Effectiveness and safety of electroacupuncture for poststroke patients with shoulder pain: study protocol for a double-center, randomized, patient- and assessor-blinded, sham-controlled, parallel, clinical trial.

BACKGROUND: Practitioners of complementary and alternative medicine have suggested that acupuncture could alleviate poststroke shoulder pain, based on the clinical evidence. This study protocol is aimed at showing the effectiveness and safety of electroacupuncture therapy for stroke survivors with shoulder pain. METHODS: After assessing their eligibility, 60 stroke survivors with shoulder pain will be enrolled from two traditional Korean medicine hospitals and randomly divided into either the verum or the sham electroacupuncture (EA) group with a 1:1 ratio. The participants will receive 9 sessions of EA procedures for 3 weeks. The verum EA consists of needling on 6 unilateral acupoints (LI4, LI15, TE14, SI9, SI11, and GB21) with electronic stimulation. A non-penetrating Park sham device and fake electronic stimulation will be used in the sham group on the same acupoints. Patients and outcome assessors will be blinded throughout the entire study. A visual analog scale will be used primarily for the evaluation, and pain rating scale, Fugl-Meyer assessment for upper extremity, modified Ashworth scale, manual muscle test, passive range of motion test, Korean version of a modified Barthel index, and Korean version of the Beck depression inventory will be also be measured. A blinding index will be assessed. For safety, adverse events will be recorded. Data will be statistically analyzed by two-sample t-test or Wilcoxon rank sum test for efficacy and a chi-squared test or Fisher's exact test for safety, at 5% of significance level. DISCUSSION: We expect this double-center, randomized, sham-controlled, patient- and assessor-blinded parallel trial to explore the effectiveness and safety of EA therapy, compared with sham EA, for poststroke shoulder pain. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT03086863.

Corrigendum to "Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence: Study Protocol of a Pilot Multicentered, Randomized, Parallel, Sham-Controlled Trial".

[This corrects the article DOI: 10.1155/2016/5709295.].

Corrigendum to "Acupuncture for Spasticity after Stroke: A Systematic Review and Meta-Analysis of Randomized Controlled Trials".

[This corrects the article DOI: 10.1155/2015/870398.].

Electroacupuncture versus sham electroacupuncture for urinary retention in poststroke patients: study protocol for a multicenter, randomized controlled trial.

BACKGROUND: This study protocol evaluates the effectiveness of adjuvant electroacupuncture (EA) for urinary retention in poststroke patients undergoing conventional treatments, in comparison with that of a sham control. METHODS/DESIGN: A multicenter, blinded, randomized controlled trial will be conducted in three hospitals in the Republic of Korea. We are recruiting 54 stroke survivors (aged >19 years), who were diagnosed with urinary retention based on the results of two consecutive post-void residual (PVR) tests, and dividing them randomly into two arms: the EA and Park-sham control groups. They will receive ten sessions of EA or sham treatment for 2 weeks. The participants will be blinded with non-penetrating needles and fake sounds of EA stimulators. The daily PVR ratio will be primarily measured at baseline and at the end of the study to statistically test the effectiveness of EA for poststroke urinary retention. Then, the Korean version of the Qualiveen Questionnaire, the Korean version of the International Prostate Symptom Score, and the blinding index will be assessed. After each EA session or sham EA, adverse events will be reported to evaluate the safety of EA. Results will be analyzed by using the independent t-test or Mann-Whitney U test, based on both intention-to-treat and per-protocol principles. DISCUSSION: The findings will provide clinical evidence for the effectiveness of EA treatment to improve urinary retention in stroke survivors. TRIAL REGISTRATION: This study protocol was registered in ClinicalTrials.gov (NCT02472288) on 10 June 2015.

Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence: Study Protocol of a Pilot Multicentered, Randomized, Parallel, Sham-Controlled Trial.

This pilot multicentered, randomized, parallel, sham-controlled trial is intended to evaluate the effectiveness and safety of electroacupuncture therapy for poststroke patients with urinary incontinence. Forty stroke survivors aged >19 years will be recruited in 2 hospitals in the Republic of Korea. Patients who experienced stroke within 2 years and satisfy criteria of urinary frequencies ≥2 with either 3 to 4 points on the Patient Perception of Intensity of Urgency Scale or 13 points or more on the Korean version of the International Prostate Symptom Scale (K-IPSS) will be identified, along with other eligibility criteria. Patients will be randomly allocated to either a treatment or control group to receive 10 sessions of electroacupuncture or sham therapies, respectively. Patients and outcome assessors will be blinded. The primary outcome is the change of Total Urgency and Frequency Score between the baseline and the trial endpoint. The K-IPSS, the International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form, and the Lower Urinary Tract Symptoms Outcome Score will be evaluated for effectiveness assessment. Adverse events will be reported after every session. The Blinding Index will also be calculated. Data will be statistically analyzed with 0.05 significance levels by 2-sided testing.

Acupuncture for spasticity after stroke: a systematic review and meta-analysis of randomized controlled trials.

The aim of this systematic review was to determine how effective acupuncture or electroacupuncture (acupuncture with electrical stimulation) is in treating poststroke patients with spasticity. We searched publications in Medline, EMBASE, and the Cochrane Library in English, 19 accredited journals in Korean, and the China Integrated Knowledge Resources Database in Chinese through to July 30, 2013. We included randomized controlled trials (RCTs) with no language restrictions that compared the effects of acupuncture or electroacupuncture with usual care or placebo acupuncture. The two investigators assessed the risk of bias and statistical analyses were performed. Three RCTs in English, 1 in Korean, and 1 in Chinese were included. Assessments were performed primarily with the Modified Ashworth Scale (MAS). Meta-analysis showed that acupuncture or electroacupuncture significantly decreased spasticity after stroke. A subgroup analysis showed that acupuncture significantly decreased wrist, knee, and elbow spasticity in poststroke patients. Heterogeneity could be explained by the differences in control, acupoints, and the duration after stroke occurrence. In conclusion, acupuncture could be effective in decreasing spasticity after stroke, but long-term studies are needed to determine the longevity of treatment effects.

Efficacy and safety of gwakhyangjeonggi-san retention enema in normal rats and spontaneously hypertensive rats.

The purpose of this study is to establish a protocol of retention-enema experiments and evaluate the antihypertensive effect and the safety of Gwakhyangjeonggi-san retention enema. Normal and spontaneously hypertensive rats (SHRs) were divided into treatment and control groups, respectively. We applied the Gwakhyangjeonggi-san extract by decoction and 0.9% NaCl in each group, estimated the blood pressure and body weight, and performed HPLC analysis. ALT, AST, BUN, and creatinine were examined. The systolic blood pressure within each group in normal rats differed significantly in time effect, and so did the diastolic blood pressure in the treatment group of normal rats. The systolic, diastolic, and mean blood pressure showed significant differences in group effect in the treatment group of the SHRs. The time effect of the body weight in both groups of normal rats differed significantly, so did group × time and time effects in both groups of SHRs. AST, ALT, BUN, and creatinine showed no significant difference between groups. We concluded that the Gwakhyangjeonggi-san retention enema has a hypotensive effect in normal rats within the regular range of blood pressure, but an antihypertensive effect in SHRs. Also, the intervention is safe and does not affect the liver and kidney functions in normal rats.

Sasang constitutional medicine and traditional chinese medicine: a comparative overview.

Sasang constitutional medicine (SCM) is a holistic typological constitution medicine which balances psychological, social, and physical aspects of an individual to achieve wellness and increase longevity. SCM has the qualities of preventative medicine, as it emphasizes daily health management based on constitutionally differentiated regimens and self-cultivation of the mind and body. This review's goal is to establish a fundamental understanding of SCM and to provide a foundation for further study. It compares the similarities and differences of philosophical origins, perspectives on the mind (heart), typological systems, pathology, and therapeutics between SCM and traditional Chinese medicine (TCM). TCM is based on the Taoist view of the universe and humanity. The health and longevity of an individual depends on a harmonious relationship with the universe. On the other hand, SCM is based on the Confucian view of the universe and humanity. SCM focuses on the influence of human affairs on the psyche, physiology, and pathology.

The Sasang constitutional types can act as a risk factor for hypertension.

It has been suggested that an approach to hypertension based on the constitutional make-up of an individual may be effective. We conducted a retrospective chart review to explore the association of Sasang constitution with hypertension. The results show that the prevalence of hypertension was highest in the Taeeum (TE) constitutional type, and that the TE constitutional type can act as an independent risk factor for hypertension (OR in TE group = 1.37 (CI 1.06-1.78) (vs. non-TE group)). This indicates that the Sasang constitutional type could explain the variability in individual susceptibilities to hypertension, suggesting a novel constitution-based approach to hypertension.

Sasang constitutional types can act as a risk factor for insulin resistance.

The prevalence of insulin resistance (IR) was found to differ across different constitutional types defined by the Sasang constitutional medicine, a sub-division of the Korean traditional medicine, implying that the constitutional type of an individual is a trait that can act as an independent risk factor for IR.

Acupuncture for peripheral joint osteoarthritis.

BACKGROUND: Peripheral joint osteoarthritis is a major cause of pain and functional limitation. Few treatments are safe and effective. OBJECTIVES: To assess the effects of acupuncture for treating peripheral joint osteoarthritis. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2008, Issue 1), MEDLINE, and EMBASE (both through December 2007), and scanned reference lists of articles. SELECTION CRITERIA: Randomized controlled trials (RCTs) comparing needle acupuncture with a sham, another active treatment, or a waiting list control group in people with osteoarthritis of the knee, hip, or hand. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. We contacted study authors for additional information. We calculated standardized mean differences using the differences in improvements between groups. MAIN RESULTS: Sixteen trials involving 3498 people were included. Twelve of the RCTs included only people with OA of the knee, 3 only OA of the hip, and 1 a mix of people with OA of the hip and/or knee. In comparison with a sham control, acupuncture showed statistically significant, short-term improvements in osteoarthritis pain (standardized mean difference -0.28, 95% confidence interval -0.45 to -0.11; 0.9 point greater improvement than sham on 20 point scale; absolute percent change 4.59%; relative percent change 10.32%; 9 trials; 1835 participants) and function (-0.28, -0.46 to -0.09; 2.7 point greater improvement on 68 point scale; absolute percent change 3.97%; relative percent change 8.63%); however, these pooled short-term benefits did not meet our predefined thresholds for clinical relevance (i.e. 1.3 points for pain; 3.57 points for function) and there was substantial statistical heterogeneity. Additionally, restriction to sham-controlled trials using shams judged most likely to adequately blind participants to treatment assignment (which were also the same shams judged most likely to have physiological activity), reduced heterogeneity and resulted in pooled short-term benefits of acupuncture that were smaller and non-significant. In comparison with sham acupuncture at the six-month follow-up, acupuncture showed borderline statistically significant, clinically irrelevant improvements in osteoarthritis pain (-0.10, -0.21 to 0.01; 0.4 point greater improvement than sham on 20 point scale; absolute percent change 1.81%; relative percent change 4.06%; 4 trials;1399 participants) and function (-0.11, -0.22 to 0.00; 1.2 point greater improvement than sham on 68 point scale; absolute percent change 1.79%; relative percent change 3.89%). In a secondary analysis versus a waiting list control, acupuncture was associated with statistically significant, clinically relevant short-term improvements in osteoarthritis pain (-0.96, -1.19 to -0.72; 14.5 point greater improvement than sham on 100 point scale; absolute percent change 14.5%; relative percent change 29.14%; 4 trials; 884 participants) and function (-0.89, -1.18 to -0.60; 13.0 point greater improvement than sham on 100 point scale; absolute percent change 13.0%; relative percent change 25.21%). In the head-on comparisons of acupuncture with the 'supervised osteoarthritis education' and the 'physician consultation' control groups, acupuncture was associated with clinically relevant short- and long-term improvements in pain and function. In the head on comparisons of acupuncture with 'home exercises/advice leaflet' and 'supervised exercise', acupuncture was associated with similar treatment effects as the controls. Acupuncture as an adjuvant to an exercise based physiotherapy program did not result in any greater improvements than the exercise program alone. Information on safety was reported in only 8 trials and even in these trials there was limited reporting and heterogeneous methods. AUTHORS' CONCLUSIONS: Sham-controlled trials show statistically significant benefits; however, these benefits are small, do not meet our pre-defined thresholds for clinical relevance, and are probably due at least partially to placebo effects from incomplete blinding. Waiting list-controlled trials of acupuncture for peripheral joint osteoarthritis suggest statistically significant and clinically relevant benefits, much of which may be due to expectation or placebo effects.

Perspective of the human body in sasang constitutional medicine.

The Sasang constitutional medicine (SCM), a medical tradition originating from Korea, is distinguished from the traditional Chinese medicine in its philosophical background, theoretical development and especially, the fundamental rationale that analyzes the structure and function of the human body within a quadrifocal scheme. In SCM, the structure of the body is comprehended within the Sasang quadrifocal scheme, and the function of the body is understood within the context of the energy-fluid metabolism and the water-food metabolism controlled by the four main organs (lung, spleen, liver and kidney). Also, the concept of Seong-Jeong is used to explain the structural and functional variations between different constitutional types that arise from the constitutional variations in organ system scheme, which are in turn caused by deviations in the constitutional Seong-Jeong. Therefore, understanding the SCM perspective of the human body is essential in order to fully appreciate the advantages of the constitutional typological system (which focuses on individual idiosyncrasies) found in SCM.

2005 Sasangin Diagnosis Questionnaire for Mongolian (05'SDQ-M): test of reliability.

OBJECTIVES: This study was proposed to evaluate the reliability by 2005 Sasangin Diagnosis Questionnaire for Mongolian (05' SDQ-M). DESIGN: Questions from the 05'SDQ were translated into Mongolian, and the 05'SDQ-M was constructed. The questionnaire was administered to 193 Mongolians and they were asked to complete the questionnaire again 2 weeks after the first administration. To evaluate the internal consistency, Cronbach's alpha coefficient was calculated. A reliability analysis for each individual question was conducted using the test-retest method to verify the independence and agreement between the questions. To verify independence, a chi(2) test with crosstabs analysis and p-values was used. The agreement verification was conducted by using the Cohen kappa coefficient. In addition, the constitutional variable was defined as the constitutional attribute of each question, and Pearson's correlation coefficient was confirmed after testing the scale. RESULTS AND CONCLUSIONS: After testing the internal consistency of the scale, the consistency was shown to range from 0.59 to 0.67, suggesting that the questions on the questionnaire were reliable. The test-retest method showed that Pearson's correlation coefficients for the results of the two tests ranged from 0.65 to 0.80. The x(2) test results indicated that one independent item demanded close attention. Among the other 123 questions, the agreement test revealed that 80 questions (64.5%) showed common agreement.

Studies on absorption, distribution and metabolism of ginseng in humans after oral administration.

AIM OF THE STUDY: This study was aimed to characterize the absorption, distribution and metabolism of ginseng in human subjects using pharmacokinetic experiments based on the metabolism by microflora obtained from the feces. MATERIALS AND METHODS: We examined how intestinal microflora transforms ginsenoside-Rb1 (G-Rb1) and ginseng extracts into Compound k (C-K) using in vitro experiments with microbial flora obtained from the feces of 32 male subjects. Subsequently, Cmax, Tmax and the area under the blood concentration curve (AUC) for C-K in plasma were estimated by quantitative analysis using LC-MS/MS. The correlation between C-K transforming activity and the AUC of C-K in plasma and other properties were analyzed. RESULTS: C-K was absorbed into the blood 24h after oral administration of ginseng, with average values for Tmax, Cmax, and AUC as follows: 10.76+/-2.07 h, 27.89+/-24.46(ng/ml), and 221.98+/-221.42(microg h/ml), respectively. There was a correlation between the C-K transforming activity of G-Rb1 and the C-K transforming activity of ginseng extract by intestinal microflora (Spearman's correlation coefficient=0.402, p<0.05). CONCLUSION: The absorption of the final metabolites ginseng is independent of the metabolite transforming activity of intestinal microflora, but the Tmax, Cmax and AUC of the transformed metabolites are dependent on the activity of each individual's microbial flora.

Sasangin diagnosis questionnaire: test of reliability.

BACKGROUND: The concept of Sasang Constitutional Medicine (SCM) has been in existence in Traditional Korean Medicine for more than 100 years. It is of great importance that the Sasang constitution type be determined accurately before any therapeutic treatment. OBJECTIVES: Reliability analyse were carried out to evaluate the Sasangin Diagnosis Questionnaire (SDQ). DESIGN: The data were collected through multi-center research in collaboration with the Departments of SCM in the nine Korean Colleges of Oriental Medicine. The internal consistency test and the test-retest method were applied in the reliability analysis. SUBJECTS: The test-retest data of 88 respondents were used to analyze the reliability. The internal consistency reliability analysis was carried out using the data collected from 423 respondents. RESULTS: The test-retest reliability was examined using the Pearson's correlation coefficients, which ranged from 0.44 to 0.74. The chi-square test results showed that there were five independent items in the retest that demanded careful attention. The Cronbach's alpha coefficient showed that all items were acceptable. CONCLUSIONS: All the categories of SDQ can be accepted as being reliable scales.

Clinical trial of herbal formula on weight loss in obese Korean children.

A traditional Korean herbal formula (KH), which is based on Taeumjowi-tang, is currently the most widely used herbal formula in Korea. In this study, KH was administered to obese children for 30 days, and was found to be clinically safe and effective. The subjects were children admitted to hospital to be treated for obesity with relative body weights (%RBW) of 20% or more. Originally, there were 31 subjects, but nine dropped out during the experiment. There were eight girls and 14 boys, whose average age was 11.00 +/- 2.62 years, average weight was 53.37 +/- 17.29 kg, and average period (30-day amount) of KH dosage was 51.18 +/- 22.58 days. The short-term effects of KH on obese children were the reduction of their BMI from 24.34 +/- 3.10 to 23.26 +/- 3.00 kg/m2, of %RBW from 34.41 +/- 10.90 to 25.94 +/- 11.18% (p < 0.01), of body fat mass from 17.99 +/- 5.37 to 16.50 +/- 4.82 kg, and of body fat from 34.16 +/- 3.75 to 32.08 +/- 3.15% (p < 0.01). Concerning anthropometrical measurements, abdominal skin-fold decreased from 26.16 +/- 9.08 to 22.90 +/- 8.35 mm, as did subscapular skin-fold from 20.86 +/- 5.20 to 18.46 +/- 5.31 mm (p < 0.01). In terms of serum lipid levels, which are indices of heart disease, their total cholesterol decreased from 195.38 +/- 31.39 to 183.25 +/- 33.27 mg/dl, the arteriosclerosis index from 4.100 +/- 0.81 to 3.84 +/- 0.64 mg/dl (p < 0.05), and serum leptin level from 14.91 +/- 6.59 to 12.24 +/- 4.98 ng/ml (p < 0.01). Concerning the safety of KH, there were no significant changes in the subjects' livers, hearts, or kidneys. Nor were there any short-term signs of clinically serious side effects or withdrawal symptoms observed. The short-term effects of KH on obese children are weight loss and a decrease in obesity.