• Journal of Periodontal and Implant Science
• /
• v.44 no.2
• /
• pp.71-78
• /
• 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.

• Journal of Oriental Neuropsychiatry
• /
• v.21 no.4
• /
• pp.151-161
• /
• 2010

Objectives : This study aimed to evaluate any clinical studies regarding the herbal medicine for dementia focusing on Korean literature for future rigorous clinical research. Methods: Every article relevant to dementia was initially obtained from oriental medical related journals 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 randomized controlled trial and non randomized controlled trial. quality assessment was also conducted. Results: From ninety seven patients initially obtained articles. twenty three patients were finally analyzed. One article was randomized controlled study. Four articles were prospective whereas eighteen patients were retrospective. In the qualitative evaluation of prospective articles. there was deduction regarding pre-calculated study size and prospective data collecting. Assessment measurement most frequently used was Mini Mental State Examination. The order of frequency of use herbs were identified. Conclusions : According to our study. the herbal medicine for dementia in general showed a positive effect in the cognitive aspects of dementia patients. Further well-designed randomized controlled studies should be conducted.

• Herbal Formula Science
• /
• v.28 no.2
• /
• pp.199-209
• /
• 2020

Objectives : The purpose of this systematic review is to confirm whether Gwibitang is beneficial in chronic fatigue syndrome (CFS). Methods : Clinical trials were searched from databases including Pubmed, Embase, Central Cochrane, CNKI, Wanfang, CQVIP, CiNii, OASIS, Koreamed, and NDSL. The eligible study design was limited into randomized controlled trial, quasi-randomized controlled trial and controlled clinical trial. The outcomes included general effectiveness as nominal scale, and fatigue severity, insomnia severity and quality of life as interval or ratio scale. The meta-analysis and assessment of risk of bias was performed based on the data extracted from the selected trials. Results : The results of eight randomized controlled trials (n=596) were included in the meta-analysis. The results of the synthesis showed Gwibitang is beneficial substantially for relieving and managing the general symptoms, and its heterogeneity was not in important level (RR 0.26 [95% CI 0.17, 0.39], Z=6.47, P<0.00001, I²=0%). Gwibitang was beneficial for alleviating fatigue (SMD -0.78 [95% CI -1.27, -0.30], Z=3.17, P=0.002), but its certainty was low. In case of insomnia, too few trials had been found and their risk of bias was substantial, so no conclusions had been brought to. Conclusions : We found an evidence that Gwibitang could be beneficial for managing and alleviating main symptoms in CFS patients.

• Korean Medical Education Review
• /
• v.10 no.2
• /
• pp.25-44
• /
• 2008

Objectives: Through using of the strong research method like a Randomized Controlled Trial: RCT, we have to heighten quality of Medical Education study. I'd like to introduce "CONSORT", which stands for Consolidated Standards of Reporting Trials. Contents: Preventive Service Task Force(200l) in USA proposed Levels of evidence for enlarging evidence-based Practice: EBP. And the CONSORT was introduced, which encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled trials (RCTs). the CONSORT has 13 guides like these: 1. How participants were allocated to interventions 2. Scientific background and explanation of rationale 3. Eligibility criteria for participants. The settings and locations where the data were collected. 4. Precise details of the interventions intended for each group and how and when they were actually administered 5. Specific objectives and hypotheses 6. Clearly defined primary and secondary outcome measures, When applicable. any methods to enhance the quality of measurements (e.g., multiple observations, training of assessors) 7. How sample size was determined. When applicable, explanation of any interim analyses and stopping rules 8. Method used to generate the random allocation sequence, Details of any restriction [of randomization] 9. Method used to implement the random allocation sequence 10. Who generated the allocation sequence, who enrolled participants. and who assigned participants to their groups 11. Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment. If done, how the success of blinding was evaluated 12. Statistical methods used to compare groups for primary outcome(s), Methods for additional analyses, such as subgroup analyses and adjusted analyses 13. Flow of participants through each stage (a diagram is strongly recommended) Specifically, for each group report the numbers of participants randomly assigned. receiving intended treatment, completing the study protocol. and analyzed for the primary outcome. Results and Conclusion: Randomized Controlled Trial: RCT guided of CONSORT will contribute to do stronger evidence-based medical studies.

• Journal of Acupuncture Research
• /
• v.41 no.2
• /
• pp.107-114
• /
• 2024

Background: Low back pain (LBP) is a common musculoskeletal disorder worldwide, with a lifetime prevalence of up to 80%. Among nonsurgical treatments for chronic LBP, Korean medicine treatments are highly preferred, and pharmacopuncture therapy combining acupuncture and herbal medicine is widely used. However, no evidence-based study has focused on the use of various types of pharmacopuncture. Methods: The pragmatic randomized controlled clinical trial will include 44 participants; recruitment will start in July 2023. All participants will receive integrated Korean medicine treatment including acupuncture, cupping, and infrared therapy, and the intervention group will also receive pharmacopuncture. After 16 treatment sessions, twice a week for 8 weeks, follow-up assessments will be performed at week 9. As a pragmatic randomized controlled clinical protocol, the type, dose, and acupoints of acupuncture and pharmacopuncture are not determined in advance but are selected and recorded according to the clinical judgment of the Korean medicine doctor. Results: The primary outcome will be measured using a visual analog scale score, and the secondary outcomes include the Oswestry disability index, patient global impression of change, no worse than mild pain, and range of motion. Safety will be assessed by examining participants' self-reported adverse events and vital signs and conducting blood tests before and after the test. Conclusion: This study aims to provide clinical evidence of the effectiveness and safety of pharmacopuncture for chronic LBP.

• Journal of Pharmacopuncture
• /
• v.18 no.1
• /
• pp.79-85
• /
• 2015

Objectives: A vertebral compression fracture (VCF) is characterized by back pain and fracture of a vertebral body on spinal radiography. VCFs of the thoraco lumbar spine are common in the elderly. In general, appropriate analgesics should be prescribed to reduce pain and, thus, promote early mobilization. The ideal treatment approach for VCFs has not been determined. In Korea, acupuncture and herbal medication have been used to treat VCFs for many years. There is empirical evidence that acupuncture might benefit patients with a VCF. However, no randomized, controlled, clinical trials evaluating the efficacy and the safety of acupuncture for treating a VCF have been published. Therefore, we designed a randomized, controlled, pilot, clinical trial to obtain information for the design of a further full scale trial. Methods: A five week protocol for a randomized, controlled, pilot, clinical trial is presented. Fourteen patients will be recruited and randomly allocated to two groups: a control group receiving interlaminar epidural steroid injections once a week for three weeks, and an experimental group receiving interlaminar epidural steroid injections plus acupuncture treatment (three acupuncture sessions per week for three weeks, nine sessions in total). The primary outcomes will be the pain intensity (visual analogue scale and PainVision$^{TM}$ system). The secondary outcome measurements will be the answers on the short form McGill pain questionnaire and the oswestry disability index. Assessments will be made at baseline and at one, three, and five weeks. The last assessment (week five) will take place two weeks after treatment cessation. This study will provide both an indication of feasibility and a clinical foundation for a future large scale trial. The outcomes will provide additional resources for incorporating acupuncture into existing treatments, such as nonsteroidal anti-inflammatory medications, narcotics and vertebral augmentation. This article describes the protocol.

• Asian-Australasian Journal of Animal Sciences
• /
• v.20 no.9
• /
• pp.1433-1437
• /
• 2007

Two field trials were carried out to evaluate the performance of a soluble glass copper, cobalt and selenium bolus for maintaining adequate levels of the three trace elements in yaks. Forty yaks were used in trial 1 and 60 yaks were used in trial 2. In each trial two commercial soluble glass boluses were administered to half of the yaks. Blood samples were taken from the jugular vein at day 0, 30, 60, 90 in trial 1 and at day 0, 45, 75 and 105 in trial 2. The samples were analysed for copper status (serum caeruloplasmin activity and copper concentration), cobalt status (serum vitamin $B_{12}$ concentration and cobalt concentration), selenium status (erythrocyte glutathione peroxidase activity and selenium concentration) and serum zinc concentration. The erythrocyte glutathione peroxidase activities, serum caeruloplasmin activities and serum vitamin $B_{12}$ concentrations for trial 1 and 2 were all significantly increased for the bolused yaks (p<0.001 or p<0.01) on all sampling days. The bolused yaks had a significantly higher selenium and copper status in serum than the control yaks on all sampling days in trial 1 and 2 (p<0.05 or p<0.01). There were no significant differences in zinc and cobalt concentrations between the bolused yaks and the controls.

• Journal of the Korea Academia-Industrial cooperation Society
• /
• v.11 no.11
• /
• pp.4395-4403
• /
• 2010

The aim of this study is to know about condition of alternative medicine. Methods which An literature search in Pubmed January 2000 to March, 2010 was performed. RCT(Randomized Controlled Trial), CCT(Controled Clinical Trials), and OD(efficacy studies with either a controlled or an Other than controlled Design) were included. PubMed databases were searched using key terms relating to alternative medicine. 19 clinical trials were included among 682 studies searched. RCT was 44%, CCT was 16% and OD was 40% in the review. In the all of included studies, the acupuncture and the massage was the biggest part. The using rate was 20% of pain control about Disease of the Musculoskeletal system and Connective tissue, 15% of Certain infectious and parasitic diseases, and 15% of Neoplasms. There was lack of evidence that alternative medicine was effective for progress. Future well-designed clinical trials is needed.

• Journal of Oriental Neuropsychiatry
• /
• v.20 no.4
• /
• pp.79-89
• /
• 2009

Objectives : To address suitable method for designing clinical trial intervening Traditional Korean Herbal Medicine on General anxiety disorder through the recent clinical research in Chinese Herbal Medicine. Methods : Randomized, controlled trials(RCTs) of treatment of general anxiety disorder intervening herbal medicine were searched through CNKI databases. We examined several item of studies and evaluated using Jadad scale. We searched articles in CNKI with the key word "General anxiety disorder or 廣範性焦慮症", among them we selected the clinical trial studies related with herbal medicine except for case reports, studies of acupuncture therapy or west medicines. Results : 11 RCT studies of herbal medicine met inclusion criteria. The Studies used CCMD-3, HAMA as inclusion tool and mainly HAMA as a evaluation tool. Studies were progressed for 2-8 weeks, mostly used various positive control. Experiment medicine were mainly 理氣劑, 安神劑. In most studies, experiment group made similar or higher efficacy in comparison with control group. Mean Jadad score of studies was $1.3{\pm}0.67$, and only one study was double-blinded among 11 studies. Conclusions : RCT studies on general anxiety disorder of chinese herbal medicine tend to focus on investigating effect of herbal medicine through setting positive control group with CCMD-3 and HAMA. But, most studies had low quality of trial, for lack of pattern identification, evaluation and inclusion tool of chinese medicine. Clinical trials of general anxiety disorder should provide good quality by randomization, double-blinding, and multi-site trial.

• Korean Journal of Acupuncture
• /
• v.35 no.2
• /
• pp.70-81
• /
• 2018

Objectives : To investigate the association of trial registration status with presence of reporting bias including publication bias and outcome reporting bias in recently published randomized controlled trials (RCTs) of acupuncture. Methods : A PubMed search for RCTs of acupuncture published from March 2016 to February 2017 was conducted. Primary outcomes were identified and the direction of the results was judged as positive (i.e., statistically significant) or negative. The trial registration was identified by manually screening the trial registration number in the main text of the published article and classified into 1) prospective registration; 2) retrospective registration based on the registration date or; 3) no registration. Results : Of the 125 included RCTs, only 40 studies (32.0%) prospectively registered the study protocols. Among 65 RCTs that adequately reported the primary outcome, unregistered trials were more likely to report positive results than the registered ones (p=0.013). Of the 40 prospectively registered studies, 19 trials (47.5%) had the discrepancies between the registered and published primary outcomes and furthermore, 40% of them reported the positive findings. Conclusions : Unregistered trials were more likely to report positive results and the discrepancies between the registered and published primary outcomes were detected in about a half of the prospectively registered studies, 42.1% of which tended to report positive findings. Journal editors and researchers in this field should be alerted to various reporting biases.