• Journal of Oriental Neuropsychiatry
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• v.27 no.4
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• pp.235-248
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• 2016

Objectives: The aim of this review was to investigate whether evidence of complementary and alternative medicine (CAM) was reflected in clinical practice guidelines (CPGs) for insomnia based on relevant clinical trials. Methods: We conducted a systematic search on domestic and international CPG databases and medical databases. In addition, we conducted manual searches of relevant articles. Three authors independently searched and selected relevant studies; any disagreement was resolved by discussion. We extracted and analyzed the following data: published language, country, development group, participants, interventions, presence or absence of recommendations for CAM, level of evidence, grade of recommendation for CAM, and methods of development. Results: We identified 8,241 records from domestic and international databases, and 22 CPGs were included. Eleven of the 22 CPGs mentioned CAM interventions including herbal medicine, relaxation, acupuncture moxibustion, Tai Chi, meditation, hypnosis, biofeedback, Tuina, and external herbal medicine. However, most of the CPGs indicated 'no recommendation' or 'weak recommendation' for CAM interventions. Only Valeriana dageletiana Nakai and relaxation were considered to have experimental evidence. Valeriana dageletiana Nakai was recommended for improvement of sleep latency, sleep maintenance, total sleeping time, and sleep cycle. Relaxation was recommended as effective intervention for relieving physical and psychological arousal. Conclusions: Despite systematic reviews and randomized controlled trials on CAM for insomnia, most of the CPGs for insomnia did not reflect the evidence obtained. Further CPGs for insomnia should be developed by considering the current advanced studies in the field of CAM.

• Journal of Korean Medicine Rehabilitation
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• v.25 no.3
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• pp.51-57
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• 2015

Objectives To evaluate the evidence supporting the effectiveness of Chuna manual therapy for nocturnal crying. Methods We conducted search across the 3 electronic databases (Pubmed, CAJ and Oasis) to find all of randomized controlled clinical trials(RCTs) that used Chuna manual therapy as a treatment for nocturnal crying. The methodological quality of each RCTs was assessed using the Cochrane Risk of Bias tool and nRCTs was assessed using the Cochrane Risk of Bias Assessment tool for Non-randomized Study tool. Results Two RCTs and three nRCTs met our inclusion criteria. The meta-analysis showed positive results for the use of Chuna manual therapy in terms of the efficacy rate when compared to medication treatments alone. Positive results were also obtained, in terms of the efficacy rate, when comparing Chuna manual therapy combined with acupoint application therapy to Chuna manual therapy alone, but was not statistically significant. Conclusions Our systematic review found encouraging but limited evidence of Chuna manual therapy for nocturnal crying. We recommend clinical trials which compare the effectiveness of Chuna manual therapy with usual care to obtain stronger evidence without the demerits of trial design.

• The Journal of Internal Korean Medicine
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• v.37 no.1
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• pp.109-134
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• 2016

Objectives: The aim of this study was to help develop a guideline for the common cold. We searched recent clinical studies of the common cold in Western medicine and reviewed their objectives, inclusion and exclusion criteria, primary outcome, secondary outcome, and assessment tools to establish evidenced-based guideline.Methods: We searched electronic databases (Cochrane Library, MEDLINE, EMBASE) to identify eligible randomized controlled trials (RCTs) about the common cold for the last 10 years. We included 29 RCTs and showed their research summary via their objectives, participants, interventions, control, treatment duration, and results. We also analyzed the definition of the common cold presented in the article, inclusion and exclusion criteria, primary and secondary outcomes, and assessment tools.Results: We reported the aforementioned areas in detail. At first, the definition of the common cold was confused across the articles. Second, herbal medication clinical trials for the common cold have been extensively studied recently. Third, the eligibility criteria frequently included the Jackson Symptom score. Fourth, validated assessment tools (i.e., the Wisconsin Upper Respiratory Symptom Survey-21) have only been used in a few recent studies.Conclusions: Our research will be helpful to establish Korean herbal medicine clinical trial guidelines for the common cold.

• Korean Journal of Clinical Pharmacy
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• v.21 no.4
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• pp.376-382
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• 2011

The results from eight clinical studies demonstrate that citalopram and escitalopram could be an effective option in the treatment of hot flashes with tolerable adverse effects. However, there are limitations in the above studies. The inclusion criteria of 2 studies reviewed in this paper was breast cancer patients, so it's hard to apply the results to the general population in clinical practice. Also 4 studies had less than 50 subjects included, and the duration of study was 8 weeks or less in 7 studies reviewed in this paper. Moreover, only 4 studies were randomized, placebo-controlled trials (3 for citalopram and 1 for escitalopram). Therefore, further randomized, double-blind, placebo-controlled studies with the general population should be needed to use citalopram and escitalopram for the treatment of hot flashes in clinical practice.

• Korean Journal of Clinical Pharmacy
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• v.29 no.4
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• pp.267-277
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• 2019

Backgrounds: With the globalization of drug development, multi-regional clinical trials (MRCTs) have emerged to facilitate rapid availability of medicines to patients worldwide. The present study aimed to has explored attitudes and perceptions towards adopting the Korean MRCT guideline. Methods: An online survey, consisting of 16 questions, classified into two subjects, was administered to stakeholders in Korea. Most quantitative components were measured using the Likert scales. A content analysis of the qualitative components was carried out to identify the keywords in open-ended responses. Results: A total of 94 survey responses were analyzed: 51 participants from pharmaceutical companies, 11 from clinical research organizations, and 21 from clinical trial centers. The content of the guideline was rated as appropriate for clarity, acceptability, and applicability (96.8, 96.8, and 93.6%, respectively). The local environmental impact of the systemic/political, academic/technical, and industrial/economical aspects of the guideline was rated as appropriate at 95.7, 97.9, and 91.5%, respectively. The suggested adoption period was 1~2 years (40, 42.6%). The concept and individuals' domestic circumstances were the key problems affecting the clarity, applicability, and local environmental impact of the guideline. Conclusion: The Korean MRCT guideline was well-developed. Their overall impact on the local environmental impact of MRCTs in Korea was expected to be beneficial, but methods are needed to minimize the negative impacts. The findings of this study can inform the priorities for the future adoption of the guideline in Korea.

• Korean Journal of Clinical Pharmacy
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• v.23 no.3
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• pp.239-247
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• 2013

Background: Fixed drug combinations are formulations containing two or more active ingredients in a single dosage form. Such combination therapies are commonly applied to improve efficacy, reduce adverse events and replace co-administration, etc. National and international guidelines for hypertension treatment recommend addition of other classes of antihypertensive drugs rather than incremental dose of mono-therapy, when blood pressure is not adequately controlled. Thus, many dual combinations of antihypertensive drugs have been approved and pharmaceutical companies are recently interested in developing antihypertensive triple combinations. Clinical trial designs for the fixed combinations are various depending on the target patients, dosage and clinical endpoints. Thereby, further discussions for the clinical trials of antihypertensive triple therapies are required regarding the indication claimed. Conclusion: This article provides a review for the assessment of the label and medical reports of the clinical trials on antihypertensive triple therapies in advanced foreign countries.

• Journal of Acupuncture Research
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• v.24 no.1
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• pp.209-216
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• 2007

Objectives : To review and summarize the existing evidence on acupuncture treatment for cancer and cancer related symptoms. Methods: Literature searches were made through domestic and international databases. Data were extracted according to pre-defined criteria. The methodological quality was assessed using the Modified Jadad scale. Results: Seven studies were included. Two of the studies were high in methodological quality. One study concerning acupuncture treatment for cancerous dyspnea reported insignificant differences between the treatment group and placebo group. The other study concerning auricular acupuncture for cancer related pain showed significant pain relief compared with the control group. All the other studies were non-blinded or uncontrolled trials. Conclusion : The hypothesis that acupuncture may be effective for the treatment of cancer is not supported by the data in recent clinical trials. More accurately designed randomized control trials (RCT) are needed.

• Communications for Statistical Applications and Methods
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• v.22 no.4
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• pp.389-399
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• 2015

It is important not to overcalculate sample sizes for clinical trials due to economic, ethical, and scientific reasons. Kang and Kim (2014) investigated the accuracy of a well-known sample size calculation formula based on the approximate power for continuous endpoints in equivalence trials, which has been widely used for Development of Biosimilar Products. They concluded that this formula is overly conservative and that sample size should be calculated based on an exact power. This paper extends these results to binary endpoints for three popular metrics: the risk difference, the log of the relative risk, and the log of the odds ratio. We conclude that the sample size formulae based on the approximate power for binary endpoints in equivalence trials are overly conservative. In many cases, sample sizes to achieve 80% power based on approximate powers have 90% exact power. We propose that sample size should be computed numerically based on the exact power.

• Asian Pacific Journal of Cancer Prevention
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• v.16 no.7
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• pp.2915-2921
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• 2015

Background: Some recent clinical trials have been conducted to evaluate a combination of EGFR- TKI with chemotherapy for advanced NSCLC patients as second-line therapy, but the results on the efficacy of such trials are inconsistent. The aim of this meta-analysis was to evaluate the efficacy and safety of combination of EGFR-TKI and chemotherapy for patients with advanced NSCLC who failed first-line treatment. Materials and Methods: We searched relative trials from PubMed, EMBASE, ASCO Abstracts, ESMO Abstracts, Cochrane Library and Clinical Trials.gov. Outcomes analyzed were overall response rate (ORR), progression- free survival (PFS), overall survival (OS) and major toxicity. Results: Seven trails eventually were included in this meta-analysis, covering 1,168 patients. The results showed that the combined regimen arm had a significant higher ORR (RR 1.76 [1.16, 2.66], p=0.007) and longer PFS (HR 0.75 [0.66-0.85], p<0.00001), but failed to show effects on OS (HR 0.88 [0.68-1.15], p=0.36). In terms of subgroup results, continuation of EGFR-TKI in addition to chemotherapy after first-line EGFR-TKI resistance confered no improvement in ORR (RR 0.95 [0.68, 1.33], p=0.75) and PFS (HR 0.89[0.69, 1.15], p=0.38), and OS was even shorter (HR1.52 [1.05-2.21], p=0.03). However, combination therapy with EGFR-TKI and chemotherapy after failure of first-line chemotherapy significantly improved the ORR (RR 2.06 [1.42, 2.99], p=0.0002), PFS (HR 0.71 [0.61, 0.82], p<0.00001) and OS (HR 0.74 [0.62-0.88], p=0.0008), clinical benefit being restricted to combining EGFR-TKI with pemetrexed, but not docetaxel. Grade 3-4 toxicity was found at significantly higher incidence in the combined regimen arm. Conclusions: Continuation of EGFR-TKI in addition to chemotherapy after first-line EGFR-TKI resistance should be avoided. Combination therapy of EGFR-TKI and pemetrexed for advanced NSCLC should be further investigated for prognostic and predictive factors to find the group with the highest benefit of the combination strategy.

• Journal of Oriental Neuropsychiatry
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• v.26 no.4
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• pp.383-406
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• 2015

Objectives: People with tension-type headache generally take pain relievers, but long term dependency causes problems as well as side effects. The present study aimed to provide clinical evidence of herbal medicine for tension-type headache by systematic review of randomized controlled trials on the effect of herbal medicine for tension-type headache. Methods: Randomized or quasi-randomized controlled trials that verified effects of herbal medicine intervention on patients with tension-type headache were included in the study. A literature search of English, Japanese, Chinese, Korean databases was performed. The selected literature were assessed by Jadad scale and Risk of Bias. Results: Herein, 40 reports were selected from a total of 157. Meta-analyses of 2 trials indicated that the effective rate was significantly higher in the herbal medicine treatment group, as compared to the placebo control (risk ratio: 1.49, 95% confidence interval (CI): 1.23 to 1.80, p<0.0001, I²=0%). Four trials that compared herbal medicine with routine care with routine care only group showed a significantly higher effective rate of benefits for herbal medicine with routine care, as compared to routine care only (RR: 1.57, 95% CI: 1.18 to 2.10, p=0.002, I²=0%). Conclusions: The effective rate was significantly higher than control and adverse events were less in the treatment group. Pattern analysis (辨證) indicated that the studies on wind-fire pattern (風火證) were highest. Yougeun-bang (柔筋方) in prescription and Paeoniae Radix Alba (白芍藥) in medicinal herbs were most used. This finding could be widely utilized in future clinical practice and form the basis for the development of clinical practice guidelines in advance.