• 제목/요약/키워드: Placebo Effect Analysis

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The Effect of Metformin on Antipsychotic-induced Weight Gain in Patients with Schizophrenia or Schizoaffective Disorder: A Systematic Review and Meta-analysis of Randomized Placebo-Controlled Trials (조현병 및 조현정동장애 환자에서 항정신병약물에 의한 체중증가에 미치는 메트포르민의 영향: 체계적 문헌고찰 및 메타분석)

  • Sin, Hye Yeon;Chun, Pusoon
    • Korean Journal of Clinical Pharmacy
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    • 제28권3호
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    • pp.204-215
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    • 2018
  • Background: In this systematic review and meta-analysis, the effect of metformin on weight loss was assessed to determine whether metformin should be recommended for the prevention or treatment of weight gain in patients receiving antipsychotic medication for the treatment of schizophrenia or schizoaffective disorder. Methods: The PubMed, Embase, and Cochrane Library databases were searched for all published randomized controlled trials (RCTs) from inception to June 2018. In addition, the references of relevant articles were also examined. Using Review Manager 5, the pooled estimates of the weighted mean difference (WMD) of the changes in body weight and body mass index (BMI) and the corresponding 95 % confidence intervals (CIs) were calculated. Results: The meta-analysis included 15 RCTs. The pooled analysis showed that compared with placebo, metformin led to significant reductions in body weight (WMD: -2.09, 95% CI: -2.59, -1.60; p<0.00001) and BMI (WMD: -0.90, 95% CI: -1.08, -0.72; p<0.00001). The effect of metformin on weight loss was greater in patients receiving olanzapine than in patients receiving clozapine (body weight, WMD: -2.39, 95% CI: -3.76, -1.02; p=0.0006 for olanzapine; -1.99, 95% C: -3.47, -0.51; p=0.009 for clozapine; BMI, WMD: -1.15, 95% CI: -1.74, -0.57, p=0.0001 for olanzapine; WMD: 0.76, 95% CI: -1.23, -0.28; p=0.002 for clozapine). Conclusion: Metformin can be recommended to manage olanzapine-induced weight gain in patients with schizophrenia or schizoaffective disorder. The magnitude of the reductionss in body weight and BMI implieds that the use of metformin to attenuate olanzapine-induced weight gain can minimize the risk of coronary heart disease.

Clinical Study of Cream Containing Pueraria mirifia for Skin Elasticity (Pueraria mirifica 추출물 함유 화장품의 피부 탄력 임상 효능 평가)

  • Kim Bora;Jung Sung Won;Lee Joo Dong;Ryoo Hee Chang;Cherdshewasart Wichai
    • Journal of the Society of Cosmetic Scientists of Korea
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    • 제30권3호
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    • pp.385-388
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    • 2004
  • Recently, along with the remarkable increase in interest in natural products, the application of phytoestrogens in anti-aging products has become very important. In the focus, we developed Pueraria mirifica (PM), in this in vivo study on skin elasticity and wrinkles, and investigated the anti-aging properties. Thirty healthy women volunteers, between the ages of 30 and 60, applied the cream formula with $4\% Pueraria mirifica or placebo, on the face area twice a day for 16 weeks. The evaluation was made by silicon replica analysis, Cutometer SEM 575 and Comeometer followed by statistical treatment using the student's t-test. Results of skin elasticity measurement showed that topical application on the skin increased the total surface of skin elasticity in comparison with placebo group (p<0.05). However, PM cream does not have prominent effect on the depth of wrinkles and skin moisturization. This in vivo study demonstrates that, PM exhibits a significant effect on skin elasticity therefore, is of great interest in anti-aging and firmness skin care products.

Meta-analysis of Change in Weight and Heart Rate for Phentermine in Obesity (비만환자의 펜터민 복용에 따른 체중과 심박수 변화에 대한 메타분석)

  • Woo, Yeonju;Jeong, Hyomi
    • Journal of health informatics and statistics
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    • 제43권4호
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    • pp.290-299
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    • 2018
  • Objectives: This study aimed to evaluate the change in weight and heart rate associated with the use of phentermine through meta-analysis based on the published literatures. Methods: Eight electronic databases, PubMed, EMBASE, Cochrane library, and five domestic databases were used to search the literature. Randomized controlled trials that evaluated the change in weight and heart rate with the use of phentermine compared with placebo were included in this study. The fixed-effect model weighted by the Mantel-Haenszel method was used in the meta-analysis, and the random-effects model was used when heterogeneity was present. Results: We included 12 studies comprising 677 patients. The change in weight observed with the use of phentermine (SMD = -1.37, 95% CI: -1.55, -1.19) was statistically significant compared with that observed with placebo. As per the subgroup analysis results, the change in weight by publication year, country, phentermine dosage, follow-up check was not heterogeneous. The change in heart rate observed with the use of phentermine (SMD = 0.64, 95% CI: 0.35, 0.92) was significant compared with that observed with placebo. Conclusions: Weight loss and increased heart rate were confirmed in phentermine compared with placebo.

Age of Postmenopause Women: Effect of Soy Isoflavone in Lipoprotein and Inflammation Markers

  • Barrasa, Gladys Roxana Rocha;Canete, Natalia Gonzalez;Boasi, Luis Emilio Valladares
    • Journal of Menopausal Medicine
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    • 제24권3호
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    • pp.176-182
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    • 2018
  • Objectives: Menopause is associated with adverse metabolic changes in plasma lipoprotein and inflammation markers. Estrogens have beneficial effects on lipid metabolism and inflammation. Isoflavones (ISO) have structurally similar to estradiol. Our objective was analize the effect of soy-ISO on serum lipid and inflammatory markers (sP-selectin and sCD40L) in postmenopausal women. Methods: A 12-week randomized, double-blind, placebo-controlled intervention with soy-ISO (50 mg, twice daily) was conducted in 35 healthy postmenopausal women (55-72 years old). The women were divided in 2 groups: 20 were allocated to soy-ISO, and 15 to a placebo group. Results: The changes of total cholesterol (TC), triglycerides, low-density lipoproteins-cholesterol (LDL-C), high-density lipoprotein-cholesterol, Apo-A1, sP-selectin and sCD40L in 2 groups before and after 12-week treatment showed no statistical significance. In subgroup analysis, soy-ISO supplementation significantly decreased the levels of TC, LDL-C and sCD40L in women under 65 years old, and with null effects on serum lipid and inflammation markers in women over 65 years old. Conclusions: Soy-ISO did not significantly favorable effects on the lipid profile and inflammatory markers in postmenopausal women. However, in women under 65 years of age, soy-ISO significantly decreased the TC, LDL-C and sCD40L, whereas, no effects on lipid profile and inflammation markers in women over 65 years old were observed.

Systematic Review on Herbal Treatment for Obesity in Adults (성인비만의 한약치료 임상연구에 대한 체계적 고찰)

  • Han, Kyungsun;Lee, Myeong-Jong;Kim, Hojun
    • Journal of Korean Medicine Rehabilitation
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    • 제26권4호
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    • pp.23-35
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    • 2016
  • Objectives This systematic review is to support the effectiveness of herbal medicine for the treatment of simple obesity in adults. Methods A total of 8 electronic databases were searched in English, Chinese and Korean. Standard methodologies for the systematic review were used to search, analyze and synthesize data based on NECA's guideline for undertaking systematic review and meta-analyses for intervention. Results After screening 1781 potential articles, we identified 13 randomized controlled trials (RCTs). We conducted a meta-analysis for the study using Bangpungtongsung-san and Taeeumjowi-tang to evaluate the effectiveness of herbal medicines on weight loss compared to placebo control. Both herbs showed positive effect in weight, body mass index and waist circumference. In an analysis comparing herbal effects considering constitutions showed that proper treatment can lower adverse events. Conclusions Our results provide evidence that herbal medicine can be an effective treatment for the obesity compare to placebo or to conventional medicine without serious adverse events. Further study is needed to evaluate effectiveness of herbal medicines considering personalized treatment and its safety.

THE THERAPEUTIC EFFECT OF SILVER NANOCRYSTALLINE OINTMENT ON TMJ CAPSULITIS (은 나노 연고가 측두하악관절낭염의 환자의 치료에 미치는 영향에 관한 연구)

  • Chae, Chang-Hoon;Kim, Jwa-Young;Kim, Mi-Ja;Chung, Hoon;Kim, Seung-Ho;Oh, Hyun-Woo;Kim, Young-Nam;Kim, Young-Il;Yang, Byung-Ho;Kim, Seong-Gon
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • 제32권3호
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    • pp.262-266
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    • 2006
  • The silver nanocrystalline is widely used for biological field because of its biocompatibility and anti-microbial effect. The objective of this study was to evaluate the therapeutic efficacy of the silver nanocrystalline ointment on the temporomandibular joint (TMJ) capsulitis. Total 39 patients were included in this study and all patients were received single topical application of the silver nanocrystalline ointment (group A, n=30) or placebo ointment (group B, n=19). Measured variables were maximum mouth opening (MMO), visual analog scale (VAS) for pain, and VAS for function. In results, we could not assess any therapeutic efficacy of single application in the chronic TMJ capsulitis (p>0.05). However, the single application of silver nanocrystalline ointment showed significant improvement in MMO and VAS for pain compared to placebo effect in the acute TMJ capsulitis (p<0.05). We could not find any complications related to ointment application in both groups. In conclusion, the single application of silver nanocrystalline ointment was effective in improving patient's symptom in acute TMJ capsulitis without any noticing complications.

Review on the effect of acupuncture on Parkinson's disease over the last 5 years (파킨슨병의 침 치료 효과에 대한 최신 연구 동향 고찰 - 최근 5년간의 임상 연구를 중심으로 -)

  • Kim, Seo-Young;Lim, Young-Woo;Kim, Eunjoo;Park, Seong-Uk
    • The Journal of Korean Medicine
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    • 제43권1호
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    • pp.112-135
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    • 2022
  • Objectives: The objective of this study was to summarize clinical studies conducted over the last five years that investigated the effect of acupuncture on Parkinson's disease and to propose a better process of study. Methods: Research Information Sharing Service (RISS), Korea Studies Information Service (KISS), Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, and China National Knowledge Infrastructure (CNKI) were systemically searched for clinical trials that had investigated the effect of acupuncture on the course of Parkinson's disease from May 2016 to April 2021. Results: A total of 23 studies met all the inclusion criteria. In most reports, acupuncture had significant positive effects on the course of Parkinson's disease. Furthermore, there were no serious adverse events associated with acupuncture in any of the studies. In addition to the acupuncture methods that showed effectiveness in previous studies, various types of acupuncture have been used to treat sub-symptoms of Parkinson's disease. The outcome measures were subdivided through individual symptom evaluation and mechanical analysis. Follow-up assessments were also performed to analyze the continuous effect. Conclusion: In the clinical studies conducted over the last five years, many studies investigated the various types of acupuncture used to treat Parkinson's disease and the segmentation and diversification of outcome measures focusing on individual symptoms, and a new approach for excluding placebo effects through follow-up studies has been made. Further attempts like these are needed to overcome methodological flaws in studies on the effects of acupuncture on Parkinson's disease.

Research on Immune Enhancing Effect and Safety of Wasong (Orostachys japonicus) Extract: Study Protocol for a Single Center, Randomized, Double-blind, Placebo-controlled, Clinical Trial (와송 추출물의 면역기능 개선 효과 및 안전성 연구: 단일기관, 무작위배정, 이중눈가림, 위약대조 비교, 임상연구 프로토콜)

  • Choi, Jin Yong;Choi, Jun Yong;Lim, Hyun Woo;Kim, Jeong;Kim, So Yeon;Han, Chang Woo
    • Herbal Formula Science
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    • 제25권2호
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    • pp.135-143
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    • 2017
  • Objectives : This trial aimed to determine if Wasong (Orostachys japonicus) extract can enhance immune system and is safe enough to be approved as a health functional food. Methods : Total 62 people, aged 45 and older, will be recruited to participate in a randomized, double-blind, placebo-controlled clinical trial. This study will compare Wasong extract and placebo. Wasong group will take 1g of Wasong extract, once a day, for 8 weeks. Placebo group will take 1g of crystalline cellulose as placebo, once a day, for 8 weeks. Outcomes will be measured at the baseline, the end of 4th week, and 8th week. Primary outcomes are the ratio of NK cells/total lymphocytes and the ratio of T-helper cells/T-suppressor cells. Secondary outcomes are total white blood cell count, the ratio of neutrophils, lymphocytes, and monocytes in total leukocytes, the ratio of total T cells, T-helper cells, T-suppressor cells, and B cells to lymphocytes, the amount of blood IgM, IgG, IgA, and cytomegalovirus (CMV) IgG, and blood metabolite target &global analysis. Results : This trial was approved by institutional review board of Pusan National University Korean Medicine Hospital (registry number: 2016006), and registered in Clinical Research information Service, one of WHO International Clinical Trials Registry Platform (registry number: PRE20161006-002). Recruitment opened in February 2017 and is supposed to be completed by August 2017. The result is expected to be published by June 2018. Conclusion : This trial will provide clinical information to determine the efficacy and safety of Wasong in enhancing immune system of middle-aged and older people.

Effect of intravenous ascorbic acid administration on fatigue after laparoscopic myomectomy: A randomized, double-blind, placebo-controlled trial (복강경 자궁근종절제술을 받은 여성에서 정맥 내 아스코르브산 투여가 피로에 미치는 영향: 무작위 배정 양측맹검 위약대조 임상시험)

  • Hwang, Woo Yeon;Kim, Kidong
    • Journal of the Korea Academia-Industrial cooperation Society
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    • 제22권2호
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    • pp.434-439
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    • 2021
  • We assessed the effects of intravenous (IV) ascorbic acid administration on fatigue in women undergoing laparoscopic myomectomy. We analyzed the secondary endpoint results of a randomized, double-blind, placebo-controlled trial. Fifty patients undergoing laparoscopic myomectomy received IV ascorbic acid (2g) or placebo (randomly 1:1 ratio) intravenously during surgery. On day 2 post-surgery, we measured the level of fatigue using the Brief Fatigue Inventory-Korean version. Forty-five women (experimental arm 23, control arm 22) were eligible for analysis after 5 women (experimental arm 2, control arm 3) were excluded due to withdrawal of consent, cancellation of surgery or non-measurement of the endpoints. The baseline and operative characteristics were similar between arms and the global fatigue score of the experimental arm (4.56 ± 2.63) was not significantly different from that of the control arm (5.21 ± 2.02, P = 0.351). However, the fatigue score of the experimental arm tended to be lower than that of the control arm in most domains. IV ascorbic acid administration did not significantly reduce the level of fatigue in women undergoing laparoscopic myomectomy as compared to placebo. More research is needed to better understand the effects of ascorbic acid on fatigue in surgical patients.

Effect of Kyungohkgo on Aerobic Capacity and Anti-fatigue in High School Soccer Players (경옥고 섭취가 고등학교 축구선수의 운동수행능력 향상 및 피로 회복에 미치는 영향)

  • Kim, Dong-Gun;Park, Won-Hyung;Cha, Yun-Yeop
    • Journal of Physiology & Pathology in Korean Medicine
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    • 제25권5호
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    • pp.934-944
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    • 2011
  • This study was designed to investigate the effects of Kyungohkgo to improve aerobic capacity and eliminate exercise-induced fatigue in high school soccer players. Twenty four subjects were participated and randomly assigned into two groups [KG, Kyungohkgo group (n=12); PG, Placebo control group (n=12)]. Two groups were completed treadmill exercise protocol using graded exercise test at before and after experimental treatment of 4 weeks. The $VO_2$max and endurance time were measured by gas analysis and heart rate (HR) was measured by polar system at pre, post 0, post 5, post 15, post 30 and post 60 minutes. Blood samples were collected to analyze blood components. 1. The $VO_2$max was significant increased in the group of after intake Kyungohkgo compared to the group of after intake placebo (p<.05). 2. The HR was significant decreased in the group of after intake Kyungohkgo compared to the group of after intake placebo during recovery time at post 5 mins(p<.05), 30 mins(p<.01), 60 mins(p<.01). 3. Weight, body mass index, percent body fat, anaerobic threshold, endurance time, blood lactate concentrate, lactate dyhydrogenase, creatine kinase, serum glutamic oxaloacetic transaminase, serum glutamic pyruvic transaminase, other energy sources(total-cholesterol, triglyceride, high density lipoprotein-cholesterol, low density lipoprotein-cholesterol, creatinine) and electrolyte (Na, K, Cl) were shown no significant differences between groups. These results suggested that Kyungohkgo can be used as ergogenic aids to improve aerobic capacity and eliminate exercise-induced fatigue.