• Title/Summary/Keyword: double blind test

Search Result 144, Processing Time 0.029 seconds

Single buccal infiltration of high concentration lignocaine versus articaine in maxillary third molar surgery

  • Phyo, Hnin Ei;Chaiyasamut, Teeranut;Kiattavorncharoen, Sirichai;Pairuchvej, Verasak;Bhattarai, Bishwa Prakash;Wongsirichat, Natthamet
    • Journal of Dental Anesthesia and Pain Medicine
    • /
    • v.20 no.4
    • /
    • pp.203-212
    • /
    • 2020
  • Background: This research evaluated the numbness produced by lignocaine at an equal or higher concentration than that of 4% articaine through a single point of injection for maxillary third molar surgery. This randomized double-blind study was conducted to compare the anesthetic efficiency of 4% lignocaine with that of 4% articaine in impacted maxillary third molar surgery using a single buccal infiltration alone. Methods: The study participants were 30 healthy patients requiring the bilateral surgical removal of symmetrically-positioned maxillary third molars. Using a split-mouth design, each patient randomly received buccal infiltration of 1.7 ml of 4% lignocaine and 1.7 ml of 4% articaine during two separate appointments. After 15 minutes of anesthetic injection, surgery was performed by the same surgeon using a consistent technique on both sides. Pinprick test pain scores of the buccal and palatal gingiva of the maxillary third molar after 10 minutes and 15 minutes latencies, pain scores during the surgery, the need for supplemental anesthesia, and patients' satisfaction with anesthetic efficiency were recorded. Surgery performed without supplemental anesthesia was categorized as successful. Results: The success rates of 4% lignocaine and 4% articaine (83.34% vs. 86.67%, P = 1.00) were not significantly different. Only 5 cases (4 cases in the articaine group and 1 case in the lignocaine group) reported mild pain and pressure sensation (NRS ≤ 1) on probing at the palatal side after 15 minutes of latency (P = 0.25). The pain scores of maxillary third molar surgery in the two groups were not significantly different (P > 0.05). Moreover, the statistical analysis confirmed the comparable patient satisfaction of two study groups (P = 0.284). Conclusion: This study provides evidence that single buccal infiltrations of 4% lignocaine and 4% articaine have comparable anesthetic efficacy and success rates for impacted maxillary third molar surgery. Both 4% lignocaine and 4% articaine can produce effective palatal anesthesia and pain control using buccal infiltration alone after 15 minutes of latency.

Review of Clinical and Experimental Studies on External Application Treatment for Atopic Dermatitis in the Korean Literature (아토피 피부염 외용제에 관련된 국내 임상 및 실험 논문 고찰)

  • Min, Deul Le;Park, Eun Jung;Kang, Kyung Ha
    • The Journal of Pediatrics of Korean Medicine
    • /
    • v.27 no.1
    • /
    • pp.36-49
    • /
    • 2013
  • Objectives The goal of this review is to investigate clinical and experimental studies on external application treatment for atopic dermatitis in Korean literature and to propose for the better method of clinical studies in order to seek more effective treatment. Methods Electronic researches were performed with KTKP, OASIS, National Assembly Library, Korean Medicine Database, KISS, DBpia, and KISTI. Results and Conclusions In Twenty six studies, the numbers of clinical and experimental studies are respectively 10 (38.46%) and 16 (61.54%). The numbers of studies that used herbal complex were 20 (76.92%), and out of that, 6 studies had used a single herbal medicine (23.08%). The external application with oriental medicine for the atopic dermatitis used with Phellodendri Cortex (7), Sophorae Radix (6), Scutellariae Radix (6), Lonicerae Flos (5), Coptidis Rhizoma (5) and so on. Among the clinical studies, the 5 studies were double-blind and randomized-controlled study (50%). The numbers of studies that used Hanifin and Rajka Diagnostic Criteria (1980) were 6 (60%), and that used the Diagnostic Criteria in Korean Atopic Dermatitis (2005) were 4 (40%). Among the clinical studies, categories to evaluate of atopic dermatitis are respectively SCORAD Index (80%), Total IgE (80%), Eosinophil count (70%) and so on. All of the clinical studies (100%) showed a statistically significant decline in atopic dermatitis according to the SCORAD Index, Modified SCORAD Index, the Clinic index score. Among the experimental studies, the numbers of studies that used NC/Nga mice were 9 (56.25%), and out of that 5 studies used BALB/c mice (31.25%). Most of the studies (68.75%) used DNCB as allergy inducing materials. The scales for evaluation of atopic dermatitis were Clinical skin severity score, Histopathologic examination, Immunohematologic examination, safety test and so on. In 12 cases (75%) of experimental studies, the IgE level of experimental group showed a statistically significant decline after using external application. In 8 study cases (50%), Clinical skin severity score of experimental group showed a statistically significant decline after using external application.

The Effects of Saccharomyces Cerevisiae Yeast Extract SCP-20 on Stress Response, Anxiety and Depression : A Double-Blind Placebo-Controlled Trial (Saccharomyces Cerevisiae 효모 추출물 SCP-20의 스트레스 반응, 불안 및 우울에 대한 효과 : 이중 맹검 위약 통제 연구)

  • Lee, Ha-Min;Jung, Young-Eun;Chae, Jeong-Ho
    • Anxiety and mood
    • /
    • v.5 no.1
    • /
    • pp.8-13
    • /
    • 2009
  • Objective : SCP-20, a yeast hydrolysate from Saccharomyces cerevisiae, has exhibited anti-stress, anti-anxiety, and antidepressant effects in animal studies. The objective of this study was to test the effects of SCP-20 on healthy controls and to assess its effects on stress response, depression and, anxiety. Methods : Sixty-one healthy volunteers (30 male, 31 female) were recruited and screened for significant psychiatric and medical conditions. Baseline measures of stress, anxiety, and depression were taken using questionnaires such as the Stress Response Inventory (SRI), Beck's Anxiety Inventory (BAI), Beck's Depression Inventory (BDI), and the physiological measure of heart rate variability (HRV). Each subject was assigned randomly to a group taking capsules containing either 70% SCP-20 (i.e. the SCP70 group), 99.5% SCP-20 (i.e. the SCP99.5 group), or a placebo. Follow up measures were taken at week 4. Results : Subjects taking SCP-20 showed significant improvement in SRI and BAI scores compared to those taking placebo. For BDI scores, there was no significant difference between groups. No significant adverse effects were reported. Conclusions : This study suggests that SCP-20 is effective in alleviating stress and anxiety symptoms in healthy individuals, and has little or no side effects. However, the role of of SCP-20 in alleviating depression needs further clarification. Studiess examining its effects in psychiatric populations are needed to establish its role in alternative medicine.

  • PDF

Analysis of Repeated Measured VAS in a Clinical Trial for Evaluating a New NSAID with GEE Method (퇴행성 관절염 환자를 대상으로 새로운 진통제 평가를 위한 임상시험자료의 GEE 분석)

  • Lim, Hoi-Jeong;Kim, Yoon-I;Jung, Young-Bok;Seong, Sang-Cheol;Ahn, Jin-Hwan;Roh, Kwon-Jae;Kim, Jung-Man;Park, Byung-Joo
    • Journal of Preventive Medicine and Public Health
    • /
    • v.37 no.4
    • /
    • pp.381-389
    • /
    • 2004
  • Objective : To compare the efficacy between SKI306X and Diclofenac by using generalized estimating equations (GEE) methodology in the analysis of correlated bivariate binary outcome data in Osteoarthritis (OA) diseases. Methods : A randomized, double-blind, active comparator-controlled, non-inferiority clinical trial was conducted at 5 institutions in Korea with the random assignment of 248 patients aged 35 to 75 years old with OA of the knee and clinical evidence of OA. Patients were enrolled in this study if they had at least moderate pain in the affected knee joint and a score larger than 35mm as assessed by VAS (Visual Analog Scale). The main exposure variable was treatment (SKI 306X vs. Diclofenac) and other covariates were age, sex, BMI, baseline VAS, center, operation history (Yes/No), NSAIDS (Y/N), acupuncture (Y/N), herbal medicine (Y/N), past history of musculoskeletal disease (Y/N), and previous therapy related with OA (Y/N). The main study outcome was the change of VAS pain scores from baseline to the 2nd and 4th weeks after treatment. Pain scores were obtained as baseline, 2nd and 4th weeks after treatment. We applied GEE approach with empirical covariance matrix and independent(or exchangeable) working correlation matrix to evaluate the relation of several risk factors to the change of VAS pain scores with correlated binary bivariate outcomes. Results : While baseline VAS, age, and acupuncture variables had protective effects for reducing the OA pain, its treatment (Joins/Diclofenac) was not statistically significant through GEE methodology (ITT:aOR=1.37, 95% CI=(0.8200, 2.26), PP:aOR=1.47, 95% CI=(0.73, 2.95)). The goodness-of-fit statistic for GEE (6.55, p=0.68) was computed to assess the adequacy of the fitted final model. Conclusions : Both ANCOVA and GEE methods yielded non statistical significance in the evaluation of non-inferiority of the efficacy between SKI306X and Diclofenac. While VAS outcome for each visit was applied in GEE, only VAS outcome for the fourth visit was applied in ANCOVA. So the GEE methodology is more accurate for the analysis of correlated outcomes.

Effects of Injinoryung-San on Alcoholic Hepatitis (인진오령산의 알콜성 간염에 미치는 영향)

  • Hong, Su-Hyun;Kwon, O-Sun;Kim, Sang-Heon;Kim, Hyo-Jin;Kim, Ki-Tak;Park, Sang-Eun;Kim, Won-Il;Kang, Chang-Wan;Cho, Jung-Hyo;Son, Chang-Gue;Ryu, Woo-Sang;Kim, Kyung-Nam;Hong, Sang-Hoon
    • Journal of Physiology & Pathology in Korean Medicine
    • /
    • v.22 no.1
    • /
    • pp.204-208
    • /
    • 2008
  • This study was performed to investigate the effect of the extracts from Injinoryng-San on liver injury patients induced by alcohol. Injinoryung-San was recorded the drug for jaundice at Hwang-Je-Nae-Kyung. Twenty-seven patients who have intaked alcohol above 40 g, every day, 5 years, twenty-seventy ages were selected. After take a written consent, we divide them into experimental groups and control groups by double blind test. Each groups was evaluated every 2 weeks(2,4,6 weeks). After 2 weeks, Injinoryung-San groups significantly decreased GGT in comparison with control groups(p<0.05). After 4 weeks, Injinoryung-San groups significantly decreased MCV, GGT in comparison with control groups(p<0,05). After 6 weeks, Injinoryung-San groups significantly decreased MCV in comparison with control groups(p<0.05). Reviewing these experimental results, it appears that extracts of Injinoryung-San have pharmaceutical efficacy in GGT, MCV on liver injury patients induced by alcohol. But it has not efficacy in AST, ALT. According to drinking alcohol has becomes social problems, we should effort to make efficacious oriental medicines on alcoholic hepatitis.

A CONTROL OF PLAQUE, GINGIVITIS AND ANTI-CARIES EFFECT OF DENTIFRICE CONTAINING HORSERADISH EXTRACTS (서양산 고추냉이 추출물이 함유된 세치제의 효능에 대한 임상적 실험연구)

  • Seo, Hyun-Woo;Park, Ho-Won;Kim, Jong-Soo;Lee, Si-Young;Shin, Il-Shik
    • Journal of the korean academy of Pediatric Dentistry
    • /
    • v.39 no.1
    • /
    • pp.26-33
    • /
    • 2012
  • The purpose of this study was to find out the effect of dentifrice containing Horseradish (Armoracia rustica) root extracts on improvement of oral hygiene. The clinical evaluation was done participated by 80 adults volunteers who provided a informed consent for their participation. The participants were divided into two groups ; control group (using toothpaste without Horseradish extracts) and experimental group (using toothpaste containing Horseradish extracts). The checklist of the experiment includes the plaque index, gingival index and anti-caries activity. The anti-caries activity was measured by cultivating Streptococcus mutans for 48 hours then estimating the number of increased bacteria using Dentocult SM. The double-blind method was used in this study. The results of this study can be summarized as follows; 1. The plaque formation decreased 28% in control group, 58% in experimental group using dentifrice with Horseradish extracts compared to baseline data. 2. For gingival index, control group and experimental group showed 26% and 40% decrease compared to baseline data, respectively. 3. The score of caries activity test decreased by 4% for control group and 69% for experimental group compared to baseline data. According to the results, a dentifrice containing Horseradish extracts can improve oral hygiene.

A Study on Efficacy of Preemptive Analgesia - A Comparison on Efficacy of Preoperative and Postoperative Analgesic Administration - (선행적 진통 요법의 효과성에 대한 연구 -발치 전과 후 진통 요법의 효과 비교-)

  • Jung, Young-Soo;Kim, Moon-Key;Park, Hyung-Sik;Lee, Eui-Wung;Kang, Jeong-Wan
    • Journal of The Korean Dental Society of Anesthesiology
    • /
    • v.3 no.1 s.4
    • /
    • pp.10-18
    • /
    • 2003
  • Background: Studies on the pain have been dealing with many different ways for last several centuries. Especially, preemptive analgesia is being used as a method to control the postoperative pain. Many studies on its efficacy have been processed in different ways about various drugs, administration methods and times for various operations. And the value of preemptive analgesia are still controversial regarding the results of other clinical studies. The authors performed a clinical study on efficacy of preemptive analgesia using an non-steroidal anti-inflammatory drug (NSAID) for the surgical extraction of impacted third molar teeth and present the more effective pain treatment after oral surgery with literature review. Methods: Using a randomized double blind test design, this study compared the analgesic efficacies of an NSAID, Talniflumate 370 mg. This drug administrated first either 1 hour preoperatively (experimental group) or when the pain developed moderately to severely over 5 scale of verbal rating scales (0-10) to respective 30 patients undergoing the removal of impacted third molars. Pain intensity and the time from the end of surgery were assessed postoperatively whenever the patients demanded additional drug over 5 scale for forty eight hours using same verbal rating scales. Results: The sex distribution, the age of the patients. and the time required for surgery in two groups were similar. The average first time for demanding additional drug after surgery was 163.9 minutes in experimental group and 191.5 minutes in control group. At this time, the average pain intensity was 5.8 in experimental group and 6.1 in control group. And the average second time for demanding additional drug was 365.5 minutes in experimental group and 351.8 minutes in control group. At this time. the average pain intensities were 6.6 in experimental group and 6.2 in control group. No statistically significant difference was found between the average first times and second times, and the average pain intensities at first and second times in two groups. Conclusions: From these results the efficacy of preemptive analgesia used in this study was not appeared. This clinical study indicates that many NSAIDs administrated preoperatively in present practices have weak efficacy of preemptive analgesia for postoperative pain, thus the authors recommend that only postoperative analgesics are adequate without preoperative use of analgesics.

  • PDF

Role of the Baseline Heart Rate Variability to the Effect of the Huanglian-Jie-Du Granule in Hwa-Byung Patients: Supplementary Analysis from the Randomized Trial Comparing Huanglian-Jie-Du Granule and Placebo for Hwa-Byung (화병 환자의 심박변이도 차이에 따른 황련해독탕의 효과: 화병에 대한 무작위 대조 비교임상시험 결과의 추가 분석)

  • Choi, Yu-Jin;Cho, Seung-Hun
    • Stress
    • /
    • v.26 no.4
    • /
    • pp.305-311
    • /
    • 2018
  • Background: The purpose of the study was to explore whether the effect of Huanglian-jie-du granule depends on the baseline heart rate variability in patients with Hwa-byung. Methods: We used the supplementary data from a randomized, double-blind, placebo-controlled trial of Huanglian-jie-du granule for Hwa-byung patients. Study drugs were taken orally three times per day for one week. Heart rate variability was measured three times; before the treatment, after the treatment, and month follow-up period. Spearman's rho test was done to explore the role of the baseline heart rate variability to the effect of Huanglian-jie-du granule. Results: Baseline low frequency power of heart rate variability was negatively correlated with the reduction of the insomnia severity index in experimental group (r=-0.493 p=0.02). Also, Huanglian-jie-de granule significantly decreased the low frequency power of heart rate variability in patients with Hwa-byung compared to placebo (mean difference 266 [95% CI: 29~503], p=0.028). In Hwa-byung symptoms, stuffy, pushing up in the chest, and flush of anger were correlated with low frequency power of heart rate variability (p=0.010, p=0.000, and p=0.016, respectively). Conclusions: The effect of the Huanglian-jie-de granule for insomnia seems to be lower when the baseline low frequency power of heart rate variability is higher in Hwa-byung patients. Also, Huanglian-jie-de granule is likely to decrease the sympathetic activity in patients with Hwa-byung. Measurement of heart rate variability may be the useful to understand the state of Hwa-byung patients.

Ginsenoside Rg1 supplementation clears senescence-associated β-galactosidase in exercising human skeletal muscle

  • Wu, Jinfu;Saovieng, Suchada;Cheng, I-Shiung;Liu, Tiemin;Hong, Shangyu;Lin, Chang-Yu;Su, I-Chen;Huang, Chih-Yang;Kuo, Chia-Hua
    • Journal of Ginseng Research
    • /
    • v.43 no.4
    • /
    • pp.580-588
    • /
    • 2019
  • Background: Ginsenoside Rg1 has been shown to clear senescence-associated beta-galactosidase (SA-${\beta}$-gal) in cultured cells. It remains unknown whether Rg1 can influence SA-${\beta}$-gal in exercising human skeletal muscle. Methods: To examine SA-${\beta}$-gal change, 12 young men (age $21{\pm}0.2years$) were enrolled in a randomized double-blind placebo controlled crossover study, under two occasions: placebo (PLA) and Rg1 (5 mg) supplementations 1 h prior to a high-intensity cycling (70% $VO_{2max}$). Muscle samples were collected by multiple biopsies before and after cycling exercise (0 h and 3 h). To avoid potential effect of muscle biopsy on performance assessment, cycling time to exhaustion test (80% $VO_{2max}$) was conducted on another 12 participants (age $23{\pm}0.5years$) with the same experimental design. Results: No changes of SA-${\beta}$-gal were observed after cycling in the PLA trial. On the contrary, nine of the 12 participants showed complete elimination of SA-${\beta}$-gal in exercised muscle after cycling in the Rg1 trial (p < 0.05). Increases in apoptotic DNA fragmentation (PLA: +87% vs. Rg1: +133%, p < 0.05) and $CD68^+$ (PLA:+78% vs. Rg1:+121%, p = 0.17) occurred immediately after cycling in both trials. During the 3-h recovery, reverses in apoptotic nuclei content (PLA:+5% vs. Rg1 -32%, p < 0.01) and increases in inducible nitrate oxide synthase and interleukin 6 mRNA levels of exercised muscle were observed only in the Rg1 trial (p < 0.01). Conclusion: Rg1 supplementation effectively eliminates senescent cells in exercising human skeletal muscle and improves high-intensity endurance performance.

Development of a smart cane concept for guiding the visually impaired - focused on design thinking learning practices for students - (시각장애인을 위한 길 안내용 스마트 지팡이 콘셉트 개발)

  • Park, Hae Rim;Lee, Min Sun;Yang, Ho Jung
    • Journal of Service Research and Studies
    • /
    • v.13 no.1
    • /
    • pp.186-200
    • /
    • 2023
  • This study aims to improve the usability of the white cane, which is walking equipment that most local visually impaired people use and carry when going out, and to contribute to the prevention of safety accidents and the walking rights of visually impaired people by providing improvement and resolution measures for the problems identified. Also, this study is a study on the visually impaired, primarily targeting the 1st to 2nd degree visually impaired people, who cannot go out on their own without walking equipment such as a white cane, corresponding to 20% among approximately 250,000 blind and low vision people in the Korean population. In the study process, the concept has been developed from the user's point of view in order that the white cane becomes a real help in the walking step of the visually impaired and the improvement of usability of the white cane, the main walking equipment for the visually impaired, are done by problem identification through the Double Diamond Model of Design Thinking (Empathize → Define → Ideate → Prototype → Test (verify)). As a result of the investigation in the process of Empathy, a total of five issues was synthesized, including an increase in the proportion of the visually impaired people, an insufficient workforce situation to help all the visually impaired, an improvement and advancement of assistive devices essential for the visually impaired, problems of damage, illegal occupation, demolition, maintenance about braille blocks, making braille block paradigms for the visually impaired and for everyone. In Ideate and Prototype steps, situations derived from brainstorming were grouped and the relationship were made through the KJ method, and specific situations and major causes were organized to establish the direction of the concept. The derived solutions and major functions are defined in four categories, and representative situations requiring solutions and major functions are organized into two user scenarios. Ideas were visualized by arranging the virtual Persona and Customer Journey Map according to the situation and producing a prototype through 3D modeling. Finally, in the evaluation, the final concept derived is a device such a smart cane for guidance for the visually impaired as ① a smart cane emphasizing portability + ② compatibility with other electronic devices + ③ a product with safety and convenience.