scholarly journals Effects of Kamishoyosan, a Traditional Japanese Medicine, on Menopausal Symptoms: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Kiyoshi Takamatsu ◽  
Mariko Ogawa ◽  
Tsuyoshi Higuchi ◽  
Takashi Takeda ◽  
Kunihiko Hayashi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hot Flashes ◽  
Study Drug ◽  
Menopausal Symptoms ◽  
Secondary Outcome ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Traditional Japanese Medicine ◽  
Significant Difference ◽  
Registration Number

Objective. Kampo medicine, a traditional Japanese medicine, is widely used in Japan, especially in the field of menopause medicine. However, few studies have shown evidence-based effects. This study aimed to confirm the effects of kamishoyosan on menopausal symptoms with a randomized, placebo-controlled, double-blind clinical trial. Methods. Subjects were randomly allocated to groups that received either kamishoyosan (n = 101) or a placebo resembling kamishoyosan (n = 104). The primary outcomes were the change in the number of hot flashes, depression scores, improvements of anxiety, quality of life (QOL), and menopausal symptoms before and 4 and 8 weeks after initiation of treatment with the study drug. The secondary outcome was drug safety. Results. After 8 weeks, the number of hot flashes decreased after treatment in both groups, but there was no significant difference between the two groups. The changes in SDS scores showed the same results. Moreover, no significant differences were observed between the two groups in assessments with the STAI, SF-36, and JSOG menopausal index. No serious adverse effect was reported. Conclusions. This first placebo-controlled double-blind randomized trial with kamishoyosan demonstrated that it was safe and had some effects on climacteric symptoms, but not significant compared with placebo. Some problems, such as placebo effects, in the study of Kampo therapy for menopausal symptoms, were revealed. This trial is registered with the trial registration number. UMIN 000006042.

scholarly journals Propranolol versus topiramate in prophylaxis of migraines among children and adolescents: a randomized, double-blind clinical trial

2017 ◽  
Vol 5 (10) ◽  
pp. 4307 ◽  
Author(s):  
Ramakant Yadav ◽  
S. K. Shukla
Keyword(s):  
Clinical Trial ◽  
Children And Adolescents ◽  
International Headache Society ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Relative Reduction ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Significant Difference ◽  
Propranolol Group

Background: Migraine is a common health problem in children and adolescents. This study compares the efficacy and safety of propranolol and topiramate in preventing migraine among children and adolescents.Methods: Seventy-six patients (10-18 years of age) with migraine without auras defined by the 2004 International Headache society criteria were included in a prospective double blind clinical trial were allocated to receive propranolol (0.5-2mg/kg per day) or topiramate (1-2mg/kg per day). The primary outcome measure was reduction in 50 % or more headache days in comparison to baseline headache frequency per month. Secondary outcome measures were headache related disability, migraine intensity and duration. Efficacy measures were recorded at the baseline and at 12 weeks of prophylactic treatment.Results: In this study total of 76 patients with mean age of 12.43 years were evaluated, 40 in the propranolol group and 36 in the topiramate group. At the 12-week, the percentage of patients who had a relative reduction of 50% or more in the number of headache days were 67.5% patients in the propranolol group and 75.0% patients in the topiramate group. The monthly migraine frequency, headache related disability, intensity and duration were significantly decreased in both the propranolol and topiramate groups when compared to the baseline. No significant difference was observed between these two groups in term of reduction of frequency, headache related disability, severity and duration of attack. Fatigue, hypotension and exercise induced asthma were main side effects in propranolol group and weight loss, fatigue and loss of appetite, paresthesias in topiramate group.Conclusions: Propranolol and topiramate were found effective and safe for the prevention of paediatric migraines.

The assessment of randomized double blind clinical trial of Shugan-liangxue prescription used for the treatment of hot flashes in breast cancer patients

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8584-8584
Author(s):  
P. Li
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Placebo Group ◽  
Sleep Disturbance ◽  
Hot Flashes ◽  
Oral Solution ◽  
Double Blind ◽  
Hot Flash ◽  
Double Blind Clinical Trial ◽  
Significant Difference

8584 Background: Hot flashes are a common side effect for breast cancer (BC) pts with TAM treatment. Traditional Chinese medicine (TCM) is typically given to BC pts in China. This trial is to assess the effects of TCM for relieving hot flashes. TCM oral solution is prescribed for clearing heat and cooling blood. The compound was tested and contained no phytoestrogen. A randomized, double blind clinical trial was designed to examine the effects of TCM over a 3-week period. Methods: From October 2004 to October 2005, 49 BC pts undergoing treatment with TAM who having hot flashes at least 3 times a day involved the study. Daily average of hot flashes was recorded by the pts for a week as a baseline. TCM or placebo liquid (100 ml) was administered orally three times a day for 3 weeks by a randomized double-blind method. The number of hot flashes and quantity of sleep disturbance in the two groups were evaluated. Results: 45 pts were evaluated in TCM group (n = 22) and the placebo group (n = 23). The severity of the hot flash symptoms was evaluated according to the Kupperman menopausal index (KI). Pts were distributed approximately equally between the two groups. There were 31% (7/22) and 26% (6/23)pts with mild hot flashes in TCM and placebo groups, and 68% (15/22) and 73% (17/23) with severe hot flashes in TCM and placebo groups. Hot flash relief was described as either symptom disappearing, a decrease from severe to mild symptoms, or no change. In TCM group, 50% showed no change, 27% decrease and 23% symptoms disappearing. In the placebo group, 70% no change, 30% decrease and no pts reporting symptoms disappearing. A statistically significant difference exists between the two groups (P < 0.05). In TCM group, 73% of pts sleep improvement compared to 35% in the placebo group (P < 0.05). No adverse events or any side effects were reported. Conclusion: The oral solution of TCM is effective in alleviating tamoxifen-induced hot flashes and sleep disturbance. The study of the drug’s mechanism and an expanded clinical trial are underway. No significant financial relationships to disclose.

scholarly journals Naoxuekang, Xinnaoshutong and Xuesaitong capsules for treating stroke: a protocol for a randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e015983 ◽  
Author(s):  
Huiling Chen ◽  
Hongbo Cao ◽  
Xu Guo ◽  
Meidan Zhao ◽  
Qing Xia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Facial Paralysis ◽  
Controlled Trial ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Initial Treatment Period ◽  
Double Blind Clinical Trial ◽  
Registration Number ◽  
Index Value ◽  
Randomised Controlled

IntroductionAfter stroke, hemiplegia, dysphasia and facial paralysis can manifest during the convalescent period. Currently, no Chinese patent medicine (CPM) is previously reported to cure each of these symptoms primarily, and thus, there are no relevant instructions for the use of CPM. This study presents a new approach based on comparative effectiveness research to distinguish the curative effects of three CPMs that are often used in stroke convalescence to determine the ideal medicine for the treatment of each symptom.Methods and analysisIn this multicentre and double-blind clinical trial, stratified randomisation is used to group the patients according to their primary symptoms (hemiplegia, dysphasia and facial paralysis). Three strata will be enrolled, with 80 eligible participants included in each stratum. Each stratum will be randomly and equally divided into four groups, and each group will receive one of the following treatments: Naoxuekang, Xinnaoshutong (XNST), Xuesaitong (XST) or placebo. This study will include two stages: the initial treatment period (30 days) and a follow-up period (180 days). Three replicates for each data point will be completed during this trial. The first visit will occur on day 0 after enrolment, the second visit on day 30±2 and the third visit on day 210±5. The Delphi technique is adopted to achieve index weighting, which ensures that the evaluation outcome is patient oriented. The weighted index value will be computed as the final measurement index of the outcome.Ethics and disseminationThis study has been approved by the Medical Ethics Committee of Tianjin University of Traditional Chinese Medicine (registration number TJUTCM-EC20160007). The results will be offered for publication in peer-reviewed journals.Trial registration numberThis trial was registered with the Chinese Clinical Trial Registry (ChiCTR-IOR-17010397). The date of registration was 11 January 2017.

Results of a randomized double-blind clinical trial of Shugan-liangxue prescription for relieving hot flashes in breast cancer patients

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9086-9086
Author(s):  
P. Li ◽  
H. Sun
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Hot Flashes ◽  
Oral Solution ◽  
Endocrine Treatment ◽  
Common Side Effect ◽  
Breast Cancer Patients ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Report Symptom

9086 Background: Hot flashes are a common side effect for BC pts during endocrine treatment. An oral solution of TCM is prescribed for the purpose of clearing heat and cooling blood. There is no phytoestrogen in TCM compound and each herbal with luciferase activity detection. 66 patients involved in the study from October 2004 to November 2006. Methods: A placebo controlled randomized double blind clinical trial was designed. The endpoint is hot flashes relieving. The second point is improving the sleeping disturbance. Sample numbers designed by statistician. Daily average of hot flashes was recorded by pts for a week as a baseline. The age, ER and PR status, hot flashes scores were distributed approximately equal between the two groups. Hot flashes scores were evaluated according to Kupperman menopausal index (KI). TCM or placebo liquid (100ml) was administrated orally three times a day for 3 weeks by a randomized envelope method. Results: Total 66 patients were evaluated. For hot flashes in placebo group 69.7%(23/33) no change, 30.3%(10/33) relieved, no pts report symptom disappear. There are 42.4%(14/33) hot flashes no change, 42.4 % (14/33) relieved, 15.2 %(5/33) hot flashes disappearance in TCM group (P=0.006). For sleeping disturbance in placebo group is 60.6%(20/33) no change, 39.4%(13/33) sleep improvement. In TCM group is 36.4%(12/33) no change, 63.6%(21/33) sleep improvement (P=0.049). Conclusions: According to the principle of TCM treatment hot flashes and ER and/or PR positive BC endocrine treatment characteristic, the TCM prescription is effective in alleviating tamoxifen-induced hot flashes and sleep disturbance while there is no phytoestrogen. No significant financial relationships to disclose.

scholarly journals Acquisition of Resistant Bowel Flora during a Double-Blind Randomized Clinical Trial of Ertapenem versus Piperacillin-Tazobactam Therapy for Intraabdominal Infections

2005 ◽  
Vol 49 (8) ◽  
pp. 3217-3221 ◽  
Author(s):  
Mark J. DiNubile ◽  
Joseph W. Chow ◽  
Vilas Satishchandran ◽  
Adam Polis ◽  
Mary R. Motyl ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Study Drug ◽  
Resistant Bacteria ◽  
Double Blind ◽  
E Coli ◽  
Double Blind Clinical Trial ◽  
Vancomycin Resistant ◽  
The Impact ◽  
Intraabdominal Infections ◽  
Study Therapy

ABSTRACT Bowel colonization with resistant bacteria can develop in patients receiving broad-spectrum antimicrobial therapy. We compared the impact of two antimicrobial regimens often used to treat intraabdominal infections on susceptibility patterns of bowel flora at the end of therapy. In a double-blind clinical trial, adults with complicated intraabdominal infection requiring surgery were randomized to receive piperacillin-tazobactam (3.375 g every 6 h) or ertapenem (1 g once a day) for 4 to 14 days. Rectal swabs were obtained at baseline and at the end of study therapy to determine the acquisition rates of Enterobacteriaceae resistant to the study drug, extended-spectrum β-lactamase (ESBL)-producing Escherichia coli or Klebsiella species, Pseudomonas aeruginosa resistant to imipenem or piperacillin-tazobactam, and vancomycin-resistant Enterococcus faecalis or Enterococcus faecium. Treated patients were assessable for the acquisition of resistant bacteria if appropriate specimens were obtained at both time points. Enterobacteriaceae resistant to the treatment received were acquired during study therapy by 8/122 assessable piperacillin-tazobactam recipients (6.6%) compared to 0/122 assessable ertapenem recipients (P = 0.007). Neither ESBL-producing E. coli or Klebsiella species nor P. aeruginosa resistant to piperacillin-tazobactam was isolated from patients in either treatment group. Imipenem-resistant P. aeruginosa was acquired by two of the ertapenem recipients (1.6%) versus zero of the piperacillin-tazobactam recipients (P = 0.50). Vancomycin-resistant enterococci were acquired during therapy by 8/125 assessable ertapenem recipients (6.4%) versus 2/123 assessable piperacillin-tazobactam recipients (1.6%; P = 0.10). In this study, the acquisition of resistant Enterobacteriaceae occurred significantly more often in patients treated with piperacillin-tazobactam than in those treated with ertapenem.

scholarly journals Delirium treatment in intoxicated patients in ICU: A randomized, double-blind clinical trial

2020 ◽  
Vol 7 (2) ◽  
pp. 93-96
Author(s):  
Javad Mesbahi ◽  
Shahin Shadnia ◽  
Hossein Hassanian-Moghaddam ◽  
Nasim Zamani ◽  
Peyman Erfan Talab Evini ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Total Sample ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Delirium Assessment ◽  
Diagnostic And Statistical Manual ◽  
Double Blind Clinical Trial ◽  
Dsm V ◽  
Significant Difference ◽  
Hospital Stays

Objective: Delirium is one of the most common complications in patients admitted to intensive care units (ICUs). Delirium is a definite cause for more extended hospital stays, higher mortality rates, and possibly persistent cognitive decline in the future. Antipsychotics have been frequently evaluated as first drugs of choice, but the most appropriate, evidence-based treatment is yet to be discovered. This study aims to compare the efficacy of haloperidol and olanzapine in patients admitted to our toxicology ICU. Methods: This double-blind, randomized controlled clinical trial was undertaken on 35 ICU admitted patients with delirium in Loghman Hakim hospital in Tehran, Iran. The diagnosis was based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for delirium, and clinical toxicologists included the patients according to the study’s inclusion and exclusion criteria. Patients received either haloperidol or olanzapine based on computerized randomization. The severity of delirium was measured with the Memorial Delirium Assessment Scale (MDAS) scoring on days 0 and 3 of ICU-admission. Results: The total sample size was 35 in which 16 patients received haloperidol, and 19 patients received olanzapine. The doses of haloperidol and olanzapine were 3 mg three times a day and 5 mg three times a day, respectively. There was no significant difference in baseline characteristics and the scores of MDAS between groups. Conclusion: Olanzapine and haloperidol have the same efficacy in the management of delirium in toxicology ICU-admitted patients. They can be interchangeably used for delirium treatment in these patients.

scholarly journals Comparing the Efficacy of Topical Metformin and Placebo in the Treatment of Melasma: A Randomized, Double-blind, Clinical Trial

2019 ◽  
pp. 1-8
Author(s):  
Mohammad Ali Mapar ◽  
Ali Asghar Hemmati ◽  
Ghazal Namdari
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Double Blind ◽  
Laboratory Findings ◽  
Double Blind Clinical Trial ◽  
Metformin Group ◽  
Significant Difference ◽  
Before And After ◽  
P 16 ◽  
The Mean

Introduction: Generally affecting women, melasma is the acquired disorder of hyperpigmentation, and researches are still ongoing to find an effective, fast, and low-side-effect drug treating this disease. The present study is aimed at comparing the efficacy of topical metformin and placebo in the treatment of melasma. Methods: Sixty patients with melasma were treated in placebo and topical metformin recipient groups in a double-blind clinical trial. In addition to the demographic and laboratory findings of patients before and after the intervention, the MASI Score of patients in weeks 0, 4, 8, and 12 of the study and then one month after the study were analyzed using SPSS version 20 software. Results: The mean age of the studied patients was 35.25 ± 7.11 years. No significant difference was observed between the phenotypes (P= .49) and the type of melasma (P= .63) in the two groups. The mean MASI score of patients at the time of being included in the study in the placebo group was 10.47 ± 3.08; and in the metformin group, it was 11.93 ± 4.64 (P = .16). Compared to the beginning of the study, the MASI scores were significantly decreased in both groups of placebo (P = .00) and metformin (P = .00) one month after the end of the study; nevertheless, no statistically significant difference was observed between the MASI Scores of two groups in any of the study periods (P > .05). Conclusion: The results of the present study showed that metformin cream significantly declines the patients’ MASI score and does not have any effect on patients’ laboratory markers. Of course, no significant difference was observed between the MASI scores of the patients receiving metformin and the placebo group; however, the MASI score decrease trend continued until the 12th week; while in the placebo group, no significant decrease was seen after eight weeks.

scholarly journals The Safety and Efficacy of Lansoprazole plus Metoclopramide among Neonates with Gastroesophageal Reflux Disease Resistant to Conservative Therapy and Monotherapy: A Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Peymaneh Alizadeh Taheri ◽  
Elahe Validad ◽  
Kambiz Eftekhari
Keyword(s):  
Clinical Trial ◽  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Reflux Disease ◽  
Response Rate ◽  
Clinical Manifestations ◽  
Secondary Outcome ◽  
Double Blind ◽  
Term Neonates ◽  
Significant Difference

Background. Gastroesophageal reflux disease (GERD) is one of the most common problems in neonates. The main clinical manifestations of neonatal GERD are frequent regurgitation or vomiting associated with irritability, crying, anorexia or feeding refusal, failure to thrive, arching of the back, and sleep disturbance. Aims. The efficacy and safety of ranitidine plus metoclopramide and lansoprazole plus metoclopramide in reducing clinical GERD symptoms based on I-GERQ-R scores in neonatal GERD resistant to conservative and monotherapy. Study Design. This study was a randomized clinical trial of term neonates with GERD diagnosis (according to the final version of the I-GERQ-R), resistant to conservative and monotherapy admitted to Bahrami Children Hospital during 2017-2019. Totally, 120 term neonates (mean age 10.91 ± 7.17 days; girls 54.63%) were randomly assigned to a double-blind trial with either oral ranitidine plus metoclopramide (group A) or oral lansoprazole plus metoclopramide (group B). The changes of the symptoms and signs were recorded after one week and one month. At the end, fifty-four neonates in each group completed the study and their data were analyzed. Results. There was no significant difference in demographic and baseline characteristics between the two groups. The response rate of “lansoprazole plus metoclopramide” was significantly higher than “ranitidine plus metoclopramide” ( 7.44 ± 3.86 score vs. 9.3 ± 4.57 score, p = 0.018 ) after one week and ( 2.41 ± 3.06 score vs. 4.5 ± 4.12 score, p = 0.003 ) after one month (primary outcome). There were no drug adverse effects in either group during intervention (secondary outcome). Conclusions. The response rate was significant in each group after one week and one month of treatment, but it was significantly higher in the “lansoprazole plus metoclopramide” group compared with the “ranitidine plus metoclopramide” group. The combination of each acid suppressant with metoclopramide led to a higher response rate in comparison with monotherapy used before intervention. This study has been registered at the Iranian Registry of Clinical Trails (RCT20160827029535N3).

Clomipramine versus Phenelzine in Obsessive–Compulsive Disorder

1992 ◽  
Vol 161 (5) ◽  
pp. 665-670 ◽  
Author(s):  
J. Vallejo ◽  
J. Olivares ◽  
T. Marcos ◽  
A. Bulbena ◽  
J. M. Menchón
Keyword(s):  
Clinical Trial ◽  
Depressive Symptoms ◽  
Obsessive Compulsive Disorder ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Compulsive Disorder ◽  
Double Blind Clinical Trial ◽  
Significant Difference

A double-blind clinical trial of clomipramine versus phenelzine was carried out on 30 patients suffering from DSM–III obsessive–compulsive disorder. The study period was 12 weeks, and the maximum doses used (from the fifth week on) were 225 mg/day for clomipramine (14 patients) and 75 mg/day for phenelzine (12 patients); four patients dropped out. Obsessive symptoms improved significantly in both drug groups, but there was no significant difference between groups. Depressive symptoms improved before obsessive ones.

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