• Title/Summary/Keyword: Randomized placebo controlled trials

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The Effects of Ginseng and American Ginseng on General Symptom in Koreans and Chineses - Double-blind Randomized Controlled Trials - (한국인과 중국인에서 인삼과 서양삼 복용후 전신 증상 -이중맹검 무작위배정 임상시험-)

  • Seo, Jung-Cjul;Han, Sang-Won;Byun, Joon-Seok;An, Hee-Duk;Han, Il-Do;Cho, Geon-Ho;Leem, Kang-Hyun;Heo, Zheng-Jie;Yi, Jinglin;Jin, Mingxiu
    • Journal of Ginseng Research
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    • v.29 no.1
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    • pp.27-36
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    • 2005
  • In East-South Asia it has been said that ginseng(Panax ginseng) induces flushing and epistaxis, whereas American ginseng(Panax quinquefolius) dosen't. This study was designed to find out if ginseng really could increase flushing and epistaxis, compared with American ginseng. Double-blind randomized controlled trials on general symptom, such as flushing and epistaxis, of ginseng and American ginseng in Koreans and Chinese were performed by questionnaire. There was no significant accident or improvement in Koreans. But in Chinese dried mouth was significantly observed in placebo group and chest discomfort was significant in placebo group and American ginseng(4 years) group. In addition in Chinese chest discomfort was significantly observed in American ginseng(4 years) group and American ginseng(6 years) group. It was revealed that ginseng might not increase flushing and epistaxis.토양환경학회 홈페이지 ( http://www.kossge.or.kr ) 을 참조하십시오.

Effects of Korean Red Ginseng on Dry Mouth: A Randomized, Double-Blind, Placebo-Controlled Trial

  • Park, Jae-Woo;Lee, Beom-Joon;Bu, Young-Min;Yeo, In-Kwon;Kim, Jin-Sung;Ryu, Bong-Ha
    • Journal of Ginseng Research
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    • v.34 no.3
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    • pp.183-191
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    • 2010
  • Dry mouth is easily neglected if not associated with oral diseases. Consequently, xerostomatic patients often use unconventional therapies. In traditional Korean medicine, Korean red ginseng (KRG) has long been used to relieve dry mouth. However, no clinical trials have investigated whether KRG actually has an effect on dry mouth. This study was performed to evaluate the efficacy of KRG for dry mouth. We enrolled 100 volunteers with no obvious oral or salivary gland diseases and divided them into KRG and placebo groups. Each group was divided into six subgroups according to age and gender. The subjects received 6 g/day of KRG or placebo for 8 weeks. The dry mouth visual analog scale (VAS), salivary flow rate, and a dry mouth-related symptom questionnaire were evaluated at baseline and at 4 and 8 weeks. KRG treatment did not show any significant differences for any of the variables. However, KRG improved the dry mouth VAS at 4 weeks and dry mouthrelated symptoms at 8 weeks in women, but not in men. Subgroup analyses revealed that KRG markedly improved the dry mouth VAS in women of menopausal age (40 to 59 years) at 4 and 8 weeks. KRG may have beneficial effects for dry mouth in women, especially those of menopausal age, but not in men. Further investigation in post- and perimenopausal women is required to elaborate on these findings.

A Review of Acupuncture and Moxibustion for the Treatment of Parkinson's Disease (파킨슨병의 침구치료 동향에 대한 고찰)

  • Lee, Eun;Kang, Ki-Wan;Kim, Lak-Hyung;Kang, Sei-Young;Sun, Seung-Ho;Han, Chang-Ho;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.35 no.1
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    • pp.12-23
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    • 2014
  • Objectives : The purpose of this study was to report possibility of acupuncture or moxibustion for the treatment of Parkinson's disease (PD) by reviewing literature about its effectiveness. Methods : In this review, PubMed, SCOPUS, Science Direct and CINAHL of EBSCOhost were used to search medical journals, using keywords "Parkinson's disease and acupuncture" and "Parkinson's disease and moxibustion". The search range included randomized controlled trials (RCT) about Parkinson's disease combined with another disease and other treatments with acupuncture or moxibustion. Non-randomized controlled trial (nRCT), case study, animal experiment, human experiment, review, survey, essay, letter, and protocol for review were excluded. Results : From 311 studies, 111 were selected during the title and the screening. Finally, 16 RCTs (15 for acupuncture research and one for moxibustion) were included in this review, after scanning and matching the inclusion and exclusion criteria. The number of patients varied between 5 and 88. A total of 12 studies using electroacupuncture (EA) were classified into acupuncture studies. The body acupuncture studies numbered 4, scalp acupuncture 4, body and scarp acupuncture mixed studies 4, and bee venom, ear and abdomen acupuncture were each one study. In evaluation methods, total effective rate method was used in 9 studies, the Unified Parkinson's Disease Rating Scale (UPDRS) was used in 8, and the Webster score in 2. In addition, the Berg balance scale (BBS), 30 m walking time, steps to walk 30 m, PD motor function score, and Motor Performance Series by Schoppe (MLS) method were used for evaluation. In 15 of the 16 studies, the verum acupuncture group showed significant improvement compared with the control. In 9 studies using total effective rate method, the effective rate was reported as 80.0-97.3% in verum acupuncture groups and 52.6-86.4% in controls. Conclusions : Acupuncture may be a plausible alternative method to care for the long term symptoms and treat movement impairment of Parkinson's disease. However, to confirm this result, high quality studies including randomized, placebo-controlled double-blind trials are warranted.

Efficacy of medications in adult patients with trigeminal neuralgia compared to placebo intervention: a systematic review with meta-analyses

  • Peterson-Houle, Georgia M.;AbdelFattah, Magda R.;Padilla, Mariela;Enciso, Reyes
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.5
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    • pp.379-396
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    • 2021
  • Background: Trigeminal neuralgia (TN) is characterized by brief, unilateral, sharp, stabbing, and shooting pain of the fifth cranial nerve. The objective of this systematic review with meta-analysis was to determine the effect of medications compared to placebo in adult patients with TN. Methods: Review authors identified randomized placebo-controlled trials (RCTs) from PubMed, Web of Science, Cochrane, and EMBASE up to February 2021. We assessed the inclusion and exclusion criteria as well as the risk of bias of the studies based on the Cochrane Handbook. A total of 324 unduplicated references were scanned independently and reduced to eight relevant RCTs, with 89 patients included. Medications investigated included oral carbamazepine, subcutaneous sumatriptan, lidocaine (intranasal, 8% spray on the oral mucosa or intravenous), buprenorphine (ganglionic local opioid analgesia), and oral Nav1.7, a selective sodium channel blocker. Results: Meta-analyses showed that overall patients receiving lidocaine reported a significantly lower post-treatment intensity of pain -3.8 points on a 0-10 scale (95% Cl = -4.653 to -2.873; P < 0.001). Patients who received lidocaine were 8.62 times more likely to have pain improvement than patients on placebo (P < 0.001). In one RCT, patients receiving oral carbamazepine showed a significant improvement in pain intensity of -32% compared to the placebo (P < 0.001). In one trial, patients receiving 3 mg subcutaneous sumatriptan had a significantly lower intensity of pain on average -6.1 points on a scale of 0-10 compared to placebo (P < 0.001) and a significant improvement in pain intensity of -75% compared to the improvement in the placebo group (P < 0.001). Patients who received subcutaneous sumatriptan were 10 times more likely to have pain improvement than those who received placebo (P = 0.001) in one study. Due to the unclear/high risk of bias and small sample size, the quality of the evidence for lidocaine in the treatment of TN was low. Conclusion: Further studies are needed for carbamazepine, sumatriptan, buprenorphine, and oral Nav1.7 sodium channel blockers, as only one study reported outcomes.

Effect of Cardiotonic Pills$^{(R)}$ on Chest Pain and Discomfort: A Multi-center Double-blind Randomized Controlled Trial. (심적환$^{(R)}$이 흉통 흉민에 대하여 미치는 영향에 대한 다기관 무작위배정 이중맹검 임상연구)

  • Jang Insoo;Ko Changnam;Lee In;Park Jung-mi;Kim Sehyun;Kim Sangwoo
    • The Journal of Korean Medicine
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    • v.26 no.2 s.62
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    • pp.95-104
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    • 2005
  • Objectives: This was a double blinded, randomized, placebo-controlled clinical study for evaluation of safety and effective dose finding of Cardiotonic Pills$^{(R)}$ in patients with chest pain and discomfort. Cardiotonic Pills$^{(R)}$ are composed of Salviae Miltiorrhizae Radix (丹蔘), Notoginseng Radix (三七根) and Borneolum (龍腦). Major effects of Salviae Miltiorrhizae Radix and Notoginseng Radix are vasodilatation, sedation and analgesic action. Borneolum has an antibacterial effect, and can stimulate the central nervous system. All of these substances are oriental herbs that have been used for a long time in east Asia. Cardiotonic Pills fi received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) in the USA and 40 million people in the world take this pill. We performed a phase IV clinical study to confirm its efficacy and safety in patients who have probable cardiogenic or psychogenic chest pain or chest stifling. Methods: This study was planned for a multi-center clinical trial including four university hospitals of oriental medicine in Korea. This was the first time to evaluate the 'planning treatment according to diagnosis (辨證施治)' of chest pain or chest discomfort according to oriental medical guidelines. The patients who were included in this trial were adult volunteers from 20 to 70 years old who had chest pain or chest discomfort more than twice during a recent month, and we received written consent to participate in this study from all of them. After administration of Cardiotonic Pills$^{(R)}$ for 8 weeks, number of occurrences, duration, appearance and degree of chest pain or chest discomfort was observed and degree of symptoms (severity of illness, global improvement) were measured using a patient's global assessment composite scale. Results: In the patient's global assessment scale, the severity of illness of the Cardiotonic Pills$^{(R)}$ group (n=25) was 14/25=0.56 but of the placebo group (n=25) was 7/25=0.28 (p-value=0.0449). This result indicates Cardiotonic Pills$^{(R)}$have a positive effect on the symptoms of chest pain and discomfort. However, the global improvement of the Cardiotonic Pills$^{(R)}$group was 23/25=0.92, and of the placebo group was 22/25=0.88 (p-value=0.6374). The total symptom score of the Cardiotonic Pills$^{(R)}$ group was $1.68\pm20.06$, and of the placebo group was $16.76\pm72.l4$(p-value=0.2285). The number of symptom events of the Cardiotonic Pills$^{(R)}$ group was $72\pm29.78$, and of the placebo group (n=25) was $10.80\pm38.42$ (p­value=0.3660). We could not find any effects on the other factors examined besides the severity of illness, beyond the difference of standard deviations. Conclusions: Cardiotonic Pills$^{(R)}$ significantly reduced chest pain and chest discomfort in patients. Therefore, we expect that Cardiotonic Pills$^{(R)}$ will be helpful for patients with chest pain and chest discomfort not only caused by heart disease but also by other diseases.

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The effects of remdesivir on mortality and the requirement for mechanical ventilation in patients with COVID-19: a systematic review stratified by disease severity

  • Seungeun Ryoo;Miyoung Choi;Su-Yeon Yu;Young Kyung Yoon;Kyungmin Huh;Eun-Jeong Joo
    • The Korean journal of internal medicine
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    • v.39 no.1
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    • pp.160-171
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    • 2024
  • Background/Aims: The effectiveness of remdesivir treatment in reducing mortality and the requirement for mechanical ventilation (MV) remains uncertain, as randomized controlled trials (RCTs) have produced conflicting results. Methods: We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and other data resources to find RCTs published prior to April 10, 2023. The selection of studies, assessment of risk of bias, and meta-analysis were conducted according to PRISMA guidelines. The primary outcomes were all-cause mortality and the need to initiate MV. Results: A total of 5,068 articles were screened, from eight RCTs comprising 11,945 patients. The meta-analysis found that, compared to standard care or placebo, remdesivir treatment provided no significant all-cause mortality benefit (pooled risk ratio [RR], 0.93; 95% confidence interval [CI], 0.85-1.02; 8 studies; high certainty evidence), while subgroup analyses revealed a trend towards reduced mortality among patients requiring oxygen but not MV (pooled RR, 0.88; 95% CI, 0.77-1.00; 6 studies; I2 = 4%). The need to initiate MV (pooled RR, 0.74; 95% CI, 0.59-0.94; 7 studies; moderate certainty evidence) in remdesivir-treated patients was also reduced compared to controls. Remdesivir significantly increased clinical improvement and discharge and significantly reduced serious adverse events. Conclusions: In this systematic review and meta-analysis of RCTs, it was found that remdesivir treatment did not show a substantial decrease in the risk of mortality. However, it was linked to a reduction in the necessity for additional ventilator support, suggesting remdesivir could be beneficial for COVID-19 patients, particularly those who are not on MV.

Effect of Ginseng on Blood Pressure: A Systematic Review and Meta-Analysis (인삼이 혈압에 미치는 영향: 체계적 문헌고찰 및 메타분석)

  • Ha, Hye Min;Oh, Da Hyun;Chun, Pusoon
    • Korean Journal of Clinical Pharmacy
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    • v.26 no.2
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    • pp.163-171
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    • 2016
  • Objective: A meta-analysis was performed to determine effect of ginseng on blood pressure. Methods: The databases of PubMed, Embase, Cochrane Library, RISS, DBpia, KISS, and Koreamed were searched for all published studies from inception to January 2016. The following terms were used: "ginseng", "hypertension", and "blood pressure". Using the Review Manager 5, mean differences (MDs) were pooled to measure the effect of ginseng on blood pressure compared to that of placebo. Results: Eleven randomized controlled trials were included. In this meta-analysis, ginseng treatment significantly lowered systolic blood pressure (SBP) in a dose-independent way (MD: -1.99, p = 0.04). In subgroup analysis, 8-12 week consumption of ginseng achieved significantly greater reduction in SBP (MD: -3.14, p = 0.03), while single administration of ginseng failed to show BP-lowering effect. When ingested over 8-12 weeks, ginseng significantly lowered diastolic blood pressure (DBP) (MD: -1.96, p = 0.03). No significant association was found between ginseng dose and the magnitude of BP-lowering effect. However, a significant positive relationship was observed between baseline SBP level and the magnitude of SBP reduction (r = 0.848, p = 0.033). Such a relationship was not seen in DBP. Conclusion: Consumption of ginseng for 8-12 weeks achieved significant reductions in SBP and DBP in a dose-independent way. There was a significant positive relationship between baseline SBP level and the magnitude of SBP reduction.

A Systematic Review and Meta-analysis of Acupuncture Trials in Republic of Korea that Used Sham Acupuncture as a Control Group (거짓침을 대조군으로 사용한 국내 침 임상시험에 대한 체계적 고찰과 메타분석)

  • Kim, Jung-Eun;Kang, Kyung-Won;Kim, Tae-Hun;Lee, Seung-Hoon;Kim, Joo-Hee;Baek, Seung-Min;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.28 no.6
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    • pp.1-17
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    • 2011
  • Objectives : This study aimed to review randomized controlled trials of acupuncture performed in South Korea that used sham acupuncture as a control group. Methods : The following databases were searched through the end of September 2011: Koreanstudies information service system (KISS), Korean medical database (KMbase), national discovery OR science leaders (NDSL), oriental medicine advance searching integrated system (OASIS), and research information service system (RISS). The following search terms were used: acupuncture AND (sham or placebo). The reference lists of searched articles and Korea institute of oriental medicine (KIOM) reports(2005~2009) were identified. The following data were extracted: year/first author, disease, number of participants, blinding, intervention, outcome, and result. Where appropriate, we performed meta-analysis. The methodological quality was assessed according to the Jadad scale and 'risk of bias' by Cochrane Handbook procedure. Results : Twenty-nine studies were included in this review. In eighteen studies, penetrating sham controls were used as the control intervention, whereas the remaining eleven studies adopted non-penetrating sham controls such as the Park Sham Device or blunt auricular acupuncture. Nine studies showed statistically significant difference in outcomes. Twelve studies concerning insomnia after stroke, chronic tension-type headache, idiopathic Parkinson's disease, Hwa-Byung, and smoking cessation were included in meta-analysis. A meta-analysis of insomnia after stroke only found significant difference(MD -4.31, 95% Cl -6.19 to -2.42, $p$<0.00001). In general, all of the studies showed low methodological quality(Jadad score: mean 2.1). Risk of bias by Cochrane Handbook procedure varied. Conclusions : The results of this study could not suggest conclusive evidence that acupuncture is more effective than sham acupuncture in several diseases. In the future, more studies with rigorous acupuncture trials using sham controls should be conducted.

The Review on the Evidence-Based Study of Acupuncture - Systematic review and Meta-analysis - (침(鍼)의 근거중심적(根據中心的) 연구동향(硏究動向)에 관(關)한 고찰(考察) - Systematic review & Meta-analysis를 중심으로 -)

  • Back, Yong-Hyeon;Park, Dong-Seok;Kang, Sung-Keel
    • Journal of Acupuncture Research
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    • v.19 no.3
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    • pp.138-155
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    • 2002
  • Objective : The purpose of this study is to work on the problems and on the direction of the study regarding the evidence-based study of Acupuncture. Methods : We reviewed the PubMed electronic database. Eight articles of systematic review without meta-analysis and six articles without meta-analysis were selected. Results : In the study of eight articles of systematic review without meta-analysis, there were two articles on effectiveness of acupuncture and one on non-effectiveness of acupuncture. Four articles were about the changes according to the quality of randomized controlled trials. Also, one article was about the side-effect of acupuncture. In the study of six articles of systematic review with meta-analysis, there were two articles on Odds Ratio, two on Relative Risk, one on number-needed-to-treat, and two on 18 predefined methodological criteria. Conclusion : As the quality of RCTs was high, positive response decreased and as the quality of RCTs was low, positive response increased. For the study of evidence-based acupuncture, it is necessary that we conduct research on well-planned placebo acupuncture, large sample size, statistical method, method of searching and assessing literature and method of meta-analysis.

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Safety and Efficacy of Low Level Laser for Alopecia : A Systematic Review (탈모에 대한 레이저의 안전성 및 유효성 : 체계적 문헌 고찰)

  • Lee, Bo-Ram;Lee, Ma-Eum;Ko, Kyoung-Sook;Seo, Hyung-Sik
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.32 no.4
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    • pp.90-100
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    • 2019
  • Objectives : The purpose of this study is to determine the safety and efficacy of low level laser. Methods : We searched 11 electronic databases(Pubmed, CAJ, EMBASE, Medline, Cochrane Library, KMBASE, KISS, KISTI, NDSL, RISS, Oasis) up to March 2019. We included randomized controlled trials(RCTs) using low level laser for alopecia. The methodological quality of each RCT was assessed by the Cochrane risk of bias tool. Results : 8 RCT studies were eligible in our review. The meta-analysis of 2 studies showed favorable results for the use of low level laser with minoxidil 5% than minoxidil 5% and 6 studies showed favorable results for the use of low level laser than placebo light. The results of meta-analysis showed that low-level laser has an efficacy on alopecia. There were no serious side effects or adverse effects. High risk of bias were observed in all studies. Conclusion : Now limited evidence is available to support low level laser for alopecia and further well-designed RCTs should be encouraged.