Systemic Analgesic Effects of Electroacupuncture in Healthy Individuals: Thermal Threshhold, Acupuncture Sensation Intensity and De-qi on Quantitative Sensory Test.

Background: Electroacupuncture (EA) has been known to exert analgesic effects according to several reports, but studies investigating the analgesic effect of EA using the quantitative sensory test (QST) are rare. Primary Study Objective: To investigate the analgesic effects of electroacupuncture through changes in thermal thresholds measured using the QST. Design: Pilot, randomized, single-blind, parallel design. Setting: The study was conducted at Dongguk University Bundang Oriental Hospital (DUBOH) in South Korea. Participants: We included 40 healthy participants age 20 to 40 years. Intervention: The EA group received EA for 30 minutes at 6 acupuncture points (LI4, PC6, LI10, LI11, ST36, and SP6) and the control group just rested. Outcome measures: The primary outcome measure was 4 thermal thresholds including warm detection (WDT), cold detection (CDT), hot pain (HPT), and cold pain (CPT) measured using QST at baseline and after 15, 30 and 60 minutes. The secondary outcomes were the intensity of acupuncture sensation (visual analogue scale [VAS]) and De-qi (Massachusetts General Hospital Acupuncture Sensation Scale [MASS]). Results: The EA group showed significant changes in HPT (P < .001) and CPT (P = .049) compared with the control group, whereas WDT and CDT did not significantly differ. Furthermore, the changes in thermal thresholds were more pronounced in the higher intensity acupuncture sensation group (VAS ≥40) than in the lower intensity group (VAS < 40), although not significantly. The high De-qi group presented greater changes in WDT, CDT, HPT and CPT than the low De-qi group, as measured using MASS. It was especially statistically significant at HPT a feeling of "heaviness" and "dull pain" and at CDT of "tingling." We observed no adverse events related to the study. Conclusion: The change in thermal pain thresholds effected by EA supports the analgesic effect of EA reported in previous studies. The underlying mechanisms need to be holistically considered, and further studies are needed for definitive evidence.

Temperature Characteristics of Traditional Indirect Moxibustion and Electronic Moxibustion.

Background: Electronic moxibustion (EM) was developed to minimize the side effects of traditional moxibustion, such as burns, and to overcome therapeutic compliances such as smoke or smell. Objectives: To investigate distributions and thermal stimulation of EM at various depths using silicon phantom and to compare this methodology to traditional indirect moxibustion (TIM). Methods: A silicon phantom composed of polydimethylsiloxane was heated and immersed in a hot plate containing warm water to set the phantom's temperature to that of biological tissue. K-type thermocouples were inserted into the phantom at depths of 0, 2, 5, 7, and 10 mm to measure temperature changes with thermal stimulation of EM or TIM placed on top of the phantom. Results: At the surface of the phantom, the peak temperature after applying TIM (55.04 ± 0.92℃ [Δ23.79 ± 0.96℃]) was significantly higher than after EM (43.25 ± 1.95℃ [Δ13.00 ± 2.23℃]), with both interventions reaching the highest temperature after 2 minutes. The temperature increase for TIM was also statistically significant compared to EM when measured at a depth of 2 mm. For the experimental setting with TIM, after reaching peak surface temperature, a rapid decrease was observed at the surface and 2 mm while EM showed a much more gradual decline. There was no significant difference in temperature change between the groups at depths of 5, 7, and 10 mm. Conclusion: TIM resulted in a higher temperature rise compared to EM at the surface and at a 2 mm depth reaching over 50℃, which creates risk of burns. Thermal stimulation with EM had a lower risk of burns with temperature increment not being statistically different from TIM below the depth of 5 mm.

Effectiveness and safety of electric heating moxibustion for perennial allergic rhinitis: A pilot, randomized, assessor-blind trial.

BACKGROUND: The prevalence of allergic rhinitis (AR), an inflammatory disease, is gradually increasing. Studies have reported that moxibustion is effective for treating AR. Electric heating moxibustion (EM) was developed to offer adaptable heat stimulation without the generation of smoke. OBJECTIVES: The objective of this study was to examine the possibility of EM in treating perennial allergic rhinitis (PAR) and to assess the feasibility of using this technique on a larger scale by comparing EM with acupuncture (AC). DESIGN: A randomized pilot study was conducted on 40 patients with PAR. Patients were randomly assigned to one of two treatment groups: EM or AC. The primary outcome measure was the change in the total nasal symptom score (TNSS) between before and after treatment. The secondary outcome measures were the changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ), nasal endoscopy index for pattern identification, pattern identification questionnaire for AR, total serum immunoglobulin E (IgE), eosinophil count, and adverse effects (AEs). RESULTS: The results showed a statistically significant improvement in mean TNSS and RQLQ scores in both groups (p < 0.05), but no significant difference between the two groups. However, mean changes in itching and sneezing TNSS were significantly higher in the AC group. There was no significant difference in total serum IgE or eosinophil count before versus after treatment, nor was there any significant difference of three pattern subgroups between the two groups in the mean TNSS change. While the AC group reported two treatment-related AEs, there were no treatment-related AEs in the EM group. CONCLUSION: This trial provides evidence that EM isa safe alternative treatment for patients with PAR. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03342105. Registered on 14 November 2017.

Thermal Properties of Warm- versus Heated-Needle Acupuncture.

Background: Warm-needle acupuncture (WA) and fire-needle acupuncture are treatment techniques that use the combination of acupuncture and thermal stimulation. In clinical practice, a new method of fire-needle acupuncture called "heated-needle acupuncture (HA)" has been proposed, wherein the needle is directly heated after insertion. WA and HA share similarities in their methods, and no previous study has sought to assess whether their thermal outcomes are also similar. Methods: We controlled environmental variables and measured the maximum temperatures and temperature changes of a silicon phantom in which K-type thermocouples were embedded at depths of 0, 2, 5, 7, and 10 mm. WA and HA were also performed with acupuncture needles of various thicknesses (0.30 × 40 mm, 0.40 × 40 mm, and 0.50 × 40 mm). Results: Different time-dependent temperature distributions were observed between the two acupuncture methods: HA yielded a higher maximum temperature and temperature change on the surface, whereas WA yielded higher temperatures at the other tested depths. The thermal patterns were similar among the needles of different thicknesses for each method, with the following exception: while the temperature change and maximum temperature did not differ significantly by needle thickness for WA, these parameters increased significantly with needle thickness for HA. Conclusion: The two acupuncture procedures yielded different thermal patterns in a controlled environment. Further studies are necessary to reflect the effect of external environment variables occurring in reality.

The effectiveness and safety of Wu tou decoction on rheumatoid arthritis: A protocol for systematic review and/or meta-analysis.

BACKGROUND: Rheumatoid arthritis (RA) is one of the common inflammatory diseases with arthritis due to a malfunction of the immune system. The treatments for RA include surgery, physiotherapy, occupational therapies, and medication. The representative treatment is medication and its usage has improved through several guidelines. However, it has some limitations and occurs adverse effects. Meanwhile, traditional Chinese medicine treatments have been used for RA treatment and Wu tou decoction (WTD) is one of them. Regardless of recent studies about WTD's efficacy on RA, there has been no systematic review on this issue. Therefore, this review will focus on the effectiveness and safety of WTD on RA. METHODS: The search for randomized controlled trial about WTD on RA will be performed using multiple electronic databases, manual searches, and the author's e-mail if necessary. According to predefined criteria, randomized controlled trials will be selected and summarization will be performed by the data on study participants, result measurements, interventions, adverse events, and risk of bias. Disease activity score including effective rate, swollen joint count, tender joint count, morning stiffness will be primary outcome measures while blood test about RA including erythrocyte sedimentation rate, C-reactive protein, rheumatoid factors, and adverse events will be secondary outcome measures. We will perform meta-analysis by using Review Manager software, assess the risk of bias by Cochrane Collaboration "risk of bias" tool, and determine the quality of evidence by Grades of Recommendation, Assessment, Development, and Evaluation. RESULTS: This study we will investigate the clinical evidence of the effectiveness and safety of WTD on RA. CONCLUSION: For the RA patients and clinicians, our study will be informative. It can be also a great help for the researchers and policy makers who concentrates on conservative management for RA. TRIAL REGISTRATION NUMBER: INPLASY; INPLASY202220099.

Effectiveness and safety of electrical moxibustion for knee osteoarthritis: A multicenter, randomized, assessor-blinded, parallel-group clinical trial.

BACKGROUND: The prevalence of knee osteoarthritis (KOA) is increasing, and it has emerged as a major health issue. Studies have been reported that moxibustion is effective for treating KOA, but conventional moxibustion is difficult to control the intensity of stimulation and causes smoke, harmful gases, or odors. An electrical moxibustion (EM) device was developed to solve these problems, so we conducted this study to evaluate the effectiveness and safety of EM as a treatment for KOA. METHODS: This is a multicenter, randomized, assessor-blinded, parallel-group clinical trial. Participants with KOA were randomly allocated into EM, traditional indirect moxibustion (TIM), or usual care groups. The moxibustion groups were received 12 sessions of moxibustion treatment at six acupuncture points (ST36, ST35, ST34, SP9, EX-LE4, SP10) over a period of 6 weeks. The usual care group was received usual treatment and self-care. The primary outcome was the degree of pain measured by numerical rating scale (NRS). The second outcomes were measured using visual analog scale, Korean version of the Western Ontario and McMaster Universities osteoarthritis index, patient global assessment, European quality of life five dimension five level scale, and warm sense threshold and heat pain threshold. For safety assessment, laboratory test and adverse events (AEs) were recorded. RESULTS: A total of 138 participants were assigned. While there was no significant NRS change in the usual care, EM and TIM showed significant decrease after treatment. Compared to the usual care, the mean change of NRS in the EM and TIM was significantly different, but there was no significance between two groups. Regarding secondary outcomes, EM and TIM also showed significant difference compared to the usual care, but there was no significance between two groups. Regarding safety assessment, while usual care showed significant safety among three groups, EM showed seven treatment-related AEs by four participants compared TIM's 10 events by 10 participants. In addition, there was no blister caused by burns in the EM, which occurred four cases in the TIM. CONCLUSION: This study shows that EM is effective to improve the pain and function by KOA with a certain level of safety.

Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial.

BACKGROUND: Knee osteoarthritis (KOA) is a significant health issue because it causes pain and functional limitation. Many studies have reported that moxibustion, a treatment in traditional Korean medicine, is effective in treating KOA. However, conventional moxibustion produces smoke, harmful gases, and odors that can adversely affect the eyes, skin, and throat. It is also difficult to control the intensity of stimulation in conventional moxibustion. An electrical moxibustion device was developed to circumvent these problems, but there are few studies of that device. We will evaluate the efficacy and safety of electrical moxibustion as a treatment for KOA, and compare it with traditional indirect moxibustion and usual care. METHODS: This is a multicenter, randomized, open, assessor-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated into three groups (electrical moxibustion, traditional indirect moxibustion, or usual care) with a 1:1:1 ratio. Participants in each moxibustion group will receive 12 sessions of moxibustion treatment at 6 acupoints (ST36, ST35, ST34, SP9, EX-LE4, SP10) plus up to 2 points of "ashi", if needed, over a period of 6 weeks (2 sessions per week). A specifically designed device that provides thermal stimulation using electrical energy will be used for the electrical moxibustion group. Participants in the usual care group will receive usual treatment and self-care. The primary outcome measure is change in pain on a numerical rating scale (NRS) from week 1 to week 6. The secondary outcome measures are pain assessed on a visual analog scale (VAS), the Korean version of the Western Ontario and McMaster osteoarthritis index (K-WOMAC), patient global assessment (PGA), and the European quality of life five dimension five level scale (EQ-5D-5 L). Safety will be assessed by monitoring adverse events at each visit. Follow-up measurements will be performed at 12 weeks after baseline measurements. DISCUSSION: This trial will provide evidence on the efficacy and safety of electrical moxibustion as a treatment for KOA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03287570 . Registered on 19 September 2017.

Single-dose Toxicity of Guseonwangdo-go Glucose 5% Intravenous Injection in a Rat Model.

OBJECTIVES: The purpose of this study was to examine the single-dose intravenous toxicity of Guseonwangdo-go glucose 5% pharmacopuncture (GWG5). METHODS: Forty Sprague-Dawley rats were divided into four groups of five males and five females per group: an intravenous (IV) injection of 1.0 mL of normal saline solution per animal was administered to the control group; IV injections of 0.1, 0.5, and 1.0 mL of GWG5 per animal were administered to the experimental groups (G: 0.1, G: 0.5, and G: 1.0). Observation of clinical signs and body weight measurements were carried out for 14 days following the injections. At the end of the observation period, hematological, biochemical, and histopathological tests, as well as necropsy examinations, were performed on the injected parts. RESULTS: No mortalities or adverse clinical signs were observed in any of the groups. The body weights of all groups continuously increased. In the hematological and the biochemical tests, females in G-0.1 had minimal changes, but those changes were not dose dependent. On necropsy examination, no abnormalities were observed. In the histopathological test, focal inflammatory cell infiltrations were observed in two female rats, one in the control group and one in G-1.0. Also, one female rat in the control group had an epidermis crust. These changes were concluded to have been caused by the insertion of the needle into a vein. CONCLUSION: The above findings suggest that the lethal dose of GWG5 administered via IV injection is more than 1.0 mL per animal in both male and female rats. Further studies are needed to establish more detailed evidence of its toxicity.

Quantification of the parameters of twisting-rotating acupuncture manipulation using a needle force measurement system.

BACKGROUND: To date, much research has been conducted to measure needle manipulation quantitatively and objectively. This study was performed to quantitatively measure the differences in the amount of stimulation caused by various rotation frequencies and angles in twisting-rotating acupuncture needle manipulation. METHODS: The torque Z force exerted on a tissue was measured at various rotation frequencies and angles by rotating a needle with a needle force measurement system attached to a needle insertion tissue model. RESULTS: The results show that with rotation frequency at 60°, the torque Z force increased significantly from 0.023 N mm to 0.118 N mm as the rotation angle increased (p < 0.05). In addition, the torque Z force was significantly increased from 0.082 N mm to 0.292 N mm when the rotation angle increased from 60° to 180° at 0.15 Hz. (p < 0.05). A strong linear positive relationship between the torque Z force and rotation angle or frequency was obtained [Pearson correlation coefficient (r) > 0.88; p < 0.001]. CONCLUSION: The change in needle-tissue interaction force by rotating angles showed a tendency to be higher than those by rotation frequency. Further quantitative research on various manipulations will be required for a standardized education on manipulation and stimulation as well as on needle model development to become possible.

Effects of electroacupuncture on capsaicin-induced model of atopic dermatitis in rats.

BACKGROUND: Electroacupuncture (EA) is used as a prescription to treat pruritus and atopic dermatitis. Whether EA affects experimental itch in rat models of immunologic or neuronal damages, however, is unknown. OBJECTIVES: The present study was designed to determine the therapeutic effects of high-frequency EA on atopic dermatitis-like lesions in rats. MATERIALS AND METHODS: Capsaicin (50mg/kg) was subcutaneously administered rat pups within 48h after birth. Rats then underwent 30min of EA at six acupoints (bilateral BL13, and unilateral LI11, ST36, SP10, SP6) every other day (EA group) for 3 weeks. Measurements of IgE, mast cells, scratching behavior, dynorphin release, skin thickness and dermatitis score were obtained. RESULTS: Only the dermatitis score and dynorphin expression were decreased in the EA group compared with the control non-EA group. CONCLUSION: We suggest that high-frequency EA alleviates pruritus of atopic dermatitis-like lesions in rats induced by capsaicin injection, via the release of dynorphin. These findings indicate a new potential therapeutic approach for the amelioration of symptoms of atopic dermatitis.

Single Dose Toxicity of Chukyu (spine-healing) Pharmacopuncture Injection in the Muscle of Rats.

OBJECTIVES: This study was performed to analyze the single dose toxicity of Chukyu (spine-healing) pharmacopuncture. METHODS: All experiments were conducted at the Biotoxtech, an institution authorized to perform non-clinical studies under the regulations of Good Laboratory Practice (GLP) regulations. Sprague-Dawley rats were chosen for the pilot study. Doses of Chukyu (spine-healing) pharmacopuncture, 0.1, 0.5 and 1.0 mL, were administered to the experimental groups, and a dose of normal saline solution, 1.0 mL, was administered to the control group. This study was conducted under the approval of the Institutional Animal Ethic Committee. RESULTS: No deaths or abnormalities occurred in any of the four groups. No significant changes in weight, hematological parameters or clinical chemistry between the control group and the experimental groups were observed. To check for abnormalities in organs and tissues, we used microscopy to examine representative histological sections of each specified organ; the results showed no significant differences in any of the organs or tissues except in one case, where interstitial infiltrating macrophages were found in one female rat in the 0.5-mL/animal experimental group. CONCLUSION: The above findings suggest that treatment with Chukyu (spine-healing) pharmacopuncture is relatively safe. Further studies on this subject are needed to yield more concrete evidence.

A Pilot Study on Single-dose Toxicity Testing of Scolopendrid Pharmacopuncture in Sprague-Dawley Rats.

OBJECTIVES: This study was performed to analyze single dose toxicity and the lethal dose of Scolopendrid Pharmacopuncture in rats. METHODS: All experiments were conducted at the Korea Testing & Research Institute (KTR), an institution authorized to perform non-clinical studies, under the regulations of Good Laboratory Practice (GLP). Sprague-Dawley rats were chosen for the pilot study. Doses of Scolopendrid pharmacopuncture, 0.1, 0.5, and 1.0 mL, were administered to the experimental group, and 1.0 mL doses of normal saline solution were administered to the control group. This study was conducted under the approval of the Institutional Animal Ethic Committee. RESULTS: No deaths or abnormalities occurred in any of the groups. No significant changes in the weight, hematological parameters or clinical chemistry were noted between the control group and the experimental group. To check for abnormalities in organs and tissues, we used microscopy to examine representative histological sections of each specified organ; the results showed no significant differences in any of the organs or tissues. CONCLUSION: The above findings suggest Scolopendrid Pharmacopuncture is a relatively safe to use for treatment. Further studies on the subject should be conducted to yield more concrete evidence.

Single-dose Toxicity of Guseonwangdo-go Glucose 20% Intravenous Injection in Sprague-Dawley Rats.

OBJECTIVES: This study was performed to evaluate the single-dose intravenous toxicity of Guseonwangdo-go glucose 20% pharmacopuncture. METHODS: Forty Sprague-Dawley rats were divided into four groups of five males and five females per group: an intravenous (IV) injection of 1.0 mL of normal saline solution per animal was administered to group 1 (G1, control group); an IV injections of 0.1, 0.5, and 1.0 mL of Guseonwangdo-go glucose pharmacopuncture per animal were administered to experimental groups 2, 3, and 4 (G2, G3, and G4), respectively. General symptoms, body weights, hematological and biochemical test results, and necropsy histopathological observation were recorded in all groups. In the statistical analyses, significance was determined by using the one-way analysis of variance (ANOVA). The significance level was 0.05 in all comparisons. RESULTS: For 14 days, no deaths or abnormalities were observed in any of the 4 groups. The body weights of all groups continuously increased during the observation period. In the hematological test, the WBC count was significantly increased in female rats of G4 compared to the control group, but this difference was considered not to be statistically meaningful. No significant biochemical changes were observed. On necropsy, crust formation was observed in one rat of the control group, and granulation tissues were observed around the injection site in one rat of G4; these changes were concluded to have been caused by injection of the needle into a vein. CONCLUSION: The findings suggest that the lethal dose of Guseonwangdo-go glucose pharmacopuncture is more than 1.0 mL per animal in both male and female rats. Thus, we can conclude that Guseonwangdo-go glucose pharmacopuncture injection is relatively safe to use in acute toxicity tests. Further studies are needed to establish more detailed evidences of its toxicity.

Auricular acupuncture for prehypertension and stage 1 hypertension: study protocol for a pilot multicentre randomised controlled trial.

BACKGROUND: Hypertension, a worldwide public health problem, is a major risk factor for cardiovascular and kidney disease, and the medical and economic burden of hypertension is increasing. Auricular acupuncture has been used to treat various diseases, including hypertension. Several studies have shown that auricular acupuncture treatment decreases blood pressure in patients with hypertension; however, the scientific evidence is still insufficient. Therefore, we aimed to perform a randomised controlled clinical trial in patients with prehypertension and stage 1 hypertension to evaluate the effect and safety of auricular acupuncture. METHODS/DESIGNS: This on-going study is a two parallel arm, assessor-blinded, randomised controlled trial. Sixty participants with prehypertension and stage 1 hypertension will be recruited and randomly allocated into two groups in a 1:1 ratio. Participants in the auricular acupuncture group will receive auricular acupuncture treatment two times per week for 4 weeks. Participants in the usual care group will not receive any acupuncture treatment during the study period. All participants in both groups will be provided with verbal and written educational materials regarding the dietary and physical activity habits for controlling high blood pressure, and they will self-manage their lifestyle, including diet and exercise, during the study. The primary outcome is the 24-h average systolic and diastolic blood pressure, as measured with an ambulatory monitor. The secondary outcomes are the mean change in the average systolic and diastolic blood pressure during day- and night-time, the circadian rhythm of blood pressure, the mean arterial pressure, the change in blood pressure before and after auricular acupuncture treatment, the EuroQOL-5D (EQ-5D), heart rate variability (HRV), body mass index (BMI) and laboratory examination, including lipid profile and high sensitivity C-reactive protein (hs-CRP). Safety will be assessed at every visit. DISCUSSION: This pilot multicentre randomised controlled trial will explore the feasibility of further auricular acupuncture research and provide important clinical evidence for the effect and safety of auricular acupuncture on blood pressure in patients with prehypertension and stage 1 hypertension compared with usual care. TRIAL REGISTRATION: Clinical Research Information Service: KCT0000169.

Acupuncture for lateral epicondylitis (tennis elbow): study protocol for a randomized, practitioner-assessor blinded, controlled pilot clinical trial.

BACKGROUND: Lateral epicondylitis is the most frequent cause of pain around the elbow joint. It causes pain in the region of the elbow joint and results in dysfunction of the elbow and deterioration of the quality of life. The purpose of this study is to compare the effects of ipsilateral acupuncture, contralateral acupuncture and sham acupuncture on lateral epicondylitis. METHODS/DESIGN: Forty-five subjects with lateral epicondylitis will be randomized into three groups: the ipsilateral acupuncture group, contralateral acupuncture group and the sham acupuncture group. The inclusion criteria will be as follows: (1) age between 19 and 65 years with pain due to one-sided lateral epicondylitis that persisted for at least four weeks, (2) with tenderness on pressure limited to regions around the elbow joint, (3) complaining of pain during resistive extension of the middle finger or the wrist, (4) with average pain of NRS 4 or higher during the last one week at a screening visit and (5) voluntarily agree to this study and sign a written consent. Acupuncture treatment will be given 10 times in total for 4 weeks to all groups. Follow up observations will be conducted after the completion of the treatment, 8 weeks and 12 weeks after the random assignment. Ipsilateral acupuncture group and contralateral acupuncture group will receive acupuncture on LI4, TE5, LI10, LI11, LU5, LI12 and two Ashi points. The sham acupuncture group will receive treatment on acupuncture points not related to the lateral epicondylitis using a non-invasive method. The needles will be maintained for 20 minutes. The primary outcome will be differences in the visual analogue scale (VAS) for elbow pain between the groups. The secondary outcome will be differences in patient-rated tennis elbow evaluation (PRTEE), pain-free/maximum grip strength (Dynamometer), pressure pain threshold, clinically relevant improvement, patient global assessment, and the EQ-5D. The data will be analyzed with the paired t-test and ANCOVA (P <0.05). DISCUSSION: The results of this study will allow evaluation of contralateral acupuncture from two aspects. First, if the contralateral acupuncture shows the effects similar to ipsilateral acupuncture, this will establish clinical basis for contralateral acupuncture. Second, if the effects of contralateral acupuncture are not comparable to the effects of ipsilateral acupuncture, but are shown to be similar to the effects of the sham acupuncture, we can establish the basis for using the same acupoints of the unaffected side as a control in acupuncture clinical studies. TRIAL REGISTRATION: This trial has been registered with the 'Clinical Research Information Service (CRIS)', Republic of Korea: KCT0000628.

Comparing the effects of individualized, standard, sham and no acupuncture in the treatment of knee osteoarthritis: a multicenter randomized controlled trial.

BACKGROUND: Acupuncture is an effective yet complex therapy, integrating syndrome differentiation, selection of appropriate acupoints and skillful needling techniques. Clinicians carefully tailor acupuncture treatment to each patient. However, most clinical trials of acupuncture have been based on a standardized formula of points for every patient without properly accounting for individualdifferences and, as a result, have not been reflective of the true efficacy of clinical practice. To determine the efficacy of meridian-based syndrome differentiation and Sa-am acupuncture, we have designed a simple pragmatic trial providing individualized treatments while working within a general framework. METHODS/DESIGN: The study is designed to be a parallel, patient- and assessor-blind, randomized controlled trial (RCT). A total of250 patients with knee osteoarthritis (OA) will be recruited from two independent hospitals, Semyung University Oriental Medicine Hospital in Chung-ju and Dongguk University Oriental Hospital in Ilsan, South Korea. Patients will be randomly allocated into four treatment groups: 1. individualized, meridian-based syndrome differentiation and Sa-am acupuncture treatment;2. standard acupuncture treatment;3. sham acupuncture treatment; and 4. no acupuncture treatment. Patients in groups 1 to 3 will be treated by certified oriental medicine doctors twice a week for 6 weeks. The primary outcome measure will be the self-reported total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score change. The trial will also include secondary outcome measures. DISCUSSION: This trial is designed to determine the efficacy of individualized acupuncture treatment in patients with knee OA by comparing the differences between individualized, standard, sham and no acupuncture treatments. The results of this trial may validate the efficacy of individualized acupuncture therapy, encouraging its widespread use. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01569230.

Inpatient treatment for severe atopic dermatitis in a Traditional Korean Medicine hospital: introduction and retrospective chart review.

OBJECTIVES: Patients with atopic dermatitis increasingly seek complementary and alternative medical treatment. A number of studies have demonstrated the efficacy of herbs and acupuncture in the treatment of atopic dermatitis. Some patients with extensive disease, outpatient treatment failure, acute deterioration or highly impaired everyday functioning require inpatient care. The aim of this study was to introduce and evaluate inpatient treatments for severe atopic dermatitis patients at a Traditional Korean Medicine hospital. DESIGN AND SUBJECTS: We performed a retrospective chart review of inpatients with severe atopic dermatitis between March 2008 and October 2011. Eligibility criteria for inclusion were: (1) a diagnosis of atopic dermatitis according to the criteria established by Hanifin and Rajka and (2) hospitalisation because of severe atopic dermatitis (objective scoring atopic dermatitis (SCORAD) score ≥ 40). MAIN OUTCOME MEASUREMENT: The SCORAD score was assessed by trained investigators at admission and discharge. RESULTS: Among 37 inpatients, there were 29 patients who met the criteria. Patients received treatments including acupuncture, herbal medicine and herbal wet wrap dressings. The mean total scoring SCORAD decreased from 60.63 to 37.37 during hospitalisation. Despite the relatively small sample size, these findings were statistically significant. CONCLUSION: In atopic dermatitis, Traditional Korean Medicine effectively decreased clinical disease severity. This study's weaknesses include the relatively small number of patients, some aspects of the study design, lack of follow-up assessment and lack of second measurement.

Study to establish Ojeok-San (Five Accumulation Powder: wu ji san) administration criteria and a questionnaire to evaluate the holistic effects of Ojeok-San on patients with low back pain.

OBJECTIVES: The study objectives were to establish ojeok-san (Five Accumulation Powder: wu ji san) administration criteria and a questionnaire to evaluate the holistic effects of ojeok-san on patients with low back pain (LBP). METHODS: Texts and literatures, recommended by specialists, were searched to gather ojeok-san-related symptoms. Then, the opinions of Oriental medicine doctors (OMDs) practicing in Seoul were surveyed to ask which symptoms they consider the most in clinical practice. Based on the survey, selection of potential items for the questionnaire was made. The final version was established based on the results of the survey and Delphi process of musculoskeletal diseases specialists. In order to evaluate the reliability and validity of the newly developed assessment tool (Ojeok-san Low Back Questionnaire: OLQ), patients with chronic LBP were recruited. OLQ and other tools such as visual analogue scale, numeric rating scale, Roland-Morris Disability Questionnaire, Modified-Modified Schober test, and 36-Item Short Form Health Survey were applied to the subjects in a 2-week interval. Test-retest reliability, internal consistency, and convergent and discrimination validity were assessed. RESULTS: A total of 90 potential items were generated by the research team. One hundred and two (102) OMDs fully replied to the survey. Based on the survey results, 34 items were initially selected as potential items. Through Delphi method of experts, 10 top items, rated more than 5 points on a scale of 10, were finally established. The 10 items were each established as a response scale of 0-10 (0 as no symptom and 10 as the most excessive form of symptom). Based on the above stages, an initial OLQ was established and used in the evaluation phase. The validity and reliability of OLQ assessment results showed high test-retest reliability, intraclass correlation coefficient, and internal consistency. CONCLUSIONS: The newly developed Ojeok-san administration criteria and questionnaire may be a promising tool for future Oriental medicine clinical study protocols.

Acupuncture for the treatment of dry eye: a multicenter randomised controlled trial with active comparison intervention (artificial teardrops).

PURPOSE: To evaluate the effects of acupuncture compared to a control group using artificial tears. 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.

Effects of acupuncture and moxibustion in a mouse model of allergic rhinitis.

OBJECTIVE: In this study, the authors examined the effects of acupuncture and moxibustion on the expression of various inflammatory cells and mediators in the nasal mucosa of an allergic rhinitis (AR) animal model. STUDY DESIGN: Randomized controlled animal study. SETTING: Animal laboratory in a Dongguk University. SUBJECTS AND METHODS: Twenty-eight BALB/c mice were divided into 4 groups: control, levocetirizine (Lcz), moxibustion (Mox), and acupuncture (Acu). To induce AR, mice were intraperitoneally sensitized to ovalbumin (OVA) and challenged with intranasal OVA. At 7 days following the final sensitization and every day for a further 7 days, the Lcz group was orally administered levocetirizine (50 mg/kg), the Mox group was subjected to 5 seconds of moxibustion stimulation at the juncture of the medial canthus and nostril, and the Acu group was subjected to 30 seconds of acupuncture stimuli at the same point. The authors measured the degree of positive reaction to substance P, STAT6, nuclear factor kappa B (NFκB), and iNOS via immunohistochemical staining of the nasal mucosa. RESULTS: The degree of positive reaction to substance P, STAT6, NFκB, and iNOS was markedly decreased in the treatment groups compared to that in the control group. Notably, the above indices were most significantly decreased in the Acu group, followed by the Mox group and then the Lcz group (P = .000). CONCLUSION: In an allergic rhinitis animal model, acupuncture and moxibustion are shown to exhibit an antiallergic effect and exert their effects by reducing the expression of substance P, STAT6, NFκB, and iNOS.