The randomization for the clinical trials of the SPRINT-MIND study was started on November 8, 2010, in 102 sites in the USA and Puerto Rico under the guidance of Dr. Williamson et al. Out of the 9361 randomized participants—mean age of 67.9 years and a female participation over 35%— approximately 91% of them completed one year of follow-up cognitive evaluation. The participants were randomized into two groups: in the first one, half were treated to maintain a systolic blood pressure of less than 120 mm of HG—the intensive group—and the other half was treated to maintain one of less than 140m mm HG—the standard treatment group. The median time of interventions was 3.34 years. Initially designed to end in 2018 the study was ended in August 2015 due to bioethical reasons because the researchers found benefits for the first group.
Individuals confined to a nursing home, with a diagnosis and/or treatment of dementia, diabetes or stroke were excluded form this study. The researchers did not explicitly screen participants for a diagnosis of Mild Cognitive Impairment (MCI) in their selection, which raises the possibility that a few of the participants might have already clinical signs of Dementia at the beginning. Moreover, they purposefully did not include the older patients with several co-morbid conditions, which might actually bear the higher risks of aggressive treatment of high blood pressure—orthostatic hypotension, stroke or ongoing cardiovascular failure. Another example of how trials discriminate against older patients and expose them to unknown grave risks with their cookie-cutter approach.
During a median intervention period of 3,34 years, probable dementia occurred in 149 participants of the intensive and care group and 176 in the standard treatment group; intensive BP control reduced the risk of MCI—14.6 versus 18.3 cases per 1,000 person-years—and the combined rate of MCI or probable dementia—20.2 versus 24.1 cases per 1000 person-years. The trial failed to reach statistical significance on its primary cognitive outcome of a reduction in the occurrence of dementia. Some academics claim that the study failed to reach significance because the testing was cut short and more time should be allotted for follow-up of patients; the Alzheimer’s Association has announced the provision of a U$ 800,000 grant to add two more additional years to the study.
In a Neurology Today article on this study, Dr. Emer R. McGrath said that the technique for obtaining blood pressure readings they had utilized—use the average of three automatic readings with no personnel in the room—might give mischievously low readings than the one in practices. The risk of over-treatment and adverse effects in already frail patients is worrisome indeed. Other practitioners point out that researchers do not know which BP medication might work best and at what age. However, the majority of those interviewed were hopeful that the follow-up study might bring statistical significance to the concept of controlling the BP to avoid future onset of dementia.
We already know that a methodical control of one’s blood pressure as of middle age will make a significant difference to avoid cardiovascular and renal diseases in our older years. Similarly, we believe that the same Wellness interventions will help us at least delay the mind ravages of ageing in order to have a better quality of life.
What do you think? Please tell us.
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