• Korean Journal of Acupuncture
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• v.35 no.2
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• pp.47-55
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• 2018

Objectives: Clinical improvements can be observed following placebo administrations in clinical trials. Randomized controlled trials have been conducted to disentangle the specific effects of therapeutic interventions over the past decade. In acupuncture trials, non-penetrating placebo needles offer the opportunity to determine the specific effects of needling. Methods: The present review provides an overview of the concept of the placebo effect and the characteristics of the placebo needles. Results: Placebo control can contribute to minimize for bias and the contextual and psychological components of therapeutic interventions. Placebo control should meet two criteria: blinding efficacy (indistinguishable from active treatment) and physiological inertness. In the case of acupuncture, however, it is difficult to meet both criteria simultaneously. The dilemma of placebo needles suggests that placebo needles do not constitute proper control in acupuncture research. Considering the characteristics of placebo needles, patients are more likely to perceive placebo needles as active treatment in acupuncture trials compared to placebo pills in pharmaceutical trials. Placebo response might be observed more frequently to placebo needles than to placebo pills. When acupuncture treatments are utilized in clinical use, placebo effects can be enhanced by exploiting patients' expectations in the contextual or environmental cues that surround medical intervention. Conclusions: We have to consider these unique characteristics of placebo needles in order to avoid drawing premature conclusions that acupuncture itself is just a placebo.

• Korean Journal of Acupuncture
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• v.25 no.4
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• pp.175-185
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• 2008

Objective : Acupuncture (from the Latin acus, "needle," and pungere, "to prick") is a technique of inserting and manipulating fine needles at specific points on the body. As a placebo acupuncture needle device was developed based on the visual impact of needling, it has been raised that it is useful only when acupuncture points and needling are visible to subjects. To examine the visual factor of the placebo acupuncture, the present study was aimed to compare the blinding index of the verum and placebo acupuncture between masked and unmasked situation. Methods : Thirty-six patients were randomly alloted to be stimulated with a verum or placebo acupuncture in a cross-over design. They were asked to guess a right answer whether they were stimulated with the verum or placebo acupuncture at LI4 in an unmasked or masked situation. The penetrating, pain, and deqi sensations were also measured after the stimulation using modified visual analogue scale. Results : The correct answer rate of the placebo acupuncture was 22.2% and 16.7% in an unmasked and masked situation, respectively (P>0.767). The blinding index of the placebo acupuncture was -0.56 (95%CI -0.84 to -0.27) and -0.67 (95%CI -0.91 to -0.42) in an unmasked and masked situation, respectively. The penetrating and deqi sensation of the verum acupuncture were significantly higher than those of the placebo acupuncture in both unmasked and masked situation. The pain sensation of the verum acupuncture was significantly higher than that of the placebo acupuncture in masked situation, but not in unmasked situation. Conclusion : Blinding of the placebo acupuncture was successful both in the unmasked and masked situation. These finding indicate that visual factor might not play a critical role in blinding of the placebo needle. We suggest that placebo needle would be also useful in a functional magnetic resonance imaging scan even when the subject could not see the placebo needle.

• Korean Journal of Biological Psychiatry
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• v.19 no.4
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• pp.164-171
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• 2012

The placebo effect, a response observed during the placebo arm of a clinical trial, is produced by the psychobiological action of the placebo as well as by other potential contributors to symptom amelioration such as spontaneous improvement, regression to the mean, biases, concurrent treatments, and study design. From a psychological viewpoint, there are many mechanisms that contribute to placebo effects, including expectations, conditioning, learning, and anxiety reduction. Placebo responses are also mediated by opioid and non-opioid mechanisms including dopamine, serotonin, cholecystokinin, and immune mediators. During recent years, a trend towards increased placebo effects in clinical trials of neuropsychiatric drugs has been noted. Indeed, the placebo effects observed in clinical trials constitute an increasing problem and interfere with signal-detection analyses of potential treatments. Several potential factors including protocol/study design and conduct related factors may account for the placebo effect observed in clinical trials. This paper reviews key issues related to this problem and aims to identify potential solutions.

• Journal of Acupuncture Research
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• v.20 no.2
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• pp.145-160
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• 2003

Objective : This study was designed to find out whether placebo auricular acupuncture is able to be constituted as an appropriate control group for needle insertion to Korean. Methods : We performed a randomized controlled, single-blind study(n=48) comparing subjective evaluations of needles insertion and avoidance of needles insertion. Both ears were needled concurrently, one real acupuncture(needle insertion) and the other placebo acupuncture(avoidance of needle insertion with blunt tip). Subjects then completed a questionnaire rating the intensity of five sensations in each ear, and also attempted to identity which ear received placebo and which ear received real acupuncture. Results : As for the effects of real and placebo acupuncture on each item(Warmth, Fullness, Pain, Activity, Radiating), real acupuncture was significantly warmer, fuller, more painful than placebo acupuncture. In particular, the real acupuncture only in experienced acupuncture recipients was significantly warmer, fuller, more painful than placebo acupuncture. About the ability to differentiate real and placebo acupuncture, 54.2 percent correctly identified which ear received real acupuncture and which ear received placebo acupuncture. However, the ability to differentiate real and placebo acupuncture for naive and experienced acupuncture recipients was not significantly different. Conclusions : Most of the subjects(Korean) identified which ear received placebo and which ear received real acupuncture. We found that this placebo auricular acupuncture is not able to be applied to Korean, in particular for experienced acupuncture recipients. Further study is needed for new placebo auricular acupuncture or racial difference between American.

• Tuberculosis and Respiratory Diseases
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• v.85 no.1
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• pp.67-73
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• 2022

Background: Bronchiectasis patients with neutrophilic airway inflammation develop symptoms of chronic cough, sputum production, and recurrent exacerbations. Roflumilast has anti-inflammatory actions via decreased neutrophilic airway inflammation. The effectiveness of roflumilast to reduce bronchiectasis exacerbation has never been evaluated. Methods: We conducted a double-blinded, randomized, placebo-controlled trial. Our primary objective was to assess the effect of roflumilast compared with that of a placebo in reducing exacerbation rates in bronchiectasis patients. The secondary objectives were the changes in forced expiratory volume in 1 second (FEV₁) and St. George's Respiratory Questionnaire (SGRQ). Bronchiectasis patients older than 18 years who had had two exacerbations during the previous 12 months were randomly assigned to receive either 500 ㎍ of either roflumilast or a placebo once daily for 6 months in a 1:1 ratio. Results: Forty bronchiectasis patients who had experienced exacerbations were screened. Thirty patients completed the study after 6 months of treatment: roflumilast group (n=15) and placebo group (n=15). The rates of exacerbations were 0.57 and 0.59 per patient in the roflumilast and placebo groups, respectively. Prebronchodilator FEV₁ increased by 0.07 L from baseline in the roflumilast group and decreased by 0.015 L in the placebo group, but the difference was not significant. No significant differences were observed in the change of SGRQ scores between the roflumilast and placebo groups. Roflumilast had significant side effects, including loss of appetite and headache. Conclusion: Roflumilast did not significantly affect the rate of exacerbations or quality of life. However, FEV₁ tended to improve more in the roflumilast group than in the placebo group.

• Journal of Ginseng Research
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• v.47 no.6
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• pp.766-772
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• 2023

Background: Korean Red Ginseng (KRG) is an effective anti-stress treatment. In this study, we investigated the therapeutic potential effects of KRG on relieving stress in a general population using transcriptome analysis. Methods: We conducted an 8-week clinical pilot study on 90 healthy men who reported stress. The study was completed by 43 participants in the KRG group and 44 participants in the placebo group. Participants were randomized 1:1 to the KRG and placebo groups. We evaluated the stress by stress response inventory (SRI) at baseline and 8 weeks. The main outcomes were changes in the levels of neurotransmitters (NTs) and NT-related gene expression. NTs were analyzed using automated (GC) content, and levels of gene expression were measured by reads per kilobase of transcript per million mapped reads (RPKM). Results: The KRG group showed significantly preserved epinephrine decrease compared with placebo group at 8 weeks (changes in epinephrine, KRG vs. placebo; -1623.2 ± 46101.5 vs. -35116.3 ± 86288.2, p = 0012). Among subjects who higher SRI score, meaning stress increased compared to baseline, the KRG group showed a smaller decrease in serotonin than the placebo group (changes in serotonin, KRG vs. placebo; -2627.5 ± 5859.1 vs, -8087.4 ± 7162.4, p = 0.005) and a smaller increase in cortisol than the placebo group (changes in cortisol, KRG vs. placebo; 1912.7 ± 10097.75 vs. 8046.2 ± 8050.6 , p = 0.019) in subgroup analysis. Transcriptome findings indicated that KRG intake affects gene expression related with metabolism of choline, adrenalin, and monoamine. Conclusion: These findings suggest that KRG has beneficial effects on the amelioration of stress response in NTs, and this effect is more prominent in stressful situations. Further clinical studies are required to confirm the anti-stress effect of KRG.

• The Journal of Korean Medicine
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• v.28 no.1 s.69
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• pp.105-116
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• 2007

Objectives : Mahuang (Ephedra sinica), well known as an herbal medicine in the East and West, contains a relatively high percentage of ephedrine known as sympathomimetic alkaloid. We investigated the effects of Mahuang on sympathetic nervous system with heart rate variety (HRV). Time and frequency domain analysis of HRV is a noninvasive technique capable of providing information on autonomic modulation of the sinus node. Methods : We investigated 57 healthy volunteers consisting of 37 subjects in the Mahuang group and 20 subjects in the placebo group. Study form was a randomized, placebo-controlled, double-blind clinical trial. The 37 subjects in the Mahuang group took 3 Mahuang capsules (1 capsule equivalent to 2g herb Mahuang) twice a day at 10 a.m. and 2 p.,., while the 20 subjects in the placebo group took 3 placebo-capsules filled with glutinous rice powder at the same times. Mahuang medicine and placebo medicine were made into opaque capsules. We measured HRV at 3 p.m. 1 or 2 days before medication and at 3 p.m. after medication. Results : Mean-RR and SDNN of the Mahuang group significantly decreased compared with that of the placebo group, but the heart rate of the Mahuang group significantly increased compared with the placebo. HRV-Index, RMSSD and SDSD of the Mahuang group significantly decreased compared with that of the placebo group, but PNN50 of the Mahuang group significantly increased compared with placebo. Ln(TP), Ln(VLF), Ln(LF) and Ln(HF) of the Mahuang group significantly decreased compared with those of the placebo group. There were no significant differences in normalized LF, normalized HF and LF/HF ratio between the Mahuang and placebo groups. Conclusion : The results suggest that Mahuang in healthy adults tends to reduce the autonomic nervous system within the normal range.

• Nutrition Research and Practice
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• v.6 no.3
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• pp.226-231
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• 2012

The purpose of the study was to assess the effects of a 12 weeks aged garlic extract (AGE) regimen with regular exercise on cardiovascular disease (CVD) risk in postmenopausal women. A total of 30 postmenopausal women ($54.4{\pm}5.4$ years) were randomly divided into the following four groups: Placebo (Placebo; n = 6), AGE intake (AGEI; n = 8), exercise and placebo (Ex + Placebo; n = 8), exercise and AGE (Ex + AGE; n = 8) groups. The AGE group consume 80 mg per day, and exercise groups performed moderate exercise (aerobic and resistance) three times per week. After 12 weeks of treatment, body composition, lipid profile, and CVD risk factors were analyzed. Body weight was significantly decreased in AGEI, Ex + Placebo, and Ex + AGE groups compared to baseline. Body fat % was significantly decreased in the AGEI and Ex + Placebo groups. Body mass index (BMI) was significantly decreased in the AGEI, Ex + Placebo, and Ex + AGE groups. Fat-free mass was significantly decreased in the AGEI group. Total cholesterol (TC) was significantly lower in the Ex + Placebo compared to the Placebo group. AGE supplementation or exercise effectively reduced low-density lipoprotein (LDL-C). Triglyceride (TG) was significantly increased in the AGEI group. Malondialdehyde (MDA) levels were significantly decreased in the AGEI, Ex + Placebo, and Ex + AGE compared to the placebo group. AGE supplementation reduced homocysteine levels regardless of whether the women also exercised. The present results suggest that AGE supplementation reduces cardiovascular risk factors independently of exercise in postmenopausal women.

• Child Health Nursing Research
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• v.7 no.1
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• pp.35-50
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• 2001

The ability of neonates to perceive and react to pain, has been acknowledged recently. Recent researches have been shown that even short term pain can have lasting negative effects. We know that most of the anatomical pathway and neurotrans-mitter function necessary for pain perception are fully or nearly fully developed in the neonatal period. Many people are still reluctant to believe that pain felt by neonates may be as severe as that felt by older children or adults yet. The objective of the study is to assess and compare the analgesic effects of orally administered sucrose and pacifiers. And to determine the synergistic analgesic effects of sucrose and pacifiers. The tools for this study is Lawrence's NIPS (neonatal infant pain scale) with behavioural pain responses and index for pain physiological reponses as heart rate, respiratory rate and degree of SaO₂. The participants are 96 healthy infants of neonatal age 1-7days and randomised to receive heel prick before 2minutes to blood sampling and physiological test in Nursery of K Medical University Hospital on May-July, 2000. The experimental group assigned to one of three treatment groups : no treatment; a pacifier; placebo(2ml 25％ sucrose). Collected data were analyzed with the SAS program using X²-test, ANOVA and Duncan's multiple range test as post hoc. The results were as follows. 1) Pain behaviour responses: The pain score of placebo group(2ml 25％ sucrose) is lower than no treatment group and pacifier group significantly(P=.000). Placebo group is different from no treatment and pacifier group with Duncan's multiple range test. 2) Pain physiologic responses (1) heart rate: The heart rate of placebo group(2ml 25％ sucrose) is different from that of no treatment group and pacifier group significantly(P=.000). The heart rate change of placebo group is less than the other groups. (2) respiratory rate: The respiratory rate of placebo group(2ml 25％ sucrose) is different from that of no treatment group and pacifier group insignificantly (P=.2340). But, the respiratory rate of placebo group is lower than the other groups. (3) SaO₂: The SaO₂ score of placebo group(2ml 25％ sucrose) is different from that of no treatment group and pacifier group insignificantly (P=.3265). But, the change of SaO₂ score of placebo group is less than the other groups. In conclusion, the sucrose placebo showed pain relief effect in behavior responses and less physiological responses. Accordingly, the sucrose placebo should be applied nursing intervention for simple pain management as heel prick.

• Restorative Dentistry and Endodontics
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• v.47 no.3
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• pp.25.1-25.11
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• 2022

Objectives: This study aimed to evaluate the effects of 5% lidocaine and 2.5% lidocaine/2.5% prilocaine topical anesthetic on pain during needle insertion and infiltration injection in the labial mucosa of anterior maxillary teeth, and to assess the relationship between patients' anxiety and pain scores. Materials and Methods: The Modified Dental Anxiety Scale questionnaire was applied and recorded. Patients were randomly divided into 4 groups (n = 30), as follows: G1 group: 5% lidocaine and placebo for 1 minute, G2 group: 2.5% lidocaine/2.5% prilocaine and placebo for 1 minute, G3 group: 5% lidocaine and placebo for 3 minutes, and G4 group: 2.5% lidocaine/2.5% prilocaine and placebo for 3 minutes. Before the application of topical anesthesia, one side was randomly selected as the topical anesthesia and the contralateral side as the placebo. The pain levels were measured with Visual Analog Scale (VAS) immediately after needle insertion and injection and were compared. The correlation between anxiety and pain scores was analyzed. Results: Administration of 5% lidocaine for 1 minute had significantly higher pain scores for both insertion and infiltration injection than the other groups (p < 0.05). There was a significant moderate positive correlation between dental anxiety and the injection-induced VAS pain score in the placebo side in all groups (p < 0.05). Conclusions: Topical anesthetics significantly reduced the pain caused by both needle insertion and injection pain in comparison to the placebo side. The pain scores of patients with dental anxiety were lower on the topical anesthesia compared to the placebo side.