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It’s been said that one can observe a lot just by watching. Turning such observation inward, new evidence suggests, might lead to blood pressure (BP) reductions that approach what’s possible from an antihypertensive agent.

Systolic BP fell over 6 months by almost 6 mm Hg, on average, primary care pharmacy in people with elevated BP who participated in an 8-week mindful awareness program as part of a randomized trial that included a usual-care control group.

The program taught established mindfulness-training techniques aimed at modifying behaviors regarding diet, exercise, and other controllable influences on the success of antihypertensive therapy.

Participants in the program, called Mindfulness-Based Blood Pressure Reduction (MB-BP), also the name of the single-center study, “showed potentially clinically relevant reductions in systolic blood pressure,” said principal investigator Eric B. Loucks, PhD, Brown University, Providence, Rhode Island.

The phase 2 trial has some limitations, he observed, including on generalizability. For example, it entered about 200 mostly White, college-educated adults from one metropolitan area.

But if these findings are replicated in further studies, “preferably by other research groups, in a larger and broader population, and with longer follow-up,” Loucks said, the MB-BP intervention could become “an appealing approach to help control blood pressure.”

Loucks made the comments at a press conference prior to his formal presentation of MB-BP November 6 at American Heart Association (AHA) Scientific Sessions 2022, held in Chicago and virtually.

Mindfulness-based interventions for elevated BP have not been widely studied, “so this is exactly what we need: a well-done trial with a control group to show that it actually works,” Amit Khera, MD, not connected with MB-BP, told | Medscape Cardiology.

The trial is “really important for proof of concept, but it had only 200 people. You need a larger one, and you need longer-term data,” agreed Khera, who directs the preventive cardiology program at the University of Texas Southwestern Medical Center, in Dallas. “Six months is good, but we want to see if it’s durable.”

Rhian M. Touyz, MBBCh, also not part of MB-BP, agreed that the nearly 6 mm Hg mean systolic BP reduction among program participants is clinically relevant. “I think in the context of global risk and reduction of target organ damage and cardiovascular events, it is significant in terms of events at a population level,” Touyz, McGill University Health Centre, Montreal, Canada, told | Medscape Cardiology.

Many patients on antihypertensive therapy that’s falling short resist the addition of another such agent, she observed, and instead might show further BP reduction from mindfulness training. The intervention probably also “would benefit health in general.” Mindfulness-based approaches could therefore be useful additions to treatment protocols for elevated BP, Touyz said.

How the Training Works

The MB-BP program used validated mindfulness-based stress-management techniques, adapted to address elevated BP, that included “personalized feedback and education about hypertension risk factors, mindful awareness training of participants’ relationships with hypertension risk factors, and support for behavior change,” Loucks and colleagues reported.

Participants were trained in mindfulness skills that included “self-awareness and emotion regulation,” Loucks said, which they then could apply to their “relationships with the things that we know influence blood pressure, like physical activity, diet, antihypertensive medication adherence, or alcohol consumption.”

One goal is to promote greater “attention control,” he said, “so that there’s some self-awareness that arises in terms of how we feel the next day, after a lot of alcohol consumption, for example, or lack of physical activity.” The process can provide insights that inspire patients to modify behaviors and risk factors that elevate BP, Loucks explained.

Effects on Medication Use

Systolic BP responses led some program participants to be managed on fewer or reduced dosages of antihypertensive meds, he told | Medscape Cardiology. Physicians seen outside of the trial could adjust their prescriptions, intensifying or pulling back on meds depending on their assessments of the patient. Any prescription changes would be documented by the researchers at the patient’s next class or trial-clinic visit.

The group that did the training, Loucks said, was 33% less likely to increase and 30% more likely to decrease their use of BP-lowering medications compared with the control group.

Elevated BP is so common and undertreated that “there is a need for every possible level of intervention, starting from the population level to the individual and everything else in between,” nephrologist Janani Rangaswami, MD, George Washington University, Washington DC, said at the press conference.

Therefore, “this mindfulness-based approach, in addition to standard of care with pharmacotherapy, is a really welcome addition to the hypertension literature,” said Rangaswami, who directs her center’s cardiorenal program. The systolic BP reduction seen in the intervention group, she agreed, was “clinically important and meaningful.”

Blinded Assessments

The trial entered 201 patients with systolic and diastolic BP greater than 120 mm Hg and 80 mm Hg, respectively; 58.7% were women, 81% were White, and 73% were college-educated, Loucks reported.

The 100 assigned to the “enhanced usual care” control group received educational materials on controlling high BP. They and the 101 who followed the mindfulness-based program were given and trained on a home BP-monitoring device. They were then followed for the primary endpoint of change in systolic BP at 6 months.

Data management and outcomes assessments were conducted by trialists not involved in the training intervention who were blinded to randomization assignment.

In a prespecified unadjusted analysis by intention-to-treat, systolic BP in the intervention group dropped by a mean of 5.9 mm Hg (P < .001) compared with baseline and 4.5 mm Hg (P = .045) compared with the control group.

A post hoc analysis adjusted for sex and baseline BP showed an average 4.3 mm Hg reduction (P = .056) in those following the MB-BP program compared with controls.

There were no observed significant effects on diastolic BP.

The study offered clues to how engagement in the MB-BP program might promote reductions in systolic BP, Loucks observed. For example, it may have led to increased activity levels, reduced sodium intake, and other dietary improvements.

Indeed, program participants averaged about 351 minutes less sedentary time (P = .02) and showed a 0.32-point improvement in Dietary Approaches to Stop Hypertension scores (P = .08) compared with the control group, Loucks reported. Other modifiable risk factors for elevated BP that could have responded to the mindfulness-based training, he proposed, include obesity, alcohol intake, and reaction to stress.

American Heart Association (AHA) Scientific Sessions 2022: Session LBS.04 Presented November 6, 2022.

Loucks reports that he developed the MB-BP training and was a program instructor but did not receive related financial compensation; he had no other disclosures. Khera, Touyz, and Rangaswami had no relevant financial relationships.

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