• 제목/요약/키워드: placebo

검색결과 963건 처리시간 0.031초

Effects of vitamin D supplementation on metabolic indices and hs-CRP levels in gestational diabetes mellitus patients: a randomized, double-blinded, placebo-controlled clinical trial

  • Yazdchi, Roya;Gargari, Bahram Pourghassem;Asghari-Jafarabadi, Mohammad;Sahhaf, Farnaz
    • Nutrition Research and Practice
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    • 제10권3호
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    • pp.328-335
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    • 2016
  • BACKGROUND/OBJECTIVES: Vitamin D plays an important role in the etiology of gestational diabetes mellitus (GDM). This study evaluated the effect of vitamin D supplementation on metabolic indices and hs-C-reactive protein (CRP) levels in GDM patients. SUBJECTS/METHODS: The study was a randomized, placebo-controlled, double-blinded clinical trial. Seventy-six pregnant women with GDM and gestational age between 24-28 weeks were assigned to receive four oral treatments consisting of 50,000 IU of vitamin $D_3$ (n = 38) or placebo (n = 38) once every 2 weeks for 2 months. Fasting blood glucose (FG), insulin, HbA1c, 25-hydroxyvitamin D, lipid profile, hs-CRP, and homeostasis model assessment-insulin resistance (HOMA-IR) were measured before and after treatment. Independent and paired t-tests were used to determine intra- and intergroup differences, respectively. ANCOVA was used to assess the effects of vitamin D supplementation on biochemical parameters. RESULTS: Compared with the placebo group, in the vitamin D group, the serum level of 25-hydroxyvitamin D increased (19.15 vs. -0.40 ng/ml; P < 0.01) and that of FG (-4.72 vs. 5.27 mg/dl; P = 0.01) as well as HbA1c (-0.18% vs. 0.17%; P = 0.02) decreased. Improvements in the lipid profiles were observed in the vitamin D group, but without statistical significance. Significant increases in concentrations of hs-CRP, FG, HbA1c, total cholesterol, and LDL cholesterol were observed in the placebo group. No significant change in fasting insulin and HOMA-IR was observed in either group. CONCLUSIONS: In GDM patients, vitamin D supplementation improved FG and HbA1c but had no significant effects on lipid profile or hs-CRP.

The Efficacy and Safety of Beef Tallow Extract Including Cis-9-cetylmyristoleate in Patients with Osteoarthritis - As an Adjuvant Pharmacological Treatment -

  • Lee, Sang-Hoon;Kim, June-Hyuk;Cho, Whan-Seong;Seo, Sung-Wook;Kim, Sung-Kyu;Oh, Joo-Han
    • Preventive Nutrition and Food Science
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    • 제10권3호
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    • pp.285-289
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    • 2005
  • In this double-blind, placebo-controlled trial, we assessed the efficacy and safety of beef tallow extract (BTE) including Cis-9-cetylmyristoleate in patients with arthritis. Between May and December 2003, we selected 80 patients (n=80) who showed/manifested arthritic symptoms and whose radiological findings were suggestive of arthritis, and randomly assigned them to placebo-controlled (n=40) and treatment group (n=40). The placebo (corn starch 350 mg) and BTE (208 mg) were orally administered to placebo-controlled and treatment group three times a day, respectively. We assessed the efficacy and safety based on the visual analogue scale (V AS) and modified knee society knee scores (MKSKS) at baseline and endpoint, respectively. To assess the safety, we monitored the adverse effects noted in liver, kidney, cardiovascular and gastrointestinal system for 3 weeks. Then, we performed not only a questionnaire study but also laboratory tests (e.g., liver function test, kidney function test, urinalysis, electrocardiography [EKG], complete blood cell counts [CBC] and chest X-ray). For statistical analysis, Student (-test and paired (-test were done using SPSS■ Version 11.0. Statistical significance was set at p < 0.05. The scores between V AS and MKSKS showed statistical significance (p < 0.05) with an improvement of $69.2\%$ (27/39) and $3.8\%$ (21/39) of treatment-group patients, respectively. Abnormal laboratory findings were noted in neither placebo-controlled nor treatment group. In conclusion, our results indicate that the administration of BTE was a safe and effective treatment regimen for patients with arthritis. In addition, the efficacy of BTE was more remarkable in alleviating the symptoms rather than improving the function.

체열촬영으로 관찰한 전기수지자극의 효과 (Alteration in Infrared Thermal Imaging by Use of Acupuncture-like Electric Stimulation on Finger Control Gate)

  • 이상훈;이규창;우남식;이예철;김선복;이형환
    • The Korean Journal of Pain
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    • 제7권2호
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    • pp.222-230
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    • 1994
  • Acupuncture-like transcutaneous electrical nerve stimulation(ALTENS) on acupuncture site(dorsal and ventral side of finger) were compared with a placebo site(forearm) by infrared thermal imaging. Six disease-free volunteers underwent, on different days, an ALTENS treatment and a placebo treatment in a cross-over sequences of stimulation control and inhibition control in excess of 50 treatments. ALTENS treatments were given at 30Hz at an intensity just below pain threshold delivered to acupuncture points on fingers. Placebo stimulations were administered in similar manner. After every thirty minutes of ALTENS and placebo treatment with stimulation, inhibition control sequence and vice versa, we examined whole body infrared thermal imaging and checked changed skin temperature on frontal, anterior chest, upper and lower abdomen, dorsal and ventral aspect of hand, thoracic and lumbar area, anterior and posterior aspect of lower leg. There were significant skin temperature elevations with ALTENS treatment, especially finger control gate corresponding organ area. Placebo treatment revealed no skin temperature change. We concluded that ALTENS on finger control gate influence physiologic state as opposed to conventional electric stimulation.

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Effect of Kinesiology Taping on Hyolaryngeal Complex Movement in Stroke Patient with Dysphagia

  • Hong, Junyong;Oh, Donghwan;Park, Jisu;Jung, Youngjin
    • 국제물리치료학회지
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    • 제11권2호
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    • pp.2052-2059
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    • 2020
  • Background: Kinesiology taping (KT) is a method that helps immediately increase muscle activation, strength and joint stability by being attached to various skeletal muscles and structures of the body. Objectives: To investigate the effect of KT applied below the hyolaryngeal complex on the movement of the hyolaryngeal complex during swallowing in patients with dysphagia after stroke. Design: One-group, pre-post design. Methods: Twenty individuals with dysphagia after stroke participated in this study. KT was applied to the sternum and both clavicles from the hyolaryngeal complex. We analyzed the motion of the hyolaryngeal complex during swallowing with and placebo KT and KT using the Image-J software with videofluoroscopic swallowing study. In addition, a 0-to-10 numerical rating self-report scale was used to check the required effort and resistance felt during swallowing. Results: KT condition showed that the anterior and superior movement of the hyoid bone during swallowing was significantly lower than placebo KT (P<.05, all). Also, KT condition showed that the anterior and superior movement of the larynx during swallowing was significantly lower than placebo KT (P<.05, all). In result of statistical comparison between KT group and placebo KT group, the KT group showed significantly higher self-report scale score than the placebo KT group in terms of two category; the required effort and resistance felt (P<.05, all). Conclusion: This study demonstrated that KT applied below the hyolaryngeal complex inhibits the anterior and superior movement of hyoid bone and larynx during swallowing of patients with dysphagia after stroke.

CC, CF, BV 약침의 침감에 대한 임상적 연구 -placebo 약침을 위한 기초연구- (The Clinical Study on Acupuncture Sensation in CC, CF and BV Herbal Acupuncture -The Basic Study on Placebo Herbal Acupuncture-)

  • 서정철;윤종석;한상원;박히준;이혜정
    • 대한약침학회지
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    • 제7권1호
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    • pp.63-69
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    • 2004
  • Objective : This study was designed to find out whether NS(normal saline) is able to be constituted as an appropriate control group for CC(Cervi Cornu Parvum herbal acupuncture), CF(Carthami-Flos herbal acupuncture) and BV(bee venom herbal acupuncture). Method : NS and three herbal acupuncture were inserted into Quchi(LI 11) of the subjects. After 5 minutes the subjects completed a questionnaire rating the intensity of 21 kinds of acupuncture sensation; hurting, penetrating, sharp, aching, intense, spreading, radiating, tingling, pricking, stinging, pulling, heavy, dull, numb, electric, shocking, hot, burning, cool, pulsing, and throbbing. We compared subjective evaluations of acupuncture sensation between or among the groups. Results : As for CC half items of the acupuncture sensation were significantly different from NS. As for CF all items were not significantly different from NS. As for CC all items were significantly different from NS except one item. In general the score of CF acupuncture sensation was lower than the others and the score of BV acupuncture sensation was higher than the others from comparison of sensation among herbal acupunctures(CC, CF, BV). Conclusion : We found that NS is able to be an appropriate placebo herbal acupuncture for CF. Further study is needed for new placebo herbal acupuncture for CC and BV.

만성 요통 환자에서 박동성 전자기장 치료의 효과: 무작위, 이중맹검, 위약대조법을 이용한 연구 (Efficacy of Pulsed ElectroMagnetic Therapy for Chronic Lower Back Pain: a Double-Blind, Randomized, Placebo-Controlled Study)

  • 이평복;김용철;이상철
    • The Korean Journal of Pain
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    • 제18권1호
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    • pp.43-47
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    • 2005
  • Background: The optimal management of pain using magnetic irradiation modalities continues to attract considerable debate. Therefore, we conducted a randomized, double-blind, placebo-controlled clinical trial to determine the effectiveness of pulsed electromagnetic therapy for the treatment of chronic lower back pain. Methods: Fifteen-minute sessions of active (n = 20) or placebo (n = 20) electromagnetic therapy were repeated 3 times a week for 3 weeks. Patients were assessed using the 11-point numerical rating scale and the revised Oswestry disability scores for up to 4 weeks after therapy. Results: The active magnetic group showed significantly more pain reduction than the placebo group immediately after therapy and one and four weeks after therapy (P < 0.05). At 4 weeks after therapy percentage changes in NRS from baseline were $22{\pm}24%$ and $38{\pm}11%$ in the placebo and magnetic groups, respectively. The revised Oswestry disability percentage in the active magnetic group was also significantly improved (P < 0.05). Conclusions: Pulsed electromagnetic therapy provided pain relief and ameliorated disability in patients with chronic lower back pain. According to our results, pulsed electromagnetic therapy should be considered an important potential therapeutic tool for the conservative therapy of chronic lower back pain.

슈퍼자미벼 미강 추출물 보충 섭취에 의한 항산화 대사 및 혈중 지질 개선 효과 (Effects of Improving Plasma Lipid Profiles and Antioxidant Metabolism of Superjami Extract Supplementation)

  • 남수진;정수임;강미영
    • 한국식품영양학회지
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    • 제32권3호
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    • pp.179-188
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    • 2019
  • This study was to confirm the effect of supplementation of superjami bran extract on lipid and antioxidant metabolism. Twenty-five subjects were recruited, and divided into Superjami group (n=12), and Placebo group (n=13) random assignment. Among the groups, the Superjami group took a Superjami bran extract (2 g/2 capsule/day), and the Placebo group took dextrin (2 g/2 capsule/day), for 12 weeks. As a result of the experiment, concentrations of TG, TC, and HDL-C in the blood, were significantly lower than those in the control group, and HDL-C was significantly higher. AI and HTR also showed positive values. Leptin did not differ significantly, but as a result of adipectin, the Superjami group displayed a higher value, compared to the Placebo group, and LAR also had significantly lower value. Antioxidant results showed that GPx, CAT, and RGLU, were significantly higher before as well as after intakes of the Superjami group, and significantly higher levels of the Superjami group, compared to the Placebo group. AOPP showed significantly lower values for the Superjami group, compared to the Placebo group. So, based on this study, ingestion of Superjami bran extract is effective in improving blood lipid concentrations as well as inflammatory substances, and has positive effects relative to increasing antioxidant activity.

Efficacy of topical interventions for temporomandibular disorders compared to placebo or control therapy: a systematic review with meta-analysis

  • Mena, Mariam;Dalbah, Lana;Levi, Lauren;Padilla, Mariela;Enciso, Reyes
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제20권6호
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    • pp.337-356
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    • 2020
  • This systematic review focused on the efficacy of topical products in reducing temporomandibular joint disorder (TMD)-associated pain, in comparison to placebo or control interventions. The EMBASE, Web of Science, Cochrane Library, and MEDLINE via PubMed databases were searched for randomized controlled trials (RCTs) using topical interventions in adults diagnosed with TMD. The pain intensity was the primary outcome, and other clinical findings were the secondary outcomes. The risk of bias was evaluated according to the Cochrane's handbook. The search up to February 7, 2020 identified a total of 496 unduplicated references. Nine RCTs with 355 adult patients diagnosed with TMD were included. The meta-analysis did not show a significant reduction in baseline pain intensity in the nonsteroidal anti-inflammatory drug (NSAIDs) group, when compared to the placebo group (P = 0.288). One study demonstrated a statistically significant pain score decrease for Theraflex-TMJ compared to placebo after 10 d of treatment (P = 0.003) and follow-up, 5 d after the last application (P = 0.027). Ping On reduced pain at 4 weeks of application (P < 0.001) but not after 7 d of application (P = 0.136). In one study, cannabidiol (CBD) significantly improved the pain intensity compared to placebo (P < 0.001). However, no differences were found with capsaicin in the two studies (P = 0.465). Evidence was of low quality because the studies were considered as having an unclear or a high risk of bias and a small number of studies were analyzed. The evidence is not sufficient to support the use of topical NSAIDs and capsaicin, and limited evidence was found for Threraflex-TMJ, bee venom, Ping On, and CBD, with only one study reporting for each. Additional studies are recommended to validate these results.

Efficacy of cannabis-based medications compared to placebo for the treatment of chronic neuropathic pain: a systematic review with meta-analysis

  • Sainsbury, Bradley;Bloxham, Jared;Pour, Masoumeh Hassan;Padilla, Mariela;Enciso, Reyes
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제21권6호
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    • pp.479-506
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    • 2021
  • Background: Chronic neuropathic pain (NP) presents therapeutic challenges. Interest in the use of cannabis-based medications has outpaced the knowledge of its efficacy and safety in treating NP. The objective of this review was to evaluate the effectiveness of cannabis-based medications in individuals with chronic NP. Methods: Randomized placebo-controlled trials using tetrahydrocannabinol (THC), cannabidiol (CBD), cannabidivarin (CBDV), or synthetic cannabinoids for NP treatment were included. The MEDLINE, Cochrane Library, EMBASE, and Web of Science databases were examined. The primary outcome was the NP intensity. The risk of bias analysis was based on the Cochrane handbook. Results: The search of databases up to 2/1/2021 yielded 379 records with 17 RCTs included (861 patients with NP). Meta-analysis showed that there was a significant reduction in pain intensity for THC/CBD by -6.624 units (P < .001), THC by -8.681 units (P < .001), and dronabinol by -6.0 units (P = .008) compared to placebo on a 0-100 scale. CBD, CBDV, and CT-3 showed no significant differences. Patients taking THC/CBD were 1.756 times more likely to achieve a 30% reduction in pain (P = .008) and 1.422 times more likely to achieve a 50% reduction (P = .37) than placebo. Patients receiving THC had a 21% higher improvement in pain intensity (P = .005) and were 1.855 times more likely to achieve a 30% reduction in pain than placebo (P < .001). Conclusion: Although THC and THC/CBD interventions provided a significant improvement in pain intensity and were more likely to provide a 30% reduction in pain, the evidence was of moderate-to-low quality. Further research is needed for CBD, dronabinol, CT-3, and CBDV.

Comparison of pretreatment gabapentin and pregabalin to control postoperative endodontic pain - a double-blind, randomized clinical trial

  • Verma, Jayeeta;Verma, Sidharth;Margasahayam, Sumanthini V
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제22권5호
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    • pp.377-385
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    • 2022
  • Background: Postoperative endodontic pain is an enigma for the dentist. This study aimed to evaluate the analgesic effect of 300 mg gabapentin or 75 mg pregabalin in reducing postoperative endodontic pain compared with a placebo. Methods: Ninety patients who needed root canal treatment with an initial numerical rating scale (NRS) pain score of > 4 (T0) were randomly divided into three groups (n=30). Patients were then administered either 300 mg gabapentin (group A), 75 mg pregabalin (group B), or a placebo (group C) 30 min prior to the start of endodontic treatment. A single operator performed single-visit endodontics, and pain was evaluated immediately after endodontic treatment (T1) and at 4 h (T2), 8 h (T3), 12 h (T4), 24 h (T5), 48 h (T6), and 72 h (T7) using the NRS. Ibuprofen/paracetamol (400 mg/325 mg) was administered as a rescue dose if needed. Results: Pregabalin performed significantly better when compared with gabapentin at all time points except at 72 h after treatment (P=0.170). The placebo group showed significantly higher pain scores than the other two groups. The percentage of pain relief was maximum for pregabalin (92.1%), followed by gabapentin (87.6%) and placebo (69.1%) at 72 h after treatment completion. Conclusion: This study showed that pretreatment with a single dose of pregabalin and gabapentin both had greater analgesic effects than a placebo. They can be effectively used to reduce postoperative endodontic pain.