• CELLMED
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• v.13 no.14
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• pp.18.1-18.13
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• 2023

Background and objectives: Bacterial vaginosis (BV) is recognized as the most prevalent type of vaginal infection, impacting approximately 19-24% of women in their reproductive years. The recurrence rate of BV is significant, negatively impacting the well-being of affected women. This study aimed to compare the therapeutic effects of a polyherbal Unani formulation and metronidazole in treating bacterial vaginosis. Methodology: In this prospective patient blinded standard controlled trial, a total of 40 individuals with a clinical diagnosis of bacterial vaginosis were randomly assigned to receive either an active control treatment (n = 20) or a test drug (n = 20). In the test drug combination of Acacia catechu, Azadirachta indica and Quercus infectoria in tablet (1g) form in the dose of 2 tablets orally twice daily with water was administered for 3 weeks. In the active control standard drug, metronidazole 400 mg tablet, orally twice daily was given for one week. The primary outcome measure was clinical cure; H. negative Amsel's criteria and a reduction in subjective symptoms, while the secondary outcome measure was an improvement in SF-36 quality of life (QOL). Results and conclusion: Both the experimental treatment and the metronidazole demonstrated a significant clinical cure for bacterial vaginosis as well as an increase in health-related quality of life. Based on these findings, it appears that the test medication is a potent Unani formulation for the treatment of bacterial vaginosis. A well conducted trial with a bigger sample size is required to corroborate these findings.

• Korean Journal of Oriental Medicine
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• v.17 no.2
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• pp.39-46
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• 2011

Objectives : This study was aimed to review the trend of dementia clinical studies in Korean Oriental Medicine and to suggest better clinical studies. Method : We collected 26 papers on dementia clinical studies in the internet site OASIS using the keyword 'Dementia'. Then we analyzed them. Results : There were 26 clinical study papers that were published between 1996 and 2010. Observational studies account for 61% of total clinical studies, whereas experimental studies account for only 31%. Effects of treatment in experimental studies was evaluated mainly by MMSE-K and K-DRS. Treatment period of experimental studies was longer than 100days. Conclusions : High quality experimental studies like randomized clinical trial(RCT) and intervention studies which use syndrome differentiation(辨證) have not yet been published. It is necessary to research and develop duration of treatment effect and tools for evaluating treatment effects.

• The Journal of Korean Medicine
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• v.31 no.5
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• pp.1-11
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• 2010

Objectives: This study aimed to evaluate any clinical studies regarding rhinitis published by the Korean Oriental Medical Society and its sub-societies for future rigorous clinical research. Methods: Every article relevant to rhinitis was initially obtained from journals of the Korean Oriental Medical Society and its sub-societies by electronic search at journal web sites or manual searches. Journals were limited to those registered with the Korea Research Foundation. From initial findings, two independent reviewers selected clinical articles and these articles were further analyzed separately by predefined criteria according to prospective and retrospective studies. For prospective studies, quality assessment was also conducted. Results: From 36 initially obtained articles, 17 were finally analyzed. 2 articles were randomized controlled studies, 6 articles were prospective whereas 9 were retrospective. In the prospective articles, there were no randomized controlled trials and the other non-randomized studies had no control group with several problems of quality regarding pre-calculated study size and unbiased assessment. None of the retrospective studies described rhinitis diagnosis objectively and outcome measures were either non-relevant to rhinitis or non-validated. Conclusions: Further well-designed randomized controlled studies for rhinitis are mandatory and more rigorous non-randomized controlled studies should be conducted.

• 대한예방의학회:학술대회논문집
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• 1994.02b
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• pp.206-233
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• 1994

The Medical Research Council has for some years encouraged collaborative clinical trials in leukaemia and other cancers, reporting the results in the medical literature. One unreported result which deserves such publication is the development of the expertise to design and analyse such trials. This report was prepared by a group of British and American statisticians, but it is intended for people without any statistical expertise. Part!, which appears in this issue, discusses the design of such trials; Part II, which will appear separately in the January 1977 issue of the Journal, gives full instructions for the statistical analysis of such trials by means of life tables and the logrank test, including a worked example, and discusses the interpretation of trial results, including brief reports of particular trials. Both parts of this report are relevant to all clinical trials which study time to death, and would be equally relevant to clinical trials which study time to other particular classes of untoward event: first stroke, perhaps, or first relapse, metastasis, disease recurrence, thrombosis, transplant rejection, or death from a particular cause. Part I, in this issue, collects together ideas that have mostly already appeared in the medical literature, but Part II, next month, is the first simple account yet published for non-statistical physicians of how to analyse efficiently data from clinical trials of survival duration. Such trials include the majority of all clinical trials of cancer therapy; in cancer trials, however, it may be preferable to use these statistical methods to study time to local recurrence of tumour, or to study time to detectable metastatic spread, in addition to studying total survival. Solid tumours can be staged at diagnosis; if this, or any other available information in some other disease is an important determinant of outcome, it can be used to make the overall logrank test for the whole heterogeneous trial population more sensitive, and more intuitively satisfactory, for it will then only be necessary to compare like with like, and not, by chance, Stage I with Stage III.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.36 no.1
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• pp.64-77
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• 2023

Objectives : Recently, the number of patients with dry eye syndrome has been steadily increasing. However, established treatment for it does not yet exist. This study compared electronic moxibustion with acupuncture for patients with dry eye in terms of efficacy and safety. Methods : This trial was designed as an investigator-initiated, single-blinded, comparative, randomized controlled trial. Thirty patients with dry eye were randomized to the electronic moxibustion treatment group(EMG) or the acupuncture treatment group(AG) in equal proportion. The participants who assigned to the EMG were treated with electronic moxibustion to ten acupoints including both sides of BL2, GB14, TE23, and LI4 for 12 minutes. The participants who were assigned to the AG were treated with acupuncture to the same acupoints for 15 minutes. Over 4 weeks, each intervention was carried out twelve times in total. The primary outcome was the ocular surface disease index(OSDI). The secondary outcomes were the subjective symptoms visual analog scale(VAS), quality of life(QoL), Schirmer I test(SIT), and general assessment. Adverse events and vital signs were also investigated for safety assessment. Results : In intragroup comparisons, both the EMG and the AG significantly improved the OSDI scores, the subjective symptoms VAS scores, the QoL scores, and the SIT results after 4 weeks of the trial. However, there were no statistical differences in intergroup comparisons between the two groups after 4 weeks. The safety of electronic moxibustion and acupuncture was confirmed by no occurrence of serious adverse events. Conclusions : Both electronic moxibustion and acupuncture were effective for dry eye syndrome, and they were safe. Electronic moxibustion and acupuncture can be used for dry eye syndrome as equivalent treatments.

• 대한예방의학회:학술대회논문집
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• 1994.02b
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• pp.180-187
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• 1994

A slightly modified version of the Quality-of-Life after Myocardial Infarction (QLMI) questionnaire developed by Oldridge and colleagues was applied in a self-administered mode to patients with suspected acute myocardial infarction (AMI) in a randomized controlled trial of secondary prevention. Acceptability of the questionnaire was good, with 93% of responders answering all items. Factor analysis suggested three quality-of-life (QL) dimensions which we called 'emotional', 'physical' and 'social'. These differed somewhat from the dimensions proposed by Oldtidge and colleagues. However, a sensitivity analysis showed relative invariance of results to weighting schemes. Scores on our three dimensions were responsive to differences between the treatment groups, and demonstrated construct validity based on associations between the measured QL and variables expected to affect QL. We conclude that the QLMI questionnaire has good potential as an instrument for assessing QL in post-AMI patients and that it can be successfully self-administered.

• The Journal of Korean Medicine
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• v.33 no.1
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• pp.12-23
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• 2012

Objectives: This study evaluated clinical trials of acupuncture treatment for hypertension and to assess their methodology and results. Methods: Eight Korean databases and four international databases were searched for clinical trials of acupuncture treatment for hypertension up to June 2011. Study quality was assessed using the risk of bias (ROB) tool. Results: Twenty-four trials of acupuncture for hypertension were included. There were 14 randomized and 1 non-randomized controlled trials and 9 before-after studies. The most frequently used acupuncture points were zsnli (ST36), qch (LI11), fngch (GB20), snynjio (SP06), snjin (LI03) and hgu (LI04). In more than half of the studies, needle retention time was 20~30 minutes. Compared to baseline, change of blood pressure after treatment was significant in all studies. However, the results of effect on blood pressure between acupuncture and control were not consistent. Conclusions: There is insufficient evidence to suggest that acupuncture is an effective treatment for hypertension. Further well-designed clinical trials will be required to evaluate the effects and safety of acupuncture treatment for hypertension.

• Journal of Acupuncture Research
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• v.29 no.3
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• pp.19-28
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• 2012

Objectives : The aim of this study is to evaluate present clinical evidence of oriental medical treatment for cancer in Korea. Method : A search was performed in the Korean Studies Information, Korea Institute of Science and Technology Information, KoreaMed, Oriental Medicine Advanced Searching Integrated System, National Assembly Library, RISS4u, DBPIA, and Oasis using the keyword 'cancer', 'leukemia', 'malignant tumor', 'lymphoma', 'multiple myeloma', 'melanoma'. The search period spanned between Jan 1, 1980~June 30, 2011 and the results were analyzed and evaluated according to the publication date, journal, method of treatment, type of study, and the primary outcome. Randomized clinical trials (RCTs) and Non randomized clinical trial(NRCT) were reviewed separately. Result : The results yielded 133 trials during the period of Jan 1, 1980~June 30, 2011. Most of the trials were concerned with lung cancer and 94 of the trials were simple case studies or case series studies. 61 trials used herbal Formula/herbal medicine as the primary method of treatment. A total of 4 RCTs existed compared to only one NRCT. Conclusion : The use of oriental medicine for the treatment of cancer is gaining popularity in the field of medical scientific research. However most of the studies that have been published up to date are mostly case studies or case series studies, and RCT/NRCT are rare. In order to provide appropriate evidence regarding the effectiveness of oriental medicine in the treatment of cancer, more rigorous and well-designed studies are warranted.

• Journal of Oriental Neuropsychiatry
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• v.25 no.4
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• pp.401-410
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• 2014

Objectives: This study was intended to review the research trends of treating neuropsychiatric diseases and symptoms with Traditional Chinese Medicine containing Haematitum. Methods: Articles were obtained through the CNKI (China National Knowledge Infrastructure) by searching with 'Haematitum' as the main key word, and supportive words related with neuropsychiatric diseases and symptoms were selected. There were 61 articles related to clinical fields, which were then classified according to study design. Results: The 61 articles were categorized into the following types of study design: 3 randomized controlled trials, 1 quasi-randomized trial, 3 simple-designed clinical trials, and 54 case studies. Decoctions containing Haematitum were used to treat diseases and symptoms such as vertigo, headache, stroke, epilepsy, neurosis, globus hystericus, fishbilepoisoning, insomnia, mania, post-traumatic brain syndrome, and kinesia. All articles reported a good rate of effectiveness. There was no poor responsiveness regarding the effects of Haematitum in 9 studies, but it was not mentioned in the other 52 studies. Decoctions self-prepared by the authors were used in 28 studies. Modified Seonbokdeja-tang, modified Banhabeakchulcheonma-tang, modified Ondam-tang were used in that order of frequency. The daily dosage of Haematitum provided was 0.2~6 g in powder, and 9~60 g in decoction. Conclusions: Decoctions containing Haematitum are used restrictively in the neuropsychiatric clinical scene. While there were no reports of poor responsiveness of the effects of Haematitum, more research is needed to confirm its clinical stability.

• The Journal of Internal Korean Medicine
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• v.42 no.6
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• pp.1184-1198
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• 2021

Objectives: The aim of this study was to investigate the latest clinical studies on Korean medicine treatment of post-concussion syndrome (PCS) in the Chinese National Knowledge Infrastructure Database (CNKI). Methods: We searched the last 10 years of clinical studies discussing Oriental medicine-based treatments for PCS in the CNKI database. The search focused on the authors, publication year, type of study, purpose of the study, method and duration of treatment, evaluation criteria, and results of each article. Results: Of the 22 selected studies, 1 was a non-randomized controlled trial (nRCT), 2 were case series, and 19 were randomized controlled trials (RCTs). Treatments included oral herbal medicine in 16 studies, oriental medicine through external use in 2 studies, acupuncture in 3 studies, and traditional Chinese medicine injection in 2 studies. The most frequently used herb was Cnidii Rhizoma (川芎). All 22 studies confirmed the efficacy of Oriental medicine treatments. Conclusion: More varied and scientifically designed clinical studies are required to develop treatments for PCS. The results of this study could be used as basic data for further PCS studies.