• Journal of Acupuncture Research
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• v.27 no.1
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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.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.17
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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.

• Advances in Traditional Medicine
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• v.7 no.4
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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.

• Korean Journal of Acupuncture
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• v.34 no.4
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• pp.251-264
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• 2017

Objectives : To identify the prevalence and types of spin in randomised controlled trials(RCTs) of obesity with statistically non-significant results for primary outcomes to provide adequate reporting directions. Methods : Spin is specific reporting strategy that could lead the readers to misinterpret the results of RCTs. RCTs on obesity with statistically non-significant primary outcomes published from July 2015 to June 2016 were retrieved from PubMed. All included RCTs were classified into 3 intervention categories. The identification and classification of spin in the included articles was performed by two independent researchers. Results : Among 46 RCTs with statistically non-significant primary outcomes, 32 studies were assessed as having at least one spin in title, abstract or main text. Of these, 9 articles were on complementary and alternative medicine, 7 on western medicine and 16 on dietary supplement and exercise. The frequency of spin among the types of interventions was similar. The most common type of spin was 'focusing on statistical significance within-group comparison' in results section of abstract and main text, and 'focusing only on treatment effectiveness with no consideration of statistical significance' in conclusion section of abstract and main text. Studies where random sequence generation was appropriately done was less likely to have spin. Conclusions : As a majority of obesity RCTs have spin, researchers should pay more attention to adequately interpreting and reporting statistically non-significant results.

• Journal of Periodontal and Implant Science
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• v.44 no.2
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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.

• Asian Pacific Journal of Cancer Prevention
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• v.17 no.7
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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.

• Journal of Ginseng Research
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• v.37 no.1
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• pp.30-36
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• 2013

The aim of this review was to assess the effectiveness of ginseng as a treatment option for managing menopause symptoms. We searched the literature using ll databases from their inception to 26 September 2012 and included all randomised clinical trials (RCTs) that compared any type of ginseng to a placebo controls in postmenopausal women. The methodological quality of all studies was assessed using a Cochrane risk of bias tool. Four RCTs met our inclusion criteria. Most RCTs had high risk of bias. One RCT showed that Korean red ginseng (KRG) significantly improved sexual arousal and global health compared with placebo. Another RCT reported the superiority of KRG over placebo for treating menopause symptoms on Kupperman's index and menopausal rating score. The third RCT failed to show a significant effect of KRG on hot flash frequency compared to placebo. The fourth RCT found beneficial effects of ginseng compared to placebo on depression and well-being. In conclusion, the evidence on ginseng as an effective treatment for managing menopause symptoms is limited. Most of the RCTs are burdened with a high risk of bias. Thus firm conclusions cannot be drawn. Rigorous studies seem warranted.

• Korean Journal of Acupuncture
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• v.23 no.1
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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.

• Journal of Acupuncture Research
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• v.27 no.4
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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.

• Journal of Physiology & Pathology in Korean Medicine
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• v.21 no.5
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• pp.1185-1193
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• 2007

Ginsing polysaccharide, known to have an immune regulating effect, was administered to 23 randomly selected healthy male subjects with a mean age of 23 years in accordance with an IRB approval. Then, these subjects underwent physico-chemical tests and serum proteome was analyzed from the blood sample taken from these subjects. Analyses of proteome involved image analysis, protein sections and protein identification in sequence after two-dimensional electrophoresis was carried out. During the physico-chemical test, 4 subjects were excluded from the study. In the proteome analysis, identified were 5 spots such as SP40, 40, Cytokeratin 9, hypothetical protein LOC544932, Apolipoprotein E ,similar to Human albumin, which showed differences in the amount of protein expression. In conclusion, changes of 5 proteins were remarkable before and after administration of ginsing polysaccharides. In certain cases, hepatic and renal slight injury occurred. Thus, further clinical study on dosage regimen would be necessary for securing the basis for concentration-dependent effectiveness and safety.