• 제목/요약/키워드: randomized clinical

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실용적 임상연구에 대한 이해와 적용을 위한 연구 사례 분석 (An Analysis of Clinical Trials for Understanding and Application of Pragmatic Clinical Trial)

  • 윤영주;강경원;최선미
    • Journal of Acupuncture Research
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    • 제26권5호
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    • pp.105-116
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    • 2009
  • The use of acupuncutre has been increased worldwide, and large number of researches on acupuncture with improved quality has been conducted. Nevertheless, results of acupuncture treatment in those research tend to show mixed results, while many patients continuously seek acupuncture treatment as an adjuvant or alternatives for their health. Researchers and clinicians relevant to acupuncture are faced at this problematic discrepancy between the results of acupuncture in clinical trial including an randomized controlled trial and those of day-to-day clinical practice. The methodology of pragmatic clinical trial seems to be one of the promising research tools administering this problem especially in the area of complementary alternative medicine and traditional Korean medicine. In this study we first reviewed articles on the pragmatic clinical trial, summarized the essential concepts of 'explanatory' clinical trial 'pragmatic' clinical trial and then presented recent recommendations and arguments on this issue. We also analyzed and compared two similar pragmatic clinical trial protocols to show the readers the complexity of research designing. We hope more researchers in traditional Korean medicine will be interested in the methodology of pragmatic clinical trials and this study will serve to produce various high-quality clinical trials.

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Statin 계열 약물의 제네릭 및 브랜드 제품 간 임상 치료결과 비교를 위한 체계적 문헌 고찰 (Systematic Review on Clinical Equivalence of Generic and Brand-name Drugs in Statin Therapy)

  • 심해리;이인향
    • 한국임상약학회지
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    • 제27권2호
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    • pp.105-112
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    • 2017
  • Background: Generic medications are approved on the basis of bioequivalence with brand medications in healthy volunteers rather than the target population, there remains a substantial uncertainty regarding their clinical effectiveness and safety. The object of this paper is to compare the clinical equivalence of generic statin drugs in patients. Methods: Literature published before September 2016, which is indexed in PubMed, EMBASE, RISS, comparing generic to brand products in statins. Outcomes included blood lipid level, proportion of days covered (adherence), hospitalization and mortality. Results: 511 citations were screened, of which 11 studies met eligibility criteria (6 randomized clinical trials, 5 observational studies). Generic atorvastatin was clinical equivalent with brand drugs in blood lipid level (3 RCTs) and generic simvastatin was also clinical equivalent with brand drugs (2 RCTs). 2 of 3 studies reported no significant difference in proportion of days covered except 1 study which reported generic statin significantly enhance proportion of days covered (p<0.001). Hospitalization was no significant difference in all studies (p>0.05). 1 study reported that all cause of mortality was significantly low in generic drugs (p<0.0001). Conclusion: Published data on comparing clinical efficacy of generic and brand statins were insufficient in both quantity and quality. This systematic review suggests that additional studies on clinical equivalence and safety of generic medications in patients would be needed.

Mandibular arch orthodontic treatment stability using passive self-ligating and conventional systems in adults: A randomized controlled trial

  • Rahman, Norma Ab;Wey, Mang Chek;Othman, Siti Adibah
    • 대한치과교정학회지
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    • 제47권1호
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    • pp.11-20
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    • 2017
  • Objective: This randomized controlled trial aimed to compare the stability of mandibular arch orthodontic treatment outcomes between passive self-ligating and conventional systems during 6 months of retention. Methods: Forty-seven orthodontic patients with mild to moderate crowding malocclusions not requiring extraction were recruited based on inclusion criteria. Patients (mean age $21.58{\pm}2.94years$) were randomized into two groups to receive either passive self-ligating ($Damon^{(R)}$ 3MX, n = 23) or conventional system (Gemini MBT, n = 24) orthodontic treatment. Direct measurements of the final sample comprising 20 study models per group were performed using a digital caliper at the debonding stage, and 1 month, 3 months, and 6 months after debonding. Paired t-test, independent t-test, and non-parametric test were used for statistical analysis. Results: A significant increase (p < 0.01) in incisor irregularity was observed in both self-ligating and conventional system groups. A significant reduction (p < 0.01) in second interpremolar width was observed in both groups. Mandibular arch length decreased significantly (p = 0.001) in the conventional system group but not in the self-ligating system group. A similar pattern of stability was observed for intercanine width, first interpremolar width, intermolar width, and arch depth throughout the 6-month retention period after debonding. Comparison of incisor irregularity and arch dimension changes between self-ligating system and conventional system groups during the 6 months were non-significant. Conclusions: The stability of treatment outcomes for mild to moderate crowding malocclusions was similar between the self-ligating system and conventional system during the first 6 months of retention.

퇴행성슬관절염에 대한 봉약침과 온침효과 비교 (A Comparative study of Warm needling and Bee Venom Pharmacopuncture on Osteoarthritis of the Knee - a Randomized Controlled Trial -)

  • 양가람;송호섭
    • 대한약침학회지
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    • 제11권2호
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    • pp.21-31
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    • 2008
  • Objective This study was performed to investigate whether Bee Venom Pharmacopuncture(BVP) could be a more effective modality than Warm Needling(WN) in relieving pain and symptoms of knee osteoarthritis(OA). Design Prospective, randomized and controlled clinical trial. Setting Single center trial in Korea Patients 49 volunteers with knee OA participated in the study. All the participants were screened through an inclusion and exclusion criteria. 33 participants were completed the clinical trial. Intervention The subjects were randomly assigned to one of two groups. One group received BVP(n=18), while the other group received WN(n=15). Sixteen sessions of BVP or WN were given at the pain region of the problematic knee for 8 weeks. Primary outcome measure is the Korean translation of Western Ontario and McMaster Universities Osteoarthritis Index scores(Korean WOMAC, KWOMAC). Secondary outcome measure is the physical health scores based on the 36-Item Short-Form Health Survey(SF-36) and Patient Global Assessment(PGA). KWOMAC and SF-36 were measured third (baseline, 4 and 8 weeks). PGA was measured twice(4 and 8 weeks). Results BVP group showed significant decrease compared to WN group in pain, function and total scores of KWOMAC according to the Mann-Whitney U-test. In the PGA, BVP group, compared to WN group, showed a significant increase. Conclusions BVP was more effective in relieving pain of knee OA than WN. These findings suggest that BVP is a promising alternative for treating knee OA.

A randomized, open labeled study comparing the serum levels of cobalamin after three doses of 500 mcg vs. a single dose methylcobalamin of 1500 mcg in patients with peripheral neuropathy

  • Sil, Amrita;Kumar, Hrishikesh;Mondal, Rahul Deb;Anand, Sidharth Sankar;Ghosal, Anirban;Datta, Ashis;Sawant, Sandesh V;Kapatkar, Vaibhavi;Kadhe, Ganesh;Rao, Sameer
    • The Korean Journal of Pain
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    • 제31권3호
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    • pp.183-190
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    • 2018
  • Background: Vitamin B12 deficiency has been associated with peripheral neuropathy, loss of sensation in the peripheral nerves, and weakness in the lower extremities. Methylcobalamin is the most effective analogue of vitamin B12 used to treat or prevent the complications associated with vitamin B12 deficiency. The current study aimed to compare the serum cobalamin levels after administration of two different regimes of methylcobalamin in peripheral neuropathy patients. Methods: The present study was a prospective, randomized, comparative study. The study consisted of two parallel groups, group A (methylcobalamin $500{\mu}g$ injection intramuscularly three times a week) and group B (methylcobalamin $1500{\mu}g$ injection intramuscularly once a week). A control group of healthy volunteers was also included. Results: A total of 24 patients (12 in each group) were included in the study. Five healthy volunteers were also included as a control in each group. At the end of treatment, serum cobalamin levels were significantly (P = 0.028) higher in group A ($1892.08{\pm}234.50$) as compared with group B ($1438.5{\pm}460.32$). The serum cobalamin levels in Group A healthy volunteers were also two times higher than that of group B (P = 0.056). Both the LANSS scale and DN4 questionnaire reported similar results at end of treatment. Conclusions: The $500{\mu}g$ methylcobalamin thrice weekly regime is more effective in increasing the serum cobalamin levels as compared to the $1500{\mu}g$ methylcobalamin once weekly regime.

Systematic Review of the Correlation Between Temporomandibular Disorder and Body Posture

  • Lee, Yoon-Joo;Park, Jong-Hyeon;Lee, Seung-Jeong;Ryu, Hye-Min;Kim, Su-kyeong;Lee, Young-Jun;Yoon, Hyun-Min;Jang, Sun-Hee;Song, Choon-Ho;Kim, Cheol-Hong
    • Journal of Acupuncture Research
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    • 제34권4호
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    • pp.159-168
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    • 2017
  • Background: The aim of this study was to identify well-supported evidence to aid medical treatment of temporomandibular disorder or dysfunction (TMD) in Korea by analyzing the correlation between TMD and body posture in recent international research. Methods: We looked for recent clinical studies on TMD and body posture in Korean and English databases. Bias risk was estimated using the Risk of Bias Assessment Tool for Non-Randomized Studies and the Cochrane Risk of Bias Tool for assessing randomized controlled studies. Results: Nine clinical studies, published between 2005 and 2017, were analyzed. In each, TMD was assessed using the American Academy of Orofacial Pain diagnostic criteria and the Research Diagnostic Criteria for Temporomandibular Disorder. Six studies evaluated body posture using photographs, four studies used stabilometry, and one used both photographs and stabilometry. Conclusion: Six of the nine studies found a correlation between TMD and body posture. Well-designed randomized controlled trials are needed to provide more data to assess the validity of this correlation.

척추신경추나의학회지에 수록된 무작위대조임상 연구의 양적, 질적 분석 (Randomized Controlled Clinical Trials in the Journal of Korean Society of Chuna Manual Medicine for Spine and Nerves: A Quantitative and Qualitative Analysis)

  • 조현우;이현엽;허광호;황의형;신미숙;신병철
    • 척추신경추나의학회지
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    • 제7권2호
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    • pp.15-23
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    • 2012
  • Objectives: The aim of this study is to assess the quantity and quality of randomized controlled clinical trials (RCTs) published in the journal of Korean Society of Chuna Manual Medicine for Spine and Nerves (KSCMSN). Methods: All relevant RCTs were selected and extracted. Data extract of RCTs from all the articles published in the jounal of KSCMSN up to now, quantity assessment was made on the study design, sample size, intervention, control group and medical condition. of the consolidated standards of reporting trials (CONSORT) check list. Assessment was performed by 2 independent reviewers and disagreement was discussed based on concensus. Results: Among the 276 articles, 10 RCTs were published. 1st articles were published in 2003 and half of RCTs were published in 2011. All RCTs were parallel 2-arm designed. Average sample size was 29.2 per study and 14.6 per arm. Main intervention was consisted as acupuncture 40%, pharmacopuncture 30% and Chuna 30%. Average of adequacy of CONSORT check list was 10.3% and overall reports were insufficient. Conclusions: Though RCTs published in jounal of KSCMSN were increasing, the quality remains low. KSCMSN should make a effort to follow the CONSORT statement and improve the quantity and quality of studies.

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급성기 대상포진의 침구치료에 대한 임상 연구 문헌 고찰 (A Review on Clinical Studies of Acupuncture and Moxibustion Therapy for Acute Herpes Zoster)

  • 최유민;김석희;김주용;박상훈;육태한;김종욱
    • Journal of Acupuncture Research
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    • 제32권3호
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    • pp.147-161
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    • 2015
  • Objectives : The purpose of this study was to review the effectiveness of acupuncture and moxibustion therapy for the treatment of acute herpes zoster. Methods : Data was collected by two researchers. Clinical trials on PubMed were retrieved using MeSH terms including "herpes zoster" combined with "acupuncture therapy", "moxibustion", "bloodletting", "electroacupuncture", and related keywords. We excluded irrelevant studies and included randomized and non-randomized controlled trials, case series and case reports. Finally, we selected a total of thirteen studies and conducted a literature analysis and an object quality assessment. Results : Twelve of thirteen studies were about acupuncture and moxibustion combined therapy. Only one study suggested that a single acupuncture therapy is expected to be equally as effective as a common western medicine therapy. There was some evidence related to the effectiveness of moxibustion, venesection and electroacupuncture, but it dealt with combining therapy and was insufficient, and with an inclusion of potential risk factors. Only one study was conducted under approval from an institutional review board. No severe treatment-related adverse events were observed. A quality assessment suggested that there was some weakness in the areas of blinding and concealment. Conclusions : There is some evidence that suggests the effectiveness and safety of acupuncture and moxibustion combined therapy as a treatment for acute herpes zoster.