• Title/Summary/Keyword: Placebo

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Effects of Interpretive Signs on Users' Perceived Environmental Restorativeness and Overall Healing Effectiveness: An Application of Placebo (치유의 숲길 해설판이 이용객의 회복환경 및 전반적 치유효과 지각에 미치는 효과: 플라시보 효과의 적용)

  • Kim, Sang-Mi;Choi, Sol-ah;Kim, Sang-Oh
    • Korean Journal of Environment and Ecology
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    • v.30 no.6
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    • pp.1057-1066
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    • 2016
  • This study examined how 'forest name' or 'information of forest healing effectiveness' influence their perceived environmental restorativeness (PER) and perceived healing effectiveness (PHE). Study area was the 'Forest Healing Road (FHR)' in Mudeungsan National Park. Data were collected from 247 visitors selected by convenient sampling method using questionnaire survey during May-June, 2015. Respondents who read interpretive signs (forest name and information on forest healing effectiveness of FHR were written) installed along the FHR were regarded as placebo group and respondents who didn't read them as control group. The results showed that there were no overall differences on PER and PHE between control and placebo groups. Placebo group, however, rated more positive on 'being away' factor of PER than control group. All four factors (i.e., being away, coherence, fascination, comparability) of PER statistically influenced PHE (p<0.001), and these factors explained 51.1% of PHE. The 'coherence' was the most influential to PHE, followed by 'being away', 'comparability', and 'fascination' in order. Placebo effects on PER were shown in male, in lower age group(age${\leq}54$), or respondents with lower visiting experience to FHR(${\leq}20$ times/year). Placebo effects on PHE were found in male, in small group (${\leq}2$ persons), in respondents who visited 'alone' or 'with relatives/family', or in respondents with lower visiting experience to FHR(${\leq}20$ times/year). Some research and managerial implications were suggested.

Ursodeoxycholic Acid in the Prevention of Pediatric Parenteral Nutrition-associated Cholestasis (소아 총정맥영양의 간담도계 합병증에 대한 Ursodeoxycholic acid의 예방효과에 대한 연구)

  • Kim, Ji Hee;Min, Myung Sook;In, Yong Won;Shon, Kie Ho;Choi, Kyung Eob;Choe, Yon Ho;Beck, Nam Sun;Lee, Suk Hyang;Park, Tae Sung
    • Korean Journal of Clinical Pharmacy
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    • v.15 no.1
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    • pp.9-20
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    • 2005
  • Cholestatic liver disease is a frequent complication of prolonged parenteral nutrition, especially in premature infants. Numerous factors have been cited as contributing to TPN associated cholestasis. However the exact etiology remains obscure. Ursodeoxycholic acid (UDCA) has been reported to be beneficial far children and adults with various chronic cholestatic liver disease. The aim of this prospective, randomized, double-blind, placebo-controlled study was to determine the preventive effects of UDCA administration during TPN. Seventeen pediatric patients (8 boys and 9 girls) undergoing TPN were assigned randomly to two groups, UDCA and placebo group. UDCA group (n=9) received 15 mg/kg/day UDCA and placebo group (n=8) received 15 mg/kg/day placebo enterally during the TPN period. Liver function tests (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase) were per-formed before TPN and weekly or three times a week. The patients' weights, complete blood count, composition of TPN, and the infusion rate of TPN and lipid were monitored everyday. Calcium and phosphate were monitored twice a week. Between the UDCA and placebo groups, there were no differences in weight at the onset of TPN, birth weight, duration of TPN, respiratory distress syndrome associated with prematurity, age at the onset of TPN, gestational age, the number of days the patients received antibiotics, the number of patients received enteral nutritions and the composition of TPN. In contrast, there was a significant difference between the UDCA and placebo groups in alanine aminotransferase levels during TPN. It doesn't seem that UDCA administration during TPN correlates directly with improvement of liver function. But the preventive administration of UDCA may be effective in reducing liver enzyme, alanine aminotransferase and has no adverse effects.

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Effects of Conjugated Linoleic Acid on Body Fat Reduction and Physical Exercise Enhancement of Obese Male Middle School Students (Conjugated linoleic acid의 비만 남자중학생 체지방 감소와 운동력 증진효과)

  • Ha, Yeong-L.;Jeong, So-Bong
    • Journal of Life Science
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    • v.20 no.12
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    • pp.1844-1850
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    • 2010
  • Body fat reducing and physical-activity enhancing effects, along with artherosclerosis improving effects, of conjugated linoleic acid (CLA) were elucidated on obese male middle school students with more than 30% body fat. Twenty-four volunteers were randomly divided into control (placebo, n=12) and CLA treatment (n=12) groups. Subjects were daily fed 6 g CLA (6 capsules, twice a day) or a placebo for 12 weeks. At the end of the experiment, body composition, blood lipid composition and exercise capacities of subjects were measured. CLA significantly reduced body fat content and body mass index (BMI) along with body weight, while the placebo did not have any such effects. Similarly, CLA significantly reduced low-density lipoprotein (LDL)-cholesterol, total cholesterol, and triglyceride, but elevated high-density lipoprotein (HDL)-cholesterol content in blood. Meanwhile, in terms of exercise capacity, there were significant enhancements of trunk flexion, closed-eyes foot balance, standing long jump, shuttle run, and sit-up activities in the CLA treatment group. These results indicate that CLA consumption reduced body fats, improved atherosclerosis factors in blood and improved physical activity of young male obese middle school students, and suggest that CLA could be a useful material for the heath care of obese young men.

Agrobacterium sp.-derived β-1,3-glucan enhances natural killer cell activity in healthy adults: a randomized, double-blind, placebo-controlled, parallel-group study

  • Lee, Yeon Joo;Paik, Doo-Jin;Kwon, Dae Young;Yang, Hye Jeong;Park, Yongsoon
    • Nutrition Research and Practice
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    • v.11 no.1
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    • pp.43-50
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    • 2017
  • BACKGROUND/OBJECTIVES: The present study investigated the hypothesis that a highly pure linear ${\beta}$-1,3-glucan produced by Agrobacterium sp. R259 enhances human natural killer (NK) cell activity and suppresses pro-inflammatory cytokines. SUBJECTS/METHODS: In an eight-week, double-blind, randomized, placebo-controlled clinical trial, 83 healthy adults with white blood cell counts of $4,000-8,000cells/{\mu}L$ were participated and randomly assigned to take two capsules per day containing either 350 mg ${\beta}$-1,3-glucan or placebo. Six participants withdrew their study consent or were excluded due to NK cell activity levels outside the normal range. NK cell activity and serum levels of immunoglobulin G (IgG) and cytokines, such as interferon (IFN)-${\gamma}$, interleukin (IL)-2, IL-4, IL-6, IL-10, IL-12 and tumor necrosis factor (TNF)-${\alpha}$ were measured. RESULTS: NK cell activity and the serum levels of IL-10 were significantly higher from baseline to week 8 in the ${\beta}$-glucan group compared with the placebo group (P = 0.048, P = 0.029). Consumption of ${\beta}$-1,3-glucan also significantly increased NK cell activity compared with placebo after adjusting for smoking and stress status (P = 0.009). In particular, the effect of ${\beta}$-1,3-glucan on NK cell activity was greater in participants with severe stress than in those experiencing mild stress. However, the administration ${\beta}$-1,3-glucan did not significantly modulate the levels of IFN-${\gamma}$, IL-2, IL-4, IL-6, IL-12, TNF-${\alpha}$ and IgG compared with the placebo. CONCLUSION: The results showed that supplementation with bacterial ${\beta}$-1,3-glucan significantly increased NK cell activity without causing any adverse effects. Additionally, the beneficial effect of ${\beta}$-1,3-glucan on NK cell activity was greater in participants experiencing severe stress.

Effect of Beta Glucan on White Blood Cell Counts and Serum Levels of IL-4 and IL-12 in Women with Breast Cancer Undergoing Chemotherapy: A Randomized Double-Blind Placebo-Controlled Clinical Trial

  • Ostadrahimi, Alireza;Ziaei, Jamal Eivazi;Esfahani, Ali;Jafarabadi, Mohammad Asghari;Movassaghpourakbari, Aliakbar;Farrin, Nazila
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.14
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    • pp.5733-5739
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    • 2014
  • Background: Breast cancer is the most common female malignancy in the world. Beta glucan can be a hematopoietic and an immune modulator agent in cancer patients. The aim of this trial was to determine the effect of beta glucan on white blood cell counts and serum levels of IL-4 and IL-12 in women with breast cancer undergoing chemotherapy. Materials and Methods: This randomized double-blind placebo-controlled clinical trial was conducted on 30 women with breast carcinoma aged 28-65 years. The eligible participants were randomly assigned to intervention (n=15) or placebo (n=15) groups using a block randomization procedure with matching based on age, course of chemotherapy and menopause status. Patients in the intervention group received two 10-mg capsules of soluble 1-3, 1-6, D-beta glucan daily and the control group receiving placebo during 21 days, the interval between two courses of chemotherapy. White blood cells, neuthrophil, lymphocyte and monocyte counts as well as serum levels of IL-4 and IL-12 were measured at baseline and at the end of the study as primary outcomes of the study. Results: In both groups white blood cell counts decreased after 21 days of the intervention, however in the beta glucan group, WBC was less decreased non significantly than the placebo group. At the end of the study, the change in the serum level of IL-4 in the beta glucan group in comparison with the placebo group was statistically significant (p=0.001). The serum level of IL-12 in the beta glucan group statistically increased (p=0.03) and comparison between two groups at the end of the study was significant after adjusting for baseline values and covariates (p=0.007). Conclusions: The findings suggest that beta glucan can be useful as a complementary or adjuvant therapy and immunomodulary agent in breast cancer patients in combination with cancer therapies, but further studies are needed for confirmation.

APPLICATION OF 0.2% HYALURONIC ACID GEL IN ORAL SURGICAL WOUND : A RANDOMIZED DOUBLE-BLIND STUDY (구강내 외과적 창상 치유에서 0.2% hyaluronic acid gel의 유효성에 대한 이중 맹검 연구)

  • Kim, Jae-Yoon;Lee, Jin-Yong;Bae, Kwang-Hak;Lee, Jong-Ho
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.34 no.2
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    • pp.157-165
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    • 2008
  • The aim of this study was to evaluate the efficacy of a topical 0.2% hyaluronic acid (HA) preparation in the management of wound after removal of arch bar for facial bone fracture and a suture site after orthognatic, oral cancer or oral surgery. Forty patients participated in a randomized, placebo controlled, double-blind trial to evaluate the efficacy of the topical HA and preparation. HA topically applied to the wound after removal of arch bar or stitch out, 3 times a day for 4 weeks. Evaluation is performed once a week for 4 weeks. For subjective evaluation, relative pain reduction in visual analog scale (VAS) and existence of heat sensation was accessed. For objective evaluation, gross evaluation, papilla index, existence of wound dehiscence, redness and swelling was checked. The same evaluation was performed in each arch bar group and suture group. For whole subject, 0.2% HA group resulted higher reduction than placebo group in pain of site in first week with significancy. Same findings were seen other weeks but there was no significancy. 0.2% HA group had better result than placebo in objective evaluation (papilla index, wound dehiscence, redness and swelling), but in gross evaluation placebo had better result than 0.2% HA group with no significancy. Subject was divided into suture group and arch bar group. Same aspect was seen, but only suture group had significancy not arch bar group in pain reduction score. 0.2% HA group resulted higher reduction than placebo group in pain of site in first week with significancy, especially in suture group. It reveals topical application of HA in wound especially suture site reduced pain in early stage. And 0.2% HA group had better result than placebo in papilla index, redness and swelling with no statistical significancy. In conclusion, HA has effect of pain reduction and healing promotion in the mucosal wound after oral surgery.

Effects of Loratadine, Cetirizine, and Terfenadine on Histamine-Induced Wheal and Erythema Responses in Normal Canine Skin (개 피부에서 Histamine에 의한 팽진과 발적에 대한 loratadine, cetirizine과 terfenadine의 억제효과)

  • Jeong, A-Young;Jeong, Hyo-Hoon;Heo, Woo-Phil;Eom, Ki-Dong;Jang, Kawng-Ho;Oh, Tae-Ho
    • Journal of Veterinary Clinics
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    • v.19 no.2
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    • pp.186-190
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    • 2002
  • This crossover study was performed in order to compare the effects of cetirizine, loratadine, and terfenadine in canine skin. Five healthy dogs were used. Cetirizine 0.5 mg/kg, loratadine 5 mg/kg and terfenadine 5 mg/kg were administered orally 4 hours before the experiment. Erythema indices and wheal size were assessed by Hexameter ($MX^{\circledR}$ 18, CK, Germany) and skin reaction guide, respectively. Cetirizine-induced erythema inhibition was generally higher than other drugs and was significantly different from placebo. Cetirizine was superior to placebo at 3, 4, 5, 6, 7, and 8 minutes (p< 0.01). Cetirizine also was superior to placebo at 9 minutes (p< 0.05). Loratadine and terfenadine erythema inhibition were better than after placebo treatment from 4 to 9 minutes, but erythema index of terfenadine at 7 minutes was not observed probability of 95% and 99%. At 10 minutes, intradermal injection of the histamine caused a mean wheal dimension for placebo, cetirizine, loratadine and terfenadine, which were 13.25$\pm$0.75 mm,7.5$\pm$ 1.02 mm (53% reduction, p<0.007),6.2$\pm$0.58 mm(43% reduction, p <0.01), and 8.4 $\pm$0.67 mm(37% reduction, p< 0.05), respectively, comparing with placebo. Loratadine and cetirizine were good antihistamines for clinical therapy for atopic dermatitis in dog.

Evaluation of the Efficacy of Methylprednisolone, Etoricoxib and a Combination of the Two Substances to Attenuate Postoperative Pain and PONV in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective, Randomized, Placebo-controlled Trial

  • Gautam, Sujeet;Agarwal, Amita;Das, Pravin Kumar;Agarwal, Anil;Kumar, Sanjay;Khuba, Sandeep
    • The Korean Journal of Pain
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    • v.27 no.3
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    • pp.278-284
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    • 2014
  • Background: Establishment of laparoscopic cholecystectomy as an outpatient procedure has accentuated the clinical importance of reducing early postoperative pain, as well as postoperative nausea and vomiting (PONV). We therefore planned to evaluate the role of a multimodal approach in attenuating these problems. Methods: One hundred and twenty adult patients of ASA physical status I and II and undergoing elective laparoscopic cholecystectomy were included in this prospective, randomized, placebo-controlled study. Patients were divided into four groups of 30 each to receive methylprednisolone 125 mg intravenously or etoricoxib 120 mg orally or a combination of methylprednisolone 125 mg intravenously and etoricoxib 120 mg orally or a placebo 1 hr prior to surgery. Patients were observed for postoperative pain, fentanyl consumption, PONV, fatigue and sedation, and respiratory depression. Results were analyzed by the ANOVA, a Chi square test, the Mann Whitney U test and by Fisher's exact test. P values of less than 0.05 were considered to be significant. Results: Postoperative pain and fentanyl consumption were significantly reduced by methylprednisolone, etoricoxib and their combination when compared with placebo (P<0.05). The methylprednisolone + etoricoxib combination caused a significant reduction in postoperative pain and fentanyl consumption as compared to methylprednisolone or etoricoxib alone (P<0.05); however, there was no significant difference between the methylprednisolone and etoricoxib groups (P>0.05). The methylprednisolone and methylprednisolone + etoricoxib combination significantly reduced the incidence and severity of PONV and fatigue as well as the total number of patients requiring an antiemetic treatment compared to the placebo and etoricoxib (P<0.05). Conclusions: A preoperative single-dose administration of a combination of methylprednisolone and etoricoxib reduces postoperative pain along with fentanyl consumption, PONV, antiemetic requirements and fatigue more effectively than methylprednisolone or etoricoxib alone or a placebo.

A randomized, double-blind, placebo-controlled pilot study to assess the effects of protopanaxadiol saponin-enriched ginseng extract and pectinase-processed ginseng extract on the prevention of acute respiratory illness in healthy people

  • Hwang, Jeong-Hwan;Park, Soo-Hyun;Choi, Eun-Kyung;Jung, Su-Jin;Pyo, Mi Kyung;Chae, Soo-Wan
    • Journal of Ginseng Research
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    • v.44 no.5
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    • pp.697-703
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    • 2020
  • Background: GS-3K8 and GINST, both of which are modified ginseng extracts, have never been examined in terms of their effectiveness for the prevention of acute respiratory illness (ARI) in humans. We conducted a pilot study to assess the feasibility of performing a large-scale, randomized, controlled trial. Methods: This study was a randomized, double-blind, placebo-controlled, pilot study at a single center from October 2014 to March 2015. The 45 healthy applicants were randomly divided into the GS-3K8 (n = 15), GINST (n = 15), and placebo groups (n = 15). The study drug was administered as a capsule (500 mg/cap and 3000 mg/day). GS-3K8 contained 6.31 mg/g of Rg1, 15.05 mg/g of Re, 30.84 mg/g of Rb1, 15.02 mg/g of Rc, 12.44 mg/g of Rb2, 6.97 mg/g of Rd, 1.59 mg/g of Rg3, 3.25 mg/g of Rk1, and 4.84 mg/g of Rg5. GINST contained 7.54 mg/g of Rg1, 1.87 mg/g of Re, 5.42 mg/g of Rb1, 0.29 mg/g of Rc, 0.36 mg/g of Rb2, 0.70 mg/g of Rd, and 6.3 mg/g of compound K. The feasibility criteria were the rates of recruitment, drug compliance, and successful follow-up. The primary clinical outcome measure was the incidence of ARI. The secondary clinical outcome measures were the duration of symptoms. Results: The rate of recruitment was 11.3 participants per week. The overall rate of completed follow-up was 97.8%. The mean compliance rate was 91.64 ± 9.80%, 95.28 ± 5.75%, and 89.70 ± 8.99% in the GS-3K8, GINST, and placebo groups, respectively. The incidence of ARI was 64.3% (9/14; 95% confidence interval [CI], 31.4-91.1%), 26.7% (4/15; 95% CI, 4.3-49.0%), and 80.0% (12/15; 95% CI, 54.8-93.0%) in the GS-3K8, GINST, and placebo groups, respectively. The average days of symptoms were 3.89 ± 4.65, 9.25 ± 7.63, and 12.25 ± 12.69 in the GS-3K8, GINST, and placebo groups, respectively. Conclusion: The results support the feasibility of a full-scale trial. GS-3K8 and GINST appear to have a positive tendency toward preventing the development of ARI and reducing the symptom duration. A randomized controlled trial is needed to confirm these findings.

Pain Control Effects of $Myprodol^{(R)}$ after Periodontal Surgery and Dental Implant Surgery (치주 수술 및 인공 치아 매식술 후 $Myprodol^{(R)}$의 동통 억제 효과에 대한 연구)

  • Cho, Kyoo-Sung;Lee, Jung-Hoon;Kim, Hyun-Young;Suh, Jong-Gin;Choi, Seong-Ho;Chai, Jung-Kiu;Kim, Chong-Kwan
    • Journal of Periodontal and Implant Science
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    • v.30 no.1
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    • pp.1-11
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    • 2000
  • Although various analgesics have been administrated for postoperative pain control, postoperative pain has not been adequately controlled . The purpose of this study was to evaluate the effects and patient's satisfaction of $Myprodol^{(R)}$(combination analgesics with codeine, ibuprofen, paracetamol) compared to Acetamionphen and placebo drug after periodontal surgery and dental implant surgery. We studied 98 cases of outpatients which were composed of 67 cases of flap operation(which separated to 3 groups: Placebo group(n=25), $Myprodol^{(R)}$ group(n=22), Acetaminophen group(n=20)) and 21 cases of dental implant surgery(which separated to 3 groups : Placebo group(n=10), $Myprodol^{(R)}$ group(n=12), Acetaminophen group(n=9)). We evaluated the postoperative pain(Pain 1), Pain after first drug administraion(Pain 2), the degrees of pain reduction(pain 3), patient's satisfaction for drug, and side-effects. We obtained following results; 1. In Pain 1, making a comparison among groups, there was no significant difference in both cases of flap operation-group and dental implant surgery-group 2. In Pain 2, establishing a comparison among groups, there was no significant difference in flap operation-group, but significant difference was seen between placebo group and $Myprodol^{(R)}$ group in cases of dental implant surgery group(P<0.05). 3. In Pain 3, making a comparison among groups, $Myprodol^{(R)}$ group showed significant differences compared to placebo group and Acetaminophen group in both cases of flap operation group and dental implant surgery group(P<0.05). 4. In patient's satisfactory score, making a comparison among groups, there were significant differences between placebo group and $Myprodol^{(R)}$ group in cases of flap operation group and between $Myprodol^{(R)}$ group and Acetaminophen group in cases of dental implant surgery group(P<0.05). 5. Making a comparison in side-dffect, no significant differrence was seen. Our conclusion is that $Myprodol^{(R)}$ is a effective oral analgesics to the patients who underwent periodontal surgery or implant surgery for it's synergism among three dugs.

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