• Journal of Acupuncture Research
• /
• v.25 no.6
• /
• pp.77-93
• /
• 2008

Objectives : Though there were many clinical studies of acupuncture effects they didn't have appropriate control group or use another therapy for control group. So, we didn't say it was true acupuncture effect, though subjects in clinical study improved. Recently several sham needles for control group were developed and validated. This study aimed at summarizing the validation studies of these needles and evaluating the control group of the acupuncture clinical study. Methods : Computerized literature searches were performed using 'acupuncture' and 'placebo or sham' with a limitation of the results to RCTs in Pubmed, Sciencedirect, NDSL, KISS, RISS. Data were extracted regarding study design, sample size, acupuncture point, stimulation form, credibility testing. And We have examined 106 acupuncture clinical studies published by Pubmed from January 1, 2005 to April 30, 2008. Data were extracted author's country, subject of study, type of study groups, type of control groups, type of blinding, difference between the results in the control groups. Results : Streitberger's placebo needle, Fink's sham needle, Park sham needle, Kim sham needle were developed. They were validated at domestic and abroad. But the results were deviation depending on the each of the researcher. They has shown that sample, acupuncture points, experiences or knowledge of acupuncture dependent on the results. Recent three years, acupuncture clinical trial had different results. Significant differences between Study group and control group emerged from using other therapy or non-treatment for control group. Many study has no significant differences using sham acupuncture for control groups. Conclusions : Acupuncture clinical studies need to meet several requirements. First of all, they require the basics of randomized controlled clinical studies such as blinding and the accurate implementation and description of randomization. And also need to research the unique circumstances of these studies such as the development of sham acupuncture and blinding method which differs from other clinical trials.

• Korean Journal of Acupuncture
• /
• v.31 no.3
• /
• pp.136-145
• /
• 2014

Objectives : The purpose of this randomized, placebo-controlled, cross-over trial was to examine how acupuncture treatment at Shinmun(HT7) affects the brain activity and the autonomic nervous system(ANS), using electroencephalograms(EEG) and heart rate variability(HRV). Methods : Eighteen healthy volunteers participated in two separate experiments: in each experiment, either real acupuncture(RA) or non-penetrating sham acupuncture(SA) was applied at HT7 in random sequences to each person. The EEG and HRV measurements were conducted simultaneously before and during the acupuncture stimulation for 5 minutes, respectively. Resulting EEG and HRV parameters were compared between RA and SA groups. To assess differences according to the stress levels for participants, subgroup analysis was performed based on the results of the stress response index questionnaire. Results : In the results, acupuncture stimulation at HT7 increased ${\alpha}$ band in EEG. In the HRV analysis, heart rate was decreased significantly but HF and RMS-SD were increased in the RA group, compared with those of the SA group. In the subgroup analysis by stress level, participants in the RA group with high stress exhibited an increased in ${\alpha}$ band in their EEG while the low stress participants showed decrease or little increase in the band. For the SA group, ${\alpha}$ band reported relatively moderate changes in all channels. Conclusions : Our results showed that acupuncture induces changes in brain activation and the ANS. Acupuncture was related to the activation of the parasympathetic nervous system. The brain activities of the participants were different depending on the stress level.

• Journal of Dental Anesthesia and Pain Medicine
• /
• v.18 no.1
• /
• pp.19-25
• /
• 2018

Background: Third molar extraction is associated with considerable pain and discomfort, which is mostly managed with oral analgesic medication. We assessed the analgesic effect of benzydamine hydrochloride, a topical analgesic oral rinse, for controlling postoperative pain following third molar extraction. Methods: A randomized controlled trial was conducted in 40 patients divided into two groups, for extraction of fully erupted third molar. Groups A received benzydamine hydrochloride mouthwash and group B received normal saline gargle with oral ibuprofen and paracetamol. Oral ibuprofen and paracetamol was the rescue analgesic drug in group A. Patients were evaluated on the $3^{rd}$ and $7^{th}$ post-operative days (POD) for pain using the visual analogue score (VAS), trismus, total number of analgesics consumed, and satisfaction level of patients. Results: The VAS in groups A and B on POD3 and POD7 was $4.55{\pm}2.54$ and $3.95{\pm}1.8$, and $1.2{\pm}1.64$ and $0.95{\pm}1.14$, respectively and was statistically insignificant. The number of analgesics consumed in groups A and B on POD3 ($5.25{\pm}2.22$ and $6.05{\pm}2.43$) was not statistically different from that consumed on POD7 ($9.15{\pm}5.93$ and $10.65{\pm}6.46$). The p values for trismus on POD3 and POD7 were 0.609 and 0.490, respectively and those for patient satisfaction level on POD3 and POD7 were 0.283 and 0.217, respectively. Conclusions: Benzydamine hydrochloride oral rinses do not significantly reduce intake of oral analgesics and are inadequate for pain relief following mandibular third molar extraction.

• Journal of Obesity & Metabolic Syndrome
• /
• v.25 no.3
• /
• pp.138-148
• /
• 2016

Background: The purpose of this study is to analyze the effects of an abdominal obesity management program in middle-aged women in Korea. Methods: Examination of databases, including the Research Information Sharing Service, Database Periodical Information Academic, and Korean Studies Information, resulted in identification of 772 studies performed up to 2014, of which 43 satisfied the inclusion data. Data analysis was performed using R version 3.2 to calculate the effect sizes, explore possible causes of heterogeneity, and check for publication bias, using a funnel plot and its trim-and-fill analysis. Results: The mean effect size of the management program was small (g=0.22), along with the anthropometric index (g=0.18), metabolism index (g=0.21), fat-distribution (g=0.36), and inflammatory index (g=0.36). Moderator analysis was performed to determine heterogeneity, but no significant differences were found between the randomized controlled trial (RCT) group and non-RCT group. In addition, the length of the session was found to be statistically significant after performing a meta-regression. Finally, a funnel plot with a trim-and-fill analysis was produced to check for publication bias, but no significant bias was detected. Conclusion: Based on these findings, the abdominal obesity management program affects middle-aged women in Korea. Further research is needed to target other age groups with abdominal obesity.

• Korean Journal of Radiology
• /
• v.19 no.6
• /
• pp.1119-1129
• /
• 2018

Objective: To compare the image quality of low-tube-voltage and low-iodine-concentration-contrast-medium (LVLC) computed tomography urography (CTU) with iterative reconstruction (IR) with that of conventional CTU. Materials and Methods: This prospective, multi-institutional, randomized controlled trial was performed at 16 hospitals using CT scanners from various vendors. Patients were randomly assigned to the following groups: 1) the LVLC-CTU (80 kVp and 240 mgI/mL) with IR group and 2) the conventional CTU (120 kVp and 350 mgI/mL) with filtered-back projection group. The overall diagnostic acceptability, sharpness, and noise were assessed. Additionally, the mean attenuation, signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR), and figure of merit (FOM) in the urinary tract were evaluated. Results: The study included 299 patients (LVLC-CTU group: 150 patients; conventional CTU group: 149 patients). The LVLC-CTU group had a significantly lower effective radiation dose ($5.73{\pm}4.04$ vs. $8.43{\pm}4.38mSv$) compared to the conventional CTU group. LVLC-CTU showed at least standard diagnostic acceptability (score ${\geq}3$), but it was non-inferior when compared to conventional CTU. The mean attenuation value, mean SNR, CNR, and FOM in all pre-defined segments of the urinary tract were significantly higher in the LVLC-CTU group than in the conventional CTU group. Conclusion: The diagnostic acceptability and quantitative image quality of LVLC-CTU with IR are not inferior to those of conventional CTU. Additionally, LVLC-CTU with IR is beneficial because both radiation exposure and total iodine load are reduced.

• Journal of the Korea Academia-Industrial cooperation Society
• /
• v.22 no.2
• /
• pp.434-439
• /
• 2021

We assessed the effects of intravenous (IV) ascorbic acid administration on fatigue in women undergoing laparoscopic myomectomy. We analyzed the secondary endpoint results of a randomized, double-blind, placebo-controlled trial. Fifty patients undergoing laparoscopic myomectomy received IV ascorbic acid (2g) or placebo (randomly 1:1 ratio) intravenously during surgery. On day 2 post-surgery, we measured the level of fatigue using the Brief Fatigue Inventory-Korean version. Forty-five women (experimental arm 23, control arm 22) were eligible for analysis after 5 women (experimental arm 2, control arm 3) were excluded due to withdrawal of consent, cancellation of surgery or non-measurement of the endpoints. The baseline and operative characteristics were similar between arms and the global fatigue score of the experimental arm (4.56 ± 2.63) was not significantly different from that of the control arm (5.21 ± 2.02, P = 0.351). However, the fatigue score of the experimental arm tended to be lower than that of the control arm in most domains. IV ascorbic acid administration did not significantly reduce the level of fatigue in women undergoing laparoscopic myomectomy as compared to placebo. More research is needed to better understand the effects of ascorbic acid on fatigue in surgical patients.

• The Journal of Korean Academy of Orthopedic Manual Physical Therapy
• /
• v.10 no.2
• /
• pp.45-56
• /
• 2004

OBJECTIVE: The objective of this study was to know the effects of the postoperative lumbar extensor strengthening exercise program on back muscles strength and volume, pain, and the time of return to work. METHODS: A prospective controlled trial of lumbar extensor exercise program in patients who underwent microdiscectomy or percutaneous endoscopic discectomy for prolapsed lumbar intervertebral disc. Seventy-five patients were randomized into exercise group (20 male, 15 female) and non-exercise group (18 male, 22 female). Six weeks after surgery, patients in exercise group undertook a 12-week lumbar extension exercise (MedX) program. Assessment of spinal function was performed in all patients on postoperative 6 weeks, 18 weeks. The assessment included measures of lumbar extensor power, muscle mass of erector spinalis. All patients completed the visual analog scale (VAS) for evaluation of pain, and return to work. RESULTS: In muscle power, there were statistically significant improvements between pre and post test on muscle power in exercise group. But there were not statistically significant difference on muscle power in non-exercise group. In muscle mass, there were statistically significant difference between pre and post test on muscle mass in exercise group. But there were not statistically significant difference on muscle mass in non-exercise group. In the pain, there were statistically significant decrease between pre and post test on both group. But there were not statistically significant difference on fatty tissue and obesity in non-exercise group. The percentages of return to work in postoperative 4 months were significantly greater in the exercise group than in the non -exercise group. CONCLUSIONS: Postoperative lumbar extensor strengthening exercise program appears to be more beneficial to the patients who underwent operation for prolapsed lumbar intervertbral disc.

• Journal of Korean Academy of Nursing
• /
• v.45 no.3
• /
• pp.357-366
• /
• 2015

Purpose: This study was done to develop an evidence-based incontinence care protocol through an adaptation process and to evaluate the effects of the protocol. Methods: The protocol was developed according to the guideline of adaptation. A non-randomized controlled trial was used for testing the effects of the new Incontinence Care Protocol. A total of 120 patients having bowel incontinence with Bristol stool type 5, 6, and 7 and admitted to intensive care units were recruited to this study. The newly developed incontinence care protocol was used with patients in the experimental group and conventional skin care was given to patients in the control group. Outcome variables were incontinence-associated dermatitis (IAD) severity, pressure ulcer occurrence and severity. Results: The experimental group had significantly less severe IAD (t=6.69, p <.001), lower occurrence of pressure ulcers (${\chi}^2=7.35$, p =.007), and less severity of pressure ulcers (Mann-Whitney=86.00, p =.009) than the control group. Conclusion: Use of this incontinence care protocol has the effects of preventing pressure ulcers and inhibiting worsening of IAD and pressure ulcers. Therefore, this incontinence care protocol is expected to contribute to managing IAD and pressure ulcers.

• Journal of Oriental Neuropsychiatry
• /
• v.31 no.1
• /
• pp.13-23
• /
• 2020

Objectives: The purpose of this study was to review the research trends in the treatment of hatha-style yoga on Post Traumatic Stress Disorder (PTSD). Methods: We searched articles in Pubmed and the China National Knowledge Infrastructure (CNKI) January 2010-December 2019, for studies to treat PTSD using hatha-style yoga. Selected studies were evaluated by the CLEAR-NPT (A Checklist to Evaluate a Report of a Non-pharmacological Trial). Results: Seven randomized controlled clinical trials were selected. PSS-I (PTSD Symptom Scale-Interview) was the most frequently used as diagnostic criteria. The PCL (PTSD Checklist) was also the most commonly used outcome measurement. Of the seven articles, most studies reported that hatha-style yoga was effective to reduce symptoms of PTSD. Conclusions: Hatha-style yoga practice intervention can be used to relieve symptoms of PTSD. More studies should be conducted to make hatha-style yoga as protocol (complementary therapy) for PTSD patients.

• The Journal of Pediatrics of Korean Medicine
• /
• v.29 no.3
• /
• pp.1-11
• /
• 2015

Objectives : The purpose of this study is to analyze the trends in foreign clinical trials for pediatric asthma in complementary and alternative medicine (CAM). Methods : We reviewed 31 randomized controlled trials (RCT) for pediatric asthma treatment in CAM published from 2005 to 2015 in PubMed and analyzed their treatments, compounds of herbal medicines, acupoints, methods of assessment, and treatment results. Results : The treatments used in the studies were herbal medicines, acupuncture, acupoint application, breathing training, supplement, normocaloric diet, yoga, massage therapy, and art therapy. The frequently used herbs were Asari Herba Cum Radix (細辛). Ephedrae Herba (麻黃), Astragali Radix. The most common acupoints were Feishu (肺兪, BL13). The methods of assessment in pediatric asthma were symptom scale, questionnaire of Quality of Life, lung function test, laboratory studies, and medication usage. In 28 out of 31 studies, treatment group gets better than non-treated group. Conclusions : This study shows that CAM is effective in treating pediatric asthma. More clinical studies using objective outcome measures are needed to prove its efficacy clearly.