• 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.

• 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.

• 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.

• 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.

• 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.

• 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 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.

• Journal of Periodontal and Implant Science
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• v.44 no.1
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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.

• The Korean Journal of Pain
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• v.24 no.1
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• pp.22-30
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• 2011

Background: Pregabalin has been shown to have analgesic effect in acute pain models. The primary objective was to examine the efficacy a single dose of pregabalin, would have on morphine consumption following lumbar discectomy. Methods: With ethical approval a randomized, placebo-controlled prospective trial was undertaken in 32 patients (ASA I-II, 18-65 years) with radicular low back pain for > 3 months undergoing elective lumbar discectomy. Patients received either oral pregabalin 300 mg (PG Group) or placebo (C Group) one hour before surgery. Pain intensity, the accumulative morphine consumption and adverse effects were recorded for 24 hours following surgery. Functional, psychological and quantitative sensory testing were also assessed. Results: Fourteen patients out of the 32 recruited were randomized to receive pregabalin. Morphine consumption was reduced (absolute difference of 42.3%) between groups with medium effect size. (Mann-Whitney; U =52.5, z-score= 2.84, P = 0.004, r = 0.14). This was not associated with a significant difference in the incidence of adverse effects between the two groups. The median pain intensity (VAS) on movement was not significantly different between groups. Conclusions: A single pre-operative dose of pregabalin (300 mg) did not result in a reduction in pain intensity compared to placebo in this patient cohort but the significant reduction in morphine consumption suggests that a fixed peri-operative dosing regime warrants investigation.

• Journal of Acupuncture Research
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• v.35 no.2
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• pp.95-100
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• 2018

Background: The aim of this study is to assess the feasibility of acupuncture treatment for the management of subacute and chronic post-thoracotomy pain in patients with traumatic multiple rib fractures. Methods: A total of 30 participants who have undergone thoracotomy after traumatic multiple rib fractures will be recruited. Participants will be invited and equally randomised into acupuncture plus usual care and usual care alone groups. A computer-generated random number sequence will be used and concealed using opaque, sealed, sequentially numbered envelopes. Twelve sessions of manual and electrical acupuncture performed by Korean medicine doctors will be provided over a span of 3 months to participants allocated to the acupuncture group. Participants in the usual care group will continue pain medication, exercise and physical therapy as required. Study feasibility will be measured based on the proportion of patients who complete the measurement of pain at 12 or 24 weeks after baseline. The clinical outcomes will include; the average pain intensity over the recent week at rest, movement and cough, quality of life, patient's global assessment of recovery, respiratory function measured by the pulmonary function test and use of pain medication at 4, 8, 12 and 24 weeks after enrolment. Adverse events will be recorded for all participants. Written informed consent will be obtained from all participants. The local ethics committee has approved the study. This pilot trial will inform further studies investigating the potential role of acupuncture for subacute and chronic post-thoracotomy pain in patients with traumatic multiple rib fractures.