Highlights
- •Acupuncture improves cognitive function and reduces agitation in dementia.
- •We hypothesized that acupuncture may be effective in the treatment of delirium in patients with an acute illness.
- •We have planned a randomized study that will evaluate both the specific and the non-specific effects of acupuncture on delirium, as well as its safety and cost-effectiveness.
Abstract
Background
Many hospitalized older adults experience delirium, but treatment options are limited.
Acupuncture has been shown to improve cognitive function and reduce agitation in dementia.
We hypothesize that acupuncture, when compared with a sham intervention, will reduce
the duration and severity of delirium, normalize delirium biomarkers, and improve
clinical outcomes related to delirium in acutely hospitalized older adults with a
medical illness.
Methods
This three-arm, prospective, randomized, clinical trial will evaluate adults aged
over 65 years who are acutely hospitalized to an internal-medicine ward and diagnosed
with delirium or subsyndromal delirium. The 288 patients (96 in each of three groups)
will be randomly allocated to receive either daily true acupuncture with usual care,
a daily sham procedure with usual care, or usual care only in a 1:1:1 distribution
for up to one week or until the patient is delirium-free for over 48 h. Other delirium
and clinical interventions will remain unchanged. Delirium will be diagnosed using
DSM-5 criteria and its severity will be assessed using the long Confusion Assessment
Method Severity (CAM-S) tool.
Outcomes
The primary study outcome will be the daily CAM-S score over 7 days between the three
groups. Secondary outcomes will include time to first resolution of the delirium (over
7 days), the proportion of days spent delirium-free, daily antipsychotic use, daily
pain scores, sleep quality, morning serum cortisol and T3 levels, and midnight urinary
cortisol/creatinine ratio, all determined twice a week, and delirium-related complications.
Hospital mortality, duration of hospital stay and functional status at discharge will
also be compared between the three groups. Adverse events potentially related to acupuncture
will be evaluated daily. The cost-effectiveness of acupuncture will be estimated.
Conclusion
This novel randomized study will evaluate both the specific and the non-specific effects
of acupuncture on delirium, and related outcomes, and its safety. Potential mechanism(s)
of action for acupuncture in reducing delirium will be explored and healthcare-related
costs estimated. Positive study results may prove pivotal in facilitating a multimodal,
non-pharmacologic, integrative approach to delirium treatment among older, medical
inpatients.
Keywords
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Article info
Publication history
Published online: March 06, 2019
Accepted:
March 2,
2019
Received in revised form:
January 13,
2019
Received:
December 11,
2018
Footnotes
☆Trial registration number: NCT03398928 (clinicaltrials.gov).
Identification
Copyright
© 2019 Elsevier B.V. All rights reserved.
