BRIEF COMMUNICATIONS. KEY WORDS: Ambulatory blood pressure monitoring, placebo effect, antihypertensive drug trials.

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1 AJH 1995; 8: BRIEF COMMUNICATIONS Lack of Placebo Effect on Ambulatory Blood Pressure Giuseppe Mancia, Stefano Omboni, Gianfranco Parati, Antonella Ravogli, Alessandra Villani, and Alberto Zanchetti Several studies have reported that, at variance with clinic blood pressure, ambulatory blood pressure is not reduced by treatment with placebo. However, this evidence has usually been obtained in small groups of subjects and no data are available from a larger sample of patients. To address this issue we have analyzed data from 116 outpatients involved in placebo-controlled studies on antihypertensive treatment. The patients were studied before and at the end of a 6- to 8-week period of placebo. In all patients, blood pressure was measured by sphygmomanometry and over the 24 h by automatic ambulatory monitoring. Administration of placebo was accompanied by a significant reduction in systolic and diastolic clinic blood pressure ( and -4.4 ± 0.6 mm Hg, respectively; P <.01), but not in 24-h, daytime and nighttime blood pressure. Hourly systolic and diastolic blood pressure profiles were virtually superimposable in the two different periods, except for the first 4 h, in which S everal studies have reported that, unlike clinic blood pressure, 24-h average blood,pressure is devoid of a placebo effect 1-3 and may thus allow for studying the efficacy of antihypertensive drugs with a greater power and a simpler study design. However, virtually all studies reporting a lack of Received July 25, Accepted November 15, From the Cattedra di Medicina Interna and Clinica Medica (AZ), Universita di Milano and S. Gerardo Hospital, Monza; and Centro Auxologico Italiano (GP, AR), Milano, Italy. Address correspondence and reprint requests to Professor Giuseppe Mancia, Centro di Fisiologia Clinica e Ipertensione, Via F. Sforza Milano, Italy. systolic blood pressure was slightly but significantly lower during than before placebo (149.5 _ 1.2 v ± 1.2 mm Hg; P <.05). These results provide a large database indicating that 24-h average blood pressure is not reduced by placebo, thus it is not necessary to include a placebo control group in antihypertensive drug studies in which ambulatory blood pressure monitoring is employed. A small placebo effect occurs, however, in the first hours of ambulatory monitoring. This may lead to a slight overestimation of the peak blood pressure effect of a drug and an underestimation of its trough-to-peak ratio if placebo correction of the data is not made or if the first part of ambulatory blood pressure monitoring is not excluded from data analysis. Am J Hypertens 1995;8: KEY WORDS: Ambulatory blood pressure monitoring, placebo effect, antihypertensive drug trials. placebo effect on ambulatory blood pressure involved a small number of patients. Furthermore, in one small study placebo administration was associated with a slight blood pressure reduction during the first few hours of ambulatory blood pressure monitoring, suggesting that the placebo effect displays a dyshomogeneous distribution over the 24 h. 3 In the past few years we have employed ambulatory blood pressure monitoring in a number of studies on the blood pressure effect of antihypertensive drugs. 4-7 Because of their double-blind placebocontrolled design these studies have also allowed us to collect a large database on ambulatory blood pressure values before and during placebo administration 1995 by the American Journal of Hypertension, Ltd /95/$ (94)00250-F

2 312 MANCIA ET AL AJH-MARCH 1995-VOL. 8, NO. 3 and to provide a large body of evidence on this issue. This evidence is reported in the present paper. METHODS Subjects The present study includes 116 white outpatients of either gender and of variable age, all with mild or moderate essential hypertension. In each patient, the following conditions were excluded: 1) a history or objective evidence of myocardial infarction; 2) diabetes mellitus; 3) body mass index > 30 kg/m2; 4) atrial fibrillation or another major arrhythmia; 5) history of excessive alcohol consumption; 6) another major cardiovascular or noncardiovascular disease; and 7) previous experience with ambulatory blood pressure monitoring procedures. The outpatients (39 women and 77 men; age years, mean - SEM) underwent a 3- to 4-week period of washout from previous antihypertensive treatment, followed by administration of placebo for 6 to 8 weeks. In all patients, placebo consisted of a single tablet administered according to a double-blind parallel group (n = 77) or crossover (n = 39) design with the administration of active antihypertensive treatment. Each patient agreed to participate in the study after explanation of its nature and purpose. All studies were approved by the Ethical Committee of our institution. Blood Pressure Measurements Blood pressure was measured by a doctor using a mercury sphygmomanometer, with the patient in the sitting or supine position. The 1st and 5th Korotkoff sounds were used to identify systolic and diastolic values, respectively. Three measures were obtained within a 10-rain period and the average of the three values was taken as the "clinic" systolic and diastolic blood pressure. Blood pressure was also measured over 24 h by a Spacelabs device of the or type (Spacelabs Inc, Redmond, WA), s which was programmed to provide blood pressure readings at 15- min intervals during the day (from 6 AM to midnight) and at 15- to 20-min intervals during the night (from midnight to 6 AM). Ambulatory blood pressure monitorings were performed on working days. Patients were asked to attend their usual activities during the monitoring period but also to stop and extend the arm involved in the automatic blood pressure measurement at the time of the cuff inflation. In each patient, clinic and ambulatory blood pressures were measured twice, ie, at the end of the washout period and at the end of placebo administration. Clinic blood pressures were taken between 9 AM and 10 AM. Ambulatory blood pressure monitoring started immediately after the clinic blood pressure measurements. During placebo administration the placebo tablet was taken in between the two measuring procedures. Thus clinic blood pressures were collected at trough from the placebo assumption of the previous day. Data Analysis Ambulatory blood pressure data were analyzed to obtain mean systolic and diastolic values for the 24 h, the daytime, and the nighttime. Mean values were obtained also for 4-h periods and for each hour of the 24 h. Ambulatory heart rate data were analyzed in a similar fashion. Correlations were also sought between baseline values and changes induced by treatment. Individual values were summed to obtain averages (- SEM) for the two different conditions. The differences were tested by the Student's t test for dependent samples. The minimal level of statistical significance was set at P <.05. RESULTS As shown in Figure 1, compared to the preplacebo values, administration of placebo for 6 to 8 weeks was accompanied by a significant reduction in clinic systolic and diastolic blood pressure. Twenty-four-hour average, daytime average, and nighttime average blood pressures were significantly lower than clinic blood pressures. In none of the three instances, however, was the average ambulatory blood pressure value significantly lower during than before placebo administration. Subjects with higher baseline ambulatory systolic blood pressures tended to have slightly lower ambulatory blood pressure values during than before placebo but the values of the correlations were low (r never greater than 0.33) and diastolic ambulatory blood pressures did not display a similar trend (Figure 2). Clinic and ambulatory heart rate values were superimposable before and during placebo (Ta- mmh( O 60 I 4{.41" I ~ I 41.-II- I r'~"~ L-I-~J I {- ~ 1 I N.41- Clinic 24h Day Night FIGURE 1. Clinic blood pressure and 24-h, daytime, and nighttime average systolic and diastolic blood pressure values at baseline (open bars) and during administration of placebo (striped bars). Data are shown as mean +- SEM from 116 hypertensive patients. Asterisks refer to statistical significance of the differences between baseline and placebo or baseline clinic and ambulatory values (P <.01).

3 AJH-MARCH 1995-VOL. 8, NO. 3 PLACEBO AND AMBULATORY BLOOD PRESSURE h SBP before P (mmhg] 24h DBP before P (mmhg) ~ 40 60, 80, 100,, 120, +40 ' ' ' ' +40 s a. +20 a. +20 s p i o.. i o :.qnq'b" ~- -2o :.~.".;:s & -2o ' "d'-- (n o,~ -4o -~ -4o Dey SBP before P (mmhg Day DBP before P (rnmhg} ~) 1!0. 130,. 150,. 170, ~ ,. 80,. 100,, 120, 0 ; o I.. ~.. ~ ~.-.-.; o.~-.~j~. -zo.i ; ' -2o %'" (n j a ~' -40 ] = -40 Night SBP before P (mmhg) Night DBP before P (mmhg) ~ , i I i i i I i I i ~ +4o ',....,, ~ +40 t - O. +20 m a. +20"1 ~qb to 1,... o "" ~, 1.,;,'z" -, ~... cn ee 0-20 = -40 D -40 <l <1 FIGURE 2. Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) observed during placebo (P) plotted versus SBP and DBP values before P (baseline). Individual 24-h, daytime, and nighttime average blood pressures are from the hypertensive patients of Figure 1 (n = 116). ble 1). Lack of placebo effect on ambulatory blood pressures was similarly evident in men and women. Figure 3 shows the 24-h systolic and diastolic blood pressure profiles of the outpatients of Figure 1 as hourly average values. For diastolic blood pressure, TABLE 1. CLINIC AND AMBULATORY HEART RATE VALUES (BEATS/MIN) AT BASELINE AND DURING ADMINISTRATION OF PLACEBO IN 116 HYPERTENSIVE PATIENTS Clinic 24-h Daytime Nighttime Baseline Placebo Values are mean +- SEM. the values obtained during and before placebo were substantially superimposable. For systolic blood pressure, however, the initial hourly values after the beginning of the 24-h blood pressure monitoring (and assumption of placebo) were slightly lower during than before placebo, a similar phenomenon occurring during the few hours after the afternoon rest period, ie, around 6 PM. The preplacebo-placebo difference in systolic blood pressure during the first 4 h was statistically significant (Figure 4). DISCUSSION In our 116 essential hypertensive patients, administration of a daily placebo tablet for 6 to 8 weeks was accompanied by a significant reduction in clinic sys-

4 314 MANCIA ET AL AJH-MARCH 1995-VOL. 8, NO. 3 mmhg 145,oo] I hours i, i i, i, i,, i, ' i,, i,, J FIGURE 3. Hourly average systolic and diastolic blood pressure values at baseline (open circles) and during administration of placebo (closed circles) in the hypertensive patients of Figure 1. Data are shown as mean +- SEM, n = 116. tolic and diastolic blood pressure but by no significant alteration in 24-h average blood pressure. This confirms in a large database that 24-h average blood pressure is devoid of a placebo effect and that thus this measure can be used in studies on the efficacy of antihypertensive drugs without resorting to a placebo phase or a parallel placebo group. Our data also show that although daytime or nighttime average systolic and diastolic blood pressures were similar during and before placebo, a slight but mmhg "11" I i I I i i hours FIGURE 4. Ambulatory systolic and diastolic blood pressure values at baseline (open circles) and during administration of placebo (closed circles) in the hypertensive patients of Figure 1 (n = 116). Data are shown as mean values from six different subperiods of 4 h. Asterisk refers to statistical significance of the difference between baseline and placebo (P <.05). significant reduction in blood pressure occurred during placebo in the first few hours after the beginning of ambulatory blood pressure monitoring. This provides a large-scale confirmation of previous evidence, ie, that a placebo effect takes place in the earliest part of a monitoring period, presumably because of a transient alerting reaction to the first application of the device. 3 This effect, however, involves only systolic blood pressure and is too small in size (3.1 mm Hg) and limited in time (4 h) to cause any substantial alteration of 24-h or daytime average blood pressure. It may, however, cause a slight overestimation of the peak effect of an antihypertensive drug or drug regimen (if the peak effect occurs within the first 4 h) and may thus lead to underestimating the trough-to-peak ratio. Based on our results, this underestimation might be avoided if ambulatory blood pressure monitoring 1) is performed for 30 h and 2) the antihypertensive drug or drug regimen is administered after the first 4 h and these are exduded from data analysis. Finally, our findings also require some degree of caution, insofar as the patients included had mild essential hypertension, were largely middle-aged, and were treated for about 2 months. It is not known, therefore, whether the 24-h average blood pressure is also substantially devoid of a placebo effect in patients with hypertension of different severity and type, or in patients of different ages or treatment duration. This will have to be determined in separate studies. Indeed, in a study on systolic hypertension in the elderly 9 24-h average blood pressure was reduced after a median follow-up of 12 months under placebo. However, the reduction was much less than the concomitant reduction in clinic blood pressure, small in absolute figures, and absent after the first few months of placebo administration. This strenghtens our present conclusion that a placebo group may not be required, particularly for conventional studies on antihypertensive drugs, which usually last only weeks or months. REFERENCES 1. Gould BA, Mann S, Davies AB, et al: Does placebo lower blood pressure? Lancet 1981;ii: Dupont AG, van der Niepen P, Six RO: Placebo does not lower ambulatory blood pressure. Br J Clin Pharmacol 1987;24: Mutti E, Trazzi S, Omboni S, et al: Effect of placebo on 24-hour non-invasive ambulatory blood pressure. J Hypertens 1991;9: Mancia G, De Cesaris R, Fogari R, et al: Evaluation of the antihypertensive effect of once-a-day trandolapril by 24-hour ambulatory blood pressure monitoring. Am J Cardiol 1992;70:60D-66D. 5. Mancia G, for the Italian Verapamil Study Group: 24- Hour anfihypertensive effect of verapamil sustained re-

5 AJH-MARCH 1995-VOL. 8, NO. 3 PLACEBO AND AMBULATORY BLOOD PRESSURE lease 240 mg versus nitrendipine and enalapril in essential hypertension. High Blood Press 1993;2: Omboni S, Ravogli A, Fogari R, et al: Effects of once a-day fosinopril on 24 hour ambulatory blood pressure in mild and moderate essential hypertension. High Blood Press 1994;3: Zanchetti A, for the Italian Nifedipine GITS Study Group: Antihypertensive effects of nifedipine GITS on clinic and ambulatory blood pressures. High Blood Press 1994;3: Groppelli A, Omboni S, Parati G, et al: Evaluation of non-invasive blood pressure monitoring devices Spacelabs and versus resting and ambulatory 24-hour intra-arterial blood pressure. Hypertension 1992;20: Staessen JA, Thijs L, Clement D, et al., on behalf of the Syst-Eur Investigators: Ambulatory pressure decreases on long-term placebo treatment in older patients with isolated systolic hypertension. J Hypertens 1994;12:

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