• Title/Summary/Keyword: Randomised clinical trial

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Acupuncture for Subacute and Chronic Post-thoracotomy Pain in Patients with Traumatic Multiple Rib Fractures: A Study Protocol for a Randomised-controlled, Two-arm, Parallel Design, Pilot Trial

  • Kim, Kun Hyung;Cho, Hyun Min;Lee, Chan Kyu;Seok, JunePill;Kim, Seon Hee;Kim, Jung-Eun;Shin, Yu Kyung;Kim, Min Kyung
    • Journal of Acupuncture Research
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    • v.35 no.2
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    • pp.95-100
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    • 2018
  • Background: The aim of this study is to assess the feasibility of acupuncture treatment for the management of subacute and chronic post-thoracotomy pain in patients with traumatic multiple rib fractures. Methods: A total of 30 participants who have undergone thoracotomy after traumatic multiple rib fractures will be recruited. Participants will be invited and equally randomised into acupuncture plus usual care and usual care alone groups. A computer-generated random number sequence will be used and concealed using opaque, sealed, sequentially numbered envelopes. Twelve sessions of manual and electrical acupuncture performed by Korean medicine doctors will be provided over a span of 3 months to participants allocated to the acupuncture group. Participants in the usual care group will continue pain medication, exercise and physical therapy as required. Study feasibility will be measured based on the proportion of patients who complete the measurement of pain at 12 or 24 weeks after baseline. The clinical outcomes will include; the average pain intensity over the recent week at rest, movement and cough, quality of life, patient's global assessment of recovery, respiratory function measured by the pulmonary function test and use of pain medication at 4, 8, 12 and 24 weeks after enrolment. Adverse events will be recorded for all participants. Written informed consent will be obtained from all participants. The local ethics committee has approved the study. This pilot trial will inform further studies investigating the potential role of acupuncture for subacute and chronic post-thoracotomy pain in patients with traumatic multiple rib fractures.

Improving Participation in Colorectal Cancer Screening: a Randomised Controlled Trial of Sequential Offers of Faecal then Blood Based Non-Invasive Tests

  • Symonds, Erin L;Pedersen, Susanne;Cole, Stephen R;Massolino, Joseph;Byrne, Daniel;Guy, John;Backhouse, Patricia;Fraser, Robert J;LaPointe, Lawrence;Young, Graeme P
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.18
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    • pp.8455-8460
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    • 2016
  • Background: Poor participation rates are often observed in colorectal cancer (CRC) screening programs utilising faecal occult blood tests. This may be from dislike of faecal sampling, or having benign bleeding conditions that can interfere with test results. These barriers may be circumvented by offering a blood-based DNA test for screening. The aim was to determine if program participation could be increased by offering a blood test following faecal immunochemical test (FIT) non-participation. Materials and Methods: People were invited into a CRC screening study through their General Practice and randomised into control or intervention (n=600/group). Both groups were mailed a FIT (matching conventional screening programs). Participation was defined as FIT completion within 12wk. Intervention group non-participants were offered a screening blood test (methylated BCAT1/IKZF1). Overall participation was compared between the groups. Results: After 12wk, FIT participation was 82% and 81% in the control and intervention groups. In the intervention 96 FIT nonparticipants were offered the blood test - 22 completed this test and 19 completed the FIT instead. Total screening in the intervention group was greater than the control (88% vs 82%, p<0.01). Of 12 invitees who indicated that FIT was inappropriate for them (mainly due to bleeding conditions), 10 completed the blood test (83%). Conclusions: Offering a blood test to FIT non-participants increased overall screening participation compared to a conventional FIT program. Blood test participation was particularly high in invitees who considered FIT to be inappropriate for them. A blood test may be a useful adjunct test within a FIT program.

Review of the Large-Scale Clinical Researches on Acupuncture in Germany: ASH, ART, ARC, and GERAC (2000년부터 독일에서 수행된 대규모 침 임상연구들에 대한 고찰: ASH, ART, ARC, GERAC)

  • Yoon, Juyeon;Han, Kuk-In;Jeong, Jinsu;Lee, Seungho;Jang, Insoo
    • Korean Journal of Acupuncture
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    • v.30 no.1
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    • pp.21-26
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    • 2013
  • Objectives : The purpose is to introduce the recent large-scale clinical researches for safety, efficacy and effectiveness of acupuncture in Germany. Results : In 2000, the German Federal Committee of Physicians and Health insurer proposed that large research initiatives on acupuncture, Acupuncture Model Projects(Modellvorhaben Akupunktur), could be conducted by health insurance companies for several pain that acupuncture is syndromes to justify the insurance-based reimbursement. Accordingly, 4 clinical researches were carried out; the Acupuncture Safety and Health economics studies(ASH), the Acupuncture Randomised Trial(ART), the Acupuncture in Routine Care studies(ARC), and the German Acupuncture trial(GERAC). Meanwhile, ASH is a prospective observational study for safety and costs. ART and GERAC are composed of RCTs for efficacy. ARC includes 6 pragmatic RCTs with additional non-randomized cohort study for effectiveness. We investigated the papers related to them and discussed about the outcomes. The researches showed that acupuncture is effective in practice for several chronic conditions such as migraine, tension-type headache, chronic low back pain, osteoarthritis of knee, dysmenorrhea, and allergic rhinitis. Based in part on them, the German health authorities decided that acupuncture would be included into routine reimbursement by social health insurance funds for chronic low back pain and chronic osteoarthritis of the knee in 2006. Conclusions : The German clinical researches may suggest the clues for establishing the evidence of acupuncture treatment.

The Effect of Comfrey on Enoxaparin-Induced Bruise in Patients with Acute Coronary Syndrome: A Randomised Clinical Trial

  • Bagheri, Zahra;Azizi, Azim;Oshvandi, Khodayar;Mohammadi, Younes;Larki-Harchegani, Amir
    • Journal of Pharmacopuncture
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    • v.24 no.4
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    • pp.196-205
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    • 2021
  • Objectives: Bruising is an important side effect of enoxaparin injection. Comfrey (Symphytum officinale) is used to treat different types of wounds, bone fractures, and bruising in traditional medicine in many countries for centuries. This study aimed to determine the effects of the Comfrey ointment on the bruise size and color following enoxaparin injection. Methods: This double-blind randomized clinical trial was conducted on 80 patients with acute coronary syndrome (ACS). The participants were randomly divided into two groups of 40, namely Comfrey and Placebo. Changes in bruise size and color in both groups were assessed daily before and after the intervention. Results: The Comfrey and Placebo groups were homogeneous in demographic and clinical variables. A downward trend was observed in the bruise size in both groups throughout the study. However, the bruise size was smaller in the Comfrey group than the Placebo group on day 2-5 of the intervention. Moreover, there was a significant difference in bruise color between the groups, with a shorter healing course in the Comfrey group. Conclusion: The Comfrey ointment accelerated the healing process of enoxaparin injection-induced bruising in patients with ACS. It is recommended as a safe and simple approach for these patients.

Manual Therapy in the Treatment of Temporomandibular Disorders: A Protocol for a Systematic Review (측두하악 장애 치료를 위한 수기치료에 대한 체계적 고찰의 프로토콜)

  • Kim, Hyungsuk;Jung, Jae-Young;Chung, Seok-Hee
    • Journal of Korean Medicine Rehabilitation
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    • v.25 no.4
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    • pp.41-46
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    • 2015
  • Objectives This systematic review will analyse randomised controlled trials (RCTs) of manual therapy in patients with temporomandibular disorders (TMDs) to evaluate the efficacy of this approach. Methods RCTs will be identified in the following ten databases based on searches starting with their inception: MEDLINE, EMBASE, CENTRAL, four Korean databases as KoreaMed, DBPIA, NDSL, and RISS and three Chinese databases as CNKI, VIP and Wanfang. The quality of these studies will be analysed using the Cochrane risk of bias. A meta-analysis will be conducted, and subgroup analysis will be considered if comparatively large heterogeneity is detected. Conclusions We plan to publish this systematic review in a peer-reviewed journal. Findings from this review may contribute to the treatment process in clinical situations. Trial registration number: PROSPERO 2015: CRD42015024090

A Review of the Domestic Study Trends on Climacteric Syndrome Treated with Pharmacopuncture (갱년기 증후군의 약침 치료에 대한 국내 연구 동향 고찰)

  • Hwang, Hyeon-Ji;Ahn, Soo-Yeon;Kim, Dong-Chul
    • The Journal of Korean Obstetrics and Gynecology
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    • v.34 no.3
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    • pp.79-95
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    • 2021
  • Objectives: The purpose of this review is to analyze the domestic study trends on climacteric syndrome treated with pharmacopuncture. Methods: We investigated the studies on pharmacopuncture for climacteric syndrome via searching 6 online databases. Results: 18 studies were selected. There were 2 case reports, 1 randomised controlled trial, and 15 animal experiments. There were 14 studies about osteoporosis, 1 study about hot flush and sweating, 1 study about abdominal obesity, 1 study about neck pain, and 1 study about learning disability and memory disorder. Nokyong was most frequently used for pharmacopuncture, followed by Honghwa. 陰谷 (KI10) was most frequently used for acupuncture point, followed by 腎兪 (BL23). Conclusions: This study shows that pharmacopuncture could be one of the effective treatments for climacteric syndrome. More well-designed clinical studies using pharmacopuncture for climacteric syndrome will be needed.

Research Trend of Traditional Chinese Medicine in the Treatment of Restless Legs Syndrome (하지불안증후군의 중의치료 연구 동향)

  • Kim, Tae-Heon;Jung, Jin-Hyung;Choi, Yun-Hee;Kim, Bo-Kyung
    • Journal of Oriental Neuropsychiatry
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    • v.25 no.2
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    • pp.165-178
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    • 2014
  • Objectives: This study was conducted to assess how Traditional Chinese Medicine treats the medical condition of Restless Legs Syndrome (RLS). Methods: The authors searched for relevant articles through the CNKI (China National Knowledge Infrastructure-www.global.cnki.net) with the following keywords: The main search was for the term 'RLS,' with supportive words added such as 'Acupunture', 'Acupoint', 'Meridian', 'Moxibustion', 'Massage', 'Acupoint injection'. Our search yielded a total of 233 articles; there were a total of 71 articles related to clinical fields. We then analyzed the chosen articles using a number of criteria including the study type used, the treatment method utilized, and the main effect of the treatment. Results: The 71 analyzed articles utilized the following type of study design: 4 were classified as Quasi-randomised trial, 22 as Randomized Controlled Trial, and 45 as a case report. Regarding the treatment used for RLS, 25 studies examined a single treatment modality, while 46 studies examined a complex treatment modality. There were a total of 10 types of acupuncture treatment used in treating RLS; several massage and acupoint injection method were also found. Finally, there were a few studies that used Moxibustion, as well as several supportive treatments like Cupping, Moxibustion, Steam-Washing, TDP (Teding Dancibo Pu) were found. Conclusions: Traditional Chinese Medicine has used a variety of different study designs and treatments vis-a-vis RLS. These treatments are also used to treat the condition in South Korea.

Electroacupuncture for Women with Overactive Bladder: A Systematic Review and Meta-analysis of Randomized Controlled Trials (여성 과민성 방광 전침 치료의 무작위 대조군 연구에 관한 체계적 문헌 고찰)

  • Ha, Su-Jin;Hwang, Deok-Sang;Lee, Jin-Moo;Lee, Chang-Hoon;Jang, Jun-Bock
    • The Journal of Korean Obstetrics and Gynecology
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    • v.33 no.3
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    • pp.1-19
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    • 2020
  • Objectives: The purpose of this study is to assess the efficacy and safety of electroacupuncture for women with overactive bladder (OAB) comparing with sham- acupuncture, and electroacupuncture plus drugs. Methods: We searched 8 databases upto May 26, 2020. Randomised controlled trials (RCTs) were eligible. The risk of bias was assessed by two independent authors using the Cochrane risk of bias tool. Study outcomes were calculated by standardized mean differences (SMD) with 95% confidence intervals (Cls) and mean differences (MD) with 95% Cls. Results: Of 146 screened, 5 RCTs were included. Number of participants per study ranged from 5 to 57. The combined results showed that electroacupuncture (EA) may be more effective than sham acupuncture or enhance solifenacin succinates in improving Overactive Bladder Symptom Score (OABSS) and urination frequency of 24 h. However, more trials with high quality and larger sample sizes will be needed to provide sufficient evidence. Only 5 of 187 OAB patients from the included studies reported mild adverse reactions related to EA, therefore, electroacupuncture is safe for treating OAB. Conclusions: Electroacupuncture might have effect in decreasing urination frequency of 24 h and OABSS. However, the evidences ins in sufficient to show the effect using electroacupuncture alone or additional effect to drugs in treating OAB.