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.

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 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.

Comparison of the Analgesic Effect of Intravenous Ketamine versus Intravenous Morphine in Reducing Pain of Renal Colic Patients: Double-Blind Clinical Trial Study

2019 ◽  
Vol 14 (4) ◽  
pp. 280-285 ◽  
Author(s):  
Arash Forouzan ◽  
Kambiz Masoumi ◽  
Hassan Motamed ◽  
Seyed Reza Naji Esfahani ◽  
Ali Delirrooyfard
Keyword(s):  
Clinical Trial ◽  
Renal Colic ◽  
Initial Result ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Significant Difference ◽  
Intravenous Morphine ◽  
Hospital Patients ◽  
The Mean ◽  
Intravenous Ketamine

Background: The effective relief of renal colic patients with low complications is one of the important concerns of emergency physicians. The aim of this study was to investigate the use of injectable ketamine as an alternative to routine drugs in the relief of pain in patients with renal colic. Methods: This double-blind clinical trial was conducted on patients who had suffered kidney pain due to kidney stones in 2017, referred to Ahvaz Imam Khomeini Hospital. Patients were divided into 2 groups: the first group received intravenous ketamine (0.3 mg/kg) and the second group received intravenous morphine (0.1 mg/kg) in a double-blind form. Finally, the mean pain was evaluated before injection, after 10, 20, 30, and 60 minutes as the initial result while the side effects were considered as secondary results. Results: In this study, 135 patients with renal colic participate in this study. The mean pain at the time of referral to the hospital in the group receiving morphine and ketamine was 9.2 and 9.2, respectively, which did not show any significant difference. Based on these findings, there was no significant difference between the factors evaluated during the study of the two groups. Only in the ketamine group, there were 3 cases of nausea and 1 of vomiting. However, there was a significant increase in the need for additional doses of fentanyl in the morphine recipient group (p = 0.02). Conclusion: The findings suggest that the use of ketamine can produce a more rapid relief effect, and decrease the use of opioids which create various complications, including nausea and vomiting in patients, especially patients with renal colic.

scholarly journals Clinical effect of a herbal dentifrice on the control of plaque and gingivitis: a double-blind study

2003 ◽  
Vol 17 (4) ◽  
pp. 314-318 ◽  
Author(s):  
Claudio Mendes Pannuti ◽  
Joyce Pereira de Mattos ◽  
Paula Nini Ranoya ◽  
Alberto Martins de Jesus ◽  
Roberto Fraga Moreira Lotufo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Effect ◽  
Test Group ◽  
Control Group ◽  
Double Blind Study ◽  
Gingival Index ◽  
Control Groups ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Significant Difference

The aim of this randomized, double-blind clinical trial was to evaluate the effect of the Paradontax dentifrice on the reduction of plaque and gingivitis. Subjects were randomly allocated into either the test group (n = 15, Paradontax) or the control group (n = 15, standard dentifrice with fluoride). Plaque levels were measured using the Turesky modification of the Quigley & Hein Plaque Index (PI), and gingivitis was evaluated with the Gingival Index (GI). Subjects were asked to brush their teeth with the allocated dentifrice, three times a day, for 21 days. There was no significant difference between groups in relation to the PI and GI medians, at baseline and at the end of the 21-day period. There was no significant reduction in PI in either the test or control groups. There was a significant decrease in GI in the test group. The authors concluded that there was no difference between the dentifrices in the reduction of plaque and gingivitis.

scholarly journals Comparison of Pain Score and Complications Following Acetaminophen and Pethidine Injection During Vaginal Delivery: A Double-blind Clinical Trial

2021 ◽  
Vol 36 (2) ◽  
pp. e250-e250
Author(s):  
Masoumeh Mirteimouri ◽  
Leila Pourali ◽  
Mozhgan Soltani ◽  
Maryam Salehi ◽  
Atiyeh Vatanchi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pain Score ◽  
Vaginal Delivery ◽  
Labor Pain ◽  
Maternal Complications ◽  
Double Blind ◽  
Neonatal Complications ◽  
Double Blind Clinical Trial ◽  
Significant Difference ◽  
Intravenous Acetaminophen

Objectives: Recently, intravenous acetaminophen has been introduced as an intervention with analgesic potential similar to that of opioid analgesics in labor pain management. This study aimed to compare the pain score and maternal and neonatal complications following acetaminophen and pethidine injections during vaginal delivery. Methods: This randomized, double-blind clinical trial was conducted on pregnant women during the first stage of delivery referred to Ghaem and Omolbanin Hospitals in Mashhad, Iran, from March to December 2017. The subjects were assigned randomly to one of two groups: acetaminophen and pethidine. The pain intensity was measured before and 15, 60, 120, 180, and 240 minutes after injection. Results: The pain score and pain score changes showed no significant difference between the two groups at different times. The incidence of maternal complications during delivery and the first hour after delivery was not statistically significant between the two groups, but 15 minutes after injection, vomiting (p = 0.001), nausea (p = 0.001), and dizziness (p = 0.001) were significantly higher in the pethidine group. The mean one and five minutes Apgar scores were significantly higher in the acetaminophen group. Conclusions: Intravenous acetaminophen led to fewer maternal complications than pethidine, especially during the first 15 minutes after injection and fewer neonatal complications, especially in the Apgar score.

scholarly journals Comparison of the effects of sertraline and L-carnitine on intradialytic hypotension; a double blind clinical trial

2020 ◽  
Vol 9 (3) ◽  
pp. e22-e22
Author(s):  
Sanaz Jamshidi ◽  
Sepideh Hajian ◽  
Nafiseh Rastgoo ◽  
Navid Mohammadi
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Intradialytic Hypotension ◽  
Duration Of Treatment ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Significant Difference ◽  
Blood Pressures ◽  
Pre Treatment ◽  
Positive Effect

Introduction: Although some studies have reported the positive effect of sertraline and L-carnitine on intradialytic hypotension (IDH), a common complication of dialysis, however the results are controversial. Objectives: The aim of this study was to compare the effects of sertraline and L-carnitine on blood pressure in patients with chronic renal failure who were undergoing dialysis. Patients and Methods: This double-blind clinical trial was conducted on 32 hemodialysis patients who suffered from IDH in more than 50% of dialysis sessions. Patients were randomly divided into two groups of sertraline (50 mg daily) and L-carnitine (1000 mg daily), with 16 patients in each group. Duration of treatment was four weeks, then patients were followed up for additional three weeks. The changes in patients’ blood pressure were monitored in each group and the results compared between the two groups. Results: Of all, 18 patients (56%) were female, 14 patients (44%) were male, and their mean (SD) age was 60±15 years. At the end of the study, mean systolic blood pressure (SBP), mean diastolic blood pressure (DBP), and mean arterial pressure (MAP) were significantly increased in both the sertraline and L-carnitine groups (P<0.05). In addition, nadir SBP, nadir DBP, and nadir MAP in each group were significantly increased compared to pre-treatment period (P<0.001). An increase of more than 5 mm Hg in SBP, DPB, and MAP was observed in half of the subjects in the sertraline group and more than two-thirds of the patients in the L-carnitine group, however there was no significant difference between the two groups (P>0.05). Conclusion: The findings of this study showed that the administration of sertraline or L-carnitine for one month could significantly increase SBP, DBP, MAP, and nadir blood pressures in dialysis patients suffering from IDH during dialysis sessions because there was no significant difference between the two drugs.

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