• The Korea Journal of Herbology
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• v.34 no.1
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• pp.13-21
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• 2019

Objectives : This clinical trial is performed to investigate the effect of improving the hypersensitivity reaction and the safety of powdered ethanol extract Codonopsis lanceolata (S. et Z.) Trautv. for allergic patients. Methods : This study was randomized, double blinded, placebo-controlled clinical trial. 60 allergic rhinitis subjects were randomly assigned to Treatment group(n=30) and Control group(n=30). They were received the test substance or placebo in their $1^{st}$ and $2^{nd}$ visit, and took it once a day, 1 powder bag per 1 time, for 8 weeks. The freeze dried powder of Codonopsis lanceolata (S. et Z.) Trautv. was mixed with 30% ethanol and the filtrate was collected thrice with constant stirring of the mixture. The placebo was prepared in the same form as the test substance by replacing with corn starch. Total Nasal Symptom Score(TNSS) questionnaires and laboratory tests were performed at the screening and last visit to evaluate the efficacy. And to assess safety, vital signs and adverse events were confirmed at every visit. Statistical analysis about the result was performed using SAS 9.4. Results : In treatment group, there was a significant decrease in B cell after taking the test substance(p<0.005). And there was a statistically significant difference between groups(p<0.005). Changes in nasal symptoms were not statistically significant between groups, and both groups showed statistically significant differences before and after the test(p<0.0001). Also there were no adverse events associated with the clinical trial product. Conclusions : This clinical trial showed that Codonopsis lanceolata (S. et Z.) Trautv. extract was helpful in improving the hypersensitivity reaction in allergic patients without significant side effects.

• Korean Journal of Acupuncture
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• v.32 no.3
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• pp.99-107
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• 2015

Objectives : This study was designed to obtain basic data for a further large-scale trial as evaluating the efficacy and safety of Geochangmanryeung-dan(GMD) and acupuncture on patient with spinal stenosis treated by epidural steroid injection. Methods: The study is a randomized controlled pilot clinical trial, conducted over 8 weeks. Twenty participants will be recruited and randomly allocated to 2 groups: an experimental(GMD and acupuncture with epidural steroid injection) group and a control(only epidural steroid injection) group. The epidural steroid injection will be administered once per 2 weeks for 6 weeks(3 times in total). GMD will be administered as a dose of 5 pills, 3 times per day, for 6 weeks. Acupuncture will be performed 2 times per week for 6 weeks(12 times in total). The primary outcome will be measured by visual analogue scale and self-rated walking distance. The secondary outcome will be measured by PainVision, short-form McGill Pain Questionnaire, and Oswestry Disability Index. Both primary and secondary outcomes will be measured at baseline, 2, 4, 6, and 8 weeks. The last assessment(at 8 weeks) will be performed 2 weeks after treatment cessation. Conclusions : This clinical trial, as the pilot study for a future large-scale trial, will provide clinical information for evaluating the efficacy and safety of GMD and acupuncture treatment in combination with epidural steroid injection for the treatment of spinal stenosis.

• Journal of Korean Medicine Rehabilitation
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• v.29 no.2
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• pp.171-188
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• 2019

Objectives The purpose of this thesis is to compare and analyze outcomes of case studies and controlled studies about Hwangryunhaedok-tang (HHT) pharmacopuncture in clinical studies. Based on these studies reporting clinical effects by using HHT pharmacopuncture, we object to deduct the comparative review in applying clinical disorders limitedly. And conclusionally, by using this comparative review, we aim to make the fine evidence in treating clinical specific diseases. Methods We searched 106 studies about HHT pharmacopuncture from 6 Korean web databases by using in Korean word 'Hwangryunhaedok-tang pharmacopuncture'. This search had been progressed throughout 1 month (January, 2019). There was 106 thesis and we excluded studies that are not related to HHT pharmacopuncture, experimental research, not the case report or randomized controlled trials, non-randomized controlled trials, not using HHT pharmacopuncture, not using only one pharmacopuncture, and not using HHT pharmacopuncture for major treating method. As a result, 39 thesis are selected as a population. Results We analyzed 34 case reports and 5 controlled studies. As the final outcome, HHT pharmacopuncture was used in musculoskeletal diseases, dermatopathy, and 32 specific diseases. Conclusions After analyzing 39 studies, effective symptom changes clinically and statistically by using HHT pharmacopuncture herbal acupuncture were identified. However, these thesis designs were reported deficiently in many parts such as not excluding other confounding variables. After modifying defects of thesis design and conduct study, it can play a role as the evidence using HHT pharmacopuncture more precisely.

• Journal of Korean Medicine Rehabilitation
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• v.29 no.3
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• pp.61-74
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• 2019

Objectives This study aimed to review clinical studies about Korean medicine used in peroneal nerve palsy. Methods In 11 online databases (Earticle, Research Information Sharing Service, Oriental Medicine Advanced Searching Integrated System, KMbase, Korean Traditional Knowledge Portal, National Digital Science Library, MEDLINE/Pubmed, Ebscohost, Cochrane CENTRAL, EMBASE, China National Knowledge Infrastructure), we searched clinical studies about Korean medicine. Among the studies that we've searched, we excluded the studies that are not related to Korean medicine, case reports, randomized controlled trials and retrospective studies. As a result, 16 case studies and 1 randomized controlled trial are included. Results Total number of patients was 123. In these studies, acupuncture (100%), herbal medicine (58.8%), pharmacopuncture (58.8%), Korean physical therapy (58.8%), moxibustion (41.1%), cupping (41.1%) etc. were used. In acupuncture, GB34 and ST36 were most frequently used. Most of the herbal medicines used in these studies were different. Range of movement were most frequently used in outcome measure. Conclusions In this study, we reviewed studies about Korean medicine used in peroneal nerve palsy. It was difficult to clearly determine which intervention has improved the symptom. In the future, Further clinical studies will be needed to retain the evidence for the treatment of peroneal nerve palsy. And also more randomized controlled clinical trials to prove the efficacy of Korean medicine will be needed.

• The Journal of Korean Obstetrics and Gynecology
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• v.31 no.1
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• pp.84-98
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• 2018

Objectives: The purpose of this pilot study was to examine the feasibility of recruiting women into a clinical trial designed to examine the effects of acupuncture and electroacupuncture in treating overactive bladder (OAB) in menopause women. We tried to determine if there was preliminary evidence to suggest that acupuncture may be effective in reducing OAB symptoms and improving disease-specific quality of life. We also tried to determine the appropriate treatment duration of OAB, with safety of performing acupuncture and electroacupuncture treatment. Methods: This study was a randomized clinical trial. 7 menopause women were randomly assigned to a electroacupuncture group (EA group) (n=4) or acupuncture group (AC group) (n=3) and received electroacupuncture or acupuncture treatment twice a week (16 sessions) in 8 weeks, and follow up assessment was performed after the end of treatment. Overactive Bladder Symptom Score (OABSS), 3-day bladder diary, and King's Health Questionnaire (KHQ) were performed 4 times (at baseline (visit 0), the middle of treatment (visit 8), after the end of treatment (visit 16), and at 4 weeks of follow-up (visit 17)) and analyzed. 2 subjects were dropped out, and finally 5 subjects completed the study. Statistical analysis was performed using SPSS 18.0 for window program. Results: There was an significant improvement in night-time frequency after the treatment (visit 17) in PP (Per-protocol) group analysis (p=0.042). In additional ITT (Inter-to-treat) group analysis, the OABSS (p=0.042) and night-time frequency (p=p=0.017) were improved significantly after the treatment (visit 17). But there was no significant difference of KHQ before and after the treatment. Also there was no significant difference between EA and AC group after the treatment (visit 16, 17). Conclusions: The results of this pilot study suggested that it was feasible to recruit subjects and perform the study procedures, after reconstructing several details of study protocol in performing further clinical trial.

• Asian Pacific Journal of Cancer Prevention
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• v.13 no.1
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• pp.103-110
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• 2012

Neoadjuvant chemotherapy for resectable esophageal carcinoma has been a focus of study, but no agreement has been reached on clinical randomized controlled trials and relevant systematic evaluation. The purpose of this study was to perform a meta-analysis on published randomized controlled trials (RCTs) that compared neoadjuvant chemotherapy and surgery with surgery alone for resectable esophageal carcinoma. Medline and manual searches was conducted in PubMed, ASCO (American Society of Clinical Oncology) meeting summary, Embase, the Cochrane Library (up to October 2010), Chinese Biomedical Literature Database, China National Knowledge Infrastructure, VIP Database, Wanfang Database. The selection contents were to identify all published and unpublished RCTs that compared neoadjuvant chemotherapy and surgery with surgery alone for resectable esophageal carcinoma. Sixteen RCTs which included 2,594 patients were selected. The risk ratio (RR) (95% confidence interval [CI]; P value), expressed as neoadjuvant chemotherapy and surgery versus surgery alone (treatment versus control), was 1.02 (0.95, 1.10; P=0.54) for 1-year survival, 1.29 (1.13, 1.47; P=0.0001) for 3-year survival, 1.31 (1.13, 1.51; P=0.0003) for 5-year survival, 1.00 (0.95, 1.04; P= 0.85) for rate of resection and 0.89 (0.64, 1.23; P=0.48) for operative mortality. The results showed that neoadjuvant chemotherapy for resectable esophageal carcinoma can raise the overall survival rate of patients with esophageal carcinoma, but it does not affect treatment-related mortality.

• Journal of Acupuncture Research
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• v.25 no.2
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• pp.227-242
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• 2008

Objectives : To compare the efficacy of local acupoint with distal acupuncture at relieving pain and improving function in knee osteoarthritis. Designs : A randomized, single-blinded, crossover clinical trial. Settings : One outpatient clinic(department of acupuncture & moxibustion) located in academic teaching hospital, South Korea. Patients : 17 patients with osteoarthritis of the knee(mean age 62.76[$SD{\pm}4.37$] years). Interventions : The trial had 4 stages : baseline(2weeks), phase I and II(each 2weeks), washout period(2weeks). Patients were randomly assigned to either group A or group B. Group A received acupuncture at local acupoints during phase I, then acupuncture at distal acupoints in phase II. Group B received the treatments in reverse order. In each phase, the patients were treated with acupuncture for 6 times. Measurements : The primary outcome was subjective pain as measured by a 100mm visual analogue scale(VAS) ranging from 0(no pain) to 10(worst pain ever). Secondary outcomes were changes in the Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) total and pain scores. Measurements were obtained at baseline, 1st day of phase I and II, and 2 days after last treatment of phase I and II. Results : The 17 participants in 2 groups were well matched for age, sex, target knees, baseline VAS score, WOMAC pain score and WOMAC score. Participants in local acupoint group experienced greater improvement than distal acupoint group at 2 days after last treatment in WOMAC total score(mean difference, -10.65[95% CI, -20.56 to -0.74] ; P=0.036) but not in VAS(mean difference, -12.41[95% CI, -29.56 to 4.73] P=0.15) and WOMAC pain score(mean difference, -1.82[95% CI, -3.98 to 0.33] ; P=0.094). Conclusions : Local acupoints are more effective than distal acupoints at relieving pain and improving function in knee osteoarthritis.

• Korean Journal of Acupuncture
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• v.34 no.3
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• pp.116-125
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• 2017

Objectives : The aim of this study was to assess the effectiveness of acupuncture in treating prehypertension and stage 1 hypertension in postmenopausal women. Methods : The study was a multi-center, four-arm, non-blinded, randomized clinical trial. Sixty participants were randomly assigned to experimental or control groups. The experimental groups received 10 acupuncture sessions over 4 weeks(Group A, n=20) or 20 sessions over 8 weeks(Group B, n=20) along with usual care. The acupoints were GB20, LI11, ST36, and SP6, bilaterally. The acupuncture groups were followed-up for an additional 12 weeks after acupuncture treatment. The control groups received usual care for 16 weeks(Group C, n=10) or 20 weeks(Group D, n=10). The outcomes were blood pressure, blood pressure control rates, lipid profile, and high-sensitivity C-reactive protein(hs-CRP). Results : After 4 weeks, DBP in the acupuncture groups(A+B) showed no significant decrease compared to the control group(C+D). However, after 8 weeks of acupuncture treatment, group B showed a significant decrease in DBP after acupuncture treatment and follow-up period compared to control group. Although there was no difference between the acupuncture and control groups in SBP after acupuncture treatment, group B showed a significant decrease in SBP compared to control group after follow-up period. Lipid profiles and hs-CRP did not differ significantly between acupuncture and control groups. Conclusions : Acupuncture treatment for 8 weeks showed the effect on prehypertension and mild hypertension. To verify the effect of acupuncture on blood pressure, rigorous trials including more participants are required.

• Korean Journal of Oriental Medicine
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• v.13 no.1 s.19
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• pp.93-100
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• 2007

TObjectives: Develop a sham moxibustion and determine whether subjects can distinguish a sham moxibustion from a real moxibustion. Design: Single-blinded, randomized, placebo-controlled clinical trial Methods: Sham and real moxibustion resemble each other in appearance, burning procedure, but the base of the sham moxibustion isolates the moxa-producing heat and smoke. This device was tested in a clinical trial in which subjects received moxibustion at Zhongwan(CV12), Mingmen(GV4), Quchi(LI11), Zusanli(ST36), Taichong(LR3)), Hegu(LI4). Volunteers(n=32) were given pre-treatment questionnaire to assess their experience in getting moxibustion therapy and performing it. They randomized into treatment(n=16) or sham controlled group(n=16), received moxibustion according their groups. After treatments, the effectiveness of blinding was assessed. Results: There were no significant differences between two groups in sex, age, moxibustion experience. In the treatment group and the sham group, the number of subjects who believed they received real moxibustion or sham is not different significantly.(P=.668) The consistency of a moxibustion type which subjects received actually and the their guess about that, isn't different significantly in two groups.(P=.465) Conclusion: The sham moxibustion was successfully validated in this study, The results demonstrate that this sham moxibustion blinds subjects and can be used as effective placebo-control in moxibustion clinical trials.

• Journal of The Korean Dental Society of Anesthesiology
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• v.10 no.1
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• pp.1-6
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• 2010

Background: Articaine, commercially available in South Korea from 2004, is widely being used for dental treatments. In the surgical extraction of impacted mandibular third molars, one of the most common procedures in oral and maxillofacial surgery, the anesthetic efficacy of 4% articaine and 2% lidocaine, both with 1：100,000 epinephrine, was compared. Methods: A randomized double-blind clinical trial was conducted of 80 patients for bilateral surgical extraction of mandibular third molars with informed consents. One operator carried out the routine surgical procedures using local anesthetic 4% articaine or 2% lidocaine with the same concentration of vasoconstrictor. Latency, duration of anesthesia and the amount of anesthetic solution were recorded. A visual analog scale (VAS) was used to evaluate the intraoperative pain. Results: The pain VAS scores reported similar anesthetic effect with both local anesthetics. Not in the latency of anesthesia and the amount of anesthetic solution, statistically significant difference was found in the mean duration of anesthesia. Conclusions: It was concluded that 4% articaine could offer better or at least the same clinical feasibility compared to 2% lidocaine, particularly in terms of the duration of the local anesthesia for common dental treatments.