Herbal Medicines for Post-Acute Sequelae (Fatigue or Cognitive Dysfunction) of SARS-CoV-2 Infection: A Phase 2 Pilot Clinical Study Protocol.

Long-term sequelae refer to persistent symptoms or signs for >6 months after SARS-CoV-2 infection. The most common symptoms of sequelae are fatigue and neuropsychiatric symptoms (concentration difficulty, amnesia, cognitive dysfunction, anxiety, and depression). However, approved treatments have not been fully established. Herbal medicines are administered for 12 weeks to patients who continuously complain of fatigue or cognitive dysfunction for >4 weeks that only occurred after COVID-19 diagnoses. Based on the Korean Medicine syndrome differentiation diagnosis, patients with fatigue will be administered Bojungikgi-tang or Kyungok-go, whereas those with cognitive dysfunction will be administered Cheonwangbosim-dan. Results could support evidence that herbal medicines may mitigate fatigue and cognitive dysfunction caused by COVID-19. Furthermore, by investigating the effects of herbal medicines on changes in metabolite and immune response due to COVID-19, which may be responsible for sequelae, the potential of herbal medicines as one of the therapeutic interventions for post-acute sequelae of SARS-CoV-2 infection can be evaluated. Therefore, the effects of herbal medicine on fatigue and cognitive dysfunction sequelae due to COVID-19 will be elucidated in this study to provide an insight into the preparation of medical management for the post-acute sequelae of SARS-CoV-2 infection.

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.

KCl Extracted from Chlorine Bypass Dust as Activator for Plain Concrete.

This study demonstrated the use of KCl separated from chlorine bypass dust (CBD) as an activator for plain concrete. The separated KCl was mixed with either ground granulated blast-furnace slag (BFS) alone, or a mixture of BFS and cement. The mixed paste of separated KCl and BFS set within 24 h, and exhibited a compressive strength of 22.6 MPa after 28 d. The separated KCl, cement, and BFS mixture exhibited a more rapid setting and a higher initial activity. Further, the compressive strength at 28 d was 57.7 MPa, which was 26.2% higher than that of the mixture without the activator. Water curing of samples with added separated KCl led to the generation of hydrocalumite, or Friedel's salt. However, this hydrocalumite was decomposed while being cured under autoclave conditions at 180 °C. Overall, KCl was an effective activator for composite materials containing cement, and resulted in superior properties compared to mineral admixtures without an activator.

Effects of cigarette smoke on Haemophilus influenzae-induced otitis media in a rat model.

Exposure to cigarette smoke (CS) is a factor that could delay or worsen the recovery of otitis media (OM) by causing inflammatory swelling of the Eustachian tube (ET). However, despite the suggested relationship, little is known about the association between OM and CS. Therefore, we aimed to evaluate the effects of CS on the development, progression, and recovery of OM, as well as the histological and molecular changes caused by CS exposure, by using a rat model of OM infected with non-typeable Haemophilus influenzae (NTHi). Eighty Sprague-Dawley rats with normal middle ears (MEs) were divided into four groups (n = 20 rats/group): control, CS, OM, and CS + OM. The CS and CS + OM groups were exposed to CS for 2 weeks. The inflammatory reaction to NTHi was more intense and lasted longer in the CS + OM group than in the other groups. Goblet cell proliferation and mucus secretion in the ET were more significant in the CS and CS + OM groups than in the other groups. These findings suggested that because CS directly affects the ET and ME mucosa, bacterial OM can become more severe and may resolve more slowly in the presence of CS exposure rather than in its absence.

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.

Complementary and Alternative Medicine Use in Amyotrophic Lateral Sclerosis Cases in South Korea.

Patients with amyotrophic lateral sclerosis (ALS) sometimes consider complementary and alternative medicine (CAM) because of ineffective treatment. This study investigated the prevalence and utilization pattern of CAM among patients with ALS in South Korea. Participants were recruited through homecare services for mechanical ventilation in South Korea. This study comprised a face-to-face cross-sectional survey with staff members available to address any queries. Fifty-five participants were included; all had used >1 CAM treatment option for ALS symptoms. Dietary treatments were most common, followed by functional food and massages. Most participants had obtained relevant information from family members or friends. The main reason for CAM use was an expectation that symptoms will improve with CAM; most patients were unsure of the effects. CAM use was previously discontinued by the majority of patients because of unsatisfactory effects. The mean expenditure on CAM was 288,385.28 ± 685,265.14 won per month, and the mean duration of CAM use was 11.54 ± 20.09 months. The results indicate that there is a high prevalence of CAM use among ALS patients. Healthcare providers should inquire about CAM use and openly provide accurate CAM information. Further evidence of CAM efficacy is required, as is specific guidance for consulting ALS patients regarding CAM.

Low early posttransplant serum tacrolimus levels are associated with poor patient survival in lung transplant patients.

BACKGROUND: Low-dose tacrolimus-based immunosuppression is a standard therapy in kidney and liver transplantation; however, the optimal therapeutic level of tacrolimus has not been established in lung transplantation. We aimed to identify the tacrolimus level associated with better outcomes in lung transplant patients. METHODS: This retrospective study included patients who underwent lung transplantation at Seoul National University Hospital between 2006 and 2016. Kaplan-Meier survival analysis and Cox regression were performed according to tacrolimus levels at several time-points within 1-year posttransplantation. RESULTS: A total of 43 patients received bilateral lung transplantation. The median age was 53 years and the median follow-up was 20.5 months. Overall and 1-year patient survival rates were 55.8% and 74.4%, respectively. Infection was the most common cause of death (78.9%). Chronic lung allograft dysfunction was observed in 16.3%. A tacrolimus level <9 ng/ml at 1 month was associated with lower rejection-free survival (P = 0.009). A time-averaged tacrolimus level <10 ng/ml within 1 month posttransplantation was an independent risk factor for poor patient survival (hazard ratio: 4.904; 95% confidence interval: 1.930-12.459; P= 0.001). Furthermore, higher tacrolimus levels did not increase infectious complications. CONCLUSIONS: These finding suggest that tacrolimus levels ≥10 ng/ml within 1 month after lung transplantation appear to be associated with better patient survival.

Case study projects by a Korean national research agency: Past 12 years and future.

OBJECTIVES: Scientific rigor is a known challenge to establish in heavily individualized practices of traditional medicine. A national research agency in Korea carried out a 12-year project to promote case reports among clinics of Korean Medicine (KM). This report aims at providing challenges, achievements, and thoughts for future endeavors. METHODS: We reviewed all the projects executed by the Korea Institute of Oriental Medicine between 2005 and 2017 promoting case reports in clinics of KM. The findings were categorized stage of project development, themes of project stage, achievement, and challenges. RESULTS: The implemented studies include eleven prospective- and five retrospective - case series, and one comparative trial. The project stages are divided into four, initial (surveying and building a database on Korean acupuncture), transitional (educating Korean Medicine doctors on writing case reports and building a case report system), stagnation (partially attributable to IRB's considering case report projects as clinical trial) and resurrection (building a rigorous evidence base from local clinics). The major challenges included practitioners' in clinics feeling burdened by the rigor of documentation requirement, the limited options of usable objective measurement tools available at general KM, and IRB's categorizing case report projects as clinical trials hence imposing unrealistic compliance burden. CONCLUSIONS: Promoting case reports in local clinics, while being warranted to remain as a crucial research method to build evidence based KM practice, requires supports from stakeholders including motivated clinicians of KM, extended use of diagnostic device available at KM practice, and insightful and flexible regulatory bodies' decision making.

Moxibustion for prehypertension and stage I hypertension: a pilot randomized controlled trial.

BACKGROUND: Prehypertension and hypertension are associated with cardiovascular disease, ischemic heart disease, and stroke morbidity. The purpose of this study is to evaluate the effectiveness and safety of moxibustion in patients with prehypertension or hypertension. METHODS: Forty-five subjects with prehypertension or stage I hypertension were randomized into three groups: moxibustion treatment group A (2 sessions/week for 4 weeks), moxibustion treatment group B (3 sessions/week for 4 weeks), and control group (nontreated group). The primary outcome measure was the change in blood pressure after 4 weeks of treatment. Safety was assessed at every visit. RESULTS: There were no significant differences in systolic blood pressure (SBP) or diastolic blood pressure (DBP) among three groups after 4 weeks of treatment (p = 0.4798 and p = 0.3252, respectively). In treatment group B, there was a significant decrease in SBP and DBP from baseline to 4 weeks of treatment (mean difference (MD) -9.55; p = 0.0225, MD -7.55; p = 0.0098, respectively). There were no significant differences among groups in secondary outcome measures after 4 weeks of treatment. Six adverse events (AEs) in the treatment group A and 12 AEs in the treatment group B occurred related to the moxibustion treatment. CONCLUSION: In conclusion, the results of this study show that moxibustion (3 sessions/week for 4 weeks) might lower blood pressure in patients with prehypertension or stage I hypertension and treatment frequency might affect effectiveness of moxibustion in BP regulation. Further randomized controlled trials with a large sample size on prehypertension and hypertension should be conducted. TRIAL REGISTRATION: This study was registered with the 'Clinical Research Information Service (CRIS)', Republic of Korea (KCT0000469), and the protocol for this study was presented orally at the 15th International Council of Medical Acupuncture and Related Techniques (ICMART) in Athens, 25-27 May 2012.

Efficacy and safety of acupuncture for functional constipation: a randomised, sham-controlled pilot trial.

BACKGROUND: The prevalence of functional constipation (FC) is 3-27%, and FC has been reported to cause discomfort in daily life and various complications. The treatment for FC depends on laxatives, and thus, effective and non-toxic alternative treatments are needed. METHODS: We conducted a randomised, sham-controlled parallel-design, pilot trial. Participants with FC were randomly assigned to either the real acupuncture (RA) or sham acupuncture (SA) group. The RA consisted of eight fixed acupuncture points (bilateral ST25, ST27, BL52 and BL25) and four additional points targeted to the individual based on Traditional Korean medicine (TKM). SA consisted of shallow acupuncture insertion at 12 non-acupuncture points. Twelve sessions were provided over 4 weeks. The outcome measures were weekly defecation frequency (DF), spontaneous complete bowel movement (SCBM), Bristol stool scale (BSS) score and constipation assessment scale (CAS) score. The participants were followed for 4 weeks after the treatment. RESULTS: Thirty participants were enrolled (15:15). The mean DF were 5.86 ± 5.62, 5.43 ± 3.39 and 5.79 ± 3.64 in the RA group and 3.73 ± 1.62, 5.00 ± 1.77 and 5.40 ± 1.96 in the SA group at weeks 1, 5, and 9, respectively. The increases in weekly SCBMs were 2.50 ± 3.86 and 2.71 ± 4.01 with RA and 2.33 ± 2.74 and 1.93 ± 2.25 with SA at weeks 5 and 9, respectively (mean difference [MD] 0.78). The BSS scores were 0.57 ± 1.72 and 1.09 ± 1.30 with RA and 0.15 ± 1.06 and 0.14 ± 0.88 with SA at weeks 5 and 9, respectively (MD 0.95). The CAS score changes were - 3.21 ± 2.91 and - 3.50 ± 3.98 with RA and - 2.67 + ±2.82 and - 2.87 ± 2.95 with SA at weeks 5 and 9, respectively. Greater improvements were observed in subgroup analysis of participants with hard stool. The numbers of participants who developed adverse events (AEs) were equal in both groups (four in each group), and the AEs were not directly related to the intervention. CONCLUSIONS: This clinical trial shows feasibility with minor modifications to the primary outcome measure and comparator. Acupuncture showed clinically meaningful improvements in terms of SCBMs occurring more than 3 times per week and in these improvements being maintained for 4 weeks after treatment completion. As this is a pilot trial, future studies are warranted to confirm the efficacy and safety. TRIAL REGISTRATION: KCT0000926 (Registered on 14 November 2013).

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.

Development of an ultrasound-imaging procedure and acquisition of ultrasound images of acupuncture points for safety and accuracy of needle insertion.

BACKGROUND: Acupuncture is a relatively safe, commonly used "alternative" medical treatment for various symptoms. However, adverse effects can occur, including trauma, pneumothorax, and central-nervous-system injury. Our objective was to develop a reliable and practical procedure for ultrasound imaging of acupuncture points to improve safety during needling, and to acquire ultrasound images of several (44) acupuncture points, especially those in high-risk areas, according to an in-house standard operating procedure. METHODS: We created the standard operating procedure for ultrasound imaging for acupuncture, and collected ultrasound images of acupuncture points in clinical trials. RESULTS: Ultrasound images for 44 acupuncture points considered as high-risk points were collected from 85 healthy people who were classified by body-mass index, and high-quality, clear representative images of all 44 points were obtained. CONCLUSION: These baseline images could be helpful for understanding the anatomy under the skin at acupuncture points, which would allow for an enhanced safety and more accurate needling.

Development of an adverse events reporting form for Korean folk medicine.

PURPOSE: We developed an adverse events (AEs) reporting form for Korean folk medicine. METHODS: The first version of the form was developed and tested in the clinical setting for spontaneous reporting of AEs. Additional revisions to the reporting form were made based on collected data and expert input. RESULTS: We developed an AEs reporting form for Korean folk medicine. The items of this form were based on patient information, folk medicine properties, and AEs. For causality assessment, folk medicine properties such as classification, common and vernacular names, scientific name, part used, harvesting time, storage conditions, purchasing route, product licensing, prescription, persons with similar exposure, any remnant of raw natural products collected from the patient, and cautions or contraindications were added. CONCLUSIONS: This is the first reporting form for AEs that incorporates important characteristics of Korean folk medicine. This form would have an important role in reporting adverse events for Korean folk medicine. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

Effect of acupuncture and its influence on cerebral activity in functional dyspepsia patients: study protocol for a randomized controlled trial.

BACKGROUND: Functional dyspepsia (FD) is a prevalent gastric disorder that is difficult to manage due to lack of satisfactory treatments. Acupuncture has been studied with regard to the rising need for treating FD, but the mechanism verifying its efficacy has not yet been fully revealed. The aim of this study is to explore the efficacy and mechanism of acupuncture for FD compared with a sham group. METHODS/DESIGN: We describe a proposal for a randomized, assessor-blind, sham-controlled trial with 70 eligible participants who will be randomly allocated either into an acupuncture or a sham group. Participants in the acupuncture group will receive 10 sessions of real acupuncture treatment and those in the sham group will be treated with identical sessions using a Streitberger needle. Functional magnetic resonance imaging (fMRI) and metabolomics studies will be implemented before and after 4 weeks of treatment to investigate the mechanism of acupuncture. The primary outcome is a proportion of responders with adequate symptom relief and the secondary outcomes include the Nepean Dyspepsia Index - Korean version, Functional Dyspepsia-Related Quality of Life questionnaire, Ways of Coping Questionnaire, Coping Strategies Questionnaire, perception of bodily sensation questionnaire, State-Trait Anxiety Inventory, and the Center for Epidemiological Studies - Depression Scale. The outcomes will be evaluated before and after the treatment. DISCUSSION: This is the first large-scale trial evaluating the efficacy and mechanism of acupuncture with fMRI and metabolomic methods. We will compare real acupuncture with the Streitberger sham needle to verify the specific effect of acupuncture. The results of this trial are expected to be relevant evidences affecting policy and decision-makers associated with routine healthcare. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02358486 . Date of Registration: 21 January 2015.

Experience of complementary and alternative medicine in patients with amyotrophic lateral sclerosis and their families: A qualitative study.

The purpose of this study was to explore the life experience related to complementary and alternative medicine (CAM) use among patients with amyotrophic lateral sclerosis (ALS). Data were collected though semi-structured interviews of nine patients with ALS and seven family members, who have used CAM. Audio recordings of the interviews were transcribed verbatim and checked for accuracy. The Giorgi's method of phenomenology was used for data analysis. Five constituents forming the units of meaning were: facing the limits of conventional medicine; getting to know CAM; recognizing the ineffectiveness of CAM; using CAM for symptomatic treatment; and seeking new CAM endlessly for complete cure. The study results provide an in-depth understanding of experience with CAM among patients with ALS and their family members. Healthcare providers must give accurate information about the efficacy of CAM as well as its safety and possible adverse effects and should offer patient-centred treatment through active communication throughout the process of diagnosis and treatment.

Development of a template for the classification of traditional medical knowledge in Korea.

ETHNOPHARMACOLOGICAL RELEVANCE: Traditional Medical Knowledge (TMK) is a form of Traditional Knowledge associated with medicine that is handed down orally or by written material. There are efforts to document TMK, and make database to conserve Traditional Medicine and facilitate future research to validate traditional use. Despite of these efforts, there is no widely accepted template in data file format that is specific for TMK and, at the same time, helpful for understanding and organizing TMK. AIM OF THE STUDY: We aimed to develop a template to classify TMK. MATERIALS AND METHODS: First, we reviewed books, articles, and health-related classification systems, and used focus group discussion to establish the definition, scope, and constituents of TMK. Second, we developed an initial version of the template to classify TMK, and applied it to TMK data. Third, we revised the template, based on the results of the initial template and input from experts, and applied it to the data. RESULTS: We developed the template for classification of TMK. The constituents of the template were summary, properties, tools/ingredients, indication/preparation/application, and international standard classification. We applied International Patent Classification, International Classification of Diseases (Korea version), and Classification of Korean Traditional Knowledge Resources to provide legal protection of TMK and facilitate academic research. The template provides standard terms for ingredients, preparation, administration route, and procedure method to assess safety and efficacy. CONCLUSIONS: This is the first template that is specialized for TMK for arranging and classifying TMK. The template would have important roles in preserving TMK, and protecting intellectual property. TMK data classified with the template could be used as the preliminary data to screen potential candidates for new pharmaceuticals.

Self-care use patterns in the UK, US, Australia, and Japan: a multinational web-based survey.

BACKGROUND: The trend toward patient- or consumer-centered healthcare has been accelerated by advances in technology, consumer empowerment, and a shift from infectious to chronic diseases. The purpose of this study was to examine the growing self-care market by analyzing self-care patterns. METHODS: We conducted a cross-sectional, web-based survey involving adults from nine major cities in the UK, the USA, Australia, and Japan. This study examined the extent and frequency of self-care, self-care expenditure, sources of self-care information, and reasons for self-care in each country. RESULTS: The results showed that the prevalence of self-care was highest in Japan (54.9%), followed by the UK (43.1%), the USA (42.5%), and Australia (40.4%). The primary reason for practicing self-care was "to manage my healthcare myself" (cited by 45.7%, 59.5%, 49.2%, and 4.1% of participants in Australia, Japan, the UK, and the USA, respectively). Significant linear associations were observed between age and the prevalence of self-care in all countries (p < 0.05), indicating that self-care prevalence decreased with age in the UK, the USA, and Australia, and increased with age in Japan. The frequency with which self-care was practiced was positively correlated with age in the USA (p < 0.05), Australia (p < 0.01), and Japan (p < 0.05). In addition to acquaintances, internet search engines and information obtained from pharmacies were considered reliable and widely used sources of self-care information. CONCLUSION: When developing self-care products or services, healthcare providers and policymakers should consider self-care patterns.

Acupuncture lowers blood pressure in mild hypertension patients: a randomized, controlled, assessor-blinded pilot trial.

OBJECTIVES: To preliminarily assess the effects of acupuncture on prehypertension and stage I hypertension, and to provide data for further research. DESIGN: A randomized, controlled, assessor-blinded study with an 8-week intervention period and a 4-week follow-up. INTERVENTIONS: Participants were patients with systolic blood pressure (SBP) of 120-159mmHg or diastolic blood pressure (DBP) of 80-99mmHg.Thirty participants were allocated to acupuncture group or untreated control group at a 1:1 ratio. The acupuncture group received standard acupuncture twice weekly for 8 weeks, and was followed-up for 4 weeks after treatment; the control group did not receive any type of anti-hypertensive treatment for 12 weeks. MAIN OUTCOME MEASURES: Primary outcome measure was SBP and DBP at post-treatment. The secondary outcomes were SBP and DBP at follow-up; Euro Quality of life (EQ-5D), heart rate variability (HRV), body mass index (BMI), and blood lipid profile. RESULTS: DBP (-5.7mmHg; P=0.025), but not SBP (-6.0mmHg; P=0.123), was significantly different between groups at post-treatment. Both DBP (-7.8mmHg; P=0.004) and SBP (-8.6mmHg; P=0.031) were significantly different at follow-up. Among the HRV indices, only high frequency power was significantly different between groups at weeks 4 and 8 (P=0.047 and P=0.030, respectively). There were no differences between groups in EQ-5D, BMI or lipid profile. CONCLUSION: The results of this study show that acupuncture might lower blood pressure in prehypertension and stage I hypertension, and further RCT need 97 participants in each group. The effect of acupuncture on prehypertension and mild hypertension should be confirmed in larger studies. TRIAL REGISTRATION: KCT0000496.