• Title/Summary/Keyword: Placebo-controlled study

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Oral food challenges in children

  • Yum, Hye-Yung;Yang, Hyeon-Jong;Kim, Kyung-Won;Song, Tae-Won;Kim, Woo-Kyung;Kim, Jung-Hee;Ahn, Kang-Mo;Kim, Hyun-Hee;Lee, Soo-Young;Pyun, Bok-Yang
    • Clinical and Experimental Pediatrics
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    • v.54 no.1
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    • pp.6-10
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    • 2011
  • Many patients assume that allergic reactions against foods are responsible for triggering or worsening their allergic symptoms. Therefore, it is important to identify patients who would benefit from an elimination diet, while avoiding unnecessary dietary restrictions. The diagnosis of food allergy depends on the thorough review of the patients's medical history, results of supplemented trials of dietary elimination, and in vivo and in vitro tests for measuring specific IgE levels. However, in some cases the reliability of such procedures is suboptimal. Oral food challenges are procedures employed for making an accurate diagnosis of immediate and occasionally delayed adverse reactions to foods. The timing and type of the challenge, preparation of patients, foods to be tested, and dosing schedule should be determined on the basis of the patient's history, age, and experience. Although double-blind, placebo-controlled food challenges(DBPCFC) are used to establish definitively if a food is the cause of adverse reactions, they are time-consuming, expensive and troublesome for physician and patients. In practice, An open challenge controlled by trained personnel is sufficient especially in infants and young children. The interpretation of the results and follow-up after a challenge are also important. Since theses challenges are relatively safe and informative, controlled oral food challenges could become the measure of choice in children.

Platycodi radix beverage ameliorates postprandial lipemia response through lipid clearance of triglyceride-rich lipoprotein: A randomized controlled study in healthy subjects with a high-fat load

  • Lee, Hansol;Lim, Yeni;Park, Soo-yeon;Cho, Soo-Muk;Choe, Jeong-Sook;Jeong, Sewon;Kwak, Jin Sook;Kwon, Oran
    • Nutrition Research and Practice
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    • v.12 no.5
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    • pp.371-377
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    • 2018
  • BACKGROUND/OBJECTIVES: Elevation of postprandial lipemia characterized by a rise in triglyceride (TG)-rich lipoproteins can increase the risk of atherogenesis. The objective of this study was to investigate postprandial lipemia response to a single dietary fat/sugar load test and monitor beneficial changes induced by the consumption of Platycodi radix (AP) beverage in healthy subjects. SUBJECTS/METHODS: A total of 52 subjects were randomly assigned to either placebo or AP beverage group with a high-fat shake in a randomized controlled crossover trial. Postprandial blood was collected at 0, 1, 2, 4, and 6 h and analyzed for TG and lipoprotein lipase mass. Inhibition of pancreatic lipase was determined in vitro. RESULTS: AP inhibited pancreatic lipase activity in vitro ($IC_{50}=5mg/mL$). Compared to placebo beverage, AP beverage consumption with a high-fat shake induced significant increase of plasma lipoprotein lipase mass (P = 0.0111, ${\beta}$ estimate = 4.2948) with significant reduction in very low-density lipoprotein (VLDL) TG concentration (P = 0.038, ${\beta}$ estimate = -52.69) at 6 h. Based on significant correlation between high-fat dietary scores MEDFICTS and postprandial TG responses in VLDL (P = 0.0395, r = 0.2127), subgroup analysis revealed that 6 h-postprandial VLDL TG response was significantly decreased by AP consumption in subjects with MEDFICTS ${\geq}40$ (P = 0.0291, ${\beta}$ estimate = -7214). CONCLUSIONS: AP beverage might have potential to alleviate postprandial lipemia through inhibiting pancreatic lipase activity and elevating lipoprotein lipase mass. Subgroup analysis revealed that subjects with high-fat dietary pattern could be classified as responders to AP beverage among all subjects.

Effects of Extracts from the Mushroom Keumsa Sangwhang (Phellinus linteus) on Fasting Blood Glucose and Cholesterol Levels in Human (금사상황버섯 추출물 복용이 공복혈당 및 혈중지질농도에 미치는 효과)

  • Kim, Yong-Dae;Kim, Nam-Sik;Eom, Sang-Yong;Kim, Sung-Hoon;Kang, Jong-Won;Lee, Sang-Won;Park, Soon-Young;Kim, Jeong-Su;Kim, Heon;Hong, Jang-Soo
    • Journal of the Korean Society of Food Culture
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    • v.23 no.1
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    • pp.68-72
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    • 2008
  • This study demonstrated the effects of extracts from the mushroom Keumsa sangwhang(Phellinus linteus) (KPLE) on fasting glucose and cholesterol levels in human blood. In this double-blind, placebo-controlled human intervention study, healthy volunteers were randomized to receive 3.3 g of KPLE (n=31) or placebo (n=31) per day by oral administration for 8 weeks. The cholesterol and fasting serum glucose levels were evaluated before and after treatment. The fasting serum glucose level was significantly decreased by KPLE administration (p<0.01), but the total cholesterol, triglyceride, HDLcholesterol and LDL-cholesterol concentrations did not change. This study suggests a possibility that KPLE may be useful as a functional food for the prevention of diabetes mellitus.

Effect of Ephedra Sinica and Evodia Rutaecarpa on Resting Metabolic Rate in Obese Premenopausal Women during Low-calorie Diet: A Randomized Controlled Clinical Trial (저열량 식이요법을 한 폐경 전 비만 여성의 휴식 대사량에 대한 마황과 오수유의 효과)

  • Kim, Su-Jin;Ko, Byung-Pyo;Kim, Hyung-Do;Kim, Jin-Ah;Park, Jeong-Mi;Choi, Seung-Ki;Jeon, Uoo-Hyun;Kim, Ho-Jun
    • Journal of Korean Medicine for Obesity Research
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    • v.4 no.1
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    • pp.45-54
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    • 2004
  • Objective: To evaluate the effect of Ephedra Sinica and Evodia Rutaecarpa on resting metabolic rate(RMR), weight and body composition in obese women during low-calorie diet. Methods: We recruited 90 healthy premenopausal women$(body\;mass\;index{\geq}25kg/m^2)$ and randomly assigned to three groups(ephedra group, evodia group and placebo group). Subjects were administered Ephedra Sinica(6g twice a day) or Evodia Rutaecarpa(6g twice a day) or placebo in a double-blind fashion and participated in low-calorie diet for 8 weeks. Resting metabolic rate and body composition were measured at baseline, 4 and 8 weeks. Results: RMR change for 4 weeks was significantly higher in the ephedra group compared with the placebo group(p<.05). But the change for 8 weeks was not significant and the Evodia group showed no significant RMR change. Weight and percent body fat changes for 4 weeks and 8 weeks were significantly higher than the placebo group in the ephedra group(p<.05), but the Evodia group didn't show significant level. Conclusions: This study supports and emphasizes the benefits of herbal medicine in maintaining or increasing RMR during low-calorie diet. Especially Ephedra treatment was effective on significant maintainment of RMR, loss of weight and percent body fat(P<.05).

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The Effect of Dextranase-Containing Mouthwash in Human Experimental Gingivitis (실험적 치은염에서 dextranase 함유 구강 세정액의 양치 효과)

  • Son, Eun-Ju;Kim, Young-Jun;Kim, Do-Man;Chung, Hyun-Ju
    • Journal of Periodontal and Implant Science
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    • v.31 no.2
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    • pp.401-420
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    • 2001
  • A novel glucanhydrolase from a mutant of Lipomyces starkeyi(KSM 22)has been shown effective in hydrolysis of mutan, reduction of mutan formation by Streptococcus mutans and removal pre-formed sucrose-dependent adherent microbial film and Lipomyces starkeyi KSM 22 dextranase has been strongly bound to hydroxyapatitie. These in vitro properties of Lipomyces starkeyi KSM 22 dextranase are desirable for its application as a dental plaque control agent. This study was performed to determine oral hygiene benefits and safety of dextranase(Lipomyces starkeyi KSM 22 dextranase)-containing mouthwash in human experimental gingivitis. This 3-week clinical trial was placebo-controlled double-blind design evaluating 1U/ml dextranase mouthwash and 0.12% chlorhexidine mouthwash. A total 39 systemically healthy subjects, who had moderate levels of plaque and gingivitis were included. At baseline, 1, 2 and 3 weeks, subjects were scored for plaque(Silness and $L{\ddot{o}e$ plaque index and plaque severity index), gingivitis($L{\ddot{o}e$ and Silness gingival index), and at baseline and 3 weeks of experiment, subjects were scored for plaque(Turesky-Quingley-Hein's plaque index and plaque severity index), tooth stain(Area and severity index system by Lang et al). Additionally, oral mucosal examinations were performed and subjects questioned for adverse symptoms. Two weeks after pre-experiment examinations and a professional prophylaxis, the subjects provided with allocated mousewash and instructed to use 20-ml volumes for 30s twice dailywithout toothbrushing. All the groups showed significant increase in plaque accumulation since 1 week of experiment. During 3 weeks' period, the dextranase group showed the least increase in plaque accumulation of Silness and $L{\ddot{o}e$ plaque index, compared to the chlorhexidine and placebo groups, but chlorhexidine group showed the least increase inplaque accumulation of Turesky-Quingley-Hein's plaque index. As for gingival inflammation, all the groups showed significant increase during 3 weeks of experiment. The dextranase group also showed the least increase in gingival index score, compared to the chlorhexidine as well as the placebo groups. Whereas the tooth stain was increased significantly in the chlorhexidine group, compared to the baseline score and the placebo group since 3 weeks of mouthrinsing. It was significantly increased after 3 weeks in the dextranase group, still less severe than the chlorhexidine group. As for the oral side effect, the dextranase group showed less tongue accumulation, bad taste, compared to the chlorhexidine group. From these results, mouthrinsing with Lipomyces starkeyi KSM 22 dextranase was comparable to 0.12% chlorhexidine mouthwashin inhibition of plaque accumulation and gingival inflammation and local side effects were if anything less frequent and less intense than chlorhexidine, in human experimental gingivitis. All data had provided positive evidence for Lipomyces starkeyi KSM 22 dextranase as an antiplaque agent and suggested that further development of dextranase formulations for plaque control are warranted.

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Immediate effects of kinesio taping on muscle fatigue of quadriceps on muscle strength and balance ability (넙다리네갈래근 근 피로 유발 후 키네시오 테이핑 적용이 근력과 균형에 미치는 즉각적 효과)

  • Kim, Dong Hoon;Kim, Kyung Hun
    • Journal of Korean Physical Therapy Science
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    • v.27 no.1
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    • pp.43-50
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    • 2020
  • Background: This study was to investigate the immediate effects of kinesio taping (KT) of quadriceps on muscle strengthening and balance ability. Design: Randomized controlled trial and conducted as a single-blind. Methods: Twenty-four subjects participated in this study. They were randomly allocated two groups: kinesio taping group (KT group, n=12), placebo kinesio taping group (PKT group, n=12). The participants were tested with lower extremity muscle strengthening and balance ability pre-post intervention. Results: After training, the change values of the lower extremity muscle strengthening and balance ability in the KT group were significantly greater than the PKT group (p<0.05). Conclusion: The results indicated that kinesio taping were effective the promoting the lower extremity muscle strengthening and balance ability.

Dose- and Time-Related Effects of Pilocarpine Mouthwash on Salivation

  • Song, Je-Il;Park, Jo-Eun;Kim, Hye-Kyoung;Kim, Mee-Eun;Kim, Ki-Suk
    • Journal of Oral Medicine and Pain
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    • v.42 no.3
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    • pp.72-80
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    • 2017
  • Purpose: Pilocarpine as a salivation stimulant in pill form has mostly been used to relieve oral dryness for xerostomic patients but its use may often be limited due to variable side effects from systemic absorption. Therefore, the purpose of this study was to investigate the effects of pilocarpine mouthwash on salivation according to the variable concentration and duration for healthy volunteers. Related adverse effects and subjective assessment on its effects on salivation were also examined. Methods: This study was performed as placebo-controlled, double-blind, randomized clinical trial. Thirty healthy volunteers (male=23, mean age=22.2 years) were randomly allocated to 6 groups with the different concentration of pilocarpine mouthwash (placebo, 0.1%, 0.5%, 1.0%, 1.5%, and 2.0%). The whole experiment consisted of 3 sessions according to the duration of mouthwash, i.e., 1, 3, and 5 minutes with the mean wash-out period ${\geq}2$ days between the sessions. Unstimulated whole saliva was collected before and after gargling with a mouthwash. Results: Salivation of the higher concentration groups ${\geq}1%$ significantly increased than those of lower concentration group. The application period of mouthwash did not cause any changes of salivary flow rate at the higher concentrations ${\geq}1.0%$. The lower concentrations of 0.5% and 0.1% had no effects on salivation even after 5-minute mouthwash. There was no significant difference between blood pressure and pulse rate before and after use of mouthwash. Conclusions: From the results of the current study, pilocarpine mouthwash with at least 1.0% concentration more than a minute might be clinically effective in salivation without any serious side effects. Dose of mouthwash rather than duration seems to be a critical factor to salivation.

Effects of Mahuang for Weight Loss in Healthy Adults : A Double-Blind, Controlled, Randomized, Clinical Trial (마황복용이 성인의 체중감소에 미치는 영향에 대한 이중맹검 임상연구)

  • Yeo, Jin-Ju;Hsing, Li-Chang;Yang, Chang-Sub;Jeong, Seung-Il;Seo, Eui-Seok;Jang, In-Soo
    • The Journal of Korean Medicine
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    • v.28 no.1 s.69
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    • pp.63-71
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    • 2007
  • Objectives : To provide an objective assessment of the effectiveness for weight loss of Mahuang. Methods : Effects were assessed by measuring changes in body weight, body mass index (BMI), body fat (kg, %),body muscle, and abdominal f3t ratio. The subjects of this study were healthy adults who agreed to participate in this study. Eligibility requirements include age between 20 and 50 and BMI more than 18.5 kg/m2. One hundred subjects were randomly assigned to two groups (control and Mahuang group) in a double-blind manner. Mahuang group subjects took 8g of Mahuang capsule/day for two weeks; control subjects took the same amount of indistinguishable placebo. We analyzed the body weight, body mass index, body fat, abdominal fat, body muscle and BMR (basal metabolic rate) before and after the study. Result After two weeks of clinical trial, body weight and BMI decreased in both groups, but the Mahuang group showed more significant decrease. On body fat, the Mahuang group showed significant decrease. while it increased in the placebo group. Although body muscle, body fat ratio and basic metabolic rate showed differences between the two groups, there was no statistical significance. Conclusion : It is suggested that intake of Mahuang may induce weight loss and body f3f decrease in healthy adults.

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Does transcutaneous electrical nerve stimulation affect pain, neuropathic pain, and sympathetic skin responses in the treatment of chronic low back pain? A randomized, placebo-controlled study

  • Yaksi, Elif;Ketenci, Aysegul;Baslo, Mehmet Baris;Orhan, Elif Kocasoy
    • The Korean Journal of Pain
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    • v.34 no.2
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    • pp.217-228
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    • 2021
  • Background: The purpose of this study was to assess the effectiveness of transcutaneous electrical nerve stimulation (TENS) in chronic low back pain and neuropathic pain. Methods: Seventy-four patients aged 18-65 with chronic low back pain were included in the study. Baseline measurements were performed, and patients were randomized into three groups. The first group received burst TENS (bTENS), the second group conventional TENS (cTENS), and the third group placebo TENS (pTENS), all over 15 sessions. Patients' visual analogue scale (VAS) scores were evaluated before treatment (preT), immediately after treatment (postT), and in the third month after treatment (postT3). Douleur Neuropathique 4 Questions (DN4), the Modified Oswestry Low Back Pain Disability Questionnaire (MOS), the Beck Depression Inventory (BDI), and sympathetic skin response (SSR) values were also evaluated preT and postT3. Results: A statistically significant improvement was observed in mean VAS scores postT compared to preT in all three groups. Intergroup comparison revealed a significant difference between preT and postT values, that difference being assessed in favor of bTENS at multiple comparison analysis. Although significant improvement was determined in neuropathic pain DN4 scores measured at postT3 compared to preT in all groups, there was no significant difference between the groups. No statistically significant difference was also observed between the groups in terms of MOS, BDI, or SSR values at postT3 (P > 0.05). Conclusions: bTENS therapy in patients with low back pain is an effective and safe method that can be employed in short-term pain control.

Effect of Onion Extracts on Serum Cholesterol in Borderline Hypercholesterolemic Participants (양파추출물 섭취가 경계역 고콜레스테롤혈증 대상자의 콜레스테롤 저하에 미치는 효과)

  • Lee, Hyun-Jin;Lee, Kyung-Hea;Park, Eun-Ju;Chung, Hye-Kyung
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.39 no.12
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    • pp.1783-1789
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    • 2010
  • The aim of this study was to examine the effects of 10 week onion extract supplementation on blood lipid profiles in borderline hypercholesterolemic participants. The study consisted of 10 males and 17 females aged $45.9{\pm}10.0$ years. At baseline, serum total cholesterol level was $228.6{\pm}4.1$ mg/dL (201~239 mg/dL). This study was designed as randomized single blind placebo controlled cross-over study. After 1 week wash-out period, subjects were randomized into two groups; they took onion extract (150 mL/1 pack, containing 30 mg quercetin) or placebo for 10 weeks. After 1 week wash-out period again, subjects took exchanged samples for another 10 weeks. The total-cholesterol ($226.7{\pm}4.6{\rightarrow}206.8{\pm}3.6$ mg/dL; p<0.01), LDL-cholesterol ($151.6{\pm}5.0{\rightarrow}127.1{\pm}4.1$ mg/dL; p<0.01) and atherogenic index (AI: $4.0{\pm}0.3{\rightarrow}3.4{\pm}0.2$; p<0.05) decreased significantly after 10 weeks of onion extracts supplementation, while there were no significant changes during placebo periods. The levels of HDL-cholesterol (onion extract: $46.5{\pm}2.0{\rightarrow}50.2{\pm}2.1$ mg/dL, placebo: $47.8{\pm}2.1{\rightarrow}50.1{\pm}2.4$ mg/dL), GOT (onion extract: $36.8{\pm}1.8{\rightarrow}32.3{\pm}1.8$ IU/L, placebo: $35.1{\pm}2.1{\rightarrow}32.8{\pm}2.0$ IU/L), and GPT (onion extract: $36.5{\pm}3.2{\rightarrow}32.9{\pm}1.8$ IU/L, placebo: $36.6{\pm}3.8{\rightarrow}33.8{\pm}2.8$ IU/L) showed no significant changes in both periods. These results indicate that the consumption of onion concentrated extracts exerts beneficial effects on dyslipidemia through the decrease of serum total cholesterol and LDL cholesterol levels in borderline hypercholestrolemic subjects. In conclusion, onion was useful as dietary therapy for hypercholestrolemia and adequate onion intake may help to prevent cardiovascular disease.