• Title/Summary/Keyword: Randomized controlled study

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The effect of acupuncture on hot flushes : A study protocol of multi-center randomized controlled clinical trial (갱년기 여성의 안면홍조에 대한 침치료 다기관 임상시험 : 프로토콜)

  • Park, Ji-Eun;Oh, Dal-Seok;Kang, Kyung-Won;Kim, Dong-Il;Choi, Sun-Mi
    • Korean Journal of Acupuncture
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    • v.24 no.3
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    • pp.33-45
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    • 2007
  • Background : Hot flushes are general postmenopausal symptoms which about 75% of climacteric women undergo. They affect hotness, perspirations, systemic weakness, panic disorders, insomnia. Acupuncture is effective in alleviating hot flushes in practice. Assessment effectiveness and safety of acupuncture in hot flushes would be needed through multi-center trial. Objectives : Purpose of this study is to develope the protocol of effects of acupuncture on hot flushes, a postmenopausal symptom in climacteric women. Methods & Results : It will be a multi-centered, randomized, sham controlled, comparative trial. It will be performed by Good Clinical Practice after approval of Institutional Review Board. Selection criteria will be set according those of FDA above moderate degree. There will be a notice on concomitant medication, other herbs, dietary supplements. Superficial needling on sham points will be used for control group. Treatment period will be 8 weeks with 12 weeks' follow up. Some questionnaire scale will be used as the primary and secondary outcome. Conclusions : The clinical trials based on this protocol will be performed.

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An Overview of Clinical Studies for Pompholyx in Traditional Chinese Medicine - Literature Review based on Randomized Controlled Trials - (한포진 치료의 중의학 임상연구 동향 - 무작위 대조군 임상연구를 중심으로 -)

  • Woo, Jeong A;Park, Beom Chan;Choi, Il Shin;Kim, Kibong;Cheon, Jin Hong
    • The Journal of Pediatrics of Korean Medicine
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    • v.35 no.4
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    • pp.82-95
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    • 2021
  • Objectives The purpose of this study is to analyze clinical studies on the effectiveness of TCM (traditional Chinese medicine) for pompholyx treatment and provide evidence for Korean medicine use. Methods Randomized controlled trials (RCT) which used TCM as a treatment for pompholyx were searched in China National Infrastructure (CNKI) platform. The risk of bias of studies was assessed by using Cochrane risk of bias (RoB) 2.0 tool. Results The selected 10 RCTs showed that the experimental group treated with either TCM alone or with a combination of TCM and Western medicine showed more significant therapeutic effect compared to the control group which Western medicine alone. Conclusions Based on the studies from China, TCM may be an effective treatment for pompholyx. This provides evidence for Korean medicine use, and its possible effectiveness in treating pompholyx

Comparison of the effects of transcutaneous electrical nerve stimulation, low level laser, and placebo treatment on temporomandibular joint disorders: a single-blind randomized controlled trial

  • Kim, Hyunjoong
    • Physical Therapy Rehabilitation Science
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    • v.9 no.4
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    • pp.244-251
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    • 2020
  • Objective: Physical therapy techniques are required for patients with temporomandibular joint disorder (TMD), but the effects of treatment have not been compared. Therefore, effects of transcutaneous electrical nerve stimulation (TENS) and low level laser (LLL), which are most commonly used interventions, were compared. Design: Randomized controlled trial. Methods: Thirty-six participants with pain in the temporomandibular joint were enrolled, and 12 participants were randomly assigned to either the TENS group, LLL group, or placebo group. Each intervention was performed for a total of 6 sessions for 2 weeks. For the evaluation of the participants, the mouth opening (MO), pressure pain threshold (PPT), and stress were measured at three time periods: baseline, post-test, and follow-up at 2 weeks. Results: Significant interaction between groups according to each evaluation point was found only in PPT-masseter (p<0.05). The evaluation time point at which a significant difference appeared was at the post-test and follow-up at 2 weeks time periods. As a result of the post-test, the LLL group showed a significant improvement compared to the TENS group (p<0.05), and at 2 weeks follow-up, the TENS group showed a significant improvement compared to the placebo group (p<0.05). Conclusions: In this study, an experiment was conducted to compare the treatment effects when TENS, LLL, and placebo were given to patients with TMD. In addition, by quantitatively presenting the effect size of each treatment, this study suggests clinical use of TENS and LLL treatment for TMD.

The Effect on Pain of Buzzy® and ShotBlocker® during the Administration of Intramuscular Injections to Children: A Randomized Controlled Trial

  • Birsen, Sivri Bilgen;Serap, Balci
    • Journal of Korean Academy of Nursing
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    • v.49 no.4
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    • pp.486-494
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    • 2019
  • Purpose: To investigate the effect of $Buzzy^{(R)}$ and $ShotBlocker^{(R)}$ on reducing pain induced by intramuscular penicillin injections in children. Methods: This was a randomized controlled study. A total of 150 Turkish children aged 7~12 years who presented to our pediatric emergency clinic and met the inclusion criteria were recruited. The children were randomly assigned to each group (control=50, $Buzzy^{(R)}=50$, $ShotBlocker^{(R)}=50$). Data were collected using an information form, the State-Trait Anxiety Inventory for Children, Visual Analog Scale, and Faces Pain Scale-Revised. Results: The children in the control group had significantly higher pain scores during the penicillin injection than the children in the $ShotBlocker^{(R)}$ and $Buzzy^{(R)}$ groups. The children in the $Buzzy^{(R)}$ group had significantly less pain than the children in both the $ShotBlocker^{(R)}$ and control groups (p<.001). Conclusion: $Buzzy^{(R)}$ was more effective compared with $ShotBlocker^{(R)}$ in this study.

Effectiveness of Neurofeedback Therapy in Attention Deficit/Hyperactivity Disorders (Pubmed로 검색한 주의력결핍-과잉행동장애 환아의 뉴로피드백 효과에 관한 문헌고찰)

  • Chang, Seok Joo;Kim, Jang Hyun;Min, Sang Yeon
    • The Journal of Pediatrics of Korean Medicine
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    • v.33 no.2
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    • pp.69-83
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    • 2019
  • Objectives The purpose of this study is to review the effectivenss of Neurofeedback Therapy in children with Attention Deficit/Hyperactivity Disorders Methods 16 randomized controlled trials (RCT) of Neurofeedback Treatment in ADHD from 2009 to 2019 in PubMed were reviewed and analyzed their methods of assessment, treatment, results and adverse effect. Results In 16 RCT, the most frequently used diagnostic tool in ADHD was DSM-IV. Most of the studies reported Neurofeedback Treatment isn't superior than placebo or medication group but still effective in ADHD. In 6 out of the 16 studies, there were no adverse effect reported. Conclusion Most of the studies have shown neurofeedback treatment was effective in ADHD symptoms. More clinical studies are needed to prove the effectiveness of neurofeedback in ADHD.

Chuna Manual Therapy for Tinnitus : A Systematic Review and meta-analysis (이명에 대한 추나요법의 효과 : 체계적 문헌고찰과 메타분석)

  • Chung, In-Che;Cha, Yun-Yeop;Heo, In
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.14 no.1
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    • pp.13-23
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    • 2019
  • Objectives : The purpose of this study was to evaluate the effectiveness of Chuna manual therapy (CMT) for the treatment of tinnitus. Methods : We performed a literature search using eight electronic databases, using related keywords, from January 1990 until the end of April 2019. The randomized controlled trials (RCTs) which evaluated the effectiveness of CMT in the treatment of tinnitus were included in this study. The risk of bias were evaluated using the Cochrane risk of bias tool. Results : Five appropriate RCTs were included and analyzed. The efficacy rate of the CMT group was statistically significantly higher (P<0.03) versus the control group treated with Western medicine, acupuncture, and herbal medicine-only. Conclusions : In this literature review, there was sufficient evidence that CMT is more effective than conventional therapy (including Western medicine, acupuncture, and herbal medicine) in treating tinnitus. However, it should be considered that the included studies lacked any reference of the risk of bias

Acupuncture for Endometriosis; A Systemic Review (자궁내막증의 침치료 효과에 대한 체계적 문헌 고찰)

  • Kwon, Na-Yoen;Lee, Dong-Nyung
    • The Journal of Korean Obstetrics and Gynecology
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    • v.34 no.2
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    • pp.48-61
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    • 2021
  • Objectives: This study was aimed to review the effect of acupuncture on endometriosis related pain in patients. Methods: Researchers searched data through 6 online databases up to November 2020. The data was limited to randomized controlled trial studies on endometriosis patients diagnosed with laparoscopy. Results: 7 Randomized controlled trials were included in this study. All of studies were published in Chinese, in China. Intervention of treatment group were composed of simple acupuncture and electroacupuncture. Intervention of control group were made up with mifepristone, herbal medicine and acupuncture. Outcome measurements were effective rate, serum Cancer antigen-125 (CA-125), Visual analogue scale (VAS)/pain score, and recurrence rate in 1 year. In all outcome measurements, treatment group were more effective than control group and it was statistically significant. Conclusions: Acupuncture therapy is effective in decreasing endometriosis related pain and preventing recurrence. However, because endometriosis is easy to recur, additional long-term research is needed.

Effects of a Cognitive Behavior Therapy Program for Patients with Fibromyalgia Syndrome: A Randomized Controlled Trial (섬유근통 증후군 환자를 위한 인지행동 프로그램의 효과: 무작위 대조군 전후실험설계)

  • Kong, Kyoung Ran;Lee, Eun Nam
    • Journal of Korean Academy of Nursing
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    • v.51 no.3
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    • pp.347-362
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    • 2021
  • Purpose: This study developed a cognitive behavioral therapy program aimed at altering the physical condition, emotions, and behaviors of fibromyalgia patients, and confirmed the program's clinical applicability. The program was developed by analyzing previous studies conducting in-depth interviews with fibromyalgia patients, drawing on cognitive behavior theory to establish the program contents, recruiting experts to test its validity, and conducting a preliminary survey. Methods: To confirm the program's effect, this study used a randomized controlled trial design. The participants were outpatients diagnosed with fibromyalgia in Dong-A University Hospital, Busan. The 30 patients in the experimental group took part in the program, which comprised 8 sessions (90 to 120 minutes) based on cognitive behavior theory, delivered over 8 weeks. Hypothesis testing was carried out using the repeated measures ANOVA. Results: The analysis revealed significant differences between the experimental and control groups in positive automatic thoughts, pain, fatigue, depression, and interpersonal relationships. However, there was no significant difference between the groups in terms of sleep disorders and negative automatic thoughts. Conclusion: This program is a positive effect on physical condition, emotions, and behaviors. It is thus expected to be used to help fibromyalgia patients improve their disease conditions.

Manual Therapy on Constipation in Parkinson's Disease Patients: A Systematic Review (파킨슨병 환자의 변비에 대한 수기요법의 효과: 체계적 문헌 고찰)

  • Chae, In-Cheol;Kim, Ju-Yeon;Yoon, Hee-Jae;Jeon, Cheon-Hoo
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.15 no.2
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    • pp.1-8
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    • 2020
  • Objectives This study aimed to evaluate the effectiveness of manual therapy on constipation in patients with Parkinson's disease. Methods We searched electronic databases (PubMed, EMBASE, Cochrane Library, CAJ, KISS, KISTI, KMBASE, NDSL, OASIS, and RISS) for randomized controlled trials for manual therapy on constipation in patients with Parkinson's disease. Results Three randomized controlled trials were selected from the online database. One study demonstrated that manual therapy had positive results compared to routine nursing care with western medication. However, two studies demonstrated that manual therapy had no positive results compared to routine nursing care with western medication or western medication when used alone. Conclusions Our systematic review did not verify the clinical effect of manual therapy on constipation in patients with Parkinson's disease. Thus, more high-quality studies are needed to verify the effectiveness of manual therapy for constipation in patients with Parkinson's disease.

Chuna Manual Therapy for Cerebral Palsy in Children: A Systematic Review and Meta-analysis (소아 뇌성마비에 대한 추나 요법의 효과: 체계적 문헌고찰과 메타분석)

  • Nam, Hyun seo;Han, Seung hee;An, Da young;Baek, Tae hyun
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.16 no.2
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    • pp.29-38
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    • 2021
  • Objectives This study was aimed to evaluate the effects of Chuna manual therapy (CMT) for the treatment of cerebral palsy. Methods The randomized controlled trials (RCTs) on the treatment of CMT for cerebral palsy in children were selected among the literature published until January 2021 in seven databases. The quality of the literature was evaluated using the Cochrane's risk of bias tool, and RevMan 5.3 was used for the synthesis of results. Results Total 801 pediatric patient with cerebral palsy incontinence were finally selected from twelve RCTs. The total effective rate of the combined treatment general rehabilitation and CMT is statistically significantly higher (P<0.0001) than that of general rehabilitation alone. Conclusions This study suggests that general rehabilitation combined with CMT for cerebral palsy in children might be more effective in improving symptoms than general rehabilitation alone. As the number and quality of the literature included in the meta-analysis was insufficient, high-quality clinical studies on CMT for cerebral palsy would be required.