Neural mechanisms of acupuncture for peripheral facial nerve palsy: A protocol for systematic review and meta analysis.

BACKGROUND: Peripheral facial nerve palsy (PFNP) is a cranial neuropathy that occurs when the seventh facial nerve is damaged. PFNP seriously affects patients' quality of life, and approximately 30% of patients suffer from sequelae, such as unrecovered palsy, synkinesis, facial muscle contracture, and facial spasm. Many studies have confirmed the effectiveness of acupuncture for the treatment of PFNP. However, the specific mechanism remains unclear and needs to be further explored. Therefore, the purpose of this systematic review is to investigate the neural mechanisms underlying acupuncture treatment for PFNP using neuroimaging methods. METHODS: We will search all published studies from inception to March 2023 using the following databases: MEDLINE, Cochrane Library, EMBASE, CNKI, KMBASE, KISS, ScienceON, and OASIS. All clinical studies evaluating the effectiveness of acupuncture for treating PFNP using functional neuroimaging will be selected without language restrictions. Two reviewers will independently conduct the study selection, data extraction, and risk of bias assessment, according to a predetermined protocol. The outcomes, including the types of functional neuroimaging techniques, brain function alterations, and clinical outcomes, such as the House-Brackmann scale and Sunnybrook Facial Grading System, will also be analyzed. Coordinate-based meta-analysis and subgroup analyses will be performed if possible. RESULTS: This study will analyze the effect of acupuncture on brain activity alterations and clinical improvement in patients with PFNP using functional neuroimaging. CONCLUSION: This study will provide a comprehensive summary and help elucidate the neural mechanisms of acupuncture treatment for PFNP. PROSPERO REGISTRATION NUMBER: CRD42022321827.

Clinical use of thread embedding acupuncture for facial nerve palsy: A web-based survey.

Although thread embedding acupuncture (TEA) is widely used for facial nerve palsy (FNP) in Korea, it lacks clinical evidence. Therefore, a large-scale and long-term clinical trial is needed. It is necessary to standardize and optimize TEA treatment for clinical study. Hence, we collected information about how TEA in the facial region is performed in clinical practice using a web-based survey. A questionnaire was developed consisting of 22 essential items and 30 optional items including demographic characteristics, purpose of TEA, adverse events (AE), direct medical cost, required time, and current state of TEA treatment on FNP. The questionnaire was sent via e-mail to 23,910 traditional Korean medicine doctors (TKMD). A total of 427 respondents answered the questionnaire. The most common response for the purpose for TEA was cosmetic, followed by musculoskeletal disease and nervous system disease. The most common AE that resolved without medical treatment was bruising (90.4%). The most common AE that required medical treatment was dimple (30.5). Many respondents commonly used TEA for the sequelae of FNP (71.8%). The most frequent sequelae of FNP for which TEA was used as contracture around the mouth (75.3%). The most preferred treatment method was insertion of 6-10 monofilament threads using a 29-gauge needle at intervals of 2.2 ± 1.59 weeks in the sequelae period. The results of this survey can be used to standardize and optimize the procedure of TEA for FNP for further clinical research.

Erratum: Withdrawal notice to: Electroacupuncture plus moxibustion for major depressive disorder: A randomized, sham-controlled, pilot clinical trial.

[This corrects the article DOI: 10.1016/j.imr.2021.100802.].

Appraising the safety and reporting quality of thread-embedding acupuncture: a protocol for a systematic review and meta-analysis.

INTRODUCTION: Thread-embedding acupuncture (TEA) is a special type of acupuncture treatment in which medical threads are inserted into subcutaneous tissues or muscles at therapeutic points. TEA is a medical practice that combines acupuncture and medical threads. As such, it is necessary to evaluate the safety of TEA. This systematic review and meta-analysis aimed to assess the safety of TEA and reporting quality of studies regarding TEA. METHODS AND ANALYSIS: The systematic review will be conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and the Cochrane Handbook for Systematic Reviews of Interventions. Searching strategies will be systemically conducted using the following databases from their inception date to September 2022: MEDLINE, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), CiNii, J-STAGE, Korean Medical Database, Korean Studies Information Service System (KISS), ScienceON and Oriental Medicine Advanced Searching Integrated System (OASIS). The search strategies will be adjusted for each database as appropriate. The risk of bias will be assessed using the McMaster tool to identify the quality of harm assessment and reporting in study reports (McHarm). A meta-analysis will be used to synthesise the frequency and incidence of adverse events. ETHICS AND DISSEMINATION: No ethical approval and consent is required for this systematic review. The results of this systematic review will be disseminated through peer-reviewed publications and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42022297123.

Saam Acupuncture for Treating Functional Dyspepsia: A Feasibility Randomized Controlled Trial.

Objective: Functional dyspepsia (FD) is a common gastrointestinal disorder that significantly affects sufferers' quality of life and increases the economic burden on society. Saam acupuncture, a form of traditional Korean acupuncture, is frequently used to treat FD in Korean medicine clinical settings. This study aimed to evaluate the feasibility and preliminary effectiveness and safety of Saam acupuncture for treating FD. Methods: We conducted a pilot, pragmatic, assessor-blinded randomized controlled trial. Patients with FD according to the ROME III criteria were randomly allocated to an acupuncture plus usual care group or a usual care group. Saam acupuncture based on individualized FD and systemic symptoms was conducted in the acupuncture group three times per week for 4 weeks. Study feasibility outcomes, including recruitment, completion, and acupuncture adherence rates, were calculated. In addition, preliminary evaluation of participant responses to the intervention was tested using the gastrointestinal symptom (GIS), FD-related quality of life (FD-QoL), visual analog scale (VAS), patient global assessment (PGA), and EuroQol-5 Dimensions (EQ-5D) scores. Results: Twenty-four participants who met the eligibility criteria were included. The recruitment and completion rates of the clinical trials were 60% and 79.2%, and the acupuncture adherence rate was 83.3%. Although there was no significant difference between the two groups in the dyspepsia symptoms as measured by GIS, VAS, and PGA at Week 4, significant differences were found between the two groups at the follow-up assessments (Weeks 8 and 12). In particular, the early satiety subscore of GIS was significantly improved in the Saam acupuncture group compared with the usual care group at Week 4. The quality of life measured by FD-QoL and EQ-5D improved only in the Saam acupuncture group, although there were no significant differences between the two groups. No adverse events related to Saam acupuncture were reported. Conclusions: Saam acupuncture can be a feasible, preliminarily effective, and safe treatment for FD. Further confirmatory trials with a larger sample size are needed to confirm its effectiveness and safety. The trail is registered with CRIS-KCT0000164, URL: https://cris.nih.go.kr/cris/search/detailSearch.do/2098.

Electroacupuncture for Cancer-Related Cognitive Impairment: A Clinical Feasibility Study.

BACKGROUND: Cancer-related cognitive impairment (CRCI) is a significant problem for cancer patients, as the number of cancer survivors experiencing cognitive impairments is increasing in the absence of standard treatment. There have been attempts to improve the cognitive function of patients with cancer using acupuncture; however, no studies have been conducted using electroacupuncture. Thus, we designed a preliminary study to investigate the feasibility of a clinical trial using electroacupuncture in CRCI patients. METHODS: We conducted a single-arm, pilot, clinical trial to investigate the feasibility of a study protocol for further large-scale clinical trials of electroacupuncture in CRCI patients. All participants were treated with electroacupuncture twice a week for 30 minutes at a time, for 8 weeks on acupoints GV20, GV24, EX-HN1, and GB20, HT7, PC6, and KI3. Both subjective and objective outcomes of cognitive function, quality of life (QoL), and psychological factors were measured in all participants at baseline, week 4, 8, and 12. For safety assessment, vital signs, laboratory examinations, and adverse events (AEs) were observed throughout the trial. RESULTS: A total of 12 participants were enrolled at Daejeon and Dunsan Korean Medicine Hospital of Daejeon University from 21 April 2017 to 31 January 2018. After 8 weeks of treatment, electroacupuncture significantly improved both subjective and objective cognitive outcomes, including the perceived cognitive impairments scale of the Functional Assessment of Cancer Therapy-Cognitive Function, QoL scale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire-C30, Korean version of Montreal Cognitive Assessment, Boston Naming Test, Seoul Verbal Learning Test, and Rey Complex Figure Test. During the entire trial period, 19 AEs were observed, with no serious AEs. Additionally, it was found that all feasibility outcomes, including recruitment, completion, and adherence rates, achieved successful results as the ratio exceeded 0.8. CONCLUSION: Our study results revealed that electroacupuncture improved cognitive complaints in cancer patients, and we expect electroacupuncture to be a safe and effective management therapy for CRCI patients. These feasibility trial results will be used as preliminary data for future randomized controlled clinical trials. TRIAL REGISTRATION NUMBER: Korean Clinical Trial Registry (KCT0002168).

The effectiveness and safety of Wu tou decoction on rheumatoid arthritis: A protocol for systematic review and/or meta-analysis.

BACKGROUND: Rheumatoid arthritis (RA) is one of the common inflammatory diseases with arthritis due to a malfunction of the immune system. The treatments for RA include surgery, physiotherapy, occupational therapies, and medication. The representative treatment is medication and its usage has improved through several guidelines. However, it has some limitations and occurs adverse effects. Meanwhile, traditional Chinese medicine treatments have been used for RA treatment and Wu tou decoction (WTD) is one of them. Regardless of recent studies about WTD's efficacy on RA, there has been no systematic review on this issue. Therefore, this review will focus on the effectiveness and safety of WTD on RA. METHODS: The search for randomized controlled trial about WTD on RA will be performed using multiple electronic databases, manual searches, and the author's e-mail if necessary. According to predefined criteria, randomized controlled trials will be selected and summarization will be performed by the data on study participants, result measurements, interventions, adverse events, and risk of bias. Disease activity score including effective rate, swollen joint count, tender joint count, morning stiffness will be primary outcome measures while blood test about RA including erythrocyte sedimentation rate, C-reactive protein, rheumatoid factors, and adverse events will be secondary outcome measures. We will perform meta-analysis by using Review Manager software, assess the risk of bias by Cochrane Collaboration "risk of bias" tool, and determine the quality of evidence by Grades of Recommendation, Assessment, Development, and Evaluation. RESULTS: This study we will investigate the clinical evidence of the effectiveness and safety of WTD on RA. CONCLUSION: For the RA patients and clinicians, our study will be informative. It can be also a great help for the researchers and policy makers who concentrates on conservative management for RA. TRIAL REGISTRATION NUMBER: INPLASY; INPLASY202220099.

Electroacupuncture for treating cancer-related insomnia: a multicenter, assessor-blinded, randomized controlled, pilot clinical trial.

BACKGROUND: Insomnia is one of the most frequent symptoms in people with cancer. Electroacupuncture has been widely used in people with cancer or insomnia. We explored the feasibility and preliminary effectiveness of electroacupuncture for cancer-related insomnia. METHODS: People with cancer and insomnia disorder were randomly allocated to electroacupuncture, sham-electroacupuncture, or usual care groups. Participants received either 10 sessions of electroacupuncture at real acupoints, sham-electroacupuncture at non-acupoints, or usual care in each group for 4 weeks. We calculated the recruitment, adherence, and completion rates of participants. The Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), sleep diary and actigraphy-derived sleep parameters, Functional Assessment of Cancer Therapy-Fatigue (FACT-F), Montreal Cognitive Assessment (MoCA), and salivary levels of cortisol and melatonin were evaluated as outcome measures. RESULTS: Twenty-two participants were enrolled (8, 6, and 8 respectively in the electroacupuncture, sham-electroacupuncture, and usual care groups) and 20 participants completed the trials (8, 4, and 8 respectively). The recruitment, adherence, and completion rates were 78.57% (22/28), 95.45% (21/22), and 90.91% (20/22), respectively. Most of the participants had previously received conventional treatment for insomnia, but few had received Korean medicine treatment, without any demographic or clinical differences between groups. In the electroacupuncture group, there was a statistically significant reduction of 10.13 (mean) ± 8.15 (standard deviation) and 5 ± 3.70 points in mean ISI and PSQI scores at 4 weeks post-treatment (P = .0098 and .0066), compared with sham-electroacupuncture (2.06 ± 7.15 and 1.61 ± 4.34; P = .4796 and .3632) and usual care (3.25 ± 2.60 and 1.38 ± 2.13; P = .0096 and .1112). Although there was no significant difference in ISI score between groups at 4 weeks post-treatment, the electroacupuncture group continued to improve significantly at 4 weeks' follow-up, showing borderline and significant differences compared to the sham-electroacupuncture and usual care (P = .0614 and .0015). The FACT-F scores in electroacupuncture group showed a significant improvement compared with the sham-electroacupuncture group (P = .0305). No electroacupuncture-related adverse events were reported. CONCLUSIONS: Electroacupuncture might be feasible for cancer-related insomnia, despite slow participant recruitment. Additional trials with adequately powered sample sizes and a substantial change to the recruitment procedure are needed. TRIAL REGISTRATION: Clinical Research Information Service, KCT0002162 . Submitted 27 October 2016, Registered 2 December 2016 - Retrospectively registered (The first participant enrolment: 28 November 2016).

Effectiveness and safety of bee venom pharmacopuncture for rheumatoid arthritis: a systematic review protocol.

INTRODUCTION: Rheumatoid arthritis (RA) is the common autoimmune disease with low quality of life. The representative treatment is medication and medication usage has improved through update of clinical guidelines, however, there are still limitations. Bee venom (BV) has been reported to have meaningful therapeutic effects and the possibility of alternative options for RA through several types of studies, but there is no well-organised and recent published systematic review (SR). METHODS: We will search randomised controlled trials about the BV on RA from the inception to 31 May 2022 in various databases, manual research and contacting authors. Electronic databases will include MEDLINE, EMBASE, Cochrane library, China National Knowledge Infrastructure, CiNii, J-STAGE, KoreaMed, Korean Medical Database, Korean Studies Information Service System, National Digital Science Library, Korea Institute of Science and Technology Information and Oriental Medicine Advanced Searching Integrated System. With screening and reviewing process, we will identify the eligible studies and extract the needed data. The primary outcome will be the disease activity scores indicating the improvement of RA symptoms (American College of Rheumatology response criteria 20, 50, 70), functions (Health Assessment Questionnaire, Disease Activity Score of 28 joints), joint (Western Ontario and McMaster universities osteoarthritis index), pain (Visual Analogue Scale, Numerical Rating Scale) and effective rate. The secondary outcomes will be the RA-related blood test levels and adverse events. We will perform a meta-analysis by Review Manager software, the assessment of risk of bias by Cochrane Collaboration 'risk of bias' and the determination of quality of evidence by Grades of Recommendation, Assessment, Development and Evaluation. ETHICS AND DISSEMINATION: Our SR will suggest the clinical evidence of the use of BV for RA to patient, clinicians and policymakers. We will publish our results in a peer-review journal. PROSPERO REGISTRATION NUMBER: CRD42021238058.

Electroacupuncture plus moxibustion for major depressive disorder: A randomized, sham-controlled, pilot clinical trial.

BACKGROUND: The first treatment option for major depressive disorder (MDD) is antidepressants, however, there is substantial demand for alternative therapies due to its low compliance and remission rates. This study was aimed to explore the effectiveness, safety, and feasibility of electroacupuncture plus moxibustion therapy for MDD. METHODS: Thirty adults with MDD were randomly assigned to the treatment group (TG) or control group (CG). The TG was treated with electroacupuncture plus moxibustion, and the CG received sham interventions at non-acupoints for 8 weeks. The primary outcome measure was the intergroup difference of the mean change of total score of the Hamilton rating scale for depression (HRSD) between baseline and week 9. Secondary outcome measures were Beck's depression inventory, insomnia severity index, the state-trait anxiety inventory, the EuroQol-5 dimension index, the measure yourself medical outcome profile version 2, and frontal alpha asymmetry measured by electroencephalography. Adverse events (AEs) were monitored for safety assessment. RESULTS: The primary outcome measure was not significantly different between the two groups (p=0.2641), although the scores of HRSD in both groups improved significantly after treatment. No significant difference was identified between groups in secondary outcome measures. The incidence of AE was not significantly different between the two groups (p=0.1067). CONCLUSION: A clinical trial using electroacupuncture plus moxibustion for MDD seems feasible. However, further studies with the larger size, adopting ideal controls are warranted to provide a confirmative conclusion to the efficacy and safety of electroacupuncture plus moxibustion for MDD. TRIAL REGISTRATION: The protocol was registered at Korean Clinical Trial Registry (CRIS-KCT0001810).

Acupuncture for Psychosomatic Symptoms of Hwa-byung, an Anger Syndrome: A Feasibility Randomized Controlled Trial.

Objectives: Emerging studies found the potential effects of acupuncture for treating chronic pain and mental disorders, namely, depressive and anxiety disorders. Acupuncture is widely used for treating culture-related anger syndrome, Hwa-byung. This pilot trial aimed to investigate the feasibility of a clinical trial testing acupuncture for the psychosomatic symptoms of Hwa-byung. Methods: A total of 26 patients with Hwa-byung planned to be randomly assigned to the acupuncture or sham acupuncture groups. About 10 treatment sessions were applied over 4 weeks. The 100-mm visual analog scale was used to measure the six major Hwa-byung symptoms: stuffiness in the chest, heat sensations, pushing-up in the chest, feeling a mass in the throat, feelings of unfairness, and hard feelings. The criteria for assessing the success of this pilot trial were defined as improvement in three or more of the six Hwa-byung symptoms after treatment, with an effect size >0.2. Results: A total of 15 patients were finally included and randomly assigned to the acupuncture group (n = 7) or the sham acupuncture group (n = 8). After 10 treatment sessions, the Cohen's d effect sizes for acupuncture compared to sham acupuncture were >0.2 for each one of the six major Hwa-byung symptoms, which met our a priori criteria for success. Also, the effect size for the somatic symptoms of "stuffiness in the chest" was 0.81 (95% CI -0.40, 2.20), referring to a large effect size. Conclusions: Our results suggest that acupuncture treatment would be regarded as an acceptable intervention for a full-scale study of psychosomatic symptoms in patients with Hwa-byung. Trial Registration: cris.nih.go.kr, identifier: KCT0001732.

Correction: Choi et al. Feasibility and Effect of Electroacupuncture on Cognitive Function Domains in Patients with Mild Cognitive Impairment: A Pilot Exploratory Randomized Controlled Trial. Brain Sci. 2021, 11, 756.

The authors wish to make the following correction to [...].

Electroacupuncture plus moxibustion for major depressive disorder: A randomized, sham-controlled, pilot clinical trial.

BACKGROUND: The first treatment option for major depressive disorder (MDD) is antidepressants, however, there is substantial demand for alternative therapies due to its low compliance and remission rates. This study was aimed to explore the effectiveness, safety, and feasibility of electroacupuncture plus moxibustion therapy for MDD. METHODS: Thirty adults with MDD were randomly assigned to the treatment group (TG) or control group (CG). The TG was treated with electroacupuncture plus moxibustion, and the CG received sham interventions at non-acupoints for 8 weeks. The primary outcome measure was the intergroup difference of the mean change of total score of the Hamilton rating scale for depression (HRSD) between baseline and week 9. Secondary outcome measures were Beck's depression inventory, insomnia severity index, the state-trait anxiety inventory, the EuroQol-5 dimension index, the measure yourself medical outcome profile version 2, and frontal alpha asymmetry measured by electroencephalography. Adverse events (AEs) were monitored for safety assessment. RESULTS: The primary outcome measure was not significantly different between the two groups (p=0.2641), although the scores of HRSD in both groups improved significantly after treatment. No significant difference was identified between groups in secondary outcome measures. The incidence of AE was not significantly different between the two groups (p=0.1067). CONCLUSION: A clinical trial using electroacupuncture plus moxibustion for MDD seems feasible. However, further studies with the larger size, adopting ideal controls are warranted to provide a confirmative conclusion to the efficacy and safety of electroacupuncture plus moxibustion for MDD.

Feasibility and Effect of Electroacupuncture on Cognitive Function Domains in Patients with Mild Cognitive Impairment: A Pilot Exploratory Randomized Controlled Trial.

Although Electroacupuncture (EA) has been reported to be potentially effective for cognitive disorders, there is limited information about which domains of cognitive function can be improved by EA treatment. Sixty patients with MCI were randomly assigned (1:1:1) to groups to receive 24 sessions over 12 weeks of EA, sham EA, or usual care. In the EA group, electric stimulation was applied at bilateral PC6 and HT7. Various cognitive tests included in the Seoul Neuropsychological Screening Battery II (SNSB-II) were performed at baseline and post-treatment to explore effects of EA on five cognitive domains: attention, language, visuospatial function, memory, and frontal/executive function. Among 60 randomized participants (63.7 ± 7.1 years, 89.7% females), 45 (75%) completed the study. Of the five cognitive function domains of SNSB-II, the T score of visuospatial function showed a tendency to be higher in the EA group than in the usual care group at post-treatment assessment (mean difference: 10.16 (95% CI, 1.14, 19.18), Cohen's d = 0.72, p = 0.0283). According to the results of this pilot study, the estimated effect size of EA on the visuospatial function of MCI patients compared to usual care was medium. Large-scale clinical trials are needed to confirm effects of EA on cognitive functions.

Moxibustion for treating cancer-related fatigue: A multicenter, assessor-blinded, randomized controlled clinical trial.

Cancer-related fatigue (CRF) is one of the most common chronic symptoms experienced by cancer patients. As moxibustion is a popular traditional therapy for managing fatigue, it can be an alternative strategy to treat CRF as well. Therefore, we rigorously designed a full-scale, multicenter, assessor-blinded, randomized controlled trial to evaluate the efficacy and safety of moxibustion treatment for CRF. Ninety-six subjects suffering from CRF were recruited and randomly assigned to moxibustion group, sham moxibustion group, or usual care group. Both the moxibustion group and the sham group received moxibustion treatment for 8 weeks and the usual care group did not. Brief fatigue inventory (BFI) score and Functional Assessment of Cancer Therapy-Fatigue score were used to assess CRF at baseline and weeks 5, 9, and 13. Questionnaires for the assessment of cognitive impairment, quality of life, and Cold-Heat and Deficiency-Excess patterns were also evaluated. BFI scores significantly decreased in moxibustion group compared to the usual care group (mean difference of -1.92, p < 0.001 at week 9 and mean difference of -2.36, p < 0.001 at week 13). Although the sham group also showed significant improvement during the treatment period, only the moxibustion group showed improvement after 4 weeks of follow-up period (mean difference of -1.06, p < 0.001). There were no serious adverse events. Our findings confirmed the efficacy and safety of moxibustion for CRF compared to usual care. We also found that moxibustion has a prolonged treatment effect during 4 weeks of follow-up period.

Acupuncture for dry eye syndrome after refractive surgery: A randomized controlled pilot trial.

BACKGROUND: Dry eye syndrome is the most common complication of refractive surgery. Acupuncture is widely used for the treatment of ophthalmologic diseases, but to date, few have explored the effects of acupuncture for the treatment of this condition following refractive surgery. The objective of this study is to assess the feasibility of a study design for evaluating the effectiveness of acupuncture treatment along with usual care compared with usual care only for dry eye syndrome after refractive surgery. METHODS: A total of 18 patients with dry eye syndrome occurring after refractive surgery participated in this study. For 4 weeks, the acupuncture plus usual care and usual care only groups received treatment three times a week. A series of assessments, namely the ocular surface disease index (OSDI), visual analog scale for ocular discomfort, quality of life, tear film break-up time, Schirmer 1 test, and fluorescein-stained corneal-surface photography, along with other general assessments were carried out. RESULTS: Although preliminary, changes in OSDI from the baseline values were significantly different between the two groups at week 5 (p = 0.0003). There was a significant difference in the trends of OSDI changes between the acupuncture plus usual care and the usual care only groups (p = 0.0039). No serious adverse events were reported during the study. CONCLUSION: Four weeks of acupuncture treatment in addition to usual care is a feasible treatment for dry eye syndrome after refractive surgery. A full-scale randomized controlled trial is needed to confirm the clinical effectiveness of acupuncture.

A Randomized, Noninferiority Trial Comparing ICS + LABA with ICS + LABA + LAMA in Asthma-COPD Overlap (ACO) Treatment: The ACO Treatment with Optimal Medications (ATOMIC) Study.

BACKGROUND: Current guidelines for the treatment of asthma and chronic obstructive pulmonary disease overlap (ACO) recommend initial treatment using inhaled corticosteroids (ICSs) plus 1 or more bronchodilators. OBJECTIVE: To clarify which therapeutic effect is better between the ICS + long-acting ß2 agonist (LABA) and ICS + LABA + long-acting muscarinic antagonist (LAMA) treatment in patients with ACO. METHODS: We conducted a multicenter, 48-week, randomized, noninferiority trial. Patients with ACO were enrolled if they were treated with a moderate to high dose of ICS + LABA. In total, 303 patients were involved in the present trial, with 149 receiving ICS + LABA + LAMA. The primary end point was the time to first exacerbation. Secondary outcomes included changes in FEV1, forced vital capacity, FEV1/forced vital capacity ratio, asthma control, blood eosinophil count, and fractional exhaled nitric oxide. RESULTS: In the ICS + LABA treatment group, 29 of 154 patients (18.83%) experienced exacerbation, whereas 28 of 149 patients (18.79%) experienced exacerbation in the ICS + LABA + LAMA treatment group. The results of this noninferiority study were ultimately inconclusive (hazard ratio, 1.1; 95% CI, 0.66-1.84). However, the patients treated with the addition of LAMA showed significant improvements in FEV1 and forced vital capacity (P < .001). Asthma control did not improve in either group. CONCLUSIONS: Although this study was unable to conclude that ICS + LABA treatment is not inferior to ICS + LABA + LAMA in terms of exacerbation, it is obvious that the ICS + LABA + LAMA treatment group had improved lung function in ACO.

Efficacy and Safety of Electroacupuncture for Insomnia Disorder: A Multicenter, Randomized, Assessor-Blinded, Controlled Trial.

PURPOSE: To evaluate the efficacy and safety of electroacupuncture in treating insomnia. PATIENTS AND METHODS: In a multicenter, randomized, assessor-blinded, controlled trial, 150 patients with DSM-5-diagnosed insomnia with Insomnia Severity Index (ISI) scores ≥ 15 were randomly assigned to three different groups that underwent 10 sessions of electroacupuncture, sham-electroacupuncture, or usual care for 4 weeks from October 2015 to June 2016 at four Korean medicine hospitals, Republic of Korea. The primary outcome included the ISI score at Week 4; the secondary outcomes included evaluations of Pittsburgh Sleep Quality Index (PSQI), sleep diary, Hospital Anxiety and Depression Scale (HADS), EuroQoL five dimension (EQ-5D), Patient Global Impression of Change (PGIC), and salivary melatonin and cortisol levels. Assessments were performed at baseline (Week 0) and at Weeks 2, 4, 8, and 12. RESULTS: Compared with the usual care group, electroacupuncture group showed a greater improvement in ISI, PSQI, sleep diary-derived variables and HADS and EQ-5D scores at Week 4. The effects mostly persisted until Week 12. There were no significant differences between electroacupuncture and sham-electroacupuncture groups at Week 4 in all outcome measures, except sleep diary-derived sleep efficiency. However, the ISI score showed a significant difference between these groups at Weeks 8 and 12. Treatment success as per PGIC was significantly and borderline higher for electroacupuncture compared with usual care and sham-electroacupuncture, respectively. No significant changes in salivary melatonin and cortisol levels before and after treatment were observed in all groups. No serious adverse events were reported. Blinding was maintained in the sham-electroacupuncture group. CONCLUSION: Ten sessions of electroacupuncture can improve the sleep quality of patients with insomnia without serious adverse effects. Thus, it can be recommended as an effective, safe, and well-tolerated intervention.