• Title/Summary/Keyword: Placebo-controlled study

Search Result 353, Processing Time 0.022 seconds

The Effects of Acupuncture Treatment on Hwa-byung patient's Insomnia: Patient-assessor blind, Randomized, Placebo-controlled Clinical trial (화병환자의 불면증상에 대한 침치료 유효성 평가연구: 환자-평가자 눈가림, 무작위배정, 일반대조군 임상시험)

  • Lee, Go-Eun;Kim, Nam-Kwon;Kim, Hang-Yi;Kang, Hyung-Won
    • Journal of Oriental Neuropsychiatry
    • /
    • v.23 no.1
    • /
    • pp.31-48
    • /
    • 2012
  • Objectives: The purpose of this research is to examine the effects of acupuncture treatment on Hwa-byung patient's insomnia. Methods: The study was performed through a patient-assessor blind, randomized, placebo-controlled trial in which the volunteers, data collectors and analysts were unaware of individuals who were receiving the treatment. A total of thirty-seven volunteers were divided into 2 groups. 18 subjects were placed into a trial group and 19 subjects into a control group by a randomization table. The trial group was treated on bilateral Shigu, Ahnmyun, B62 (Shinmaek), and K6 (Chohae), while the control group was not given any other treatment. The ISI(Insomnia Severity Scale) was measured as the 1st evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by a Likert scale for major symptoms of Hwa-byung, PSQI, Hwa-byung scale, BDI, STAI, and STAXI. Results: In the ISI, PSQI, and the Likert scale regarding major symptoms of Hwa-byung, Hwa-byung scale, BDI, and STAI, more significant decreases were found in those concerning the trial group compared to those of the control group from a statistical perspective. However, in the STAXI, regarding the trial group, there was no significant decrease compared to the control group. Conclusions: The results suggest that acupuncture treatment is effective in the treatment regarding Hwa-byung patients who suffer from insomnia.

Citalopram and Escitalopram for Management of Hot Flashes: A Review of Recent Clinical Trials in Humans (Citalopram과 Escitalopram의 안면홍조 증상개선효과에 대한 최근 연구 고찰)

  • Lee, Yu-Jeung
    • Korean Journal of Clinical Pharmacy
    • /
    • v.21 no.4
    • /
    • pp.376-382
    • /
    • 2011
  • The results from eight clinical studies demonstrate that citalopram and escitalopram could be an effective option in the treatment of hot flashes with tolerable adverse effects. However, there are limitations in the above studies. The inclusion criteria of 2 studies reviewed in this paper was breast cancer patients, so it's hard to apply the results to the general population in clinical practice. Also 4 studies had less than 50 subjects included, and the duration of study was 8 weeks or less in 7 studies reviewed in this paper. Moreover, only 4 studies were randomized, placebo-controlled trials (3 for citalopram and 1 for escitalopram). Therefore, further randomized, double-blind, placebo-controlled studies with the general population should be needed to use citalopram and escitalopram for the treatment of hot flashes in clinical practice.

Effects of Antioxidant Nutrient Supplementation on the Lipid Peroxidation and Antioxidative Enzyme Activities in Patients with Coronary Heart Disease

  • Joung, Hyojee;Chun, Byung Yeol;Choi, Young Sun;Kim, Sueun;Park, Wee Hyun;Jun, Jae Eun;Chae, Shung Chull;Song, Kyung Eun;Cho, Sung Hee;Oh, Hee Sook
    • Preventive Nutrition and Food Science
    • /
    • v.6 no.1
    • /
    • pp.51-56
    • /
    • 2001
  • This study was carried out to evaluate whether antioxidant nutrient suppplementation with $\alpha$-tocopherol, vitamin C, $\beta$-carotene, and selenium reduces the lipid peroxide levels and increases the antioxidative enzyme activities in patients with coronary hart disease. Eighty nine patients participated in a randomized, double-blind, placebo-controlled trial. The antioxidant group (45 patients) was given daily doses of $\alpha$-tocopherol (400 IU), vitamin C (50 mg), $\beta$-carotene (15 mg), and selenium (50 $\mu\textrm{g}$) and forty four patients received a placebo. Thirty eight subjects (84.4%) of the antioxidant group and thirty nine subjects (88.6%) of the placebo group completed the three-month supplementation. Serum levels of tocopherol, vitamin C and $\beta$-carotene significantly increased in the antioxidant group compared with the baseline (p<0.05). Thiobarbituric acid-reactive substances(TBARS) decreased significantly (0.6 nmol MDA/mL) in the antioxidant group compared with that (0.09 nmol MDA/mL) in the placebo group (p=0.03). However, antioxidant supplementation did not affect the level of oxidized-LDL measured as autoantibodies against oxidized-LDL. The superoxide dimutase activity in red blood cells increased in the antioxidant group compared with the baseline (p<0.05). However, glutathione peroxidase activities did not change after supplementation in both groups, and catalase activity significantly decreased in the placebo group (p<0.05). These results suggest that antioxidant supplementation for 3 months with $\alpha$-tocopherol, vitamin C, $\beta$-carotene and selenium in patients with coronary heat disease may be partially protective against oxidative stress.

  • PDF

Effect of Korean Red Ginseng on Sleep : A Randomized, Placebo-Controlled Trial (고려 홍삼이 수면의 질에 미치는 영향 : 무작위 위약-대조군 연구)

  • Lee, Sun-Ah;Kang, Seung-Gul;Lee, Heon-Jeong;Jung, Ki-Young;Kim, Leen
    • Sleep Medicine and Psychophysiology
    • /
    • v.17 no.2
    • /
    • pp.85-90
    • /
    • 2010
  • Objectives: Ginseng has a long history of being used in insomnia treatment and there is some evidence from animal studies of its sleep-enhancing property. From this, it can be assumed that ginseng has sleep-promoting effect in humans. The purpose of this study was to investigate the effect of Korean red ginseng on change of sleep architecture in humans. Methods: A total of 20 healthy young males with regular sleep and wake habits and without any psychiatric nor cognitive problems were selected based on review of sleep questionnaires and sleep diaries they completed followed by an interview with a board-certified psychiatrist. The subjects were randomly assigned to red ginseng or placebo for 2 weeks of trial. The total daily dose of ginseng was 4,500 mg. The polysomnographic recordings were made at baseline and at 2 weeks after. The effects of red ginseng and placebo on sleep were assessed by comparing the changes in polysomnographic variables between the two groups. Results: A total of 15 subjects, 8 from red ginseng group and 7 from placebo group, were included to undergo polysomnographic procedures. The red ginseng group showed tendencies to increase stage 3 sleep (p=0.087) and to decrease stage 2 sleep (p=0.071) from the baseline compared with the placebo group. Conclusion: Korean red ginseng tends to increase deep sleep and decrease shallow sleep. Our result is in line, at least in part, with previous findings that Korean red ginseng increased total and NREM sleep in rats. Further studies with higher ginseng dosage, larger sample size and longer trial duration should be conducted to confirm the sleep stabilizing and balancing effects of Korean red ginseng.

  • PDF

Efficacy and Safety of Gabapentin in the Treatment of Chronic Cough: A Systematic Review

  • Shi, Guanglin;Shen, Qin;Zhang, Caixin;Ma, Jun;Mohammed, Anaz;Zhao, Huan
    • Tuberculosis and Respiratory Diseases
    • /
    • v.81 no.3
    • /
    • pp.167-174
    • /
    • 2018
  • Despite recent clinical guidelines, the optimal therapeutic strategy for the management of refractory chronic cough is still a challenge. The present systematic review was designed to assess the evidence for efficacy and safety of gabapentin in the treatment of chronic cough. A systematic search of PubMed, Embase, Cochrane Library databases, and publications cited in bibliographies was performed. Articles were searched by two reviewers with a priori criteria for study selection. Seven relevant articles were identified, including two randomized controlled trials, one prospective case-series designed with consecutive patients, one retrospective case series of consecutive patients, one retrospective case series with unknown consecutive status, and two case reports comprising six and two patients, respectively. Improvements were detected in cough-specific quality of life (Leicester Cough Questionnaire score) and cough severity (visual analogue scale score) following gabapentin treatment in randomized controlled trials. The results of prospective case-series showed that the rate of overall improvement of cough and sensory neuropathy with gabapentin was 68%. Gabapentin treatment of patients with chronic cough showed superior efficacy and a good safety record compared with placebo or standard medications. Additional randomized and controlled trials are needed.

Meta-analysis of the Efficacy of Sorafenib for Hepatocellular Carcinoma

  • Wang, Zhao;Wu, Xiao-Ling;Zeng, Wei-Zheng;Xu, Gui-Sen;Xu, Hui;Weng, Min;Hou, Juan-Ni;Jiang, Ming-De
    • Asian Pacific Journal of Cancer Prevention
    • /
    • v.14 no.2
    • /
    • pp.691-694
    • /
    • 2013
  • Purpose: By carrying out a meta-analysis of randomized controlled trials that compared sorafenib or combined chemotherapy with placebo or combined chemotherapy, the effectiveness of sorafenib in hepatocellular carcinoma was evaluated in the present study, which also provided clinical practice guidelines of evidence-based-medicine. Methods: We reviewed PubMed citations concerning sorafenib treating hepatocellular carcinoma in randomized controlled trials from Jan 2000 to July 2012. All the literature was extracted by Cochrane systematic reviews and underwent meta-analysis with RewMan 5.0 software. Results: Finally, four papers documenting randomized controlled studies were included. Compared with controls, sorafenib was shown to significantly increase overall survival (OS), time to progression (TTP), and disease control rates (DCR), but not the time to symptom progression (TTSP) in hepatocellular carcinoma patients. The incidence of grade-III/IV adverse reactions, including hand-foot-skin reactions, diarrhea, hypertension and skin rash or desquamation, in sorafenib treatment group was higher than that in controls. However, there was no significant difference in the incidence of hypodynamia between the two groups. Conclusions: Sorafenib exerts significant curative effects in hepatocellular carcinoma.

Study of Complementary Medical Therapy for Allergic Rhinitis in PubMed (PubMed를 통해 살펴 본 알레르기 비염에 대한 보완 의학적 최신 연구 경향)

  • Jung, Hye-Mi;Cho, Min-Jung;Seo, Un-Kyo
    • The Journal of Internal Korean Medicine
    • /
    • v.30 no.3
    • /
    • pp.534-549
    • /
    • 2009
  • Objectives : To study trends in complementary medical therapy for the allergic rhinitis. This study analyzed research on allergic rhinitis in PubMed. Methods : We searched PubMed related to complementary medical therapy for allergic rhinitis. We analyzed 25 research papers and examined published journals, years countries, and their methods, objectives, results, interventions, participants, periods and instruments of assessment. Results : The method of studies was mostly randomized, double-blind, placebo-controlled trial. There were research papers concerning treatment and prevention with herbal medicine, acupuncture, diet, etc. There were more positive results compared to negative results for treatment and prevention. Most studies were carried out during the winter/spring period. The median for number of participants was 90.54 persons. Diagnostic criteria for enrolment were nasal symptoms, allergic skin test, serum, nasal discharge allergen specific IgE eosinophil, etc. Assessment for outcomes were nasal symptoms, serum, nasal discharge allergen specific IgE eosinophil and Quality of Life Questionnaire. Conclusions : It is necessary to study effects of acupuncture and herb medicines for allergic rhinitis and more in-depth research about trends in complementary medical therapy for allergic rhinitis.

  • PDF

Changes in Lymphocyte DNA Damage and Antioxidant Status after Supplementing Propolis to Korean Smokers: A Placebo-Controlled, Double-Blind Cross-Over Trial (프로폴리스 섭취 후 흡연자의 임파구 DNA 손상도 및 항산화 상태의 변화: 이중맹검 교차 인체시험)

  • Kang, Myung-Hee;Lee, Hye-Jin;Kim, Mi-Kyung;Sung, Mi-Kyung;Kwon, O-Ran;Park, Yoo-Kyoung
    • Journal of Nutrition and Health
    • /
    • v.42 no.5
    • /
    • pp.442-452
    • /
    • 2009
  • Smoking has been known to exacerbate the initiation and propagation of oxidative stresses. Efforts have been made to reduce the smoking-induced oxidative stresses using commercial dietary supplements. Propolis is the resinous substance collected by bees from the leaf buds and bark of trees, especially poplar and conifer trees. In this trial, we examined whether a daily supplementation of 800 mg propolis can protect endogenous lymphocytic DNA damage and modulate antioxidative enzyme activities and the level of antioxidant vitamin in smokers using a placebo-controlled, doubleblinded cross-over trial. After two weeks of running-in period, 29 smokers (mean age 34.38 ${\pm}$ 1.73) received 6 tablets/day of either propolis or placebo pills for 4 weeks. After 2 weeks of washout period the subjects switched they pills for cross-over study. The degree of DNA damage (assessed by tail DNA, tail length and tail moment) was not significantly changed with propolis intake or placebo intake. Similarly, total antioxidant status (TAS) remained at the same level regardless of the treatment. Erythrocyte catalase, glutathione peroxidase (GSH-Px), superoxide dismutase (SOD), plasma vitamin C and tocopherol level did not differ before and after propolis treatment, and did not differ between treatments. Putting all these results together, we would suggest that it is still too early to claim that propolis possess antioxidative activities.

The Effects of Evodia Rutaecarpa and Ephedra Sinica on the Resting Metabolic Rate and Body Composition of Obese Women on a Low-Calorie Diet: A Double-blinded Randomized Controlled Clinical Trial (오수유와 마황이 저열량식이요법을 병행한 비만여성환자의 체구성성분 및 휴식대사량에 미치는 영향)

  • Park Jung-Mi;Kim Ho-Jun;Kim Jin-Ah;Kim Su-Jin;Ko Byeong-Pyo
    • The Journal of Korean Medicine
    • /
    • v.26 no.3 s.63
    • /
    • pp.249-262
    • /
    • 2005
  • Backgrounds : As obesity prevails as an epidemic. diet programs including low-calorie diets are developed continuously. It is generally believed that a low-calorie diet is commonly followed by resting metabolic rate decrease and ultimate weight regain. Ephedra and Evodia are known to have sympathomimetic and anti-obesity effect. Objectives : This study was a prospective, double-blinded, randomized md placebo-controlled clinical trial to evaluate the effects of Ephedra sinica and Evodia rutaecarpa on resting metabolic rate (RMR), weight, body composition, and short-term safety in obese women on low-calorie diet. Methods : 125 otherwise healthy obese women (body mass Index ${\geq}\;25kg/m^2$) were recruited and randomly assigned to three groups: Ephedra group (n=41), Evodia group (n =45), and placebo group (n=39). Subjects were administered Ephedra extract in capsules (pseudo-ephedrine 31.52mg) or Evodia extract in capsules (evodiamine 6.75mg, rutaecarpine 0.66mg) or placebo capsules as well as participating in a low-calorie diet for 8 weeks, Resting metabolic rate and body composition were measured at baseline,4 and 8 weeks. Basic serum exams were performed to evaluate the short-term safety of the herbs and changes of lipid variables. Results : All three groups showed significant BMI decreases probably due to low-calorie diet. Among them, the Ephedra group manifested most prominent BMI-reducing effect and towered total cholesterol and triglycerides significantly. The RMR was not changed during the 8-week diet in all groups. No significant difference among the groups was found in RMR, either. Stbject with higher RMR than the mean at the baseline showed a tendency to keep their RMR more stable during the diet program. Conclusions : Ephedra with a low-calorie diet was effective in reducing BMI. RMR change was not compensated by herbal medicines. RMR change seemed to be affected rather by constitution and body composition than medicine. Ephedra and Evodia were proven to be safe for sort-term use in herbal form. Especially, Ephedra was effective in lowering total cholesterol and triglycerides during the 8 weeks.

  • PDF

Efficacy of ketamine in the treatment of migraines and other unspecified primary headache disorders compared to placebo and other interventions: a systematic review

  • Chah, Neysan;Jones, Mike;Milord, Steve;Al-Eryani, Kamal;Enciso, Reyes
    • Journal of Dental Anesthesia and Pain Medicine
    • /
    • v.21 no.5
    • /
    • pp.413-429
    • /
    • 2021
  • Background: Migraine headaches are the second leading cause of disability worldwide and are responsible for significant morbidity, reduction in the quality of life, and loss of productivity on a global scale. The purpose of this systematic review and meta-analysis was to evaluate the efficacy of ketamine on migraines and other primary headache disorders compared to placebo and other active interventions, such as midazolam, metoclopramide/diphenhydramine, and prochlorperazine/diphenhydramine. Methods: An electronic search of databases published up to February 2021, including Medline via PubMed, EMBASE, Web of Science, and Cochrane Library, a hand search of the bibliographies of the included studies, as well as literature and systematic reviews found through the search was conducted to identify randomized controlled trials (RCTs) investigating ketamine in the treatment of migraine/headache disorders compared to the placebo. The authors assessed the risk of bias according to the Cochrane Handbook guidelines. Results: The initial search strategy yielded 398 unduplicated references, which were independently assessed by three review authors. After evaluation, this number was reduced to five RCTs (two unclear risk of bias and three high risk of bias). The total number of patients in all the studies was 193. Due to the high risk of bias, small sample size, heterogeneity of the outcomes reported, and heterogeneity of the comparison groups, the quality of the evidence was very low. One RCT reported that intranasal ketamine was superior to intranasal midazolam in improving the aura attack severity, but not duration, while another reported that intranasal ketamine was not superior to metoclopramide and diphenhydramine in reducing the headache severity. In one trial, subcutaneous ketamine was superior to saline in migraine severity reduction; however, intravenous (I.V.) ketamine was inferior to I.V. prochlorperazine and diphenhydramine in another study. Conclusion: Further double-blind controlled studies are needed to assess the efficacy of ketamine in treating acute and chronic refractory migraines and other primary headaches using intranasal and subcutaneous routes. These studies should include a long-term follow-up and different ketamine dosages in diagnosed patients following international standards for diagnosing headache/migraine.