• 제목/요약/키워드: randomized controlled double blind study

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수종의 약침제제 견정혈 자입이 활력징후 변화에 미치는 영향;황기 약침, 산삼 약침, 생지황 약침을 중심으로 (The Effects of Distilled Astragali Radix Herbal Acupuncture, Wild Ginseng Herbal Acupuncture and Rehmannia Glutinosa Herbal Acupuncture on Vital Sign;A Randomized, Placebo-controlled, Double-blind Clinical Trial)

  • 이휘용;유정석;육태한;홍권의
    • Journal of Acupuncture Research
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    • 제24권5호
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    • pp.207-217
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    • 2007
  • Objectives: We investigated the safty of distilled Astragali Radix Herbal Acupuncture, Wild Ginseng Herbal Acupuncture and Rehmannia glutinosa Herbal Acupuncture on vital sign -BP, pulse, resperation-in adult man. Methods : We investigated on 106 healthy volunteers consisted of each 30 subjects in experiment (distilled Astragali Radix Herbal Acupuncture, Wild Ginseng Herbal Acupuncture and Rehmannia glutinosa Herbal Acupuncture) group and 30 subjects in control(Normal Saline) group. Study form was a randomized, placebo-controlled, double-blind clinical trial. 30 subjects in each experiment group were injected distilled Astragali Radix Herbal Acupuncture, Wild Ginseng Herbal Acupuncture, Rehmannia glutinosa Herbal Acupuncture at $GB_{21}$(Kyonjong) and 30 subjects in control group were injected Normal Saline at $GB_{21}$ (Kyonjong). except of 2 subjects(in control group) who can't be measured and 10 subjects(6 in experiment group and 4 in control group) who move or make unforceable error during measuring. Finally each 25. subject, subject, subject in experiment group and 24 subject in control group are studied. We measured resperation by PolyG-I and BP & pulse by electric manometer on 5 times : before injection per 5 minutes during and after injection per 10 minutes during 35 minutes. The SPSS 13.0 for windows was used to analyze the data and the Student t test(between two groups) were used to verify the result. Results : 1. After distilled Astragali Radix Herbal Acupuncture injection, Wild Ginseng Herbal Acupuncture and Rehmannia glutinosa Herbal Acupuncture , systolic BP is not significantly change in all experiment time. 2. After distilled Astragali Radix Herbal Acupuncture injection, Wild Ginseng Herbal Acupuncture and Rehmannia glutinosa Herbal Acupuncture , diastolic BP is not significantly change in all experiment time. 3. After distilled Astragali Radix Herbal Acupuncture injection, Wild Ginseng Herbal Acupuncture and Rehmannia glutinosa Herbal Acupuncture , pulse is not significantly change in all experiment time. 4. After distilled Astragali Radix Herbal Acupuncture injection, Wild Ginseng Herbal Acupuncture and Rehmannia glutinosa Herbal Acupuncture , resperation is not significantly change in all experiment time. Conclusions : The results suggest that distilled Astragali Radix Herbal Acupuncture, Wild Ginseng Herbal Acupuncture and Rehmannia glutinosa Herbal Acupuncture in healthy adult man don't influence vital sign within normal range. This result is derived from that distilled Astragali Radix Herbal Acupuncture, Wild Ginseng Herbal Acupuncture and Rehmannia glutinosa Herbal Acupuncture in healthy adult man are safety.

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마황 복용이 정산인의 심박변이도에 미치는 영향에 대한 무작위배정 이중맹검 임상연구 (Effect of Mahuang on Heart Rate Variability in Adults : a Double-Blind, Placebo-Controlled, Randomized Trial)

  • 손동혁;형례창;김락형;정승일;서의석;장인수
    • 대한한의학회지
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    • 제28권1호통권69호
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    • pp.105-116
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    • 2007
  • Objectives : Mahuang (Ephedra sinica), well known as an herbal medicine in the East and West, contains a relatively high percentage of ephedrine known as sympathomimetic alkaloid. We investigated the effects of Mahuang on sympathetic nervous system with heart rate variety (HRV). Time and frequency domain analysis of HRV is a noninvasive technique capable of providing information on autonomic modulation of the sinus node. Methods : We investigated 57 healthy volunteers consisting of 37 subjects in the Mahuang group and 20 subjects in the placebo group. Study form was a randomized, placebo-controlled, double-blind clinical trial. The 37 subjects in the Mahuang group took 3 Mahuang capsules (1 capsule equivalent to 2g herb Mahuang) twice a day at 10 a.m. and 2 p.,., while the 20 subjects in the placebo group took 3 placebo-capsules filled with glutinous rice powder at the same times. Mahuang medicine and placebo medicine were made into opaque capsules. We measured HRV at 3 p.m. 1 or 2 days before medication and at 3 p.m. after medication. Results : Mean-RR and SDNN of the Mahuang group significantly decreased compared with that of the placebo group, but the heart rate of the Mahuang group significantly increased compared with the placebo. HRV-Index, RMSSD and SDSD of the Mahuang group significantly decreased compared with that of the placebo group, but PNN50 of the Mahuang group significantly increased compared with placebo. Ln(TP), Ln(VLF), Ln(LF) and Ln(HF) of the Mahuang group significantly decreased compared with those of the placebo group. There were no significant differences in normalized LF, normalized HF and LF/HF ratio between the Mahuang and placebo groups. Conclusion : The results suggest that Mahuang in healthy adults tends to reduce the autonomic nervous system within the normal range.

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한국인과 중국인에서 인삼과 서양삼 복용후 전신 증상 -이중맹검 무작위배정 임상시험- (The Effects of Ginseng and American Ginseng on General Symptom in Koreans and Chineses - Double-blind Randomized Controlled Trials -)

  • 서정철;한상원;변준석;안희덕;하일도;조건호;임강현;허정걸;이경림;김명수
    • Journal of Ginseng Research
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    • 제29권1호
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    • pp.27-36
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    • 2005
  • 본 연구는 인삼이나 서양삼이 상열감이나 코피 같은 전신증상에 미치는 영향을 임상적으로 비교 연구한 것이다. 복용군을 다섯 군(위약군, 한국 양평산 홍삼 6년근 복용군, 한국 금산산 백삼 6년근 복용군, 중국 요녕산 서양삼 4년근, 미국 뉴욕산 서양삼 6년근 복용군)으로 나누어 이중 맹검 임상시험을 하였다. 한국인과 중국인을 대상으로 인삼과 서양삼 복용 후 전신증상에 미치는 영향을 비교한 결과 부작용은 한국인에서 유의하게 나타난 것은 없었으나 중국인에서 구순건조가 위약군에서, 가슴 답답함(흉민)이 위약군과 4년근 서양삼군에서 유의하게 많았다. 개선효과는 한국인에서 유의하게 나타난 것은 없었으나 중국인에서 가슴 답답함(흉민)이 4년근 서양삼군과 6년근 서양삼군에서 유의하게 개선되었다 본 연구 결과는 현재 인삼과 서양삼에 대한 인식이 아마도 한의학에서 본 초학의 기미의 개념을 상업적인 의도를 가지고 왜곡시킨 것임을 시사한다고 하겠다.

Effect of Hominis Placenta Pharmacopuncture for a Patient with Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial

  • Kim, Yunna;Eom, Yoon Ji;Kwon, Dohyung;Lee, Jae Hyok;Jung, In Chul;Cho, Eun;Lee, Ji Eun;Cho, Seung-Hun
    • 동의신경정신과학회지
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    • 제32권2호
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    • pp.81-93
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    • 2021
  • Objectives: Mild cognitive impairment (MCI) is condition of cognitive decline shown in transition from normal aging to dementia. Hominis placenta pharmacopuncture (HPP) is a treatment that combines effects of medication and acupuncture by injecting Hominis placenta into acupoints. The objective of this study was to evaluate the efficacy and safety of HPP for MCI. Methods: This was a randomized, double-blind, placebo-controlled, two-center clinical trial. Eligible patients were randomly allocated to either the HPP group or the placebo group. HPP or saline as placebo was administered to participants for eight weeks. Changes in symptoms were observed. The primary outcome was difference in mean change of Korean Version of the Montreal Cognitive Assessment (MoCA-K) score between the HPP group and the placebo group. Cognitive function, overall status of mood and sleep, and quality of life (QoL) were also assessed. Safety assessment and economic analysis were then conducted. Results: Thirty participants were enrolled. One participant in the placebo group dropped out. The score of MoCA-K increased after treatment. Its mean change was smaller in the HPP group than in the control group. HPP ameliorated Global Deterioration Scale and Korean Dementia Rating Scale subtests for attention, organization, and memory compared to the placebo. However, none of them was significantly different between the two groups. Mood, sleep, and QoL all improved more in the HPP group than in the placebo group, although differences between the two groups were not statistically significant. There was no adverse event probably related to the drug. HPP treatment needed KRW 345,000 more than the placebo group in improving Geriatric Quality of Life scale-Dementia score by one point for one year. Conclusions: Although HPP treatment did not significantly improve cognition, it changed behavioral and psychological symptoms in MCI.

레이노병의 침치료에 대한 연구동향 (A Review of Acupuncture for the Treatment of Raynaud's Disease)

  • 전상우;김호;정민정;장인수
    • 대한한방내과학회지
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    • 제38권4호
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    • pp.433-442
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    • 2017
  • Objectives: The purpose of this study was to assess the effectiveness of acupuncture for the treatment of Raynaud's disease. Methods: This review was conducted using nine electronic databases (CINAHL, CiNii, CNKI, EMBASE, J-STAGE, NDSL, OASIS, PubMed, and WANFANG) and the keywords "Raynaud's disease", "Raynaud disease", "acupuncture", and "needling". Only randomized controlled trials (RCTs) using acupuncture for Raynaud's disease were included, and the methodological quality of the trials was assessed using the Cochrane risk-of-bias tool. Results: After screening, six RCTs were selected among 67, and the total effective rate and peripheral blood flow were used as evaluation methods. In five studies, the total effective rate was significantly higher in the intervention group than in the control group. In three studies, peripheral blood flow was higher in the intervention group than in the control group, with two studies being statistically significant and the remaining study not being statistically significant. Conclusions: Acupuncture could be a suitable treatment without adverse effects for Raynaud's disease because it improves peripheral blood flow. However, further studies, including randomized, placebo-controlled, double-blind methods, and clear evaluation criteria are needed.

Effects of Fresh Yellow Onion Consumption on CEA, CA125 and Hepatic Enzymes in Breast Cancer Patients: A Double-Blind Randomized Controlled Clinical Trial

  • Jafarpour-Sadegh, Farnaz;Montazeri, Vahid;Adili, Ali;Esfehani, Ali;Rashidi, Mohammad-Reza;Mesgari, Mehran;Pirouzpanah, Saeed
    • Asian Pacific Journal of Cancer Prevention
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    • 제16권17호
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    • pp.7517-7522
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    • 2015
  • Onion (Allium cepa) consumption has been remarked in folk medicine which has not been noted to be administered so far as an adjunct to conventional doxorubicin-based chemotherapy in breast cancer patients. To our knowledge, this is the first study aimed to investigate the effects of consuming fresh yellow onions on hepatic enzymes and cancer specific antigens compared with a low-onion containing diet among breast cancer (BC) participants treated with doxorubicin. This parallel design randomized controlled clinical trial was conducted on 56 BC patients whose malignancy was confirmed with histopathological examination. Subjects were assigned in a stratified-random allocation into either group received body mass index dependent 100-160 g/d of onion as high onion group (HO; n=28) or 30-40 g/d small onion in low onion group (LO; n=28) for eight weeks intervention. Participants, care givers and laboratory assessor were blinded to the assignments (IRCT registry no: IRCT2012103111335N1). The compliance of participants in the analysis was appropriate (87.9%). Comparing changes throughout pre- and post-dose treatments indicated significant controls on carcinoembryonic antigen, cancer antigen-125 and alkaline phosphatase levels in the HO group (P<0.05). Our findings for the first time showed that regular onion administration could be effective for hepatic enzyme conveying adjuvant chemotherapy relevant toxicity and reducing the tumor markers in BC during doxorubicin-based chemotherapy.

Citalopram과 Escitalopram의 안면홍조 증상개선효과에 대한 최근 연구 고찰 (Citalopram and Escitalopram for Management of Hot Flashes: A Review of Recent Clinical Trials in Humans)

  • 이유정
    • 한국임상약학회지
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    • 제21권4호
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    • pp.376-382
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    • 2011
  • 폐경기는 여성들에게 신체적, 정신적으로 많은 변화 및 불편함을 야기시킨다. 특히 안면홍조는 폐경기 초기 많은 여성들에게 나타나는 증상이며 혈중 에스트로겐 수치가 낮아졌을 때 나타나기 때문에 현재까지 에스트로겐을 기본으로 한 호르몬 요법이 안면홍조 증상의 1차 치료제로 여겨졌다. 그러나 2002년 호르몬 요법이 유방암, 뇌졸중 등의 발생 위험도를 증가시킨다는 연구 결과가 발표된 이후 많은 보건의료인들은 호르몬 요법 대신 사용 가능한 다른 치료제의 등장을 고대하고 있다. 안면홍조 증상을 지닌 많은 폐경기 여성들 또한 호르몬 요법 대신 안전하게 사용할 수 있는 효과적인 치료제를 기다리고 있다. 현재 citalopram과 escitalopram은 안면홍조 증상 치료제로 허가된 의약품은 아니지만 최근 여러 국가에서 시행된 연구들은 citalopram과 escitalopram이 효과적인 안면홍조 증상 치료제일 수 있다는 가능성을 보여주고 있다. 따라서 본 연구는 citalopram과 escitalopram의 안면홍조 증상 치료효과에 대한 최신 지견을 얻고자, 1990년부터 2011년 1월까지 MEDLINE에 등재된 논문을 Citalopram 또는 Escitalopram과 Hot flashes라는 MeSH terms로 검색하여 추출한 자료 중에서 임상연구 사례만을 선별하여 임상적 유용성을 평가하였다.

Clinical and microbiological effects of egg yolk antibody against Porphyromonas gingivalis as an adjunct in the treatment of moderate to severe chronic periodontitis: a randomized placebo-controlled clinical trial

  • Xu, Yan;Selerio-Poely, Tshepiso;Ye, Xingru
    • Journal of Periodontal and Implant Science
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    • 제48권1호
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    • pp.47-59
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    • 2018
  • Purpose: To evaluate the clinical and microbiological effects of the local use of egg yolk immunoglobulin against Porphyromonas gingivalis (anti-P.g. IgY) as an adjunct to scaling and root planing (SRP) in the treatment of moderate to severe chronic periodontitis. Methods: This was a randomized, placebo-controlled, double-blind trial involving 60 systematically healthy patients with moderate to severe chronic periodontitis. Subjects (n=20/group) were randomly assigned to receive SRP combined with subgingival irrigation of anti-P.g. IgY and anti-P.g. IgY mouthwash, subgingival irrigation of 0.2% chlorhexidine and 0.2% chlorhexidine mouthwash, or subgingival irrigation of placebo and placebo mouthwash for 4 weeks. Probing pocket depth, clinical attachment level, bleeding on probing, and the plaque index were evaluated at baseline and at 4 weeks. Subgingival plaque, gingival crevicular fluid, and saliva were simultaneously collected for microbiological analysis. Results: Our results showed that anti-P.g. IgY mouthwash was as effective as chlorhexidine at improving clinical parameters over a 4-week period. All the groups showed a significant reduction in levels of P.g. at 4 weeks. No significant difference was observed in the test group when compared to placebo regarding the reduction in the levels of P.g. Anti-P.g. IgY significantly suppressed the numbers of red complex bacteria (RCB) in subgingival plaque and saliva in comparison with placebo. No adverse effects were reported in any of the subjects. Conclusions: Within the limitations of the study, the present investigation showed that passive immunization with anti-P.g. IgY may prove to be effective in the treatment of chronic periodontitis due to its ability to improve clinical parameters and to reduce RCB. No significant differences were found between the anti-P.g. IgY and placebo groups in the reduction of P.g.

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

  • 김기태;고흥;신선미;김형준
    • 대한한방부인과학회지
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    • 제25권2호
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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.

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.