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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 &lt, 0.001) and systolic blood pressure (−10.34 mmHg, 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.

Objectives: The present study was undertaken to investigate the relationship between acupuncture therapy and surgery rate. Design: Matched, retrospective cohort study. Materials and Methods: From nationwide health insurance data (2002–2013 cohort data published by the National Health Insurance Service of Korea), patients with new cases of knee osteoarthritis that occurred between January 1, 2004 and December 31, 2010 were analyzed. Patients were divided into an acupuncture group (AG) and a control group (CG), based on records of acupuncture therapy. Propensity scores were calculated by using gender, age, income level, and Charlson comorbidity index (CCI), with the groups matched at a ratio of 1:3 (AG:CG). The final analysis period was 2 years after the first acupuncture therapy for AG and 2 years after initial diagnosis for CG; surgery rates were compared between the two groups. Stratified analyses were performed based on age, gender, and income level; sensitivity analyses were performed based on the frequency and duration of acupuncture therapy. Results: Propensity score-matched AG and CG included 8,605 and 25,815 subjects, respectively. Post-matching surgery rates were 0.26 and 0.93% in AG and CG, respectively. For all age groups, AG showed a lower surgery rate than CG. In the analysis based on gender, the female group showed a significantly lower hazard ratio of 0.225. In analysis based on income level, the results of the entire group were significant, with the lower income group showing the lowest hazard ratio. In sensitivity analyses, AG tended to show a lower surgery rate than CG. Conclusions: The present study demonstrated that acupuncture therapy is associated with a low rate of surgery for knee osteoarthritis. Additional studies are needed to support this conclusion.

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

Objective: Surgical treatment of neck pain often entails high costs and adverse events. The present cohort study investigated whether utilisation of acupuncture in neck pain patients is associated with a reduced rate of cervical surgery. Methods: The Korean National Health Insurance Service National Sample Cohort (NHIS-NSC) database was retrospectively analysed to identify the 2 year incidence of cervical surgery in Korean patients suffering neck pain from 2004 to 2010. The incidence was calculated and compared between patients receiving and not receiving acupuncture treatment using Cox proportional hazards models. Cumulative survival rates were compared using Kaplan-Meier survival analysis. Results: The acupuncture and control groups included 50 171 and 128 556 neck pain patients, respectively. A total of 50 161 patients were selected in each group following propensity score matching with regard to sex, age, income and Charlson comorbidity index. The hazard ratio (HR) for surgery within 2 years was significantly lower in the acupuncture group compared with the control group (HR 0.397, 95% CI 0.299 to 0.527). In addition, subgroup analyses according to gender, age and income revealed consistent results for both men (HR 0.337, 95% CI 0.234 to 0.485) and women (HR 0.529, 95% CI 0.334 to 0.836); the results were consistently observed across all age and income strata. Sensitivity analysis with varying numbers of acupuncture treatments and treatment course duration also consistently indicated lower HRs for surgery within 2 years in the acupuncture group compared with the control group. Conclusions: A significantly lower HR for cervical surgery was observed in neck pain patients following acupuncture treatment. Acupuncture treatment may therefore be an effective method for managing neck pain, and has the potential to mitigate unnecessary surgery. These findings need to be confirmed by prospective studies.

Objectives : This study aims to evaluate the effectiveness and safety of acupuncture and explore the appropriate number of treatment for postmenopausal women diagnosed with prehypertension and stage 1 hypertension. Methods : A 4-arm randomized open label pilot trial will be performed at 2 centers. Sixty participants will be divided into 2 treatment groups and 2 control groups. Treatment groups will receive acupuncture at 8 points(bilateral GB20, LI11, ST36, SP6) for 4 weeks(treatment group A, 10 total sessions) or 8 weeks(treatment group B, 20 total sessions), while maintaining usual care. Control groups will not receive acupuncture but will be under usual care for 16 weeks(control group C) or 20 weeks(control group D). Each patient`s living habits will be corrected and drugs that may affect blood pressure(BP) will be prohibited. Treatment group A and control group C will be evaluated at 4, 8, 12, and 16 weeks after randomization, while treatment group B and control group D will be evaluated at 4, 8, 12, 16, and 20 weeks after randomization. The major outcome variable is the magnitude of change in diastolic BP levels at 4 weeks after randomization; auxiliary outcome variables are (1) diastolic BP change at 8, 16, and 20 weeks, (2) systolic BP change, (3) BP control rate, (4) lipid profiles, and (5) high-sensitivity C-reactive protein. Patient safety will be assessed at every visit. Results and Conclusions : The study findings may help develop evidence for the effectiveness and safety of acupuncture for BP control.

Aim The aim of this trial was to determine whether bee venom acupuncture (BVA) is more effective than a sham control in reducing pain and disability in subjects suffering from chronic low back pain. Participants and methods The trial design was a randomised, sham-controlled, triple-blind, two-group parallel clinical trial. After screening, 60 participants were randomly divided into the BVA group or sham control group (normal saline injection: NSI). Both groups were treated twice a week for 4 weeks; 6 acupoints (BL23, BL24 and BL25 on bilateral sides) were injected with 0.1 ml BVA or normal saline, respectively. The primary outcome measurement was the change in pain intensity (as measured with the visual analogue scale: VAS), and the secondary outcomes were assessed using the Oswestry Disability Questionnaire (ODQ) for disability and the SF-36 questionnaire for quality of life. Results Both groups had significant improvements in pain intensity, ODQ, and SF-36 from baseline levels. Measurements of pain intensity showed a statistically significant difference in the VAS score in favour of BVA over control at the 8th treatment ( p = 0.0087). However, there was no significant difference between the two groups in either the ODQ and SF-36 measurements. All adverse reactions disappeared spontaneously without medical interventions. Conclusions These results suggest that BVA is effective for treating chronic low back pain and appears to be a safe therapy. Future trials need to consider more effective controls and blinding.

OBJECTIVES Patients undergoing hemodialysis suffer from a variety of complications related to end-stage renal disease. This prospective, observational pilot study aims to determine the feasibility, safety, and possible benefits of acupuncture for symptom management in patients undergoing hemodialysis. METHODS Twenty-four (24) patients undergoing hemodialysis received acupuncture treatment for their symptoms. Manually stimulated, individualized acupuncture treatments were provided twice a week for 6 consecutive weeks on a nondialysis day or on the day of hemodialysis prior to initiating treatment. Symptoms were evaluated using the Measure Your Medical Outcome Profiles 2 questionnaire, and quality of life was measured by Kidney Disease Quality of Life-Short Form (KDQOL-SF(™)) Version 1.3 at baseline, 7 weeks and 11 weeks from baseline. Statistical analysis was conducted on the basis of the intention-to-treat principle. RESULTS Twenty-one (21) patients (87%) completed the whole treatment course and follow-up evaluation. Three (3) patients dropped out due to increased fatigue (n = 1), pancreatic and renal transplantation (n = 1), and infections of the arteriovenous fistula used for hemodialysis access (n = 1). Patients experienced a significant improvement of symptoms considered the most bothersome, reporting a decrease of 1.87 and 2.08 points on a 0-6 symptom scale at 7 weeks and 11 weeks, respectively (both p

The aim of this study was to evaluate the effect of acupuncture treatment on dry eye syndrome.This was a prospective observational study.The study was conducted at a clinical evaluation center for acupuncture and moxibustion of the Korean Institute of Oriental Medicine, Republic of Korea.The subjects were patients with dry eye disease (N = 36), defined by Schirmer test scores of10 mm/5 min and tear film break-up times (BUTs) of10 seconds.Participants were treated with acupuncture three times per week for 4 weeks. MEASURE OF EFFECTIVENESS: Schirmer test scores, BUTs, symptom scores, ocular surface disease index (OSDI) scores and dry eye symptom questionnaires were compared before and after treatment to evaluate the efficacy of acupuncture treatment.After treatment, symptom scores, OSDI scores and the number of dry eye symptoms were all significantly lower (p 0.0001). Although tear wettings were significantly higher (left: p 0.0001, right: p = 0.0012), there were no significant differences in BUTs.This study suggests that acupuncture treatment can effectively relieve the symptoms of dry eye and increase watery secretion.

Acta Ophthalmol. 2010: 88: e328–e333 Abstract. Purpose: To evaluate the efficacy and safety of acupuncture for ocular symptoms, tear film stability and tear secretion in dry eye patients. Methods: This is a randomized, patient-assessor blinded, sham acupuncture controlled trial. Forty-two participants with defined moderate to severe dry eye underwent acupuncture treatment three times a week for 3 weeks. Seventeen standard points (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8 on the left for men and right for women) with ‘de qi’ manipulation for the verum acupuncture group and seventeen sham points of shallow penetration without other manipulation for the sham group were applied during the acupuncture treatment. Differences were measured using the ocular surface disease index (OSDI), the visual analogue scale (VAS) of ocular discomfort, the tear film break-up time (BUT) and the Schimer I test with anaesthesia. In addition, adverse events were recorded. Results: There were no statistically significant differences between results on the OSDI, VAS, BUT or Schimer I tests from baseline between the verum and sham acupuncture groups. However, results from the within-group analysis showed that the OSDI and VAS in both groups and the BUT in the verum acupuncture group were significantly improved after 3 weeks of treatment. No adverse events were reported during this trial. Conclusion: Both types of acupuncture improved signs and symptoms in dry-eye patients after a 4-week treatment. However, verum acupuncture did not result in better outcomes than sham acupuncture.

Introduction Low back pain (LBP) is a globally prevalent disorder with high social significance. Invasive surgical procedures are increasingly being used to treat LBP despite a lack of solid evidence supporting their long-term benefits. This nationwide retrospective cohort study investigated the association between acupuncture treatment and lumbar surgery rate in patients with LBP. Methods Using the National Health Insurance Service Sample Cohort Database for 2002–2013, we identified newly diagnosed LBP patients in Korea between 2004 and 2010 and divided them into an acupuncture group and control group according to whether or not they received acupuncture. Propensity scores based on age, sex, income, and Charlson Comorbidity Index were matched between the two study groups. The lumbar surgery rate in the two years following the first visit (control group) or the first acupuncture session (acupuncture group) was calculated. In addition to the overall analysis, stratified analyses were also conducted in different age, sex, and income strata. Sensitivity analyses were further performed using varying definitions of acupuncture treatment. Results After matching, 130,089 subjects were included in each study group. The lumbar surgery rate was significantly lower in the acupuncture group than in the control group (hazard ratio [HR] 0.633, 95% confidence interval [CI] 0.576–0.696). Decrease in HR was consistently observed in the acupuncture group for all age strata, except for patients in their 20s (HR 1.031, 95% CI 0.804–1.323). HR for lumbar surgery tended to be further reduced in the older age groups upon acupuncture treatment, with no apparent sex-related differences. Lowered HR in the acupuncture group was continuously observed across all income groups; the higher income group showed a tendency of greater decrease. Sensitivity analyses showed that the number of acupuncture sessions had no major impact on the likelihood of lumbar surgery, but also that more intensive acupuncture treatment was associated with further reduction in lumbar surgery rates. Conclusion The present results found that administration of acupuncture treatment is associated with lower lumbar surgery rates for LBP patients in Korea. Prospective studies are warranted in the future to further investigate the effect of acupuncture treatment on lumbar surgery incidence.

This study evaluated whether improvements in nicotine withdrawal symptoms (NWS), depression and anxiety are greater for body acupuncture than for sham acupuncture. Smoking volunteers from the public were randomized to receive six sessions of either real or sham acupuncture for 2 weeks. The primary outcome measure was NWS measured by the Minnesota Nicotine Withdrawal Score, and the secondary measures were scores on the Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI). Eighty volunteers were randomized into real acupuncture (n= 38) and sham acupuncture (n= 42) groups, of which 46 subjects (22 and 24 in the real and sham acupuncture groups, respectively) completed the treatment and the 2-week follow-up. An intention-to-treat analysis revealed that the NWS did not differ significantly between the real and sham acupuncture groups immediately after the treatment (12.2 ± 9.7 and 12.8 ± 7.7, respectively; mean ± SD) and at the 2-week follow-up (11.7 ± 10.2 and 12.6 ± 7.8). Both groups also showed similar improvements in BDI and BAI scores. These results indicate that the real acupuncture treatment tested in this trial was no more effective than sham acupuncture at reducing NWS, depression and anxiety for smoking cessation.

Objective A hot flash is a general postmenopausal symptom experienced by approximately 75% of climacteric women. Women often turn to complementary and alternative medicines to relieve hot flashes. Moxibustion is one such medication. The aim of this study was to evaluate the effect of moxibustion on hot flashes in perimenopausal and postmenopausal women. Methods Fifty-one participants were randomly assigned into three groups, namely, moxibustion 1, moxibustion 2, and waiting list (control). The moxibustion groups received 14 sessions of moxibustion treatment for 4 weeks at acupuncture points. Our protocol was supported by evidence from clinical experts (Moxa 1) or published literature (Moxa 2), and we followed all participants for an additional 2 weeks after the end of the study. Our primary outcome measures were frequency and severity of hot flashes. Secondary outcome parameters included quality of life (Menopausal-Specific Quality of Life Scale) and Menopause Rating Scale. Results Fifty-one women participated in our study. By week 4, the difference in severity and frequency of hot flashes had become statistically significant between the treatment groups and the control participants. In addition, there was a statistically significant difference in Menopausal-Specific Quality of Life Scale scores between treatment group 2 and the other groups. Conclusions Our results suggest that moxibustion reduces both the frequency and severity of menopausal hot flashes as compared with those in control participants. We would recommend further studies with larger samples and possibly including placebo controls.

Background The causes of chronic fatigue syndrome (CFS) and idiopathic chronic fatigue (ICF) are not clearly known, and there are no definitive treatments for them. Therefore, patients with CFS and ICF are interested in Oriental medicine or complementary and alternative medicine. For this reason, the effectiveness of complementary and alternative treatments should be verified. We investigated the effectiveness of two forms of acupuncture added to usual care for CFS and ICF compared to usual care alone. Methods A three-arm parallel, non-blinded, randomized controlled trial was performed in four hospitals. We divided 150 participants into treatment and control groups at the same ratio. The treatment groups (Group A, body acupuncture; Group B, Sa-am acupuncture) received 10 sessions for 4 weeks. The control group (Group C) continued usual care alone. The primary outcome was the Fatigue Severity Scale (FSS) at 5 weeks after randomization. Secondary outcomes were the FSS at 13 weeks and a short form of the Stress Response Inventory (SRI), the Beck Depression Inventory (BDI), the Numeric Rating Scale (NRS), and the EuroQol-5 Dimension (EQ-5D) at 5 and 13 weeks. Results Group A showed significantly lower FSS scores than Group C at 5 weeks (P = 0.023). SRI scores were significantly lower in the treatment groups than in the control group at 5 (Group A, P = 0.032; B, P

Introduction This study tested the effectiveness of moxibustion on pain and function in chronic knee osteoarthritis (KOA) and evaluated safety. Methods A multi-centre, non-blinded, parallel-group, randomised controlled trial compared moxibustion with usual care (UC) in KOA. 212 South Korean patients aged 40–70 were recruited from 2011–12, stratified by mild (Kellgren/Lawrence scale grades 0/1) and moderate-severe KOA (grades 2/3/4), and randomly allocated to moxibustion or UC for four weeks. Moxibustion involved burning mugwort devices over acupuncture and Ashi points in affected knee(s). UC was allowed. Korean Western Ontario and McMaster Universities Questionnaire (K-WOMAC), Short Form 36 Health Survey (SF-36v2), Beck Depression Inventory (BDI), physical performance test, pain numeric rating scale (NRS) and adverse events were evaluated at 5 and 13 weeks. K-WOMAC global score at 5 weeks was the primary outcome. Results 102 patients (73 mild, 29 moderate-severe) were allocated to moxibustion, 110 (77 mild, 33 moderate-severe) to UC. K-WOMAC global score (moxibustion 25.42+/−SD 19.26, UC 33.60+/−17.91, p

Objective This study aimed to identify the descriptive characteristics of patients with pain conditions who visited an academic medical centre for traditional Korean medicine (TKM). Methods This work was a retrospective review of the electronic medical records of patients who received at least one session of acupuncture for pain management from March 2010 to February 2012 in the Korean medical hospital of Pusan National University. Demographic characteristics and data on patient conditions, treatment interventions received and costs associated with acupuncture treatments were analysed. Results We identified a total of 2167 patients, including 2105 outpatients and 237 inpatients. The mean age (SD) of the patients was 52.0 (15.3) years, and approximately two-thirds of the patients were women (64.0%). The average number of acupuncture treatment sessions was 8.0 (6.6 for outpatients and 14.5 for inpatients). The most treated conditions were low back pain (30.5%), neck pain (23.9%) and shoulder pain (17.5%). Interventions included needle acupuncture with manual (52.6%) or electrical (47.4%) stimulation, herbal medicine (44.2%), cupping (21.2%) and moxibustion (3.5%). Over one-third of outpatients (33.5%) received at least six sessions of acupuncture. The median total cost of each outpatient and inpatient care per person was 169 604 and 1 001 707 Korean Won (approximately £98 and £577), respectively. Conclusions Acupuncture was primarily used for the treatment of low back, neck and shoulder pain with a wide range of related interventions at an academic medical centre for traditional Korean medicine. These data reflect real clinical practice and should inform the design of future prospective clinical research of acupuncture.

Background The purpose of this study is to conduct a basic analysis of the effectiveness and safety of electroacupuncture in the treatment of painful diabetic neuropathy (PDN) as compared to placebo and usual care and to evaluate the feasibility of large-scale clinical research. Methods/design This study is a protocol for a three-armed, randomized, patient-assessor-blinded (to the type of treatment), controlled pilot trial. Forty-five participants with a ≥ six month history of PDN and a mean weekly pain score of ≥ 4 on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) will be assigned to the electroacupuncture group (n = 15), sham group (n = 15) or usual care group (n = 15). The participants assigned to the electroacupuncture group will receive electroacupuncture (remaining for 30 minutes with a mixed current of 2 Hz/120 Hz and 80% of the bearable intensity) at 12 standard acupuncture points (bilateral ST36, GB39, SP9, SP6, LR3 and GB41) twice per week for eight weeks (a total of 16 sessions) as well as the usual care. The participants in the sham group will receive sham electroacupuncture (no electrical current will be passed to the needle, but the light will be seen, and the sound of the pulse generator will be heard by the participants) at non-acupuncture points as well as the usual care. The participants in the usual care group will not receive electroacupuncture treatment during the study period and will receive only the usual care. The follow-up will be in the 5th, 9th and 17th weeks after random allocation. The PI-NRS score assessed at the ninth week will be the primary outcome measurement used in this study. The Short-Form McGill Pain Questionnaire (SF-MPQ), a sleep disturbance score (11-point Likert scale), the Short-Form 36v2 Health Survey (SF-36), the Beck Depression Inventory (BDI) and the Patient Global Impression of Change (PGIC) will be used as outcome variables to evaluate the effectiveness of the acupuncture. Safety will be assessed at every visit. Discussion The result of this trial will provide a basis for the effectiveness and safety of electroacupuncture for PDN. Trial registration Clinical Research information Service. Unique identifier:KCT0000466.

Background The treatment of knee osteoarthritis, which is a major cause of disability among the elderly, is typically selected from multidisciplinary options, including complementary and alternative medicine. Moxibustion has been used in the treatment of knee osteoarthritis in Korea to reduce pain and improve physical activity. However, there is no sufficient evidence of its effectiveness, and it cannot therefore be widely recommended for treating knee osteoarthritis. We designed a randomised controlled clinical trial to evaluate the effectiveness, safety, cost-effectiveness, and qualitative characteristics of moxibustion treatment of knee osteoarthritis compared to usual care. Methods/designs This is a protocol for a multicentre, pragmatic, randomised, assessor-blinded, controlled, parallel-group study. A total of 212 participants will be assigned to the moxibustion group (n = 106) and the usual care group (n = 106) at 4 clinical research centres. The participants assigned to the moxibustion group will receive moxibustion treatment of the affected knee(s) at 6 standard acupuncture points (ST36, ST35, ST34, SP9, Ex-LE04, and SP10) 3 times per week for 4 weeks (a total of 12 sessions). Participants in the usual care group will not receive moxibustion treatment during the study period. Follow-up will be performed on the 5th and 13th weeks after random allocation. Both groups will be allowed to use any type of treatment, including surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs, and other active treatments. Educational material that explains knee osteoarthritis, the current management options, and self-exercise will be provided to each group. The global scale of the Korean Western Ontario and McMaster Osteoarthritis Index (K-WOMAC) will be the primary outcome measurement used in this study. Other subscales (pain, stiffness, and function) of the K-WOMAC, the Short-Form 36v2 Health Survey, the Beck Depression Inventory, the Physical Function test, Patient Global Assessment, and the Pain Numerical Rating Scale will be used as outcome variables to evaluate the effectiveness of moxibustion. Safety will be assessed at every visit. In addition, an economic evaluation and a qualitative study will be conducted as a mixed-methods approach. Discussion This trial may contribute to developing evidence for the effectiveness and safety of moxibustion for treating knee osteoarthritis. Trial registration Trial registration number:KCT0000130

Objectives: Patients undergoing hemodialysis suffer from a variety of complications related to end-stage renal disease. This prospective, observational pilot study aims to determine the fe...

Objectives: A survey was conducted to determine ear acupuncture usage by clinical traditional Korean medicine doctor and to lay a foundation for standards for its clinical application. Methods: Twice over two weeks, e-mail were sent to Korean medicine doctors whose email addresses were registered at the Association of Korea Oriental Medicine. Two hundred eighty(280) completed questionnaires were used for the analysis. Results: Of the respondents, 66.07% answered in use, but the answer “less than 10 per 100 patient applied” was 54.29%. The major field of treatment were addictive disorders, such as smoking, and 80.11% of the patients had less than 3 days of treatment. The ear was the most commonly treated area with 66.67%. The self-removal frequency was as high as 65.05%. The rate of side effects was less than 10% (96.70% replies in total), and these side effects showed light symptoms such as “pain” (46.95%), itchiness (29.27%), and flaring (19.51%). The recommendations for improving ear acupuncture treatment was “the development of effective treatment manual” (28.57%) and “increasing insurance costs” (27.86%). Conclusions: Based on the survey, a vast majority of the Traditional Korean medicine doctors used ear acupuncture, but the frequency of use was low. We hope this study can form the basis for developing of treatment manuals for various indications and safe treatment guidelines.

Seung-Hoon Lee, Kun-Hyung Kim, Tae-Hun Kim, Jung-Eun Kim Joo-Hee Kim, Kyung-Won Kang, So-Young Jung, Ae-Ran Kim Hyo-Ju Park, Mi-Suk Shin, Kwon-Eui Hong, Sun-Mi Choi 1Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine 2Dept. of acupuncture & moxibustion, Pusan National University, Korean Medicine Hospital 3Dept. of acupuncture & Moxibusion, College of Oriental Medicine, Dae-Jeon University Abstract Objectives : The purpose of this study is to evaluate the feasibility of massive clinical research and to make a basic analysis on the effectiveness and safety of moxibustion treatment on knee osteoarthritis compared to usual care. Methods and Results : This study is a protocol for a pilot randomized controlled trial. Forty participants are assigned to the moxibustion group (n=20) and usual care group (n=20). Participants assigned to the moxibustion group receive moxibustion treatment on the affected knee(s) at six standard acupuncture points (ST36, ST35, ST34, SP9, Ex-LE04 and SP10) three times per week for four weeks (total of 12 sessions). Participants in the usual care group don't receive moxibustion treatment during the study period and follow-up are made on the 5th, 9th and 13th weeks after random allocation. Both groups are allowed to use any kind of treatment, including surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs and other active treatments. Education material that explains knee osteoarthritis and current management options and self-exercise is provided for each group. The pain scale of the Korean Western Ontario and McMaster Universities Questionnaire (K-WOMAC) is the primary outcome measurement used in this study. Other subscales of the K-WOMAC, the Short-Form 36 Health Survey (SF-36), Beck Depression Inventory (BDI), Physical Function test, Patient Global Assessment, and Pain Numeric Rating Scale (NRS) are used as outcome variables to evaluate the effectiveness of acupuncture. Safety is assessed at every visit. Conclusions : The result of this trial will provide a basis for the effectiveness and safety of acupuncture treatment for knee osteoarthritis.

Objectives : Our aim is to evaluate feasibility for massive clinical research and to make basic analysis of efficacy and safety of acupuncture treatment for chronic fatigue syndrome and idiopathic chronic fatigue. Methods : This study is a protocol for a pilot randomized controlled trial. It was developed through literature searches and discussions among researchers. Results : Forty participants allocated to acupuncture group and wait-list group. Participants allocated to acupuncture group will be treated three times per week for a total of 12 sessions over four weeks. Eight points (GV20; bilatral GB20, BL11, BL13, BL15, BL18, BL20, BL23) have been selected for the acupuncture group. Participants in the wait-list group will not receive acupuncture treatment during study period and follow-up will be made in the 5th and 9th weeks after random allocation. Then the same acupuncture treatment as that performed to the acupuncture group will be made to the wait-list group. Fatigue Severity Scale, a short form of Stress Response Inventory, Beck Depression Inventory, and Insomnia Severity Index will be used as outcome variables to evaluate the efficacy of acupuncture. Safety will be assessed at every visit. Conclusions : The trial based on this study will be performed. The results of the trial will provide basis for the efficacy and safety of acupuncture treatment for chronic fatigue syndrome and idiopathic chronic fatigue.

Purpose To evaluate the effects of acupuncture compared to a control group using artificial tears. Methods Setting & design: multicenter randomised controlled trial (three local research hospitals of South Korea). Study Population: 150 patients with moderate to severe dry eye. Intervention: Participants were randomly allocated into four weeks of acupuncture treatment (bilateral BL2, GB14, TE 23, Ex1, ST1, GB20, LI4, LI11 and single GV23) or to the artificial tears group (sodium carboxymethylcellulose). Main Outcome Measure(s): The ocular surface disease index (OSDI), tear film break-up time (TFBUT), Schirmer Ι test, visual analogue scale (VAS) for self-assessment of ocular discomfort, general assessment (by both acupuncture practitioners and participants) and quality of life (QOL) through the Measure Yourself Medical Outcome Profile-2 (MYMOP-2). Results There was no statistically significant difference between two groups for the improvement of dry eye symptoms as measured by OSDI (MD −16.11, 95% CI [−20.91, −11.32] with acupuncture and −15.37, 95% CI [−19.57, −11.16] with artificial tears; P = 0.419), VAS (acupuncture: −23.84 [−29.59, −18.09]; artificial tears: −22.2 [−27.24, −17.16], P = 0.530) or quality of life (acupuncture: −1.32 [−1.65, −0.99]; artificial tears: −0.96 [−1.32, −0.6], P = 0.42) immediately after treatment. However, compared with artificial tears group, the OSDI (acupuncture: −16.15 [−21.38, −10.92]; artificial tears: −10.76 [−15.25, −6.27], P = 0.030) and VAS (acupuncture: −23.88 [−30.9, −16.86]; artificial tears: −14.71 [−20.86, −8.55], P = 0.018) were significantly improved in the acupuncture group at 8 weeks after the end of acupuncture treatment. TFBUT measurements increased significantly in the acupuncture group after treatment. Conclusions Acupuncture may have benefits on the mid-term outcomes related to dry eye syndrome compared with artificial tears. Trial registration ClinicalTrials.gov NCT01105221.

Objectives To determine the effect of acupuncture in treating hot flushes in perimenopausal or postmenopausal women. Methods The study was a randomised single-blind sham-controlled clinical trial. Perimenopausal or postmenopausal women with moderate or severe hot flushes were randomised to receive real or sham acupuncture. Both groups underwent a 4-week run-in period before the treatment. The real acupuncture group received 11 acupuncture treatments for 7 weeks, and the control group underwent sham acupuncture on non-acupuncture points during the same period. Both groups were followed for 8 weeks after the end of treatment period. Changes from baseline in the hot flush scores at week 7, measured by multiplying the hot flush frequency and severity, were the primary outcome. Hot flush frequency, severity and menopause-related symptoms measured with the Menopause Rating Scale Questionnaire were regarded as secondary outcomes. Results 54 participants were randomised into the real acupuncture group (n=27) and the sham acupuncture group (n=27). The mean change in hot flush scores was −6.4±5.2 in the real acupuncture group and −5.6±9.2 in the sham group at week 7 from values at the start of the acupuncture treatment (10.0±8.1 vs 11.7±12.6), respectively (p=0.0810). No serious adverse events were observed during the whole study period. Conclusions Compared to sham acupuncture, acupuncture failed to show significantly different effects on the hot flush scores but showed partial benefits on the hot flush severity. Further consideration is needed to develop appropriate strategies for distinguishing non-specific effects from observed overall effectiveness of acupuncture for hot flushes. Whether acupuncture has point-specific effects for hot flushes should be also considered in designing future researches.

The aim of this study was to evaluate the effectiveness of acupuncture plus usual care for relief of hot flashes and menopause-related symptoms compared with usual care alone in perimenopausal or postmenopausal women.A multicenter, randomized, controlled trial was conducted. Perimenopausal or postmenopausal women with average hot flash scores of 10 or higher during the week before the screening visit were enrolled and randomly divided into two groups. The treatment group received 12 sessions of acupuncture and maintained usual care for 4 weeks, whereas the control group underwent usual care alone. Hot flash scores were calculated by multiplying frequency by severity of hot flashes recorded in a daily diary. The primary outcome was the mean change in the average 24-hour hot flash score at week 4 from baseline. The secondary outcome was the mean change in menopause-related symptoms as estimated by the Menopause Rating Scale questionnaire at week 4. Follow-up assessment at week 8 was conducted in the treatment group only.The mean change in the average 24-hour hot flash score was -16.57 in the treatment group (n = 116) and -6.93 in the control group (n = 59), a difference of 9.64 (P0.0001). The total Menopause Rating Scale score, as well as the subscale scores for the psychological, somatic, and urogenital dimensions of menopause, showed significant improvement in the acupuncture group compared with the control group (P0.001). The mean change in the treatment group in the primary outcome was -17.58 at week 8.Our results suggest that acupuncture in addition to usual care is associated with marked clinical improvement in hot flashes and menopause-related symptoms in perimenopausal or postmenopausal women.

Background Allergic rhinitis is one of the most common health complaints worldwide. Complementary and alternative medical approaches have been employed to relieve allergic rhinitis symptoms and to avoid the side effects of conventional medication. Acupuncture has been widely used to treat patients with allergic rhinitis, but the available evidence of its effectiveness is insufficient. Our objective is to evaluate the effectiveness of acupuncture in patients in Korea and China with persistent allergic rhinitis compared to sham acupuncture treatment or waitlist control. Methods This study consists of a multi-centre (two centres in Korea and two centres in China), randomised, controlled trial with three parallel arms (active acupuncture, sham acupuncture, and waitlist group). The active acupuncture and sham acupuncture groups will receive real or sham acupuncture treatment, respectively, three times per week for a total of 12 sessions over four weeks. Post-treatment follow-up will be performed a month later to complement these 12 acupuncture sessions. Participants in the waitlist group will not receive real or sham acupuncture treatments during this period but will only be required to keep recording their symptoms in a daily diary. After four weeks, the same treatment given to the active acupuncture group will be provided to the waitlist group. Discussion This trial will provide evidence for the effectiveness of acupuncture as a treatment for persistent allergic rhinitis. The primary outcome between groups is a change in the self-reported total nasal symptom score (i.e., nasal obstruction, rhinorrhea, sneezing, and itching) from baseline at the fourth week. Secondary outcome measures include the Rhinitis Quality of Life Questionnaire score and total non-nasal symptom score (i.e., headache, itching, pain, eye-dropping). The quantity of conventional relief medication used during the follow-up period is another secondary outcome measure. Trial registration Current Controlled Trials ISRCTN90807007

Tae-Hun Kim1,4, Kun Hyung Kim2, Jung Won Kang3, MinHee Lee4, Kyung-Won Kang4, Jung Eun Kim4, Joo-Hee Kim4, Seunghoon Lee4, Mi-Suk Shin4, So-Young Jung4, Ae-Ran Kim4, Hyo-Ju Park 4, Hee-Jung Jung4, Ho Sueb Song5, Hyeong Jun Kim6, Jin-Bong Choi7, Kwon Eui Hong8, Sun-Mi Choi4 1 Kyung Hee Unitversity Korean Medicine Hospital Korean Medicine Clinical Trial Center (K-CTC) 2 Korea Institute of Oriental Medicine, Department of Acupuncture & Moxibustion 3 Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung-Hee University 4 Korea Institute of Oriental Medicine 5 Kyungwon University Incheon Gill Oriental Medical Hospital 6 Semyung University Jecheon Oriental Medical Hospital 7 Dongshin University Gwangju Oriental Hospital 8 Department of Acupuncture and Moxibustion, Daejeon University

Background Even though chronic fatigue syndrome and idiopathic chronic fatigue are quite common, there are no clearly known causes. Most treatments are therefore symptomatic in nature, and chronic fatigue syndrome and idiopathic chronic fatigue patients are highly interested in using oriental medicine or complementary and alternative medicine treatment. Acupuncture, one of the major treatments used in oriental medicine, is effective in treating various diseases. This study will attempt to analyze the effectiveness and safety of acupuncture in the treatment of chronic fatigue by comparing the two treatment groups (body acupuncture, Sa-am acupuncture) and the control group (usual care). Methods/design This study consists of a four-center, three-arm, randomized, controlled, and open-label trial. One hundred and fifty participants are randomly divided into treatment groups A and B and a control group. The treatment groups will receive acupuncture treatments either two or three times per week for a total of 10 sessions over a period of 4 weeks. The control group will not receive acupuncture treatments and will continue their usual care during this period. The primary outcome variable is the Fatigue Severity Scale, which will be utilized 5 weeks after randomization. Secondary outcome variables are the Fatigue Severity Scale at 13 weeks, a short form of the Stress Response Inventory, the Beck Depression Inventory, the Numeric Rating Scale, and the EuroQol-5 Dimension at 5 and 13 weeks after randomization. Discussion This study will provide evidence with high external validity on the effectiveness and safety of acupuncture as a treatment for chronic fatigue syndrome and idiopathic chronic fatigue. Trial registration Clinical Research Information Service KCT0000508

Background The objectives of this study were to compare the efficacy of acupuncture among different types and to evaluate point-selective pain relief effects between selected adjacent or distant points in participants with temporomandibular joint disorders (TMDs). Methods Forty-two participants were randomly allocated to three groups: an adjacent point selection group (Trt, n = 14), a distant point selection group (Con1, n = 14), or a combination group (Con2, n = 14). All three groups received a total of six acupuncture sessions (twice a week for 3 weeks), the outcomes being assessed pain intensity using a 10-cm visual analogue scale, and the palpation index of the muscle and temporomandibular joint every week of treatment and 4 weeks after the end of treatment. Results The pain intensity was reduced in the Trt (34%), Con1 (31%), and Con2 (36%) groups after 3 weeks compared with each group's baseline, with no significant difference among the three groups ( p = 0.5867). Similarly, the palpation index was decreased by 52% (Trt), 62% (Con1), and 50% (Con2) after 3 weeks of treatment, but no significant differences between groups were shown ( p = 0.3289). Conclusion Our results suggest that point-selective effects among adjacent, distal, or a combination of acupoints are hardly associated with pain intensity or palpation index in participants with TMDs. Larger sample size trials are required to overcome the shortcomings of the study.

Background Hot flushes are the most frequent climacteric symptom and a major cause of suffering among menopausal women. The condition negatively influences many aspects of women's lives. To date, conventional hormone replacement therapy (HRT) is considered the most effective treatment for hot flushes. However, HRT is associated with a host of negative side effects. Complementary and alternative medical (CAM) approaches have been employed to relieve symptoms and to avoid these side effects. Acupuncture is one of the most strongly preferred CAM treatments for many diseases, causing few serious adverse effects, and is frequently used in Korea. We aim to evaluate the effectiveness of Traditional Korean Acupuncture (TKA) in conjunction with usual care, compared to usual care alone, on hot flushes in perimenopausal and postmenopausal women in Korea. Methods This study consists of a multi-center randomized controlled trial with 2 parallel arms. Participants included in the study will meet the following criteria: 1) a documented daily average hot flush score ≥ 10 for one week prior to the screening visit 2) not taking HRT and other pharmaceutical therapies which might affect hot flushes or other vasomotor symptoms. While maintaining usual care, the treatment group will receive acupuncture 3 times a week, for a total of 12 sessions over 4 weeks. The control group will receive usual care alone during the same period. Post-treatment follow-up will be performed one month after completing 12 sessions of acupuncture. Discussion This trial will provide evidence for the effectiveness of acupuncture as a treatment for hot flushes. The primary endpoint in both groups is a change in hot flush score from baseline to week 4 and/or week 8. As the secondary endpoint, we will employ the Menopause Rating Scale (MRS), a health-related quality of life questionnaire. Further analysis will examine the frequency, severity and difference in symptoms for daytime vs. nighttime hot flushes, sub-domain analysis of MRS, and participants' expectations of acupuncture treatment. Trial registration Current Controlled Trials ISRCTN49335612

Background Previous studies of acupuncture show favourable results for both subjective and objective outcomes of dry eye. However, firm conclusions could not be drawn from these studies because the quality of the trials was too low to establish concrete evidence. Therefore, this study was designed both to avoid the flaws of the existing trials and to assess the effectiveness, cost-effectiveness and qualitative characteristics of acupuncture treatment for dry eye. Methods/design One hundred fifty participants with dry eye will be recruited into three independent hospitals from different areas: Korea Institute of Oriental Medicine, DongGuk University Ilsan Oriental Hospital and Dongshin University Gwangju Oriental Hospital. The number of participants required was calculated from the data of a previous, relevant study. These patients will be randomly allocated into acupuncture treatment or artificial tear groups. Either 17 acupuncture points (bilateral BL2, GB14, TE 23, Ex1, ST1, GB20, LI4, LI11 and single GV23) will be used 3 times a week or disposable artificial tear drops (Refresh Plus®, ALLERGAN) will be provided for use at least once a day for 4 weeks. The ocular surface disease index (OSDI), tear film break-up time (TFBUT), Schirmer I test, visual analogue scale (VAS) for self-assessment of ocular discomfort, general assessment (by both acupuncture practitioners and participants) and quality of life (QOL) through the Measure Yourself Medical Outcome Profile-2 (MYMOP-2) will be assessed for approximately 3-months for each study participant. In addition, qualitative study and cost-effectiveness of acupuncture treatment will be conducted. Trial registration ClinicalTrials.gov (Identifier: NCT01105221).

Background Moxibustion is an ancient traditional medicine using burning mugworts to stimulate acupuncture points. The aim of this study was to investigate the safety and efficacy of moxibustion for the treatment of constipation using a randomized, sham-controlled, participant-blinded, pilot trial. Methods Twenty-six participants (identified with either qi (vital energy) deficiency or qi excess syndrome) were randomly divided into either a moxibustion or sham group. Participants were treated with real or sham moxibustion at 4 acupuncture points, ST23 and ST27, bilaterally, 3 times per week for four weeks. The primary outcome was the frequency of defecations; secondary outcomes were the Bristol stool form scale (BSS) and the constipation assessment scale (CAS). Results Of the 26 participants that were randomized, 24 completed the study. Defecation frequency, BSS, and CAS showed no difference between the moxibustion and sham groups. The differences were -0.25 (95% CI: -2.08, 1.58, p = 0.78), -1.22 (95% CI: -2.7, 0.26, p = 0.1), 0.91 (95% CI: -1.46, 3.28, p = 0.44) in defecation frequency, BSS, CAS, respectively. The defecation frequency increased from an average of 3.3 to 4.6 times per week in the moxibustion group (1.5[-0.5, 2], p = 0.06) and from 2.7 to 3.7 stools per week in the sham group (1[-1, 2], p = 0.15) after four weeks of treatment. The difference between participants with a deficiency or an excess syndrome, determined based on assessment of sweat, facial features, pain, body energy, and pulse type, was significant in only defecation frequency. The difference was 3.3 (95% CI: 0.41, 6.19, p = 0.03). Conclusion Moxibustion treatment appears safe, but showed no positive effect on constipation. The effectiveness of moxibustion treatment may depend on the syndrome pattern, and further long-term studies with a larger number of subjects are warranted. Trial registration Clinical Research Information Service, KCT0000168