• Title/Summary/Keyword: Acupuncture randomized trial

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Association of Trial Registration with Reporting Biases in Randomized Controlled Trials of Acupuncture (침 무작위 대조 임상 시험에서 보고 비뚤림과 프로토콜 등록 여부의 관련성 연구)

  • Kim, Seoyeon;Won, Jiyoon;Park, Hi-Joon;Lee, Hyangsook
    • Korean Journal of Acupuncture
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    • v.35 no.2
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    • pp.70-81
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    • 2018
  • Objectives : To investigate the association of trial registration status with presence of reporting bias including publication bias and outcome reporting bias in recently published randomized controlled trials (RCTs) of acupuncture. Methods : A PubMed search for RCTs of acupuncture published from March 2016 to February 2017 was conducted. Primary outcomes were identified and the direction of the results was judged as positive (i.e., statistically significant) or negative. The trial registration was identified by manually screening the trial registration number in the main text of the published article and classified into 1) prospective registration; 2) retrospective registration based on the registration date or; 3) no registration. Results : Of the 125 included RCTs, only 40 studies (32.0%) prospectively registered the study protocols. Among 65 RCTs that adequately reported the primary outcome, unregistered trials were more likely to report positive results than the registered ones (p=0.013). Of the 40 prospectively registered studies, 19 trials (47.5%) had the discrepancies between the registered and published primary outcomes and furthermore, 40% of them reported the positive findings. Conclusions : Unregistered trials were more likely to report positive results and the discrepancies between the registered and published primary outcomes were detected in about a half of the prospectively registered studies, 42.1% of which tended to report positive findings. Journal editors and researchers in this field should be alerted to various reporting biases.

Acupuncture for Upper Extremity Peripheral Nerve Injury: A Systematic Review (상지말초신경손상에 대한 침술치료의 효과: 체계적 문헌고찰)

  • Kim, Young-Jun;Kim, Tae-Ryeong;Woo, Chang-Hoon;Shin, Byung-Cheul
    • Journal of Korean Medicine Rehabilitation
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    • v.28 no.2
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    • pp.73-82
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    • 2018
  • Objectives The purpose of this study is to systematically explore the effects and safety of acupuncture treatment for upper extremity peripheral nerve injury and to review the methodology of clinical trials. Methods We searched 9 electronic databases(3 international, 1 Chinese, 5 Korean) including English, Korean and Chinese, up to December 2017 for randomized controlled trials which evaluated the effects of the acupuncture in patients with upper extremity peripheral nerve injury. We abstracted the designs of the randomized clinical trials and the method of acupuncture treatment according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA). Results A total of 8 papers were reviewed. All randomized clinical trials were conducted in China. Of them, five studies(62.5%) were electro-acupuncture as intervention. All randomized clinical trials reported favorable effects of acupuncture treatments compared to baseline or control group with outcomes of efficacy rate. However risk of bias seemed high. LI4, LI11, SI3, PC3, PC6 were most frequently used for acupoints to treat upper extremity peripheral nerve injury. Conclusions These results suggest that it is recommended to develop more detailed reporting standards for acupuncture treatment method. In the future, well designed randomized clinical trials which evaluate the effects and safety of acupuncture treatment for upper extremity peripheral nerve injury is highly needed.

The Effects of Acupuncture Treatment on Hwa-byung patient's Insomnia: Patient-assessor blind, Randomized, Placebo-controlled Clinical trial (화병환자의 불면증상에 대한 침치료 유효성 평가연구: 환자-평가자 눈가림, 무작위배정, 일반대조군 임상시험)

  • Lee, Go-Eun;Kim, Nam-Kwon;Kim, Hang-Yi;Kang, Hyung-Won
    • Journal of Oriental Neuropsychiatry
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    • v.23 no.1
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    • pp.31-48
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    • 2012
  • Objectives: The purpose of this research is to examine the effects of acupuncture treatment on Hwa-byung patient's 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 individuals who were receiving the treatment. A total of thirty-seven volunteers were divided into 2 groups. 18 subjects were placed into a trial group and 19 subjects into a control group by a randomization table. The trial group was treated on 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 1st evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by a Likert scale for major symptoms of Hwa-byung, PSQI, Hwa-byung scale, BDI, STAI, and STAXI. Results: In the ISI, PSQI, and the Likert scale regarding major symptoms of Hwa-byung, Hwa-byung scale, BDI, and STAI, more significant decreases were found in those concerning the trial group compared to those of the control group from a statistical perspective. However, in the STAXI, regarding the trial group, there was no significant decrease compared to the control group. Conclusions: The results suggest that acupuncture treatment is effective in the treatment regarding Hwa-byung patients who suffer from insomnia.

Review and Analysis of Sham Acupuncture in Acupuncture Clinical Trials (침 임상연구에 사용된 거짓침의 분석)

  • Jang, Jin-Young;Kim, So-Jung;Kim, Nam-Sik;Nam, Sang-Soo;Kim, Yong-Suk
    • Journal of Acupuncture Research
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    • v.28 no.5
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    • pp.29-38
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    • 2011
  • Objectives : Recent well-designed randomized controlled trials(RCTs) and their meta-analysis have been published on the efficacy of acupuncture in different condition. In most of them, real acupuncture is compared with sham acupuncture including invasive and non-invasive sham methods. But it is not clear how active sham methods are. These results tend to lead the conclusion that acupuncture has no more effective than sham acupuncture. In order to investigate that sham acupuncture is appropriate as a control, we reviewed several acupuncture trials using different sham acupuncture as a control. Methods : We searched Cochrane researches of acupuncture, reviewed and analyzed 25 RCTs in 42 Cochrane reviews. And especially we compared the effect of acupuncture according to the type of sham acupuncture. Results : Invasive sham acupunctures are used in 12 RCTs and non-invasive types are used in the rest. The majority of studies(19 RCTs) fail to show effects beyond a sham acupuncture. Streitberger's sham needle is a validated sham acupuncture of non-invasive type that was used in 8 trials and also no significant group differences are shown except one trial. Conclusions : Acupuncture is a complex intervention. Clinical trials of acupuncture need to be reexamined and redesigned to remove several bias. Especially, sham acupuncture as a control might be investigated for physiological effects as well as validation test including patient-blinding and de qi sensation. Other research need to be investigated and developed for acupuncture trials.

Acupuncture and Moxibustion for Primary Dysmenorrhea in Korean Literatures: A Systematic Review of Randomized Controlled Trials (원발성 월경곤란증에 대한 침구치료 관련 무작위배정 임상시험의 체계적 고찰: 한국 문헌을 중심으로)

  • Kim, Jung Wan;Park, Bong Ki;Jeon, Jong Ik;Yim, Yun Kyoung
    • Journal of Acupuncture Research
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    • v.32 no.2
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    • pp.123-130
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    • 2015
  • Objectives : Primary dysmenorrhea is one of the most common female gynecological diseases. Acupuncture and moxibustion therapy have been used to treat dysmenorrhea in Korea. The aim of this review was to examine the effectiveness of acupuncture and moxibustion therapy for primary dysmenorrhea as described in studies in Korea. Methods : A total of 8 databases were searched, with the search concluding February 15, 2015. These were the Oriental Medicine Advanced Searching Integrated System, DBpia, Korean Studies Information Service System, National Digital Science Library, Korean Traditional Knowledge Portal, Research Information Sharing Service, and Pubmed. Randomized controlled Trails(RCTs) comparing acupuncture or moxibustion therapy with non acupoints stimulation or medication were selected. Data abstraction and assessment of methodology was conducted by authors and disagreements were resolved by discussion. Results : 7 trials were included in this review, with a total of 308 participants. 4 trials reported on acupuncture, 1 trial reported on acupress by magnet, 1 trial reported on pharmacopuncture, and the other trial reported on moxibustion. Quality of methodology was low. 2 trials showed that experimental therapy was effective for pain relief compared to the controlled group. However, 5 trials did not show a significant difference in pain relief. Conclusions : Acupuncture and moxibustion therapy may reduce period pain, however, it is needed for well designed RCTs in Korea.

Clinical Efficacy and Safety of Gyebutang Granules Combined with Acupuncture for the Treatment of Knee Osteoarthritis: Protocol for a Multicenter, Randomized, Assessor-blinded, 2-armed Parallel, Controlled Trial

  • Lee, Cham-Kyul;Kang, Ha-Ra;Lee, Yeon-Sun;Sung, Won-Suk;Lim, Chi-Yeon;Jung, Chan-Yung;Kim, Eun-Jung;Seo, Byung-Kwan;Baek, Yong-Hyeon;Kim, Kyung-Ho;Lee, Eun-Young
    • Journal of Acupuncture Research
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    • v.37 no.2
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    • pp.102-109
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    • 2020
  • Background: Due to the aging population in Korea, knee osteoarthritis (KOA) has become an increasingly common condition. Many patients with KOA prefer analgesics, herbal medicines, acupuncture, or exercise, rather than arthroscopic surgery or a knee replacement. Gyebutang (GB) granules are a herbal extract widely used to treat KOA in traditional Korean medicine, but there is insufficient evidence of its efficacy and safety. Methods: A multicenter, randomized, assessor-blinded, 2-armed parallel, controlled clinical trial has been designed to investigate the efficacy and safety of GB combined with acupuncture for the treatment of KOA. There will be 100 patients with KOA enrolled in the study from 3 traditional Korean medicine hospitals. The participants will be randomly allocated to an experimental group (GB and acupuncture) or a control group (celecoxib and acupuncture) in a 1:1 ratio. Both groups will receive acupuncture treatment once a week for 6 weeks; one group will receive GB and the other will receive celecoxib for the same duration. Results: The primary outcome will be the change of knee osteoarthritic pain, based on scores on a 100 mm visual analog scale. The secondary outcomes will be scores on a numeric rating scale, the Western Ontario and McMaster Universities osteoarthritis index, patient global assessment, European quality of life 5-dimension 5-level scale, and adverse events. Conclusion: The results of this study will provide evidence of efficacy and safety of GB as a treatment for patients with KOA.

Randomized Clinical Controlled Trials with Herbal Acupuncture (Pharmacopuncture) in Korea - A Systematic Review (무작위 배정 비교 임상 시험을 통한 국내의 약침 연구에 대한 체계적 고찰)

  • Park, Bong-Ky;Cho, Jung-Hyo;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.30 no.5
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    • pp.115-126
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    • 2009
  • Objective: By assessing the quality of methodology and synthesis of results of RCTs (Randomized Controlled Clinical Trials) with herbal acupuncture (pharmacopuncture), we hope to help with administrating herbal acupuncture therapy in clinic and conducting RCT with herbal acupuncture. Methods: Reports of RCT conducted in Korea published in medical journals until February 2009 were collected. We surveyed elementary information of RCTs, evaluated randomization, double-blinding, allocation concealment and put together the results of RCTs by seven clinical topics. Results: 38 RCTs with herbal acupuncture were selected, then adequate methods for randomization and allocation concealment were found in 39% and 5% of studies. Complete double-blinding and a clear accounting of all participants were conducted in 42% and 50% of reports. The synthesis of RCTs revealed that herbal acupuncture was useful and effective on degenerative gonarthritis, omarthralgia on cerebrovascular accident, acute ankle sprain, back sprain, neck sprain, headache, rheumatoid arthritis and tennis elbow, generally. Conclusions: Although further improvement in quality of methodology of RCTs with herbal acupuncture is required, clinical usefulness of herbal acupuncture was shown especially on disorders of musculoskeletal system via RCTs.

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Individualized Acupuncture versus Standardized Acupuncture in Symptomatic Treatment of Osteoarthritis of the Knee-a Randomized Controlled Trial (ISRCTN 40706107) (퇴행성 슬관절염에 대한 맞춤형 침 치료 효과 검증 무작위 대조군 임상연구(RCT) (ISRCTN 40706107))

  • Byun, Hyuk;Kim, Sun-Woong;Ahn, Ji-Hyun;Kim, Yong-Suk;Seo, Jung-Chul;Choi, Sun-Mi;Park, Ji-Eun;K., Kawakita;N., Takahashi;E., Sumiya;Lee, Seung-Deok
    • Journal of Acupuncture Research
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    • v.24 no.4
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    • pp.183-195
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    • 2007
  • Objectives : To determine whether individualized acupuncture (IA) provides greater pain relief and improved function compared with standardized acupuncture (SA) in patients with osteoarthritis of the knee. Methods: Design is a randomized single blind controlled trial with two intervention arms (IA vs SA) of 6 weeks' duration and 3 months follow up. An orthopedist diagnosed 50 patients' symptoms as knee osteoarthritis. Interventions were applied by 2 residents studying the acupuncture and moxibustion specially in Dongguk University International Hospital. Primary outcome measure is pain as measured by visual analogue scale (VAS). Secondary measures of pain and disability include WOMAC, SF-36, LFI and KHAQ. Results : The 50 participants were well matched for age, sex, bad side, VAS, WOMAC, SF-36, LFI and KHAQ scores at the baseline. 3 participants dropped out. There have not been any adverse events in both groups. Participants in both groups experienced great improvement in all measures except SF-36at 3 and 6 weeks. At 18 weeks, the IA group experienced significantly greater improvement than the SA group in VAS but not in WOMAC, SF-36, LFI and KHAQ. Conclusions : Manipulation of IA seems to provide pain relief longer for osteoarthritis of the knee when compared with SA.

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Research Trends of Randomized Controlled Trial Studies on the Herbal Treatment of Avascular Necrosis of the Femoral Head Using China National Knowledge Infrastructure Database (대퇴골두 무혈성 괴사의 탕약 치료에 대한 무작위대조군 연구의 최신 경향 분석: 중국지망(中國知網) 검색을 중심으로)

  • Kim, Hyeon-Jin;Ahn, Jae-Young;Shin, Na-Young;Koh, Ah-Ra;Lee, Young-Jin;Park, Jae-Eun;Lee, Min-Cheol;Jeon, Myung-Kyu;Kim, Hyun-Woo;Jo, Hye-Jeong;Chae, Go-Eun;Nam, Hye-Jin
    • Journal of Korean Medicine Rehabilitation
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    • v.32 no.3
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    • pp.37-53
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    • 2022
  • Objectives This study was conducted to investigate a randomized controlled trial study on the clinical treatment of herbal medicines for avascular necrosis of the femoral head. Methods By March 2022, the China National Knowledge Infrastructure (CNKI) was reviewed about randomized controlled trial studies on the herbal treatment of avascular necrosis of the femoral head through. The publication year, evaluation criteria, treatment period, treatment method and effectiveness were analyzed for articles published from 2017 to 2022. Results 16 articles were selected and 14 kinds of herbal medicines were used. In most studies, Western medical treatments such as injection therapy, oral drug administration, traction therapy and mid-frequency electric therapy were treated alone in the control group, and a combination of Western medical treatment and herbal treatment was administered to the experimental group. Conclusions In China, there have been many studies on herbal treatment for avascular necrosis of the femoral head. In Korea, more clinical studies on the herbal treatment of avascular necrosis of the femoral head are needed. This study will be helpful for future research in Korean medicine on avascular necrosis of the femoral head.

A Review of Randomized Controlled Trials of Pes Anserinus Tendinitis/Bursitis Syndrome in the China National Knowledge Infrastructure Database

  • Choi, Hyo Jung;Back, Hye Kyung;Kim, Young-Jun;Oh, Da Yoon;Park, Cheol Woo;Namgoong, Jin
    • Journal of Acupuncture Research
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    • v.38 no.4
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    • pp.284-292
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    • 2021
  • The purpose of this study was to review randomized controlled trials (RCTs) of pes anserinus tendinitis or bursitis (PATB) syndrome in the China National Knowledge Infrastructure database to investigate the efficacy of traditional Chinese medicine treatment for PATB syndrome. There were 20 RCTs published from 2001 to 2021 which were selected for analysis by publication year, number of samples, evaluation criteria, treatment duration, and treatment method. Out of the 142 retrieved RCTs, 20 were relevant to this review, and had performed Chinese medicine treatments including acupuncture (the most common treatment typically using acupoints SP10, ST35, SP9, and LR8), manipulation (typically using acupoints ST35, SP10, and SP9), and external application therapy (typically herbal medicine) in the treatment of PATB syndrome. Chinese medicine treatments were used widely in the treatment of PATB syndrome. We hope in the future, this review may initiate the development of treatments for PATB syndrome using Korean medicine.