• 동의신경정신과학회지
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• 제29권1호
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• pp.35-46
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• 2018

Objectives: The aim of this trial is to evaluate the efficacy and safety of Yukwool-tang (Liuyu-tang) for the treatment of major depression in women by comparing the Yukwool-tang (Liuyu-tang)-treated group with the placebo-treated group and assessing the association of various biological factors related to depression through various outcome measures. Methods: This study is a single-center, randomized, double-blind, placebo-controlled, parallel-design clinical trial. The subjects to be selected are women between the ages of 19 and 65, and the registered subjects are to be randomly assigned to treatment with Yukwool-tang or the placebo control. The Yukwool-tang group will take 1 bottle of Yukwool-tang (30 mg) for 8 weeks, 3 times a day, before meals. The control group will take the placebo in the same way. The primary outcome to be examined will be the change between the total score after 8 weeks and the total score before the start of the study of the K-HDRS score. Secondary outcomes are assessed by the change in total score after 12 weeks of K-HDRS, K-HDRS remission rate, K-HDRS improvement rate, BDI-K, PITD, KSCL-95, ISI, STAI-K, EQ-5D, VAS, Emotional Stimulation Test, BDNF test, inflammatory cytokine and tumor necrosis factor test, intestinal microbiome test, dietary report and Beck's hopelessness scale. Results: This protocol has been approved by the IRB of Dunsan Korean Medicine Hospital of Daejeon University and is registered in the CRIS, and it is made public in advance to ensure transparency of the research process and conduct ethical clinical trials. Conclusions: Based on this protocol, when the trial is completed, its data can be used to access the validity and safety of Yukwool-tang for major depression in women, and it is also expected to be helpful in the study of the correlation between future treatment of Korean medicine for depression and related biological factors, and quality of life.

• Clinical and Experimental Reproductive Medicine
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• 제48권4호
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• pp.311-315
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• 2021

Objective: As clinicians and patients await consensus on intraovarian platelet-rich plasma (PRP) treatment, this project evaluated contemporary research trends in the literature. Methods: A PubMed/NLM search aggregated all ovarian PRP-related publications (n=54) to evaluate their scope, abstract utility, submission-to-publication interval, journal selected, article processing charge (APC), free reader access to full-text manuscripts, number and nationality of authors, and inclusion of international collaborators. The NIH Clinical Trials database was also audited. Results: Published output on intraovarian PRP has increased consistently since 2016, especially among investigators in Greece, Iran, USA, and Turkey. Between 2013 and 2021, 42 articles met the relevancy criteria, of which 40.5% reported clinical studies, small series, or case reports, 33% described experimental animal models, and 23.8% were opinion/review papers. Only two works included a placebo control group. The submission-to-publication interval (mean±standard deviation) was 130±96 days, there were 5.9±3.2 authors per project, and journals invoiced US $1,613±1,466 (range, $0-$3,860) for APCs. Conclusion: There was no correlation between APC and time to publish (Pearson's r=-0.01). Abstract content was inconsistent; sample size and patient age were often missing, yet free full-text "open access" was available for most publications (59.5%). The NIH Clinical Trials portal lists eight registered studies on "ovarian rejuvenation," of which two are actively recruiting patients, while four have been terminated or have an uncertain status. Two studies have concluded, with results from one posted to the NIH website. PRP and its derivatives for ovarian treatment show early promise, but require further investigation. Research is accelerating and should be encouraged, particularly placebo-controlled randomized clinical trials.

• Safety and Health at Work
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• 제6권3호
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• pp.256-262
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• 2015

Background: Heart attack is the most common cause of line-of-duty death in the fire service. Daily aspirin therapy is a preventative measure used to reduce the morbidity of heart attacks but may decrease the ability to dissipate heat by reducing skin blood flow. Methods: In this double-blind, placebo-controlled, crossover study, firefighters were randomized to receive 14 days of therapy (81-mg aspirin or placebo) before performing treadmill exercise in thermal-protective clothing in a hot room [$38.8{\pm}2.1^{\circ}C$, $24.9{\pm}9.1%$ relative humidity (RH)]. Three weeks without therapy was provided before crossing to the other arm. Firefighters completed a baseline skin blood-flow assessment via laser Doppler flowmetry; skin was heated to $44^{\circ}C$ to achieve maximal cutaneous vasodilation. Skin blood flow was measured before and after exercise in a hot room, and at 0 minutes, 10 minutes, 20 minutes, and 30 minutes of recovery under temperature conditions ($25.3{\pm}1.2^{\circ}C$, $40.3{\pm}13.7%\;RH$). Platelet clotting time was assessed before drug administration, and before and after exercise. Results: Fifteen firefighters completed the study. Aspirin increased clotting time before and after exercise compared with placebo (p = 0.003). There were no differences in absolute skin blood flow between groups (p = 0.35). Following exercise, cutaneous vascular conductance (CVC) was $85{\pm}42%$ of maximum in the aspirin and $76{\pm}37%$ in the placebo groups. The percentage of maximal CVC did not differ by treatment before or after recovery. Neither maximal core body temperature nor heart rate responses to exercise differed between trials. Conclusion: There were no differences in skin blood flow during uncompensable heat stress following exercise after aspirin or placebo therapy.

• Journal of Dental Anesthesia and Pain Medicine
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• 제20권6호
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• pp.337-356
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• 2020

This systematic review focused on the efficacy of topical products in reducing temporomandibular joint disorder (TMD)-associated pain, in comparison to placebo or control interventions. The EMBASE, Web of Science, Cochrane Library, and MEDLINE via PubMed databases were searched for randomized controlled trials (RCTs) using topical interventions in adults diagnosed with TMD. The pain intensity was the primary outcome, and other clinical findings were the secondary outcomes. The risk of bias was evaluated according to the Cochrane's handbook. The search up to February 7, 2020 identified a total of 496 unduplicated references. Nine RCTs with 355 adult patients diagnosed with TMD were included. The meta-analysis did not show a significant reduction in baseline pain intensity in the nonsteroidal anti-inflammatory drug (NSAIDs) group, when compared to the placebo group (P = 0.288). One study demonstrated a statistically significant pain score decrease for Theraflex-TMJ compared to placebo after 10 d of treatment (P = 0.003) and follow-up, 5 d after the last application (P = 0.027). Ping On reduced pain at 4 weeks of application (P < 0.001) but not after 7 d of application (P = 0.136). In one study, cannabidiol (CBD) significantly improved the pain intensity compared to placebo (P < 0.001). However, no differences were found with capsaicin in the two studies (P = 0.465). Evidence was of low quality because the studies were considered as having an unclear or a high risk of bias and a small number of studies were analyzed. The evidence is not sufficient to support the use of topical NSAIDs and capsaicin, and limited evidence was found for Threraflex-TMJ, bee venom, Ping On, and CBD, with only one study reporting for each. Additional studies are recommended to validate these results.

• Journal of Dental Anesthesia and Pain Medicine
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• 제21권6호
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• pp.479-506
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• 2021

Background: Chronic neuropathic pain (NP) presents therapeutic challenges. Interest in the use of cannabis-based medications has outpaced the knowledge of its efficacy and safety in treating NP. The objective of this review was to evaluate the effectiveness of cannabis-based medications in individuals with chronic NP. Methods: Randomized placebo-controlled trials using tetrahydrocannabinol (THC), cannabidiol (CBD), cannabidivarin (CBDV), or synthetic cannabinoids for NP treatment were included. The MEDLINE, Cochrane Library, EMBASE, and Web of Science databases were examined. The primary outcome was the NP intensity. The risk of bias analysis was based on the Cochrane handbook. Results: The search of databases up to 2/1/2021 yielded 379 records with 17 RCTs included (861 patients with NP). Meta-analysis showed that there was a significant reduction in pain intensity for THC/CBD by -6.624 units (P < .001), THC by -8.681 units (P < .001), and dronabinol by -6.0 units (P = .008) compared to placebo on a 0-100 scale. CBD, CBDV, and CT-3 showed no significant differences. Patients taking THC/CBD were 1.756 times more likely to achieve a 30% reduction in pain (P = .008) and 1.422 times more likely to achieve a 50% reduction (P = .37) than placebo. Patients receiving THC had a 21% higher improvement in pain intensity (P = .005) and were 1.855 times more likely to achieve a 30% reduction in pain than placebo (P < .001). Conclusion: Although THC and THC/CBD interventions provided a significant improvement in pain intensity and were more likely to provide a 30% reduction in pain, the evidence was of moderate-to-low quality. Further research is needed for CBD, dronabinol, CT-3, and CBDV.

• 대한한방내과학회지
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• 제38권4호
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• pp.433-442
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• 2017

Objectives: The purpose of this study was to assess the effectiveness of acupuncture for the treatment of Raynaud's disease. Methods: This review was conducted using nine electronic databases (CINAHL, CiNii, CNKI, EMBASE, J-STAGE, NDSL, OASIS, PubMed, and WANFANG) and the keywords "Raynaud's disease", "Raynaud disease", "acupuncture", and "needling". Only randomized controlled trials (RCTs) using acupuncture for Raynaud's disease were included, and the methodological quality of the trials was assessed using the Cochrane risk-of-bias tool. Results: After screening, six RCTs were selected among 67, and the total effective rate and peripheral blood flow were used as evaluation methods. In five studies, the total effective rate was significantly higher in the intervention group than in the control group. In three studies, peripheral blood flow was higher in the intervention group than in the control group, with two studies being statistically significant and the remaining study not being statistically significant. Conclusions: Acupuncture could be a suitable treatment without adverse effects for Raynaud's disease because it improves peripheral blood flow. However, further studies, including randomized, placebo-controlled, double-blind methods, and clear evaluation criteria are needed.

• 한방재활의학과학회지
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• 제26권4호
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• pp.23-35
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• 2016

Objectives This systematic review is to support the effectiveness of herbal medicine for the treatment of simple obesity in adults. Methods A total of 8 electronic databases were searched in English, Chinese and Korean. Standard methodologies for the systematic review were used to search, analyze and synthesize data based on NECA's guideline for undertaking systematic review and meta-analyses for intervention. Results After screening 1781 potential articles, we identified 13 randomized controlled trials (RCTs). We conducted a meta-analysis for the study using Bangpungtongsung-san and Taeeumjowi-tang to evaluate the effectiveness of herbal medicines on weight loss compared to placebo control. Both herbs showed positive effect in weight, body mass index and waist circumference. In an analysis comparing herbal effects considering constitutions showed that proper treatment can lower adverse events. Conclusions Our results provide evidence that herbal medicine can be an effective treatment for the obesity compare to placebo or to conventional medicine without serious adverse events. Further study is needed to evaluate effectiveness of herbal medicines considering personalized treatment and its safety.

• Clinical Nutrition Research
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• 제13권3호
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• pp.201-213
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• 2024

This systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to test our hypothesis that herbal tea may improve anthropometric parameters, metabolic factors, and hormone levels in women with polycystic ovarian syndrome (PCOS). A literature search was conducted on Information Sciences Institute, Medline (PubMed), Scopus, Embase, and Google Scholar, up to March 2023 without applying language or date restrictions. RCTs that assigned herbal tea vs. placebo on PCOS women and evaluated changes in anthropometric measurements, metabolic indices, or hormonal profiles were included. Six RCTs with 235 PCOS women (119 in the intervention and 116 in the control group) were included. Meta-analysis showed that herbal tea consumption led to significant decreases in weight (weighted mean difference [WMD], -2.02 kg; 95% confidence interval [CI], -3.25, -0.80), body mass index (BMI) (WMD, -0.88 kg/m²; 95% CI, -1.47, -0.28) and fasting blood glucose (FBG) (WMD, -6.47 mg/dL; 95% CI, -8.49, -4.45), compared to the control group. Herbal tea supplementation has also significantly increased follicle-stimulating hormone (FSH) concentration (WMD, 0.56 IU/L; 95% CI, 0.17, 0.95). Meanwhile, the effect of herbal tea on the waist/hip ratio, hip circumference, waist circumference, body fat, fasting insulin, FBG/insulin ratio, luteinizing hormone, total testosterone, and dehydroepiandrosterone sulfate was not significant. Herbal tea might be a potential supplemental therapy to manage weight, BMI, FBG, and FSH in PCOS women. Further large randomized clinical trials are recommended to affirm these findings.

• 대한족부족관절학회지
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• 제15권3호
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• pp.115-118
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• 2011

족관절 내 히알루론산 주사 후 효과에 대한 참고 자료를 살펴 본 결과 대부분의 연구들이 족관절 내 히알루론산 주사에 대한 효과와 안전에 대해 긍정적으로 보고하고 있지만, 아직까지는 결론을 짓기는 어렵다고 하겠다. 추후 많은 환자를 대상으로 한 무작위 이중맹검 위약대조군 연구(randomized double-blind placebo-controlled trials)를 통해 그 결과를 평가해야 할 것으로 사료되며, 또한 장기 추시를 통해 효과 발현 시기 및 지속 기간을 평가해야 할 것이다.

• 대한약침학회지
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• 제23권1호
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• pp.8-17
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• 2020

Aim of the study: The objective of this systematic review is to critically evaluate the evidence of the effectiveness and safety of external application of herbal medicines (EAHM) for acne vurgalis (AV). Methods: English, Chinese and Korean language databases were searched up to May 2018. Randomized clinical trials (RCTs) that reported the effects of EAHM for AV were included and analysed. Results: A total of 10 randomized trials with 656 AV patients were identified. A meta-analysis of two RCTs indicated that EAHM had a significant effect on improving primary outcome 'global assessment' compared with placebo (mean difference (MD) = -2.62, confidence interval (CI) = -4.84 to -0.40, p = 0.02). Furthermore, data extracted from two RCTs showed that EAHM significantly reduce primary outcome 'inflammatory lesion count of acne' (MD = -1.25, CI = -1.68 to -0.83, p < 0.00001) and 'non-inflammatory lesion count of acne' (MD = -1.32, CI = -1.75 to -0.90, p < 0.00001). No significant difference was observed between groups in secondary outcome 'sebum of skin' (MD = -0.21, CI = -0.53 to 0.11, p = 0.20) and 'patient-reported changes in symptom' (relative risk (RR) = 2.56, CI = 0.43 to 15.22, p = 0.30). No severe adverse events (AEs) were found and no treatment was stopped due to AEs of EAHM. Conclusions: EAHM seems to have affirmative effects, but quality of evidence, and non-standardized use of EAHM make our conclusion weak. Our suggestion is rigorously designed RCTs and standardization of EAHM are required in the future.