Efficacy and safety of Tuina for chronic nonspecific low back pain: A PRISMA-compliant systematic review and meta-analysis.

OBJECTIVE: Chronic nonspecific low back pain (CNLBP) is a serious medical and social problem resulting in functional decline and decreased work ability. Tuina, a form of manual therapy, has been sparsely used to treat patients with CNLBP. To systematically assess the efficacy and safety of Tuina for patients with CNLBP. METHODS: Multiple English and Chinese literature databases were searched until September 2022 for randomized controlled trials (RCTs) of Tuina in the treatment of CNLBP. The methodological quality was assessed using the Cochrane Collaboration's tool, and certainty of the evidence was determined with the online Grading of Recommendations, Assessment, Development and Evaluation tool. RESULTS: Fifteen RCTs with 1390 patients were included. Tuina demonstrated a significant effect on pain (SMD: -0.82; 95% CI -1.12 to -0.53; P < .001; I2 = 81%) and physical function (SMD: -0.91; 95% CI -1.55 to -0.27; P = .005; I2 = 90%) when compared to control. However, Tuina resulted in no significant improvement for quality of life (QoL) (SMD: 0.58; 95% CI -0.04 to 1.21; P = .07; I2 = 73%;) compared to control. The Grading of Recommendations, Assessment, Development and Evaluation evidence quality was determined to be low level for pain relief, physical function, and QoL measurements. Only six studies reported adverse events; none were serious. CONCLUSION: Tuina might be an effective and safe strategy for treating CNLBP in terms of pain and physical function, but not for QoL. The study results should be interpreted with caution for their low-level evidence. More multicenter, large-scale RCTs with a rigorous design are required to further confirm our findings.

Dietary Supplements for Pain Relief in Patients with Fibromyalgia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Pain is the most frequently encountered symptom by patients with fibromyalgia (FM). Dietary supplements (DSs) in particular have a proven impact as a possible adjunctive therapy for symptom management in FM. However, there is currently no conclusive review outlining the evidence for DSs in pain management in FM. This study aims to assess currently available studies evaluating the use of DSs for pain relief in FM. Randomized controlled trials regarding the use of DSs on adult FM patients were included for evidence synthesis. Study results indicated that DSs significantly relieved pain in FM (SMD 1.23; 95% CI 0.02-2.43, P = 0.046) but did not improve quality of life (QoL) (SMD 0.73; 95% CI -0.07-1.53, P = 0.075) in the data. Adverse events of DSs varied from mild to severe, with the most common being gastrointestinal symptoms and androgenic side effects in 5.7% and 3.9% of patients, respectively. More well-designed RCTs are required in the future. The protocol for this review has been published on PROSPERO (CRD42020149941).

Ginseng for the Treatment of Chronic Fatigue Syndrome: A Systematic Review of Clinical Studies.

BACKGROUND: Chronic fatigue syndrome (CFS) is a complex and often disabling chronic condition emerging worldwide, with no curative or definitive therapy yet identified. Ginseng has been widely used to treat fatigue in other patient groups and conditions; however, a systematic review focusing solely on the impact of ginseng on fatigue in patients with CFS has not been performed. OBJECTIVE: This study aimed to assess the current state of evidence regarding ginseng for CFS. METHODS: Multiple databases were searched from inception to October 2020. All data was extracted independently and in duplicates. Outcomes of interest included the effectiveness and safety of ginseng in patients with CFS. RESULTS: 2 studies enrolling 68 patients were deemed eligible, including one randomized clinical trial and one prospective observational study. The certainty of evidence in the effectiveness outcome was low and moderate from both studies, while the safety evidence was very low as reported from one study. CONCLUSION: Study findings highlight a potential benefit of ginseng therapy in the treatment of CFS. However, we are not able to draw firm conclusions due to limited clinical studies. The paucity of data warrants limited confidence. There is a need for future rigorous studies to provide further evidence.

Dietary supplements and herbal medicine for COVID-19: A systematic review of randomized control trials.

BACKGROUND: The world is currently struggling with the Coronavirus disease 2019 (COVID-19) pandemic. Dietary supplements (DSs) and herbal medicine provide a potentially convenient and accessible method for its recovery, but direct evidence is limited. OBJECTIVE: This study aims to investigate the effectiveness of DSs and herbs in patients with COVID-19. METHODS: A systematic literature search was conducted in multiple electronic English and Chinese databases. Randomized controlled trials (RCTs) involving DSs or herbal medicine interventions on patients with COVID-19 from November 2019 to February 2021 were included. Data was extracted, summarized and critically examined. RESULTS: Out of 9402 records identified in the initial search, twelve RCTs were included in this review. Risk of bias of these RCTs was deemed high. Most of the trials were of low methodologic quality. Nine studies showed herbal supplements were beneficial to the recovery of COVID-19 patients; zinc sulfate could shorten the duration of loss of smell but not total recovery from COVID-19. No severe adverse events were reported. CONCLUSION: Herbal supplements may help patients with COVID-19, zinc sulfate is likely to shorten the duration of olfactory dysfunction. DS therapy and herbal medicine appear to be safe and effective adjuvant therapies for patients with COVID-19. These results must be interpreted with caution due to the overall low quality of the included trials. More well-designed RCTs are needed in the future.

Multicentre randomised controlled clinical trial of electroacupuncture with usual care for patients with non-acute pain after back surgery.

BACKGROUND: The purpose of this study was to investigate the effectiveness and safety between electroacupuncture (EA) combined with usual care (UC) and UC alone for pain reduction and functional improvement in patients with non-acute low back pain (LBP) after back surgery. METHODS: In this multicentre, randomised, assessor-blinded active-controlled trial, 108 participants were equally randomised to either the EA with UC or the UC alone. Participants in the EA with UC group received EA treatment and UC treatment twice a week for 4 weeks; those allocated to the UC group received only UC. The primary outcome was the VAS pain intensity score. The secondary outcomes were functional improvement (Oswestry Disability Index [ODI]) and the quality of life (EuroQol-5-dimension questionnaire [EQ-5D]). The outcomes were measured at Week 5. RESULTS: Significant reductions were observed in the VAS (mean difference [MD] -8.15; P=0.0311) and ODI scores (MD -3.98; P=0.0460) between two groups after 4 weeks of treatment. No meaningful differences were found in the EQ-5D scores and incidence of adverse events (AEs) between the groups. The reported AEs did not have a causal relationship with EA treatment. CONCLUSIONS: The results showed that EA with UC treatment was more effective than UC alone and relatively safe in patients with non-acute LBP after back surgery. EA with UC treatment may be considered as an effective, integrated, conservative treatment for patients with non-acute LBP after back surgery. CLINICAL TRIAL REGISTRATION: KCT0001939.

Association of Cost and Medical Service Satisfaction with Korean and Conventional Medicine Use before and after Surgery in Postsurgical Patients: A Questionnaire Survey of Korean Patients with Postsurgical Pain Visiting Korean Medicine Hospitals.

This study aimed to assess the costs, health status, and medical service satisfaction with Korean and conventional medicine use before and after surgery of patients visiting Korean medicine hospitals for postsurgical musculoskeletal pain. The study population comprised patients who visited KM hospitals for the first time between June and November 2017 for persistent or recurrent pain and discomfort after low back, neck, shoulder, or knee surgery. Various validated questionnaires were used to collect data. A total of 100 participants were enrolled, and the majority had undergone low back surgery (n = 82). The participants had received 1.3 ± 0.7 magnetic resonance imaging (MRI) examinations and 2.4 ± 2.8 X-rays before surgery. Conventional interventions used before surgery were physical therapy (43%), medications (34%), and injections (28%), in descending order, while 48% of patients reported having received acupuncture 51.3 ± 81.1 times. The mean satisfaction score for surgery was 5.5 ± 2.8 points based on a 9-point Likert scale, while that for KM-based interventions was 6.3 ± 1.7 points. With respect to health-related information, the mean scores were 6.0 ± 2.2 points on the Numeric Rating Scale (NRS), 0.6 ± 0.2 points on the 5-Level EuroQol-5 Dimension (EQ-5D-5L), and 15.3 ± 10.2 on Beck's Depression Index II (BDI-II). The mean score on the Oswestry Disability Index (ODI) in patients with low back pain was 40.1 ± 19.2 points. Work impairment, as measured using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH), was 62.5 ± 47.8%, while activity impairment was 5.9 ± 2.6%. Participants tended to show low satisfaction regarding surgery and high preference for KM-based interventions. In particular, low back surgery patients reported high ODI scores, indicating high dysfunctional levels and poor prognosis after surgery. It can be inferred that it is therefore important to provide appropriate presurgical and postsurgical care for patients with musculoskeletal pain to improve pain, function, and quality of life.

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.

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.

The efficacy and safety of the herbal medicine geonchildan for patients with active rheumatoid arthritis: study protocol for a randomized, double-blind, placebo-controlled, parallel pilot trial.

BACKGROUND: This study aims to assess the efficacy and safety of geonchildan, a Korean traditional herbal medicine, for patients with active rheumatoid arthritis (RA) and evaluate the feasibility of a large-scale confirmatory clinical trial. METHODS/DESIGN: This is a randomized, double-blind, placebo-controlled, parallel two-arm pilot trial in Seoul, Korea. Altogether, 30 patients diagnosed with RA for at least 3 months and with a Disease Activity Score for 28 joints (DAS28) ≥ 3.2 will be enrolled. Participants are randomly assigned to one of two groups, the experimental group or the placebo group, in a 1:1 ratio and will make four scheduled visits. The participants will be administered geonchildan or a placebo three times per day for 12 weeks. The change in DAS28 will be examined as the primary efficacy outcome. The secondary efficacy outcomes include the proportion of patients achieving ACR20, ACR50, ACR70, and EULAR responses; the DAS28 sub-items; the consumption of medication; Korean Health Assessment Questionnaire scores; inflammatory parameters; and the Korean medical diagnostic pattern indicator. Adverse events and laboratory test results will be recorded to evaluate safety. The process, resources used, and management of the study will also be assessed to determine the feasibility of a large-scale trial. DISCUSSION: This is the first clinical trial to explore the efficacy and safety of geonchildan in patients with active RA. If the superiority of geonchildan versus the placebo is demonstrated and the study design is feasible, this study could form the foundation for a large-scale clinical trial. The results will be published in a peer-reviewed journal. TRIAL REGISTRATION: Clinical Research Information Service, KCT0001943 . Registered on 14 June 2016.

Impact of acupuncture treatment on the lumbar surgery rate for low back pain in Korea: A nationwide matched retrospective cohort study.

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.

Electroacupuncture as a complement to usual care for patients with non-acute low back pain after back surgery: a pilot randomised controlled trial.

OBJECTIVES: The aim of this pilot study was to estimate the sample size for a large pragmatic study of the comparative effectiveness of electroacupuncture (EA) for low back pain (LBP) after back surgery. DESIGN: A randomised, active-controlled, assessor-blinded trial. PARTICIPANTS: Patients with recurrent or persistent LBP, defined as a Visual Analogue Scale (VAS) score of ≥50 mm, with or without leg pain after back surgery. INTERVENTIONS: Patients were randomised to an EA plus usual care (UC) group or to a UC alone group at a 1:1 ratio. Patients assigned to each group received UC, including drug therapy, physical therapy and back pain education, twice a week for 4 weeks; those assigned to the EA plus UC group additionally received EA. OUTCOME MEASURES: The primary outcome was severity of LBP as measured by VAS. Secondary outcomes included back pain-related disability, assessed using the Oswestry Disability Index (ODI) and quality of life, assessed using the EuroQol Five Dimensions (EQ-5D) questionnaire. Statistical analysis was performed using paired and independent t-tests. A p value of <0.05 was considered statistically significant. RESULTS: Thirty-nine patients were allocated to receive EA plus UC (n=18) or UC alone (n=21). There was no statistically significant difference in VAS or EQ-5D scores between the two groups, but there was a significant decrease in ODI scores (p=0.0081). Using G*Power, it was calculated that 40 participants per group would be needed for a future trial according to VAS scores. Considering for a 25% dropout rate, 108 participants (54 per group) would be needed. CONCLUSIONS: A future trial addressing the risk of bias and including the estimated sample size would allow for better clinical assessment of the benefits of EA plus UC in treatment of patients with non-acute pain after back surgery. TRIAL REGISTRATION NUMBER: NCT01966250; Results.

A multi-center, randomized controlled clinical trial, cost-effectiveness and qualitative research of electroacupuncture with usual care for patients with non-acute pain after back surgery: study protocol for a randomized controlled trial.

BACKGROUND: Although pain after back surgery is known to be difficult to control, various treatment options are available to patients and physicians. A protocol for a confirmatory randomized controlled trial (RCT) on pain and function after back surgery was designed based on the results of a pilot trial. The aim of this study is to compare the effectiveness and safety of electroacupuncture (EA) with usual care (UC) versus UC alone on pain control and functional improvement after back surgery. METHODS/DESIGN: This study is a multi-center, randomized, assessor-blinded trial with an active control conducted in conjunction with a cost-effectiveness analysis and qualitative research. Participants with non-acute low back pain with or without leg pain after back surgery who have a Visual Analogue Scale (VAS) pain intensity score ≥ 50 mm will be randomly assigned to either the EA with UC group (n = 54) or the UC group (n = 54). Following randomization, participants in both groups will receive the same UC treatment twice a week for a four-week treatment period. Participants assigned to the EA with UC group will additionally receive EA twice a week for the same four-week period. The primary outcome measure will be assessed using a VAS pain intensity score for low back pain. The secondary outcomes will include the Oswestry Disability Index, EuroQol 5-Dimension score, and drug intake. The primary and secondary outcomes will be measured at one, four, and eight weeks post randomization. DISCUSSION: The results of this study will provide evidence of the effectiveness and cost-effectiveness of EA in managing postoperative pain following back surgery. In addition, the qualitative research results will help improve the quality of integrative medical interventions. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), Republic of Korea, KCT0001939 . Registered on 8 June 2016.

Integrative Medicine for Postoperative Patients: A Survey of Korean Medicine Doctors.

The purpose of this survey was to document the experience of Korean Medicine doctors (KMD) who provided postoperative care to patients through integrative medicine and to understand their opinions about integrative medicine utilization. Three researchers (two with a KMD license) of the Korea Institute of Oriental Medicine conducted the survey. The questionnaire was distributed via e-mail to the 17,041 members of the Association of Korean Medicine in 2015. In total, 487 KMD answered the questionnaires. The majority of respondents worked in a Korean Medicine (KM) clinic, KM hospital, or long-term care hospitals (94.7%). The respondents mostly treated patients after musculoskeletal (26.7%), spinal (23.7%), or neuropathic surgery (22.2%). Patients predominantly experienced pain (23.0%), fatigue and tiredness (17.4%), delayed scar recovery (13.7%), and paralysis (13.0%). We analyzed subgroups in accordance with institution of employment, specialization, and clinical experience. Most KMD wanted to utilize integrative medicine for postoperative care of patients (92.6%). Moreover, a relatively active collaboration was noted in long-term care hospitals (mean rate: 60.73% [95% CI: 42.25 to 79.20]). Further studies and clinical trials are needed to determine whether integrative medicine is essential for providing postoperative care to Korean patients.

Long-Term Course of Failed Back Surgery Syndrome (FBSS) Patients Receiving Integrative Korean Medicine Treatment: A 1 Year Prospective Observational Multicenter Study.

BACKGROUND: With increase of spine surgeries, failed back surgery syndrome (FBSS) prevalence is also rising. While complementary and alternative medicine (CAM) is commonly used for low back pain (LBP), there are no studies reporting use of integrative Korean medicine in FBSS patients. METHODS: Patients with pain continuing after back surgery or recurring within 1 year and visual analogue scale (VAS) of LBP or leg pain of ≥6 (total n = 120) were recruited at 2 hospital sites from November 2011 to September 2014. Weekly sessions of integrative Korean medicine treatment were conducted for 16 weeks (herbal medicine, acupuncture/electroacupuncture, pharmacopuncture/bee venom pharmacopuncture, and Chuna manual therapy) with additional follow-ups at 24 weeks and 1 year. Outcome measures included VAS of LBP and leg pain (primary outcome), Oswestry Disability Index (ODI), Short-Form 36 (SF-36), medical use, and patient global impression of change (PGIC). RESULTS: VAS of LBP and leg pain improved at 6 months (LBP from 6.1±2.0 at baseline to 2.9±2.3; and leg pain from 5.4±2.6 to 2.4±2.5, respectively). Eighty patients (66.7%) showed improvement of 50% or more in main pain of LBP or leg pain from baseline. Disability and quality of life also improved at 6 months (ODI from 41.3±12.3 at baseline to 23.6±13.6; and SF-36 from 42.8±14.5 to 62.7±16.8). At 1 year follow-up, conventional medical management use decreased, improvement in pain and disability was maintained, and 79.2% reported improvement of PGIC. CONCLUSIONS: Despite limitations as an observational study, integrative Korean medicine treatment showed positive results in pain, function, and quality of life of FBSS patients.

Minimum Clinically Important Difference and Substantial Clinical Benefit in Pain, Functional, and Quality of Life Scales in Failed Back Surgery Syndrome Patients.

STUDY DESIGN: .: Prospective observational 1-year study. OBJECTIVE: .: To determine minimum clinically important difference (MCID) and substantial clinical benefit (SCB) of outcome measures in failed back surgery syndrome (FBSS) patients, as these metrics enable assessment of whether and when an intervention produces clinically meaningful effects in a patient. SUMMARY OF BACKGROUND DATA: .: Several methods have been devised to quantify clinically important difference, but MCID and SCB for FBSS patients has yet to be determined. METHODS: .: Patients with persisting/recurrent low back pain (LBP) and/or leg pain after lumbar surgery who completed 16 weeks of treatment (n = 105) at two hospitals in Korea from November 2011 to September 2014 were analyzed. Global perceived effect was used to determine receiver operating characteristic curves in visual analogue scale (VAS), Oswestry disability index (ODI), and short form-36 (SF-36) in an anchor-based approach. RESULTS: .: MCIDs for ODI, LBP and leg pain VAS, physical component summary, mental health component summary (MCS), and overall health scores of SF-36 were 9.0, 22.5, 27.5, 10.2, 4.0, and 8.9, and SCBs were 15.0, 32.5, 37.0, 19.7, 19.3, and 21.1, respectively. MCID and SCB area under the curve was ≥0.8, and ≥0.7, respectively. CONCLUSION: .: LBP and leg pain VAS, ODI, and physical component summary of SF-36 may be used to measure responsiveness in FBSS patients. LEVEL OF EVIDENCE: 3.

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.

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.

Serial Ultrasound Findings After Laser Ablation for Benign Breast Lesions on Long-Term Follow-Up: Implications for Evaluation of Procedural Success.

OBJECTIVE: The purpose if this study was to describe the follow-up ultrasound (US) findings of percutaneous US-guided laser ablation for small benign breast lesions, and to define the procedural success. BACKGROUND DATA: There are limited reports on follow-up imaging after laser ablation, because the ablated tumors were generally resected by surgery. MATERIALS AND METHODS: US-guided laser ablation was performed on 19 benign breast lesions in 10 patients. The median size of the lesions was 7.8 mm (range, 3-11 mm). The lesions were diagnosed as image-pathology concordant benign by US-guided core biopsy. After ablation, we performed follow-up US with an interval of 3-12 months; the median follow-up period was 32 months (range, 30-36 months). We evaluated the morphologic and size changes by using serial follow-up US. RESULTS: US findings of the 13 cases followed within the first 6 months after ablation showed hypoechoic lesions having inner hyperechogenicity with or without a hypoechoic center. The size of these lesions during this period increased in comparison with the initial lesion size, and then decreased or became stable on serial follow-up US. On the last follow-up US examination, in 14 cases (73.6%), the lesions were invisible, 4 cases (21.1%) showed scar changes, and 1 case (5.3%) showed a hypoechoic remnant lesion. CONCLUSIONS: US findings within 6 months after laser ablation showed mixed echoic lesions with increased size, followed by gradual decrease in size. Therefore, the success of laser ablation may be evaluated by checking the changes in the lesions by comparing the size of the lesions with the first follow-up US within 6 months and not the original tumor.

Acupuncture for chronic fatigue syndrome and idiopathic chronic fatigue: a multicenter, nonblinded, randomized controlled trial.

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 <0.001) and 13 weeks (Group A, P = 0.037; B, P <0.001). Group B showed significantly lower BDI scores than Group C at 13 weeks (P = 0.007). NRS scores from the treatment groups were significantly reduced compared to control at 5 (Group A and B, P <0.001) and 13 weeks (Group A, P = 0.011; B, P = 0.002). CONCLUSIONS: Body acupuncture for 4 weeks in addition to usual care may help improve fatigue in CFS and ICF patients. TRIAL REGISTRATION: Clinical Research Information Service (CRIS) KCT0000508; Registered on 12 August 2012.