• Title/Summary/Keyword: Randomized controlled clinical trials

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Effects of Yigong-san for the Treatment of Anorexia in Children: A Systematic Review and Meta-Analysis (소아 식욕부진에 대한 이공산(異功散) 치료의 효과 : 체계적 문헌고찰 및 메타분석)

  • Lee, Bo-ram;Ha, Da-jung;Huh, Tae-young;Park, Sang-eun;Lee, Sun-haeng;Chang, Gyu-tae
    • The Journal of Internal Korean Medicine
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    • v.43 no.4
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    • pp.542-558
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    • 2022
  • Objectives: The purpose of this study was to assess the effect of Yigong-san on anorexia in children by conducting a systematic review and meta-analysis of randomized controlled trials (RCTs). Methods: Eleven electronic databases were searched on May 30, 2022 to collect relevant studies. All studies published up to the search date were considered. RCTs reporting the effect of Yigong-san on the treatment of anorexia in children were included. The primary outcome was an improvement in clinical anorexia symptoms after treatment. In this meta-analysis, continuous and binary outcomes were assessed, and the data were presented as the mean difference and risk ratio with their 95% confidence intervals. The risk of bias was assessed using the Cochrane Collaboration's risk of bias tool. Results: A total of nine studies were included in this systematic review. The treatment group (Yigong-san only or Yigong-san plus conventional treatment) showed a statistically significant effect compared to the control group (conventional treatment only) in total effective rate (Yigong-san only: RR 1.26, 95% CI 1.17, 1.36, I2=0%; Yigong-san plus conventional treatment: RR 1.32, 95% CI 1.18, 1.47, I2=0%), clinical symptoms, some of the anthropometric outcomes, and biological markers related to appetite and growth in children with anorexia. No serious adverse events related to Yigong-san were reported. Conclusions: Yigong-san showed statistically significant effects as a treatment for anorexia in children. However, the number of studies included in the meta-analysis was insufficient, and the herbs contained in the Yigong-san used in the included studies were not standardized. Future research should focus on the implementation of methodologically robust clinical research.

Randomized Controlled Clinical Trials of Warm Herbal Foot Bath Therapy for Insomnia: A Literature Review Based on the CNKI (불면증에 대한 한방 족욕요법의 무작위 대조군 임상연구 현황 : CNKI를 중심으로)

  • Chan-Young Kwon;Boram Lee;Kyoungeun Lee
    • The Journal of Internal Korean Medicine
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    • v.44 no.4
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    • pp.726-740
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    • 2023
  • Objectives: This review investigated the research on warm herbal foot bath therapy (WHFT) for insomnia. Methods: A search was conducted on the China National Knowledge Infrastructure (CNKI) database to collect relevant studies published up to August 29, 2023. Randomized controlled trials (RCTs) comparing WHFT and sleeping pills in patients with insomnia were included. The methodological quality of the included studies was assessed using the Cochrane risk-of-bias assessment tool. The results of the meta-analysis were presented as risk ratios (RRs) or mean differences (MDs) and their 95% confidence intervals (CIs). Results: A total of 11 RCTs were included. WHFT as monotherapy resulted in a significantly higher total effective rate (TER) (RR, 1.25; 95% CI, 1.15 to 1.36; I2=25%) and an improved Pittsburgh Sleep Quality Index (PSQI) global sore (MD, -3.10; 95% CI, -4.24 to -1.95; I2=73%) compared to benzodiazepines. Additionally, WHFT as a combined therapy with benzodiazepines resulted in a significantly higher TER (RR, 1.15; 95% CI, 1.04 to 1.27; I2=0%) and an improved PSQI global score (MD, -2.23; 95% CI, -4.09 to -0.38; I2=80%) compared to benzodiazepines alone. In network analysis visualizing the components of HWFT, four clusters were discovered, and Polygoni Multiflori Ramuls and Ziziphi Spinosae Semen were the key herbs used in WHFT. Overall, the methodological quality of the included studies was poor. Conclusions: There was limited evidence that WHFT as a monotherapy or combined therapy was effective in improving insomnia. The findings can be used as basic data for future WHFT research in South Korea.

Evaluation of Pregnancy and Thyroid Function (임신과 갑상선 기능의 평가)

  • Park, Chang-Eun
    • Korean Journal of Clinical Laboratory Science
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    • v.50 no.1
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    • pp.1-10
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    • 2018
  • During early pregnancy, before the development of a functioning thyroid gland, thyroid stimulating hormone (TSH) is a very sensitive marker of thyroid dysfunction during pregnancy. Normal values have been modified during gestation with a downward shift. The fetus is influenced by the TSH supplied by the mother. TSH and free thyroxine (FT4) concentrations vary during pregnancy and conventional units can vary between laboratories. A downward shift of the TSH reference range occurs during pregnancy, with a decrease in both the lower and upper limits of maternal TSH, relative to the typical non-pregnant TSH reference range. Each laboratory produces its own reference TSH and FT4 concentrations because there are many different assays that yield different results in pregnancy. Therefore, automated immunoassays used for serum FT4 analysis are still used widely, but the important considerations discussed above must be noted. The use of population-based, trimester-specific reference ranges remains the best way to handle this issue The slight downward shift in the upper reference range of TSH occurring in the latter first trimester (7~12 weeks) of pregnancy, typically not observed prior to 7 weeks. Their use indicates high or low levels in a quantitative manner independent of the reference ranges. These data highlight the importance of calculating population-based pregnancy-specific thyroid parameter reference intervals. A precision medicine initiative in this area will require the collection and analysis of a large number of genetic, biological, psychosocial, and environmental variables in large cohorts of individuals. Large prospective randomized controlled trials will be needed to resolve these controversies.

Early gonadotropin-releasing hormone antagonist start improves follicular synchronization and pregnancy outcome as compared to the conventional antagonist protocol

  • Park, Chan Woo;Hwang, Yu Im;Koo, Hwa Seon;Kang, Inn Soo;Yang, Kwang Moon;Song, In Ok
    • Clinical and Experimental Reproductive Medicine
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    • v.41 no.4
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    • pp.158-164
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    • 2014
  • Objective: To assess whether an early GnRH antagonist start leads to better follicular synchronization and an improved clinical pregnancy rate (CPR). Methods: A retrospective cohort study. A total of 218 infertile women who underwent IVF between January 2011 and February 2013. The initial cohort (Cohort I) that underwent IVF between January 2011 and March 2012 included a total of 68 attempted IVF cycles. Thirty-four cycles were treated with the conventional GnRH antagonist protocol, and 34 cycles with an early GnRH antagonist start protocol. The second cohort (Cohort II) that underwent IVF between June 2012 and February 2013 included a total of 150 embryo-transfer (ET) cycles. Forty-three cycles were treated with the conventional GnRH antagonist protocol, 34 cycles with the modified early GnRH antagonist start protocol using highly purified human menopause gonadotropin and an addition of GnRH agonist to the luteal phase support, and 73 cycles with the GnRH agonist long protocol. Results: The analysis of Cohort I showed that the number of mature oocytes retrieved was significantly higher in the early GnRH antagonist start cycles than in the conventional antagonist cycles (11.9 vs. 8.2, p=0.04). The analysis of Cohort II revealed higher but non-significant CPR/ET in the modified early GnRH antagonist start cycles (41.2%) than in the conventional antagonist cycles (30.2%), which was comparable to that of the GnRH agonist long protocol cycles (39.7%). Conclusion: The modified early antagonist start protocol may improve the mature oocyte yield, possibly via enhanced follicular synchronization, while resulting in superior CPR as compared to the conventional antagonist protocol, which needs to be studied further in prospective randomized controlled trials.

Systematic Review of Hominis Placenta Pharmacopuncture in English and Korean Literature

  • Ryoo, Dek-Woo;Kim, Hong-Guk;Kim, Sung-Jin;Baek, Seung-Won;Jeong, Seong-Mok;Yoon, Jin-Young;Lee, Chang-Hee;Goo, Bon-Hyuk;Kim, Min-Jeong;Park, Yeon-Cheol;Baek, Yong-Hyeon;Nam, Sang-Soo;Seo, Byung-Kwan
    • Journal of Acupuncture Research
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    • v.34 no.4
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    • pp.153-158
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    • 2017
  • Background: Hominis placenta (HP) is used in Korean medicine to tonify qi and blood, and enrich yin and tonify yang. HP has been reported to have therapeutic effects. Methods: A survey of international and Korean electronic databases was conducted using the search terms "hominis placenta pharmacopuncture" and "hominis placenta extract". The search was limited to material published up to May 31, 2017. Results: A total of 83 studies were included in this systematic review: 50 were clinical studies, 25 were basic studies, and 8 were other types of study. Among clinical studies, the most frequently treated disease groups were musculoskeletal diseases and nervous system diseases. In vitro studies were conducted mainly on anti-inflammatory, analgesic, and anti-cell necrosis models. Most of the in vivo studies were performed in rheumatoid arthritis or diabetic complications models. Conclusion: HP pharmacopuncture has effects in the treatment of various diseases. Further large-scale randomized controlled trials are needed to improve the level of evidence for HP pharmacopuncture. It would be helpful if future in vitro and in vivo studies could identify the mechanism of action of HP pharmacopuncture.

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.

The Effect of Dachaihu Decoction for Hyperlipidemic Acute Pancreatitis: A Systematic Review and Meta-Analysis (고지혈성 급성 췌장염에 대한 대시호탕의 효과 : 체계적 문헌고찰과 메타분석)

  • Kim, Yoon-jung;Jung, Yu-jin;Park, Dong-il
    • The Journal of Internal Korean Medicine
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    • v.41 no.3
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    • pp.306-325
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    • 2020
  • Objectives: The aim of this study is to investigate the effect of a Dachaihu decoction for hyperlipidemic acute pancreatitis (HLAP) by systematic review and meta-analysis of Chinese clinical studies. Methods: China National Knowledge Infrastructure (CNKI) was utilized as the major search engine. The date of the literature search was March 7, 2020. Randomized controlled trials (RCTs) about using a Dachaihu decoction for HLAP were included in this study. Meta-analysis was performed by synthesizing outcome data, including total effective rate, abdomen pain relief time, first bowel movement time, blood amylase recovery time, and triglyceride (TG) levels (mmol/L). The selected literature was assessed using Cochrane's risk of bias (RoB). Results: Twelve of 44 RCTs met the inclusion criteria. Most studies were evaluated with RoB as having unclear risk. The total effective rate of herbal medicine treatment based on the Dachaihu decoction was significantly higher than that of symptomatic supportive treatment in 10 articles (risk ratio=1.15, 95% CI: 1.08 to 1.21, p<0.00001, I2=0%). Herbal medicine treatment based on a Dachaihu decoction was significantly more effective than symptomatic supportive treatment in terms of reducing abdomen pain relief time (in all articles; mean difference=-1.70, 95% CI: -1.91 to -1.41, p<0.00001, I2=45%), first bowel movement time (in 7 articles; mean difference=-1.46, 95% CI: -1.86 to -1.05, p<0.00001, I2=73%), blood amylase recovery time (in 8 articles; mean difference=-1.48, 95% CI: -2.04 to -0.92, p<0.00001, I2=90%), and TG levels (in 8 articles; mean difference=-1.59, 95% CI: -2.28to -0.91, p<0.00001, I2=90%). Only one article reported side effects of treatment among the intervention group and control group, citing pancreatic ulcer and pancreatic pseudocyst formation. Conclusions: This study suggests that herbal medicine treatment based on a Dachaihu decoction could yield higher efficacy for HLAP than symptomatic supportive treatment alone. However, the results might be somewhat biased because of the poor quality and small sample size of the included RCTs. Well-qualified clinical studies are needed to prove the effectiveness of Dachaihu decoction therapy for HLAP.

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.

A Systematic Review of effect on Heat-sensitive Moxibustion for Benign Prostatic Hyperplasia (전립선비대증에 대한 열민구(熱敏灸)의 효과에 관한 체계적 문헌 고찰)

  • Kim, MinSeok;Ju, HongMin;Kim, MinHwa;Park, SunYoung;Yun, YoungJu;Park, SeongHa
    • The Journal of Korean Medicine
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    • v.42 no.3
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    • pp.153-164
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    • 2021
  • Objectives: The aim of this study is to investigate the effect of Heat-sensitive Moxibustion on Benign Prostatic Hyperplasia Methods: We searched articles from Academic Journals(CAJ) online databases, Oriental Medicine Advanced Searching Integrated System (OASIS), Searching key words were '前列腺增生', '熱敏灸' and '열민구', '전립선비대'. The search range included randomized controlled trials (RCTs). Among the articles published to 2020, 10 articles were found. After review the title, abstract and original, 3 articles were selected finally to rule out treatment combined with completely different treatments. Result: The Heat-sensitive moxibustion at acupoints in the treatment of Benign prostatic hyperplasia were significantly superior to control group after treatment in the symptoms of patients, IPSS, QOL, PVR and Qmax(P<0.05). The Heat-sensitive moxibustion can significantly reduce the incidence of temporary urinary incontinence after Transurethral resection of the prostate(TURP) and improve life quality and satisfaction of patients(P<0.05). The individualized desensitization saturated time and amount of Heat-sensitive moxibustion is superior effective to general amount and time of traditional moxibustion in the total effective rate, IPSS, Ru and Qmax(P<0.01) for Benign prostatic hyperplasia. Conclusion: Heat sensitive moxibustion directly transfer heat to the source of a disease. So it can be considered as a good treatment for Benign prostate hypertrophy. It was also shown a better effect on BPH compared to traditional moxibustion, According to the thermo principles of tumor, if the tumor cell's death temperature of 43℃ is reached, that can cause tumor degeneration. Therefore I think Heat sensitive moxibustion can be applied to various tumor disease. The results of this study could be applied to clinical treatment of BPH. However, additional large-scale clinical researches should be conducted.

A Narrative Review of the Korean Medicine Treatments for Achilles Tendinopathy (아킬레스 건병증의 한의학적 치료에 대한 국내외 연구 동향 분석)

  • Yoon, Kyung-Young;Hwang, Dong-Wook;Bae, In-Su;Youn, Jun-Heum;Lee, Yu-Jin;Jang, Won-Suk;Yoo, Sang-Joon;Lee, Do-Hoon;Kang, Dong-Hyeob;Son, Ja-Yean;Yang, Seok-Gyu;Cho, Hyun-Woo
    • Journal of Korean Medicine Rehabilitation
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    • v.32 no.4
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    • pp.33-45
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    • 2022
  • Objectives The purpose of this review was to investigate clinical treatment trends of Achilles tendinopathy. Methods Clinical studies about Korean medicine treatments on Achilles tendinopathy were searched in 5 databases. The included studies were classified according to the authors, published years, study designs, purposes of study, methods, interventions outcome measures and adverse event. Results In 23 studies, total number of patients were 1,135. The included studies consist of 14 randomized controlled trials (RCT), 5 non-RCT, 2 retrospective study and 2 case reports. Patients were conducted with 9 kinds of treatment, which is acupuncture, electro-acupuncture, pharmacopuncture, acupotomy, moxibustion, cupping, Chuna, herbal medicine, physiotherapy. Most studies used visual analogue scale as primary outcome. Conclusions Based on the results of the collected studies, the use of Korean medicine treatment on Achilles tendinopathy seem to be effective. Despite the large number of RCTs, the level of research cannot be guaranteed, so it is considered that more rigorous researches are needed in future studies.