• Title/Summary/Keyword: randomized clinical controlled trial

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Review of Randomized Controlled Trials using Herbal Remedies on Cancer Patients (한약물을 이용한 암 치료 관련 무작위 배정 임상시험에 대한 고찰)

  • Park, Bong-Ky;Wang, Jing-Hua;Cho, Jung-Hyo;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.31 no.5
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    • pp.12-32
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    • 2010
  • Objective: This study aimed to review herbal remedy-based RCTs on cancer patients in order to produce helpful information for clinical study of herbal medicine in the future. Methods: We collected all RCTs using herbal remedies on cancer patients from Pubmed and Cochrane databases until November 1st, 2009. Elementary information such as nation where performed, clinical question, design, randomization, double-blinding and allocation concealment were analyzed. Results: 153 RCTs were finally selected. 119 RCTs were conduced in China while only 2 were done in Korea. The most frequent targeted cancer was lung cancer as 29 RCTs. The main clinical questions included improvement of quality of life, elongation of survival rate and regression of tumor being 83, 62 and 55 respectively. 112 RCTs used herbal remedies with western therapy. Adequate methods for randomization and allocation concealment were found in 37% and 10% of trials respectively. Conclusions: We found that herbal remedies are used on cancer patients in aspects of both caring for the human body and tumor treatment itself. The study might provide us useful data for cancer-related clinical study using herbal remedies in the future.

Type of tooth movement during en masse retraction of the maxillary anterior teeth using labial versus lingual biocreative therapy in adults: A randomized clinical trial

  • Sadek, Mais M.;Sabet, Noha E.;Hassan, Islam T.
    • The korean journal of orthodontics
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    • v.49 no.6
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    • pp.381-392
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    • 2019
  • Objective: The objective of this two-arm parallel trial was to compare the type of tooth movement during en masse retraction of the maxillary anterior teeth using labial versus lingual biocreative therapy. Methods: Twenty-eight subjects were randomized in a 1 : 1 ratio to either the labial or lingual group. En masse anterior retraction was performed using labial biocreative therapy in group A and lingual biocreative therapy in group B. Cone beam computed tomography scans were taken before and after retraction and the primary outcome was the type of tooth movement during anterior retraction. Data were analyzed using paired t-tests for comparisons within each group and independent-sample t-test for comparison of the mean treatment changes between the two groups. Results: Significant differences were found between the two groups in relation to the type of tooth movement (labiolingual inclination of the central incisor; mean difference, $5.85{\pm}1.85^{\circ}$). The canine showed significant distal tipping in the lingual group (mean difference, $6.98{\pm}1.25^{\circ}$). The canine was significantly more intruded in the lingual group (mean difference, $1.67{\pm}0.49mm$). Good anchorage control and significant soft tissue changes occurred in both groups. No serious adverse effects were detected. Conclusions: With a 10-mm retraction hook, the labial biocreative technique with the reverse curve overlay provided anterior retraction with good torque control, while in the lingual group, anterior retraction occurred with controlled tipping movement with significant distal tipping and intrusion of the canine (trial registration: The trial was registered at ClinicalTrials.gov [NCT03239275]).

Electroacupuncture for Carpal Tunnel Syndrome: A Review of Randomized Controlled Trials

  • Park, Cheol Woo;Lim, Min Ji;Lee, Se Won;Yi, Yeon Hoo;Song, Da Woon;Yu, Sang Gu;Kim, Min Ju;Oh, Da Yoon;Choi, Hyo Jung;Ju, Ah Ra
    • Journal of Acupuncture Research
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    • v.39 no.2
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    • pp.96-104
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    • 2022
  • This study aimed to examine the clinical efficacy of electroacupuncture treatment for carpal tunnel syndrome by reviewing published randomized controlled trials. Among the 186 studies retrieved from 7 online databases (PubMed, Cochrane library, CNKI, NDSL, RISS, OASIS, KMbase) on October 29, 2021, 4 studies were selected according to the inclusion, exclusion criteria, and were evaluated using risk of bias. Control groups for electroacupuncture were wearing a splint at night, traditional acupuncture, and medication. Methods such as total effective, functional status scale, symptom severity scale, electromyography, tip pinch strength, visual analogue scale, numeric rating scale, and ultrasound were used to evaluate the therapeutic effect. Electroacupuncture was reported to have significant treatment results compared with the control group in methods such as total effectiveness, electromyography, and tip pinch strength. However, the quality of the studies (using risk of bias) does not allow reliable conclusions to be made. Many high quality (low risk of bias) randomized controlled trials are needed to examine the efficacy of electroacupuncture treatment for carpal tunnel syndrome.

Effects of Ellagic Acid on Oxidative Stress Index, Inflammatory Markers and Quality of Life in Patients With Irritable Bowel Syndrome: Randomized Double-blind Clinical Trial

  • Zahra Mirzaie;Ali Bastani;Ali Akbar Haji-Aghamohammadi;Mohammadreza Rashidi Nooshabadi;Bahman Ahadinezhad;Hossein Khadem Haghighian
    • Clinical Nutrition Research
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    • v.11 no.2
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    • pp.98-109
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    • 2022
  • Irritable bowel syndrome (IBS) is a common disorder that affects the large intestine. Oxidative stress and inflammation play a major role in IBS. Considering the antioxidant properties of ellagic acid (EA), this study was designed to evaluate the effect of EA on oxidative stress index, inflammatory markers, and quality of life in patients with IBS. This research was conducted as a randomized, double-blind, placebo-controlled clinical trial; 44 patients with IBS were recruited. Patients who met the inclusion criteria were randomly allocated to consume a capsule containing 180 mg of EA per day (n = 22) or a placebo (n = 22) for 8 weeks. Serum levels of total antioxidant capacity (TAC), malondialdehyde (MDA), C-reactive protein (CRP), and interleukin-6 (IL-6) were measured at the beginning and the end of the study. Also, quality of life was assessed using a self-report questionnaire for IBS patients (IBS-QOL). At the end of the study, we saw a significant decrease and increase in the MDA and TAC in the intervention group, respectively (p < 0.05). Also, EA consumption reduced CRP and IL-6 levels, and these changes were significant in comparison with placebo group changes (p < 0.05). The overall score of IBS-QOL significantly decreased, and quality of life was increased (p < 0.05), but there were no significant changes in the placebo group. According to these findings, receiving polyphenols, such as EA, may help maintain intestinal health by modulating inflammation and oxidative stress and ultimately improving the quality of life in IBS patients.

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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    • v.37 no.2
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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.

Rview of Recent Clinical Research for Herbal Medicine Treatment on Vitiligo in Children - Focused on Chinese Randomized Controlled Trials - (소아 백반증의 한약 치료에 대한 최신 임상 연구 동향 - 중국 무작위 대조군 연구를 중심으로 -)

  • Jang, Jin Woo;Choi, Il Shin;Park, Beom Chan;Kim, Ki Bong;Cheon, Jin Hong
    • The Journal of Pediatrics of Korean Medicine
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    • v.35 no.4
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    • pp.141-155
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    • 2021
  • Objective The purpose of this study is to gather information from clinical studies conducted in China and analyze the effects of herbal medicine treatment for childhood vitiligo. Methods The randomized controlled trials (RCTs) with herbal medicine treatment for childhood vitiligo from the Chinese Academic Journal (CAJ) from China National Knowledge Infrastructure (CNKI) were searched. Then, each study was analyzed by demographics, disease durations, interventions, treatment periods, outcomes, adverse events, and compositions of the herbal medicine used. Result A total of 6 RCTs were included. All the trials except for one used a combination of Chinese herbal medicine with Western medicine as their treatment groups. The total efficacy rate was used to measure the effectiveness, and the treatment groups reported a significantly higher total efficacy rate compared to the control groups in all studies. In one study, a control group treated with compound glycyrrhizin capsule and topical compound kaliziran tincture combination treatment was compared with a treatment group which used the same treatment that the control group received in addition to oral herbal medicine. This study also showed higher total effectiveness in the treatment group than the control group. Conclusions In pediatric vitiligo, a combination of herbal medicine treatment rather than Western medical treatment alone can improve symptoms. In addition, it was suggested that the therapeutic effect can be enhanced when oral herbal medicine is used in combination with other herbal medicine treatments.

Chuna Manual Therapy for Postpartum Low Back Pain: Systematic Review (출산 후 요통에 대한 추나요법의 효과: 체계적 문헌고찰)

  • Cho, Ju-chan;Park, In-hwa;Hwang, Man-Suk;Heo, In
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.16 no.2
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    • pp.1-8
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    • 2021
  • Objectives This study aimed to evaluate the effect of chuna manual therapy (CMT) for postpartum low back pain using a systematic review. Methods We performed a literature search using 12 electronic databases up to the end of September 2021. We included randomized controlled trials (RCTs) that evaluated the effect of CMT in the treatment of postpartum low back pain. The risk of bias was evaluated using the Cochrane risk-of-bias tool. Results Four randomized controlled trials were reported statistically significant effect in pain VAS, ODI and JOA of chuna manual therapy compared with moxibution, electro acupuncture, hyperthermia or usual care. As a result of assessing the risk of bias tool, most of the contents of the evaluation items were not identified, so it was evaluated as an uncertain risk. Conclusions CMT may be effective in treating postpartum low back pain. However, evidence was limited due to the small sample size, lack of well-designed RCTs and regional bias. Further well-designed studies are required to obtain stronger evidence.

A Literature Review of Randomized Controlled Trials on Tobacco Cessation Using Auricular Acupuncture and Auricular Acupressure

  • Min-Gi, Jo;Jun-Yeong, Jang;Min-Jung, Ko;Sang-Yeup, Chae;Seungeun, Lee;Dongmin, Lee;Won Suk, Sung;Jung-Hyun, Kim;Bonhyuk, Goo;Yeon-Cheol, Park;Yong-Hyeon, Baek;Sang-Soo, Nam;Byung-Kwan, Seo
    • Journal of Acupuncture Research
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    • v.39 no.4
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    • pp.258-266
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    • 2022
  • This study aimed to analyze auricular acupressure and auricular acupuncture used in smoking cessation research by analyzing published randomized controlled trials. Eight databases (PubMed, Cochrane, EMBASE, CNKI, CiNII, KMbase, KISS, OASIS) were searched until December 2021, and 21 out of 1,919 studies met inclusion criteria. Data on the treatment site, time, frequency, period, and outcomes were analyzed. Lung (MA-IC1) and Ear Shenmen (MA-TF1) were the most used acupoints. The number of treatments varied between a minimum of 2 to a maximum of 24, and treatment duration varied between a minimum of 2 weeks to a maximum of 8 weeks. Cigarette consumption and smoking cessation rate were the most studied outcome, followed by multiple other psychological indications.

Electroacupuncture Treatment for Primary Dysmenorrhea: A Review of Randomized Controlled Trials

  • Jeon, Myung Kyu;Park, Jae Eun;Lee, Min Cheol;Kim, Hyeon Jin;Ahn, Jae Young;Shin, Na Young;Nam, Hye Jin;Chae, Go Eun;Jo, Hye Jeong;Kim, Hyun Woo;Lee, Young Jin;Koh, Arha;Kim, Woo Young
    • Journal of Acupuncture Research
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    • v.39 no.3
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    • pp.182-189
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    • 2022
  • To evaluate the effectiveness of electroacupuncture treatment for primary dysmenorrhea (PD), a literature review of a randomized controlled trials (RCTs) was performed where electroacupuncture was used as a treatment intervention in patients diagnosed with PD. Relevant clinical studies (N = 226) were retrieved from multiple databases according to the study inclusion/exclusion criteria, and interventions and outcomes were analyzed. As a result of the review, there were 6 RCTs which met the criteria. In all 4 studies that measured pain indicators (visual analog scales), electroacupuncture showed significantly positive changes. In addition, positive changes were observed in most indicators (MMDQ, PGF2a, PGE2, 6-keto PGF1, TXB2, clinical efficacy score, uterine arterial blood flow parameters, and blood viscosity). 2 studies showed that electroacupuncture had a stronger therapeutic effect than NSAIDs. No major side effects were reported. Electroacupuncture may be an effective and safe treatment for PD however, further RCTs are required.

A Systematic Review and Quality Assessment of Scalp Acupuncture for Musculoskeletal Diseases: Focused on Randomized Controlled Trials (근골격계 질환의 두침치료에 대한 체계적 문헌 고찰과 질 평가: 무작위 배정 대조 임상연구를 중심으로)

  • Do-Hun Kong;Byung-Cheul Shin
    • Journal of Korean Medicine Rehabilitation
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    • v.33 no.4
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    • pp.61-78
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    • 2023
  • Objectives This systematic review aimed to analyze the effectiveness, safety and the reporting quality of scalp acupuncture (SA) treatment for musculoskeletal disease (MSD). Methods Eleven databases were systematically searched up to July 12th 2023. Randomized controlled trials (RCTs) of SA treatment for MSD were selected manually by the inclusion criteria. The risk of bias of RCTs was assessed using the Cochrane's Risk of Bias (RoB) 1.0 and the reporting quality of studies was evaluated using Consolidated Standards of Reporting Trials (CONSORT) 2010 statement and Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) 2010 checklist. Results Ten clinical studies were met the inclusion criteria. Most of studies reported SA treatment significantly alleviated pain and functional disability of MSD patients and no serious adverse effects were reported. In RoB assessment, blinding of participants and personnel was found to have the highest RoB and allocation concealment was found to have the most unclear RoB. In CONSORT 2010 statement evaluation, all studies reported 15.3 items (41.4%) on average. In STRICTA 2010 checklist evaluation, all studies reported 11.2 items (65.9%) on average. Conclusions The systematic review found that SA treatment may alleviate pain and functional disability of MSD patients and have little severe adverse effect. The reporting quality of included studies was mainly low, therefore, further studies with strict adherence to the CONSORT and STRICTA checklist should be encouraged.