Acupuncture Treatment of Delirium in Older Adults Hospitalized in Internal Medicine Departments: An Open-Label Pragmatic Randomized-Controlled Trial.

BACKGROUND: Acupuncture seems to improve cognitive function in experimental models and to reduce agitation in dementia. The addition of acupuncture to standard-of-care (SOC) may improve clinical outcomes related to delirium in hospitalized older adults. METHODS: This pragmatic open-label randomized-controlled trial evaluated 81 older adults hospitalized in an internal medicine ward and diagnosed with delirium. Fifty were randomized to daily acupuncture combined with SOC and 31 to SOC only for up to 1 week. Delirium was diagnosed using Confusion Assessment Method (CAM) tool, and its severity was assessed by the long CAM-Severity (CAM-S) tool. The primary study outcome was delirium resolution evaluated as time-to-first delirium remission (over 7 days) and the number of days spent delirium-free. RESULTS: Time-to-first delirium remission was shorter in the acupuncture arm as compared to the SOC only arm (p < 0.001). A multivariate Cox regression analysis showed a shorter time-to-first remission of delirium in the acupuncture arm as compared with SOC arm [Hazard Ratio 0.267 (95% CI 0.098-0.726, p = 0.010)]. In the 7 days of evaluation, a significantly higher number of delirium-free days was found in the acupuncture arm compared to the SOC arm (p < 0.001), and CAM-S sum from day 2 to day 7 of evaluation was significantly lower in the acupuncture group compared to the control group (p = 0.002). No adverse safety event was found in the acupuncture group. CONCLUSION: Acupuncture seems to be safe and effective in the treatment of delirium in older patients hospitalized in internal medicine departments.

Treatment of acute exacerbations of chronic obstructive pulmonary disease with acupuncture during hospitalization: a three-arm double-blinded randomized sham-controlled trial.

BACKGROUND: Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are a healthcare burden. Acupuncture improves dyspnea in patients with chronic obstructive pulmonary disease (COPD) but, to the best of our knowledge, has not been tested in AECOPD. Here, we evaluated the efficacy and safety of true acupuncture added to standard of care (SOC), as compared with both sham procedure plus SOC and SOC only, for the treatment of AECOPD among inpatients. METHODS: This double-blinded randomized sham-controlled trial was set in a tertiary hospital in Israel. Patients with a clinical diagnosis of AECOPD were assigned to true acupuncture with SOC, sham procedure with SOC or SOC only. The primary outcome was dyspnea improvement as measured daily by the validated modified Borg (mBorg) scale. Secondary outcomes included improvement of other patient-reported outcomes and physiologic features, as well as duration of hospitalization and treatment failure. Acupuncture-related side effects were evaluated by the validated Acup-AE questionnaire. RESULTS: Seventy-two patients were randomized: 26 to acupuncture treatment, 24 to sham and 22 to SOC only arms. Baseline characteristics were similar in the three groups. A statistically significant difference in dyspnea intensity was found from the first day of evaluation after treatment (p = 0.014) until day 3 after treatment. Similar results were found for sputum production, but no statistical significance was found when comparing physiologic features between the three arms. Acupuncture was not associated with adverse events. CONCLUSION: Acupuncture seems to be efficacious in the treatment of AECOPD among inpatients hospitalized in internal medicine departments. TRIAL REGISTRATION NUMBER: NCT03398213 (ClinicalTrials.gov).

The study protocol for a randomized, controlled trial of acupuncture versus a sham procedure versus standard care alone for the treatment of delirium in acutely hospitalized older adults with a medical illness.

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.