• 제목/요약/키워드: randomised control trial

검색결과 18건 처리시간 0.021초

$\ll$대한침구학회지\gg$에 실린 중재 관련 비무작위 비교연구논문의 질적 평가 (Quality Assessment of Non-randomised Comparative Clinical Studies in The Journal of Korean Acupuncture and Moxibustion Society)

  • 선종인;백용현;이상훈;이재동
    • Journal of Acupuncture Research
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    • 제27권1호
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    • pp.109-116
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    • 2010
  • Objectives : Since The Journal of Korean Acupuncture and Moxibustion Society(JKAMS) started publishing in 1984, randomised controlled trials(RCTs) and non-randomised clinical studies(NRSs) consistently have increased in quality and quantity. There has been no study on quality assessment of NRSs. Thus, this study evaluted non-randomised comparative clinical trials in the JKAMS to assess the quantity and quality. Methods : Upon extracting NRSs for assessing the intervention effects from all the articles published in the JKAMS from 1984 to 2009, assessments were made on methodological index for non-randomised studies(MINORS). Also, the analysis were made upon the proportion of non-randomised comparative clinical trials within original articles. The mean scores by research methods and years, and total scores and mean scores of yearly research methods were analyzed. Results : A total of 44 trials on non-randomised comparative clinical trials were selected. In 1980s, 4.3% of the total selected original articles, in 1990s, 4.1%, and in 2000s 14.2% were NRSs. According to the research designs, the mean scores of MINORS were Case-control study 18.3, Controlled before and after 18.5, Quasi randomised trial 18.5, and non randomised trial 17.9(out of 24), respectively. Cross-sectional study was the most frequently used(41.9%). Conclusion : Although NRSs consistently increased in quantity, the assessed mean scores were low and most articles used Cross-sectional study. Thus, there should be studied using appropriate research methods in the future.

Effectiveness of a Brief Physician Counselling Session on Improving Smoking Behaviour in the Workplace

  • Han, Yung Wen;Mohammad, Mohazmi;Liew, Su May
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권17호
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    • pp.7287-7290
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    • 2014
  • Background: Brief physician counselling has been shown to be effective in improving smokers' behaviour. If the counselling sessions can be given at the workplace, this would benefit a larger number of smokers. This study aimed to determine the effectiveness of a ten-minute physician counseling session at the workplace in improving smoking behaviour. Materials and Methods: This prospective randomised control trial was conducted on smokers in a factory. A total of 163 participants were recruited and randomised into control and intervention groups using a table of random numbers. The intervention group received a ten-minute brief physician counselling session to quit smoking. Stages of smoking behaviour were measured in both groups using a translated and validated questionnaire at baseline, one month and three months post intervention. Results: There was a significant improvement in smoking behaviour at one-month post intervention (p=0.024, intention to treat analysis; OR=2.525; CI=1.109-5.747). This was not significant at three-month post intervention (p=0.946, intention to treat analysis; OR=1.026; 95% CI=0.486-2.168). Conclusions: A session of brief physician counselling was effective in improving smokers' behaviour at workplace, but the effect was not sustained.

A single blind randomised placebo controlled clinical trial of a classical Ayurvedic formulation Ashokarista in the treatment of menorrhagia and dysmenorrhoea

  • Akhtar, Yasmeen;Alamgir, Mahiuddin;Khan, Mahmud Tareq Hassan;Hannan, JMA.;Choudhuri, M Shahabuddin Kabir
    • Advances in Traditional Medicine
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    • 제7권4호
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    • pp.372-378
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    • 2007
  • A well known Ayurvedic formulation Ashokarista, used for menstrual disorders has been studied in a single blind randomised placebo controlled clinical trial for the treatment of menorrhagia and dysmenorrhoea. Dysmenorrhoea and menorrhagia patients who were taking Ashokarista (20 ml twice daily) for 10 menstrual cycles had an increase in haemoglobin level. Menorrhagia treated group has shown to reduce the erythrocyte sedimentation rate level that has been increased in the menorrhagia control group. The platelet count, total count and differential count were observed unchanged in the study. The Ashokarista did not affect the SGPT and SGOT level, which signify its lack of toxicity in hepatic function. The treated menorrhagic patients showed an increase in serum albumin content and decrease in blood clotting time, whereas the serum protein content was observed unchanged. There was a significant increase in both serum cholesterol and triglyceride level, which usually associated with the use of oral contraceptives. No major side effects were observed by the clinicians during the study.

Herbal anti-inflammatory immunomodulators as host modulators in chronic periodontitis patients: a randomised, double-blind, placebo-controlled, clinical trial

  • Deore, Girish D.;Gurav, Abhijit N.;Patil, Rahul;Shete, Abhijeet R.;Naiktari, Ritam S.;Inamdar, Saurabh P.
    • Journal of Periodontal and Implant Science
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    • 제44권2호
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    • pp.71-78
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    • 2014
  • Purpose: Host modulatory therapy has been proposed as a treatment for periodontal diseases. A class of herbal medicines, known to be immunomodulators, alters the activity of immune function through the regulation of informational molecules such as cytokines. In the current study, we tested the hypothesis that herbal immunomodulator drugs act as an adjuvant to scaling and root planing (SRP) in alleviating periodontal inflammation by improving clinical and biochemical parameters. Methods: Sixty healthy subjects (30 in each group) with moderate and severe chronic periodontitis were enrolled in a double-blind, placebo-controlled, double-masked randomised controlled trial. The control group was treated with SRP and a placebo, whereas the test group was treated with SRP followed by dietary supplementation of Septilin for 3 weeks. Periodontal clinical parameters and serum C-reactive protein (CRP) levels were evaluated for all patients at the baseline, 3 weeks, and 6 weeks. Results: Improved gingival index scores found in the test group as compared to the control group were found to be statistically significant only after 3 weeks (P<0.001). In contrast, the decrease in the sulcus bleeding index and pocket depth scores was statistically highly significant in the test group as compared to the control group after 3 weeks and 6 weeks (P<0.001). However, reduced clinical attachment level and CRP scores, as reflected in the test group as compared to the control group, were not found to be statistically significant after both 3 weeks (P>0.05) and 6 weeks (P>0.05). Conclusions: The results of this clinical-biochemical study suggest that dietary supplementation with herbal immunomodulatory agents may be a promising adjunct to SRP and may aid in improving periodontal treatment outcomes.

Randomized Double-Blind Placebo-Controlled Trial of Propolis for Oral Mucositis in Patients Receiving Chemotherapy for Head and Neck Cancer

  • Akhavan-Karbassi, Mohammad Hasan;Yazdi, Mohammad Forat;Ahadian, Hakimeh;Sadr-Abad, Maryam Jalili
    • Asian Pacific Journal of Cancer Prevention
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    • 제17권7호
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    • pp.3611-3614
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    • 2016
  • Background: Propolis based preparations have a wide range of applications in various specialties of dentistry. The aim of this clinical trial was to test the efficacy of propolis as a mouthwash in the reduction of chemotherapy induced oral mucositis (OM) in a single center. Materials and Methods: In this randomised, controlled study patients undergoing chemotherapy were included consecutively and randomised to an experimental group receiving propolis mouthwash (n = 20) and a control group receiving diluted water (n=20). Oral mucositis, erythema and eating and drink ability were assessed at baseline and after 3 and 7 days using the World Health Organization (WHO) scale and the oral mucositis assessment scale (OMAS). Results: There were significant differences in OM, wound and erythema in propolis group compared to placebo, but no significant difference in eating and drink ability. However, it was interesting that 65% of the patients in the propolis group were completely healed at day 7 of the trial. No significant adverse events were reported by the patients. Conclusions: This study found that oral care with propolis as mouthwash for patients undergoing chemotherapy is an effective intervention to improve oral health. Our findings shouldlencourage health practitioners to apply propolis mouth rinse for the oral care of patients under chemotherapy.

교통사고 후 두통을 호소하는 환자의 풍지혈.후계혈 자침 효과에 대한 임상적 고찰 -무작위 임상 연구- (The Effect of Acupuncture at Fengchi($GB_{20}$) and Houxi($SI_3$) for Acute Headache Due to Whiplash Injury -Randomised Clinical Trial-)

  • 정원제;왕개하;김경호;배재익;김승현;조현석
    • Journal of Acupuncture Research
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    • 제27권4호
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    • pp.127-135
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    • 2010
  • Objectives : The main purpose of this study is to evaluate effects of acupuncture at Fengchi($GB_{20}$) and Houxi($SI_3$) for acute headache due to whiplash injury. Methods : This study was observed among 50 patients with acute headache due to whiplash injury who admitted to Bundang oriental medicine hospital of Dongguk University from June 16, 2009 to January 31, 2010. These patients were divided into two groups; One was control group that was acupunctured at general acupuncture points except Fengchi($GB_{20}$), Houxi($SI_3$)(Control group) and the other was acupunctured at Fengchi($GB_{20}$), Houxi($SI_3$) with general acupuncture points(Experimental group). Each patient was acupunctured once a day. The effect was assessed through self-rating headache index. Results & Conclusions : As a result of evaluation by using self-rating headache index, pain score at 8th day declined in both groups. But they were not difference between two groups at 8th day.

거짓침을 이용한 침연구의 현황 (Current evidence on acupuncture from sham needle studies)

  • 이향숙
    • Korean Journal of Acupuncture
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    • 제23권1호
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    • pp.95-109
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    • 2006
  • Objectives : There has been a considerable debate about how to best control for placebo effects in clinical trials of acupuncture. Recently several sham needles were developed and validated. This study aimed at summarising the validation studies of these needles and evaluating the outcomes of the randomised controlled trials (RCTs) using them. Methods : Computerised literature searches were performed using 'acupuncture' AND 'placebo OR sham' with a limitation of the results to RCTs in Medline via PubMed and the Cochrane Library. Only formally validated sham needle controlled studies were included. Data were extracted regarding study design, condition, sample size, credibility testing, intervention and outcomes. Methodological quality was assessed using a modified Jadad scale. Results : Three validated sham needles by Streitberger, Park, and Fink, were identified. Acupuncture's effectiveness for various conditions was tested using these needles in 12 RCTs. Real acupuncture was superior to sham acupuncture for rotator cuff tendonitis and hypertension. No significant differences between real acupuncture and sham acupuncture emerged for chemotherapy-related nausea and vomiting, postoperative nausea and vomiting, menstrually related migraine, acute stroke rehabilitation, chronic/episodic tension-type headache, neutrophil respiratory burst in healthy volunteers, alcohol withdrawal symptoms and chronic poststroke leg spasticity. Conclusions : The new sham devices have been adequately validated and may be useful tools for investigating specific research question. In spite of the sham needle's limits, the results of RCTs using such devices tend to suggest that the clinical effects of acupuncture are largely due to a placebo response.

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Omega 3 fatty acids as a host modulator in chronic periodontitis patients: a randomised, double-blind, palcebo-controlled, clinical trial

  • Deore, Girish D.;Gurav, Abhijit N.;Patil, Rahul;Shete, Abhijeet R.;NaikTari, Ritam S.;Inamdar, Saurabh P.
    • Journal of Periodontal and Implant Science
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    • 제44권1호
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    • pp.25-32
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    • 2014
  • Purpose: Periodontitis is an infectious disease caused predominantly by gram-negative anerobes. The host inflammatory response to these bacteria causes alveolar bone loss that is characterized as periodontitis. Omega-3 fatty acids (${\omega}$-3 FAs) have anti-inflammatory properties, thus have been used to treat some chronic inflammatory diseases such as cardiovascular disease and rheumatoid arthritis. We aimed to evaluate the effect of dietary supplementation with ${\omega}$-3 FAs as a host modulating agent in patients with chronic periodontitis. Methods: Sixty otherwise healthy subjects with moderate and severe chronic periodontitis were enrolled in our randomised, double-blind, placebo-controlled trial. The control group (CG, n=30) was treated with scaling and root planing (SRP) and given a placebo; the treatment group (TG, n=30) was treated with SRP and dietary supplementation of ${\omega}$-3 FAs (one 300 mg tablet daily for 12 weeks). Periodontal clinical parameters and serum C-reactive protein (CRP) levels were evaluated in all patients at baseline, a 6-week and 12-week period after treatment. Results: A significant reduction in the gingival index, sulcus bleeding index, pocket depth, and clinical attachment level was found in the TG compared to the CG at a 12-week period. However, no statistically significant changes in serum CRP levels were found. Conclusions: Our findings suggest that ${\omega}$-3 FAs can successfully reduce gingival inflammation, pocket depth, and attachment level gain. Dietary supplementation with ${\omega}$-3 FAs may have potential benefits as a host modulatory agent in the prevention and/or C management of chronic periodontitis.

Improving Participation in Colorectal Cancer Screening: a Randomised Controlled Trial of Sequential Offers of Faecal then Blood Based Non-Invasive Tests

  • Symonds, Erin L;Pedersen, Susanne;Cole, Stephen R;Massolino, Joseph;Byrne, Daniel;Guy, John;Backhouse, Patricia;Fraser, Robert J;LaPointe, Lawrence;Young, Graeme P
    • Asian Pacific Journal of Cancer Prevention
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    • 제16권18호
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    • pp.8455-8460
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    • 2016
  • Background: Poor participation rates are often observed in colorectal cancer (CRC) screening programs utilising faecal occult blood tests. This may be from dislike of faecal sampling, or having benign bleeding conditions that can interfere with test results. These barriers may be circumvented by offering a blood-based DNA test for screening. The aim was to determine if program participation could be increased by offering a blood test following faecal immunochemical test (FIT) non-participation. Materials and Methods: People were invited into a CRC screening study through their General Practice and randomised into control or intervention (n=600/group). Both groups were mailed a FIT (matching conventional screening programs). Participation was defined as FIT completion within 12wk. Intervention group non-participants were offered a screening blood test (methylated BCAT1/IKZF1). Overall participation was compared between the groups. Results: After 12wk, FIT participation was 82% and 81% in the control and intervention groups. In the intervention 96 FIT nonparticipants were offered the blood test - 22 completed this test and 19 completed the FIT instead. Total screening in the intervention group was greater than the control (88% vs 82%, p<0.01). Of 12 invitees who indicated that FIT was inappropriate for them (mainly due to bleeding conditions), 10 completed the blood test (83%). Conclusions: Offering a blood test to FIT non-participants increased overall screening participation compared to a conventional FIT program. Blood test participation was particularly high in invitees who considered FIT to be inappropriate for them. A blood test may be a useful adjunct test within a FIT program.

Effect of Screening on the Risk Estimates of Socio Demographic Factors on Cervical Cancer - A Large Cohort Study from Rural India

  • Thulaseedharan, Jissa Vinoda;Malila, Nea;Hakama, Matti;Esmy, Pulikottil Okuru;Cherian, Mary;Swaminathan, Rajaraman;Muwonge, Richard;Sankaranarayanan, Rengaswami
    • Asian Pacific Journal of Cancer Prevention
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    • 제14권1호
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    • pp.589-594
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    • 2013
  • Background: Prospective cohort studies to determine cofactors with oncogenic HPV-infections for cervical cancer are very rare from developing countries and such data are limited to the few screening trials. Large screening trials provide such data as a by product. Some of the cases are prevented by screening and do not surface as invasive cancers at all. Also, pre-invasive lesions are detected almost entirely by screening. Screening causes selection bias if attendance in or effectiveness of screening is correlated with the risk factors. The aim of this study was to quantify the influence of screening on risk factors for cervical cancer. Materials and Methods: Our material stems from a rural cohort of 80,000 women subjected to a randomised screening trial. The effect of screening on the incidence of cervix cancer was estimated with reference to socio-demographic and reproductive risk factors of cervical cancer. We compared these risks with the incidence of cancer in the randomised control population by the same determinants of risk. Results: The results in the screening arm compared to the control arm showed that the women of low SES and young age were benefitting more than those of high SES and old age. The relative risk by age (30-39 vs 50-59) was 0.33 in the control arm and 0.24 in the screening arm. The relative risk by education (not educated vs educated) was 2.8 in the control arm and 1.8 in the screening arm. The previously married women did not benefit (incidence 113 and 115 per 100,000 women years in control vs screening arms) whereas the effect was substantial in those married (86 vs 54). Conclusions: The results in controls were consistent with the general evidence, but results in attenders and nonattenders of the screening arm showed that screening itself and self-selection in attendance and effectiveness can influence the effect estimates of risk factors. The effect of cervical cancer screening programmes on the estimates of incidence of cervical cancer causes bias in the studies on etiology and, therefore, they should be interpreted with caution.