scholarly journals The comparison of the effect of flaxseed oil and vitamin E on mastalgia and nodularity of breast fibrocystic: a randomized double-blind clinical trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Gholamali Godazandeh ◽  
Shahram Ala ◽  
Tahereh Madani Motlaq ◽  
Adeleh Sahebnasagh ◽  
Aliyeh Bazi
Keyword(s):  
Clinical Trial ◽  
Vitamin E ◽  
Luteal Phase ◽  
Flaxseed Oil ◽  
Breast Pain ◽  
Double Blind ◽  
Benign Condition ◽  
Double Blind Clinical Trial ◽  
Significant Difference

Abstract Background Fibrocystic changes are a common benign condition in women aged 20–50. The medical intervention aims to stop fibrocystic disease progress and relieve the breast’s pain and tenderness. In the long-term, reversing the fibrocystic changes is also desirable. Methods In this randomized double-blind clinical trial, the effect of flaxseed oil on the severity of pain and breast nodularity was investigated against vitamin E. This study was conducted on 100 women with mastalgia. The intervention group received Flaxseed oil pearls and the control group received vitamin E pearl 200 IU twice a day for 2 months. The duration and severity of breast pain were evaluated by Cardiff chart and VAS (Visual Analogue Scale). The nodularity was assessed by Lucknow-Cardiff scale at baseline, then the first and second months of intervention. Results At baseline, there was no statistically significant difference between the two groups in characteristics. The breast pain improved in both groups during the first and second months of intervention (P-value within group< 0.001). However, the mean breast pain was not significantly different between the two groups at the end of the first and second month (P1= 0.54, P2= 0.73). Furthermore, the breast pain during four phases of the menstrual cycle showed no difference between vitamin E and flaxseed oil groups (menstruation phase= 0.76, follicular phase= 0.48, the first week of luteal phase= 0.86, the second week of luteal phase=0.30). The breast nodularity also decreased during the first and second months of intervention, yet no significant difference between the two groups was found (p= 0.9). Conclusions This study showed that flaxseed oil and vitamin E both could be effective in breast pain-relieving and decreasing nodularity with minimal side effects in contrast with the baseline. But there are no significant differences between these two agents. Larger scale prospective studies are needed to evaluate these effects in the long-term. Trial registration IRCT201612243014N18, Registration date: 2017-10-15.

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 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.

Management of a Potentially Harmful Health Behavior by Clinical Trial

PEDIATRICS ◽  
1980 ◽  
Vol 66 (2) ◽  
pp. 294-297
Author(s):  
Robert E. Coifman
Keyword(s):  
Clinical Trial ◽  
Vitamin E ◽  
Health Behavior ◽  
Health Behaviors ◽  
Respiratory Infection ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
The Face ◽  
Face Saving

A parent had been giving mega-doses of vitamin E to an 8-year-old child with 21-D trisomy for five years in the firmly rooted belief that this therapy was responsible for the child's freedom from constant symptoms of systemic and respiratory infection. The design of an unbiased double-blind clinical trial permitted the parent to reach, on her own, the face-saving conclusion that continuation of this therapy was no longer necessary. Applications of this approach and the underlying nonjudgmental attitude to other potentially harmful health behaviors and practices are discussed.

A Long Term Double-Blind Clinical Trial of Ibuprofen and Indomethacin in Rheumatoid Arthritis

1975 ◽  
Vol 3 (3) ◽  
pp. 158-171 ◽  
Author(s):  
G L Royer ◽  
T E Moxley ◽  
M S Hearron ◽  
A Miyara ◽  
B M Shenker
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Side Effects ◽  
Double Blind ◽  
Double Blind Clinical Trial

Two-hundred and eighteen individuals with rheumatoid arthritis were randomly assigned to six months treatment with ibuprofen (900-1800 mg/day) or indomethacin (75-150 mg/day). The drugs were equally effective in the treatment of rheumatoid arthritis while the incidence of indomethacin side-effects was 1·5 times greater than the incidence of ibuprofen side-effects.

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.

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