Acupuncture in the Treatment of Panitumumab Skin Toxicity: A Case Report.

BACKGROUND: Inflammatory skin rash resulting from treatment with epidermal growth factor receptor inhibitors may cause physical and mental disabling to patients treated for their oncologic condition and may, in some cases, lead to the cessation of biological treatment. CASE REPORT: In this case report, acupuncture treatment was provided to a patient with metastatic colorectal carcinoma who developed skin toxicity from panitumumab including rash, itching, and skin inflammation. Itching, infection, and inflammation symptoms improved significantly following acupuncture, subsequently relapsed following treatment cessation, and improved once again following reintroduction of acupuncture. CONCLUSION: Acupuncture may be effective in alleviating panitumumab-related skin inflammatory symptoms.

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).

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.

The effectiveness of foot reflexology in reducing anxiety and duration of labor in primiparas: An open-label randomized controlled trial.

BACKGROUND AND PURPOSE: Reflexology alleviates anxiety and may shorten the duration of labor. We evaluated the effect of reflexology on anxiety level and duration of labor in primiparas with moderate-to-severe anxiety. MATERIALS AND METHODS: In this open-label randomized-controlled trial, primiparas with moderate-to-severe anxiety were randomized into one of two groups: addition of reflexology to usual care, or usual care only. The primary outcome was a change in the level of anxiety during reflexology treatment. RESULTS: Ninety-nine women were assigned to reflexology treatment while ninety received usual care only. A larger alleviation of anxiety was observed immediately after reflexology treatment as compared to the control group during the 30 min following group assignment. Reflexology did not affect the length of delivery. CONCLUSION: Foot reflexology had a positive short-term anxiolytic effect during labor in primiparas with moderate-to-severe anxiety but did not affect the duration of labor.

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.

Postoperative analgesia by adding acupuncture to conventional therapy, a non-randomized controlled trial.

Background Postoperative pain is common in patients hospitalized in surgical departments, yet it is currently not sufficiently controlled by analgesics. Acupuncture, a complementary medical practice, has been evaluated for its benefits in postoperative pain with heterogeneous results. We tested the feasibility of a controlled study comparing the postoperative analgesic effect of acupuncture together with standard-of-care to standard-of-care only. Methods In this pilot non-randomized controlled study conducted at a tertiary medical center in Israel, patients received either acupuncture with standard-of-care pain treatment (acupuncture group) or standard-of-care treatment only (control group) following surgery. Visual Analogue Scale (VAS) ratings for pain level at rest and in motion were evaluated both at recruitment and two hours after treatment. Acupuncture-related side effects were reported as well. Results We recruited 425 patients; 336 were assigned to the acupuncture group and 89 to the control group. The acupuncture group exhibited a decrease of at least 40% in average level of pain both at rest (1.8±2.4, p<0.0001) and in motion (2.1±2.8, p<0.0001) following acupuncture, whereas the control group exhibited no significant decrease (p=0.92 at rest, p=0.98 in motion). Acupuncture's analgesic effect was even more prominent in reducing moderate to severe pain at baseline (VAS ≥4), with a decrease of 49% and 45% of pain level at rest and in motion respectively (p<0.001), compared with no significant amelioration in the control group (p=0.20 at rest, p=0.12 in motion). No major side effects were reported. Conclusion Integrating acupuncture with standard care may improve pain control in the postoperative setting.

First, keep it safe: Integration of a complementary medicine service within a hospital.

OBJECTIVES: This paper sought to explore risk/safety considerations associated with the integration of a complementary medicine (CM) service within a public academic medical centre in Israel. METHODS: We reviewed various sources pertaining to the CM service (interviews with CM staff, patients' electronic charts, service guidelines, correspondence with hospital administration) and conducted a thematic analysis to evaluate safety-related incidents during the 7 years of operation. In addition, we systematically assessed the charts for reports of treatment-associated adverse effects, which were documented in an obligatory field on treatment reports. RESULTS: After reviewing transcripts of interviews with 12 CM practitioners and with the director and vice-director of the CM service as well as transcripts of 8560 consultations that included 7383 treatments, we categorised 3 major domains of CM safety management: (i) prevention of safety-related incidents by appropriate selection of CM practitioners and modalities, (ii) actual adverse incidents and (iii) prevention of their recurrence using both hospital and CM service safety protocols. CM staff reported 5 categories of adverse incidents, most of which were minor. Twenty-nine adverse incidents were documented in the 7383 treatment sessions (0.4%). CONCLUSIONS: Safety management needs to be addressed both before introducing CM services in hospitals and throughout their integration. Important considerations for the safe integration of CM practices in the hospital include communication between CM and conventional practitioners, adherence to hospital safety rules, implementing a systematic approach for detecting and reporting safety-related incidents and continuous adaptation of the CM service safety protocols.

Complementary medicine for treatment of agitation and delirium in older persons: a systematic review and narrative synthesis.

BACKGROUND: Agitation and delirium frequently occur in cognitively impaired older people. We conducted a systematic review with narrative synthesis of the literature aiming to assess effectiveness of complementary and alternative medicine (CAM) modalities to address these conditions. METHODS: Following preliminary search, we included 40 original researches on CAM treatment of delirium and agitation in older persons. Then, the quality of these studies was assessed using the Downs and Black Checklist and Quality Assessment Tool for Studies with Diverse Designs, and the effect sizes were calculated. We subsequently conducted a narrative synthesis of the main findings, including theory development, preliminary synthesis, exploration of relationships within and between studies, and assessment of synthesis robustness. RESULTS: Forty articles that met the inclusion criteria were analyzed. Sixteen of these were randomized controlled trials. One article specifically addressed CAM treatment of delirium in patients without dementia, and the remaining 39 articles described treatments of agitated older persons with dementia. Thirty-five of the 40 included studies suggested that the investigated CAM therapies may ameliorate the severity of agitation and delirium. The physiological surrogates of agitation assessed in these studies included cortisol level, chromogranin A level, and heart rate variability. Very few of the studies systematically assessed safety issues, although no major adverse effects were reported. CONCLUSION: Overall, the systematic review of the literature suggests that several CAM modalities are potentially beneficial in the treatment of agitation and delirium among older persons. We suggest that promising CAM modalities should be further explored through large-scale randomized controlled trials in different clinical settings. Copyright © 2017 John Wiley & Sons, Ltd.

Mind the gap: Disclosure of dietary supplement use to hospital and family physicians.

OBJECTIVE: We aim to compare patients' perspectives on communication with their hospital physicians (HPs) and primary care physicians (PCPs) on patients' dietary and herbal supplements (DHS) use. METHODS: We conducted a cross-sectional prospective study among in-patients using structured questionnaires on DHS use. Multivariate logistic regression models assessed variables influencing doctor-related reasons for patients' nondisclosure of supplement use. RESULTS: Of 452 DHS users identified, 133 (29.4%) used herbs and 319 (70.6%) used non-herbal supplements. DHS users reported that PCPs were more aware of DHS consumption than HPs (70.1% vs. 34.1%, P<0.0001). PCPs initiative to detect supplement use was higher compared with HPs (P<0.0001). Doctor-related reasons for non-disclosure of DHS use were more prominent in a hospital setting. Multivariate logistic regression model suggested association between older patient age and doctor-related non-disclosure (p=0.03). DHS use was recorded in only 33 patients medical files. CONCLUSIONS: Doctor-patient communication concerning DHS use is significantly poorer during hospitalization compared with primary-care settings. A significant barrier for in-hospital disclosure is doctor-related. PRACTICE IMPLICATIONS: Continuity of care between community and hospital physicians regarding patients' DHS use should be improved due to the safety implications of such use. Educating physicians on DHS and improving communication could bridge this gap.

Potential drug interactions with dietary and herbal supplements during hospitalization.

Dietary and herbal supplements (DHS) are widely used in the general population, including during hospitalization. Yet, their potential interactions with prescription drugs have seldom been delineated among inpatients. We aimed to evaluate potentially dangerous interactions of DHS with prescribed medications among inpatients. This was a cross-sectional prospective study involving a cohort of patients hospitalized in 12 departments of a public academic medical center (Bnai Zion Medical Center, Haifa, Israel) from 2009 to 2014. DHS users were determined via a questionnaire. The Natural Medicine database was used to search for potential DHS-drug interactions for identified DHS, and the clinical significance was evaluated using Lexi-interact online interaction analysis. Medical files were assessed for documentation of DHS use. Univariate and multivariate logistic regression analyses were used to characterize potential risk factors for DHS-drug interactions. Of 927 patients consenting to answer the questionnaire, 458 (49 %) reported DHS use. Of these, 215 (47 %) had at least one potential interaction during hospitalization (759 interactions). Of these interactions, 116 (15 %) were potentially clinically significant. Older age [OR = 1.02 (1.01-1.04), p = 0.002], males [OR = 2.11 (1.35-3.29), p = 0.001] and increased number of used DHS [OR = 4.28 (2.28-8.03), p < 0.001] or drugs [OR = 1.95 (1.17-3.26), p = 0.011] were associated with potential interactions in DHS users. Physicians documented only 16.5 % of DHS involved in these interactions in patients' medical files. In conclusion, a substantial number of inpatients use DHS with potential interactions with concomitant medications. Medical staff should be aware of this, question patients on DHS usage and check for such interactions.

Perioperative Risks of Dietary and Herbal Supplements.

BACKGROUND: Patients undergoing surgery often use Dietary and Herbal Supplements (DHS). We explored the risk of DHS-drug interactions in the perioperative setting. METHODS: In this cross-sectional prospective study, participants hospitalized for surgery completed a questionnaire regarding DHS use. We used pharmacological databases to assess DHS-drug interactions. We then applied univariate and multivariate logistic regression analyses to characterize patients at risk for DHS-drug interactions. RESULTS: Of 526 interviewees, 230 (44%) patients reported DHS use, with 16.5% reporting using DHS that could potentially interact with anesthesia. Twenty-four (10%) patients used DHS that could potentially interact with antithrombotic drugs taken perioperatively. The medical files of three patients included reports of intraoperative bleeding. The patient files of only 11% of DHS users documented DHS use. CONCLUSIONS: DHS use poses a significant health risk due to potential interactions. Guidelines should emphasize perioperative management of DHS use.

Adverse events associated with interactions with dietary and herbal supplements among inpatients.

AIMS: Dietary and herbal supplements (DHS) are commonly used among inpatients and may cause interactions with drugs or other DHS. This study explored whether adverse events were actually associated with such interactions and examined specific characteristics among inpatient DHS users prone to such adverse events. METHODS: This was a cross-sectional study of 947 patients hospitalized in 12 departments of a tertiary academic medical centre in Haifa, Israel. It evaluated the rate of DHS use among inpatients, the potential for interactions, and actual adverse events during hospitalization associated with DHS use. It also assessed whether DHS consumption was documented in patients' medical files. Statistical analysis was used to delineate DHS users at risk for adverse events associated with interactions with conventional drugs or other DHS. RESULTS: In 17 (3.7%) of the 458 DHS users, an adverse event may have been caused by DHS-drug-DHS interactions. According to the Drug Interaction Probability Scale, 14 interactions 'probably' caused the adverse events, and 11 'possibly' caused them. Interactions occurred more frequently in older patients (P = 0.025, 95% CI: 2.26-19.7), patients born outside Israel (P = 0.025, 95% CI: 0.03-0.42), those with ophthalmologic (P = 0.032, 95% CI: 0.02-0.37) or gastrointestinal (P = 0.008, 95% CI: 0.05-0.46) comorbidities, and those using higher numbers of DHS (P < 0.0001, 95% CI: 0.52-2.48) or drugs (P = 0.027, 95% CI: 0.23-3.77). CONCLUSIONS: Approximately one in 55 hospitalizations in this study may have been caused by adverse events associated with DHS-drug-DHS interactions. To minimize the actual occurrence of adverse events, medical staff education regarding DHS should be improved.

Interactions between dietary supplements in hospitalized patients.

Inpatient consumption of dietary and herbal supplements (DHS) has recently received research attention, particularly due to potential DHS-drug interactions. Nevertheless, DHS-DHS interactions have seldom been evaluated among hospitalized patients. We evaluated potential DHS-DHS interactions among inpatients. The study was a cross-sectional prospective study, conducted at Bnai Zion Medical Center (Haifa, Israel) in 2009-2014. A multi-disciplinary team of researchers constructed a questionnaire aimed at detecting DHS use among inpatients. The Natural Medicine Database was used to examine identified DHS for potential DHS-DHS interactions. Then, medical files were reviewed to identify side effects potentially caused by such interactions and rate of documentation of DHS use. Univariate and multivariate logistic regression analyses were conducted to characterize potential risk factors for DHS-DHS interactions among hospitalized DHS users. Of 927 patients who agreed to answer the questionnaire, 458 (49.4 %) reported the use of 89 different DHS. Potential DHS-DHS interactions were identified in 12.9 % of DHS users. Three interactions were associated with the actual occurrence of adverse events. Patients at risk of DHS-DHS interactions included females (p = 0.026) and patients with greater numbers of concomitant medications (p < 0.0001) and of consumed DHS (p < 0.0001). In 88.9 % of DHS users, DHS use was not reported in medical files and only 18 % of the DHS involved in interactions were documented. Potential DHS-DHS interactions are common in inpatients, and may lead to hospitalization or worsen existing medical conditions. The causal relationship between potential interactions and actual adverse events requires further study.