• Osteoporosis and Sarcopenia
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• 제2권4호
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• pp.228-237
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• 2016

Objective: There has been no prospective study that examined intramuscular injection of high-dose vitamin D in Korean adults. The aim of this study was to assess the efficacy and safety of high-dose vitamin $D_3$ after intramuscular injection in Korean adults with vitamin D deficiency. Method: This study was a 24-week, prospective, multicenter, randomized, double-blind, placebo-controlled trial. A total of 84 subjects ${\geq}19$ and <65 years of age were randomly allocated to either the vitamin $D_3$ or placebo group in a 2:1 ratio. After randomization, a single injection of plain vitamin $D_3$ 200,000 IU or placebo was intramuscularly administered. If serum 25-hydroxyvitamin D (25[OH]D) concentrations were <30 ng/mLon week 12 or thereafter, a repeat injection was administered. Results: After a single intramuscular injection of vitamin $D_3$ to adults with vitamin D deficiency, the proportion of subjects with serum 25(OH)D concentrations ${\geq}30ng/mL$ within 12 weeks was 46.4% in the vitamin $D_3$ group and 3.6% in the placebo group (p<0.0001). The proportion of subjects with serum 25(OH)D concentrations ${\geq}30ng/mL$ within 24 weeks was 73.2% in the vitamin $D_3$ group and 3.6% in the placebo group (p<0.0001). Mean change in serum 25(OH)D concentrations at weeks 12 and 24 after vitamin $D_3$ injection was $12.8{\pm}8.1$ and $21.5{\pm}8.1ng/mL$, respectively, in the vitamin $D_3$ group, with no significant changes in the placebo group. Serum parathyroid hormone concentrations showed a significant decrease in the vitamin $D_3$ group but no change in the placebo group. Conclusion: Intramuscular injection of vitamin $D_3$ 200,000 IU was superior to placebo in terms of its impact on serum 25(OH)D concentrations, and is considered to be safe and effective in Korean adults with vitamin D deficiency.

• Journal of Dental Anesthesia and Pain Medicine
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• 제21권5호
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• pp.379-396
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• 2021

Background: Trigeminal neuralgia (TN) is characterized by brief, unilateral, sharp, stabbing, and shooting pain of the fifth cranial nerve. The objective of this systematic review with meta-analysis was to determine the effect of medications compared to placebo in adult patients with TN. Methods: Review authors identified randomized placebo-controlled trials (RCTs) from PubMed, Web of Science, Cochrane, and EMBASE up to February 2021. We assessed the inclusion and exclusion criteria as well as the risk of bias of the studies based on the Cochrane Handbook. A total of 324 unduplicated references were scanned independently and reduced to eight relevant RCTs, with 89 patients included. Medications investigated included oral carbamazepine, subcutaneous sumatriptan, lidocaine (intranasal, 8% spray on the oral mucosa or intravenous), buprenorphine (ganglionic local opioid analgesia), and oral Nav1.7, a selective sodium channel blocker. Results: Meta-analyses showed that overall patients receiving lidocaine reported a significantly lower post-treatment intensity of pain -3.8 points on a 0-10 scale (95% Cl = -4.653 to -2.873; P < 0.001). Patients who received lidocaine were 8.62 times more likely to have pain improvement than patients on placebo (P < 0.001). In one RCT, patients receiving oral carbamazepine showed a significant improvement in pain intensity of -32% compared to the placebo (P < 0.001). In one trial, patients receiving 3 mg subcutaneous sumatriptan had a significantly lower intensity of pain on average -6.1 points on a scale of 0-10 compared to placebo (P < 0.001) and a significant improvement in pain intensity of -75% compared to the improvement in the placebo group (P < 0.001). Patients who received subcutaneous sumatriptan were 10 times more likely to have pain improvement than those who received placebo (P = 0.001) in one study. Due to the unclear/high risk of bias and small sample size, the quality of the evidence for lidocaine in the treatment of TN was low. Conclusion: Further studies are needed for carbamazepine, sumatriptan, buprenorphine, and oral Nav1.7 sodium channel blockers, as only one study reported outcomes.

• 한국미생물·생명공학회지
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• 제40권3호
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• pp.237-242
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• 2012

본 연구에서는 비수리 추출물 함유 크림의 피부 보습 효능과 안정성을 평가하였다. 비수리 추출물의 0.2% 에틸아세테이트 분획을 함유한 크림을 제조하고 임상실험으로 피부보습 효과를 측정하였다. 크림을 도포한 후에 피부 수분량과 경표피 수분 손실량을 조사하였다. 추출물의 0.2% 에틸아세테이트 분획을 함유한 크림의 피부 보습효과는 placebo 크림보다도 10~20% 정도 크게 나타났다. 에틸아세테이트 분획을 함유한 크림의 경표피 수분 손실량(TEWL, $7.7g/m^2h$)은 대조군($10.2g/m^2h$) 및 placebo 크림($8.9g/m^2h$)에 비교하여 TEWL의 감소를 나타내었다. 비수리 추출물의 0.2% 에틸아세테이트 분획을 함유한 크림의 안정성을 평가하였다. 4개의 서로 다른 온도($4^{\circ}C$, $20^{\circ}C$, $37^{\circ}C$, $45^{\circ}C$)와 태양 광선 하에 12주 동안 추출물 함유 크림을 처리한 후 pH, 점도 및 흡광도를 측정하였다. 추출물 함유 크림과 placebo 크림 사이의 pH 변화는 위에 언급된 여러 가지 온도 하에서 유의적인 차이를 나타내지는 않았다. 하지만 추출물 함유 크림의 pH 변화(${\Delta}ph$ = 1.60) placebo 크림(${\Delta}ph$ = 1.65)보다 태양 광선 하에서 크게 나타났다. 추출물 함유 크림과 placebo 크림의 점도를 12주 동안 여러 온도에 처리한 후 측정하였다. 추출물 함유 크림과 placebo 크림 모두 $45^{\circ}C$에서 큰 점도 감소(약 59%)를 나타내었다. 하지만, 4, 20, 및 $37^{\circ}C$와 태양광선 하에서는 큰 변화가 없었다. 추출물 함유 크림과 placebo 크림의 흡광도는 모든 조건에서 비슷하게 감소하였다. 이러한 흡광도의 감소는 태양광선 하에서 에탄올 용액에 있는 추출물의 흡광도 감소와 비교하여 상대적으로 작게 나타났다(Fig. 7). 첨부해서, 실험 기간 12주 동안 크림의 변색이나 변취에 있어서 어떠한 변화도 관찰되지 않았다. 또한, 크리밍이나 응집과 같은 물리적인 변화도 관찰할 수 없었다. 이러한 결과들은 비수리 추출물의 에틸아세테이트 분획 함유 크림이 피부 보습 효과를 가지며 상대적으로 안정함을 가리킨다. 따라서 이는 비수리 추출물의 에틸아세테이트 분획은 이미 보고된 항산화 및 항균 활성과 함께 새로운 화장품 소재로서 응용 가능성이 있음을 시사한다.

• Journal of Ginseng Research
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• 제42권2호
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• pp.192-198
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• 2018

Background: Ginseng has been used as an ergogenic agent, although evidence for its effectiveness is weak. A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the effect of a ginsenoside complex (UG0712) on changes in exercise performance. Methods: Sedentary individuals (n = 117) were randomly assigned into one of three groups: low-dose ginsenoside supplementation (100 mg/d, n = 39), high-dose ginsenoside supplementation (500 mg/d, n = 39), or a placebo group (500 mg/d, n = 39). All participants underwent a supervised 12-wk aerobic and resistance exercise training course. To assess the effects of supplementation on physical performance, maximal oxygen consumption ($VO_2max$), anaerobic threshold (AT), lactic acid, and muscle strength of the dominant knee were measured at baseline, every visit, and after the training program. Results: Both ginsenoside groups showed significant increases in $VO_2max$ and muscular strength during exercise training. There were no definite changes in AT and lactic acid levels over time. After exercise training, there were definite differences in the $VO_2max$ (28.64.9 to $33.7{\pm}4.9ml/kg/min$ in high-dose group vs. $30.4{\pm}6.7$ to $32.8{\pm}6.6ml/kg/min$ in placebo, p = 0.029) and AT ($19.3{\pm}4.2$ to $20.9{\pm}3.5ml/kg/min$ in high-dose group vs. $20.0{\pm}5.1$ to $20.0{\pm}4.9ml/kg/min$ in placebo, p = 0.038) between the high-dose ginsenoside and placebo groups. However, there was no difference in $VO_2max$ between the low-dose ginsenoside and placebo groups (p = 0.254). There were no differences in muscular strength during exercise training among the three groups. Conclusion: High-dose ginsenoside supplementation (UG0712) augmented the improvement of aerobic capacity by exercise training.

• 한국식품과학회지
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• 제41권3호
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• pp.307-312
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• 2009

체중이 정상이면서 체지방률 함량이 30% 이상인 여성을 대상으로 CLA 보충과 운동 여부가 체지방함량과 체중 및 혈당, 혈중 지질 농도에 미치는 영향에 대하여 살펴 본 결과는 다음과 같다. 실험 대상자들의 평균 연령은 22세였으며, 실험이 진행되는 동안 대상자들은 식이 조절을 하지 않았다. 실험 대상자들의 실험 후 체중과 BMI, 체지방 함량의 변화를 살펴본 결과, CLA-운동군이 placebo-비운동군에 비해 체중과 BMI가 유의적으로 작았으며, 체지방 함량도 적은 것으로 나타났다. 또한, 복부지방을 나타내는 허리둘레도 CLA-운동군이 placebo-비운동군과 비교하여 유의적으로 감소하여 CLA를 섭취하고 운동을 하는 것이 운동을 하거나, CLA만 섭취하는 것보다 체중 조절에 더 효과적인 것으로 나타났다. 대상자들의 평균 공복혈당, TG, total cholesterol, LDL-C, HDL-C은 모두 정상 범위에 속하였고, CLA를 섭취하거나 운동을 하는 경우 혈중 HDL-콜레스테롤의 함량을 증가시키는 것으로 나타났으나, CLA와 운동을 병행하는 경우 상승효과를 보이지는 않았다. 이러한 결과, CLA를 보충함으로써 체중 조절을 하는 것보다는 CLA와 운동을 함께 병행하는 것이 체중 조절에 효과적이며, 혈중 지질 농도를 개선시킬 수 있을 것으로 사료된다.

• Journal of Gastric Cancer
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• 제17권2호
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• pp.120-131
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• 2017

Purpose: Tumor bleeding is a major complication in inoperable gastric cancer. The study aim was to investigate the effects of proton pump inhibitor (PPI) treatment for the prevention of gastric tumor bleeding. Materials and Methods: This study was a prospective double-blind, randomized, placebo-controlled trial. Patients with inoperable gastric cancer were randomly assigned to receive oral lansoprazole (30 mg) or placebo daily. The primary endpoint was the occurrence of tumor bleeding, and the secondary endpoints were transfusion requirement and overall survival (OS). Results: This study initially planned to enroll 394 patients, but prematurely ended due to low recruitment rate. Overall, 127 patients were included in the analyses: 64 in the lansoprazole group and 63 in the placebo group. During the median follow-up of 6.4 months, tumor bleeding rates were 7.8% and 9.5%, in the lansoprazole and placebo groups, respectively, with the cumulative bleeding incidence not statistically different between the groups (P=0.515, Gray's test). However, during the initial 4 months, 4 placebo-treated patients developed tumor bleeding, whereas there were no bleeding events in the lansoprazole-treated patients (P=0.041, Gray's test). There was no difference in the proportion of patients who required transfusion between the groups. The OS between the lansoprazole (11.7 months) and the placebo (11.0 months) groups was not statistically different (P=0.610). Study drug-related serious adverse event or bleeding-related death did not occur. Conclusions: Treating patients with inoperable gastric cancer with lansoprazole did not significantly reduce the incidence of tumor bleeding. However, further studies are needed to evaluate whether lansoprazole can prevent tumor bleeding during earlier phases of chemotherapy (ClinicalTrial.gov, identifier No. NCT02150447).

• 한방안이비인후피부과학회지
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• 제33권3호
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• pp.27-44
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• 2020

Objectives : The authors conducted randomized, Double-blinded, and placebo-controlled parallel-group clinical experiment study to evaluate efficacy of fermented soybean(Bio-Peptone)cream in pruritus. Methods : The research had been conducted for 4 months from the date of IRB approval(May 26 in 2017) to Sept 2017. The experiment started by randomly distributing 25 subjects with pruritus into experimental group and control group, respectively. The experimental group applied fermented soybean(Bio-Peptone)cream twice a day, in the morning and evening, for one week on itchy area. The effect of the product was evaluated by comparing the PSS(Patient subjective score), moisture level by measuring skin moisture content(Corneometer) and transepidermal water loss(Tewameter), and the Korean version of Skindex-29(index of quality of life improvement) before applying the cream, after applying the cream for one week and after stop applying the cream for one week. The control group conducted identical experiment with the experimental group, except the control group applied placebo instead of the fermented soybean(Bio-Peptone)cream. Results : Pruritus, criterion of the first validation testing, indicates fermented soybean(Bio-Peptone)cream tend to reduce pruritus compare to placebo, although the result is not statistically noticeable. Significant difference in reduction of prutitus, the second validation test was not discovered in both groups. Corneometer and life quality tend to be improved with soy cream than placebo, but not statistically effective and both groups did not show any difference in terms of Tewameter measurement. Conclusions : The result of clinical experiment didn't prove that the fermented soybean(Bio-Peptone)cream is more effective in reducing pruritus than placebo, statistically. The clinical use of soybean product for pruritus requires further studies to be verified.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• 제24권5호
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• pp.423-431
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• 2021

Purpose: To assess the effect of combination probiotic Saccharomyces boulardii CNCM-I 3799 and Bacillus subtilis CU-1 in outpatient management of acute watery diarrhea in children. Methods: A randomized double-blind placebo-controlled study was conducted in 180 participants aged six months to five years with acute mild to moderate diarrhea. All were enrolled from six centers across India and centrally randomized to receive S. boulardii CNCM-I 3799 and B. subtilis CU-1 or a placebo along with oral rehydration salts and zinc supplementation. Each participant was followed up for three months to assess recurrence of diarrhea. Results: The mean duration of diarrhea in the probiotic and placebo groups were 54.16 hours and 59.48 hours, respectively. The difference in the duration of diarrhea in those administered with probiotic or placebo within 24 hours of diarrhea onset was 25.21 hours. Furthermore, the difference in duration of diarrhea was 13.84 hours (p<0.05) for participants who were administered with probiotics within 48 hours. There were no significant differences in the stool frequencies between the two arms. After three months, 15% in the probiotic group and 18.5% in the placebo group reported episodes of diarrhea. The mean duration of diarrhea was considerably lower in the probiotic group, 31.02 hours versus 48 hours in placebo (p=0.017). Conclusion: S. boulardii CNCM-I 3799 and B. subtilis CU-1 combination was effective in reducing the duration of diarrhea when administered within 48 hours of diarrhea onset. Similarly, it reduced recurrence of diarrhea and its intensity in the subsequent three months.

• Journal of Nutrition and Health
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• 제52권2호
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• pp.149-156
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• 2019

본 연구에서는 12주간 김치에서 추출한 유산균 Lactobacillus plantarum 섭취가 피부의 산도 및 관련인자인 유리아미노산, 젖산 및 유리지방산의 함량을 변화시키는지 파악하였다. CJLP 군에서 12주차에 피부 산도가 대조군에 비해 개선되었다. 표피의 유리아미노산 함량은 대조군에 비해 변화하지 않았으며, 총 유리지방산 및 Stearic acid (C18:0), Palmitic acid (C16:0)의 함량은 감소하였다. 그러나 CJLP군에서 젖산의 함량은 대조군에 비해 12주차에 유의적으로 증가하였다. 즉 김치유산균 Lactobacillus plantarum 섭취는 CJLP 군에서 젖산 함량 증가와 함께 산도를 개선하였다.

• Korean Journal of Acupuncture
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• 제25권2호
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• pp.57-69
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• 2008

Objectives : To review the controlling methods used in RCTs (randomized controlled trials) of auricular acupuncture. Methods : To investigate the controlling methods used in clinical trials of auricular acupuncture, 46 articles were retrieved from PUBMED (from August 1976 to August 2007, with limits: english, clinical trial) using the key words of "ear acupuncture", "auricular acupuncture", "auriculo-medicine", and sorted out according to the types of control treatments. Among them, 10 articles were selected based on STRICTA (Standards for Reporting Intervention in Controlled Trials of Acupuncture), and the controlling methods used in those articles were reviewed. Results : In clinical trials of auricular acupuncture, 'sham acupoints (non-acupoints and non-treatment acupoints included)', 'minimal acupuncture', 'pseudo-intervention', and 'placebo devices' have been used as controlling methods, but their 'inactivity' have been in question. To compensate the disadvantages of 'minimal acupuncture', and 'pseudo-intervention' control, placebo auricular acupuncture needles have been developed, although these needles didn't satisfy the conditions of 'blinding' and 'physical inactivity' simultaneously. Conclusions : Further researches on 'sham acupoints' and new development of 'placebo auricular acupuncture needles' are needed.