• Title/Summary/Keyword: RCT(randomized controlled trials)

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Efficacy of ketamine in the treatment of migraines and other unspecified primary headache disorders compared to placebo and other interventions: a systematic review

  • Chah, Neysan;Jones, Mike;Milord, Steve;Al-Eryani, Kamal;Enciso, Reyes
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.5
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    • pp.413-429
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    • 2021
  • Background: Migraine headaches are the second leading cause of disability worldwide and are responsible for significant morbidity, reduction in the quality of life, and loss of productivity on a global scale. The purpose of this systematic review and meta-analysis was to evaluate the efficacy of ketamine on migraines and other primary headache disorders compared to placebo and other active interventions, such as midazolam, metoclopramide/diphenhydramine, and prochlorperazine/diphenhydramine. Methods: An electronic search of databases published up to February 2021, including Medline via PubMed, EMBASE, Web of Science, and Cochrane Library, a hand search of the bibliographies of the included studies, as well as literature and systematic reviews found through the search was conducted to identify randomized controlled trials (RCTs) investigating ketamine in the treatment of migraine/headache disorders compared to the placebo. The authors assessed the risk of bias according to the Cochrane Handbook guidelines. Results: The initial search strategy yielded 398 unduplicated references, which were independently assessed by three review authors. After evaluation, this number was reduced to five RCTs (two unclear risk of bias and three high risk of bias). The total number of patients in all the studies was 193. Due to the high risk of bias, small sample size, heterogeneity of the outcomes reported, and heterogeneity of the comparison groups, the quality of the evidence was very low. One RCT reported that intranasal ketamine was superior to intranasal midazolam in improving the aura attack severity, but not duration, while another reported that intranasal ketamine was not superior to metoclopramide and diphenhydramine in reducing the headache severity. In one trial, subcutaneous ketamine was superior to saline in migraine severity reduction; however, intravenous (I.V.) ketamine was inferior to I.V. prochlorperazine and diphenhydramine in another study. Conclusion: Further double-blind controlled studies are needed to assess the efficacy of ketamine in treating acute and chronic refractory migraines and other primary headaches using intranasal and subcutaneous routes. These studies should include a long-term follow-up and different ketamine dosages in diagnosed patients following international standards for diagnosing headache/migraine.

Development of a Guidelines of the Herbal Medicine Treatment for Gastric Cancer on the Use of Systemic Review and Delphi Technique (체계적 문헌 고찰과 델파이 기법을 활용한 위암의 한약 치료에 관한 한의표준임상진료 지침 개발)

  • Song, Si Yeon;Ban, Kyung-tae;Ha, Su-jeung;Park, So-jung;Lee, Yeon-weol;Cho, Chong-kwan;Cho, Seung-Hun;Yoo, Hwa-Seung
    • Journal of Korean Traditional Oncology
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    • v.23 no.1
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    • pp.1-14
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    • 2018
  • Objectives: This study was conducted towards developing guidelines of herbal medicine treatment for gastric cancer. Methods: We performed a systematic review and meta-analysis designed to investigate the efficacy of herbal medicine treatment for gastric cancer on four cancer questions; survival rate, metastasis, immune function, and quality of life. Based on the findings, we utilized a two-round delphi process with panel of 22 experts for their level of agreement. Results: Combined therapy group, herbal medicine treated with chemotherapy, was significantly higher in the 1-year survival rate (RR=1.27, 95% CI: 1.14 to 1.40, P=0.005, $I^2=71%$) and 3-years survival rate (RR=1.41, 95% CI: 1.16 to 1.71, P=0.91, $I^2=0%$) than chemotherapy group. The suppression of metastasis was higher in the combined therapy group (RR=0.62, 95% CI: 0.45 to 0.84, P=0.09, $I^2=54%$). The immunology function was higher in the combined therapy group compared with the chemotherapy group (MD=16.43, 95% CI: 13.25 to 29.61, P<0.001, $I^2=99%$). The quality of life score was higher in the combined therapy group compared with the chemotherapy group (RR=1.55, 95% CI: 1.21 to 2.00, P<0.66, $I^2=0%$). Conclusions: Among the Randomized controlled trials (RCT) included, the levels of survival rates, suppression of metastasis, immune function, and quality of life of the group treated with chemotherapy were lower compared to those treated with herbal medicine in addition to chemotherapy.

Literature Review on clinical studies for cold hypersensitivity of hands and feet -Focusing on journals published in Korea (수족냉증의 임상연구에 관한 문헌적 고찰 - 국내에 출판된 논문을 중심으로 -)

  • Lee, Hye-Sol;Han, In-Sik;Sun, Seung-Ho;Kim, Geun-yeob;Go, Ho-Yeon;Kim, Tae-Hoon;Lee, Jin-Moo;Jang, Jun-Bok;Song, Yun-Kyung;Ko, Seong-Gyu;Choi, You-Kyung;Jeong, Jong-Jin;Ko, Youme;Jeong, Keum Ran;Jeon, Chan-Yong
    • Journal of Society of Preventive Korean Medicine
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    • v.21 no.1
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    • pp.83-93
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    • 2017
  • Objectives : This study's aim is to investigate clinical studies of cold hypersensitivity of hands and feet (CHHF) published in Korea and to explore the direct of future research. Methods : We searched clinical studies of CHHF using the database, such as DBpia(http://www.dbpia.co.kr/), NDSL(www.ndsl.kr), OASIS(http://oasis.kiom.re.kr), and RISS(www.riss.kr). The search words were 'cold hypersensitivity(冷症)' and 'syncope(厥證)'. Inclusion criteria were randomized controlled trials (RCTs), non RCTs, Before and after clinical study (B&A) about CHHF. Selection journals and data extraction were conducted by HS Lee and SH Sun independently. Results : Total twenty-one articles were selected finally. RCTs, non-RCTs, and B&A were 3, 12, and 6, respectively. The topics for CHHF were classified into three categories: effect of treatment (n=2) characteristics (n=11), and diagnosis (n=8). Conclusions : This results showed that RCT about CHHF and treatment effect of cold hypersensitivity of hands and feet were small in number. Further systemic and larger studies about CHHF will be needed.

Clinical Practice Guideline on Acupuncture for Post-stroke Spasticity (뇌졸중후 경직에 대한 침치료 임상진료지침)

  • Kim, Je-Shin;Shin, Seung-Won;Lee, Eui-Ju;Shin, Byung-Cheul;Lee, Myeong-Soo;Lim, Sung-Min;Nam, Dong-Woo;Moon, Sang-Kwan
    • The Journal of Korean Medicine
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    • v.36 no.1
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    • pp.1-8
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    • 2015
  • Objectives: This study is aimed to develop a Clinical Practice Guideline (CPG) on acupuncture treatment for the patients with post-stroke spasticity. Methods: Experts committee, consisting of stroke or methodology specialists, searched Medline, EMBASE, Cochrane Library, China National Knowledge Infrastructure, and 19 Korean medicine journals. The search terms were selected to screen the randomized controlled trials (RCTs) or systematic reviews for the effectiveness of acupuncture on post-stroke spasticity, compared with placebo or conventional group. Levels of evidence and grades of recommendations were appraised based on Recommendations for Development of Clinical Practice Guideline in Korean Medicine. Results & Conclusions: One systematic review and 7 RCT were included to build the CPG. There was a strong evidence to support the effectiveness of electroacupuncture treatment for post-stroke spasticity. However, it did not show any sufficient evidence to treat the patients with post-stroke spasticity with the sole acupuncture. The moderate evidence was presented that over 3 times of the electroacupuncture treatments with 1-100 Hz frequency should be performed every week on the acupoints, such as LI11, LI10, TE5, LI4, ST36, GB34, ST40, or LR3, for 20-30 minutes. It was also suggested that the procedure should begin at the acute stage just after the vital signs of the patients are stabilized. Finally, there was a moderate evidence to support safety of acupuncture treatment for post-stroke spasticity.

Effect of luteal phase support with vaginal progesterone on pregnancy outcomes in natural frozen embryo transfer cycles: A meta-analysis

  • Seol, Aeran;Shim, Yoo Jin;Kim, Sung Woo;Kim, Seul Ki;Lee, Jung Ryeol;Jee, Byung Chul;Suh, Chang Suk;Kim, Seok Hyun
    • Clinical and Experimental Reproductive Medicine
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    • v.47 no.2
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    • pp.147-152
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    • 2020
  • Objective: The purpose of this study was to determine the effect of vaginal progesterone for luteal phase support (LPS) on the clinical pregnancy rate (CPR) in natural frozen embryo transfer (FET) cycles via a meta-analysis. Methods: We performed a meta-analysis of randomized controlled trials (RCTs) and retrospective studies that met our selection criteria. Four online databases (PubMed, Embase, Medline, and the Cochrane Library) were searched between January 2017 and May 2017. Studies were selected according to predefined inclusion criteria and meta-analyzed using R software version 2.14.2. The main outcome measure was CPR. Results: A total of 18 studies were reviewed and assessed for eligibility. One RCT (n = 435) and three retrospective studies (n = 3,033) met the selection criteria. In a meta-analysis of the selected studies, we found no significant difference in the CPR (odds ratio [OR], 0.96; 95% confidence interval [CI], 0.60-1.55) between the vaginal progesterone and control groups. An analysis of the two retrospective cohort studies that reported the live birth rate (LBR) following FET showed a significantly higher LBR in the vaginal progesterone group (OR, 1.72; 95% CI, 1.21-2.46). A subgroup meta-analysis of FET conducted 5 days after injection of human chorionic gonadotropin showed no significant differences between the two groups with regard to the CPR (OR, 1.18; 95% CI, 0.90-1.55) or miscarriage rate (OR, 0.73; 95% CI, 0.36-1.47). Conclusion: The results of this meta-analysis of the currently available literature suggest that LPS with vaginal progesterone in natural FET cycles does not improve the CPR.

A Review on Treatment of Essential Tremor in Traditional Chinese Medicine (본태성 진전에 대한 중의학 연구동향)

  • Shin, A-Ri;Bae, Yeong-Long;Lim, Jae-Yu;Lee, Seung-Hwan;Kim, Sang-Ho;Lim, Jung-Hwa
    • Journal of Oriental Neuropsychiatry
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    • v.28 no.2
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    • pp.95-107
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    • 2017
  • Objectives: This study was performed to review studies on Essential Tremor (ET) in Traditional Chinese medicine (TCM). Methods: We reviewed papers in the China National Knowledge Infrastructure (CNKI) from 2007~2016. Search keywords were 原发性震颤, 特发性震颤, essential tremor and idiopathic tremor, and excluded non-clinical studies, non-related to ET or TCM studies, theses for degrees and non-Randomized Controlled Trial (RCT). The quality of the articles was assessed by Jadad scale and the Risk of Bias (RoB). Results: Thirteen studies were selected. 'Criteria for the diagnosis of ET' was most frequently used as diagnostic criteria. 'Tremor rating scale' was primarily used for outcome measurement. Meta-analysis of nine trials revealed the effective rate of acupuncture and Western medicine (WM+Acu) groups was significantly higher compared to the WM group (RR: 1.48, 95 percent CI: 1.20 to 1.82, p=0.0002, $I^2=0$ percent) and tremor rating scale was also significantly decreased in the treatment group (MD: -1.35, 95 percent CI: -2.17 to -0.54, p=0.001, $I^2=0$ percent). Also, effective rates of Electro-acupuncture (EA) and Chinese herbal medicine (CHM) groups were significantly higher than that of the WM group {(RR: 1.53, 95 percent CI: 1.22 to 1.92, p=0.0003, $I^2=0$ percent) in EA vs. WM and (RR: 1.35, 95 percent CI: 1.16 to 1.57, p<0.0001, $I^2=0$ percent) in CHM vs. WM}. However, the quality of selected clinical studies was poor. Conclusions: Treatment of ET in TCM may be more effective and safe than in Western medicine. Therefore, we hope this study will lead to further clinical research on treatment of ET in Korean medicine.

Clinical Practice Guideline for acupuncture in Post-stroke urinary incontinence (뇌졸중 후 요실금에 대한 침치료 임상진료지침)

  • Lee, Ji-Won;Shin, Byung-Cheul;Lee, Myeong-Soo;Lim, Sung-Min;Yoo, Jung-Hee;Cho, Chung-Sik;Moon, Sang-Kwan;Yook, Tae-Han;Joo, Jong-Cheon;Lee, Eui-Ju
    • Journal of Sasang Constitutional Medicine
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    • v.29 no.4
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    • pp.317-325
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    • 2017
  • Objectives This study is aimed to develop a Clinical Practice Guideline (CPG) on acupuncture treatment for the stroke patients with Post-stroke Urinary Incontinence(PSUI). Methods Experts committee, consisting of stroke or methodology specialists, searched Medline, EMBASE, Cochrane Library, China National Knowledge Infrastructure, and 19 Korean medicine journals. The search terms were selected to screen the randomized controlled trials (RCTs) or systematic reviews for the effectiveness of acupuncture on PSUI, compared with placebo or conventional group. Levels of evidence and grades of recommendations were appraised based on Recommendations for Development of Clinical Practice Guideline in Korean Medicine. Results & Conclusions 8 RCT were included to build the CPG. There was a strong evidence to support the effectiveness of acupuncture treatment for PSUI. The moderate evidence was presented that over 3 times a week of the acupuncture should be performed over 4 weeks on the acupoints, such as BL23, CV3, SP6, CV4, CV6, ST28, BL28, BL32, GV20, BL22, GV4 or ST36, for 15-30 minutes. 1-150 Hz frequency is suggested if electro-acupuncture treatments is performed with. It was also suggested that the procedure should begin at the acute stage just after the vital signs of the patients are stabilized. There was a moderate evidence to support safety of acupuncture treatment for PSUI. We recommend acu-points of constitutional acupuncture for Sasangin on the healthy side.

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.

Efficacy of alpha-lipoic acid in patients with burning mouth syndrome compared to that of placebo or other interventions: a systematic review with meta-analyses

  • Christy, Jessica;Noorani, Salman;Sy, Frank;Al-Eryani, Kamal;Enciso, Reyes
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.5
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    • pp.323-338
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    • 2022
  • Burning mouth syndrome (BMS) is a chronic oral disorder of unknown etiology which presents therapeutic challenges. Alpha-lipoic acid (ALA) has been studied as a potential treatment for BMS. The objective of this systematic review and meta-analysis was to evaluate the effectiveness of ALA compared to that of placebo or other interventions in individuals with BMS. Randomized controlled trials (RCT) using ALA to treat BMS were identified from MEDLINE, Cochrane Library, EMBASE, and Web of Science up to February 3, 2021. The assessment of the risk of bias in the included studies was based on the Cochrane guidelines. The primary outcome evaluated was the visual analog scale (VAS) pain intensity. ALA was compared with placebo, clonazepam, gabapentin, pregabalin, ALA plus gabapentin, capsaicin, Biotène®, and laser therapy. Altogether, 137 records were scanned for inclusion/exclusion, and nine RCTs (two unclear and seven at high risk of bias) were included in the qualitative and quantitative analyses, with a total of 594 patients with BMS included in this review. All studies reported an improvement in VAS pain scores ranging from -0.72 to -2.77. Meta-analysis results showed a non-significant reduction in pain intensity for ALA (P = 0.616) compared to that of placebo on a VAS of 0-10. Patients taking ALA were 1.923 times more likely to show an improvement in self-reported BMS symptoms (P = 0.031) than those in the placebo group. Clonazepam and pregabalin showed a significant VAS pain reduction of 4.08 and 4.68 (P < 0.001), respectively, compared to that with ALA. Although ALA intervention provided a non-significant improvement in the pain score and was more likely to produce a reduction in BMS symptoms, the evidence was of low quality. Further research is needed to establish clear guidelines for the use of ALA for BMS treatment.

Clinical Application of Focused Ultrasound in Korean Medicine (집속초음파 치료의 한의 임상 활용에 대한 고찰)

  • Yoomin Choi;Maeum Lee;Nayeon Hur;Eunhee Lee;Hyugyong Choi;Hyung-Sik Seo;Eui-Hyoung Hwang;Insoo Jang
    • Korean Journal of Acupuncture
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    • v.40 no.3
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    • pp.79-89
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    • 2023
  • Objectives : The purpose of this study is to investigate various application methods of focused ultrasound and apply them to clinical use in Korean medicine. Methods : Search was performed using the search engines of electronic databases, including PubMed, ScienceDirect, Cumulative Index to Nursing and Allied Health Literature (CINAHL), ScienceON, Oriental Medicine Advanced Searching Integrated System (OASIS), China National Knowledge Infrastructure (CNKI), Wanfang Data, Japan Science Technology Information Aggregator, Electronic (J-STAGE) and Citation Information by NII (CiNii), from inception to July 2023 without language limitation. Inclusion criteria were clinical studies including randomized controlled trials (RCTs), and animal experimental studies related with focused ultrasound treatments for acupoints or meridian sinews. Results : Total 17 papers, 7 for RCT, 6 for in vivo animal studies, and other experimental studies, were finally selected. Indications used in studies were shoulder pain, back pain, chronic back pain, and degenerative knee arthritis. In experimental studies, studies on animal models of hypoxic ischemic brain damage and hyperlipidemia were also conducted. As for the acupoints, LR3, LI4, and ST36 were used in clinical studies and, in animal experimental studies, GV20, KI1, and ST36 were used. As for the dose, 4 studies below 3 W/cm2 and 3 studies in the range of 0.625 to 5 W/cm2 in clinical studies, and all studies did not exceed 5 W/cm2. In animal experimental studies, 0.5 W/cm2, 2 W/cm2, 7.5 WW/cm2, 15 W/cm2, 10~20 W/cm2 were used. In all three studies describing the penetration depth during irradiation, it was less than 1 cm. Conclusions : We suggest that focused ultrasound is an appropriate treatment tool for stimulating the acupoints to transfer heat energy. Future studies with rigorous and well-designed RCTs for various diseases will be required to ascertain the focused ultrasound stimulate acupoints or meridian sinews.