• Journal of Acupuncture Research
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• v.23 no.5
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• pp.127-144
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• 2006

Background and Purpose : Though there were many clinical studies of acupuncture effects they didn't have appropriate control group. So we didn't say it was true acupuncture effect, though subjects in clinical study improved. To investigate the possibility of sham acupuncture application, we examined how well subjects distinguished real acupuncture from sham acupuncture. Methods : We investigate the possibility of sham acupuncture application as the following 3 kinds of methods. 1. The public (n=60) and Oriental Medicine Doctors (n=20) looked at the appearance of acupuncture and then were treated with randomly allocated acupuncture and judged it as real or sham. 2. The public (n=60) and Oriental Medicine doctors (n=20) were treated with randomly allocated acupuncture, then they looked at the appearance of acupuncture and judged it as real or sham. 3. The public (n=60) were treated with randomly allocated acupuncture (right-real-left-sham), (right-sham-left-real), (left-real-right-sham), (left-sham-right-real), then they judged it as real or sham. Results : 1. When the public (n=60) looked at the acupuncture appearance, the correct judgement ratio was 63.3%. After they were treated with acupuncture, the correct judgement ratio was 50.0%. 2. When Oriental Medicine doctors (n=20) looked at the acupuncture appearance, the correct judgement ratio was 25.0%. After they were treated with acupuncture, the correct judgement ratio was 45.0%. 3. When the public (n=60) were treated with acupuncture, the correct judgement ratio was 50.0%. After they looked at the acupuncture appearance, the correct judgement ratio was 63.3%. 4. When Oriental Medicine doctors (n=20) were treated with acupuncture, the correct judgement ratio was 65.5%. After they looked at the acupuncture appearance, the correct judgement ratio was 65.0%. 5. After the public (n=60) were treated with randomly allocated sham or real acupuncture as (right-real-left-sham), (right-sham-left-real), (left-real-right-sham), or (left-sham-right-real). the correct judgement ratio was 66.7% in looking at the acupuncture appearance group, and in not looking at 60.0%. Conclusion : These results indicated that Kim Sham Acupuncture could apply to the double blind clinical study of acupuncture effect. And more continuous studies are needed on Sham Acupuncture apparatus.

• 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.

• Korean Journal of Acupuncture
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• v.23 no.4
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• pp.85-99
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• 2006

Objectives : Proper acupuncture stimulation is associated with a characteristic set of sensation usually referred to as 'De-Qi'. In order to develop the appropriate sham acupuncture, various sensations to each stimulation should be considered through analysis of the profiles of acupuncture sensation. It was therefore investigated to compare the acupuncture sensation scale (ASS) of two types of sham acupuncture to that of the real acupuncture. Methods : Ninety-four participants (mean age 26.4, range 26-49) were asked to complete five point-Likert scale ASS developed by Vincent et al. after real or two-kinds of sham acupuncture stimulation: blunted tip sham acupuncture (BT) and round tip sham acupuncture (RT). Needling was done at LI4 acupoint on non-dominant hand and stimulated for 30 seconds with real or two-kinds of sham needle. Finger withdrawal latency (FWL) of each group was also measured to evaluate the pain sensitivity to noxious heat stimuli. Results : BT acupuncture significantly less produced penetrating, numb, intense, hurting, pulling, shock, tingling, throbbing sensation than real acupuncture stimulation. RT acupuncture significantly less produced penetrating, burning, electric, numb, intense, hurting, pulling, aching, shasharp, shock, stinging, tingling, throbbing sensation than real acupuncture. Each group did not demonstrate the differences of pain sensitivity to noxious stimuli. Conclusions : These results indicated that types of tip of acupuncture produced different kinds of acupuncture sensation. Our finding provides a general information of sensations to two kinds of sham acupuncture for development of ideal placebo sham needle.

• Korean Journal of Acupuncture
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• v.23 no.1
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• pp.95-109
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• 2006

Objectives : There has been a considerable debate about how to best control for placebo effects in clinical trials of acupuncture. Recently several sham needles were developed and validated. This study aimed at summarising the validation studies of these needles and evaluating the outcomes of the randomised controlled trials (RCTs) using them. Methods : Computerised literature searches were performed using 'acupuncture' AND 'placebo OR sham' with a limitation of the results to RCTs in Medline via PubMed and the Cochrane Library. Only formally validated sham needle controlled studies were included. Data were extracted regarding study design, condition, sample size, credibility testing, intervention and outcomes. Methodological quality was assessed using a modified Jadad scale. Results : Three validated sham needles by Streitberger, Park, and Fink, were identified. Acupuncture's effectiveness for various conditions was tested using these needles in 12 RCTs. Real acupuncture was superior to sham acupuncture for rotator cuff tendonitis and hypertension. No significant differences between real acupuncture and sham acupuncture emerged for chemotherapy-related nausea and vomiting, postoperative nausea and vomiting, menstrually related migraine, acute stroke rehabilitation, chronic/episodic tension-type headache, neutrophil respiratory burst in healthy volunteers, alcohol withdrawal symptoms and chronic poststroke leg spasticity. Conclusions : The new sham devices have been adequately validated and may be useful tools for investigating specific research question. In spite of the sham needle's limits, the results of RCTs using such devices tend to suggest that the clinical effects of acupuncture are largely due to a placebo response.

• 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.

• The Journal of Korean Obstetrics and Gynecology
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• v.24 no.1
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• pp.42-62
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• 2011

Objective: This study was performed to investigate the effect of acupuncture at HT8 on brain activity in perimenopausal women using fMRI. Methods: 15 healthy perimenopausal women volunteered in the study. No stimulation, sham stimulation, duration of acupuncture treatment on HT8, and rotation of acupuncture treatment on HT8 were randomly given for 6 minutes, with 20 seconds' intervals. Results: 1. In comparison with sham stimulation(Sham-B) and duration of acupucture (S1-B, S1-Sham, S2-S1), the areas of fMRI signal activation areas were just like cases including no stimulation. But the areas of vision were activated in S1-Sham. 2. In comparison with duration of acupuncture(S1-B, S1-Sham, S2-S1) and rotation of acupuncture(S2-B, S2-Sham, S2-S1), the areas of vision were activated in duration of acupuncture, and Supplementary motor area(SMA) were especially activated in rotation of acupuncture. Conclusions: After using fMRI and analysing effect of acupuncture treatment at HT8, we could confirm that fMRI signal activation areas by acupuncture treatment at HT8 were different from areas by sham stimulation. And according to acupuncture stimulation methods with duration and rotation, etc, we could confirm the specific reactions of series, and could get useful basic data for research of acupuncture from now on.

• Journal of Acupuncture Research
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• v.23 no.6
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• pp.133-143
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• 2006

Objectives : To Investigate Severity Measurement and the Correlation between Acupoints on the Face and the Upper limb in Bell's Palsy Patients by Using of DITI. Methods : We recreated the persons in the Wonkwang oriental hospital, KwangJu and the public health center, Hwasoon from April 2005 to October 2005. the 60 persons randomized allocated were not showed the acupuncture and treated in the acupuncture points used for treatment of the shoulder pain. the 30 persons were treated with real acupuncture and the others were treated with Kiln Sham Acupuncture. Conclusion : This report suggest that we must except Kyon-lyo(TE14), kyon-u(LI15), and hu-gye(SI03) from the shoulder pain study with Kim Sham Acupuncture because the persons significantly distinguished Real acupuncture from Sham acupuncture at the Kyon-lyo(TE14), kyon-u(LI15) and hu-gye(SI03) and so We cannot blind a person.

• 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.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 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.