructing patients notto practice blood pressure lowering tech-niques during blood pressure measure-ments were intended to permit more validevaluation of the carryover of effects onblood pressure. Only the studies of trans-cendental meditation by Benson et al. (13,14) and by Pollack et al. (10) appear to haveexplicitly utilized these precautions..Without them, it is possible that bloodpressure lowering was conditioned tospecific settings and occurred only whenblood pressure lowering maneuvers wereactually practiced. [This may partially ac-count for the results in the study of Pateland North (11).] In the absence of meas-urements of carryover of effects, a patientand his physician might incorrectly as-



sume that the patient was protected andmight forego necessary medical therapy.

The long baseline (6-8 weeks) in thisstudy was an uncommon feature of previ-ous studies. Many of the patients initiallyreferred to as hypertensives in this studywere rejected because their blood pressurefell to and remained at normotensivelevels during base-line observations. Instudies with a short base-line period andno control group this spontaneous fallmight have been interpreted as a result oftherapy. This study utilized both sham andno-treatment control groups' as aids in dif-ferentiating nonspecific from treatment ef-fects. Only the studies of Patel and North(11) and Taylor et al. (12) were comparableto this study in having equivalent numbersand frequency of active treatment arid con-trol sessions. However, Patel and North'scontrol procedure, nonspecific relaxation,is unlikely to have been as convincing topatients as the combination of feedbackand yoga which was employed for treat-ment and would not be preferred to thenoncontingent feedback used in thisstudy. Pronounced reductions in bloodpressure have been reported in response tocredible placebo treatments (30) and toverbal directional instructions (23); inview of these, nonspecific relaxation or notreatment do not appear to be the optimalcontrol procedures for assessing the clini-cal specificity of complex psychophys-iologic therapies, biofeedback in particu-lar. One needs to have a sham treatmentgroup.

Finally, the systematic assessment ofpatient compliance with home practiceschedules has been generally absent inprevious studies with the exception of thework of Taylor et al. (12) and Kristt andEngel (4), the latter innovatively utilizingthe daily mailing of postcards from hometo laboratory Studies utilizing even rela-

tively simple drug regimens have de-scribed difficulties in achieving adherenceto treatment schedules (31). The high levelof compliance reported by patients in thisstudy may have reflected the special con-ditions of an experimental situation; simi-lar compliance might be more difficult toachieve under usual conditions of prac-tice. There was no obvious correlation be-tween reports of home practice and effectson blood pressure.

Although the active and sham treatmentprotocols were similar with regard to ef-fecting average within-session or sus-tained blood pressure reductions, it wasonly the former that was associated withimprovement in other symptoms such astension headache and with the one in-stance of pronounced sustained decreasein blood pressure. On the other hand, onlyin association with active treatment didsome patients have significant blood pres-sure increases requiring interruption of ac-tive treatment (Patients 12 and 19); forthese patients the frustration experiencedin unsuccessfully coping with the de-mands of the blood pressure and EMGfeedback procedures may have contri-buted to a pressor effect, whereas the shamblood pressure feedback may have beenless demanding because it conveyed theappearance of moderate success.

In conclusion, our overall findings donot support the practical usefulness of thecombination of blood pressure feedbackand relaxation techniques that was inves-tigated. Even in other studies that reportedsubstantial within-session reduction ofblood pressure with nondrug therapiesthere was usually little indication of car-ryover of effects to other settings or tostressful situations. The hypertensive pa-tient requires continuous control of hisblood pressure but often does not have theincentive that comes from achieving


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symptomatic relief. Behavioral techniques We are grateful to Dr. Donald L. Fry forfor the treatment of hypertension, even if his support throughout this study; to Drs.effective, have the disadvantage of being Edward Freis, Joseph Franciosa, /. Christ-time consuming and requiring exceptional ian GiJJin, and Fred Hegge for the use ofmotivation. If used, they are best intro- their laboratory facilities and equipment;duced as supplements to management to David Mott, William Anixter, Thomaswith drugs, with care that they do not di- Talbot, and Angela Moore for technicalvert a patient from effective medical assistance; and to Marian Fisher /or assis-therapy. tance in the statistical analyses.

REFERENCES

1. Benson H, Shapiro D, Tursky B, Schwartz GE: Decreased systolic blood pressure through operantconditioning techniques in patients with essential hypertension. Science 173:740-741, 1971

2. Goldman H, Kleinman KM, Snow MY, Bidus DR, Korol B: Relationship between essential hypertensionand cognitive functioning. I: Effects of biofeedback, Psychophysiology 12:569-573, 1975

3. Kleinman KM, Goldman H, Snow MY, Korol B: Relationship between essential hypertension and cogni-tive functioning. II: Effects of biofeedback generalize to non-laboratory environment. Psychophysiology14:192-197, 1977

4. Kristt DA, Engel BT: Learned control of blood pressure in patients with high blood pressure. Circulation51:370-378, 1975

5. Miller NE: Learning of glandular and visceral responses: postscript, in Current Status of PhysiologicalPsychology: Readings (edited by D Singh and CT Morgan). Monterey, Calif., Brooks/Cole, 1972, pp.245-250

6. Elder ST, Ruiz, ZR, Deabler HL, Dillenkoffer RL: Instrumental conditioning of diastolic blood pressure inessential hypertensive patients. I Appl Behav Anal 6:377-382, 1973

7. Elder ST, Eustis NK: Instrumental blood pressure conditioning in out-patient hypertensives. Behav ResTher 13:185-188, 1975

8. Schwartz GE, Shapiro D: Biofeedback and essential hypertension: current findings and theoreticalconcerns. Semin Psychiatry 5:493-503, 1973

9. Surwit RS, Shapiro D: Biofeedback and meditation in the treatment of borderline hypertension. Paperpresented at the annual meeting of the American Psychosomatic Society, Pittsburgh, March 1976

10. Pollack AG, Weber MA, Case DB, Laragh JH: Limitations of transcendental meditation in the treatment ofessential hypertension. Lancet 1:71-73, 1977

11. Patel D, North WRS: Randomized controlled trial of yoga and biofeedback in management of hyper-tension. Lancet 2:93-95,1975

12. Taylor CB, Farquhar JW, Nelson E, Agras S: Relaxation therapy and high blood pressure. Arch GenPsychiatry 34:339-342, 1977

13. Benson H, Rosner BA, Marzetta BR, Klemchuk HP: Decreased blood pressure in pharmacologicallytreated hypertensive patients who regularly elicited the relaxation response. Lancet 1:289-291, 1974

14. Benson H, Rosner, BA, Marzetta BR, Klemchuk HP: Decreased blood pressure in borderline hypertensivesubjects who practiced meditation. J Chron Dis 27:163-169, 1974

15. Blackwell B, Hanenson I, Bloomfield S, Magenheim H, Gartside P, Nidich S, Robinson A, Zigler R:Transcendental meditation in hypertension: individual response patterns. Lancet 1:223-226, 1976

16. Datey KK, Deshmukh SN, Dalvi CP, Vinkekar SL: A yogic exercise in the management of hyperten-sion. Angiology 20:324-333,1969

17. Deabler HL, Fidel E, Dillenkoffer RL, Elder ST: The use of relaxation and hypnosis in lowering highblood pressure. Am J Clin Hypn 16:75-83,1973


BIOFEEDBACKAND RELAXATION IN HYPERTENSION

18. Brady JP, Luborsky L, Kroti RE: Blood pressure reduction in patients with essential hypertension throughmetronome-conditioned relaxation: a preliminary report. Behav Ther 5:203-209, 1974

19. Stone RA, DeLeo J: Psychotherapeutic control of hypertension. N Engl J Med 294:80-84, 197620. Jacobson E: Variation of blood pressure with skeletal muscle tension and relaxation. Ann Int Med

12:1194-1212, 193921. Case DB, Fogel DH, Pollack AA, Laragh JH: Acute and long-term effects of self-hypnosis in hyperten-

sive patients. Clin Res 25:212A, 197722. Montgomery DD, Love WA, Moeller TA: Effects of electromyographic feedback and relaxation training on

blood pressure in essential hypertensives. Paper presented l\. the Biofeedback Research Society AnnualMeeting, Colorado Springs,-Colo., 1974

23. Redmond DP, Gaylor MS, McDonald RH, Shapiro AP: Blood pressure and heart-rate response to verbalinstruction and relaxation in hypertension. Psychosom Med 36:285-297, 1974

24. Tursky B, Shapiro D, Schwartz GE: Automated constant cuff pressure system to measure average systolicand diastolic blood pressure in man. IEEE Trans Biomed Eng 19:271-275, 1972

25. Budzynski TH Stoyva JH: An instrument for producing deep muscle relaxation by means of analoginformation feedback. J Appl Behav Anal 2:231-237, 1969

26. Luthe W: Autogenic Therapy. New York, Grune & Stratton, 196927. Pascal GR: The effect of relaxation upon recall. Am J Psychol 62:32-47, 194928. Wolpe j , Lazarus AA: Behavior Therapy Techniques, New York, Pergamon Press, 196929. Miller NE: Clinical .applications of biofeedback: voluntary control of heart rate, rhythm, and blood

pressure, in New Horizons in Cardiovascular Practice (edited by HI Russek). Baltimore, Md., UniversityPress, 1975, pp. 239-249

30. Goldring W, Chasis H, Schreiner GF, Smith HW: Reassurance in the management of benign hypertensivedisease. Circulation 14:260-264, 1956

31. Wilber JA, Barrow JG: Reducing elevated blood pressure: experience found in a community. Minn Med52:1303-1306, 1969

32. Shoemaker JE, Tasto DL: The effects of muscle relaxation on blood pressure of essential hypertensives.Behav Res Ther 13:29-43, 1975

33. Blanchard EB, Young LD, Haynes MR: A simple feedback system for the treatment of elevated bloodpressure. Behav Ther 6:241-245, 1975

34. Shapiro AP, Schwartz GE, Ferguson DCE, Redmond DP, Weiss SM: Behavioral methods in the treatmentof hypertension: a review of their status. Ann Int Med 86:626-636, 1977


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