• Title/Summary/Keyword: Placebo-controlled study

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The Effect of Carrot Juice, ${\beta}$-carotene Supplementation on Plasma Antioxidant Status of Korean Smokers (당근즙 및 ${\beta}$-Carotene의 섭취가 흡연자의 혈장 항산화 영양 상태에 미치는 영향)

  • Lee, Hye-Jin;Park, Yoo-Kyoung;Kang, Myung-Hee
    • Journal of Nutrition and Health
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    • v.42 no.8
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    • pp.750-758
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    • 2009
  • Smoking is associated with an increased incidence of numerous cancers and other degenerative diseases. It has been suggested that high consumption of fruits and vegetables may give some protection. Especially carrot is the most important source of dietary ${\beta}$-carotene. Therefore, the objective of this study is to investigate whether carrot juice supplementation to smokers have different or superior effect of compared to the effect supplementing purified ${\beta}$-carotene. The study was conducted in a randomized and placebo-controlled design, after a depletion period of 14 days, 48 smokers were supplemented either carrot juice (n = 18), purified ${\beta}$-carotene (n = 16) or placebo (n = 14). Each group was supplemented for 8 weeks with approximately 20.49 mg of ${\beta}$-carotene/day and 1.2 mg of vitamin C/day, as carrot juice (300 mL/day) or purified ${\beta}$-carotene (1 capsule/day). Plasma vitamin C, vitamin E and ${\beta}$-carotene level were significantly increased after carrot juice and ${\beta}$-carotene supplementation. These results suggest that carrot juice containing ${\beta}$-carotene or ${\beta}$-carotene itself have similar antioxidative potentials by increasing the antioxidant potential in smokers. Therefore, we suggest moderate dose of vitamin supplementation (amount of two servings of vegetable intake) may help to replenish the decreased oxidative stress levels in smokers.

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
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    • v.5 no.1
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    • pp.8-13
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    • 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.

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Effect of Pretreatment with Lactobacillus delbrueckii and Streptococcus thermophillus on Tailored Triple Therapy for Helicobacter pylori Eradication: A Prospective Randomized Controlled Clinical Trial

  • Tongtawee, Taweesak;Dechsukhum, Chavaboon;Leeanansaksiri, Wilairat;Kaewpitoon, Soraya;Kaewpitoon, Natthawut;Loyd, Ryan A;Matrakool, Likit;Panpimanmas, Sukij
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.12
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    • pp.4885-4890
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    • 2015
  • Background: Helicobacter pylori plays an important role in gastric cancer and typical eradication regimens are no longer effective in many countries, including Thailand. The aim of our study was to compare the effect of Lactobacillus delbrueckii and Streptococcus thermophillus on tailored triple therapy for Helicobacter pylori eradication. Materials and Methods: This prospective single-center study was conducted in Thailand. Helicobacter pylori associated gastritis patients were randomized to 2 groups: group 1 (n=100) was tailored triple therapy with placebo (esomeprazole 20 mg bid, clarithromycin 500 mg bid or metronidazole 400 mg tid if clarithromycin resistance and amoxicillin 1000 mg bid), and group 2 was tailored triple therapy plus pretreatment with probiotic containing yogurt. Successful eradication was defined as both negative histology and negative rapid urease test at four weeks after treatment. Results: A total of 200 infected patients were enrolled. PP analysis involved 194 patients: 96 in the tailored triple therapy with placebo group (group 1) and 98 the in tailored triple therapy plus pretreatment with probiotic containing yogurt group (group 2). Successful eradication was observed in 170 (87.6%) patients; by PP analysis, the eradication rate was significantly higher in group 2 (P = 0.04, 95%CI; 0.02-0.13) than in group 1. ITT analysis also showed that the value was significantly higher in the tailored triple threapy plus pretreatment with probiotic containing yogurt group (group 2) (89/100; 89%) than in the tailored triple therapy with placebo group (group 1) (P= 0.01, 95%CI; 0.04-0.15). In terms of adverse events, there was no significant difference between the two groups. Conclusions: Pretreatment with probiotic containing yogurt can improve Helicobacter pylori eradication rates with tailored triple therapy. Adding probiotics does not reduce adverse effects of the medication.

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
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    • v.26 no.4
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    • pp.305-311
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    • 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.

The Review on the Evidence-Based Study of Acupuncture - Systematic review and Meta-analysis - (침(鍼)의 근거중심적(根據中心的) 연구동향(硏究動向)에 관(關)한 고찰(考察) - Systematic review & Meta-analysis를 중심으로 -)

  • Back, Yong-Hyeon;Park, Dong-Seok;Kang, Sung-Keel
    • Journal of Acupuncture Research
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    • v.19 no.3
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    • pp.138-155
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    • 2002
  • Objective : The purpose of this study is to work on the problems and on the direction of the study regarding the evidence-based study of Acupuncture. Methods : We reviewed the PubMed electronic database. Eight articles of systematic review without meta-analysis and six articles without meta-analysis were selected. Results : In the study of eight articles of systematic review without meta-analysis, there were two articles on effectiveness of acupuncture and one on non-effectiveness of acupuncture. Four articles were about the changes according to the quality of randomized controlled trials. Also, one article was about the side-effect of acupuncture. In the study of six articles of systematic review with meta-analysis, there were two articles on Odds Ratio, two on Relative Risk, one on number-needed-to-treat, and two on 18 predefined methodological criteria. Conclusion : As the quality of RCTs was high, positive response decreased and as the quality of RCTs was low, positive response increased. For the study of evidence-based acupuncture, it is necessary that we conduct research on well-planned placebo acupuncture, large sample size, statistical method, method of searching and assessing literature and method of meta-analysis.

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Role of dexmedetomidine as adjuvant in postoperative sciatic popliteal and adductor canal analgesia in trauma patients: a randomized controlled trial

  • Ahuja, Vanita;Thapa, Deepak;Chander, Anjuman;Gombar, Satinder;Gupta, Ravi;Gupta, Sandeep
    • The Korean Journal of Pain
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    • v.33 no.2
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    • pp.166-175
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    • 2020
  • Background: The effect of dexmedetomidine as an adjuvant in the adductor canal block (ACB) and sciatic popliteal block (SPB) on the postoperative tramadol-sparing effect following spinal anesthesia has not been evaluated. Methods: In this randomized, placebo-controlled study, ninety patients undergoing below knee trauma surgery were randomized to either the control group, using ropivacaine in the ACB + SPB; the block Dex group, using dexmedetomidine + ropivacaine in the ACB + SPB; or the systemic Dex group, using ropivacaine in the ACB + SPB + intravenous dexmedetomidine. The primary outcome was a comparison of postoperative cumulative tramadol patient-controlled analgesia (PCA) consumption at 48 hours. Secondary outcomes included time to first PCA bolus, pain score, neurological assessment, sedation score, and adverse effects at 0, 5, 10, 15, and 60 minutes, as well as 4, 6, 12, 18, 24, 30, 36, 42, and 48 hours after the block. Results: The mean ± standard deviation of cumulative tramadol consumption at 48 hours was 64.83 ± 51.17 mg in the control group and 41.33 ± 38.57 mg in the block Dex group (P = 0.008), using Mann-Whitney U-test. Time to first tramadol PCA bolus was earlier in the control group versus the block Dex group (P = 0.04). Other secondary outcomes were comparable. Conclusions: Postoperative tramadol consumption was reduced at 48 hours in patients receiving perineural or systemic dexmedetomidine with ACB and SPB in below knee trauma surgery.

Study of the Efficacy and Safety of "adenophorae radix extract" in the Obese Patients or Overweight (비만 및 과체중 환자에 대한 사삼추출물의 유효성 및 안전성 평가)

  • Kim, Gi-Tae;Go, Heung;Shin, Seon-Mi;Kim, Hyung-Jun
    • The Journal of Korean Obstetrics and Gynecology
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    • v.25 no.2
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    • pp.131-141
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    • 2012
  • Objectives: The purpose of this study is to evaluate the efficacy and biosafety of Adenophorae Radix(AR) extract in obesity or overweight patient. Methods: This study is double-blind, randomized, placebo-controlled intervention Study. 30 patients with BMI $25{\leq}$ and 30> were allotted into two groups at random. In 0, $6^{th}$, $12^{th}$ week, we had checked body weight, waist line, hip line, body fat and abdominal CT scan. In 0, $12^{th}$ week, we also had checked lipid metabolism and biosafety with blood test. Results: AR treatment had a significant effect on suppressing body wight gain (p<0.01) and BMI index(p<0.01). AR treatment reduced plasma TG level but we couldn't find statistical significance. AR treatment had produced no adverse reactions. Conclusions: This study shows that Adenophorae Radix(AR) extract can reduce the weight, BMI. Adenophorae Radix(AR) extract can be used in obesity or overweight patient.

Clinical Efficacy of herbal medicine for Chemo-Radiotherapy-induced oral mucositis

  • SongWon Park;MinJee Kim;Seong-Woo Lim
    • The Journal of Korean Medicine
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    • v.43 no.4
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    • pp.89-101
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    • 2022
  • Objectives: The purpose of this systematic review was to evaluate the effects of herbal medicine on Chemo-Radiotherapy-induced oral mucositis. Methods: Electronic databases were used to search for studies published through 10 years until October 2022, and a randomized controlled study was conducted to evaluate efficacy of herbal medicine on chemo-radiotherapy-induced oral mucositis. Study quality was assessed using the Cochran's risk bias tool. Results: Two-hundred and three articles were initially searched, and 11 studies (head and neck cancer, breast cancer, colorectal cancer, esophageal cancer etc. undergoing radio-chemotherapy were included in analysis. The effect of herbal medicine on chemo-radiotherapy-induced oral mucositis, 9 studies reported that herbal medicine was more effective than the placebo group or conventional treatment. One study reported that the effect of the herbal compound treatment group was similar to that of the conventional herbal medicine, and one study reported that there was no difference in effect between the two herbal medicines and the group without treatment. Conclusion: This study suggests that herbal medicine effectively relieves the symptoms of chemo-radiotherapy-induced oral mucositis. However, there is limited evidence that herbal medicine may relief chemo-radiotherapy-induced oral mucositis, so further investigation is needed.

Systematic Review and Meta-Analysis on Herbal Medicine for Generalized Anxiety Disorder: Focusing on Clinical Studies over the Past 5 Years (범불안장애의 한약 치료에 관한 체계적 문헌고찰 및 메타분석: 최근 5년 임상연구를 중심으로)

  • Min-Jae Kim;Hyun-Seob Park;Chan-Young Kwon
    • Journal of Oriental Neuropsychiatry
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    • v.34 no.4
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    • pp.403-420
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    • 2023
  • Objectives: This study investigated the effectiveness of herbal medicine for generalized anxiety disorder (GAD) based on recent clinical studies. Methods: Studies were searched through four databases. Clinical research studies on herbal medicine treatment for GAD patients were included. The studies were analyzed according to study design, diagnostic criteria, population, and intervention. A risk of bias assessment was performed to assess the quality of the included randomized controlled trials (RCT). If the intervention applied to the treatment and control groups was the same and two or more studies were reporting the same items as outcome indicators, a meta-analysis was performed. Results: A total of 19 studies, including 12 RCTs were selected. The most common pattern identification was 'Phlegm fire disturbing upward' (痰熱上擾), and the most used herb for therapeutic purposes was 'Rhizome of Poria cocos' (茯苓). Meta-analysis results of three studies showed that there were no significant differences in effectiveness between the herbal medicine intervention and the Western medicine intervention. Meta-analysis results of five studies showed that the Hamilton Anxiety Rating Scale was significantly reduced in the case of herbal medicine intervention compared to Western medicine intervention. Conclusions: The results of our study demonstrated that herbal medicine treatment for GAD is effective in alleviating anxiety symptoms and chief symptoms of GAD. However, this study has several limitations; there was a lack of placebo-controlled RCT and an absence of objective diagnostic criteria in case reports. Therefore, further well-designed clinical studies, conducted based on the results of this study, are recommended.

The Effect of Alpha-tocopherol Supplementation on the Improvement of Antioxidant Status and Lymphocyte DNA Damage in Postmenopausal Women (비타민 E 보충섭취가 폐경기 여성의 혈장 항산화 영양상태 및 DNA 손상 개선에 미치는 영향)

  • Kim, Chang-Suk;Kang, Hae-Jin;Lee, Soon-Hee;Park, Yoo-Kyoung;Kang, Myung-Hee
    • Journal of Nutrition and Health
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    • v.40 no.8
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    • pp.708-718
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    • 2007
  • The purpose of this project was to evaluate whether vitamin E supplementation could improve the antioxidant status and lymphocyte DNA damage in Korean postmenopausal women. This was double blinded, placebo-controlled trial. Thirty-five subject were randomized to receive either placebo 400 mg/capsule or natural $\alpha$-tocopherol 400 IU/capsule, 2 times a day for 6 weeks. We measured plasma vitamin C, $\alpha$-tocopherol, $\gamma$-tocopherol, $\alpha$-carotenoid, $\beta$-carotenoid, lycopene concentration and tail length, %DNA in tail, tail moment in lymphocyte DNA damage index. Vitamin E supplementation group had significantly increased plasma vitamin C(p<0.05), $\alpha$-tocopherol(p<0.000), whereas $\gamma$-tocopherol(p<0.000) and tail length(p<0.05) were significantly decreased. However, placebo supplementation group also had significantly increased plasma vitamin C(p<0.05). In conclusion, our study shows that vitamin E supplementation to Korean postmenopausal women may partially improve antioxidant status and lymphocyte DNA damage.