• Title/Summary/Keyword: Randomized Clinical Trials

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Subcutaneous progesterone versus vaginal progesterone for luteal phase support in in vitro fertilization: A retrospective analysis from daily clinical practice

  • Schutt, Marcel;Nguyen, The Duy;Kalff-Suske, Martha;Wagner, Uwe;Macharey, Georg;Ziller, Volker
    • Clinical and Experimental Reproductive Medicine
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    • v.48 no.3
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    • pp.262-267
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    • 2021
  • Objective: Progesterone application for luteal phase support is a well-established concept in in vitro fertilization (IVF) treatment. Water-soluble subcutaneous progesterone injections have shown pregnancy rates equivalent to those observed in patients receiving vaginal administration in randomized controlled trials. Our study aimed to investigate whether the results from those pivotal trials could be reproduced in daily clinical practice in an unselected patient population. Methods: In this retrospective cohort study in non-standardized daily clinical practice, we compared 273 IVF cycles from 195 women undergoing IVF at our center for luteal phase support with vaginal administration of 200 mg of micronized progesterone three times daily or subcutaneous injection of 25 mg of progesterone per day. Results: Various patient characteristics including age, weight, height, number of oocytes, and body mass index were similar between both groups. We observed no significant differences in the clinical pregnancy rate (CPR) per treatment cycle between the subcutaneous (39.9%) and vaginal group (36.5%) (p=0.630). Covariate analysis showed significant correlations of the number of transferred embryos and the total dosage of stimulation medication with the CPR. However, after adjustment of the CPR for these covariates using a regression model, no significant difference was observed between the two groups (odds ratio, 0.956; 95% confidence interval, 0.512-1.786; p=0.888). Conclusion: In agreement with randomized controlled trials in study populations with strict selection criteria, our study determined that subcutaneous progesterone was equally effective as vaginally applied progesterone in daily clinical practice in an unselected patient population.

A Systematic Review of Placenta Pharmacopuncture for Neuropsychiatric Diseases in Practice (자하거 약침의 신경정신과 임상 응용에 관한 체계적 문헌 고찰)

  • Shin, Haegue;Lee, Jae-Hyok;Kang, Hyung Won
    • Journal of Oriental Neuropsychiatry
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    • v.33 no.2
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    • pp.157-180
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    • 2022
  • Objectives: To perform a systematic review of placenta pharmacopuncture for treating neuropsychiatric diseases, focusing on its efficacy and the safety so that evidence on its clinical use could be obtained, thus contributing to further studies. Methods: Through Korean, English, and Chinese databases (OASIS, Korean TK, KISS, RISS, ScienceON, Pubmed, Cochrane, EMBASE, CINAHL, AMED, CNKI, and Wanfang), combinations of keywords (placenta, pharmacopuncture, etc.) were used to select clinical studies published until January 2021 about placenta pharmacopuncture for neuropsychiatric diseases. Interventions included combined treatments. Study design included cases studies, series, and clinical trials. Cohort studies, literature reviews, in vitro and animal experiments were excluded. The primary outcomes involved measurements of symptoms, Visual Analogue Scale, or questionnaires. Data extracted from databases were imported to Endnote X7 to remove duplicates. The quality of the literature was assessed based on CAse REports Guidelines and Cochrane's Risk of Bias (ROB). Results: Twenty-one studies were selected, including ten case reports, three case series, two one-armed clinical trials, one non-randomized clinical trial, and five randomized clinical trials. There were six studies on sleep disorders, five studies on stroke sequela, two on mood disorders, two on enuresis, two on Guillain-Barré syndrome, two on multiple sclerosis, one on neurocognitive disorder, and one on vertigo. The most frequent combined treatment was acupuncture in both the experimental group (n=10) and the control group (n=3). Acupoints were ST36, SP6, BL23, CV4, GB20, GV20, N-HN54, and so on. All studies reported improvement of symptoms. The quality of case studies was relatively high. Assessment of ROBs resulted in low risks. Conclusions: Placenta pharmacopuncture is effective for neuropsychiatric diseases such as sleep disorders, mood disorders, enuresis, and neurocognitive disorders. Regarding insomnia, several studies have reported significant improvements with placenta pharmacopuncture. There was no adverse event associated with placenta pharmacopuncture.

Review of Pragmatic Clinical Trials on Acupuncture

  • Lee, Sang-Hoon;Seo, Byung-Kwan;Seo, Jung-Chul;Lee, Seung-Deok;Choi, Sun-Mi;Kim, Yong-Suk
    • Journal of Acupuncture Research
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    • v.22 no.2
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    • pp.163-170
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    • 2005
  • Background : Over the last thirty years, majority of researches on clinical effectiveness of acupuncture have been explanatory (or experimental) randomized controlled trial. The benefits of acupuncture in clinical trials are still controversial and most studies concluded that further control studies were required. Standardized combinations of acupuncture points for all the experimental subjects in various past studies have been criticized because such treatments do not reflect current routine clinical treatment. Objective : This paper aims to review pragmatic clinical trials on the effect of acupuncture treatment and to develop the ideal clinical research methodology of acupuncture study. Method : Clinical studies of acupuncture relevant with pragmatic or individualized trials were searched mainly in Pubmed and Science direct databases. All articles were fully reviewed by researchers, and data were evaluated by usage of a standardized form. Results & Suggestion : Pragmatic acupuncture researches were tried for various symptoms (eg. low back pain, hypertension, depression during pregnancy, sleep quality in HIV disease, chronic poststroke leg spasticity, headache, etc). Individualized acupuncture treatments based on oriental disease pattern diagnosis reflexes practical treatments which is more effective than unified and fixed acupuncture treatments without any theoretical basis of oriental medical philosophy. Conclusion : To overcome the controversies and limitations of past explanatory acupuncture trials, more individualized and tailored acupuncture trials with the theoretical basis of oriental medical diagnosis is highly recommended. Also clear definition and categorization of pattern identification should be established for further active clinical researches and applications of acupuncture.

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Efficacy and Safety of Gabapentin in the Treatment of Chronic Cough: A Systematic Review

  • Shi, Guanglin;Shen, Qin;Zhang, Caixin;Ma, Jun;Mohammed, Anaz;Zhao, Huan
    • Tuberculosis and Respiratory Diseases
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    • v.81 no.3
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    • pp.167-174
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    • 2018
  • Despite recent clinical guidelines, the optimal therapeutic strategy for the management of refractory chronic cough is still a challenge. The present systematic review was designed to assess the evidence for efficacy and safety of gabapentin in the treatment of chronic cough. A systematic search of PubMed, Embase, Cochrane Library databases, and publications cited in bibliographies was performed. Articles were searched by two reviewers with a priori criteria for study selection. Seven relevant articles were identified, including two randomized controlled trials, one prospective case-series designed with consecutive patients, one retrospective case series of consecutive patients, one retrospective case series with unknown consecutive status, and two case reports comprising six and two patients, respectively. Improvements were detected in cough-specific quality of life (Leicester Cough Questionnaire score) and cough severity (visual analogue scale score) following gabapentin treatment in randomized controlled trials. The results of prospective case-series showed that the rate of overall improvement of cough and sensory neuropathy with gabapentin was 68%. Gabapentin treatment of patients with chronic cough showed superior efficacy and a good safety record compared with placebo or standard medications. Additional randomized and controlled trials are needed.

The Effect of Manual Stretching and Positioning and Developmental Treatment in Congenital Muscular Torticollis: randomized Controlled Trials (선천성 근성 사경 환아에서 수기신장과 자세와 발달을 이용한 치료의 효과에 대한 무작위 연구)

  • Lee, In-Hee
    • Physical Therapy Korea
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    • v.16 no.1
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    • pp.34-41
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    • 2009
  • The purpose of this study is to compare the outcomes of manual stretching treatment with those of motor development and positioning physical therapy (MDPPT) for congenital muscular torticollis (CMT). This study was designed to be randomized controlled trials and to evaluate the outcomes of 43 consecutive patients with CMT who were first seen when they were average 26 days old. Before treatments, the patients were unintentionallv classified into two clinical groups along with the treatment methods. Among the 43 patients, 22 were classified to the manual stretching group and 21 to the MDPPT group. By means of independent t-test on the result. the duration of treatment according to methods was not significantly different in two groups (p>.05). The duration of treatment in accordance with head tilt level was not significantly different in two groups (p>.05). There was change of mass diameter, between at the beginning day of treatment and after treatment in manual stretching group with a strong positive linear correlation (p=.000, r=.734), but slightly positive linear correlation in MDPPT group. The result of this study indicates that two therapeutic methods make little difference in effectiveness.

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Traditional Herbal Medicine for Dysfunctional Uterine Bleeding versus Western Medicine: A Systematic Review of Randomized Controlled Trials (기능성 자궁출혈에 대한 한약치료 : 체계적 문헌 고찰)

  • Park, Eo-Jin;Jo, Hee-Geun;Choi, Ji-Hyun
    • The Journal of Korean Obstetrics and Gynecology
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    • v.31 no.4
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    • pp.110-127
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    • 2018
  • Objectives: To evaluate the effectiveness and safety of traditional herbal medicine (THM) in the treatment of dysfunctional uterine bleeding (DUB) versus conventional western medicine. Methods: Randomized Controlled Trials (RCTs) comparing THM vs. conventional western medicine for DUB, were obtained from PubMed, Cochrane Library, Embase, CNKI, RISS, NDSL, KISS and OASIS. The risk of bias was assessed by using Cochrane's risk of bias tool. Results: 16 RCTs with 1,659 patients were identified and reviewed. 10 RCTs reported THM was statistically effective than control group in effective rate. Also recurrent rate was estimated in 6 RCTs and was lower than control group. 7 studies observed adverse events (AEs) and severe AEs were not reported. Conclusions: Despite several limitations, this review suggested that THM was safe and effective in the treatment of DUB. THM may also decrease the recurrence rate. However, this could not be proven conclusively. To ensure evidence-based clinical practice, more sternly designed trials are warranted.

Application of Traditional East Asian Herbal Medicine for Atrophic Vaginitis: A Systematic Review of Randomized Controlled Trials (위축성 질염에 대한 한약 투약의 효과 : 체계적 문헌 고찰)

  • Park, Eo-Jin;Jo, Hee-Geun
    • The Journal of Korean Obstetrics and Gynecology
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    • v.32 no.3
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    • pp.227-244
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    • 2019
  • Objectives: To evaluate the effectiveness and safety of application of Traditional East Asian Herbal Medicine (TEAM) in the treatment of Atrophic Vaginitis (AV). Methods: Randomized Controlled Trials (RCTs) were obtained from PubMed, Cochrane Library, Embase, CNKI, RISS, NDSL, and KISS. The risk of bias was assessed by using Cochrane's risk of bias tool, and RevMan 5.3 software was used. Results: 26 RCTs with 3,162 patients were identified and reviewed. Among them, 21 RCTs observe the effect of integrated traditional Chinese and Western medicine. 23 RCTs reported treatment groups was statistically effective than control groups in the study. Also, the recurrence rate was estimated in 10 RCTs and was lower than control groups. 12 studies observed adverse events (AEs) and severe AEs were not reported. Conclusions: This review suggested that TEAM was safe and effective in the treatment of AV. TEAM may also decrease the recurrence rate. However, this could not be proven conclusively. To ensure evidence-based clinical practice, well-designed trials with larger sample sizes are needed.

Effect of Acupuncture and Moxibustion for Vitiligo: A Scoping Review of Randomized Controlled Trials (백반증의 침구(鍼灸) 치료 효과: 무작위 대조 시험에 대한 주제 범위 문헌 고찰)

  • Do Kyung Han;Jeewon Shon;Won Gun An
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.36 no.4
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    • pp.145-155
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    • 2023
  • Objectives : The aim of this study is to review the effect of acupuncture/moxibustion on vitiligo. Methods : Using 5 databases(Pubmed, EMBASE, Cochrane Library, RISS, OASIS) clinical studies about effect of acupuncture/moxibustion on vitiligo were searched. Only randomized controlled trials(RCTs) were selected to analyze. Results : Total 235 studies were searched. After screening those studies 5 studies were selected from china and Iran. 3 studies used effective rate to measure the effect of acupuncture for vitiligo. 1 study used Vitiligo Area Scoring Index(VASI) and 1 study assessed 4 grade of repigmentation to prove acupuncture's effect on vitiligo. All studies showed repigmentation in acupuncture/moxibustion group. Adverse effects reported in the five studies were temporary erythema, itching, and dryness. Conclusions : These findings suggest that acupuncture and moxibustion can be considered a safe treatment for vitiligo. However, due to the small number of RCTs conducted on acupuncture and moxibustion for vitiligo, more RCTs should be conducted to confirm the effectiveness of acupuncture and moxibustion for vitiligo.

Acupuncture Treatment for Restless Legs Syndrome: A Review of Randomized Controlled Trials

  • Go Eun Chae;Hyun Woo Kim;Hye Jeong Jo;Ahra Koh;Young Jin Lee;Ji Eun Choi;Woo Young Kim
    • Journal of Acupuncture Research
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    • v.40 no.4
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    • pp.308-318
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    • 2023
  • To determine the effectiveness of acupuncture in treating restless legs syndrome (RLS), we conducted a literature review of randomized controlled trials (RCTs) that utilized acupuncture as an intervention for patients diagnosed with RLS. Relevant clinical studies (n = 158) from seven databases (the Cochrane Library, PubMed, Embase, CNKI, KISS, RISS, and OASIS) were included based on the inclusion and exclusion criteria and analyzed. Moreover, 6 RCTs were selected for review. In all six studies, it was indicated people who underwent acupuncture treatment showed significant improvements in their overall health. An increase in the treatment efficacy rate, sleep quality, and quality of life indicators after the acupuncture treatment was confirmed. The severity of pain as assessed using the visual analog scale (VAS) scores and International RLS Study Group Rating Scale (IRLSRS) scores and the severity of RLS symptoms were significantly reduced. Any significant side effects were not reported. Acupuncture is suggested as an effective and safe treatment method for RLS. However, further large-scale RCT studies are needed to confirm our findings.

Review and Analysis of Sham Acupuncture in Acupuncture Clinical Trials (침 임상연구에 사용된 거짓침의 분석)

  • Jang, Jin-Young;Kim, So-Jung;Kim, Nam-Sik;Nam, Sang-Soo;Kim, Yong-Suk
    • Journal of Acupuncture Research
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    • v.28 no.5
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    • pp.29-38
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    • 2011
  • Objectives : Recent well-designed randomized controlled trials(RCTs) and their meta-analysis have been published on the efficacy of acupuncture in different condition. In most of them, real acupuncture is compared with sham acupuncture including invasive and non-invasive sham methods. But it is not clear how active sham methods are. These results tend to lead the conclusion that acupuncture has no more effective than sham acupuncture. In order to investigate that sham acupuncture is appropriate as a control, we reviewed several acupuncture trials using different sham acupuncture as a control. Methods : We searched Cochrane researches of acupuncture, reviewed and analyzed 25 RCTs in 42 Cochrane reviews. And especially we compared the effect of acupuncture according to the type of sham acupuncture. Results : Invasive sham acupunctures are used in 12 RCTs and non-invasive types are used in the rest. The majority of studies(19 RCTs) fail to show effects beyond a sham acupuncture. Streitberger's sham needle is a validated sham acupuncture of non-invasive type that was used in 8 trials and also no significant group differences are shown except one trial. Conclusions : Acupuncture is a complex intervention. Clinical trials of acupuncture need to be reexamined and redesigned to remove several bias. Especially, sham acupuncture as a control might be investigated for physiological effects as well as validation test including patient-blinding and de qi sensation. Other research need to be investigated and developed for acupuncture trials.