Patient- and Therapist-Related Risk Factors for Adverse Events in Acupuncture and Moxibustion in Japan: Multicenter Survey of Acupuncture and Moxibustion Teaching Clinics.
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ABSTRACT:
SUBMITTER: Uehara A
PROVIDER: S-EPMC8716478 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:The present study assessed the safety of outpatient oral anticancer chemotherapeutic drugs by investigating the type and frequency of serious adverse effects (SAEs). Emergency hospitalization, unplanned consultations and telephone calls were investigated in 1,832 patients who received oral anticancer drug treatment at the National Cancer Center Hospital East between December 1, 2014 and November 30, 2015. Oral cytotoxic anticancer and molecular targeted drugs were administrated to 1,140 (62.2%) and 692 (37.8%) patients, respectively. A total of 52 (2.8%) SAEs were reported, with 32 (2.8%) occurring following cytotoxic anticancer drug administration and 20 (2.9%) occurring after molecular targeted drug treatment. The most common SAE was gastrointestinal toxicity. The median time to SAE occurrence was 32 days (range, 5-1,705 days). The rate of unplanned consultations and telephone calls were 5.5 and 37.9% among all patients, respectively, with skin reactions being the most common reason for unplanned consultations. SAEs often occurred early after treatment initiation. It was concluded that measures against gastrointestinal toxicity are particularly important were administering chemotherapeutic agents.
| S-EPMC7709566 | biostudies-literature
Project description:Japanese traditional medicine (Kampo medicine) is an important subject in Japanese medical schools. Acupuncture and moxibustion (AM), essential categories of Kampo medicine, are taught in a few medical schools today. However, the current state of postgraduate AM education is unknown.To compare medical residents' awareness of AM before their AM education in the 4th year of medical school with that after completion of their 2-year postgraduate medical residency.We conducted a postal questionnaire survey of medical residents at the end of their 2-year residency. We required a signature on this questionnaire so that we could examine for changes in their awareness of AM with those determined by similar, signed, former questionnaire surveys conducted before and at the end of their 4th-year AM lectures in medical school (reported previously). The completed questionnaires were returned by mail or facsimile.Among 93 residents, there were 72 (77.4%) effective responses. Only three residents (4%) had opportunities to learn AM during residency. Among the 68 residents who were not afforded the opportunity to do so, after completing their two-year residency, 32(47%) stated that they would like to study AM. Interest in AM was significantly less than that of the proportion of medical students (81%) who were initially interested in AM when surveyed just before their fourth year lectures on AM.Postgraduate AM education for medical residents appears to be relatively scarce in Japan. Moreover, medical residents' levels of interest in AM were lower than those demonstrated before their 4th-year AM lectures in medical school.
| S-EPMC5561359 | biostudies-other
Project description:ObjectiveOverview on risks of acupuncture-related adverse events (AEs).DesignSystematic review and meta-analyses of prospective studies.Data sourcesPubMed, Scopus and Embase from inception date to 15 September 2019.Eligibility criteria for selecting studiesProspective studies assessing AEs caused by needle acupuncture in humans as primary outcome published in English or German.Data extraction and synthesisTwo independent researchers selected articles, extracted the data and assessed study quality. Overall risks and risks for different AE categories were obtained from random effects meta-analyses.Main outcomesOverall risk of minor AEs and serious adverse events (SAEs) per patients and per treatments.ResultsA total of 7679 publications were identified. Twenty-two articles reporting on 21 studies were included. Meta-analyses suggest at least one AE occurring in 9.31% (95% CI 5.10% to 14.62%, 11 studies) of patients undergoing an acupuncture series and in 7.57% (95% CI 1.43% to 17.95%, 5 studies) of treatments. Summary risk estimates for SAEs were 1.01 (95% CI 0.23 to 2.33, 11 studies) per 10 000 patients and 7.98 (95% CI 1.39 to 20.00, 14 studies) per one million treatments, for AEs requiring treatment 1.14 (95% CI 0.00 to 7.37, 8 studies) per 1000 patients. Heterogeneity was substantial (I2 >80%). On average, 9.4 AEs occurred in 100 treatments. Half of the AEs were bleeding, pain or flare at the needle site that are argued to represent intended acupuncture reaction. AE definitions and assessments varied largely.ConclusionAcupuncture can be considered among the safer treatments in medicine. SAEs are rare, and the most common minor AEs are very mild. AEs requiring medical management are uncommon but necessitate medical competence to assure patient safety. Clinical and methodological heterogeneity call for standardised AE assessments tools, clear criteria for differentiating acupuncture-related AEs from therapeutically desired reactions, and identification of patient-related risk factors for AEs.Prospero registration numberCRD42020151930.
| S-EPMC8422480 | biostudies-literature
Project description:BackgroundMetabolic syndrome is a growing concern among patients with schizophrenia because metabolic abnormalities are widely regarded as a major risk factor for cardiovascular disease and premature death. The current study assessed attitudes toward metabolic adverse events among patients with schizophrenia.MethodsA brief questionnaire was constructed to investigate patient recognition of the following broad areas: dietary habits, lifestyle, self-monitoring, knowledge, and medical practice. Between January 2012 and June 2013, questionnaires were sent to patients associated with 520 outpatient facilities and 247 inpatient facilities belonging to the Japan Psychiatric Hospital Association. All of the participants (n=22,072; inpatients =15,170, outpatients =6,902) were diagnosed with schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, or the International Classification of Diseases, tenth revision.ResultsApproximately 55.0% (8,069/14,669) of inpatients and 44.8% of outpatients (2,978/6,649) reported that they did not exercise at all. Although 60.9% (4,116/6,760) of outpatients reported that they felt obese, only 35.6% (5,261/14,794) of inpatients felt obese. More than half of the inpatients (51.2%; 7,514/14,690) and outpatients (60.8%; 4,086/6,721) hoped to receive regular blood tests to prevent weight gain and diseases such as diabetes.ConclusionAlthough more than half of patients hoped to prevent weight gain and diabetes, only a minority of patients were mindful of eating balanced meals and having physical exercise. Educational efforts and the promotion of the best pharmacotherapy and monitoring practices are needed for patients with schizophrenia.
| S-EPMC4771408 | biostudies-literature
Project description:Primary osteoporosis (PO) is a common disease that was characterized by a systemic impairment of bone mass and microarchitecture that results in fragility fractures and constitutes a pressing public health problem. But the effect of acupuncture or moxibustion treatment for PO is controversial.To provide a comprehensive systematic overview of current evidence from systematic reviews (SR)/Meta-analysis of acupuncture treatment for PO pertaining to risk of bias, quality of evidence and report quality.A total of 9 international and Chinese databases were searched for SR/meta-analysis of randomized controlled trials (RCTs). The risk of bias of SR/meta-analysis was appraised using the risk of bias in systematic reviews (ROBIS) instrument, the quality of the evidence was evaluated via Grading of Recommendations Assessment, Development and Evaluation (GRADE), and the report quality of the included studies are estimated by Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA).According to ROBIS, only 2 articles were with risk of low bias; according to PRISMA, and most articles were reported incomplete, mainly in Q2, Q7, Q24, and Q27; according to GRADE, a total of 28 outcome indicators were evaluated under 4 different interventions of experimental group and control group: the evidence quality of bone mineral density (BMD) from treatment of acupuncture and moxibustion/acupuncture and moxibustion plus was high or moderate; Visual Analogue Score (VAS) of acupuncture plus moxibustion or acupuncture plus moxibustion plus other was low or very low; clinical effectiveness of acupuncture plus moxibustion or acupuncture plus moxibustion plus other was uncertain.Acupuncture and moxibustion can improve the BMD of PO patients according to high-quality evidence, and may benefit VAS, pain score, clinical efficacy based on moderate or low-quality evidence. Further research that provides higher quality evidence of SR/RCTs of acupuncture and moxibustion treatment for PO is required.
| S-EPMC7478384 | biostudies-literature
Project description:In order to evaluate the safety of acupuncture in China objectively, we investigated the adverse events associated with acupuncture based on three multicentre randomized controlled trials (RCTs) to assess the safety of acupuncture, identifying the common types of acupuncture adverse events, and analysing the related risk factors for their occurrence.This observational study included patients who received acupuncture from three multicentre RCTs respectively for migraine, functional dyspepsia and Bell's palsy. The 1968 patients and their acupuncturists documented adverse events associated with acupuncture after treatment. We collected data about adverse events due to acupuncture treatment from their case report forms. We analysed the incidence and details of the adverse effects, and studied the risk factors for acupuncture adverse events with non-conditional logistic regression analysis.Among the 1968 patients, 74 patients (3.76%) suffered at least one adverse event throughout the treatment period. We did not observe the occurrence of serious adverse events. 73 patients with adverse events recovered within 2 weeks through effective treatment such as physiotherapy or self-treatment. A total of 3 patients withdrew because of adverse events. There were 9 types of adverse events related to acupuncture, including subcutaneous haematoma, bleeding, skin bruising and needle site pain. Subcutaneous haematoma and haemorrhage in the needling points were the most common adverse events. Age and gender were related to the occurrence of acupuncture adverse events. The older the patients were, the higher the risk of adverse events was. In addition, male patients had slightly higher risk of an adverse event than female patients.Acupuncture is a safe therapy with low risk of adverse events in clinical practice. The risk factors for adverse events (AEs) were related to the patients' gender and age and the local anatomical structure of the acupoints. AEs could be reduced and mitigated by improving the medical environment, ensuring a high technical level of the acupuncture practitioners and establishing a good relationship of mutual trust between doctor and patient.ClinicalTrials.gov: NCT00599586, NCT00599677, NCT00608660.
| S-EPMC3072923 | biostudies-literature
Project description:Background/aimsTacrolimus is effective for refractory ulcerative colitis in adults, while data for children is sparse. We aimed to evaluate the effectiveness and safety of tacrolimus for induction and maintenance therapy in Japanese children with ulcerative colitis.MethodsWe retrospectively reviewed the multicenter survey data of 67 patients with ulcerative colitis aged < 17 years treated with tacrolimus between 2000 and 2012. Patients' characteristics, disease activity, Pediatric Ulcerative Colitis Activity Index (PUCAI) score, initial oral tacrolimus dose, short-term (2-week) and long-term (1-year) outcomes, steroid-sparing effects, and adverse events were evaluated. Clinical remission was defined as a PUCAI score < 10; treatment response was defined as a PUCAI score reduction of ≥ 20 points compared with baseline.ResultsPatients included 35 boys and 32 girls (median [interquartile range] at admission: 13 [11-15] years). Thirty-nine patients were steroid-dependent and 26 were steroidrefractory; 20 had severe colitis and 43 had moderate colitis. The initial tacrolimus dose was 0.09 mg/kg/day (range, 0.05-0.12 mg/kg/day). The short-term clinical remission rate was 47.8%, and the clinical response rate was 37.3%. The mean prednisolone dose was reduced from 19.2 mg/day at tacrolimus initiation to 5.7 mg/day at week 8 (P< 0.001). The adverse event rate was 53.7%; 6 patients required discontinuation of tacrolimus therapy.ConclusionsTacrolimus was a safe and effective second-line induction therapy for steroid-dependent and steroid-refractory ulcerative colitis in Japanese children.
| S-EPMC6821948 | biostudies-literature
Project description:ObjectivesTraditional approaches to safety and quality screening in the emergency department (ED) are porous and low yield for identifying adverse events (AEs). A better approach may be in the use of trigger tool methodology. We recently developed a novel ED trigger tool using a multidisciplinary, multicenter approach. We conducted a multicenter test of this tool and assess its performance.MethodsIn design and participants, we studied the ED trigger tool for a 13-month period at four EDs. All patients 18 years and older with Emergency Severity Index acuity levels of 1 to 3 seen by a provider were eligible. Reviewers completed standardized training modules. Each site reviewed 50 randomly selected visits per month. A first-level reviewer screened for presence of predefined triggers (findings that increase the probability of an AE). If no trigger is present, the review is deemed complete. When present, a trigger prompts an in-depth review for an AE. Any event identified is assigned a level of harm using the Medication Event Reporting and Prevention (MERP) Index, ranging from a near miss (A) to patient death (I). Events are noted as present on arrival or in the ED, an act of commission or omission, and are assigned one of four event categories. A second-level physician performs a confirmatory review of all AEs and independently reviews 10% of cases to estimate the false-negative rate. All AEs or potential AEs were reviewed in monthly group calls for consensus on findings. The primary outcome is the proportion of visits in which an AE is identified, overall and by site. Secondary outcomes include categories of events, distribution of harm ratings, and association of AEs with sociodemographic and clinical factors and triggers. We present sociodemographic data and details about AEs and results of logistic regression for associations of AEs with of triggers, sociodemographics, and clinical variables.ResultsWe captured 2594 visits that are representative, within site, of their patient population. Overall, the sample is 64% white, 54% female, and with a mean age of 51. Variability is observed between sites for age, race, and insurance, but not sex. A total of 240 events were identified in 228 visits (8.8%) of which 53.3% were present on arrival, 19.7% were acts of omission, and 44.6% were medication-related, with some variability across sites. A MERP F score (contributing to need for admission, higher level of care, or prolonged hospitalization) was the most common severity level (35.4% of events). Overall, 185 (77.1%) of 240 events involved patient harm (MERP level ≥ E), affecting 175 visits (6.7%). Triggers were present in 951 visits (36.6%). Presence of any trigger was strongly associated with an AE (adjusted odds ratio = 4.6, 95% confidence interval = 3.2-6.6). Ten triggers were individually associated with AEs (adjusted odds ratio = 2.1-7.7). Variability was observed across sites in individual trigger associations, event rates, and categories, but not in severity ratings of events. The overall false-negative rate was 6.1%.ConclusionsThe trigger tool approach was successful in identifying meaningful events. The ED trigger tool seems to be a promising approach for identifying all-cause harm in the ED.
| S-EPMC6343477 | biostudies-literature
Project description:To evaluate the clinical efficacy and safety of acupuncture and moxibustion for the treatment of active Crohn's disease (CD).Ninety-two patients were equally and randomly divided into the treatment group and received herb-partitioned moxibustion combined with acupuncture, and the control group received wheat bran-partitioned moxibustion combined with superficial acupuncture. The patients received three treatment sessions per week for 12 wk and were followed up for 24 wk. The main outcome was evaluated using the CD Activity Index (CDAI) score, and the secondary outcomes were evaluated using laboratory indicators such as hemoglobin (HGB), C-reactive protein (CRP), erythrocyte sedimentation rate, quality-of-life, endoscopic ratings, and intestinal histology scores.The CDAI scores of both the treatment and control groups were significantly reduced after treatment compared with those measured before treatment. However, the degree of improvement in the treatment group was significantly greater than that of the control group. The improvement in symptoms in patients of the treatment group was sustained at follow-up, whereas that of the control group was not. The overall efficacy of the treatment was significantly greater than that of the control. Both groups demonstrated significant improvements in quality-of-life ratings after treatment, but the improvement was significantly greater in the treatment group than in the control group. In addition, the patients in the treatment group showed significantly increased HGB and significantly decreased CRP levels and histopathological scores at the end of treatment, whereas the control group did not exhibit significant changes.Moxibustion with acupuncture provided significant therapeutic benefits in patients with active CD beyond the placebo effect and is therefore an effective and safe treatment for active CD.
| S-EPMC4138481 | biostudies-literature
Project description:In Japan, medical costs are increasing annually, and the increase in national medical costs, particularly in the direct cost of managing adverse drug events, is high. An in-depth understanding of these costs is important for their reduction. This study aimed to calculate the direct cost of managing adverse drug events in all ages, including older adults, and that of avoidable adverse drug events in older adults. We conducted a retrospective survey on patients aged 1 year or older who visited Gifu Municipal Hospital in Japan. We investigated and calculated the direct cost of managing adverse drug events and that of avoidable adverse drug events based on the Beers Criteria Japanese version (BCJ) and "Guidelines for medical treatment and its safety in the elderly 2015" (GMTSE-2015) in inpatients and outpatients. Among 6,504 patients, 11.1% visited the hospital or were hospitalized due to adverse drug events. The direct costs per patient with adverse drug events were 21,281 and 22,590 yen (166 and 176 euros as on September 13, 2021) for outpatients, and 853,175 and 874,582 yen (6,648 and 6,815 euros) for inpatients of all ages and older adults, respectively. The direct costs of avoidable adverse drug events per patient using drugs listed in the BCJ and GMTSE-2015 for older adults were 3,212 and 3,341 yen (25 and 26 euros) for outpatients, and 55,548 and 80,246 yen (433 and 625 euros) for inpatients, respectively. In sum, considering both inpatients and outpatients in the whole country, the direct costs of managing adverse drug events were 804.53 billion and 597.19 billion yen (6,269 million and 4,653 million euros) per year for all ages and older ages, respectively. The direct cost of avoidable adverse drug events in older adults was 83.43-258.44 billion yen (650-2,013 million euros) per year. We found that, in Japan, high medical costs are often caused by managing adverse drug events, and that the costs of avoidable adverse drug events in older adults based on the BCJ and GMTSE-2015 account for a substantial proportion of the medical cost. Therefore, by using the BCJ and GMTSE-2015, avoiding adverse drug events and reducing medical costs may be possible.
| S-EPMC8635725 | biostudies-literature