• 제목/요약/키워드: Double-blind

검색결과 545건 처리시간 0.031초

Efficacy of ketamine in the treatment of migraines and other unspecified primary headache disorders compared to placebo and other interventions: a systematic review

  • Chah, Neysan;Jones, Mike;Milord, Steve;Al-Eryani, Kamal;Enciso, Reyes
    • Journal of Dental Anesthesia and Pain Medicine
    • /
    • 제21권5호
    • /
    • pp.413-429
    • /
    • 2021
  • Background: Migraine headaches are the second leading cause of disability worldwide and are responsible for significant morbidity, reduction in the quality of life, and loss of productivity on a global scale. The purpose of this systematic review and meta-analysis was to evaluate the efficacy of ketamine on migraines and other primary headache disorders compared to placebo and other active interventions, such as midazolam, metoclopramide/diphenhydramine, and prochlorperazine/diphenhydramine. Methods: An electronic search of databases published up to February 2021, including Medline via PubMed, EMBASE, Web of Science, and Cochrane Library, a hand search of the bibliographies of the included studies, as well as literature and systematic reviews found through the search was conducted to identify randomized controlled trials (RCTs) investigating ketamine in the treatment of migraine/headache disorders compared to the placebo. The authors assessed the risk of bias according to the Cochrane Handbook guidelines. Results: The initial search strategy yielded 398 unduplicated references, which were independently assessed by three review authors. After evaluation, this number was reduced to five RCTs (two unclear risk of bias and three high risk of bias). The total number of patients in all the studies was 193. Due to the high risk of bias, small sample size, heterogeneity of the outcomes reported, and heterogeneity of the comparison groups, the quality of the evidence was very low. One RCT reported that intranasal ketamine was superior to intranasal midazolam in improving the aura attack severity, but not duration, while another reported that intranasal ketamine was not superior to metoclopramide and diphenhydramine in reducing the headache severity. In one trial, subcutaneous ketamine was superior to saline in migraine severity reduction; however, intravenous (I.V.) ketamine was inferior to I.V. prochlorperazine and diphenhydramine in another study. Conclusion: Further double-blind controlled studies are needed to assess the efficacy of ketamine in treating acute and chronic refractory migraines and other primary headaches using intranasal and subcutaneous routes. These studies should include a long-term follow-up and different ketamine dosages in diagnosed patients following international standards for diagnosing headache/migraine.

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
    • /
    • 제52권2호
    • /
    • pp.149-156
    • /
    • 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 on postoperative nausea and vomiting of nefopam versus fentanyl following bimaxillary orthognathic surgery: a prospective double-blind randomized controlled trial

  • Choi, Eunhye;Karm, Myong-Hwan;So, Eunsun;Choi, Yoon Ji;Park, Sookyung;Oh, Yul;Yun, Hye Joo;Kim, Hyun Jeong;Seo, Kwang-Suk
    • Journal of Dental Anesthesia and Pain Medicine
    • /
    • 제19권1호
    • /
    • pp.55-66
    • /
    • 2019
  • Background: Postoperative nausea and vomiting (PONV) frequently occurs following bimaxillary orthognathic surgeries. Compared to opioids, Nefopam is associated with lower incidences of PONV, and does not induce gastrointestinal tract injury, coagulopathy, nephrotoxicity, or fracture healing dysfunction, which are common side effects of Nonsteroidal anti-inflammatory drugs. We compared nefopam- and fentanyl-induced incidence of PONV in patients with access to patient-controlled analgesia (PCA) following bimaxillary orthognathic surgeries. Methods: Patients undergoing bimaxillary orthognathic surgeries were randomly divided into nefopam and fentanyl groups. Nefopam 120 mg or fentanyl $700{\mu}g$ was mixed with normal saline to a final volume of 120 mL. Patients were given access to nefopam or fentanyl via PCA. Postoperative pain intensity and PONV were measured at 30 minutes and 1 hour after surgery in the recovery room and at 8, 24, 48, and 72 hours after surgery in the ward. The frequency of bolus delivery was compared at each time point. Results: Eighty-nine patients were enrolled in this study, with 48 in the nefopam (N) group and 41 in the fentanyl (F) group. PONV occurred in 13 patients (27.7%) in the N group and 7 patients (17.1%) in the F group at 8 hours post-surgery (P = 0.568), and there were no significant differences between the two groups at any of the time points. VAS scores were $4.4{\pm}2.0$ and $3.7{\pm}1.9$ in the N and F groups, respectively, at 8 hours after surgery (P = 0.122), and cumulative bolus delivery was $10.7{\pm}13.7$ and $8.6{\pm}8.5$, respectively (P = 0.408). There were no significant differences in pain or bolus delivery at any of the remaining time points. Conclusion: Patients who underwent bimaxillary orthognathic surgery and were given nefopam via PCA did not experience a lower rate of PONV compared to those that received fentanyl via PCA. Furthermore, nefopam and fentanyl did not provide significantly different postoperative pain control.

Rapid onset of efficacy predicts response to therapy with certolizumab plus methotrexate in patients with active rheumatoid arthritis

  • Kang, Young Mo;Park, Young-Eun;Park, Won;Choe, Jung-Yoon;Cho, Chul-Soo;Shim, Seung-Cheol;Bae, Sang Cheol;Suh, Chang-Hee;Cha, Hoon-Suk;Koh, Eun Mi;Song, Yeong-Wook;Yoo, Bin;Lee, Shin-Seok;Park, Min-Chan;Lee, Sang-Heon;Arendt, Catherine;Koetse, Willem;Lee, Soo-Kon
    • The Korean journal of internal medicine
    • /
    • 제33권6호
    • /
    • pp.1224-1233
    • /
    • 2018
  • Background/Aims: The objective of this study was to determine the efficacy and safety of add-on therapy with certolizumab pegol (CZP) in active rheumatoid arthritis (RA) patients of a single ethnicity. Methods: In this 24-week, phase 3, randomized, double-blind, placebo-controlled trial, eligible patients (n = 127) were randomized 2:1 to subcutaneous CZP + methotrexate (MTX; 400 mg at week 0, 2, and 4 followed by 200 mg every 2 weeks) or placebo + MTX. Results: At week 24, the American College of Rheumatology criteria for 20% (ACR20) response rate was significantly greater with CZP + MTX than with placebo (66.7% vs. 27.5%, p < 0.001). Differences in ACR20 response rates for CZP vs. placebo were significant from week 1 (p < 0.05) and remained significant through week 24. The CZP group reported significant improvement in physical function and disability compared to the placebo group (p < 0.001) at week 24, as assessed by Korean Health Assessment Questionnaire-Disability Index (KHAQ-DI). Post hoc analysis indicated that the proportion of patients who had ACR70 responses, Disease Activity Score 28 (DAS28) low disease activity, and DAS28 remission at week 24 was greater in CZP + MTX-treated patients who achieved a decrease in DAS28 ${\geq}1.2$ (43.8%) at week 4 than in nonresponders. Among 18 (22.2%) and 14 patients (35.0%) in CZP and placebo groups who had latent tuberculosis (TB), none developed active TB. Most adverse events were mild or moderate. Conclusions: CZP treatment combined with MTX in active RA patients with moderate to severe disease activity and an inadequate response to MTX resulted in rapid onset of efficacy, which is associated with better clinical outcome at week 24 and has an acceptable safety profile, especially in an intermediate TB-burden population.

화병 환자의 심박변이도 차이에 따른 황련해독탕의 효과: 화병에 대한 무작위 대조 비교임상시험 결과의 추가 분석 (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)

  • 최유진;조성훈
    • 스트레스연구
    • /
    • 제26권4호
    • /
    • pp.305-311
    • /
    • 2018
  • 화병은 뚜렷한 스트레스 사건과 관련되어 가슴의 답답함, 열감, 치밀어 오름, 억울하고 분한 감정 등이 나타나는 증후군이다. 본 논문에서는 화병에 대한 황련해독탕의 임상시험 결과를 교감신경의 활성도를 반영한다고 알려져 있는 심박변이도의 저주파(0.04~0.15 Hz) 영역 값을 중심으로 분석하여 다음과 같은 결과를 얻었다. 첫째, 황련해독탕 시험군에서 초기 심박변이도 저주파 값이 클수록 불면 증상의 개선 정도가 작게 나타났다. 둘째, 위약과 비교했을 때, 황련해독탕은 복용 7일 후 심박변이도 저주파 값을 유의하게 감소시켰다. 셋째, 화병 증상 중 가슴이 답답함, 치밀어 오름, 분노가 심박변이도 저주파 값과 유의미한 상관성이 있었다. 이를 바탕으로 심박변이도는 화병 환자를 평가할 때 유용할 것이라고 기대된다.

Ginsenoside Rg1 supplementation clears senescence-associated β-galactosidase in exercising human skeletal muscle

  • Wu, Jinfu;Saovieng, Suchada;Cheng, I-Shiung;Liu, Tiemin;Hong, Shangyu;Lin, Chang-Yu;Su, I-Chen;Huang, Chih-Yang;Kuo, Chia-Hua
    • Journal of Ginseng Research
    • /
    • 제43권4호
    • /
    • pp.580-588
    • /
    • 2019
  • Background: Ginsenoside Rg1 has been shown to clear senescence-associated beta-galactosidase (SA-${\beta}$-gal) in cultured cells. It remains unknown whether Rg1 can influence SA-${\beta}$-gal in exercising human skeletal muscle. Methods: To examine SA-${\beta}$-gal change, 12 young men (age $21{\pm}0.2years$) were enrolled in a randomized double-blind placebo controlled crossover study, under two occasions: placebo (PLA) and Rg1 (5 mg) supplementations 1 h prior to a high-intensity cycling (70% $VO_{2max}$). Muscle samples were collected by multiple biopsies before and after cycling exercise (0 h and 3 h). To avoid potential effect of muscle biopsy on performance assessment, cycling time to exhaustion test (80% $VO_{2max}$) was conducted on another 12 participants (age $23{\pm}0.5years$) with the same experimental design. Results: No changes of SA-${\beta}$-gal were observed after cycling in the PLA trial. On the contrary, nine of the 12 participants showed complete elimination of SA-${\beta}$-gal in exercised muscle after cycling in the Rg1 trial (p < 0.05). Increases in apoptotic DNA fragmentation (PLA: +87% vs. Rg1: +133%, p < 0.05) and $CD68^+$ (PLA:+78% vs. Rg1:+121%, p = 0.17) occurred immediately after cycling in both trials. During the 3-h recovery, reverses in apoptotic nuclei content (PLA:+5% vs. Rg1 -32%, p < 0.01) and increases in inducible nitrate oxide synthase and interleukin 6 mRNA levels of exercised muscle were observed only in the Rg1 trial (p < 0.01). Conclusion: Rg1 supplementation effectively eliminates senescent cells in exercising human skeletal muscle and improves high-intensity endurance performance.

슈퍼홍미 미강 추출물의 폐경 후 여성의 혈중 지질 농도 및 대사성 질환 개선 효과 (Superhongmi bran extract improves lipid profile and menopause symptoms: a randomized, placebo-controlled clinical trial)

  • 정수임;남수진;;;강미영
    • 한국식품과학회지
    • /
    • 제51권2호
    • /
    • pp.182-187
    • /
    • 2019
  • 본 연구는 슈퍼홍미 미강 추출물이 폐경 후 갱년기 증상에 및 대사 개선 효과를 확인하고자 수행되었다. 무월경이 지속된 지 5년 미만의 여성을 대상으로 12주동안 진행되었으며 위약대조군 15명, 실험군 15명으로 배정하였고, 1일 2개의 캡슐을 섭취하도록 하였다(슈퍼홍미 미강추출물 700 mg/day). 시험 종료 후 슈퍼홍미 미강 추출물 섭취군의 체중과 BMI 그리고 중성지질과 및 총콜레스테롤은 수준이 유의하게 감소하였다. 혈중 HDL 콜레스테롤과 ApoA1 농도는 약 10% 증가하여 지질대사 개선에 효과를 기대할 수 있었다. 항당뇨과 관련된 지표 중 혈중 glucose와 인슐린이 유의하게 감소하여 인슐린 저항성 지표인 HOMA-IR이 감소한 것을 확인할 수 있었고, 아디포넥틴 수준이 유의하게 증가하였으며, $TNF-{\alpha}$는 슈퍼홍미 미강 추출물 섭취군에서 투여 전보다 유의하게 감소하여 폐경 이후 당질대사 개선에 도움을 줄 수 있을 것으로 보인다. 항산화활성 분석 결과 SOD1, GSH 그리고 TBARS 수준이 실험군에서 감소하였으며, AOPP 는 유의적인 차이를 보이지 않았다. 여성호르몬 중 $17{\beta}-estradiol$과 progesterone 농도는 위약대조군에서 유의하게 감소하였으나 실험군은 섭취기간동안 호로몬 농도를 유지한 것으로 나타나 대조군에 비해 높은 수준을 나타났다. 폐경을 겪은 여성들은 여성호르몬 저하로 인해 갱년기 증상 및 대사증후군 발병 가능성이 증가하는데 슈퍼홍미 미강과 같은 기능성 식품 섭취로 대사증후군 위험인자들에 대한 호전이 높을 것이라 보고 이러한 연구 결과는 갱년기 여성 건강에 시사하는 바가 크다고 생각된다.

일차성 만성불면증 환자에서 경두개 직류전기자극법 치료 효과: 개념 증명 연구 (Effects of Transcranial Direct-Current Stimulation Therapy on Primary Chronic Insomnia: A Proof-of Concept Clinical Trial)

  • 전진선;김태준;구선아;박지숙;김근태;양태원;임정아;변정익;선우준상;정기영
    • Journal of Sleep Medicine
    • /
    • 제15권2호
    • /
    • pp.37-42
    • /
    • 2018
  • Objectives: To assess the effect and safety of transcranial direct-current stimulation (tDCS) in primary chronic insomnia. Methods: A one-month, double-blind, randomized, sham-controlled trial was performed. A total of 7 patients with primary chronic insomnia received tDCS using anodal (n=3), cathodal (n=2), or sham stimulation (n=2). They were followed up at 1 week and 1 month after treatment. The primary outcome measures included improvement in total sleep time (TST), sleep latency (SL), and sleep efficiency (SE) at 1 month follow-up. Results: TST and SE were improved with tDCS at 1 month follow-up in all patients (100%) of the anodal group, one (50%) of the cathodal group, and one (50%) of the sham group. tDCS improved SL at 1 month follow-up in two patients (67%) of the anodal group, one (50%) of the cathodal group, and none (0%) of the sham group. With respect to adverse events, transient itching sensation occurred in one patient of the anodal group. None of the other groups reported adverse events. Conclusions: Our results suggest that tDCS may be effective and safe for treatment of primary chronic insomnia. A larger controlled study needs to be further investigated.

숙잠 함유 복합물의 알코올 대사 및 숙취개선 효능평가 (Evaluation of the effects of Hangover-releasing agent containing freeze-dried mature silkworm larval powder (SMSP) on alcohol metabolism and hangover improvement)

  • 우미선;차지현;김용환;강희택;김현덕;조경원;박성선;이종훈
    • 한국식품과학회지
    • /
    • 제53권1호
    • /
    • pp.72-77
    • /
    • 2021
  • 숙취를 해결하기 위해서는 숙취를 직접적으로 유발하는 물질인 아세트알데하이드의 조절이 가장 중요한 인자로 작용한다. 숙잠을 함유하는 복합물인 시험식품(CKDHC)의 섭취로 혈중 아세트알데하이드 농도가 대조식품 대비 통계적으로 유의하게 감소하여 숙취개선 효능을 확인하였다. 특히, 30분부터 각 시간별(mg/L), 혈중 아세트알데하이드 농도-시간곡선하 면적(AUC), 최고 혈중 아세트알데하이드 농도(Cmax)의 감소를 통해 30분부터 빠른 숙취개선 효능을 확인하였다. 본 연구의 주원료로 사용된 숙잠은 Ji 등(2016a)에 따르면 18종의 아미노산 및 무기질을 모두 함유하며, 고단백 식용곤충으로 간에 좋은 주요 아미노산인 Alanine, Arginine 등을 많이 함유하여 간의 효소활성에 긍정적인 영향을 줄 수 있음을 알수있다. 본 연구결과를 통해 숙잠을 함유하는 시험식품이 숙취해소제로 작용할 수 있으며, 특히 음주 전 섭취시 아세트알데하이드를 빠르게 분해하여 30분부터 숙취 개선에 효과가 있음을 입증하였다.

NMED-01과 NMED-02의 간기능 개선에 대한 인체 효능 평가 (A Randomized, Double-blind, Placebo-controlled Study to the efficacy and Safety of NMED-01 and NMED-02 in Mild Alcoholic Liver Subjects)

  • 박상욱;권용범;김기태;신선미;임강현;고흥;송미경;정윤철;김호철;박주연
    • 대한본초학회지
    • /
    • 제28권6호
    • /
    • pp.31-38
    • /
    • 2013
  • Objectives : The purpose of this study was to determine whether NMED-01 or NMED-02 improves laboratory test results in participants with liver function disorder. Methods : This is a randomized, placebo-controlled trial in which participants, treating physicians and data management staff were blinded to treatment group. The study was conducted at Semyung university oriental medicine hospital in Jecheon where participants with high level of serum ${\gamma}$-GTP (60-350 U/L) were enrolled. The intervention consisted of three times daily ingestion of either two capsules of placebo, NMED-01 (NeuMed. co. ltd., Seoul), or NMED-02 (NeuMed. co. ltd., Seoul) for twelve weeks. To evaluate the efficacy and safety of NMED-01 and NMED-02, we primarily evaluated the degree of decrement of serum ${\gamma}$-GPT level among three groups. Secondarily the decrement of serum ALT, AST, and triglyceride level in each group were also evaluated. Adverse effects were monitored during the twelve weeks treatment. Results : The change of ${\gamma}$-GTP level of NMED-01 group was lower than that of placebo group at the end of 12-week administration ($28.1{\pm}38.7U/L$ vs. $9.3{\pm}27.0U/L$, p=0.046). Other variables including AST, ALT, and triglyceride level were not significantly reduced. The decrement of ${\gamma}$-GPT, AST, ALT, and triglyceride level of NMED-02 group was not significant. There were no significant adverse effects or toxicities during treatment period. Conclusions : Participants receiving NMED-01 had improvement in laboratory test results. Despite a modest sample size, our results suggest that NMED-01 are safe and may be potentially effective in improving liver function. However, NMED-02 have lack of a detectable effect in this study.