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.

Solumedrol Treatment for Severe Sepsis in Humans with a Blunted Adrenocorticotropic Hormone-Cortisol Response: A Prospective Randomized Double-Blind Placebo-Controlled Pilot Clinical Trial

2021 ◽  
pp. 088506662110388
Author(s):  
Divya Birudaraju ◽  
Sajad Hamal ◽  
John A. Tayek
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Adrenocorticotropic Hormone ◽  
Serum Cortisol ◽  
High Dose ◽  
Cortisol Response ◽  
Acth Stimulation ◽  
Double Blind ◽  
Significant Difference ◽  
To Receive

Purpose To test the benefits of Solumedrol treatment in sepsis patients with a blunted adrenocorticotropic hormone (ACTH)-cortisol response (delta <13 µg/dL) with regard to the number of days on ventilator, days on intravenous blood pressure support, length of time in an intensive care unit (ICU), 14-day mortality, and 28-day mortality. The trial was prospective, randomized, and double-blind. As part of a larger sepsis trial, 54 patients with sepsis had an intravenous ACTH stimulation test using 250 µg of ACTH, and serum cortisol was measured at times 0, 30, and 60 min. Eleven patients failed to increase their cortisol concentration above 19.9 µg/dL and were excluded from the clinical trial as they were considered to have adrenal insufficiency. The remaining 43 patients had a baseline cortisol of 32 ± 1 µg/dL increased to 38 ± 3 µg/dL at 30 min and 40 ± 3 at 60 min. All cortisol responses were <12.9 µg/dL between time 0 and time 60, which is defined as a blunted cortisol response to intravenous ACTH administration. Twenty-one were randomized to receive 20 mg of intravenous Solumedrol and 22 were randomized to receive a matching placebo every 8 h for 7-days. There was no significant difference between the two randomized groups. Data analysis was carried out bya two-tailed test and P < .05 as significant. Results Results: The mean age was 51 ± 2 (mean ± SEM) with 61% female. Groups were well matched with regard to APACHE III score in Solumedrol versus placebo (59 ± 6 vs 59 ± 6), white blood cell count (18.8 ± 2.2 vs 18.6 ± 2.6), and incidence of bacteremia (29 vs 39%). The 28-day mortality rate was reduced in the Solumedrol treated arm (43 ± 11 vs 73 ± 10%; P < .05). There was no change in days in ICU, days on blood pressure agents, or days on ventilator. Seven days of high-dose intravenous Solumedrol treatment (20 mg every 8 h) in patients with a blunted cortisol response to ACTH was associated with an improved 28-day survival. This small study suggests that an inability to increase endogenous cortisol production in patients with sepsis who are then provided steroid treatment could improve survival.

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 sertraline in the prevention of low blood pressure in patients undergoing hemodialysis

2019 ◽  
Vol 41 (4) ◽  
pp. 492-500
Author(s):  
Christine Zomer Zomer Dal Molin ◽  
Thiago Mamoru Sakae ◽  
Fabiana Schuelter-Trevisol ◽  
Daisson Jose Trevisol
Keyword(s):  
Blood Pressure ◽  
Placebo Group ◽  
Major Complication ◽  
Number Needed To Treat ◽  
Intradialytic Hypotension ◽  
Double Blind ◽  
Kaplan Meier ◽  
Significant Difference ◽  
Two Phases ◽  
Intradialytic Symptoms

Abstract Introduction: Intradialytic hypotension (IDH) is a major complication of hemodialysis, with a prevalence of about 25% during hemodialysis sessions, causing increased morbidity and mortality. Objective: To study the effects of sertraline to prevent IDH in hemodialysis patients. Methods: This was a double-blind, crossover clinical trial comparing the use of sertraline versus placebo to reduce intradialytic hypotension. Results: Sixteen patients completed the two phases of the study during a 12-week period. The IDH prevalence was 32%. A comparison between intradialytic interventions, intradialytic symptoms, and IDH episodes revealed no statistical difference in the reduction of IDH episodes (p = 0.207) between the two intervention groups. However, the risk of IDH interventions was 60% higher in the placebo group compared to the sertraline group, and the risk of IDH symptoms was 40% higher in the placebo group compared to the sertraline group. Survival analysis using Kaplan-Meier estimator supported the results of this study. Sertraline presented a number needed to treat (NNT) of 16.3 patients to prevent an episode from IDH intervention and 14.2 patients to prevent an episode from intradialytic symptoms. Conclusion: This study suggests that the use of sertraline may be beneficial to reduce the number of symptoms and ID interventions, although there was no statistically significant difference in the blood pressure levels.

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 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.

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.

A Prospective Multicenter Clinical Trial of Chinese Herbal Formula JZQG (Jiangzhuoqinggan) for Hypertension

2013 ◽  
Vol 41 (01) ◽  
pp. 33-42 ◽  
Author(s):  
Xiao-Lin Tong ◽  
Feng-Mei Lian ◽  
Qiang Zhou ◽  
Li-Peng Xu ◽  
Hang-Yu Ji ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Waist Circumference ◽  
Ambulatory Blood Pressure ◽  
Blood Pressure Measurement ◽  
Multicenter Clinical Trial ◽  
Beneficial Effects ◽  
Chinese Herbal ◽  
Significant Difference ◽  
Blood Pressures

A prospective multicenter clinical trial was conducted to compare the beneficial effects of a Chinese herbal medicine formula Jiangzhuoqinggan (JZQG) and western antihypertension drug irbesartan. JZQG is mainly composed of rhubarb, coptis, cassia, and uncaria. A total of 240 patients with mild to moderate hypertension were enrolled in the trial. Patients were assigned into two groups after screening: JZQG group and the irbesartan group. After four weeks of treatment, we compared the changes in routine blood pressure, 24 h ambulatory blood pressure, and waist circumference. There was a significant reduction in systolic blood pressure and diastolic blood pressure in the JZQG group (both p < 0.01). There were no significant differences between the reduction of systolic and diastolic blood pressures in the two treatment groups. From the 24 h ambulatory blood pressure measurement, the JZQG group showed a greater reduction in both systolic and diastolic blood pressures (in both daytime and nighttime) than the irbesartan group. Furthermore, there was a significant difference in waist circumference in the JZQG group (1.51 cm reduction; P < 0.05) but not the irbesartan group (0.42 cm). Thus, the JZQG formula may have therapeutic value in patients with both hypertension and metabolic syndrome.

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