Evaluation of a minimal-therapist-contact thermal biofeedback treatment program for essential hypertension

We compared a clinic-based regimen of 16 individual sessions (2 per week) of thermal biofeedback with a largely home-based regimen of 5 sessions (spread over 8 weeks) for the treatment of essential hypertension in patients who required at least two drugs to maintain control of blood pressure (BP). On the basis of the clinical end point of being successfully withdrawn from the second stage medication while BP remained under control, the clinic-based regimen (5 of 9) was superior (X<(1)=4.0,p<.05) to the home-based regimen (1 of 9). Internal analyses point to more frequently obtaining a hand temperature of at least 95° F by the office-based patients as possibly the reason for the difference.This research was supported by a grant from NHLBI, HL-27622.     

Patient Preferences and Willingness-To-Pay for a Home or Clinic Based Program of Chronic Heart Failure Management: Findings from the Which? Trial

Background

Beyond examining their overall cost-effectiveness and mechanisms of effect, it is important to understand patient preferences for the delivery of different modes of chronic heart failure management programs (CHF-MPs). We elicited patient preferences around the characteristics and willingness-to-pay (WTP) for a clinic or home-based CHF-MP.

Methodology/Principal Findings

A Discrete Choice Experiment was completed by a sub-set of patients (n = 91) enrolled in the WHICH? trial comparing home versus clinic-based CHF-MP. Participants provided 5 choices between hypothetical clinic and home-based programs varying by frequency of nurse consultations, nurse continuity, patient costs, and availability of telephone or education support. Participants (aged 71±13 yrs, 72.5% male, 25.3% NYHA class III/IV) displayed two distinct preference classes. A latent class model of the choice data indicated 56% of participants preferred clinic delivery, access to group CHF education classes, and lower cost programs (p<0.05). The remainder preferred home-based CHF-MPs, monthly rather than weekly visits, and access to a phone advice service (p<0.05). Continuity of nurse contact was consistently important. No significant association was observed between program preference and participant allocation in the parent trial. WTP was estimated from the model and a dichotomous bidding technique. For those preferring clinic, estimated WTP was ≈AU$9-20 per visit; however for those preferring home-based programs, WTP varied widely (AU$15-105).

Conclusions/Significance

Patient preferences for CHF-MPs were dichotomised between a home-based model which is more likely to suit older patients, those who live alone, and those with a lower household income; and a clinic-based model which is more likely to suit those who are more socially active and wealthier. To optimise the delivery of CHF-MPs, health care services should consider their patients’ preferences when designing CHF-MPs.     

Controlled evaluation of thermal biofeedback in treatment of elevated blood pressure in unmedicated mild hypertension

In the first of two studies, 42 unmedicated mild hypertensives completed either 16 sessions of thermal biofeedback (TBF) training for hand (7 sessions) and foot (9 sessions) warming or 8 weeks of monitoring BPs at home. There was a trend (p<.10) for more of those treated (57.1%) to have DBPs lower than 90 mm Hg than for those only monitoring BPs at home (33%). Analyses of clinic BP values from random zero sphygmomanometer measurements, from 24-hour ambulatory BP monitoring, and from home BP measurements made by the patient showed no advantage for treatment versus BP monitoring. Sixteen of the 21 patients in BP monitoring were later treated. Analyses of treatment effects across all treated subjects by gender revealed a significant (p=.02) decrease in DBP for treated female subjects (n=13) but not for males (n=24). In the second study the 22 initial treatment successes, that is, those whose DBP was below 90 mm Hg at posttreatment (59.4% of those who completed treatment), were randomized to an intensive follow-up (monthly visits for 6 months, then visits every two months) emphasizing regular home practice with an electronic TBF device or regular follow-up (visits every 3 months). Twelve of the 22 were still normotensive at 12 months. There were no differences at any point during the follow-up between the two conditions in success rate or BPs despite a numerical advantage in reported frequency of home practice by those in the intensive follow-up condition.This research was supported by a grant from NHLBI, HL-31189.     

Cardiovascular Risk of Resistant Hypertension: Dependence on Treatment-Time Regimen of Blood Pressure–Lowering Medications

In resistant hypertension, ingesting one or more blood pressure (BP)-lowering medications at bedtime is associated with significant reduction of sleep-time BP, a sensitive prognostic marker of cardiovascular disease (CVD) risk. This randomized trial investigated if bedtime therapy with at least one hypertension medication exerts better BP control and CVD risk reduction than conventional, morning-time therapy with all medications. We conducted a prospective, open-label, blinded-endpoint trial on 776 patients (387 men/389 women) with resistant hypertension, 61.6?±?11.2 (mean?±?SD) yrs of age. Patients were randomized to ingest all their prescribed hypertension medications upon awakening or ≥1 of them at bedtime. BP was measured by ambulatory monitoring for 48?h at baseline, and again annually or more frequently (quarterly) if treatment adjustment was required. After a median follow-up of 5.4 yrs (range, .5–8.5 yrs), participants ingesting ≥1 hypertension medications at bedtime showed a significantly lower hazard ratio (HR) of total CVD events (adjusted by age, sex, and diabetes) than those ingesting all medications upon awakening (.38 [95% CI: .27–.55]; number of events 102 vs. 41; p?<?.001). The difference between groups in the adjusted HR of major CVD events (a composite of CVD death, myocardial infarction, ischemic stroke, and hemorrhagic stroke) was also statistically significant (.35 [95% CI: .18–.68]; number of events 32 vs. 12; p?=?.002). At the last evaluation, patients treated with the bedtime versus awakening-time-treatment regimen showed significantly lower sleep-time systolic/diastolic BP mean values (121.6/65.4 vs. 113.0/61.1?mm Hg; p?<?.001) and higher prevalence of controlled ambulatory BP (61% vs. 46%; p?<?.001). The progressive decrease in the sleep-time systolic BP mean during follow-up was the most significant predictor of event-free survival (15% risk reduction per 5?mm Hg decreased asleep systolic BP mean). Among patients with resistant hypertension, ingestion of at least one hypertension medication at bedtime, compared with all medications upon waking, resulted in improved ambulatory BP control and fewer hard and soft CVD events. (Author correspondence: rhermida@uvigo.es)     

Clinic-Based vs. Home-Based Interventions for Preventing Weight Gain in Men

Objective : Weight gain occurs frequently in men aged 25–40. This study compared the effectiveness of a clinic-based and a home-based intervention with a no-treatment control group in preventing this weight gain. Research Methods and Procedures : Men (n = 67)—aged 25 to 40, sedentary, with a body mass index of 22 to 30, recruited from the University of Pittsburgh—were randomly assigned to 4-month treatments focused on increasing aerobic exercise and reducing fat intake through a clinic-based (CB) or a home-based (HB) program, or to a de-layed-treatment control group. Subjects were reassessed at 4 months. Results : Adherence and outcome did not differ significantly between the CB and HB programs, except that CB subjects recorded their food intake more frequently, and a greater number of CB subjects achieved a total of 120 miles of exercise over the 4 months. Subjects in the two intervention conditions combined lost significantly more weight (-1.6 ± 2.5 kg) than control subjects, who gained 0.2 ±1.9 kg (p<0.01); this effect of treatment was seen primarily in men with a body mass index of 27 to 30 (-2.7 kg for CB and HB combined vs. +1.5 kg for control). Treated subjects also had somewhat greater improvements in body composition, aerobic fitness, and weekly energy expenditure than controls, although these differences did not reach significance. Discussions: Both CB and HB intervention show promise in preventing weight gain in young men, especially in those who are slightly overweight. Larger studies, using more representative samples of young men, appear warranted.     

Biofeedback-Assisted Cardiovascular Control in Hypertensives Exposed to Emotional Stress: A Pilot Study

The study was aimed at examining the effect of a short Heart Rate-Biofeedback (HR-BF) protocol on systolic (SBP) and diastolic (DBP) blood pressure levels and BP emotional reactivity. Twenty-four unmedicated outpatients with pre- and stage 1 hypertension, were randomly assigned to active treatment (BF-Training) or control (BP-Monitoring) group. Subjects in BF-Training Group underwent four BF sessions. Guided imagery of stressful events was introduced during sessions 3 and 4. Control participants self-monitored their BP at home for 4?weeks. Subjects in both groups performed an emotional Speech Test before and after the training (or monitoring) period. SBP and mean arterial pressure responses to the emotional Speech Test were significantly smaller after the BF-training than the BP-monitoring. Moreover, clinic SBP and DBP were significantly reduced by about 10?mmHg in BF-Training Group, whereas they remained unchanged in control group. Self-monitored BP decreased significantly in the active treatment group and not in control group. A short BF-training, including guided imagery of stressful events, was effective in reducing BP reactions to a psychosocial stressor. BP measured in the clinic, and self-monitored at home were also significantly reduced in the BF-Training Group. HR-BF appears to be a suitable intervention for hypertensive patients, mostly when BP increase is associated with emotional activation.     

Ambulatory Goeckerman treatment of psoriasis: experience with 200 patients.

At a psoriasis day care centre 200 patients were treated with an ambulatory Goeckerman regimen, 25 of them twice, because of recurrence. This treatment consists of the application of a coal tar preparation at home at bedtime, followed the next day by exposure to high-intensity short wavelength ultraviolet radiation (UVB) at the centre. Treatment was given 5 days a week for 1 month. The psoriasis cleared in 86% of the patients after a mean of 21.6 UVB treatment sessions. The mean length of remission was 5.1 months, but at the time of follow-up 15 patients were still free of psoriasis. Compliance with the regimen was good to excellent in 94% of the patients. In our hands ambulatory treatment of psoriasis is much less expensive than hospital treatment and gives better results than photochemotherapy.     

A modified regimen of extracorporeal cardiac shock wave therapy for treatment of coronary artery disease

ABSTRACT: BACKGROUND: Cardiac shock wave therapy (CSWT) improves cardiac function in patients with severe coronary artery disease (CAD). We aimed to evaluate the clinical outcomes of a new CSWT treatment regimen. METHODS: The 55 patients with severe CAD were randomly divided into 3 treatment groups. The control group (n = 14) received only medical therapy. In group A (n = 20), CSWT was performed 3 times within 3 months. In group B (n = 21), patients underwent 3 CSWT sessions/week, and 9 treatment sessions were completed within 1 month. Primary outcome measurement was 6-minute walk test (6MWT). Other measurements were also evaluated. RESULTS: The 6MWT, CCS grading of angina, dosage of nitroglycerin, NYHA classification, and SAQ scores were improved in group A and B compared to control group. CONCLUSIONS: A CSWT protocol with 1 month treatment duration showed similar therapeutic efficacy compared to a protocol of 3 months duration.Clinical trial registryWe have registered on ClinicalTrials.gov, the protocol ID is CSWT IN CHINA.     

Stress-Management Training for Essential Hypertension: A Controlled Study

Forty three patients with essential hypertension participated in a study on the effectiveness of stress-management training for essential hypertension. After 6–9 clinic and 48 self-measured readings of systolic and diastolic blood pressures (SBP and DBP), 22 patients were treated with a program based on education, relaxation, and problem-solving training; and another 21 patients were assigned to a waiting list control group. At post-treatment, mean reductions of clinic BP (17/13 mm Hg vs. 6.9/4.7 mm Hg for SBP/DBP), percentages of subjects who achieved at least a 5 mm Hg reduction (86/86% vs. 48/48% for SBP/DBP) and percentages of subjects who in addition achieved a normotensive level (59/68% vs. 29/14% for SBP/DBP) were significantly higher in the treated group than in the control group. Concerning self-measured BP, the effectiveness of the stress-management training was not so considerable (mean reductions of 3.6/2.4 mm Hg and percentages of subjects who achieved a 5 mm Hg reduction of 52/38% for SBP/DBP), but it was significant and maintained in a 4-month follow-up assessment (mean reductions of 4/2 mm Hg and percentages of subjects who achieved a 5 mm Hg reduction of 48/33% for SBP/DBP). It is suggested that stress-management training can be beneficial for treatment of essential hypertension.     

Subjective experiences associated with thermal biofeedback treatment of hypertension

Reports of subjective experiences of 73 hypertensive patients who were treated with thermal biofeedback for hand warming were obtained over 16 treatment sessions. Most of the differential responding in subjective report occurred in the first 5 sessions. Differences in reports of throbbing were associated with medication status during treatment (presence of sympatholytic antihypertensive agent). From 4 to 9% of patients report negative subjective experiences at any one session. When short-term clinical successes (either elimination of medication or reduction of BP) were compared with short-term failures, it was found that successes reported more warmth, more likelihood of falling asleep, and more dreamlike experiences. The latter were more likely to occur suddenly for the successes. Correlational analyses revealed consistent positive associations between reports of warmth and relaxation with highest temperature achieved in the session and consistent negative associations between experiencing physical sensations and degree of temperature change within the session.     

Inhibition of the mutagenicity of benzo[a]pyrene in the V79/HGPRT system by bioantioxidants

In the presence of metabolic activation (S9 microsomal fraction of mouse-liver homogenate) the mutagenicity of benzo[a]pyrene (BP) in Chinese hamster V79 cells was inhibited by the phenolic bioantioxidants (BA) Dibunol (2,6-di-tert-butyl-4-methylphenol-D) and 5-methylresorcine(5-MR). The mixture BP + D and BP + 5-MR at molar ratios of 1:1 and 1:85 respectively showed no mutagenic activity compared to the control. One can assume that D and 5-MR inhibited BP-induced mutagenesis by binding the free radicals of BP metabolites with the formation of less active phenolic derivatives and also by linkage with cytochrome P-450, which prevents further metabolic activation of BP.     

Role of Time-of-Day of Hypertension Treatment on the J-Shaped Relationship Between Blood Pressure and Cardiovascular Risk

Several previous studies found that too great a reduction of clinic blood pressure (BP) by treatment increased cardiovascular disease (CVD) risk, whereas moderate reduction decreased it. Thus, it has been suggested that the relationship between BP and CVD events is J-shaped, with CVD risk decreasing as BP is lowered, and then rising as BP is further decreased. Correlation between BP level and CVD risk, however, is stronger for ambulatory BP monitoring (ABPM) than clinical BP measurements. We previously established that the hypertension treatment-time regimen, upon awakening versus at bedtime, exerts differential effect on BP control during the day and nighttime, which translates into a differential degree of CVD risk prevention. We, therefore, investigated the role of hypertension treatment-time scheme on the nature of the relationship between achieved clinic and ambulatory BP and CVD risk in the MAPEC (Monitorización Ambulatoria para Predicción de Eventos Cardiovasculares, i.e., Ambulatory Blood Pressure Monitoring for Prediction of Cardiovascular Events) study, a prospective, open-label, blinded-endpoint trial on 2156 hypertensive patients (1044 men/1112 women), 55.6?±?13.6 (mean?±?SD) yrs of age, randomized to ingest all prescribed once-a-day hypertension medications upon awakening or the entire daily dose of ≥1 of them at bedtime. Ambulatory BP was measured for 48-h at baseline and annually thereafter, and more frequently (quarterly) when adjustment of treatment was necessary. After a median follow-up of 5.6 yrs, a J-shaped relationship was detected between total CVD events and clinic as well as awake BP mean, but only for the group of patients ingesting all medications upon awakening. The relationship was different in the group of patients who ingested ≥1 medications at bedtime; the risk of CVD events progressively diminished in a linear, rather than J-shaped, manner with treatment-induced decrease in awake BP mean. The adjusted hazard ratio of CVD events was significantly lower with the progressive reduction in the asleep BP mean, independent of the hypertension treatment-time regimen. There was no single major event, i.e., CVD death, myocardial infarction, or stroke, in patients who achieved an asleep systolic BP mean <103?mm Hg. Our findings indicate that bedtime hypertension treatment is not associated with a J-shaped relationship between achieved BP and CVD risk. The decreased CVD risk associated with the progressive reduction in asleep BP, more feasible by bedtime than morning hypertension treatment, has clinical implications, in particular, the need to consider the proper timing of hypertension medications, in conjunction with ABPM for proper assessment of BP control, as an improved and potentially safer means of reducing CVD risk of hypertensive patients. (Author correspondence: rhermida@uvigo.es)     

Thermal biofeedback as an effective substitute for sympatholytic medication in moderate hypertension: A failure to replicate

Thirty-three moderate hypertensives were converted to a 2-drug regimen of metoprolol and diuretic and BPs stabilized at a well-controlled level. They then completed one of three conditions over an 8-week interval: (I) 16 sessions of TBF (hand and foot warming); (II) 16 sessions of frontal EMG-BF; (III) regular home monitoring of BP. Attempts were then made to withdraw the patients from the sympatholytic medication. Those successfully withdrawn were followed up for one year. There were no significant advantages for TBF over the other two conditions in the short term or with long-term follow-up. Only 27% of treated patients (including Condition III failures who were remedicated and treated with TBF) were successfully off of the sympatholytic at a one-year follow-up. The generally poor results on clinical outcome were confirmed by clinic BPs, home BPs by patients, and 24-hour ambulatory BPs.This research was supported by grant No. HL-27622 from NHLBI. The authors wish to thank Dr. Guy C. McCoy for his role in the initial conceptualization of the study, Dr. Jim Jaccard and Barbara Greene for their assistance in the analyses of the 24-hour ambulatory BP data, and Annabel Prins, Bruce Steffek, and Debra Belkin, who served as therapists for a portion of the study.     

Dicrimination of systolic blood pressure

The ability of humans to discriminate systolic blood pressure (BP) was investigated in two experiments. In Experiment 1, 14 normal subjects were asked to make estimates of their systolic BP while performing both BP-elevating and BP-lowering tasks. They were given intermittent feedback throughout all 10 45-min sessions. Results indicated significant correlations and small absolute differences between estimated and measured BP for all subjects in almost all sessions. Experiment 2, undertaken 6 months after Experiment 1, assessed whether estimation accuracy by subjects who had available both external and interoceptive cues surpassed that of subjects which access to external cues only. Three subjects from the original group who showed consistently high motivation, and who improved in accuracy across the 10 sessions in the previous experiment, made estimates of BP while performing novel tasks with no feedback. Correlations between estimated and measured BP remained high for 2 of the 3. These results were compared with the accuracy of control subjects (3 for each experimental subject) who were asked to estimate experimental subjects' BP using only the cognitive information available to the experimental subjects. Control subjects also had high correlations between their estimates and the experimental subjects' measured BP but at lower levels than two experimental subjects. These findings are discussed in relation to subjects' possible use of interoceptive information.     

Efficacy of lomustine, teniposide, doxorubicin, bleomycin and prednisone (LTABP) or adriamycin, bleomycin, vinblastine and dacarbazine (ABVD) in the treatment of malignant lymphogranulomatosis resistant to MOPP]

LTABP regimen was applied to 18 patients in IIB and IV stage of malignant lymphogranulomatosis resistant to MOPP. The obtained results were compared with historical control group of 18 patients with similar stage of the disease treated according to ABVD regimen. In both regimens courses were repeated every 28 days or more rarely, when leucopenia and thrombocytopenia prolonged. Only patients who had received at least 3 courses were analysed. In the LTABP group the complete remission was obtained in 10 cases (55%) while partial remission in 6 (33%). In the group treated with ABVD complete remission was obtained in 4 cases (22%) and partial in 9 cases (50%). In the LTABP group 11 patients are still alive and remain in complete remission, while in ABVD group--4 patients. The most frequent side effects in both groups included leucopenia, thrombocytopenia and symptoms of gastrointestinal intolerance. The LTABP regiment allows to obtain higher percentage of the complete remission than ABVD.     

Subjective experiences associated with thermal biofeedback treatment of hypertension

Reports of subjective experiences of 73 hypertensive patients who were treated with thermal biofeedback for hand warming were obtained over 16 treatment sessions. Most of the differential responding in subjective report occurred in the first 5 sessions. Differences in reports of throbbing were associated with medication status during treatment (presence of sympatholytic antihypertensive agent). From 4 to 9% of patients report negative subjective experiences at any one session. When short-term clinical successes (either elimination of medication or reduction of BP) were compared with short-term failures, it was found that successes reported more warmth, more likelihood of falling asleep, and more dreamlike experiences. The latter were more likely to occur suddenly for the successes. Correlational analyses revealed consistent positive associations between reports of warmth and relaxation with highest temperature achieved in the session and consistent negative associations between experiencing physical sensations and degree of temperature change within the session.This research was supported in part by grants from NHLBI, HL-27622 and HL-31189.     

Influence of exercise order on maximum strength and muscle volume in nonlinear periodized resistance training

The purpose of this study was to examine the influence of exercise order on strength and muscle volume (MV) after 12 weeks of nonlinear periodized resistance training. The participants were randomly assigned into 3 groups. One group began performing large muscle group exercises and progressed to small muscle group exercises (LG-SM), whereas another group started with small muscle group exercises and advanced to large muscle group exercises (SM-LG). The exercise order for LG-SM was bench press (BP), machine lat pull-down (LPD), triceps extension (TE), and biceps curl (BC). The order for the SM-LG was BC, TE, LPD, and BP. The third group did not exercise and served as a control group (CG). Training frequency was 2 sessions per week with at least 72 hours of rest between sessions. Muscle volume was assessed at baseline and after 6 weeks and 12 weeks of training by ultrasound techniques. One repetition maximum strength for all exercises was assessed at baseline and after 12 weeks of training. Effect size data demonstrated that differences in strength and MV were exhibited based on exercise order. Both training groups demonstrated greater strength improvements than the CG, but only BP strength increased to a greater magnitude in the LG-SM group as compared with the SM-LG. In all other strength measures (LPD, TE, and BC), the SM-LG group showed significantly greater strength increases. Triceps MV increased in the SM-LG group; however, biceps MV did not differ significantly between the training groups. In conclusion, if an exercise is important for the training goals of a program, then it should be placed at the beginning of the training session, regardless of whether or not it is a large muscle group exercise or a small muscle group exercise.     

Previous exercise attenuates muscle sympathetic activity and increases blood flow during acute euglycemic hyperinsulinemia.

Insulin infusion causes muscle vasodilation, despite the increase in sympathetic nerve activity. In contrast, a single bout of exercise decreases sympathetic activity and increases muscle blood flow during the postexercise period. We tested the hypothesis that muscle sympathetic activity would be lower and muscle vasodilation would be higher during hyperinsulinemia performed after a single bout of dynamic exercise. Twenty-one healthy young men randomly underwent two hyperinsulinemic euglycemic clamps performed after 45 min of seated rest (control) or bicycle exercise (50% of peak oxygen uptake). Muscle sympathetic nerve activity (MSNA, microneurography), forearm blood flow (FBF, plethysmography), blood pressure (BP, oscillometric method), and heart rate (HR, ECG) were measured at baseline (90 min after exercise or seated rest) and during hyperinsulinemic euglycemic clamps. Baseline glucose and insulin concentrations were similar in the exercise and control sessions. Insulin sensitivity was unchanged by previous exercise. During the clamp, insulin levels increased similarly in both sessions. As expected, insulin infusion increased MSNA, FBF, BP, and HR in both sessions (23 +/- 1 vs. 36 +/- 2 bursts/min, 1.8 +/- 0.1 vs. 2.2 +/- 0.2 ml.min(-1).100 ml(-1), 89 +/- 2 vs. 92 +/- 2 mmHg, and 58 +/- 1 vs. 62 +/- 1 beats/min, respectively, P < 0.05). BP and HR were similar between sessions. However, MSNA was significantly lower (27 +/- 2 vs. 31 +/- 2 bursts/min), and FBF was significantly higher (2.2 +/- 0.2 vs. 1.8 +/- 0.1 ml.min(-1).100 ml(-1), P < 0.05) in the exercise session compared with the control session. In conclusion, in healthy men, a prolonged bout of dynamic exercise decreases MSNA and increases FBF. These effects persist during acute hyperinsulinemia performed after exercise.     

Response-oriented therapy with CHOP and VIM-Bleo in high-grade malignant non-Hodgkin's lymphomas

Twenty four patients with high grade malignant NHL (stage II 8, stage III 4, stage IV 12 patients respectively) were treated with a response-oriented regimen: Treatment was initiated according to the CHOP-protocol. Patients achieving at least a partial remission after 2 and a complete remission (CR) after 4 cycles were continued on CHOP to a total of 9 cycles. Patients not meeting these criteria were switched to a combination of Etoposide, Ifosfamide, Methotrexate, and Bleomycin (VIM-Bleo). With CHOP treatment, 16 patients (67%) achieved a CR. Of the remaining 8, 7 were treated with VIM-Bleo; 5 of these entered CR for a overall CR rate of 21/24 (88%). With a median follow up of 28 months 7 patients relapsed: 6 relapses occurred in patients with a rapid initial response and treated only with CHOP. We conclude, that there is a significant risk of relapse even in patients readily responding to CHOP and that consolidation therapy with a non cross-resistant regimen may improve results in these patients.