Safety and efficacy of acupuncture for mild cognitive impairment: a study protocol for clinical study.

Background: Mild cognitive impairment (MCI) is an intermediary condition between typical cognitive decline that occurs owing to aging and dementia. It is necessary to implement an intervention to slow the progression from MCI to Alzheimer's disease. This manuscript reports the protocol for a clinical trial on the effect of acupuncture in patients with MCI. Methods: The trial will be a randomized, prospective, parallel-arm, active-controlled trial. Sixty-four patients with MCI will be randomized to the Rehacom or acupuncture group (n = 32 each). The participants in the acupuncture group will receive electroacupuncture at GV24 (Shenting) and GV20 (Baihui) and acupuncture at EX-HN1 (Sishencong) once (30 min) a day, twice per week for 12 weeks. The patients in the Rehacom group will receive computerized cognitive rehabilitation using RehaCom software once (30 min) daily, twice weekly for 12 weeks. The primary outcome measure is the change in the Montreal Cognitive Assessment Scale score. The secondary outcome measures are the Geriatric Depression Scale, Alzheimer's Disease Assessment Scale-Korean version-cognitive subscale-3 scores, and European Quality of Life Five Dimensions Five Level Scale. The safety outcomes will include the incidence of adverse events, blood pressure, blood chemistry parameters, and pulse rate. The efficacy outcome will be assessed at baseline and at six weeks, 13 weeks, and 24 weeks after baseline. Discussion: The findings of this protocol will provide information regarding the effects of acupuncture on MCI. Clinical trial registration: https://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&focus=reset_12&search_page=M&pageSize=10&page=undefined&seq=25579&status=5&seq_group=25579, KCT0008861.

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.].

Combination therapy with tamsulosin and traditional herbal medicine for lower urinary tract symptoms due to benign prostatic hyperplasia: A double-blinded, randomized, pilot clinical trial.

OBJECTIVES: To evaluate the efficacy and safety of tamsulosin and Hachimijiogan or Ryutanshakanto in patients with lower urinary tract symptoms due to benign prostatic hyperplasia. METHODS: A prospective, randomized, double-blind method was used to determine the efficacy and safety of the combination or placebo at baseline and 4, 8, and 12 weeks of study. The International Prostate Symptom Score, quality of life index, complete voiding diary, and National Institutes of Health-Chronic Prostatitis Symptom Index were studied. Uroflowmetery and postvoid residual urine volume were measured and compared. Laboratory tests including prostate-specific antigen were performed. RESULTS: In all groups, International Prostate Symptom Score and quality of life showed improvement, but no significant differences were shown among the groups. Prostate volume increased after treatment, and uroflowmetric parameters showed improvements after treatment without significance among the three groups. The total score of the National Institutes of Health-Chronic Prostatitis Symptom Index showed a significant improvement in all groups, without significant differences among the groups. Only the pain sub-score of the National Institutes of Health-Chronic Prostatitis Symptom Index showed a significant decrease in the tamsulosin with Ryutanshakanto group compared to the control group. A total of 11 adverse reactions occurred, but they were mild and not related to the study drugs. CONCLUSION: Ryutanshakanto can provide pain relief in patients with chronic prostatitis and chronic pelvic pain syndrome. If more research is conducted, Hachimijiogan and Ryutanshakanto may be applied as add-on treatments in patients with storage symptoms with alpha-blocker monotherapy.

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).

Feasibility and Effectiveness of Assessing Subhealth Using a Mobile Health Management App (MibyeongBogam) in Early Middle-Aged Koreans: Randomized Controlled Trial.

BACKGROUND: Mobile health (mHealth) is a major source of health management systems. Moreover, the demand for mHealth, which is in need of change due to the COVID-19 pandemic, is increasing worldwide. Accordingly, interest in health care in everyday life and the importance of mHealth are growing. OBJECTIVE: We developed the MibyeongBogam (MBBG) app that evaluates the user's subhealth status via a smartphone and provides a health management method based on that user's subhealth status for use in everyday life. Subhealth is defined as a state in which the capacity to recover to a healthy state is diminished, but without the presence of clinical disease. The objective of this study was to compare the awareness and status of subhealth after the use of the MBBG app between intervention and control groups, and to evaluate the app's practicality. METHODS: This study was a prospective, open-label, parallel group, randomized controlled trial. The study was conducted at two hospitals in Korea with 150 healthy people in their 30s and 40s, at a 1:1 allocation ratio. Participants visited the hospital three times as follows: preintervention, intermediate visit 6 weeks after the intervention, and final visit 12 weeks after the intervention. Key endpoints were measured at the first visit before the intervention and at 12 weeks after the intervention. The primary outcome was the awareness of subhealth, and the secondary outcomes were subhealth status, health-promoting behaviors, and motivation to engage in healthy behaviors. RESULTS: The primary outcome, subhealth awareness, tended to slightly increase for both groups after the uncompensated intervention, but there was no significant difference in the score between the two groups (intervention group: mean 23.69, SD 0.25 vs control group: mean 23.1, SD 0.25; P=.09). In the case of secondary outcomes, only some variables of the subhealth status showed significant differences between the two groups after the intervention, and the intervention group showed an improvement in the total scores of subhealth (P=.03), sleep disturbance (P=.02), depression (P=.003), anger (P=.01), and anxiety symptoms (P=.009) compared with the control group. CONCLUSIONS: In this study, the MBBG app showed potential for improving the health, especially with regard to sleep disturbance and depression, of individuals without particular health problems. However, the effects of the app on subhealth awareness and health-promoting behaviors were not clearly evaluated. Therefore, further studies to assess improvements in health after the use of personalized health management programs provided by the MBBG app are needed. The MBBG app may be useful for members of the general public, who are not diagnosed with a disease but are unable to lead an optimal daily life due to discomfort, to seek strategies that can improve their health. TRIAL REGISTRATION: Clinical Research Information Service KCT0003488; https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=14379.

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.

Low nutritional status links to the prevalence of pre-metabolic syndrome and its cluster in metabolically high-risk Korean adults: A cross-sectional study.

ABSTRACT: Diet plays a crucial role as a modifiable risk factor related to the development of metabolic syndrome (MetS) and its cluster. Constitution type of traditional Korean medicine has shown accuracy to predict the risk for MetS. We attempted to examine the association between nutritional status, pre-MetS, and its cluster in Korean adults by their constitution type.Participants aged 30 to 55 years who had no cancer or cardiovascular diseases (CVDs) were assigned to join in the present study. Pre-MetS was defined as ≥2 of the following factors: abdominal obesity; elevated triglycerides (TG); reduced high-density lipoprotein cholesterol (HDL-C); elevated blood pressure (BP); and elevated fasting plasma glucose (FPG). Constitution type was categorized into Tae-Eumin (TE) or non-TE. Dietary assessment of the subjects were surveyed using a short-form of the food frequency questionnaire (FFQ) and the nutrition quotient (NQ), which uses 4 factors, namely, balance, diversity, moderation, and dietary behavior.A total of 986 subjects were evaluated by constitution type with MetS status. Of these subjects, 48.6% had pre-MetS, 89.5% were obese and had the highest waist circumference (WC) in Pre-MetS TE. BP, FPG, TG were higher, while HDL-C was lower, than normal TE or non-TE both in Pre-MetS TE and non-TE. The prevalence of pre-MetS was positively associated with lower status of dietary behavior (odds ratio [ORs]: 2.153, 95% confidence interval [CI]: 1.179-3.931) while negatively related to higher vegetables and fruits intakes (ORs: 0.594, 95% CI: 0.359-0.983) in TE. Lower status of NQ had about 2 times higher risk of Pre-MetS (ORs: 1.855, 95% CI: 1.018-3.380) and abdominal obesity (ORs: 2.035, 95% CI: 1.097-3.775) in TE compared with higher status of NQ after controlling for covariates.Poor diet was a key contributor to the development of Pre-MetS and abdominal obesity in Korean adults with TE. Customized nutrition care and integrated medicinal approaches are strongly suggested to conduct optimal preventive care for people who are vulnerable to health risk.

Effects of Acupuncture on Lowering Blood Pressure in Postmenopausal Women with Prehypertension or Stage 1 Hypertension: A Propensity Score-Matched Analysis.

Postmenopausal women have a higher prevalence of hypertension compared to premenopausal women. Hypertension is a risk factor for cardiovascular diseases, the prevalence of which is ever increasing. This study investigated the effects of long-term acupuncture on lowering the blood pressure of postmenopausal women with prehypertension and stage 1 hypertension. Participants were 122 postmenopausal women aged less than 65 years, diagnosed with prehypertension or stage 1 hypertension (systolic blood pressure 120-159 mmHg or diastolic blood pressure 80-99 mmHg). We used a propensity score-matched design. The experimental group (n = 61) received acupuncture for four weeks every six months over a period of two years. The control group (n = 61) received no intervention. An Analysis of covariance (ANCOVA) was performed for the primary efficacy analysis. Relative risk ratios were used to compare group differences in treatment effects. Acupuncture significantly reduced the participants' diastolic blood pressure (-9.92 mmHg; p < 0.001) and systolic blood pressure (-10.34 mmHg; p < 0.001) from baseline to follow-up. The results indicate that acupuncture alleviates hypertension in postmenopausal women, reducing their risk of developing cardiovascular diseases and improving their health and quality of life.

Lifestyle, genomic types and non-communicable diseases in Korea: a protocol for the Korean Medicine Daejeon Citizen Cohort study (KDCC).

INTRODUCTION: Non-communicable diseases (NCDs) are the leading cause of death worldwide, including in Korea; thus, customised techniques for chronic disease management for the prevention, early diagnosis and treatment of NCDs are crucial. The Korean Medicine Daejeon Citizen Cohort (KDCC) study has been tasked with developing precise health promotion model for preventing and managing chronic diseases that considers individual traits, lifestyle factors and clinical data based on traditional Korean medicine. METHODS AND ANALYSIS: The KDCC study is a prospective cohort study of the community-based population in Korea. This study will sample 2000 adults aged 30-55 years in Daejeon area using stratified cluster sampling. The baseline survey began in 2017 and was completed in 2019, and follow-up surveys will be conducted three times every 2 years until 2025. In follow-ups, factors related to cardiovascular disease, metabolic syndrome and relevant diseases, as well as respondents' health status information, will be examined via questionnaire surveys and health examinations. DISCUSSION: The KDCC study will investigate the effects of an interaction of Korean medicine type with genome based, lifestyle and various clinical information on chronic diseases and individuals' health status using longitudinal epidemiological data. These findings are expected to inform the development of tailored health promotion programmes based on precision Korean medicine. TRIAL REGISTRATION NUMBER: KCT0004297.

Nonsurgical integrative inpatient treatments for symptomatic lumbar spinal stenosis: a multi-arm randomized controlled pilot trial.

BACKGROUND: Lumbar spinal stenosis (LSS) is a chronic condition that causes low back pain and neurogenic claudication, often resulting in significant limitation of daily activities. In this open-label randomized controlled pilot study, we assessed the safety and feasibility of 4-week novel integrative inpatient treatments for LSS. METHODS: Thirty-six symptomatic LSS patients were randomly and equally allocated to one of the three groups: Mokhuri Chuna treatment 1 (MT1) group, Mokhuri Chuna treatment 2 (MT2) group, or conventional management treatment (CMT) group. MT1 patients were treated with herbal medication, Mokhuri Chuna, and acupuncture, and received daily physician consultation; MT2 patients were treated with Mokhuri Chuna and acupuncture without any herbal medication, and received daily physician consultation; and CMT patients received conventional pain management therapy that included epidural steroid injection, oral NSAID, and muscle relaxant medication, along with daily physiotherapy. The primary outcome of this pilot study was safety as measured by the type and incidence of adverse events (AEs). The secondary outcome measures included VAS score for low back pain and leg pain, Oswestry Disability Index, Oxford Claudication Score (OCS), walking capacity on a 50 m flat track and treadmill, and EuroQol-5D score. Magnetic resonance imaging was also performed up to 6 months after treatment cessation. RESULTS: Thirty-four treated patients were included in the analysis, based on the modified intention-to-treat principle. No serious AEs were observed or reported. Compared to the CMT group, the MT1 and MT2 groups did show significant improvement at 3 and 6 months in various domains, including pain (VAS score for leg and back pain) and function (OCS and treadmill walking). CONCLUSION: These novel multimodal integrative treatments for LSS are both clinically safe and logistically feasible. Larger, adequately powered randomized controlled trials will be necessary to assess comparative efficacy and thoroughly analyze the cost-effectiveness of each treatment approach. CLINICAL TRIAL REGISTRATION NUMBER CRIS: KCT0001218.

Effects of acupuncture in postmenopausal women with prehypertension or stage 1 hypertension: study protocol for a prospective, comparative, interventional cohort study.

BACKGROUND: Hypertension is a major cause of cardiovascular disease and associated mortality, and postmenopausal women are at a high risk of hypertension. We aim to investigate the hypotensive effect and safety of acupuncture, focusing on postmenopausal women with prehypertension and stage 1 hypertension. In addition, we aim to investigate whether the effect of acupuncture treatment differed, depending on Sasang Constitution and cold-heat pattern. METHODS: This study is designed as an intervention cohort study. Two hundred postmenopausal women aged <65 years with prehypertension or stage 1 hypertension living in Daejeon city in Korea will be recruited, and randomly assigned to either an acupuncture or no-treatment control group. The intervention will consist of four sessions; one session will include acupuncture performed 10 times for 4 weeks. There will be a 20-week observation period after each session, and the total study duration will be 96 weeks. Acupuncture will be applied at the bilateral Fengchi (GB20), Quchi (LI11), Zusanli (ST36), and Sameumgyo (SP6) acupoints. The effect of acupuncture will be evaluated by comparing the change in systolic and diastolic blood pressure between the acupuncture and control groups every 4 weeks until the end of the study. DISCUSSION: To evaluate the success of blood pressure management, long-term observation is required, but no long-term studies have been conducted to evaluate the effect of acupuncture on blood pressure in postmenopausal women. To our knowledge, this study will be the first long-term study to investigate this issue for more than 6-8 weeks.

Electroacupuncture for insomnia disorder: study protocol for a randomized controlled trial.

BACKGROUND: Insomnia is a common sleep disorder that affects many adults either transiently or chronically. The societal cost of insomnia is on the rise, while long-term use of current drug treatments can involve adverse effects. Recently, electroacupuncture (EA) has been used to treat various conditions including insomnia. The objective of this study is to provide scientific evidence for the effect and safety of using EA to treat insomnia. METHODS/DESIGN: In this multicentre, assessor-blind, three-arm, parallel-design, randomised controlled trial, 150 participants will be assigned to the EA group, the sham EA (SEA) group, or the usual care group. The EA and SEA groups will receive the specific treatments 2-3 times a week for 4 weeks, for a total of 10 sessions, whereas the usual care group will not receive EA and will continue with usual care during the same time period. The primary outcome measure will be changes in the Insomnia Severity Index 5 weeks after randomisation. The secondary outcomes will include the Pittsburgh Sleep Quality Index, the Hospital Anxiety and Depression Scale, a sleep diary, the EuroQoL-5 dimension questionnaire, the levels of melatonin and cortisol, and the Patient Global Impression of Change. Safety will be assessed at each visit. DISCUSSION: The results of this multicentre randomised controlled trial will contribute to provide rigorous clinical evidence for the effects and safety of EA for insomnia disorder. TRIAL REGISTRATION: Korean Clinical Trial Registry, CRIS, KCT0001685 . Registered on 2 November 2015 (retrospectively registered). Date of enrolment of the first participant to the trial 13 October 2015.

Electroacupuncture plus moxibustion therapy for patients with major depressive disorder: study protocol for a randomized controlled trial.

BACKGROUND: Major depressive disorder (MDD) is one of the most prevalent mental health disorders and has a significant societal economic burden. Antidepressants and cognitive behavioral therapy are two primary interventions for the standardized treatment of MDD. However, their weaknesses, such as a low response rate, a high risk of adverse events from medication, and the high cost of cognitive behavioral therapy, have resulted in a need for complementary and alternative medicine (CAM). Among the various therapeutic interventions in CAM, electroacupuncture and moxibustion have been widely used to treat various mental illnesses, including MDD. The aim of this study is to evaluate the feasibility of conducting a full-scale randomized controlled trial to investigate the efficacy and safety of electroacupuncture plus moxibustion therapy for MDD. METHODS/DESIGN: We will include patients between the ages of 19 to 65 years with MDD. A total of 30 participants will be recruited, and they will be randomly allocated into two groups at a 1:1 ratio. Patients in the treatment and control groups will, respectively, receive real and sham electroacupuncture/moxibustion treatments, for a total of 20 sessions over 8 weeks. The primary outcome will be the Hamilton Rating Scale for Depression, and the secondary outcomes will be Beck's Depression Inventory, the Insomnia Severity Index, the State-Trait Anxiety Inventory, the EuroQol 5-Dimension Index, the Measure Yourself Medical Outcome Profile version 2, and electroencephalography. Adverse events will be monitored at each visit to assess safety. All outcomes will be assessed and analyzed by researchers blinded to the treatment allocation. DISCUSSION: This is a two-armed, parallel-design, patient-assessor blinded, multicenter, randomized, sham-controlled pilot clinical trial. Data will be analyzed before and after treatment and during a 4-week follow-up. The results of the trial will provide a basis for further studies assessing the efficacy and safety of electroacupuncture plus moxibustion treatment for MDD. TRIAL REGISTRATION: Korean Clinical Trial Registry, CRIS-KCT0001810 . Registered on 5 February 2016 (retrospectively registered; date of enrollment of the first participant to the trial: 2 December 2015).

Nonsurgical Korean Integrative Treatments for Symptomatic Lumbar Spinal Stenosis: A Three-Armed Randomized Controlled Pilot Trial Protocol.

This is a study protocol for a pilot three-armed randomized controlled trial on nonsurgical integrative Korean medicinal treatment for symptomatic lumbar spinal stenosis (LSS). Thirty-six participants who have been diagnosed with (LSS) and recommended for spinal surgery by neurosurgeons or orthopedics and have had spinal symptoms such as severe low back pain and neurological claudication regardless of at least three months of conservative treatments will be recruited. Participants will be randomly assigned to be one of the three intervention groups, including the Mokhuri treatment program group 1 or 2 or usual care group. All treatments will be administered in inpatient units over a period of 4 weeks. The primary outcomes are 0 to 100 Visual Analogue Scales for low back pain and leg pain and the secondary outcomes are Oswestry Disability Index; EQ-5D; Roland-Morris Disability Questionnaire; Oxford Claudication Score; physical function test, including treadmill test, walking duration, and distance assessment for free leg pain; radiologic testing; and adverse events which will be assessed during the 4-week treatment period as well as after 3 and 6 months of follow-up. Then, we will assess the feasibility of the clinical trial design as well as a nonsurgical integrative treatment program. This trial is registered with CRIS registration number: KCT0001218.

Factors affecting the quality of life of middle-aged women suffering Hwa-Byung.

AIMS AND OBJECTIVES: To test a staged theoretical model designed to explain causal relationships affecting the quality of life (QOL) of middle-aged Korean women suffering from Hwa-Byung (HB). BACKGROUND: The model contains three stages comprised of antecedents (stage 1), perception (stage 2) and outcome variable (stage 3). Stage 1 contains individual characteristic and emotional distress variables. In stage 2, the perception variable is depression (DEP). In stage 3, the outcome factor is QOL. Design. A cross-sectional, descriptive design was used. METHODS: A convenience sample of 135 community dwelling middle-aged women was recruited over a five-month period in the neuropsychology outpatient clinic at an Oriental hospital in Korea. The instruments were the Korean version of WHO Quality of Life-BREF (WHOQOL-BREF), Korean version of State-Trait Anger Expression Inventory (STAXI-K), The Korean version of State-Trait Anxiety Inventory (STAI-K) and Korean version of Beck Depression Inventory (K-BDI). RESULTS: Forty-five per cent of the variance in the QOL of women with HB was explained by the direct effect of depression (ß = -0·356, p = 0·000) and trait anxiety (ß = -0·324, p = 0·001). State anger (ß = 0·429, p = 0·000) and spouse (ß = -0·180, p = 0·021) explained 45·0% of the variance in (of) depression. CONCLUSION: The findings showed that depression mediates the relationship between the emotional distress and QOL as a negative outcome. RELEVANCE TO CLINICAL PRACTICE: These relationships can guide researchers and psychiatric mental health nurses to understand depression as a mediating factor and to develop nursing interventions to improve QOL of HB women.