• The Korean Journal of Pain
• /
• v.10 no.2
• /
• pp.170-178
• /
• 1997

Background: The analgesic efficacy and safety of propacetamol, an injectable prodrug of acetoaminophen, in combination with intravenous morphine PCA were studied in 40 patients after gynecological surgery requiring lower abdominal incision. Methods: Using a double-blind, randomized, parallel-group design, the effects of four(every 6 hr) intravenous injections of 2 g propacetamol(=1 g acetoaminophen) were compared with four injections of placebo(PL) immediately after surgery. Efficacy of cumulative dose of morphine and number of boluses requested was assessed over 24 hours by automated recording on the PCA device. It was assessed on pain scores rated on a ten-point verbal scale along with vital signs, $K^+$, glucose, BUN, creatinine, PT and PTT were measured along with stress hormones(epinephrine, norepinephrine and cortisol). Results: There were no differences in demographic data between two groups. Propacetamol group demonstrated approximately 21% morphine sparing effect compared to placebo group($33.1{\pm}10.4$ mg vs $41.4{\pm}8.0$ mg). No significant differences noted in $K^+$, glucose, BUN, Creatinine, PT and PTT levels. There were significant increases in norepinephrine and cortisol in placebo group postoperatively, compared to preoperative values. At the same time, propacetamol group also showed significant changes in these hormones. Both group revealed high degree of patient satisfaction. Conclusion: Propacetamol showed significant morphine sparing effect to some degree. Side effects were much less in propacetamol group with subsequently high patient satisfaction. The secretion of stress hormone were not blocked by postoperative propacetamol injections. Authors concluded that propacetamol should be considered as an excellent adjuvant analgesics in postoperative pain control in opioid patient controlled analgesia.

• Journal of Korean Medicine Rehabilitation
• /
• v.30 no.1
• /
• pp.105-113
• /
• 2020

Objectives Excess weight and obesity are a crucial public health problem worldwide and are considered as the main cause of many chronic diseases. The present study evaluated the effects of Aronia melanocarpa extract (AMEX) supplementation on body compositions in overweight or obese people. Methods This randomized, double-blind, placebo-controlled clinical trial was carried out on 66 healthy overweight or obese peoples. The eligible subjects were divided into AMEX and placebo supplement treatment for 12 weeks. Anthropometrics, body composition (dual-energy X-ray absorptiometry), and blood analysis were performed preand post intervention. Results We observed significant reductions in the body weight and body mass index in both groups; however, the decrease was higher in the AMEX group. Body fat mass and percent body fat showed a tendency to decreases after AMEX supplementation. No clinically significant changes were observed for any safety parameter. Conclusions In conclusion, the data of this trial indicate that AMEX were not effective in reducing body compositions, but as a safe supplement, it may help weight loss in overweight or obese people.

• Journal of Periodontal and Implant Science
• /
• v.46 no.1
• /
• pp.46-56
• /
• 2016

Purpose: We evaluated the efficacy of a mouthwash containing potassium nitrate ($KNO_3$) as its main component, along with sodium fluoride (NaF) and cetylpyridinium chloride (CPC). The primary endpoint was the relief of dentin hypersensitivity (DH) against the cold stimuli. The effects on other DH tests and periodontal inflammation were also evaluated. Methods: We used a single-center, double-blind, placebo-controlled, randomized design. A total of 82 patients with DH (40 in the test group, 42 placebo controls) were analyzed using visual analog scales (VASs) for a cold test, a tactile test, a compressive air test, and self-reported pain during daily activities, as well as clinical parameters including plaque index, gingival index, modified sulcular bleeding index (mSBI), gingival recession, and probing depth, which were collected at baseline and after four and six weeks of mouthwash use. Results: VAS scores for cold sensations, tactile sensations, the compressive air test, and self-reported pain significantly decreased from baseline during the six weeks in both groups (P<0.01), and no significant differences between the groups were found. In male patients (10 in the test group and 7 in the control group), both groups showed significant reductions in VAS scores for the cold test over the six weeks, and greater reductions were found in the test group than in the control group between four and six weeks (P=0.01) and between baseline and six weeks (P<0.01). In addition, the mSBI in the test group significantly decreased from baseline during the six weeks (P<0.01), and the changes at four and six weeks from baseline were significantly greater in the test group compared to the control group (P=0.03 and P=0.02, respectively). Conclusions: A mouthwash containing a mixture of $KNO_3$, NaF, and CPC reduced DH and gingival inflammation, however, the efficacy was comparable to the control group.

• Journal of Korean Medicine for Obesity Research
• /
• v.17 no.2
• /
• pp.87-95
• /
• 2017

Objectives: This study was conducted to evaluate efficacy and safety of Punica granatum L. Actinidia chinensis Planch. mixed extract on body fat. Methods: Thirty women were recruited ($25kg/m^2{\leq}body$ mass index [BMI]${\leq}29.9kg/m^2$) ($19yr{\leq}age{\leq}38yr$) and randomized to receive Punica granatum L. Actinidia chinensis Planch. mixed extract or placebo for 8 weeks. During the test, they visited four times including screening. Body fat mass, body fat rate, anthropometric dimensions at waist and hip, waist-hip ratio, total cholesterol, triglyceride, low density lipoprotein-cholesterol (LDL-C), and high density lipoprotein-cholesterol (HDL-C) were measured at screening and 8 weeks after screening. Adverse reaction were also checked each visit. Results: There were no significant differences in all index. But when divide experimental group by BMI index, age, and compliance, less than BMI $27kg/m^2$ group decreased body weight, body fat mass and more than BMI $27kg/m^2$ group also decreased body weight, body fat mass and waist circumference. Less than age 30 years group showed decline of waist circumference, fat free rate and T-cholesterol and more than age 30 years group showed decline of fat free mass. Group with compliance more than 95% was decreased BMI, fat free mass, and hip circumference. Conclusions: There was no significant efficacy as compared with placebo group, but as divide experimental group according to BMI index, age, compliance, mixed extract might be effective to reduce obesity index.

• The Journal of Pediatrics of Korean Medicine
• /
• v.35 no.2
• /
• pp.11-20
• /
• 2021

Objectives The purpose of the study is to evaluate the safety of the Allium Fistulosum extract in children and its effectiveness in height growth. Methods This study is randomized, double-blind, placebo-controlled trial. The participants are children between the 3rd and 25th percentiles in height, and between the ages of 5 and 12 years. They are randomly assigned to treatment group or control group. The treatment group will take 5 g (1 g as Allium Fistulosum extract) for 24 weeks, 1 time a day. The control group will take the 5 g (0 g as Allium Fistulosum extract) of placebo for 24 weeks, 1 time a day. The primary outcome is change in height, and the secondary outcomes are growth rate, height standard deviations, Insulin-like growth factor-1 (IGF-1), Insulin-like growth factor binding protein-3 (IGFBP-3), IGF1-1/IGFBP-3 ratio, growth hormone, bone age, osteocalcin, and Z-score for growth. Results This protocol has been approved by the institutional review board (IRB) of Daejeon Korean Medicine Hospital of Daejeon University (IRB No. DJDSKH-20-BM-15), and registered in the Clinical Research Information Service (CRIS) (Registry No. KCT0005981). Conclusions This study will provide clinical information about the effectiveness and safety of Allium Fistulosum extract in children for their growth.

• The Korean Journal of Pain
• /
• v.37 no.4
• /
• pp.367-378
• /
• 2024

Background: Fibromyalgia is characterized by the presence of chronic widespread pain that may impair patient's quality of life. Currently, the use of naltrexone as a therapeutic agent for fibromyalgia is not supported by enough evidence, especially from randomized controlled trials (RCTs). This study aims to analyze the efficacy and safety of low-dose naltrexone (LDN) for the management of fibromyalgia. Methods: A comprehensive search was conducted on the Scopus, Medline, ClinicalTrials.gov, and Cochrane Library databases up until May 20th, 2024. This review incorporates RCTs that examine the comparison between LDN and placebo in fibromyalgia patients. We employed random-effect models to analyze the odds ratio and mean difference (MD) for presentation of the outcomes. Results: A total of 4 RCTs with 222 fibromyalgia patients were incorporated. The results of our meta-analysis showed a significant reduction in pain scores (MD: -0.86, 95% confidence interval [CI]: -1.20, -0.51, P < 0.001, I² = 33%) and higher increment in pressure pain threshold (MD: 0.17, 95% CI: 0.08, 0.25, P < 0.001, I² = 0%) among fibromyalgia patients who received LDN than those who only received a placebo. The fibromyalgia impact questionnaire revised and pain catastrophizing scale did not differ significantly between the two groups. LDN was also associated with higher incidence of vivid dreams and nausea, but showed no significant difference with the placebo in terms of serious adverse events, headache, diarrhea, and dizziness. Conclusions: This study suggests the efficacy of LDN in mitigating pain symptoms for fibromyalgia patients with a relatively good safety profile.

• Nutrition Research and Practice
• /
• v.18 no.5
• /
• pp.663-673
• /
• 2024

BACKGROUND/OBJECTIVES: Poly-γ-glutamic acid (γ-PGA), a natural polymer found in fermented soybean products, has been reported to play a prebiotic role in the gut. This intervention study investigated the effects of γ-PGA-containing supplement consumption on urinary microbiota in healthy adults because of limited data on such investigation. SUBJECTS/METHODS: A 4-week parallel trial including 39 male and female Korean adults, who were free of chronic diseases and infection, was designed as a randomized, double-blinded, placebo-controlled study. A total of 30 participants completed the study wherein the intervention group (n = 17) received a mixture supplement containing 600 mg/day of γ-PGA and 100 mg/day of vitamin B6, while the control group (n = 13) received a placebo. Paired datasets (baseline and endpoint data) of microbiota profiles, which were constructed via urinary assays of microbe-derived extracellular vesicles, were analyzed and compared between the two groups. RESULTS: Only the intervention group yielded significant results for the Bray-Curtis and Jaccard dissimilarity indices between baseline and endpoint data (P < 0.05). In the phylum-level analysis of microbial composition, the Firmicutes to Bacteroidetes ratio (FB ratio) tended to decrease from baseline in the intervention group; however, it increased in the control group. Differences between the baseline and endpoint FB ratios were significant between the two groups (P < 0.05). CONCLUSION: This study's findings suggest that γ-PGA-vitamin B6 supplementation potentially alters the microbial community composition of a host. Further investigation into the biological consequences of commensal microbiota alteration by γ-PGA-containing supplement consumption is warranted.

• Journal of Acupuncture Research
• /
• v.26 no.1
• /
• pp.99-109
• /
• 2009

목적 : 두통의 침술효과에 대한 연구가 꾸준히 이루어지고 있다. 하지만 많은 연구들에서 서로 상충되는 결과를 내놓고 있다. 이에 저자는 대조군 집단 시술의 역할과 시험의 특성에 대해 연구하는 데 있어 몇 가지 유형의 두통, 특히 긴장성 두통(Tension-type headache, TTH)과 편두통에 대한 침술의 대조군 시험에서 나타나는 일관성 없는 발견 사항들의 원인이 무엇인지에 대해 밝히려고 하였다. 방법 : 두통의 침술효과에 대해 보고하고 있는 11개의 임의대조군 시험(Randomized controlled trials, RCTs)을 대상으로 하여 위약 침술과 방법론적 특성 범주 III과 IV를 중심으로 위약 시술 분석, 비교를 실시하였다. 결과 : 임상적 유효성과의 상관관계에 있어 범주 III과 IV 사이에는 유의한 차이가 없었다. 표본 크기 계산, 표본 전체 크기, 진짜 집단과 위약 집단에 속한 피험자의 수에는 긍정적 결과와 중립적 결과 사이에 유의한 차이가 없었다. 결론 : 두통의 임의대조군 시험에 대한 다양한 유형의 위약 대조군과 침술의 방법론적 특성이 임상적 효과를 예측해 주는지의 여부에 대해 추가 연구가 이루어져야 하겠다.

• Advances in Traditional Medicine
• /
• v.7 no.4
• /
• pp.372-378
• /
• 2007

A well known Ayurvedic formulation Ashokarista, used for menstrual disorders has been studied in a single blind randomised placebo controlled clinical trial for the treatment of menorrhagia and dysmenorrhoea. Dysmenorrhoea and menorrhagia patients who were taking Ashokarista (20 ml twice daily) for 10 menstrual cycles had an increase in haemoglobin level. Menorrhagia treated group has shown to reduce the erythrocyte sedimentation rate level that has been increased in the menorrhagia control group. The platelet count, total count and differential count were observed unchanged in the study. The Ashokarista did not affect the SGPT and SGOT level, which signify its lack of toxicity in hepatic function. The treated menorrhagic patients showed an increase in serum albumin content and decrease in blood clotting time, whereas the serum protein content was observed unchanged. There was a significant increase in both serum cholesterol and triglyceride level, which usually associated with the use of oral contraceptives. No major side effects were observed by the clinicians during the study.

• Nutrition Research and Practice
• /
• v.17 no.4
• /
• pp.698-716
• /
• 2023

BACKGROUND/OBJECTIVES: The aim of this study was to evaluate the sensory properties of antioxidant-rich bread made by adding pomegranate peels and their effects on anthropometric measurements and metabolic and oxidative parameters of individuals with type 2 diabetes after consumption. SUBJECTS/METHODS: This randomized, double-blind, placebo-controlled study was conducted with 22 individuals aged between 19 and 64 years who had been diagnosed with type 2 diabetes for at least 5 years, used only metformin, did not lose more than 10% of their body weight in the last 6 months, and had a body mass index of ≥ 25.0 kg/m². While the study group (n = 11) consumed bread containing 500 mg pomegranate peel daily for 8 wk, the control group (n = 11) consumed standard bread. Anthropometric measurements and metabolic and oxidative parameters of individuals were evaluated at the beginning and end of the study. RESULTS: Decreases were detected in the waist circumference, waist/hip and waist/height ratios, body fat percentages, blood pressure, and serum insulin, triglyceride, and total cholesterol levels in the individuals in the treatment group, compared with those in the control group (P < 0.05). CONCLUSIONS: Pomegranate peel consumption by individuals with type 2 diabetes may have positive effects on anthropometric measurements and glycemic and lipid parameters.