• 제목/요약/키워드: randomized clinical trial

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A comprehensive quality analysis of randomized controlled clinical trials of Asian ginseng and American ginseng based on the CONSORT guideline

  • Chen, Weijie;Li, Xiuzhu;Chen, Zhejie;Hao, Wei;Yao, Peifen;Li, Meng;Liu, Kunmeng;Hu, Hao;Wang, Shengpeng;Wang, Yitao
    • Journal of Ginseng Research
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    • 제46권1호
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    • pp.71-78
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    • 2022
  • Ginseng is an international herb that has been used for thousands of years. Two species most commonly applied and investigated in the ginseng family are Asian ginseng and American ginseng. The number of randomized controlled clinical trials (RCTs) has conspicuously increased, driven by the rapid development of ginseng. However, the reporting of RCT items of ginseng is deficient because of different trial designs and reporting formats, which is a challenge for researchers who are looking for the data with high quality and reliability. Thus, this study focused on providing an extensive analysis of these two species and examined the quality of the RCTs, based on the Consolidated Standards of Reporting Trials (CONSORT) guideline. Ninety-one RCTs conducted from 1980 to 2019 that were related to Asian ginseng and American ginseng used singly met our inclusion criteria. We found that the reporting quality of the two species has improved during the past 40 years. Publication date and sample size were significantly associated with the reporting quality. Rigorous RCTs designed for the species of ginseng are warranted, which can shed light on product research and development of ginseng in the future.

Clinical Efficacy and Safety of Gyebutang Granules Combined with Acupuncture for the Treatment of Knee Osteoarthritis: Protocol for a Multicenter, Randomized, Assessor-blinded, 2-armed Parallel, Controlled Trial

  • Lee, Cham-Kyul;Kang, Ha-Ra;Lee, Yeon-Sun;Sung, Won-Suk;Lim, Chi-Yeon;Jung, Chan-Yung;Kim, Eun-Jung;Seo, Byung-Kwan;Baek, Yong-Hyeon;Kim, Kyung-Ho;Lee, Eun-Young
    • Journal of Acupuncture Research
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    • 제37권2호
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    • pp.102-109
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    • 2020
  • Background: Due to the aging population in Korea, knee osteoarthritis (KOA) has become an increasingly common condition. Many patients with KOA prefer analgesics, herbal medicines, acupuncture, or exercise, rather than arthroscopic surgery or a knee replacement. Gyebutang (GB) granules are a herbal extract widely used to treat KOA in traditional Korean medicine, but there is insufficient evidence of its efficacy and safety. Methods: A multicenter, randomized, assessor-blinded, 2-armed parallel, controlled clinical trial has been designed to investigate the efficacy and safety of GB combined with acupuncture for the treatment of KOA. There will be 100 patients with KOA enrolled in the study from 3 traditional Korean medicine hospitals. The participants will be randomly allocated to an experimental group (GB and acupuncture) or a control group (celecoxib and acupuncture) in a 1:1 ratio. Both groups will receive acupuncture treatment once a week for 6 weeks; one group will receive GB and the other will receive celecoxib for the same duration. Results: The primary outcome will be the change of knee osteoarthritic pain, based on scores on a 100 mm visual analog scale. The secondary outcomes will be scores on a numeric rating scale, the Western Ontario and McMaster Universities osteoarthritis index, patient global assessment, European quality of life 5-dimension 5-level scale, and adverse events. Conclusion: The results of this study will provide evidence of efficacy and safety of GB as a treatment for patients with KOA.

일차성 불면증의 추나 치료에 대한 문헌 연구 보고 (Chuna Manual Therapy for Primary Insomnia; A Review of Clinical Study)

  • 황만석
    • 한방재활의학과학회지
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    • 제26권3호
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    • pp.79-84
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    • 2016
  • Objectives To evaluate the evidence supporting the effectiveness of Chuna manual therapy for primary insomnia. Methods The researcher 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 primary insomnia. Results Four RCTs met inclusion criteria. The meta-analysis showed positive results for the use of Chuna manual therapy in terms of the PSQI when compared to medication treatments alone. Positive results were also obtained, in terms of the PSQI, when comparing Chuna manual therapy combined with acupuncture therapy to acupuncture therapy alone, but was not statistically significant. Conclusions The review found encouraging but limited evidence of Chuna manual therapy for primary insomnia. 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.

비만치료에 응용되는 매선요법의 최근 연구 동향 고찰 (Review on Clinical Trials of Catgut Embedding for Obesity Treatment)

  • 송미영;김호준
    • 한방비만학회지
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    • 제12권2호
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    • pp.1-7
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    • 2012
  • Objectives: The purpose of this report was to review the clinical trials of the catgut embedding for obesity treatment. Methods: We searched the clinical trial papers with key words of obesity and catgut embedding via searching Pubmed, Scopus and KISS etc. Results: We reviewed 8 searched articles, 7 articles were conducted in China and only 1 article was published in Korea. Most of Chinese articles used acupuncture as a control group and revealed the equality or superiority of catgut embedding in body weight loss. The only Korean article, which was uncontrolled, implanted catgut in localized fat area, it had changes partially in fat thick, body size. Conclusions: The acupoint catgut embedding has the efficacy of body weight loss, but to confirm the efficacy of localized fat loss, more randomized controlled trials are needed.

Limited Impact of Music Therapy on Patient Anxiety with the Large Loop Excision of Transformation Zone Procedure - a Randomized Controlled Trial

  • Kongsawatvorakul, Chompunoot;Charakorn, Chuenkamon;Paiwattananupant, Krissada;Lekskul, Navamol;Rattanasiri, Sasivimol;Lertkhachonsuk, Arb-Aroon
    • Asian Pacific Journal of Cancer Prevention
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    • 제17권6호
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    • pp.2853-2856
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    • 2016
  • Background: Many studies have pointed to strategies to cope with patient anxiety in colposcopy. Evidence shows that patients experienced considerable distress with the large loop excision of transformation zone (LLETZ) procedure and suitable interventions should be introduced to reduce anxiety. This study aimed to investigate the effects of music therapy in patients undergoing LLETZ. Materials and Methods: A randomized controlled trial was conducted with patients undergoing LLETZ performed under local anesthesia in an out patient setting at Ramathibodi Hospital, Bangkok, Thailand, from February 2015 to January 2016. After informed consent and demographic data were obtained, we assessed the anxiety level using State Anxiety Inventory pre and post procedures. Music group patients listened to classical songs through headphones, while the control group received the standard care. Pain score was evaluated with a visual analog scale (VAS). Statistical analysis was conducted using Pearson Chi-square, Fisher's Exact test and T-Test and p-values less than 0.05 were considered statistically significant. Results: A total of 73 patients were enrolled and randomized, resulting in 36 women in the music group and 37 women in the non-music control group. The preoperative mean anxiety score was higher in the music group (46.8 VS 45.8 points). The postoperative mean anxiety scores in the music and the non-music groups were 38.7 and 41.3 points, respectively. VAS was lower in music group (2.55 VS 3.33). The percent change of anxiety was greater in the music group, although there was no significant difference between two groups. Conclusions: Music therapy did not significantly reduce anxiety in patients undergoing the LLETZ procedure. However, different interventions should be developed to ease the patients' apprehension during this procedure.

국소한약외용제의 알레르기성 비염 치료 효과에 대한 문헌 고찰 (A Literature Study of Topical Application of Chinese Herbal Medicine for Allergic Rhinitis)

  • 방미란;김장현;민상연
    • 대한한방소아과학회지
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    • 제30권3호
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    • pp.52-60
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    • 2016
  • Objectives The purpose of this study is to analyze studies about the effects of topical application of Chinese herbal medicine for allergic rhinitis within randomized controlled trials (RCT). Methods The search database includes KJTK (Korean Traditional Knowledge Portal), OASIS (Oriental Medicine Advanced Searching Integrated system), CNKI (China National Knowledge Infrastructure), PubMed, and EMBASE. We used the following key search terms: "allergic rhinitis", "traditional Chinese medicine", "traditional Korean medicine", "Chinese herbal medicine", "randomized controlled trial", "clinical study", "nasal spray", and "nasal drop" Results Five studies were selected for analysis. Three studies used nasal spray of Chinese herbal medicine and two studies used nasal drops of Chinese herbal medicine for the intervention. Frequently used herbs were Magnoliae Flos (辛夷), Scutellariae Radix (黃芩), Coptidis Rhizoma (黃連), and Astragali Radix (黃芪). For the outcome measures, studies used symptom score, questionnaire of Quality of Life, nasal airway resistance, or laboratory studies. From all 5 studies, it has been shown that topical application of Chinese herbal medicine was effective for improving symptoms of allergic rhinitis. Two out of five studies showed statistical difference between study group and control group. Conclusions This study shows that topical application of Chinese herbal medicine can improve symptoms of allergic rhinitis. Well-designed RCT studies with low risk of bias and studies with outcome measures for assessing the immunomodulatory effects are necessary to confirm these findings.

Effect of Sihogayonggolmoryeo-Tang on Hwa-byung: A Multicenter, Randomized, Double-Blinded, Placebo-Control Trial

  • Choi, Woo-Chang;Lee, Hun-Soo;Kim, Ju-Yeon;Kang, Wee-Chang;Park, Yang-Chun;Kim, Geun-Woo;Kim, Jong-Woo;Jung, In Chul
    • 동의신경정신과학회지
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    • 제31권3호
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    • pp.135-147
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    • 2020
  • Objectives: Hwa-byung is a mental illness. It is also known as a Korean culture-related syndrome. In traditional Korean medicine, Sihogayonggolmoryeo-tang is used to treat Hwa-byung related neuropsychiatric symptoms. The purpose of this research was to examine the effect of Sihogayonggolmoryeo-tang on Hwa-byung. Methods: A multicenter, randomized, double-blinded, placebo-controlled study was performed for 160 patients with Hwa-byung. Patients were divided into a Sihogayonggolmoryeo-tang group and a placebo group. Treatment period was 8 weeks. Hamilton Rating Scale for Anxiety (HAM-A), Likert scale for major symptoms of Hwa-byung, Hwa-byung Scale (HBS), Korean Beck Depression Inventory (K-BDI), Korean State-Trait Anxiety Inventory (K-STAI), Korean State-Trait Anger Expression Inventory (K-STAXI), and Korean WHO Quality of Life Scale Abbreviated Version (WHOQOL-BREF) were used to evaluate the effect of Sihogayonggolmoryeo-tang on Hwa-byung. We also used an Instrument of Pattern Identification for Hwa-Byung to evaluate different responses for six patterns of patients. Results: Scores of all the measurements improved significantly for each group, showing no significant differences between the two groups. In the case of deficiency of both Qi and blood pattern, the Sihogayonggolmoryeo-tang group showed a significant decrease in the HAM-A score compared to the placebo group. Conclusions: The effect of Sihogayonggolmoryeo-tang on Hwa-byung did not exceed that of the placebo. Further studies involving more elaborate pattern identification are needed.

국내에서 수행된 건강인 대상 침 관련 무작위 대조 임상연구에 대한 체계적 문헌 고찰 (Randomized Controlled Trials of Acupuncture for Healthy Volunteers in Korea: A Systematic Review)

  • 사공혜선;김현태;허인;신병철
    • 한방재활의학과학회지
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    • 제31권1호
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    • pp.137-147
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    • 2021
  • Objectives Domestic acupuncture research is being actively conducted in various fields. The aim of this study is to systematically analyze the current acupuncture randomized controlled trials (RCTs) conducted on healthy volunteers. Methods We searched RCTs by the search terms of (acupuncture & random & healthy) in 10 electronic databases and related journals. Then, we analyzed the characteristics and assessed the risk of bias by Cochrane tool. Results Finally, 49 acupuncture RCTs on health volunteers were included in our analysis. The purpose of research could be classified into five major categories: (1) checking the effects on physiological function, (2) comparing the effects of different acupuncture/acupuncture methods, (3) a study confirming improvement after inducing a specific condition, (4) a sham acupuncture study, and (5) a comparison of acupuncture sense. The Cochrane risk of bias was generally high, especially only 1 trial adopted allocation concealment (1/49, 2.0%) and 9 ones with assessor blinding (9/49, 18.4%). Conclusions Acupuncture RCTs in healthy subjects have confirmed various effects in various age/sex groups. However the research quality should be updated for future clinical research and to draw clear conclusion within rigorous methodology.

Is conventional radiofrequency ablation of the superolateral branch, one of the three genicular nerves targeted as standard, necessary or not? A non-inferiority randomized controlled trial

  • Osman Albayrak;Canan Sanal Toprak;Osman Hakan Gunduz;Savas Sencan
    • The Korean Journal of Pain
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    • 제37권3호
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    • pp.264-274
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    • 2024
  • Background: Radiofrequency ablation is an effective treatment modality in the symptomatic treatment of knee osteoarthritis. Our aim was to compare the efficacy of radiofrequency ablation of the superomedial and inferomedial genicular nerves (2 branches) with the superolateral, superomedial, and inferomedial genicular nerves (3 branches) and to show whether the 2-branch procedure is inferior to the 3-branch procedure. Methods: This study is a prospective, randomized, single-blind clinical study. Eligible participants were randomized into 2 groups: group A, which applied the procedure to the superomedial and inferomedial genicular nerves, and group B, which applied it to the superomedial, superolateral and inferomedial genicular nerves. Pain was evaluated with the numerical rating scale, quality of life with the Short Form-36 (SF-36), and disability with the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index before, and at 1 and 3 months after the procedure. Results: A total of 41 patients were included. There were no differences between the groups except for the SF-36 physical health sub-score at baseline. A significant improvement was seen in the numeric rating scale (NRS) score, SF-36 sub-scores, WOMAC Index total, as well as pain and physical function scores in both groups, though no significant difference was detected between the groups during follow-up. Conclusions: Although we were unable to establish the noninferiority of conventional radiofrequency ablation (CRFA) applied to 2 branches to CRFA applied to 3 branches, in this trial, significant and similar improvement was observed in NRS, WOMAC total, pain, and physical function and SF-36 scores in both groups.

비부비동염의 보완대체의학 약물치료에 대한 최신 임상 연구 동향 -RCT 연구를 중심으로 - (Review of Clinical Research for Herbal Medicine Treatment on Rhinosinusitis)

  • 장은하;민상연;김장현
    • 대한한방소아과학회지
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    • 제32권3호
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    • pp.44-54
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    • 2018
  • Objectives The purpose of this study is to analyze clinical studies on effectiveness of herbal medicine in rhinosinusitis. Methods We searched the randomized controlled trials (RCTs) with herbal medicine treatment on rhinosinusitis from the Pubmed in recent 10 years (from 2008 to 2018). Results 11 RCTs were reviewed. In 10 out of 11 studies showed that the herbal medicine may be effective in the treatment of chronic rhinosinusitis without nasal polyp and uncomplicated acute rhinosinusitis. However, inclusion and exclusion criteria, and outcome measures were varied among different studies. No serious adverse reactions were reported from the herbal medicine treatment. Conclusions The results of these trials showed that herbal medicine may be effective in the treatment of rhinosinusitis. Well-designed RCTs for domestic herbal medicine treatment on rhinosinusitis are needed to prove its efficacy clearly.