• Title/Summary/Keyword: Randomized controlled trials

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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.

A Systematic Review and Meta-Analysis of Herbal Medicine for Frozen Shoulder (동결견의 한약 치료에 대한 체계적 문헌고찰 및 메타분석)

  • Oh, Tae-Young;Kim, Yeon-Hee;Oh, Eun-Mi;Hong, Su-Min;Ha, Hyun-Ju;Lee, Eun-Jung;Oh, Min-Seok
    • Journal of Korean Medicine Rehabilitation
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    • v.29 no.3
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    • pp.15-33
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    • 2019
  • Objectives The objective of this study is to provide the evidence of the effectivness of herbal medicine for frozen shoulder. Methods 2 Korean medical on-line databases (Oriental Medicine Advanced Searching Integrated System, Korean Traditional Knowledge), and 3 foreign databases (Pubmed, Cochrane library, China National Knowledge Infrastructure) were searched to find articles concerning herbal medicine for frozen shoulder. We selected randomized controlled trials (RCTs). Several repeated articles and those not relevant to the topic were excluded, as well as review articles and commentaries. The methodological quality of RCTs were evaluated using the Cochrane risk of bias tool and meta-analyes were perfomed. Results Total 474 studies were founded and 22 RCTs were selected for systematic review. Efficiency rate was used as the primary evaluation method. Almost studies reported that herbal medicine has significant effect on pain reduction, increasing shoulder function on frozen shoulder. 3 studies comparing herbal medicine and chuna with chuna and 3 studies comparing herbal medicine with ibuprofen were included in the meta-analysis. At herbal medicine and chuna with chuna meta-analysis, it showed positive results of herbal medicine for efficiency rate (risk ratio: 1.18, 95% confidence interval: 1.09-1.27, p<0.0001). At herbal medicine with ibuprofen medta-analysis, it showed positive results of herbal medicine for efficiency rate (risk ratio: 1.15, 95% confidence interval: 1.05-1.27, p=0.003). Conclusions The studies showed that herbal medicine can significantly effective on frozen shoulder. However, the risk of bias in RCTs were evaluated as uncertain. In the future, further well-designed RCTs are needed to prove the effectiveness of herbal medicine for frozen shoulder and reduce the risk of bias.

Systematic Review of Korean Medicine for the Treatment of Sixth Cranial Nerve Palsy (외전신경마비의 한의학 치료에 대한 체계적 문헌 고찰)

  • Won, Seo-young;Kim, Min-ji;Cha, Ji-yun;Jung, Eun-sun;Cho, Hyun-kyoung;Yoo, Ho-ryong;Seol, In-chan;Kim, Yoon-sik
    • The Journal of Internal Korean Medicine
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    • v.40 no.3
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    • pp.409-424
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    • 2019
  • Objectives: This research aimed to confirm the efficacy of oriental medicine in sixth cranial nerve palsy and to evaluate the quality of the studies. Methods: Using the medical subject heading (MeSH) keywords "abducens nerve palsy", "abducens nerve paralysis", "sixth nerve palsy", "herbal medicine", "Chinese medicine", "oriental medicine" and "acupuncture", we collected the research papers through an electronic database search in Oriental Medicine Advanced Searching Integrated System (OASIS), National Discovery for Science Leaders (NDSL), PubMed, Cochran Library, and China National Knowledge Infrastructure (CNKI). Results: A total of 136 papers were searched from the databases. Among these, 15 case reports and 8 randomized controlled trials (RCTs) met our criteria. 17 articles were found on the use of acupuncture as the main intervention, 11 on the use of herbal medicine as the main intervention, and 9 on the use of electroacupuncture as the main intervention. The frequently used acupoints were LI4, EX-HN5, GB1, BL2, TE23, LR3, BL1, ST2, GB20, and ST36. All 23 studies confirmed the efficacy of Korean medicine. According to the assessment using the risk of bias, the overall quality of the RCTs was low. Conclusions: Twenty-three papers suggested that Korean medicine treatment for abducens nerve palsy was effective in many cases. Analyzing the potential bias was difficult.

Effects on Muscle Activities after the Kinesio Tape Application in Each Lower Extremity of Normal People during Stand-broad Jumping (키네시오 테이프 적용이 제자리멀리뛰기 시 건강한 남녀의 각 다리근육 근 활성도에 미치는 영향)

  • We, Jun-hyeong;Lee, Sang-ha;Lee, Jin-hwa;Lee, Ho-sung;Yoon, Hyun-seok;Yang, Seung-soo;Yang, Jung-won;Kim, Sang-deuk;Kim, Sang-hyun;Shim, Na-young;Jang, Hee-jin;Cho, Gun-hee;Yoo, Hyun-kyung;Lee, Cu-rie
    • Journal of Korean Physical Therapy Science
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    • v.26 no.1
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    • pp.61-68
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    • 2019
  • Purpose: This study was to examine the differences in muscle activities for some muscles of the legs used in a broad jump after applying tape to healthy people. The purpose of this study was to improve the exercising ability of patients and athletes during the rehabilitation training. Design: Randomized Controlled Trial. Methods: The experimental group was attached with the Kinesio tape on Rectus femoris, Biceps femoris and Gastrocnemius. Before doing broad jumping, they had stretching with the following order. And we measured broad jumps five times. We gave the rest period between trials. After every trial was measured, they were performed to cool-down exercise with the same way of warm-up exercise. And the control group did the same exercises as the experimental group except for attaching the Kinesio tape on muscles. Results: The results of Rectus femoris, Biceps femoris and Gastrocnemius activities according to tape application of femoris muscle were significantly increased (p<.05) compared to untreated group. Conclusion: Therefore, Kinesio tape has an effect on the improvement of the broad jump recorded by affecting the increase in muscle activities.

Ginsenoside Rg1 supplementation clears senescence-associated β-galactosidase in exercising human skeletal muscle

  • Wu, Jinfu;Saovieng, Suchada;Cheng, I-Shiung;Liu, Tiemin;Hong, Shangyu;Lin, Chang-Yu;Su, I-Chen;Huang, Chih-Yang;Kuo, Chia-Hua
    • Journal of Ginseng Research
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    • v.43 no.4
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    • pp.580-588
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    • 2019
  • Background: Ginsenoside Rg1 has been shown to clear senescence-associated beta-galactosidase (SA-${\beta}$-gal) in cultured cells. It remains unknown whether Rg1 can influence SA-${\beta}$-gal in exercising human skeletal muscle. Methods: To examine SA-${\beta}$-gal change, 12 young men (age $21{\pm}0.2years$) were enrolled in a randomized double-blind placebo controlled crossover study, under two occasions: placebo (PLA) and Rg1 (5 mg) supplementations 1 h prior to a high-intensity cycling (70% $VO_{2max}$). Muscle samples were collected by multiple biopsies before and after cycling exercise (0 h and 3 h). To avoid potential effect of muscle biopsy on performance assessment, cycling time to exhaustion test (80% $VO_{2max}$) was conducted on another 12 participants (age $23{\pm}0.5years$) with the same experimental design. Results: No changes of SA-${\beta}$-gal were observed after cycling in the PLA trial. On the contrary, nine of the 12 participants showed complete elimination of SA-${\beta}$-gal in exercised muscle after cycling in the Rg1 trial (p < 0.05). Increases in apoptotic DNA fragmentation (PLA: +87% vs. Rg1: +133%, p < 0.05) and $CD68^+$ (PLA:+78% vs. Rg1:+121%, p = 0.17) occurred immediately after cycling in both trials. During the 3-h recovery, reverses in apoptotic nuclei content (PLA:+5% vs. Rg1 -32%, p < 0.01) and increases in inducible nitrate oxide synthase and interleukin 6 mRNA levels of exercised muscle were observed only in the Rg1 trial (p < 0.01). Conclusion: Rg1 supplementation effectively eliminates senescent cells in exercising human skeletal muscle and improves high-intensity endurance performance.

A Systematic Review of Korean Medicine for Non-Alcoholic Fatty Liver Disease (비알콜성 지방간질환의 한방치료에 대한 체계적 문헌고찰)

  • Lee, Yu-ri;Cho, Na-kyung;Choi, Hong-sik;Kim, Seung-mo;Kim, Kyung-soon
    • The Journal of Internal Korean Medicine
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    • v.40 no.1
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    • pp.13-37
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    • 2019
  • Objectives: The purpose of this study was to assess the effects of Korean medicine for non-alcoholic fatty liver disease (NAFLD). We analyzed the result of randomized controlled trials (RCTs) that applied Korean medicine to NAFLD patients through meta analysis and systematic review. Methods: The key question was to the effects of Korean medicine for NAFLD patients according to the PICO-SD (participants, intervention, comparison, outcome, study design) and we included only RCTs. We searched 10 databases including NDSL, KMBASE, KISS, KISTI, KoreaMed, Koreantk, OASIS, Cochrane, Pubmed, EMBASE without a language restriction. We assessed risk of bias by Cochrane group's Risk of Bias tool. Results: The finally selected 12 RCTs were analyzed. Total number of participants was 1189 (male 719, female 470) as 684 and 505 in the oriental medicine group (i.e. herbal drugs, acupuncture, acupoint embedding therapy) and control group (conventional drugs, placebo), respectively. The meta analysis results of examining 7 RCTs comparing the therapeutic efficacy of herbal medicine with that of Western medicine showed statistically significant (p<0.05) differences in the efficacy evaluation, liver function test results, blood lipids, and TNF-${\alpha}$. Furthermore, the meta analysis results of investigating 3 RCTs comparing the therapeutic efficacy of herbal medicine with that of a placebo showed statistically significant (p<0.05) differences in the liver function test results, blood lipids, and waist circumference. Conclusions: The research showed that Korean medicine for NAFLD can be effective treatment. But more studies are required to enhance the level of evidence and we should report on safety.

Systematic Review on Presbycusis Treated by Herbal Medicine Focusing on Kidney Deficiency (노인성 난청의 한약 치료에 대한 체계적 문헌고찰: 신허(腎虛)을 중점으로)

  • Lim, Hui-yeong;Jin, Han-Sol;Ko, Woo-Shin;Yoon, Hwa-Jung
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.34 no.4
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    • pp.49-70
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    • 2021
  • Objectives : This study was conducted to approve the effectiveness and safety of herbal medicine on presbycusis with kidney deficiency. Methods : We searched randomized controlled trials(RCTs) on presbycusis patients diagnosed with kidney deficiency through 10 electronic databases from the start to Sep 7, 2021. Study collection and data extraction, and evaluation of risk of bias were conducted by two independent collaborator. The evaluation of the risk of bias in included RCTs was carried out by using Cochrane risk-of-bias tool. And the data synthesis was conducted by using Review Manager(RevMan, ver.5.4). Results : 1. The treatment group which used herbal medicine(HM) alone was more effective than the control group which used only western medicine(WM) on effective rate of hearing loss. 2. In 3 studies comparing the HM-WM combination treatment group with the control groups using the same WM treatment, the effective rate was statistically significantly higher in the HM-WM combination treatment group. 3. Of the 5 studies that reported adverse reactions, one study reported mild nausea and dizziness, but the difference between the HM treatment group and the WM control group was not statistically significant, and no side effects occurred in other 3 studies. 4. In studies comparing HM and WM, the HM treatment group improved hearing loss, whole blood viscosity, serum TNF-𝛼, IL-1𝛽, IL-6, and oxidative stress indicators better than the WM control group, and there was no significant difference. 5. In studies comparing the HM-WM treatment group with the WM control group, the severity of tinnitus, quality of life, and feelings of anxiety and depression were better in the treatment group than the control group. Conclusions : This study shows that the herbal medicine can improve symptoms of presbycusis with kidney deficiency.

A Systematic Review of Acupuncture for Allergic Rhinitis (알레르기 비염의 침 치료에 대한 체계적 고찰)

  • Mun, Byeong-gwon;Lee, Yu-ri;Cho, Na-kyung;Kim, Kyung-soon;Choi, Hong-sik;Kim, Seung-mo
    • The Journal of Internal Korean Medicine
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    • v.41 no.6
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    • pp.1100-1118
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    • 2020
  • Objectives: The purpose of this study was to assess the effects of acupuncture as a treatment for allergic rhinitis (AR). We used a meta-analysis and systematic review to analyze the results of randomized controlled trials (RCTs) that applied acupuncture to AR patients. Methods: The key question assessed the effects of acupuncture on patients with AR, and we included only RCTs. We searched the KoreaMed, NDSL, KMBASE, Koreantk, OASIS, PubMed, EMBASE, and Cochrane databases, with no language restriction. We assessed risk of bias with the Cochrane Risk of Bias tool. The random effects model was used to adjust for the heterogeneity of the included studies, and the effect sizes between two groups were reported as mean differences (MD) and risk ratios (RR). Results: Twelve RCTs were analyzed, with a total of 1788 participants; 824 participants were in the treatment group (i.e., acupuncture) and 964 were in the control group (sham acupuncture, western medicine, or waitlist). The meta-analysis results of 7 RCTs comparing the therapeutic efficacy of acupuncture with that of sham acupuncture showed a statistically significant difference (p<0.05) in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and the Change of Total Nasal Symptom Score (TNSS). The meta-analysis of 4 RCTs comparing the therapeutic efficacy of acupuncture with western medicine showed statistically significant differences (p<0.05) in the RQLQ but not in the changes in effective rate (p>0.05). Conclusions: Acupuncture can be an effective treatment for AR, but more studies are required to enhance the level of evidence and to confirm safety.

Effects of Korean Medicine on Pain in Patients with Parkinson's Disease: A Retrospective Study (파킨슨병 환자의 통증에 대한 한의치료의 효과 : 후향적 연구)

  • Jeong, Hye-seon;Kim, Ha-ri;Kim, Seo-young;Yim, Tae-bin;Jin, Chul;Kwon, Seungwon;Cho, Seung-yeon;Jung, Woo-sang;Moon, Sang-kwan;Park, Jung-mi;Ko, Chang-nam;Park, Seong-uk
    • The Journal of Internal Korean Medicine
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    • v.41 no.6
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    • pp.947-958
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    • 2020
  • Objectives: To investigate efficacy of Korean medicine for patients with Parkinson's Disease (PD) with pain. Methods: We performed a retrospective review of the medical records for patients diagnosed with PD between 2012 and 2019 at Gangdong Kyung Hee University Korean Medicine Hospital in South Korea. Results: Twenty-two patients with King's Parkinson's Disease Pain Scale(KPPS) scores at least twice were analyzed for evaluating the efficacy of Korean medicine for pain treatment in PD. The mean total scores before and after Korean medicine treatment were 15.23±1 .01 and 9.2±8.7, respectively, and the mean difference between the before/after total scores was 6.0±5.8 (P<0.001). Specifically, the score of radicular pain was significantly decreased (P=0.048). Conclusions: These findings suggest that Korean medicine could be beneficial for reducing pain associated with PD. Clinical efficacy should be confirmed by further studies, such as large-sample cohort studies and randomized controlled trials to clarify the pathological pain relief mechanism and the analgesic effect of Korean medicine.

A Review of Korean Medical Pathogenesis, Pattern Identification, Treatment Principle and Herbal Medicines for Allergic Conjunctivitis in Pediatric Patients (소아 알레르기 결막염의 한의학적 병인, 변증, 치법 및 한약재 선택에 대한 문헌적 고찰)

  • Kim, Ye Ji;Seo, Hae Sun;Park, Yong Seok;Park, Sul Gi;Lee, Sun Haeng;Lee, Jin Yong
    • The Journal of Pediatrics of Korean Medicine
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    • v.35 no.2
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    • pp.21-36
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    • 2021
  • Objectives We aimed to understand etiology, pattern differentiation, treatment principle, and the role of selected herbs in the treatment of Korean herbal medicine for allergic conjunctivitis (AC) in children. Methods We searched relevant literature published up to February 20, 2021 through CNKI, using search formula of (SU= '結膜炎'+'conjunctivitis') AND (SU='儿童'+'小儿'+'少儿'+'幼年') AND (SU='治療'+'中医治療'+'中藥'+'中医藥'+'顆粒'+'胶囊'+'自擬'+'湯'+'丸'+'散'+'方'). Results Among 81 searched studies, 9 randomized controlled trials and 1 case report were selected and analyzed. In all studies included, the efficacy of herbal treatment for AC was confirmed, and there was no evidence that herbal medicine treatment has higher risk of developing side effects compared to conventional eye drop treatment. As an etiology, wind (風邪) was observed the most frequently, and Saposhnikoviae Radix (防風) and Schizonepetae Spica (荊芥) were in frequent use to dispel wind (祛風). As visceral pattern identification, spleen (脾) and lung (肺) were two important keywords, and spleen deficiency (脾虛), dampness-heat in the spleen and stomach (脾胃濕熱), lung qi deficiency (肺氣虛) were main pathologic mechanisms. Else, treatments related to liver (肝) and removing dampness-heat (濕熱) were mentioned next. Conclusions This study is significant in that AC in children, which has a lack of research compared to other allergic diseases, has been studied in the contents of Korean medicine and laid foundation that can be used as basic data in the actual clinical field. Based on this study, it is hoped that clinical data of Korean herbal medicine treatment for childhood AC will be further accumulated.