• Korean Journal of Oriental Medicine
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• v.13 no.1 s.19
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• pp.93-100
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• 2007

TObjectives: Develop a sham moxibustion and determine whether subjects can distinguish a sham moxibustion from a real moxibustion. Design: Single-blinded, randomized, placebo-controlled clinical trial Methods: Sham and real moxibustion resemble each other in appearance, burning procedure, but the base of the sham moxibustion isolates the moxa-producing heat and smoke. This device was tested in a clinical trial in which subjects received moxibustion at Zhongwan(CV12), Mingmen(GV4), Quchi(LI11), Zusanli(ST36), Taichong(LR3)), Hegu(LI4). Volunteers(n=32) were given pre-treatment questionnaire to assess their experience in getting moxibustion therapy and performing it. They randomized into treatment(n=16) or sham controlled group(n=16), received moxibustion according their groups. After treatments, the effectiveness of blinding was assessed. Results: There were no significant differences between two groups in sex, age, moxibustion experience. In the treatment group and the sham group, the number of subjects who believed they received real moxibustion or sham is not different significantly.(P=.668) The consistency of a moxibustion type which subjects received actually and the their guess about that, isn't different significantly in two groups.(P=.465) Conclusion: The sham moxibustion was successfully validated in this study, The results demonstrate that this sham moxibustion blinds subjects and can be used as effective placebo-control in moxibustion clinical trials.

• Journal of Acupuncture Research
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• v.27 no.1
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• pp.117-127
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• 2010

Background : To demonstrate the efficacy of moxibustion therapy, randomized controled trials are required. But, clinical trials of moxibustion had limitations due to the absence of a sham moxibustion model for an appropriate placebo. Objectives : To develop a new sham moxibustion model based on the thermal characteristics of commercial indirect moxibustion, especially temperature, and to evaluate whether it could be applied in clinical trials. Methods : By applying heat insulation, we created a sham moxibustion device that was indistinguishable from a real one with the naked eye. It also stimulated heat but had inert remedial value. A clinical trial was performed on subjects to test double blinding. The subjects were randomly assigned into two groups, a treatment group and a sham group. Acupoint Zusanli($ST_{36}$) was used in each group for 3 times. A sham acupuncture credibility questionnaire was modified into a moxibustion credibility questionnaire and was filled out after treatment. Results : No major difference was detected in the subjects' baseline data. Most subjects and practitioners could not distinguish the sham moxibustion device from the real one. But, subjects who had experience of moxibustion therapy more likely to distinguish the sham moxibustion device from the real one than subjects who didn't have experience of moxibustion therapy. The treatment group showed a significant difference in the VAS(Visual Analog Scale) for intensity of sensation during treatment than that of the sham group. Conclusions : The sham moxibustion device in this study is proved sufficient and credible to be applied in investigations of the effect of moxibustion. But it is more appropriate for the people who don't have experience of moxibustion therapy.

• 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.

• The Journal of Korean Medicine
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• v.17 no.1 s.31
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• pp.247-265
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• 1996

To study the clinical effect of moxibustion on the urinary disturbance, which is one of the most common complications of CVA, 60 patients with urinary disturbance due to CVA, who had been hospitalized in Hespital of Oriental Medicine, KyungHee University Medical Cental from May 1st, 1995, to September 20th, 1995, had been selected, and moxibustion treatment had been done. The results were as follows ; 1. In the relation between the radiological size of the lesion and recovery, the real moxibustion group showed significant recovery compared to sham moxibustion group and non moxibustion group in the middle size lesion patients. 2. In the relation between the anatomical lesion and recovery, there was no significant difference among real moxibustion group, sham moxibustion group and non moxibustion group. 3. In the relation between the initial state of urinary disturbance and recovery, the real moxibustion group showed significant recovery compared to sham moxibustion group and non moxibustion group in Gr 3 patients. 4. In the relation between the type of urinary disturbance and recovery, there was no significant difference among real moxibustion group, sham moxibustion group and non moxibustion group.

• Journal of Acupuncture Research
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• v.28 no.6
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• pp.1-17
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• 2011

Objectives : This study aimed to review randomized controlled trials of acupuncture performed in South Korea that used sham acupuncture as a control group. Methods : The following databases were searched through the end of September 2011: Koreanstudies information service system (KISS), Korean medical database (KMbase), national discovery OR science leaders (NDSL), oriental medicine advance searching integrated system (OASIS), and research information service system (RISS). The following search terms were used: acupuncture AND (sham or placebo). The reference lists of searched articles and Korea institute of oriental medicine (KIOM) reports(2005~2009) were identified. The following data were extracted: year/first author, disease, number of participants, blinding, intervention, outcome, and result. Where appropriate, we performed meta-analysis. The methodological quality was assessed according to the Jadad scale and 'risk of bias' by Cochrane Handbook procedure. Results : Twenty-nine studies were included in this review. In eighteen studies, penetrating sham controls were used as the control intervention, whereas the remaining eleven studies adopted non-penetrating sham controls such as the Park Sham Device or blunt auricular acupuncture. Nine studies showed statistically significant difference in outcomes. Twelve studies concerning insomnia after stroke, chronic tension-type headache, idiopathic Parkinson's disease, Hwa-Byung, and smoking cessation were included in meta-analysis. A meta-analysis of insomnia after stroke only found significant difference(MD -4.31, 95% Cl -6.19 to -2.42, $p$<0.00001). In general, all of the studies showed low methodological quality(Jadad score: mean 2.1). Risk of bias by Cochrane Handbook procedure varied. Conclusions : The results of this study could not suggest conclusive evidence that acupuncture is more effective than sham acupuncture in several diseases. In the future, more studies with rigorous acupuncture trials using sham controls should be conducted.

• Journal of Acupuncture Research
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• v.25 no.6
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• pp.77-93
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• 2008

Objectives : Though there were many clinical studies of acupuncture effects they didn't have appropriate control group or use another therapy for control group. So, we didn't say it was true acupuncture effect, though subjects in clinical study improved. Recently several sham needles for control group were developed and validated. This study aimed at summarizing the validation studies of these needles and evaluating the control group of the acupuncture clinical study. Methods : Computerized literature searches were performed using 'acupuncture' and 'placebo or sham' with a limitation of the results to RCTs in Pubmed, Sciencedirect, NDSL, KISS, RISS. Data were extracted regarding study design, sample size, acupuncture point, stimulation form, credibility testing. And We have examined 106 acupuncture clinical studies published by Pubmed from January 1, 2005 to April 30, 2008. Data were extracted author's country, subject of study, type of study groups, type of control groups, type of blinding, difference between the results in the control groups. Results : Streitberger's placebo needle, Fink's sham needle, Park sham needle, Kim sham needle were developed. They were validated at domestic and abroad. But the results were deviation depending on the each of the researcher. They has shown that sample, acupuncture points, experiences or knowledge of acupuncture dependent on the results. Recent three years, acupuncture clinical trial had different results. Significant differences between Study group and control group emerged from using other therapy or non-treatment for control group. Many study has no significant differences using sham acupuncture for control groups. Conclusions : Acupuncture clinical studies need to meet several requirements. First of all, they require the basics of randomized controlled clinical studies such as blinding and the accurate implementation and description of randomization. And also need to research the unique circumstances of these studies such as the development of sham acupuncture and blinding method which differs from other clinical trials.

• Journal of Pharmacopuncture
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• v.26 no.3
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• pp.211-226
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• 2023

Objectives: Crohn's disease is a chronic gastrointestinal disease that belongs to inflammatory bowel disease. This systematic review aims to assess the level of evidence in randomized controlled trials (RCTs) on the effects of acupuncture for Crohn's disease. Methods: We searched 12 databases from the date of the establishment of each database up to May, 2023 for relevant RCTs. The risk of bias of each study was assessed independently by three reviewers. The level of evidence of meta-analysis was assessed using GRADE (Grading of Recommendations, Assessment, Development, and Evaluation). Results: A total of 12 studies were included. The effective rate (odds ratio [OR] 3.23, 95% confidence interval [CI] 1.43, 7.30) for mild to moderate Crohn's disease patients showed a significant difference between the acupuncture with moxibustion group and the sham-acupuncture with sham-moxibustion group. CDAI change (mean difference [MD] -74.15, 95% CI -93.28, -55.01) for mild to moderate Crohn's disease showed a significant difference between the acupuncture with moxibustion group and the sham-acupuncture with sham-moxibustion group. Conclusion: Although acupuncture with moxibustion showed significant effects compared to sham-acupuncture with sham-moxibustion, the effect of acupuncture alone is inconclusive. Moreover, only the effect of acupuncture treatment on mild to moderate Crohn's disease patients was derived as a remarkable result. To confirm the effectiveness of acupuncture treatment for Crohn's disease, studies using only acupuncture for intervention or more RCTs targeting various Crohn's disease patients according to the CDAI are required.

• Journal of Acupuncture Research
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• v.29 no.6
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• pp.47-56
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• 2012

Objectives : This study was performed to investigate the effect of acupuncture at Yintang point(EX-$HN_3$) on heart rate variability in healthy adults with mental stress. Methods : 38 healthy volunteers(sham point group : 19, Yintang point group 19) participated in this study. The study was established by randomized trial. After 10 minutes rest period, mental stress was provided for 10 minutes. HRV was recorded before and after stress. And then simple acupuncture was applied at sham or Yintang point for 15 minutes. We measured HRV 3 times: before and after stress, and after acupuncture. Results : In sham point group, LF norm and HF norm changed significantly after mental stress. In Yintang point group, LF, HF, LF norm, HF norm and LF/HF showed a significant change after mental stress. In sham point group, all indicators were not affected after acupuncture. In Yintang point group, HF norm decreased significantly. LF, LF norm and LF/HF increased significantly. There were significant differences between two groups(p<0.05). Conclusions : The results suggest that acupuncture at Yintang point(EX-$HN_3$) can regulate and prevent the alteration of autonomic nerve system by mental stress.

• Asian Pacific Journal of Cancer Prevention
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• v.14 no.5
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• pp.3067-3074
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• 2013

Background: Faced with highly prevalent and recalcitrant cancer-related fatigue (CRF), together with the absence of any official guidelines on management, numerous groups have been striving to seek and test alternative therapies including acupuncture and moxibustion. However, different patients have various feedbacks, and the many clinical trials have given rise to varied conclusions. In terms of the therapeutic effect of acupuncture and moxibustion, there exist vast inconsistencies. Objective: The aim of the study was to evaluate the auxiliary effectiveness of acupuncture and moxibustion in the treatment of CRF, and to provide more reliable evidence to guide clinical practice. Methods: Randomized controlled trials (RCTs) published before December 2012 were all aggregated, focusing on evaluation of acupuncture or moxibustion for CRF. The quality of the included studies was assessed basing on Cochrane handbook 5.1.0, and the available data were analyzed with RevMan software (version 5.2.0). Descriptive techniques were performed when no available data could be used. Results: A total of 7 studies involving 804 participants were eligible. With real acupuncture versus sham acupuncture, subjects receiving true acupuncture benefited more in the reduction of fatigue. With real acupuncture versus acupressure or sham acupressure, fatigue level appeared 36% improved in the acupuncture group, but 19% in the acupressure group and only 0.6% with sham acupressure. When real acupuncture plus enhanced routine care was compared with enhanced routine care, the combination group improved mean scores for general fatigue, together with physical and mental fatigue. With real acupuncture versus sham acupuncture or wait list controls, the real acupuncture group displayed significant advantages over the wait list controls at 2 weeks for fatigue improvement and better well-being effects at 6 weeks. When moxibustion plus routine care was compared with routine care alone, the meta-analyses demonstrated the combination had a relatively significant benefit in improving severe fatigue and QLQ-C30. Conclusion: Up to the search date, there exist few high quality RCTs to evaluate the effect of acupuncture and moxibustion, especially moxibustion in English. Yet acupuncture and moxibustion still appeared to be efficacious auxiliary therapeutic methods for CRF, in spite of several inherent defects of the included studies. Much more high-quality studies are urgently needed.

• Journal of Acupuncture Research
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• v.24 no.5
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• pp.67-88
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• 2007

Objectives : To present proper protocol as global standard- clinical study about acupuncture treatment, and to demonstrate effectiveness of Sa-am Acupuncture treatment for obesity. Methods : We randomly allocated participants to treatment group 1 and 2. The group 1 is treated by real acupuncture and the group 2 is treated by Kim Sham Acupuncture. We treated Bi-jang seung-gyeok (脾臟勝格) ; Daedon(LR1), EunBaek(SP1) Gyoung-geo(LU8) Sang-gu(SP5), to both group. Primary outcomes were measured by the Body Composition Analysis(Inbody. Korea). Secondary outcomes were measured by Blood Cholesterol, Triglyceride, HDL, LDL Cholesterol. Results : After treatment, the group 1 shown significant weight loss that analysed by Kruskal-Wallis certification, but didn't show notable change in body fat, total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol. Group 2 didn't show significant change in body weight, body fat, triglyceride, HDL cholesterol, LDL cholesterol, but total cholesterol was notably decreased. Controled group was not changed in body weight, body fat. Aftter treatment, 3 groups didn't show significant change in body weight, body fat, triglyceride, HDL cholesterol, LDL cholesterol, total cholesterol.