• Title/Summary/Keyword: randomized controlled clinical trials

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Efficacy of Combination Treatment of Herbal Medicine and Western Medicine for the Treatment of Type 1 Diabetes in children : Systemic Review and Meta-analysis (소아 1형 당뇨의 한약과 양약 병용 치료에 대한 체계적 문헌 고찰 및 메타분석)

  • Kim, Mi Yeon;Kang, Jeong In;Jeong, Min Jeong
    • The Journal of Pediatrics of Korean Medicine
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    • v.33 no.3
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    • pp.15-29
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    • 2019
  • Objectives The purpose of this study is to investigate the clinical studies on the effect of herbal medicine in type 1 diabetes in children and to seek better approach of herbal medicine to treat type 1 diabetes in children. Methods This study researched randomized controlled trials through various databases in the world about herbal medicine treatments in type 1 diabetes in children. Results 10 out of 337 studies were selected and analyzed. All studies were conducted in China. All studies were using herbal medicines, as an adjunctive treatment to the main regimen. As a result, the integrated Chinese medicine and western medicine lowered FPG by -1.56 mmol/L and 2hPG by -1.94 mmol/L on average, respectively. The HbA1c also decreased by -1.11% in the treatment group compared to the control group. Total efficacy of the treatment was 1.21 times more effective in the treatment group than in the control group. Conclusions Based on the results of the studies, it seems that the herbal medicine for the treatment of type 1 diabetes in children will be effective as a combination with conventional medicines. Further research is needed to prove the findings of this observatoional studies.

Systematic Review of Acupuncture Treatment for Mild Cognitive Impairment

  • Kim, Min Wook;Yoo, Jae Hee;Go, Hong Je;Kim, Seon Woo;Jang, Seung Won;Jeong, Hyun Jin;Kim, Jae Hong
    • Journal of Acupuncture Research
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    • v.36 no.2
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    • pp.72-79
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    • 2019
  • Background: The aim of this study was to review clinical efficacy of acupuncture treatment of mild cognitive impairment. Methods: Randomized controlled trials that performed acupuncture treatment for mild cognitive impairment were retrieved from 6 online databases (PubMed, Cochrane Library, EMBASE, CNKI, NDSL, OASIS) on September $30^{th}$, 2018. Studies were selected according to inclusion and exclusion criteria, and were reviewed by Risk of Bias assessment. Results: In total, 21 studies were included in this review. All studies were Chinese (19 studies published in Chinese and 2 in English). The sample size, 50 to 100, and the number of treatment times, 20 to 30, were the largest range in all studies. The most treatments performed was 30. The longest treatment period was 56 days, which accounted for 33% of the studies. The most frequently used evaluation index was the Mini Mental State Examination followed by the Montreal Cognitive Assessment, each used 17 times and 15 times, respectively. The most frequently used acupoints were GV20, EX-HN1, GB20, and GV24, which accounted for 47% of total number of acupoints used. In 48% of the studies, needle retention time was 30 minutes. Western medicine treatment was the most common control group. Most studies reported that the intervention group was statistically significantly different to the control group. Conclusion: These results suggest that acupuncture for mild cognitive impairment was effective. However, it is difficult to confirm this conclusion because the quality of most of these studies were of low quality.

The Effect of Bojungikgi-tang on Stress Urinary Incontinence: A Systematic Review and Meta-Analysis (복압성 요실금에 대한 보중익기탕의 효과 : 체계적 문헌고찰과 메타분석)

  • Nam, Hyun-seo;Baek, Tae-hyun
    • The Journal of Internal Korean Medicine
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    • v.42 no.3
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    • pp.293-307
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    • 2021
  • Objectives: This study investigates the effects and safety of Bojungikgi-tang for stress urinary incontinence by systemic review and meta-analysis of randomized controlled trials (RCTs). Methods: RCTs were selected from articles published until December 2019 in seven domestic and foreign databases. The quality of the literature was evaluated using Cochrane's risk of bias (RoB) tool, and RevMan 5.3 was used to synthesize the results. Results: A total of 694 patients with stress urinary incontinence participated in eight RCTs. Meta-analysis showed that the total effective rate of treatment that combines pelvic floor muscle training (PFMT) and Bojungikgi-tang was significantly higher than that of PFMT alone. The volume of urine leakage per hour after the combined treatment was significantly lower than that of PFMT alone. The International Consultation on Insurance Questionnaire-Short Form (ICIQ-SF) scores from combining PFMT and Bojungikgi-tang were significantly lower than those for PFMT alone. Conclusion: This study suggests that Western medical treatment combined with Bojungikgi-tang for urinary incontinence from stress might be more effective in improving symptoms than conventional Western medical treatment alone. However, the number of studies included in the meta-analysis was insufficient, and the quality of the selected literature was generally low. Therefore, high-quality clinical studies on herbal medicine treatment for urinary incontinence would be required in the future.

Acupotomy for Osteoarthritis of the Knee; A Systematic Review and Meta-Analysis

  • Lee, Seung Min;Lee, Cham Kyul;Kim, Kyung Ho;Kim, Eun Jung;Jung, Chan Yung;Seo, Byung-Kwan;Goo, Bon Hyuk;Baek, Yong Hyeon;Lee, Eun Yong
    • Journal of Acupuncture Research
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    • v.38 no.2
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    • pp.96-109
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    • 2021
  • The purpose of this study was to evaluate the effectiveness and safety of acupotomy for the treatment of patients with knee osteoarthritis. There were 9 databases searched to retrieve randomized controlled trials until August 3, 2019 regarding acupotomy versus conventional Western medicine, conventional Western medicine treatment with and without acupotomy, and Korean medicine treatment with and without acupotomy, and meta-analysis was performed. Of 303 potentially relevant studies retrieved, 43 were systematically reviewed. All studies were conducted in China. Effective rate, visual analogue scale, and Western Ontario and McMaster Universities Osteoarthritis index were used as the evaluation scales. The Ashi point was selected most frequently. In all studies, the intervention group was more effective than the control group. Meta-analysis revealed that acupotomy showed statistically significant beneficial results. Although acupotomy had a beneficial effect on knee osteoarthritis, the risk of bias of the included studies was not low. The majority of the results from the evaluation scales used were highly heterogeneous (> 50%) which reduced confidence in the estimation of effect, or had a small sample size. Further clinical research and development is required in the future.

Efficacy of topical interventions for temporomandibular disorders compared to placebo or control therapy: a systematic review with meta-analysis

  • Mena, Mariam;Dalbah, Lana;Levi, Lauren;Padilla, Mariela;Enciso, Reyes
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.20 no.6
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    • pp.337-356
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    • 2020
  • This systematic review focused on the efficacy of topical products in reducing temporomandibular joint disorder (TMD)-associated pain, in comparison to placebo or control interventions. The EMBASE, Web of Science, Cochrane Library, and MEDLINE via PubMed databases were searched for randomized controlled trials (RCTs) using topical interventions in adults diagnosed with TMD. The pain intensity was the primary outcome, and other clinical findings were the secondary outcomes. The risk of bias was evaluated according to the Cochrane's handbook. The search up to February 7, 2020 identified a total of 496 unduplicated references. Nine RCTs with 355 adult patients diagnosed with TMD were included. The meta-analysis did not show a significant reduction in baseline pain intensity in the nonsteroidal anti-inflammatory drug (NSAIDs) group, when compared to the placebo group (P = 0.288). One study demonstrated a statistically significant pain score decrease for Theraflex-TMJ compared to placebo after 10 d of treatment (P = 0.003) and follow-up, 5 d after the last application (P = 0.027). Ping On reduced pain at 4 weeks of application (P < 0.001) but not after 7 d of application (P = 0.136). In one study, cannabidiol (CBD) significantly improved the pain intensity compared to placebo (P < 0.001). However, no differences were found with capsaicin in the two studies (P = 0.465). Evidence was of low quality because the studies were considered as having an unclear or a high risk of bias and a small number of studies were analyzed. The evidence is not sufficient to support the use of topical NSAIDs and capsaicin, and limited evidence was found for Threraflex-TMJ, bee venom, Ping On, and CBD, with only one study reporting for each. Additional studies are recommended to validate these results.

Research trends and clinical applications of neural mobilization in Korea: A scoping review (신경가동술의 국내 연구 동향과 임상적 활용: 주제범위 문헌고찰)

  • Lee, Eun-Kyung;Kim, Jin-Hyun;Lee, Jung-Han;Cho, Eun-Byul
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.16 no.1
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    • pp.53-66
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    • 2021
  • Objectives The purpose of this scoping review is to investigate the trends and gaps in existing research on neural mobilization in Korea and to suggest further directions for study. Methods A scoping review was sequentially conducted according to the five steps outlined by Arksey and O'Malley, and the PRISMA-ScR checklist. We searched five domestic databases (RISS, DBpia, KISS, ScienceON, and KMBASE) and identified relevant literature reported until April 15, 2021. The key search terms used were "Neural mobilization" and "Neurodynamic". Results Of the 1383 studies identified in the search, 50 were finally selected. Of these, 45 studies were in the field of medicine and pharmacy and physical therapy as the most common sub-field. Thirty-eight of the 50 studies (76%) were randomized controlled trials. Neural mobilization was most frequently used in the treatment of stroke (n = 13) and of various neuromusculoskeletal diseases such as cervical radiculopathy (n = 8) and low back pain (n = 5). The main targets of neural mobilization were the median nerve (n = 20) and sciatic nerve (n = 14). The most commonly used technique for neural mobilization was that developed by Butler and Jones in 1991 (n = 10). Conclusions This is the first scoping review of neural mobilization in Korea. We believe that further research on neural mobilization with other types of research design is necessary to investigate the utility of neural mobilization and to establish standard protocols. Our findings indicate that neural mobilization can be considered as an intervention for neuromusculoskeletal diseases in Korean medicine.

The effects of diagnostic hysteroscopy on the reproductive outcomes of infertile women without intrauterine pathologies: a systematic review and meta-analysis

  • Yang, Soo Yeon;Chon, Seung-Joo;Lee, Seon Heui
    • Women's Health Nursing
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    • v.26 no.4
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    • pp.300-317
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    • 2020
  • Purpose: Hysteroscopy can be used both to diagnose and to treat intrauterine pathologies. It is well known that hysteroscopy helps to improve reproductive outcomes by treating intrauterine pathologies. However, it is uncertain whether hysteroscopy is helpful in the absence of intrauterine pathologies. This study aimed to confirm whether hysteroscopy improves the reproductive outcomes of infertile women without intrauterine pathologies. Methods: We conducted a systematic review of 11 studies retrieved from Ovid-MEDLINE, Ovid-Embase, and the Cochrane Library. Two independent investigators extracted the data and used risk-of-bias tools (RoB 2.0 and ROBINS-I) to assess their quality. Results: Diagnostic hysteroscopy prior to in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) was associated with a higher clinical pregnancy rate (CPR) and live birth rate (LBR) than non-hysteroscopy in patients with recurrent implantation failure (RIF) (odds ratio, 1.79 and 1.46; 95% confidence interval, 1.40-2.30 and 1.08-1.97 for CPR and LBR, respectively) while hysteroscopy prior to first IVF was ineffective. The overall meta-analysis of LBR showed statistically significant findings for RIF, but a subgroup analysis showed effects only in prospective cohorts (odds ratio, 1.40 and 1.47; 95% confidence interval, 0.62-3.16 and 1.04-2.07 for randomized controlled trials and prospective cohorts, respectively). Therefore, the LBR should be interpreted carefully and further research is needed. Conclusion: Although further research is warranted, hysteroscopy may be considered as a diagnostic and treatment option for infertile women who have experienced RIF regardless of intrauterine pathologies. This finding enables nurses to educate and support infertile women with RIF prior to IVF/ICSI.

Qigong Exercise Therapy for Hypertension: A Systematic Review (기공 운동 치료가 고혈압에 미치는 영향: 체계적 문헌 고찰)

  • An, Jae-Gyu;Lee, Sang-Hyun;Kim, Hyun-Tae;Park, Sun-Young;Heo, In;Jeong, Min-Jeong;Hwang, Eui-Hyoung;Jang, In-Soo
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.15 no.2
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    • pp.9-18
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    • 2020
  • Objectives This study verified the clinical effectiveness of Qigong exercise therapy for individuals with hypertension. Methods Ten electronic databases were used for information retrieval. Only randomized controlled trials (RCTs) using Qigong exercise therapy as a treatment for hypertension were included in this study. Cochrane risk of bias tool was used to assess the methodological quality of each RCT. Results After a thorough review, six RCTs were deemed eligible. These studies were divided into two groups: Qigong vs. no intervention and Qigong plus anti-hypertensive drug vs. anti-hypertensive drug alone. Among the six RCTs, four studies were Qigong vs. no intervention, and two studies were Qigong plus anti-hypertensive drug vs. anti-hypertensive drug alone. The meta-analysis demonstrated that adding Qigong exercise to anti-hypertensive drug treatment lowers diastolic blood pressure more than the anti-hypertensive drug alone. Conclusions Although Qigong exercise is not widely used in the Korean medical field, the results of this study demonstrated the necessity of exercise while controlling hypertension. However, the number of included studies was small, with their high risk of bias. In conclusion, although it is difficult to determine whether Qigong exercise lowers blood pressure in hypertensive patients, exercise including Qigong must be parallel with the intake of anti-hypertensive drugs.

Effect of Manual Acupuncture for Mild-to-Moderate Carpal Tunnel Syndrome: A Systematic Review

  • Huh, Jeong Ho;Jeong, Hye In;Kim, Kyeong Han
    • Journal of Pharmacopuncture
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    • v.24 no.4
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    • pp.153-164
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    • 2021
  • Objectives: Despite the low cost and high accessibility of manual acupuncture (MA) treatments for the carpal tunnel syndrome (CTS), this intervention has not been uniformly evaluated in systematic reviews (SR), and no SR has evaluated MA monotherapy for CTS. This review was conducted to summarize the findings and undertake a quality assessment of randomized controlled trials (RCTs) of acupuncture treatment methods for mild-to-moderate CTS to identify clinical evidence for the use of MA in CTS. Methods: We searched five databases for articles on relevant RCTs that were published until June 2021 without imposing specific restrictions, such as age or sex, on CTS patients. RCTs that evaluated MA were included without any restriction on comparator interventions. Measurement tools for evaluating pain reduction and functional improvement or for evaluating efficacy using electrophysiological indicators were included as outcome measures. Results: We included seven RCTs, of which three studies reported both post-treatment improvement effects and statistical significance using p-values for all outcomes. Five studies reported statistically significant intergroup differences (p-values for all outcomes) in posttreatment improvement. None of the studies reported severe adverse effects of MA. In all of the RCTs, the reporting rates of the 2c, 2a, and 6a items of STRICTA 2010 were 14%, 29%, and 29%, respectively. PC7 (Daereung) was used to treat CTS in all of the included studies. Conclusion: MA can be used for CTS treatment without serious adverse effects. PC7 was the most commonly used acupoint. In order to ensure objective and reliable reporting, accurate standardization of acupuncture treatment methods acupoint terms should be undertaken in future RCTs.

Efficacy of cannabis-based medications compared to placebo for the treatment of chronic neuropathic pain: a systematic review with meta-analysis

  • Sainsbury, Bradley;Bloxham, Jared;Pour, Masoumeh Hassan;Padilla, Mariela;Enciso, Reyes
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.6
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    • pp.479-506
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    • 2021
  • Background: Chronic neuropathic pain (NP) presents therapeutic challenges. Interest in the use of cannabis-based medications has outpaced the knowledge of its efficacy and safety in treating NP. The objective of this review was to evaluate the effectiveness of cannabis-based medications in individuals with chronic NP. Methods: Randomized placebo-controlled trials using tetrahydrocannabinol (THC), cannabidiol (CBD), cannabidivarin (CBDV), or synthetic cannabinoids for NP treatment were included. The MEDLINE, Cochrane Library, EMBASE, and Web of Science databases were examined. The primary outcome was the NP intensity. The risk of bias analysis was based on the Cochrane handbook. Results: The search of databases up to 2/1/2021 yielded 379 records with 17 RCTs included (861 patients with NP). Meta-analysis showed that there was a significant reduction in pain intensity for THC/CBD by -6.624 units (P < .001), THC by -8.681 units (P < .001), and dronabinol by -6.0 units (P = .008) compared to placebo on a 0-100 scale. CBD, CBDV, and CT-3 showed no significant differences. Patients taking THC/CBD were 1.756 times more likely to achieve a 30% reduction in pain (P = .008) and 1.422 times more likely to achieve a 50% reduction (P = .37) than placebo. Patients receiving THC had a 21% higher improvement in pain intensity (P = .005) and were 1.855 times more likely to achieve a 30% reduction in pain than placebo (P < .001). Conclusion: Although THC and THC/CBD interventions provided a significant improvement in pain intensity and were more likely to provide a 30% reduction in pain, the evidence was of moderate-to-low quality. Further research is needed for CBD, dronabinol, CT-3, and CBDV.