• Journal of Pharmacopuncture
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• v.6 no.1
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• pp.33-34
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• 2003

배경: 독일 의사와 보험회사 위원회 (The German Board of Physicians and Insurance Companies:Bundesausschuss der Arzte und Krankenkassen)가 앞으로 일부 적응증에 대한 침치료에 대해 공적 보험회사가 보험료를 지급해야 할 지에 대한 추가 결정을 하기 위해 침의 효과를 평가하기로 했다. 목적: 1) 침치료가 편두통의 예방, 긴장성 두통, 요통, 무릎과 고관절의 골관절염치료에 대조군 침치료보다 효과가 있는지 검증 2) 침치료가 편두통의 예방적 치료에 표준 약물 치료와 비슷하게 효과가 있는지 검증 3) 보건의료 서비스체계 안에서 주어진 조건에 대한 일상적 침치료의 질적인 부분을 서술하고, 안전성을 평가하며, 다른 침술학파간의 임상결과의 차이와 비용의 효용적 활용부분을 평가한다. 4) 위의 적응증에 해당하는 모든 임상실험연구를 찾아내어 기존의 고찰내용을 갱신한다. 방법: 1) 무작위 표본추출 임상 실험, 침치료, 거짓침 치료, 대기자 명단 대조군, 출발시점 4주, 28주 관찰 2) 무작위 표본추출 임상 실험, 침치료, 표준약물치료 대조군, 츨발시점 4주, 28주 관찰 3) 전향적 다중 의료기관 관찰 연구, 두 가지 다른 자료를 활용하여서, 치료 결과를 침 시술자에 의한 모든 환자 평가 자료와, 열 두 명의 환자 가운데 한 명의 환자로부터 직접 받은 평가 자료 (관찰 출발시점, 치료 출발 시점, 치료 시작 후 6 개월) 실험공간: 1) and 2) 높은 수준의 수련을 한 침 시술 의사가 시술하는 병원이나 일차 진료기관의 외래. 3) 보건 의료 서비스내 저급의 침 시술 의사 (140 시간 수강, 학점 이수 필수) 참가자: 1) $4{\times}320$ 편두통의 예방, 긴장성 두통, 요통, 무릎과 고관절의 골관절염 환자 2) 480 편두통 환자(긴장성 두통 환자 추가적) 3) 약 500,000 환자, 2년 반 동안: 대략 한 적응증 당 10,000 환자 치료법: 모든 침치료 자리는 체침만 허용함. 1) 진짜 침은 학파의 지침에 따른 심자, 거짓 침은 비특이적 자리의 표피만 찌르는 자침 (12-15회, 8주): 대기자 대조군은 12주 동안에 아무 치료도 받지 않는다. 2) Group 1(N=240): 최대 15회 치료, 12주 동안: Group II (N=240) 투약 Proponolol (80-240mg), Metoprolol (100-200mg) or Flunarizin (5-10mg) 하루, 16주 이상 3) 치료회수와 침자리의 선정은 참가자가 결정 주된 임상 결과 지표: 1) 군 간의 치료 전 및 치료 진행 도중 4주 마다의 두통을 느낀 날 수의 차이 (평균 혹은 이상의 편두통이나 긴장성 두통) 2) 요통환자 군간의 기능을 측정하는 FFbH-R (Funktionsfragebogen Hannover) 비교 3) 관절염 환자의 군간 WOMAC 지표 비교 4) 군 간의 24주 동안 두통을 느낀 날 수의 차이(평균 혹은 이상의 편두통이나 긴장성 두통) 5) 적응증, 부작용, 성공율에 대한 거시적 평가, 사용한 침수, 환자의 만족도, SES(?). ADS(?) 통증 장애 지표(PDI), 삶의 질 지표(SF36). 예비 결과 위의 결과가 큰 관찰 연구에 초점을 맞추면서 소개될 것임.

• Korean Journal of Acupuncture
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• v.31 no.3
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• pp.136-145
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• 2014

Objectives : The purpose of this randomized, placebo-controlled, cross-over trial was to examine how acupuncture treatment at Shinmun(HT7) affects the brain activity and the autonomic nervous system(ANS), using electroencephalograms(EEG) and heart rate variability(HRV). Methods : Eighteen healthy volunteers participated in two separate experiments: in each experiment, either real acupuncture(RA) or non-penetrating sham acupuncture(SA) was applied at HT7 in random sequences to each person. The EEG and HRV measurements were conducted simultaneously before and during the acupuncture stimulation for 5 minutes, respectively. Resulting EEG and HRV parameters were compared between RA and SA groups. To assess differences according to the stress levels for participants, subgroup analysis was performed based on the results of the stress response index questionnaire. Results : In the results, acupuncture stimulation at HT7 increased ${\alpha}$ band in EEG. In the HRV analysis, heart rate was decreased significantly but HF and RMS-SD were increased in the RA group, compared with those of the SA group. In the subgroup analysis by stress level, participants in the RA group with high stress exhibited an increased in ${\alpha}$ band in their EEG while the low stress participants showed decrease or little increase in the band. For the SA group, ${\alpha}$ band reported relatively moderate changes in all channels. Conclusions : Our results showed that acupuncture induces changes in brain activation and the ANS. Acupuncture was related to the activation of the parasympathetic nervous system. The brain activities of the participants were different depending on the stress level.

• Progress in Medical Physics
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• v.20 no.4
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• pp.277-289
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• 2009

Recently, functional MRI has been used to investigate the neurobiological mechanisms of acupuncture and the specificity of acupoint. The group data tend to be regarded as more important than the individual data in the most of previous studies. This study was designed to investigate the effect of the variability of individual data on the group results. A functional MRI (fMRI) of the whole brain was performed in fifteen healthy subjects during placebo and acupuncture stimulations at the ST36 acupoint. After remaining at rest for 30 seconds, the acupuncture was inserted and twisted at the rate of 2 Hz for 45 seconds and then the acupuncture was removed immediately. This process was repeated three times. Individual and group analyses were performed by voxel-based analyses using SPM2 software. Visual inspections of the activation and deactivation maps from individual sessions have shown the large variability across fifteen subjects. This means that the group data reflected the brain activation responses of only a few subjects. We suggest that the individual data should be presented to demonstrate the effect of acupuncture.

• Journal of Physiology & Pathology in Korean Medicine
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• v.28 no.1
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• pp.107-112
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• 2014

This study aimed to prove the effects of acupuncture treatment on acupoint Joksamni(ST36) related to gastrointestinal movement. Electrogastrogram (EGG) data were obtained in 11 healthy subjects treated by real or sham needle in single-blinded condition for 40 min, including before, during acupuncture treatment, and after removing needle. According to frequency analysis of EGG, median frequency(MF) was increased by real needle in 4 subjects, MF for another 2 subjects were increased by real and sham needle and no trend shift in MF showed in other 5 subjects. Our result showed that acupuncture treatment on Joksamni has some effects on gastrointestinal movement. In this study we have applied both real acupuncture and sham acupuncture on the same subjects. So its blinding was regarded as good but was effective in about 36%~55%. Two subjects were assumed that they showed placebo effects on both real and sham acupuncture. Therefore it is necessary to perform further study on case-control and a larger number of subjects with functional dyspepsia, in order to confirm our findings.

• Journal of the Korea Institute of Information and Communication Engineering
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• v.19 no.12
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• pp.2785-2791
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• 2015

In this paper, neddle detection algorithm for the removal of needle stuck into skin in oriental clinic is presented. First, in the proposed method, potential candidate areas of each needle are selected by using the morphological open operation in a gray image, and the false candidates are removed by considering their area size. Next, edge points are extracted using canny edge detector in selected candidate areas, line segments are approximated using the edge points. Based on the direction of line segment and the distance between two line segments, two main line segments of the needle are extracted. The final verification of needle is accomplished by using the morphological analysis of these two line segments. In the experiments, the detection rate of proposed method reaches to 97.5% for the 16 images containing 119 needles.

• 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.

• Journal of Acupuncture Research
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• v.26 no.1
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• pp.99-109
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• 2009

목적 : 두통의 침술효과에 대한 연구가 꾸준히 이루어지고 있다. 하지만 많은 연구들에서 서로 상충되는 결과를 내놓고 있다. 이에 저자는 대조군 집단 시술의 역할과 시험의 특성에 대해 연구하는 데 있어 몇 가지 유형의 두통, 특히 긴장성 두통(Tension-type headache, TTH)과 편두통에 대한 침술의 대조군 시험에서 나타나는 일관성 없는 발견 사항들의 원인이 무엇인지에 대해 밝히려고 하였다. 방법 : 두통의 침술효과에 대해 보고하고 있는 11개의 임의대조군 시험(Randomized controlled trials, RCTs)을 대상으로 하여 위약 침술과 방법론적 특성 범주 III과 IV를 중심으로 위약 시술 분석, 비교를 실시하였다. 결과 : 임상적 유효성과의 상관관계에 있어 범주 III과 IV 사이에는 유의한 차이가 없었다. 표본 크기 계산, 표본 전체 크기, 진짜 집단과 위약 집단에 속한 피험자의 수에는 긍정적 결과와 중립적 결과 사이에 유의한 차이가 없었다. 결론 : 두통의 임의대조군 시험에 대한 다양한 유형의 위약 대조군과 침술의 방법론적 특성이 임상적 효과를 예측해 주는지의 여부에 대해 추가 연구가 이루어져야 하겠다.

• 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.

• 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.

• 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.