Positive short term effects of an integrative korean medicine treatment package for low back pain caused by motor vehicle accidents: A retrospective chart review of real - world practice data.

Backgrounds No standard treatment exist for reducing symptoms related to sequelae of motor vehicle accidents (MVAs). In Korea, comprehensive Korean Medicine (KM) treatment that includes botanical drugs (herbal medicine), acupuncture, pharmacopuncture, tuina, moxibustion, and cupping is covered by automobile insurance and increasingly used to help alleviate such pain. This study aimed to analyze real-world data and to evaluate the effectiveness and safety of comprehensive KM treatment for low back pain caused by MVAs. Methods We conducted a retrospective chart review of patients who received KM treatment during hospitalization. Records that lacked follow-up outcome assessments were excluded. The Verbal Numerical Rating Scale (VNRS), the Korean version of the Oswestry Disability Index (K-ODI) and the Korean version of the Roland-Morris Disability Questionnaire (K-RMDQ) were evaluated at admission and discharge. Adverse events were also analyzed. A paired t-test was used to identify the effectiveness of KM treatment. Results A total of 50 patients, 30 males and 20 females, were included in the analysis. The mean age of the patients was 40.72 ± 13.31 years and the average treatment period was 7.22 ± 3.84 days. After treatment, VNRS, K-ODI and K-RMDQ were significantly improved (p < 0.001). There was a decrease from 5.06 ± 1.60 to 3.40 ± 1.81 in VNRS, 33.38 ± 16.88 to 24.54 ± 13.63 in K-ODI, and 6.84 ± 6.27 to 4.14 ± 4.38 in K-RMDQ. During this period, a total of two adverse events were reported. Discussion Although this retrospective chart review looked into the short term effects only, comprehensive KM treatment might be an effective and safe therapeutic option to reduce acute low back pain especially after MVA. Prospective research data is needed to support this hypothesis.

Safety of acupotomy in a real-world setting: A prospective pilot and feasibility study.

OBJECTIVE: Acupotomy is a modern acupuncture method that includes modern surgical methods. Since acupotomy is relatively more invasive than filiform acupuncture treatment, it is important to establish the safety profile of this practice. To justify further large-scale prospective observational studies, this preliminary study was performed to assess the feasibility of the approach and investigate the safety profile and factors potentially associated with adverse events (AEs). METHODS: This was a prospective pilot study that assessed the feasibility of a large-scale forthcoming safety study on acupotomy treatment in a real-world setting. The feasibility (call response rate, drop-out rate, response rate for each variable and recruitment per month) and safety profile (incidence, type, severity and causality of AEs, and factors potentially associated with AEs) were measured. RESULTS: A total of 28 participants joined the study from January to May 2018. A follow-up assessment was achieved in 258 (1185 treatment points) out of 261 sessions (1214 treatment points). The response rate via telephone on the day after treatment was 87.3%. There were 8 systemic AEs in all the sessions (8/258; 3.11%) and 27 local AEs on the total points treated (27/1185; 2.28%). Severe AEs did not occur. Total AE and local AE occurrence were associated with blade width and the number of needle stimulations per treatment point. CONCLUSION: The findings suggest that it could be feasible to analyze the safety of acupotomy in a real-world setting. Moreover, the primary data on some relevant AEs could be determined. We are planning large-scale prospective studies based on these findings. TRIAL REGISTRATION: Clinical Research Information Service (CRIS) KCT0002849 (https://cris.nih.go.kr/cris/search/detailSearch.do/11487).

Observational study of home-based integrative Korean medicine program to satisfy unmet healthcare needs of persons with disability.

OBJECTIVE: To overcome the limitations of the previous studies by implementing traditional east Asian medicine home-based healthcare program for People with disabilities (PWDs)1 based on a standard protocol developed by the government. METHODS: Twenty participants with limb or brain impairment with severe grade were selected from a Public Health Center in Korea. Objective outcome variables were used, a patient perspective was provided, and a standardized treatment regimen was adopted to overcome the limitations of previous studies. RESULTS: Participants reported significant improvements in Overall pain and Quality of life. CONCLUSIONS: IKMHP showed possibility of integrative management for PWDs in terms of pain, quality of life, safety and overall satisfaction.

Utilization of Acupuncture and Herbal Ointment Instead of Skin Graft Surgery for the Treatment of Burn Injuries: A Case Series and Literature Review.

Skin graft surgery is a standard treatment that increases the survival rate of patients with burn injuries; however, it leaves many sequelae. Conventional external preparations for the treatment of burns also have various side effects. In this retrospective case study, we assessed the cases of four patients with topical third-degree burns who did not wish to undergo the skin graft surgeries recommended by medical doctors and were thus treated using traditional medicine alone. A Korean medicine doctor administered integrative traditional medicine treatment to the patients using acupuncture and herbal ointments. Analysis of the patients' treatment photographs, quantitative evaluation indices, and vivid narratives suggested that their skin recovered well without adverse effects. Traditional Korean medicine treatment, including acupuncture and herbal ointment treatment, can be a new alternative therapeutic strategy for the treatment of patients with topical burns who do not want to undergo skin graft surgery or who have higher risks for poor surgical outcomes.

Integrative traditional Korean medicine management, including acupuncture and Chuna-manual therapy, for stroke-related central facial palsy: A study of three case reports.

Central facial palsy, which is a sequela of stroke, is associated with decreased quality of life and psychosocial function. Integrative Korean medicine management, including acupuncture and Chuna-manual therapy, has been used to treat neurological diseases, including facial palsy. We report three cases of central facial palsy patients who had these symptoms over three months after a stroke. They had received rehabilitation treatment for the paralyzed upper and lower extremities. However, as their central facial palsy symptom did not improve, Chuna-manual therapy (SJS nonresistance technique) for facial palsy was started along with acupuncture. Oral region movement improved after four weeks of integrative acupuncture and Chuna-manual therapy. After ten to sixteen weeks of treatment, the facial nerve grading system 2.0 grades improved by one in two cases. In one case, although there was no significant change in the grade, she was satisfied with the results after adding Chuna-manual therapy to acupuncture. There were no adverse events. Integrative management, including acupuncture and Chuna-manual therapy, might be an effective treatment strategy for central facial palsy. Further prospective, controlled studies are warranted.

Gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) in Degenerative Knee Osteoarthritis Patients: Lessons and Responders from a Multicenter Randomized Placebo-Controlled Double-Blind Clinical Trial.

BACKGROUND: Gyejigachulbutang (GUI-ZHI-JIA-SHU-FU-TANG, GCB) is an herbal formula widely prescribed in traditional East Asian medicine practice for arthritis and muscle pain. We evaluated the efficacy and safety of GCB for degenerative knee osteoarthritis (KOA). METHODS: Eighty patients with KOA were randomly assigned to the GCB group or the placebo group in a 1 : 1 ratio in two Korean medicine hospitals. Patients took GCB or placebo three times a day for 4 weeks. Primary outcome was the change in the visual analogue scale (VAS) score for knee pain from baseline to 4th week. Secondary outcomes were the change in the VAS score from baseline to 2nd week and 8th week, Korean Western Ontario and McMaster Universities Osteoarthritis Index (K-WOMAC), European Quality of Life Five Dimensions questionnaire (EQ-5D), and safety. RESULTS: There was no significant difference between the compared indicators of the GCB and placebo groups. However, in subgroup analysis, GCB was effective for subjects with a BMI lower than 25 kg/m2. The dose of pain medication was significantly lower in the GCB group than in the placebo group after four weeks (p=0.016). There were no serious adverse events in the GCB group. CONCLUSIONS: GCB was not effective in primary outcome analysis. In exploratory subgroup analysis, GCB might be effective for individuals with BMI lower than 25 kg/m2 for the treatment of degenerative KOA. GCB may also help reduce the consumption of pain medication. Furthermore, research is required for our hypothesis. This trial is registered with KCT0003024.

Efficacy and safety of gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) for knee pain in patients with degenerative knee osteoarthritis: a randomized, placebo-controlled, patient and assessor blinded clinical trial.

BACKGROUND: Degenerative knee osteoarthritis is a leading cause of disability in the elderly. If patients do not respond to pharmacological or nonpharmacological intervention, total knee replacement surgery is recommended. However, owing to the contraindications and adverse effects of surgery, the need for a new treatment strategy is emerging. Traditional herbal medicine is a widely used intervention in east Asia to treat knee osteoarthritis. Gyejigachulbutang is one of the frequently prescribed herbal formulae. The aim of our study is to evaluate the efficacy and safety of gyejigachulbutang for knee osteoarthritis. METHODS: This study is a randomized, placebo-controlled, patient and assessor blinded, superiority clinical trial. A total of 80 patients with knee osteoarthritis will be enrolled. The participants will be randomly assigned to the gyejigachulbutang or placebo group in a 1:1 ratio in two Korean medical hospitals. Every participant will take gyejigachulbutang or placebo at a dose of 2.5 g three times a day for 4 weeks. Additional follow-up will be conducted 4 weeks after treatment completion. Any concomitant treatment to relive knee pain will not be allowed except for rescue medicine (acetaminophen). The primary outcome will be a comparison of the change in the visual analogue scale score for knee pain from baseline to visit 3 (week 4) for both the treatment and placebo groups. Secondary outcomes include clinical relevance, minimal clinically important difference, disability, quality of life, and safety. DISCUSSION: This protocol presents a research methodology for clinical trials of gyejigachulbutang for knee osteoarthritis. Various secondary outcomes make this trial more informative. Our trial will provide fundamental evidence for knee osteoarthritis management via herbal medicine treatment. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), KCT0003024 . Registered on 25 July 2018.

Herbal medicine for acute management and rehabilitation of traumatic brain injury: A protocol for a systematic review.

BACKGROUND: This systematic review protocol describes the methods that will be used to evaluate the efficacy and safety of herbal medicine in treating traumatic brain injury. METHODS AND ANALYSIS: The following electronic databases will be searched up to December 2018 without language or publication status restrictions: Medline, EMBASE, the Cochrane Central Register of Controlled Trials, Allied and Complementary Medicine Database, and Cumulative Index to Nursing and Allied Health Literature. We will also search Korean, Chinese, and Japanese databases. Any randomized controlled trials related to herbal medicine for traumatic brain injury will be included. The functional outcome, consciousness state, morbidity, and mortality will be assessed as primary outcomes. The quality of life, adverse events, and total effective rate will be evaluated as secondary outcomes. Two researchers will independently perform the study selection, data extraction, assessment of study quality, and evaluation of the quality of evidence for the main findings. Data synthesis and analysis will be performed using RevMan version 5.3. The results will be expressed as a risk ratio for the binary outcome and as the mean difference or standardized mean difference for a continuous outcome. We will synthesize the data by either fixed effects or random effects model according to a heterogeneity test or the number of studies included in the meta-analysis. The methodological quality of the included studies will be evaluated using the Cochrane Collaboration's risk of bias tool. The quality of evidence for each main outcome will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation approach. ETHICS AND DISSEMINATION: Ethical approval is not required because individual patient data are not included. The findings of this systematic review will be disseminated through a peer-reviewed publication or conference presentations. PROSPERO REGISTRATION NUMBER: CRD42018116559.

Development of a survey form through Delphi study about adverse events associated with the miniscalpel needle, for application in prospective observational studies regarding safety of miniscalpel needles: Study protocol.

BACKGROUND: Despite the wide usage of miniscalpel-needles (MSNs), information about MSN treatment-related adverse events (AEs) is insufficient. As the definition of AE might vary among physicians, without an exact definition for pain and hemorrhage, it is difficult to provide accurate information about AEs in MSN treatment to physicians, researchers, and patients. The aim of our study is to reach a consensus about the items and definitions of AEs that should be included in the survey form for prospective observational multicenter studies to record MSN treatment-related AEs. We will especially focus on obtaining a consensus on the definition of pain and hemorrhage caused by MSN treatment. METHODS: Our study protocol is composed of 6 steps. First, we will identify the aim of the study. Next, we will conduct a systematic review to investigate MSN treatment-related AEs reported till date in Korea. Third, we will conduct a pilot observational prospective single-center study on AEs in MSN treatment. We will develop a standardized case report form to record MSN treatment-related AEs, including the causality, severity, and details of the MSN procedure at every site. Next, based on the pilot study, the Delphi study questionnaire will be developed by a panel composed of 13 physicians. The Delphi study will have 4 rounds with open questions and 4-point Likert-scale closed questions. Through these rounds, we will develop a consensus about the items and definitions of AEs that should be included in the survey form for future multicenter studies about MSN treatment-related AEs. Following this, a face-to-face consensus meeting will be held for a final agreement of survey form. The final survey form will then be approved by the related academic society for dissemination. DISCUSSION: The aim of this protocol is to develop a survey form for future prospective observational multicenter studies on MSN treatment-related AEs. This protocol will present the research methodology for developing a survey form, which will improve consistency and reliability between MSN treatment studies. We believe that this protocol can evaluate the safety of MSN treatment. TRIAL REGISTRATION: Clinical Research Information Service: KCT0002849.

Inpatient treatment effect and Minnesota Multiphasic Personality Inventory characteristics of motor vehicle collision injuries in a traditional korean medicine hospital: Retrospective chart review.

OBJECTIVES: To examine the changes in pain, disability, and quality of life in motor vehicle collision injury (MVCI) patients after treatment with traditional Korean medicine (TKM), and to investigate the psychological characteristics of these patients. METHODS: Forty-one patients with MVCI were treated with TKM including acupuncture, pharmacopuncture, moxibustion, cupping, herbal medication, chuna manual therapy, and physical therapy. Numeric Rating Scale (NRS), Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), Neck Disability Index (NDI), Oswestry Disability Index (ODI), and Lysholm Knee Scoring Scale were assessed at admission and discharge. The Minnesota Multiphasic Personality Inventory (MMPI) was assessed at admission. RESULTS: After treatment, NRS scores for headache, cervical pain, and lumbar pain were significantly decreased (P<0.05); NDI, ODI scores were significantly decreased, and Lysholm score was signifificantly increased (P<0.05). The following SF-36 scores were signifificantly increased: physical and mental component summary, bodily pain, role-physical, role-emotional, social functioning, and mental health scores (all P<0.05). MMPI identifified 3-1 profifile conversion V shape. CONCLUSIONS: Treatment of MVCI with TKM provided effective management of complex symptoms such as pain, disability, and loss of quality of life. A comprehensive plan must be implemented for treatment and research in cases of MVCIs owing to the correlation between physical symptoms and psychological profifiles.

The effectiveness of moxibustion for the treatment of functional constipation: a randomized, sham-controlled, patient blinded, pilot clinical trial.

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

Acupuncture for symptom management in hemodialysis patients: a prospective, observational pilot study.

OBJECTIVES: Patients undergoing hemodialysis suffer from a variety of complications related to end-stage renal disease. This prospective, observational pilot study aims to determine the feasibility, safety, and possible benefits of acupuncture for symptom management in patients undergoing hemodialysis. METHODS: Twenty-four (24) patients undergoing hemodialysis received acupuncture treatment for their symptoms. Manually stimulated, individualized acupuncture treatments were provided twice a week for 6 consecutive weeks on a nondialysis day or on the day of hemodialysis prior to initiating treatment. Symptoms were evaluated using the Measure Your Medical Outcome Profiles 2 questionnaire, and quality of life was measured by Kidney Disease Quality of Life-Short Form (KDQOL-SF(™)) Version 1.3 at baseline, 7 weeks and 11 weeks from baseline. Statistical analysis was conducted on the basis of the intention-to-treat principle. RESULTS: Twenty-one (21) patients (87%) completed the whole treatment course and follow-up evaluation. Three (3) patients dropped out due to increased fatigue (n = 1), pancreatic and renal transplantation (n = 1), and infections of the arteriovenous fistula used for hemodialysis access (n = 1). Patients experienced a significant improvement of symptoms considered the most bothersome, reporting a decrease of 1.87 and 2.08 points on a 0-6 symptom scale at 7 weeks and 11 weeks, respectively (both p < 0.0001). Some subscales of KDQOL-SF(™) showed significant improvement at 7 weeks (effects of kidney disease, burden of kidney disease, role-limitations physical, emotional well-being, and energy/fatigue) and 11 weeks (physical functioning and energy/fatigue). No serious adverse events related to acupuncture occurred. CONCLUSIONS: Acupuncture seems feasible and safe for symptom management in patients undergoing hemodialysis. Future controlled trials are needed to confirm the benefits of acupuncture.

Acupuncture for erectile dysfunction in a non-diabetic haemodialysis patient: a case report.

Erectile dysfunction (ED) significantly affects the quality of life in male haemodialysis patients. This study reports the observed effects of acupuncture for ED in a non-diabetic haemodialysis patient. A 43-year-old man undergoing haemodialysis received 12 sessions of manual acupuncture over 6 weeks and was observed for 6 months after the end of treatment. Total International Index of Erectile Function Questionnaire scores of the patient were changed from 32 at baseline to 60 at post-treatment evaluation, which means there was a significant improvement of ED. All International Index of Erectile Function subscales also increased. This beneficial effect lasted up to 6 months after the end of treatment. No adverse events were observed. An interview revealed that the lowered self-esteem of the patient was restored with the improvement of ED following acupuncture. Further controlled studies are needed to determine whether acupuncture might be a feasible and useful treatment option for erectile dysfunction in haemodialysis patients.