• 제목/요약/키워드: Placebo-controlled study

검색결과 358건 처리시간 0.021초

암성통증에 대한 SBVP 효과 - 무작위대조시험, 이중맹검 (The Effect of Sweet Bee Venom Pharmacopuncture(SBVP) on Cancer-Related Pain : A Randomized Controlled Trial and Double Blinded - Pilot study)

  • 유화승;김정선
    • 대한약침학회지
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    • 제11권1호
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    • pp.21-29
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    • 2008
  • Objectives : To investigate the therapeutic effects of SBVP in the treatment of patients with cancer-related pain. Design : A prospective randomized, double-blind, placebo-controlled study of SBVP. Setting : The study was conducted at the East West Cancer Center of Daejeon University Dunsan Oriental Hospital from March 1, 2007 to June 20, 2007. Patients : 11 patients diagnosed with cancer-related pain of over 3rd degree on the Numeric Rating Scale(NRS)(0, no pain at all, 10, worst pain imaginable) were entered into a double-blind, placebo-controlled trial of SBVP. They were randomized into Groups A and B(SBVP and control group, respectively) using the table of random sampling numbers and never informed of their affiliation by the coordinator. 5 of 6 patients in Group A and 4 of 5 patients in Group B completed the clinical trial. Intervention : SBVP(1ml/day) for group A and Normal Saline Placebo(1ml/day) for group B was injected into the abdomen acupoint, Zhong Wan(CV 12). The treatment was administered daily for five days. Outcome Measures : Degree of cancer-related pain was measured using the Numeric Rating Scale(NRS) before and after each treatment for "Pain right now" and "Average pain in last 24 hours". Statistical Analysis : Analysis regarding variations in NRS was carried out by applying t-tests(independent sample t-test and paired sample t-test) and Wilcoxon signed rank test with level of significance at 5%. Results : Differences in NRS of "Pain right now" for the two groups were statistically significant. The mean improvement point of SBVP was significantly higher than the control group($2.48^{\circ}{\pm}1.52$ vs $0.97^{\circ}{\pm}1.88$, p<0.05). Differences in average pain score before and after treatment in SBVP group were also significant($5.13^{\circ}{\pm}1.77$ vs $2.65^{\circ}{\pm}0.67$, p<0.05) compared with control group. The two groups showed no significant differences for long term effects in "Average pain in last 24 hours." Conclusion : Although further study will be needed on the large scale, SBVP shows potential as an effective treatment for immediate relief of cancer-related pain.

공복 혈당장애 및 내당능장애자에서 홍국의 섭취가 혈중지질 및 혈당 조절에 미치는 영향 (The Effect of Red-Yeast-Rice Supplement on Serum Lipid Profile and Glucose Control in Subjects with Impaired Fasting Glucose or Impaired Glucose Tolerance)

  • 강미란;김지영;현예정;김혜진;여현양;송영득;이종호
    • Journal of Nutrition and Health
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    • 제41권1호
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    • pp.31-40
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    • 2008
  • 내당능 장애와 공복혈당장애는 장차 당뇨병으로 진행되거나 심혈관 질환을 일으키는 위험인자로 간주되어 적절한 혈당 및 혈중지질수치의 조절이 필요하다. 홍국의 기능성분인 모나콜린-K는 stalin계열 약물의 주원료로서 이미 지질 강하제로 잘 알려져 있다. 홍국의 지질 강하제 이외의 다른 효과로서 동물 자체 효력 시험과 문헌 고찰을 통해 혈당 강하 효과가 보고되고 있으므로 이중 맹검, 무작위배정, 위약 대조 인체시험을 통하여 홍국의 혈중 지질 및 혈당 개선에 대한 효능을 확인하는 목적으로 본 연구를 실시하였다. $18{\sim}80$세 사이의 남녀를 대상으로, 스크리닝 시 공복혈당이 110 mg/dl이상 126 mg/dl 이하인 공복 혈당 장애이거나 경구 당 부하 검사 2시간 후 혈당이 140 mg/dl 이상 199 mg/dl 이하인 내당능 장애자이거나 당화혈색소 수치가 6% 이상 7% 이하인 자로서 심각한 합병증이 없는 사람을 대상으로 하였으며, 홍국 저용량군 21명, 고용량군 23명, 위약군 20명으로 총 64명을 대상으로 12주간 검사에 대한 결과분석을 실시하였다. 1차 유효성 지표로 혈중 지질관련 지표인 중성지방, 총 콜레스테롤, LDL 콜레스테롤, HDL 콜레스테롤, Atherogenic index (AI)를 측정하였으며, 2차 유효성 지표로 혈당 지표인 공복 혈당, 경구 당부하 검사 2시간 혈당치, 당화혈색소, 인슐린, MOHAIR, 유리지방산을 측정하였다. 시험군에서 홍국제제 섭취 전후로 중성지방, 총 콜레스테롤, LDL 콜레스테롤, HDL콜레스테롤 수치가 유의적으로 개선되었으며 동맥경화지수도 유의적으로 향상되었다. 홍국 고용량군의 총 콜레스테롤, HDL 콜레스테롤과 LDL 콜레스테롤 및 동맥경화지수 개선 정도는 위약군의 변화량과 비교하여 유의적으로 개선되는 것으로 나타났고, 저용량군의 경우에도 LDL 콜레스테롤과 동맥경화지수 개선 정도가 위약군의 변화량과 비교하여 유의적으로 개선되었다. 홍국의 섭취가 혈당조절에 미치는 영향은 모든 시험군에서 제제 섭취 12주 후 공복혈당이 감소하였고, 시험군이 위약군에 비해 더욱 감소하였으나 통계적으로는 유의하지 않았다. 주평가지표인 공복혈당을 기준으로 공복혈당 110mg/dl 이상인 피험자만을 대상으로 당대사 관련 지표를 분석한 결과, 홍국 고용량군에서 공복혈당의 감소경향이 관찰되었고, 홍국 저용량군에서는 당화혈색소의 유의적인 감소효과를 확인하였으나 위약군의 변화량과 비교하여 유의적이지 않았다. 공복혈당 장애자 또는 내당능 장애자에서 하루 홍국 분말 2.52 g (저용량군) 또는 5.04 g (고용량군)을 포함한 건강기능식품을 12주간 섭취시킨 결과 혈중 지질 농도와 동맥경화 지수의 개선으로 심혈관 질환의 위험도를 낮출 수 있을 것으로 보이며, 고용량군일 경우 더 효과적일 것으로 사료된다.

김치유산균 Lactobacillus plantarum CJLP55 섭취가 성인 남녀의 피부 산도 및 관련 구성 인자의 변화에 미치는 영향 (Dietary effect of Lactobacillus plantarum CJLP55 isolated from kimchi on skin pH and its related biomarker levels in adult subjects)

  • 한상신;신지혜;임선희;안희윤;김봉준;조윤희
    • 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.

Effects of Copper Reduction on Angiogenesis-Related Factors in Recurrent Glioblastoma Cases

  • Jazayeri, Shima;Feli, Alireza;Bitaraf, Mohammad Ali;Dodaran, Masoud Solaymani;Alikhani, Mazdak;Hosseinzadeh-Attar, Mohammad Javad
    • Asian Pacific Journal of Cancer Prevention
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    • 제17권10호
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    • pp.4609-4614
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    • 2016
  • Purpose: To evaluate the therapeutic effects of copper reduction on angiogenesis-related factors in patients with glioblastoma multiforme treated by gamma knife radiosurgery. Materials and Methods: In the present block randomized, placebo-controlled trial, fifty eligible patients with a diagnosis of glioblastoma multiforme who were candidates for gamma knife radiosurgery were randomly assigned into two groups to receive daily either 1gr penicillamine and a low copper diet or placebo for three months. The intervention started on the same day as gamma knife radiosurgery. Serum interleukin-6 (IL-6), tumor necrosis $factor-{\alpha}$ ($TNF-{\alpha}$), vascular endothelial growth factor (VEGF) and copper levels were measured at baseline and after the intervention. The serum copper level was used as the final index of compliance with the diet. In order to control probable side effects of intervention, laboratory tests were conducted at the beginning, middle and end of the study. Results: The patients had a mean age and Karnofsky Performance Scale of 43.7 years and 75 respectively. Mean serum copper levels were significantly reduced in intervention group. Mean survival time was 18.5 months in intervention group vs. 14.9 in placebo group. VEGF and IL-6 levels in the intervention group were also significantly reduced compared to the placebo group and $TNF-{\alpha}$ increased less. Conclusions: It seems that reducing the level of copper in the diet and dosing with penicillamine leads to decline of angiogenesis-related factors such as VEGF, IL-6 and $TNF-{\alpha}$. Approaches targeting angiogenesis may improve survival and can be used as a future therapeutic strategy.

Efficacy of Korean Red Ginseng by Single Nucleotide Polymorphism in Obese Women: Randomized, Double-blind, Placebo-controlled Trial

  • Kwon, Dong-Hyun;Bose, Shambhunath;Song, Mi-Young;Lee, Myeong-Jong;Lim, Chi-Yeon;Kwon, Bum-Sun;Kim, Ho-Jun
    • Journal of Ginseng Research
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    • 제36권2호
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    • pp.176-189
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    • 2012
  • This study examined the effects of Korean red ginseng (KRG) on obese women and aimed to confirm that the effects of KRG on obesity differ dependently on a gene. Fifty obese women were recruited and randomized to receive KRG (n=24) or placebo (n=26) for 8 wk. Measurements of blood pressure, height, weight, waist circumference, waist-hip ratio (WHR), total fat mass, percentage of body fat, resting metabolic rate, basal body temperature, and daily food intake (FI), blood test (serum lipid, liver and renal function), Korean version of obesity-related quality of life scale (KOQOL), and a gene examination were performed. Comparisons of subjects before and after the administration of KRG revealed significant improvements of obesity in terms of weight, body mass index (BMI), WHR, FI, and KOQOL. However, in the comparison between KRG group and placebo group, only KOQOL was significantly different. KRG displayed significant efficacy on BMI and KOQOL in the CT genotype of the G protein beta 3 gene, but not in the CC genotype, on blood sugar test in the Trp64/Arg genotype of the beta 3 adrenergic receptor gene, but not in Trp64/Trp genotype, on KOQOL in the DD genotype of the angiotensin I converting enzyme gene, but not in the ID and DD genotypes. The effects of KRG on obesity were confirmed to some extent. However, a distinct effect compared to placebo was not confirmed. KRG is more effective for improving the secondary issues of the quality of life derived from obesity rather than having direct effects on the obesity-related anthropometric assessment and blood test indices.

Balance trainer training with transcutaneous electrical nerve stimulation improves spasticity and balance in persons with chronic stroke

  • Yang, Youjin;Lee, Jungeun;Choi, Wonjae;Joo, Younglan;Lee, Seungwon
    • Physical Therapy Rehabilitation Science
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    • 제9권2호
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    • pp.67-73
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    • 2020
  • Objective: The purpose of this study was determine the effect of Balance Trainer training with Transcutaneous Electrical Nerve Stimulation (TENS) on spasticity and balance in persons with chronic stroke. Design: Randomized controlled trial. Methods: A total of 30 subjects with hemiparetic stroke were recruited and randomly divided into the Balance Trainer training with TENS group (n=15) and Balance Trainer training with placebo TENS group (n=15). The Balance Trainer training with TENS group practiced additional Balance Trainer training with TENS for 30 minutes a day, 5 days per a week during 4 weeks and the Balance Trainer training with placebo TENS group practiced additional Balance Trainer training with placebo TENS for the same period. Spasticity and balance were assessed by ability (static balance, dynamic balance) and were measured before and after the 4-week programs. Results: The result of spasticity and dynamic balance were improved significantly in both groups (p<0.05). The Balance Trainer training with TENS group showed significantly greater improvement in spasticity of the gastrocnemius & dynamic balance, compared to the Balance Trainer training with placebo TENS group (p<0.05). The Balance trainer training with TENS group showed a significant improvement in static balance, especially during the eye-closed condition (p<0.05). Conclusions: The Balance Trainer training with TENS was effective in improving spasticity and balance in subjects with chronic stroke. Based on these results, it is suggested that Balance Trainer training with TENS could clinically be used more actively in conjunction with conventional physical therapy.

Lactobacillus reuteri DSM 17938 Improves Feeding Intolerance in Preterm Infants

  • Kaban, Risma K.;Wardhana, Wardhana;Hegar, Badriul;Rohsiswatmo, Rinawati;Handryastuti, Setyo;Amelia, Novie;Muktiarti, Dina;Indrio, Flavia;Vandenplas, Yvan
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • 제22권6호
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    • pp.545-553
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    • 2019
  • Purpose: Feeding tolerance is extremely important in preterm infants. This study aimed to evaluate whether preterm infants receiving Lactobacillus reuteri DSM 17938 would develop fewer symptoms of feeding intolerance. Secondary outcomes were duration of parenteral nutrition, time to reach full feeding, length of hospital stay, sepsis, necrotizing enterocolitis (NEC), diarrhea, and mortality. Methods: This double-blind randomized controlled trial of L. reuteri DSM 17938 versus placebo included 94 neonates with a gestational age of 28-34 weeks and birth weight of 1,000-1,800 g. Results: Feeding intolerance (vomiting and/or distension) was less common in the probiotic group than in the placebo group (8.5% vs. 25.5%; relative risk, 0.33; 95% confidence interval, 0.12-0.96; p=0.03). No significant intergroup differences were found in proven sepsis, time to reach full feeding, length of hospital stay, or diarrhea. The prevalence of NEC (stages 2 and 3) was 6.4% in the placebo group vs. 0% in the probiotic group (relative risk, 1.07; 95% confidence interval, 0.99-1.15; p=0.24). Mortality rates were 2.1% in the probiotic group and 8.5% in the placebo group, p=0.36). Conclusion: The administration of L. reuteri DSM 17938 to preterm infants was safe and significantly reduced feeding intolerance. No significant differences were found in any other secondary outcomes.

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

  • 김재윤;이진용;배광학;이종호
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • 제34권2호
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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.

Localized probiotic-guided pocket recolonization in the treatment of chronic periodontitis: a randomized controlled clinical trial

  • Kumar, Vikram;Singhal, Rameshwari;Rastogi, Pavitra;Lal, Nand;Pandey, Shivani;Mahdi, Abbas Ali
    • Journal of Periodontal and Implant Science
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    • 제51권3호
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    • pp.199-212
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    • 2021
  • Purpose: This randomized clinical placebo-controlled trial was conducted to evaluate the effectiveness of Lactobacillus reuteri as a probiotic in guided pocket recolonization (GPR) for the treatment of chronic periodontitis (CP) adjunctive to scaling and root planing (SRP). Methods: Forty-eight CP patients were randomly assigned to 3 treatment groups: group 1 (SRP+placebo), group 2 (SRP+single application of probiotic), and group 3 (SRP+incremental application of probiotic). Clinical parameters were evaluated at baseline and at 8, 12, and 24 weeks, whereas biochemical parameters were measured at baseline and 12 weeks. Results: At 24 weeks, the probing pocket depth and clinical attachment level improved in all 3 groups from baseline with no significant intergroup differences; however, a statistically significant difference was observed in localized plaque and gingival scores between groups 1 and 3 (P<0.05). At 12 weeks, matrix metalloproteinase-8 (MMP-8), nitric oxide (NO), and gingipains-R (Rgps) levels improved in all 3 groups, with statistically significant differences between groups 1 and 3 for MMP-8 and NO (P<0.05), but no difference for Rgps levels. Conclusions: Within its limitations, the results of this study show that incremental 3-time application of L. reuteri as a probiotic led to improvements in clinical and biochemical parameters. This protocol can be a useful adjunct to SRP in the non-surgical management of CP.

Intrathecal Meperidine Plus Lidocaine for Prevention of Shivering during Cesarean Section

  • Rastegarian, Ahmad;Ghobadifar, Mohamed Amin;Kargar, Hossein;Mosallanezhad, Zahra
    • The Korean Journal of Pain
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    • 제26권4호
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    • pp.379-386
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    • 2013
  • Background: Shivering related to spinal anesthesia may interfere with monitoring and is uncomfortable. The aim of the present study was to investigate low-dose intrathecal meperidine for the prevention of shivering after induction of spinal anesthesia in parturients with cesarean section. Methods: This was a prospective randomized, double-blind, placebo-controlled trial including 100 parturients, of American Society of Anesthesiologists (ASA) physical status I or II, scheduled for elective cesarean section under spinal anesthesia who were randomly assigned to a meperidine (0.2 mg/kg) plus hyperbaric lidocaine (5%, 75 mg, n = 50; group M) group or a placebo plus hyperbaric lidocaine (5%, 75 mg, n = 50; group L) group. Demographic and surgical data, adverse events, and the mean intensity for each parturient were assessed during the entire study period by a blinded observer. Results: There were no significant differences between the two study groups regarding the demographic and surgical data (P > 0.05). The incidence of shivering during the entire study period significantly decreased in the group of parturients who received intrathecal meperidine (P = 0.04). There were no significant differences in nausea and vomiting between the two groups. Conclusions: Low-dose intrathecal meperidine (10 mg) is safe and effective in reducing the incidence and severity of shivering associated with spinal anesthesia in parturients with cesarean section.