• Title/Summary/Keyword: randomized comparative trial

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A Review on Clinical Studies of the Acupuncture and Moxibustion Therapy for Gastroesophageal Reflux Disease in China by Searching CAJ (CAJ 검색을 통해 살펴 본 중국에서의 역류성 식도질환 침구치료 임상연구 동향에 대한 고찰)

  • Kang, Sei-Young
    • Korean Journal of Acupuncture
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    • v.32 no.1
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    • pp.1-12
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    • 2015
  • Objectives : The purpose of this study was to review the acupuncture and moxibustion therapy for gastroesophageal reflux disease(GERD) in China. Methods : The literatures were searched using the database-China Academic Journals(CAJ)(~2015.1.). Clinical studies of acupuncture and moxibustion therapy for GERD such as randomized controlled trial(RCT), non-randomized controlled trial(NRCT), case series, or case report were included. Results : Thirty studies met our inclusion criteria: 24 RCTs, 4 NRCTs, 1 case series, 1 case report. Various kinds of treatment such as body acupuncture, abdominal acupuncture, acupuncture therapy with finger on back-shu point, electroacupuncture, acupoint injection, auricular acupuncture, and moxibustion were used in the clinical studies. The treatment groups take herbal medicines at the same time in 16 studies, and proton pump inhibitor(PPI) and histamine 2 receptor antagonist were used as a comparative treatment in the most of studies. Acupuncture or moxibustion treatments were done daily or 2~3 times a week for 5 days~18 weeks. All of studies reported higher effective rate in the acupuncture or moxibustion treatment group compared to the western medication control group. Conclusions : The results of this study could be used for the future practice and the clinical research about the acupuncture and moxibustion therapy for GERD.

Acupuncture for Parkinson's Disease in China (중국에서의 파킨슨병 침치료 임상연구 동향)

  • Kim, Lak-Hyung;Jang, In-Soo;Kang, Sei-Young
    • Korean Journal of Acupuncture
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    • v.28 no.4
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    • pp.147-158
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    • 2011
  • Objectives : The purpose of this study was to obtain some knowledge about the acupuncture treatments on Parkinson's disease for the future practice and the research from the clinical studies in China. Methods : The literatures were searched using the data base-China Academic Journals (CAJ) (1994-2011). Clinical studies of acupuncture for Parkinson's disease such as randomized controlled trial (RCT), non-randomized controlled trial (NRCT), case series, case report were included. Results : Of 145 articles, 52 Clinical studies met our inclusion criteria: 20 RCTs, 7 NRCTs, 22 case series and 3 case reports. Various kinds of acupuncture treatments such as scalp acupuncture, body acupuncture, abdominal acupuncture, acupoint injection, eye acupuncture and thick needle acupuncture (粗鍼) were used in the clinical studies. The treatment and control groups take Madopa Tablet (Levodopa + Benserazide HCl) in the same time in many studies, and Madopa treatment was used as a comparative treatment in the most of studies. Acupuncture treatment was done daily or 2~3 times a week for 2~20 weeks. All of studies reported high effective rate in the treatment group compared to control group. Conclusions : The results of this study could be used for the future study about the acupuncture therapy for Parkinson's disease.

Changes in body weight, blood pressure and selected metabolic biomarkers with an energy-restricted diet including twice daily sweet snacks and once daily sugar-free beverage

  • Nickols-Richardson, Sharon M.;Piehowski, Kathryn E.;Metzgar, Catherine J.;Miller, Debra L.;Preston, Amy G.
    • Nutrition Research and Practice
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    • v.8 no.6
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    • pp.695-704
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    • 2014
  • BACKGROUND/OBJECTIVES: The type of sweet snack incorporated into an energy-restricted diet (ERD) may produce differential effects on metabolic improvements associated with body weight (BW) loss. This study compared effects of incorporating either twice daily energy-controlled dark chocolate snacks plus once daily sugar-free cocoa beverage (DC) to non-chocolate snacks plus sugar-free non-cocoa beverage (NC) into an ERD on BW loss and metabolic outcomes. MATERIALS/METHODS: In an 18-week randomized comparative trial, 60 overweight/obese premenopausal women were assigned to DC (n = 30) or NC group (n = 30). Dietary intake was measured at baseline and week 18, and BW, anthropometrics, blood pressure (BP) and serum glucose, insulin and lipid concentrations were measured at baseline, and weeks 6, 12 and 18. Data were analyzed using repeated measures ANOVA. RESULTS: Using intention-to-treat analysis, women in DC and NC groups reduced energy intake (both P < 0.001) and lost $4.4{\pm}0.6kg$ and $5.0{\pm}0.9kg$ (both P < 0.001), respectively. Both groups lowered systolic and diastolic BP [DC = 2.7 (P < 0.05), 2.7 (P < 0.01); NC = 3.4 (P < 0.01), 4.2 (P < 0.01) mmHg, respectively]. Glucose and insulin concentrations decreased by 0.72 mmol/L (P < 0.001) and 13.20 pmol/L (P < 0.01) in DC group and by 0.83 mmol/L (P < 0.001) and 13.20 pmol/L (P < 0.01), respectively, in NC group. Total cholesterol increased in NC group (P < 0.05), with no significant lipid changes in DC group. There were no significant differences in biomarker outcomes between groups. CONCLUSIONS: Overweight/obese premenopausal women following an 18-week ERD that included either DC or NC sweet snack and sugar-free beverage lost equivalent amounts of BW and improved BP measurements and glucose and insulin concentrations.

Analysis of the current status of quantitative literature evidence for the prescription of 56 herbal medicines covered by health insurance (건강보험 급여 한약제제 56종 처방의 계량적 문헌 근거 현황 분석)

  • Chul Kim;Hyeun-kyoo Shin
    • The Journal of Korean Medicine
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    • v.44 no.3
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    • pp.189-200
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    • 2023
  • Objectives: The purpose of this study is to analyze the current state of quantitative literature evidence for the prescription of 56 herbal medicines covered by health insurance that have been studied in Korea for the past 30 years, to evaluate the reliability of the evidence, and to find out the research direction of herbal medicine prescription in the future. Methods: 56 kinds of herbal medicine prescriptions were searched in domestic literature search databases OASIS, DBpia, and overseas PubMed, classified into chemistry, toxicity, cells, animals, clinical cases, and clinical trial studies, and built into an EBM pyramid structure. Results: When classified according to research contents, there were 61 cases (7.5%) of physicochemical analysis to identify constituent substances, 80 cases (9.8%) of toxicity evaluation, and 672 cases (82.7%) of efficacy evaluation. The efficacy evidence was classified according to the evidence-based medical pyramid structure: 196 cell trials (29.1%), 372 animal trials (55.4%), 89 case and case reporting series (13.3%), 7 comparative case studies (1.1%), and 8 randomized control clinical trials (1.2%). In the pyramid composition, the basis for the validity of 56 kinds of herbal medicines prescribed was 568 cases (84.5%) in cell and animal units, which could not be said to be highly reliable. There was no relationship between the ranking of quantitative literature evidence for herbal medicine prescriptions and the ranking of salary administration. Conclusions: In an era that continues to require scientific evidence for herbal medicine, traditional herbal medicine should secure the basis for safety validity even for the 10th most frequent prescription among 56 herbal medicine prescriptions for consumers. In particular, traditional herbal medicine should increase the quantitative and qualitative level of case reports on related herbal medicine prescriptions, focusing on each clinical society, and move toward comparative case studies and randomized clinical trial so that traditional herbal medicine is positioned as Evidence-based medicine.

An Intensive Review On Clinical Thesis about Hwangryunhaedok-tang Pharmacopuncture Treatment: Focused on Case Reports and Controlled Studies in Korean Academic Journals (황련해독탕약침 치료에 대한 임상 논문 고찰: 국내 학술지의 증례보고와 대조군 연구 중심으로)

  • Lee, Soo-Hwan;Kim, Soon-Joong
    • Journal of Korean Medicine Rehabilitation
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    • v.29 no.2
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    • pp.171-188
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    • 2019
  • Objectives The purpose of this thesis is to compare and analyze outcomes of case studies and controlled studies about Hwangryunhaedok-tang (HHT) pharmacopuncture in clinical studies. Based on these studies reporting clinical effects by using HHT pharmacopuncture, we object to deduct the comparative review in applying clinical disorders limitedly. And conclusionally, by using this comparative review, we aim to make the fine evidence in treating clinical specific diseases. Methods We searched 106 studies about HHT pharmacopuncture from 6 Korean web databases by using in Korean word 'Hwangryunhaedok-tang pharmacopuncture'. This search had been progressed throughout 1 month (January, 2019). There was 106 thesis and we excluded studies that are not related to HHT pharmacopuncture, experimental research, not the case report or randomized controlled trials, non-randomized controlled trials, not using HHT pharmacopuncture, not using only one pharmacopuncture, and not using HHT pharmacopuncture for major treating method. As a result, 39 thesis are selected as a population. Results We analyzed 34 case reports and 5 controlled studies. As the final outcome, HHT pharmacopuncture was used in musculoskeletal diseases, dermatopathy, and 32 specific diseases. Conclusions After analyzing 39 studies, effective symptom changes clinically and statistically by using HHT pharmacopuncture herbal acupuncture were identified. However, these thesis designs were reported deficiently in many parts such as not excluding other confounding variables. After modifying defects of thesis design and conduct study, it can play a role as the evidence using HHT pharmacopuncture more precisely.

A Randomized Comparative Study of Unani Formulations in Abnormal Uterine Bleeding due to Endometrial Hyperplasia

  • Abothu Suhasini;Wasia Naveed;Arshiya sultana;Shahzadi Sultana
    • CELLMED
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    • v.13 no.14
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    • pp.19.1-19.16
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    • 2023
  • Objectives: To compare the efficacy of polyherbal Unani formulations in heavy menstrual bleeding due to endometrial hyperplasia. Methodology: A prospective, randomized comparative trial was conducted at Govt. Nizamia Tibbi College. Group A (n=20) received Itrifal Aftimoon 5g orally BID from menstruation day 3 to day 21 plus suprapubic Marham Dakhilyun application and per vaginally Marham Dakhilyun (5g) and Roghan Gul (10ml) application from menstruation day 5 to day 14. Group B (n=20) received Gulnar Farsi (2g), Phitakri Biryan (0.25g), Dammul Aqwain (0.25g), and Geru (2g), 2.5g powder orally BID, menstruation day 3 for 20 days plus Douche Bargh Sambhalu then Ḥamūl of Safuf Mazu (2g), Kalijiri (2g) and Roghan Gul (10ml) from menstruation day 3 to day 12 for 3 consecutive cycles. The primary outcome was pelvic ultrasound findings of endometrial thickness. The secondary outcome measures were improvement in haemoglobin percentage, change in menstrual flow and menstrual pattern. The level of significance was 5%. Results and conclusion: The intragroup comparison showed that the mean endometrial thickness at baseline and after treatment in groups A and B was extremely significantly different (P<0.0001). The intragroup comparison showed the mean haemoglobin percent at baseline and after treatment in group, A was significantly different (P<0.0001). After treatment, 50% and 60% of participants had normal duration and menstrual blood loss after treatment from baseline in Groups A and B respectively. However, further, phase II and III randomized standard controlled trials in larger samples are recommended to assess the efficacy of these group medicines.

The Effects of Acupuncture Treatment on the Autonomic Nervous Systems of Hwa-byung Patients' Insomnia (화병환자의 불면증 침치료가 인체의 자율신경계에 미치는 영향)

  • Bae, Dal-Bit;Lyu, So-Jung;Lee, Go-Eun;Lee, Seung-Jae;Kang, Hyung-Won;Lyu, Yeoung-Su
    • Journal of Oriental Neuropsychiatry
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    • v.25 no.3
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    • pp.235-242
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    • 2014
  • Objectives: The purpose of this research is to examine effects of acupuncture treatment on the autonomic nervous systems of Hwa-byung patients with insomnia. Methods: The study was performed through a patient-assessor blind, randomized, placebo-controlled trial in which the volunteers, data collectors, and analysts were unaware of which individuals were receiving the treatment. A total of thirty-seven volunteers were divided into 2 groups. Eighteen subjects were placed into a trial group and 19 subjects into a control group using a randomization table. The trial group was treated with bilateral Shigu, Ahnmyun, B62 (Shinmaek), and K6 (Chohae), while the control group was not given any other treatment. The ISI (Insomnia Severity Scale) was measured as the first evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by ANS (BVP/HR, respiration rate, peripheral temperature, skin conductance, EMG). Results: In the BVP/HR, statistically significant decreases were found in those from the trial group compared to those of the control group. Skin conductance was found to be significantly increased in the trial group, as compared to the control group. However, there were no significant differences between the groups with respect to peripheral temperature, respiration rate, and EMG. Conclusions: The results suggest that acupuncture treatment is effective in the treatment of hwa-byung patients who suffer from insomnia due to their autonomic nervous systems.

Comparative evaluation of efficacy of Physics Forceps versus conventional forceps in pediatric dental extractions: a prospective randomized study

  • Elicherla, Sainath Reddy;Bandi, Sujatha;Nunna, Mahesh;Saikiran, Kanamarlapudi Venkata;Sahithi, Varada;Nuvvula, Sivakumar
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.6
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    • pp.547-556
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    • 2021
  • Background: This study aimed to determine the efficacy of Physics Forceps in pediatric dental extractions. Methods: This was a double-blind, randomized controlled trial with a parallel-arm design and identical allocation ratio (1:1). Children (n=104) were randomly divided into two groups for extraction of mandibular primary teeth (group I: Physics Forceps; group II: conventional forceps). The outcome variables assessed in the study were the time taken for extraction, pre- and postoperative anxiety (using RMS pictorial scale), incidence of fractured teeth, and postoperative pain on the first and third days (using the Wong-Baker faces pain scale). Results: A significant reduction (P < 0.001) in intraoperative time, anxiety, and incidence of tooth fracture was confined to group I. The pain significantly reduced from the first to the third postoperative day in both groups, but the mean reduction in RMS scores in the physics forceps group was far better than that in the conventional forceps group. Conclusion: Physics Forceps aid in extraction of primary teeth with minimal trauma to supporting structures, as well as reducing anxiety in the pediatric population.

Randomized, Double Blind, Placebo-Controlled Study of Bofu-tsusho-san on Obese Patients (비만환자에 대한 방풍통성산(防風通聖散)의 무작위배정, 이중맹검, 위약-대조군 임상시험)

  • Lee, Ji-Eun;Song, Yun-Kyung;Lim, Hyung-Ho
    • Journal of Korean Medicine for Obesity Research
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    • v.10 no.1
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    • pp.1-16
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    • 2010
  • Objectives The clinical trial was designed to investigate the safety and effects of Bofu-tsusho-san extracts on the change of the weight, body compositions, serum in obese patients. Methods This study was a 4-weeks, double blind, comparative clinical trial. Eligible subjects had a body mass index(BMI) greater than $25\;kg/m^2$ and waist circumference(WC) longer than 85 cm in woman or 90 cm in man. Among 38 subjects, 36 subjects were randomized either to Bofu-tsusho-san or placebo. After 4 weeks of treatment, we measured anthropometric factors(weight, height, WC, BMI etc.), abdominal fat area by CT scanning, serum lipid(total cholesterol(TC), triglyceride(TG), HDL cholesterol, LDL cholesterol), blood level of variety(glucose, adiponectine, leptin, C-reactive protein(CRP) etc.), blood pressure(BP). Adverse events also evaluated. Results BMI, BP, TG, CRP were reduced and weight, WC, score of KOQOL(Korean version of obesity-related QOL scale), SRI(Stress response inventory) were significant changed in Bofu-tsusho-san. But there were no considerable difference between Bofu-tsusho-san and placebo. there were no serious adverse events in either group. Conclusion There were limitations in this study that it conducted within a short period of 4 weeks. but its weight and WC loss effect was significant and it had few adverse events.

Randomized, Double-blind, Comparative Clinical Trial on the Efficacy of 4% Articaine and 2% Lidocaine in Inferior Alveolar Nerve Block Anesthesia (하치조신경 전달마취 시 4% 아티카인과 2% 리도카인의 임상적 효과에 관한 비교연구)

  • Im, Tae-Yun;Hwang, Kyung-Gyun;Park, Chang-Joo;Kim, Kwang-Soo;Oh, Young;Han, Ji-Young;Shim, Kwang-Sup
    • Journal of The Korean Dental Society of Anesthesiology
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    • v.10 no.1
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    • pp.1-6
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    • 2010
  • Background: Articaine, commercially available in South Korea from 2004, is widely being used for dental treatments. In the surgical extraction of impacted mandibular third molars, one of the most common procedures in oral and maxillofacial surgery, the anesthetic efficacy of 4% articaine and 2% lidocaine, both with 1:100,000 epinephrine, was compared. Methods: A randomized double-blind clinical trial was conducted of 80 patients for bilateral surgical extraction of mandibular third molars with informed consents. One operator carried out the routine surgical procedures using local anesthetic 4% articaine or 2% lidocaine with the same concentration of vasoconstrictor. Latency, duration of anesthesia and the amount of anesthetic solution were recorded. A visual analog scale (VAS) was used to evaluate the intraoperative pain. Results: The pain VAS scores reported similar anesthetic effect with both local anesthetics. Not in the latency of anesthesia and the amount of anesthetic solution, statistically significant difference was found in the mean duration of anesthesia. Conclusions: It was concluded that 4% articaine could offer better or at least the same clinical feasibility compared to 2% lidocaine, particularly in terms of the duration of the local anesthesia for common dental treatments.