• Journal of Acupuncture Research
• /
• 제23권5호
• /
• pp.127-144
• /
• 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
• /
• 제28권5호
• /
• pp.29-38
• /
• 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 Nutrition and Health
• /
• 제27권9호
• /
• pp.949-956
• /
• 1994

The effect of zinc deficiency on certain immunological parameters was investigated using intragastric tube feeding to obviate decreased food intake and altered eating pattern. Male, Fischer 344 rats were bilaterally adrenalectomized(ADX) or sham operated(SHAM). ADX rats received 0.9% NaCl in their drinking water and corticosterone injections at the dose of 1mg/kg of body weight three times per day. After recovery, one half of ADX and SHAM animals were tube-fed a purified, liquid diet containing either two ppm of zinc(zinc-deficient, force-fed ; ZDF) or 50ppm(zinc-replete, force-fed ; ZRF) for 19 days. They received identical amounts of diet based on the intake of ad libitum-fed, zinc-replete rats. Although they received identical amounts of food, ZDF rats grew at a slower rate compared to ZRF rats in both SHAM and ADX rats. Regardless of surgery, force-feeding rats the zinc-deficient diet resulted in a substantial decrease in serum zinc levels. The weights of the thymus, lymph node, and spleen were lower in SHAM-ZRF rats compared to SHAM-ARF rats. Marginal zinc deficiency caused lymphopenia in SHAM animals. However, these differences in lymphoid tissues and cells between SHAM-ZDF and SHAM-ZRF rats disappeared in ADX rats. These results indicate that the impaired growth of lymphoid tissues observed in zinc-deficient, sham-operated animals can be attributed to elevated serum corticosterone levels under the conditions of our experiments.

• Korean Journal of Acupuncture
• /
• 제23권1호
• /
• pp.95-109
• /
• 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.

• 한국한의학연구원논문집
• /
• 제13권1호통권19호
• /
• pp.93-100
• /
• 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.

• 대한의생명과학회지
• /
• 제17권1호
• /
• pp.13-20
• /
• 2011

The peroxisome proliferator-activated receptor ${\alpha}$ ($PPAR{\alpha}$) is a nuclear transcription factor that plays a central role in lipid and lipoprotein metabolism. To investigate whether swim training improves obesity and lipid metabolism through $PPAR{\alpha}$ activation in female sham-operated (Sham) and ovariectomized (OVX) mice, we measured body weight, visceral adipose tissue mass, serum free fatty acid at 6 weeks as well as the expression of hepatic $PPAR{\alpha}$ target genes involved in fatty acid oxidation. Swim-trained mice had decreased body weight, visceral adipose tissue mass and serum free fatty acid levels compared to high fat diet fed control mice in both female Sham and OVX mice. These reductions were more prominent in OVX than in Sham mice. Swim training significantly increased hepatic mRNA levels of $PPAR{\alpha}$ target genes responsible for mitochondrial fatty acid ${\beta}$-oxidation, such as carnitine palmitoyltransgerase-1 (CPT-1), very long chain acyl-CoA dehydrogenase (VLCAD), and medium chain acyl-CoA dehydrogenase (MCAD) in OVX mice. However, swim trained female Sham mice did not increase hepatic mRNA levels of $PPAR{\alpha}$ target genes responsible for mitochondrial fatty acid ${\beta}$-oxidation compared to Sham control mice. These results indicate that swim training differentially regulates body weight and adipose tissue mass between OVX and Sham mice, at least in part due to differences in liver $PPAR{\alpha}$ activation.

• Korean Journal of Acupuncture
• /
• 제23권4호
• /
• pp.85-99
• /
• 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.

• 생명과학회지
• /
• 제9권2호
• /
• pp.216-221
• /
• 1999

In order to observe the bioactivity of ovariectomized rats, ovariectomized group (Ovx), nonovariectomized group(Sham) and ovariectomized aloe-treat group(Ovx＋Aloe) were made. Lipidperoxides of liver and kidney, serum AST.ALT, BUN, total cholesterol and HDL-cholesterol were investigated as follows. Lipidoxides of the liver and the kidney in Ovx group were 1.74 times and 1.38 times increased compared to Sham group respectively. But they were significantly decreased in Ovx+Aloe group compared to Ovx group. Serum AST and ALT in Ovx group were increased 1.49 times and 1.65 times respectively compared to Sham group respectively. But they were decreased compared to Ovx group. Serum total cholesterol in Ovx group was increased 1.48 times compared to Sham group. While it was increased 50% in Ovx＋Aloe group. Serum HDL-cholesterol in Ovx group was decreasd 23$\%$ compared to Sham group. While it was increasd 58% in Ovx＋Aloe group compared to Ovx group. Serum BUN in Ovx group was increased slightly compared to Sham group. In Ovx＋Aloe serum BUN had no change compared to Ovx group.

• 한국식품과학회지
• /
• 제33권5호
• /
• pp.619-625
• /
• 2001

현재까지 인슐린의 작용력을 향상시키는 약으로 시판되고 있는 것은 thiazolidinediones이 있고 그외에도 몇가지 종류의 물질에 대해서 그 효과를 조사하고 있다. 본 연구에서는 당뇨병의 치료에 효과가 있다고 알려진 한약재로부터 추출한 POD의 인슐린 저항성에 미치는 영향을 조사하였다. 체중이 $338{\pm}35\;$ 인 Sprague Dawley 백서를 두군으로 나누어 한군은 sham 수술을 하여 정상군으로, 다른 한군은 90% 췌장 적제술을 하여 당뇨군(Px)으로 정하였다. Px 백서는 90% 췌장제거 수술을 한 후 2 주동안 혈당을 측정하여 공복 혈당이 9.4 mmol/L이상인 백서를 선택하였다. Sham 백서와 당뇨 백서는 다시 각각 2군으로 나누어 한군은(n=10) 하루에 POD을 0.3 g/kg 체중의 용량으로 식이에 섞어 공급하였고, 다른 한군은(n=10) 위약(P)을 8 주 동안 투여하였다. 식이는 40%지방 식이를 자유롭게 섭취하도록 하였다. 7 주 째 되었을 때 인슐린 저항성을 측정하기 위해 경동맥과 경정맥에 도관을 삽입하였고, 8주째에 $15{\sim}18$시간 금식후 EH clamp 실험을 실시하였다. POD와 P를 투여하기 전에 Px 백서의 혈당은 $9.9{\pm}0.6\;mmol/L$이었고, 정상군의 혈당은 $6.4{\pm}0.5\;mmol/L$이었다. EH clamp를 할 때 체중은 Px 백서에 비해 Sham백서에서 높았으며, 혈당은 POD 투여와 당뇨에 의한 차이가 있었다. Px 백서가 Sham 백서에 비해 기초 인슐린 농도가 낮았고, Sham 백서에서는 POD군이 P군에 비해 낮았다. 체내 포도당 제거 속도는 Sham+POD군이 $53.9{\pm}7.7$, Sham+P군이 $38.7{\pm}13.6$, Px+POD군이 $36.0{\pm}10.6$, Px+P군이 $29.2{\pm}6.8\;mg/kg$ 체중/min이었다. 체내 포도당 제거속도는 POD군이 P군에 비해 높았고, Px군이 Sham군에 비해 낮았다(P<0.01). Soleus 근육의 글리코겐 양은 POD군에서 P군에 비해 높았다. Px 백서에서는 soleus과 quadriceps 근육의 글리코겐 양은 정상군에 비해 낮았다. Soleus근육의 glycogen synthase의 활성은 P군에 비해 POD군에서 높았고(P<0.05), Px 백서가 Sham 백서에 비해 낮았다(P<0.05). Px 백서의 quadriceps 근육내 중성지방 축적량이 Sham 백서에 비해 높았는데, P에 비해 POD를 공급하였을 때 중성지방의 축적양이 낮아졌다. 결론적으로 POD은 당뇨와 정상 백서에서 인슐린 저항성을 감소시킴을 알 수 있었고 이러한 인슐린 저항성의 감소 현상은 근육에서의 glycogen synthase 활성과 관련이 있을 것으로 생각되었다.

• 동의생리병리학회지
• /
• 제16권4호
• /
• pp.788-800
• /
• 2002

Aging is characterized by an age-dependent reduction in bone density. Pronounced bone loss by postmenopausal estrogen deficiency induces a bad effect on dynamic balance of bone metabolism. When the bone density is reduced to the level below the fracture threshold, the risk for fracture is greatly increased. The purpose of this study is to examine what are the effects of the Yuklinzu(YLZ: 毓麟珠) on the ovariectomized rat model of postmenopausal osteoporosis. The results of the experiment are as follows: Body weight in control group showed significant increase in comparison with sham, but that in YLZ-treated showed no change in comparison with control. The level of serum albumin in control group showed significant decrease in comparison with sham. That in YLZ-treated was slightly decreased in comparison with control. The level of serum ALP activity in control group showed significant increase in comparison with sham, but that in YLZ-treated was significantly decreased in comparison with control. The level of serum phosphorous in control group showed significant increase in comparison with sham, but that in YLZ-treated showed no change in comparison with control. The level of serum calcium in control group showed no change in comparison with sham, but that in YLZ-treated was significantly decreased in comparison with control. The level of serum GOT in control group showed no change in comparison with sham, but that in YLZ-treated was significantly decreased in comparison with control. The level of serum GPT did not significant change among the three groups. The level of serum estrogen in control group showed slightly increased in comparison with sham, but that in YLZ-treated showed no change in comparison with control. The level of serum T3 in control group showed no change in comparison with sham, and that in YLZ-treated showed no change in comparison with control. The level of serum T4 in control group showed significant increase in comparison with sham, but that in YLZ-treated was significantly decreased in comparison with control. Mechanical strength of the femur neck in control group showed significant decrease in comparison with sham. That in YLZ-treated showed slightly increased in comparison with control. Trabecular bone area as well as trabecular thickness in control group showed significant decrease in comparison with sham. Those in YLZ-treated showed significant increase in comparison with control. Trabecular number and did not significant change among the three groups. Trabecular separation only in YLZ-treated showed significant decrease in comparison with control. Osteoclast number and oseoblast surface in control group showed significant increase in comparison with sham. Those in YLZ-treated showed slightly decreased in comparison with control. According to the above these results, YLZ has shown to be capable of preventing and curing osteoporosis caused by old-aged and postmenopause.