• 제목/요약/키워드: Placebo-controlled study

검색결과 358건 처리시간 0.027초

Pharmacological Treatment of Major Depressive Episodes with Mixed Features: A Systematic Review

  • Shim, In Hee;Bahk, Won-Myong;Woo, Young Sup;Yoon, Bo-Hyun
    • Clinical Psychopharmacology and Neuroscience
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    • 제16권4호
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    • pp.376-382
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    • 2018
  • We reviewed clinical studies investigating the pharmacological treatment of major depressive episodes (MDEs) with mixed features diagnosed according to the dimensional criteria (more than two or three [hypo]manic symptoms+principle depressive symptoms). We systematically reviewed published randomized controlled trials on the pharmacological treatment of MDEs with mixed features associated with mood disorders, including major depressive disorder (MDD) and bipolar disorder (BD). We searched the PubMed, Cochrane Library, and ClinicalTrials.gov databases through December 2017 with the following key word combinations linked with the word OR: (a) mixed or mixed state, mixed features, DMX, mixed depression; (b) depressive, major depressive, MDE, MDD, bipolar, bipolar depression; and (c) antidepressant, antipsychotic, mood stabilizer, anticonvulsant, treatment, medication, algorithm, guideline, pharmacological. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We found few randomized trials on pharmacological treatments for MDEs with mixed features. Of the 36 articles assessed for eligibility, 11 investigated MDEs with mixed features in mood disorders: six assessed the efficacy of antipsychotic drugs (lurasidone and ziprasidone) in the acute phase of MDD with mixed features, although four of these were post hoc analyses based on large randomized controlled trials. Four studies compared antipsychotic drugs (olanzapine, lurasidone, and ziprasidone) with placebo, and one study assessed the efficacy of combination therapy (olanzapine+fluoxetine) in the acute phase of BD with mixed features. Pharmacological treatments for MDEs with mixed features have focused on antipsychotics, although evidence of their efficacy is lacking. Additional well-designed clinical trials are needed.

Effectiveness of low-level laser therapy on recovery from neurosensory disturbance after sagittal split ramus osteotomy: a systematic review and meta-analysis

  • Firoozi, Parsa;Keyhan, Seied Omid;Kim, Seong-Gon;Fallahi, Hamid Reza
    • Maxillofacial Plastic and Reconstructive Surgery
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    • 제42권
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    • pp.41.1-41.11
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    • 2020
  • Background: Orthognathic surgery such as bilateral sagittal split ramus osteotomy (BSSRO) for the treatment of mandibular deformities is one of the most common procedures in maxillofacial operations that may lead to neurosensory disturbance. In this study, we aimed to evaluate the effectiveness of low-level laser therapy (LLLT) on augmenting recovery of neurosensory disturbance of inferior alveolar nerve (IAN) in patients who underwent BSSRO surgery. Methods: A comprehensive literature search was conducted by two independent authors in PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, Embase, and Google Scholar electronic databases. Besides, a manual search of all textbooks and relevant articles were conducted. Searches took place in August 2020 and were limited to published and peer-reviewed articles from 2000 to 2020. All analysis was performed using the comprehensive meta-analysis (CMA) and the STATA MP (version:16) software. The weighted mean difference (WMD) using the inverse variance method and the standard mean difference (SMD) was considered for continuous variables. Results: Seventy-four papers were retrieved after removing duplicate studies and finally, eight studies were assessed for qualitative synthesis and five for meta-analysis. Totally, 94 patients were included in the meta-analysis. Based on the meta-analysis, it was shown that LLLT was not effective in a short interval (0 to 48 h) after surgery, but in a period of more than 1 month after surgery, the positive results of treatment can be observed strikingly. Also, LLLT side/group showed no significant difference in some aspects of neurosensory recovery such as thermal sensation compared to the placebo side/group. Conclusions: The meta-analysis of randomized controlled trials revealed that LLLT generally improves IAN sensory disturbance caused by BSSRO. Further high-quality clinical trials with longer follow-up periods and larger sample sizes are recommended.

긴장성두통에 대한 한약치료: 체계적 문헌고찰 및 메타분석 (Herbal Medicine for Tension-type Headache: Systematic Review and Meta Analysis of Randomized Controlled Trials)

  • 최은지;권찬영;한경훈;김종우;정선용
    • 동의신경정신과학회지
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    • 제26권4호
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    • pp.383-406
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    • 2015
  • Objectives: People with tension-type headache generally take pain relievers, but long term dependency causes problems as well as side effects. The present study aimed to provide clinical evidence of herbal medicine for tension-type headache by systematic review of randomized controlled trials on the effect of herbal medicine for tension-type headache. Methods: Randomized or quasi-randomized controlled trials that verified effects of herbal medicine intervention on patients with tension-type headache were included in the study. A literature search of English, Japanese, Chinese, Korean databases was performed. The selected literature were assessed by Jadad scale and Risk of Bias. Results: Herein, 40 reports were selected from a total of 157. Meta-analyses of 2 trials indicated that the effective rate was significantly higher in the herbal medicine treatment group, as compared to the placebo control (risk ratio: 1.49, 95% confidence interval (CI): 1.23 to 1.80, p<0.0001, I2=0%). Four trials that compared herbal medicine with routine care with routine care only group showed a significantly higher effective rate of benefits for herbal medicine with routine care, as compared to routine care only (RR: 1.57, 95% CI: 1.18 to 2.10, p=0.002, I2=0%). Conclusions: The effective rate was significantly higher than control and adverse events were less in the treatment group. Pattern analysis (辨證) indicated that the studies on wind-fire pattern (風火證) were highest. Yougeun-bang (柔筋方) in prescription and Paeoniae Radix Alba (白芍藥) in medicinal herbs were most used. This finding could be widely utilized in future clinical practice and form the basis for the development of clinical practice guidelines in advance.

비타민과 불포화지방산, 그리고 피크노제놀을 함유한 복합제제의 주름 완화 및 자외선에 의한 색소침착 개선 효과 (Effects of the Mixture of Vitamin C, Vitamin E, Pycnogenol and Evening Primrose Oil on the UV-Induced Pigmentation and Wrinkle Reductions in Human Skin)

  • 장민열;박상기;곽택종;박형국;이천구;이헌식;이선영;김성진
    • Journal of Nutrition and Health
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    • 제42권6호
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    • pp.516-522
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    • 2009
  • 총 108명의 피시험 자원자들을 대상으로 각각 54명씩 두 군으로 무작위 배정한 후 12주 동안 시험제제를 섭취시키고 피부 색조도와 주름 정도, 혈청 내 $\alpha$-tocopherol의 변화를 이중맹검법으로 평가한 결과 다음과 같은 결론을 얻었다. 1) 12주 동안의 시험제제 섭취 성실성 (순응도)에 대한 익명의 자가응답조사 결과, 응답에 응한 피시험 자원자 45명 중 31명이 90$\sim$100%, 14명이 70$\sim$80%의 비율로 시험 제제를 섭취하였다고 응답하여, 순응도는 만족할 만한 수준이었다. 2) 대조군 (가나다 군)은 남자 22명, 여자 32명으로서 평균 연령 22.8 $\pm$ 3.0세였으며, 시험군 (ABC 군)은 남자 25명, 여자 29명으로서 평균 연령 23.0 $\pm$ 3.4세로 군간 차이가 없었다. 그 외 시험시작전 군별 최소홍반량, 자외선 조사전후의 피부 색조도는 모두 동일한 수준으로 평가되었다. 3) 상완부 내측 피부에 자외선으로 유도한 인공 색소 침착 후 미백 효과를 측정한 색차계 L값의 변화도 ($\Delta$L값)는 12주째에 시험군 ($\Delta$L = 3.817 $\pm$ 2.228)에서 대조군 ($\Delta$L = 2.731 $\pm$ 2.138)보다 유의하게 높았다 (p = 0.011). 4) 안면부 안와 주위 주름을 대상으로 모사판을 획득하고 영상 분석한 음영 비율을 주름 완화 유효 백분율로 비교한 결과, 8주, 12주에 시험군에서 대조군보다 유의한 증가를 나타내었다 (p = 0.0217, p = 5.317E-06). 5) 혈청 내 유효성분 vitamin E ($\alpha$-tocopherol) 농도의 정량적 변동을 시험제제 섭취 전과 섭취 12 후에 측정한 결과, 시험군에서 대조군보다 유의하게 증가하였다 (p = 0.0001). 6) 시험제제를 12주간 섭취한 후 측정한 결과들을 종합하여 볼 때 ABC 군이 가나다 군에 비해 피부의 미백 및 주름 완화 효과가 유의하게 높은 것을 알 수 있었는데, ABC군이 LGNC-5를 유효 성분으로 함유한 시험제제를 섭취한 군이었다.

금사상황버섯 추출물이 사람의 natural killer 세포 활성에 미치는 영향 (Effects of Keumsa Sangwhang (Phellinus linteus) Mushroom Extracts on the Natural Killer Cell Activity in Human)

  • 엄상용;장연위;김남식;강종원;한윤수;신경섭;송형근;박순영;김정수;김헌;김용대
    • 한국식품과학회지
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    • 제38권5호
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    • pp.717-719
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    • 2006
  • 금사상황버섯의 추출물이 NK 세포 활성에 미치는 영향을 인체 실험을 통해 조사하였다. 대상자는 금사상황버섯 추출물 복용 군과 위약 복용군 각각 31명씩이었으며 총 8주간 상황버섯 추출물 및 위약을 하루 3캡슐씩 2회, 총 6캡슐 (3.3 g/일) 매일 경구 복용하였다. 연구 결과, NK 세포의 지표로 알려진 $CD56^+$ 세포의 수는 금사상황버섯 추출물 복용에 의해 근소한 증가를 나타냈으나 통계적인 유의성은 없었고, 대조군과의 비교에서도 유의한 차이를 나타내지 않았다. 한편, NK 세포의 활성은, 금사상황 버섯 추출물을 복용한 군에서는 Jurkat 세포주에 대한 세포독성이 복용 전에 비해 유의하게 증기한 반면, 대조군의 경우는 차이가 없는 것으로 나타났다. 본 연구의 결과로부터 금사상황버섯 추출물의 복용은 NK 세포의 수적인 증가를 유도하지는 않지만 그 가능의 활성화를 통해 세포성면역을 향상시키는 것으로 생각된다.

Does dexmedetomidine combined with levobupivacaine in inferior alveolar nerve blocks among patients undergoing impacted third molar surgery control postoperative morbidity?

  • Patil, Shweta Murlidhar;Jadhav, Anendd;Bhola, Nitin;Hingnikar, Pawan;Kshirsagar, Krutarth;Patil, Dipali
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제22권2호
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    • pp.145-153
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    • 2022
  • Background: Postoperative analgesia (POA) is an important determinant of successful treatment. Dexmedetomidine (DEX) has recently gained attention as a promising adjuvant to local anesthetics (LA). The present study aimed to evaluate the efficacy and safety of levobupivacaine (LB) as an adjuvant during inferior alveolar nerve block (IANB) in the extraction of lower impacted third molars (LITM). Methods: A prospective, randomized, placebo-controlled, triple-blind, parallel-arm, and clinical study was performed on 50 systemically healthy participants who required removal of an asymptomatic LITM. Using a 1:1 distribution, the participants were randomized into two groups (n = 25). Group L (control group) received 1.8 mL of 0.5% LB and 0.2 mL normal saline (placebo) and Group D (study group) received a blend of 1.8 mL of 0.5% LB and 0.2 mL (20 ㎍) DEX. The primary outcome variable was the duration of POA and hemodynamic stability, and the secondary variable was the total number of analgesics required postoperatively for up to 72 h. The participants were requested to record the time of rescue analgesic use and the total number of rescue analgesics taken. The area under the curve was plotted for the total number of analgesics administered. The pain was evaluated using the visual analog scale. Data analysis was performed using paired students and unpaired t-test, Mann-Whitney U test, Chi-square test, and receiver operating characteristic analysis. Statistical significance was set at P < 0.05. Results: The latency, profoundness of anesthesia, and duration of POA were statistically significant (P < 0.05). The differences between mean pain scores at 6, 12, 24, 48, and 72 h were found to be significant (each P = 0.0001). Fewer analgesics were required by participants in group D (2.12 ± 0.33) than in L (4.04 ± 0.67), with a significant difference (P = 0.0001). Conclusion: Perineurally administered LA with DEX is a safe, effective, and therapeutic approach for improving latency, providing profound POA, and reducing the need for postoperative analgesia.

총정맥영양법의 간담도 합병증에 대한 Ursodeoxycholic Acid 조기투여의 이중맹검 위약대조군 연구 (A Randomized, Double-Blind, Placebo-Controlled Trial of Early Ursodeoxycholic Acid Administration for Prevention of Total Parenteral Nutrition-Induced Hepatobiliary Complications)

  • 최연호;백남선;김지희;이숙향;박태성
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • 제5권2호
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    • pp.174-180
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    • 2002
  • 목 적: 총정맥영양법의 합병증인 간담도계 장애시 ursodeoxycholic acid (UDCA) 투여는 독성이 있는 내인성 담즙의 분비를 촉진하여 간손상을 감소시키는 역할을 하는 것으로 알려져 있다. 그러나 대부분의 연구는 합병증 발생 후 치료에 관한 것이어서 본 연구자들은 UDCA를 총정맥영양법의 시작과 동시에 조기 투여할 경우 그 예방효과를 이중맹검 위약대조군 연구로써 알아보고자 하였다. 방 법: 2000년 5월부터 2002년 5월까지 10일 이상의 총정맥영양을 받은 13명의 환아를 대상으로 하였다. 총정맥영양 시작과 동시에 UDCA를 투여받는 시험군 7명, 위약을 투여받는 대조군 6명을 이중맹검법으로 구분하였다. 연령은 생후 1일부터 13세까지이고 환아들의 진단은 경관영양이 불가능한 미숙아와 뇌성마비아, 만성설사, 거식증, 췌장염, 주기성 구토증 등이었다. 총정맥영양의 기간은 10일에서 70일까지였다. 주기적으로 간기능을 비롯한 검사항목등을 측정하였으며 총정맥영양의 기간, 조성, 투여속도, 열량 등이 조사 기록되었고 total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase에 대하여 군간 비교하였다. 결 과: Mixed procedure model을 이용한 분석에서 시험군을 reference로 하였을 때 대조군의 autoregressive coefficient 값은 total bilirubin의 경우 0.4419 (p=0.0651), AST는 -0.0431 (p=0.7923), ALT는 0.2398 (p=0.2416), 그리고 alkaline phosphatase는 0.2459 (p=0.1922)였다. 결 론: 총정맥영양과 UDCA를 초기부터 동시 투여하였을 때 total bilirubin은 대조군에 비하여 상승하지 않는 것으로 나타났으나 통계적으로 유의하지는 않았다.

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파킨슨병의 침구치료 동향에 대한 고찰 (A Review of Acupuncture and Moxibustion for the Treatment of Parkinson's Disease)

  • 이은;강기완;김락형;강세영;선승호;한창호;장인수
    • 대한한방내과학회지
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    • 제35권1호
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    • pp.12-23
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    • 2014
  • Objectives : The purpose of this study was to report possibility of acupuncture or moxibustion for the treatment of Parkinson's disease (PD) by reviewing literature about its effectiveness. Methods : In this review, PubMed, SCOPUS, Science Direct and CINAHL of EBSCOhost were used to search medical journals, using keywords "Parkinson's disease and acupuncture" and "Parkinson's disease and moxibustion". The search range included randomized controlled trials (RCT) about Parkinson's disease combined with another disease and other treatments with acupuncture or moxibustion. Non-randomized controlled trial (nRCT), case study, animal experiment, human experiment, review, survey, essay, letter, and protocol for review were excluded. Results : From 311 studies, 111 were selected during the title and the screening. Finally, 16 RCTs (15 for acupuncture research and one for moxibustion) were included in this review, after scanning and matching the inclusion and exclusion criteria. The number of patients varied between 5 and 88. A total of 12 studies using electroacupuncture (EA) were classified into acupuncture studies. The body acupuncture studies numbered 4, scalp acupuncture 4, body and scarp acupuncture mixed studies 4, and bee venom, ear and abdomen acupuncture were each one study. In evaluation methods, total effective rate method was used in 9 studies, the Unified Parkinson's Disease Rating Scale (UPDRS) was used in 8, and the Webster score in 2. In addition, the Berg balance scale (BBS), 30 m walking time, steps to walk 30 m, PD motor function score, and Motor Performance Series by Schoppe (MLS) method were used for evaluation. In 15 of the 16 studies, the verum acupuncture group showed significant improvement compared with the control. In 9 studies using total effective rate method, the effective rate was reported as 80.0-97.3% in verum acupuncture groups and 52.6-86.4% in controls. Conclusions : Acupuncture may be a plausible alternative method to care for the long term symptoms and treat movement impairment of Parkinson's disease. However, to confirm this result, high quality studies including randomized, placebo-controlled double-blind trials are warranted.

알레르기 비염에 대한 소청용탕(小靑龍湯)의 효과 평가 연구 : 체계적 문헌고찰과 메타분석 (A Study on Effectiveness of Socheongryong-tang for Allergic Rhinitis : A Systematic Review and Meta-analysis)

  • 민경진;신선호;강정인;이동효
    • 한방안이비인후피부과학회지
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    • 제33권4호
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    • pp.74-99
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    • 2020
  • Objectives : The purpose of this study is to assess the effectiveness and safety of Socheongryong-tang(SCRT) for allergic rhinitis(AR). Methods : We searched randomized controlled trials(RCTs) that used SCRT for AR in 8 databases(PubMed, Cochrane Library, CNKI, CiNii Articles, OASIS, NDSL, KISS, KMbase) from their inception until August 2019. The primary outcome was effective rate and scores evaluating the improvement of AR symptoms. The secondary outcome was quality of life scale, adverse events, recurrence rate, and laboratory indicators. Two researchers assessed the risk of bias in the included trials through the Cochrane Risk of Bias tool independently. The study synthesized outcomes using RevMan 5.3. Results : Eighteen RCTs involving 1686 participants were included in this review. The risk of bias was unclear for the majority of the included studies. Meta-analysis of 12 RCTs showed that there was no statistically significant difference between the SCRT group and usual care group in the effective rate(RR 1.18, 95% CI(0.98, 1.41), p=0.09, I2=46%). Meta-analysis of 5 RCTs showed that the combination treatment group of SCRT and usual care was significantly higher than the usual care group in the effective rate(RR 1.24, 95% CI(1.12, 1.38), p<0.0001, I2=0%). The SCRT group was more effective in improving nasal symptoms and quality of life than the placebo group according to one RCT. Mild adverse events such as dry mouth were identified in 5 RCTs, but no serious adverse events were reported. Conclusion : This review showed that in terms of the effective rate for AR, there was no statistically significant difference between SCRT and usual care and the combination treatment of SCRT and usual care was more effective than usual care. There were no serious adverse events. However, it is difficult to make a definite conclusion because of few included studies and heterogeneity between studies, and the quality of included studies was mostly insufficient. Further well-designed randomized controlled trials are needed.

만성치주염 환자에 대한 저용량 독시싸이클린의 임상적 효과 (Clinical Effect of the Subantimicrobial Dose of Doxycycline ( SDD ) on the Chronic Periodontitis)

  • 김윤식;백정원;김창성;최성호;김종관
    • Journal of Periodontal and Implant Science
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    • 제32권2호
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    • pp.415-428
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    • 2002
  • Periodontal disease is a complex infectious disease caused by bacteria in the oral mucosa, which results in gingival inflammation, breakdown of periodontal tissues, bone resorption, and finally tooth loss. Mechanical plaque control methods-scaling and root planing are effective methods to stop the progression of such periodontal disease. It was reported that subantimicrobial dose of doxycycline(SDD) regimen could improve clinical conditions of periodontal tissues without causing the overgrowth of opportunistic organisms that was a typical antibiotic side effect. Therefore pharmacological therapy, used in conjunction with mechanical therapy could be considered a useful treatment modality in the treatment of chronic periodontal disease. In this study, 30 patients diagnosed as moderate to advanced chronic periodontitis were divided into 2 groups. In this double-blind, placebo-controlled study, the patients were administered 20mg doxycycline capsule or placebo capsule b.i.d. for 4months, after scaling and root planing. Clinical parameters-bleeding on probing, pocket depth and clinical attachment level were compared and evaluated between these groups at periods of first visit, 1 month, 2 months, 3 months, 4 months. The results were as follows ; 1. In case of moderate periodontitis, pocket depth showed significant reduction after treatment in both the control & experiment groups, when compared with the baseline values(p<0.01), but in case of advanced periodontitis, only the experiment group showed significant reduction after treatment when compared with the baseline values(p<0.05). Statistically significant reduction in pocket depth was observed in the experiment group compared to the control group(p<0.05). 2. In case of moderate periodontitis, clinical attachment level showed significant reduction after treatment in both the control & experiment groups, when compared with the baseline values(p<0.01), but in case of advanced periodontitis, only the experiment group showed significant reduction after treatment when compared with the baseline values(p<0.05). Statistically significant reduction in clinical attachment level was observed in the experiment group compared to the control group(p<0.05). 3. Bleeding on probing improved after treatment in both the groups. In case of moderate periodontitis, the experiment group showed statistically significant reduction of bleeding on probing when compared with the control group at 1 and 4 months after treatment(p<0.05). In case of advanced periodontitis, treatment resulted in statistically significant reduction of bleeding on probing in both the groups(p<0.05). These results indicate that the use of subantimicrobial dose of doxycycline is a useful supplement to mechanical treatment for periodontal patients in ameliorating the clinical parameters such as periodontal pocket, attachment level, and bleeding on probing.