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 N-Acetylcystein has Potential Effect to Reduce Haematological Abnormalities in HIV/AIDS Patients Undergoing ARV Treatment

2020 ◽  
Vol 10 (4-s) ◽  
pp. 197-200
Author(s):  
Filia Yuniza ◽  
Eddy Mart Salim ◽  
Nova Kurniati ◽  
Harun Hudari ◽  
Erial Bahar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Potential Effect ◽  
Aids Patients ◽  
Exclusion Criteria ◽  
Double Blind ◽  
Before And After ◽  
The Mean ◽  
Hematological Abnormalities ◽  
Hiv Aids

Aims: to determine the effect of NAC administration on hematological abnormalities in HIV/AIDS patients who are undergoing ARV treatment. Method: This was a pilot study using a double blind randomized clinical trial. A total of 32 subjects who met the inclusion and exclusion criteria were divided into 2 groups, namely placebo and NAC. Subjects in the NAC group were given NAC at a dose of 3x200 mg/day, while the placebo group was given lactose at a dose of 3x200 mg/day. Each group was given treatment for 12 weeks. Before and after treatment, subjects were examined for hematologic parameters. Results:  Most of subjects had normal hematological features. NAC administration did not have a significant effect on the mean levels of Hb, Ht, number of erythrocytes, leukocytes and platelets (p> 0.05). However, NAC administration can reduce the degree of anemia and improve the condition of thrombocytopenia, leukopenia and lymphopenia. Conclusion: NAC administration can reduce hematological abnormalities HIV/AIDS patients undergoing ARV treatment. Keywords: ARV, Hematological abnormalities, HIV/AIDS, NAC.

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.

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 Evaluation of the Additive Effect of Domperidone on Patients with Refractory Gastroesophageal Reflux Disease; A Randomized Double Blind Clinical Trial

2018 ◽  
Vol 11 (1) ◽  
pp. 24-31 ◽  
Author(s):  
Tarang Taghvaei ◽  
Arash Kazemi ◽  
Vahid Hosseini ◽  
Mehdi Hamidian ◽  
Hafez Tirgar Fakheri ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Erosive Esophagitis ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Significant Difference ◽  
Before And After

BACKGROUND Gastroesophageal reflux disease (GERD) is a common problem with annoying symptoms. It is associated with negative impact on quality of life. Prokinetic agents may be used in combination with acid suppression agents as an adjunctive in patients with GERD refractory to proton pump inhibitors (PPI) therapy, rather than as sole treatment. This study aimed to evaluate the efficacy of combination of PPI with domperidone (a prokinetic agent) compared with PPI alone in the treatment of patients with refractory GERD. METHODS This study was a double blind clinical trial on 29 patients with GERD refractory to PPI during the period of one month. By randomization, the patients were divided into two groups. Group A was treated by pantoprazole 40 mg twice daily and domperidone three times a day for a month, while group B was treated by pantoprazole 40 mg twice daily and placebo three times a day. In this study endoscopy was performed to evaluate the prevalence of erosive esophagitis, non-erosive reflux, and hiatal hernia. Manometry was conducted to study the prevalence of dysmotility. GERD symptom questionnaires including the Gastrointestinal Symptom Rating Scale (GSRS), Carlson Dennett, and the Medical Outcomes Study Short Form-36 health survey (SF36) were used before and after treatment for screening GERD and assessing treatment response. RESULTS There were 17 (58.62%) women and 12 (41.37%) men. The prevalence of erosive esophagitis and non-erosive reflux, was 10.34% and 89.66%, respectively. There was a significant difference comparing reflux symptoms before and after treatment between the two groups according to reflux and Carlson Dennett questionnaires. At the end of the study, symptoms of reflux significantly improved by treatment. Although, the quality of life questionnaire scores improved by treatment, there was no statistically significant difference in response to treatment between the two groups. CONCLUSION In this research, we showed that adding domperidone to PPI could not make any improvement in patients with refractory reflux regarding the quality of life and improving the symptoms.

Homœopathic treatment of acute childhood diarrhoea

1993 ◽  
Vol 82 (02) ◽  
pp. 83-86 ◽  
Author(s):  
Luz Margarita Jiminez ◽  
Steven Gloyd ◽  
Felix Esponiza Carares ◽  
Margarita Paniagua Gaitan ◽  
Dean Crothers ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Treated Group ◽  
Aetiological Agent ◽  
Double Blind ◽  
Oral Rehydration ◽  
Childhood Diarrhoea ◽  
Significant Difference ◽  
The Mean ◽  
Larger Sample

AbstractA double-blind, randomized clinical trial to compare homœopathic treatment versus placebo in the treatment of acute childhood diarrhoea was carried out in Leon, Nicaragua, in July 1990. 34 children aged 6 months to 5 years were randomized into active and placebo groups, both of which also received oral rehydration treatment. The mean duration of diarrhoea after treatment in the active group was 2.4 days, compared to 3.0 days in the placebo group, which was not statistically significant. Exploratory analysis revealed a statistically significant decrease (p=0.04) in the subgroup of patients for which an aetiological agent was found. There was also a significant difference in number of stools per day in the treated group (p=0.002) at the end of the treatment period. Since small numbers prevent a definitive conclusion from this study, further study with a larger sample size would seem appropriate.

Value of Whole-Body Washing With Chlorhexidine for the Eradication of Methicillin-ResistantStaphylococcus aureus:A Randomized, Placebo-Controlled, Double-Blind Clinical Trial

2007 ◽  
Vol 28 (9) ◽  
pp. 1036-1043 ◽  
Author(s):  
C. Wendt ◽  
S. Schinke ◽  
M. Württemberger ◽  
K. Oberdorfer ◽  
O. Bock-Hensley ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Treatment Group ◽  
Solution Treatment ◽  
University Hospital ◽  
Whole Body ◽  
Double Blind ◽  
Antiseptic Solution ◽  
Double Blind Clinical Trial ◽  
Double Blinded

Background.Whole-body washing with antiseptic solution has been widely used as part of eradication treatment for colonization with methicillin-resistantStaphylococcus aureus(MRSA), but evidence for the effectiveness of this measure is limited.Objective.To study the efficacy of whole-body washing with chlorhexidine for the control of MRSA.Design.Randomized, placebo-controlled, double-blinded clinical trial.Setting.University Hospital of Heidelberg and surrounding nursing homes.Patients.MRSA carriers who were not treated concurrently with antibiotics effective against MRSA were eligible for the study.Intervention.Five days of whole-body washing with either 4% chlorhexidine solution (treatment group) or with a placebo solution. All patients received mupirocin nasal ointment and chlorhexidine mouth rinse. The outcome was evaluated 3, 4, 5, 9, and 30 days after treatment with swab samples taken from several body sites.Results.Of 114 patients enrolled in the study (56 in the treatment group and 58 in the placebo group), 11 did not finish treatment (8 from the treatment group and 3 from the placebo group [P= .02]). At baseline, the groups did not differ with regard to age, sex, underlying condition, site of MRSA colonization, or history of MRSA eradication treatment. Eleven patients were MRSA-free 30 days after treatment (4 from the treatment group and 7 from the placebo group [P= .47]). Only groin-area colonization was significantly better eradicated by the use of chlorhexidine. The best predictor for total eradication was a low number of body sites positive for MRSA. Adverse effects were significantly more frequent in the treatment group than in the placebo group (any symptom, 71% vs 33%) but were reversible in most cases.Conclusion.Whole-body washing can reduce skin colonization, but it appears necessary to extend eradication measures to the gastrointestinal tract, wounds, and/or other colonized body sites if complete eradication is the goal.Trial Registration.ClinicalTrials.gov identifier: NCT00266448.

scholarly journals Subcutaneous granulocyte colony-stimulating factor administration for subacute traumatic spinal cord injuries, report of neurological and functional outcomes: a double-blind randomized controlled clinical trial

2019 ◽  
Vol 30 (1) ◽  
pp. 19-30 ◽  
Author(s):  
Nazi Derakhshanrad ◽  
Hooshang Saberi ◽  
Mir Saeed Yekaninejad ◽  
Mohammad Taghi Joghataei
Keyword(s):  
Clinical Trial ◽  
Spinal Cord ◽  
Placebo Group ◽  
Spinal Cord Injuries ◽  
Functional Improvement ◽  
Granulocyte Colony Stimulating Factor ◽  
Double Blind ◽  
Cord Injury ◽  
The Mean ◽  
Stimulating Factor

OBJECTIVEGranulocyte-colony stimulating factor (G-CSF) is a major cytokine that has already been clinically verified for chronic traumatic spinal cord injuries (TSCIs). In this study, the authors set out to determine the safety and efficacy of G-CSF administration for neurological and functional improvement in subacute, incomplete TSCI.METHODSThis phase II/III, prospective, double-blind, placebo-controlled, parallel randomized clinical trial was performed in 60 eligible patients (30 treatment, 30 placebo). Patients with incomplete subacute TSCIs with American Spinal Injury Association Impairment Scale (AIS) grades B, C, and D were enrolled. Patients were assessed using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scale, Spinal Cord Independence Measure (SCIM-III) and International Association of Neurorestoratology Spinal Cord Injury Functional Rating Scale (IANR-SCIFRS), just before intervention and at 1, 3, and 6 months, after 7 daily subcutaneous administrations of 300 μg/day of G-CSF in the treatment group and placebo in the control group.RESULTSAmong 60 participants, 28 patients (93.3%) in the G-CSF group and 26 patients (86.6%) in the placebo group completed the study protocol. After 6 months of follow-up, the AIS grade remained unchanged in the placebo group, while in the G-CSF group 5 patients (45.5%) improved from AIS grade B to C, 5 (45.5%) improved from AIS grade C to grade D, and 1 patient (16.7%) improved from AIS grade D to E. The mean ± SEM change in ISNCSCI motor score in the G-CSF group was 14.9 ± 2.6 points, which was significantly greater than in the placebo group (1.4 ± 0.34 points, p < 0.001). The mean ± SEM light-touch and pinprick sensory scores improved by 8.8 ± 1.9 and 10.7 ± 2.6 points in the G-CSF group, while those in the placebo group improved by 2.5 ± 0.60 and 1.2 ± 0.40 points, (p = 0.005 and 0.002, respectively). Evaluation of functional improvement according to the IANR-SCIFRS instrument revealed significantly more functional improvement in the G-CSF group (10.3 ± 1.3 points than in the placebo group (3.0 ± 0.81 points; p < 0.001). A significant difference was also observed between the 2 groups as measured by the SCIM-III instrument (29.6 ± 4.1 vs 10.3 ± 2.2, p < 0.001).CONCLUSIONSIncomplete subacute TSCI is associated with significant motor, sensory, and functional improvement after administration of G-CSF.Clinical trial registration no.: IRCT201407177441N3 (www.irct.ir)

scholarly journals The efficacy of trimethoprim-sulfamethoxazole treatment in children with acute bloody diarrhea

2007 ◽  
Vol 47 (1) ◽  
pp. 17
Author(s):  
Selvi Nafianti ◽  
Oke R. Ramayani ◽  
Dedy G. Daulay ◽  
Supriatmo Supriatmo ◽  
Berlian Hasibuan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Developing Countries ◽  
Placebo Group ◽  
Campylobacter Jejuni ◽  
Bloody Diarrhea ◽  
Fecal Analysis ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Stool Analysis

Background The etiologies of bloody diarrhea are shigella,amoeba, enterocolitis, trichuriasis, and other causes i.e, EIEC,Campylobacter jejuni or rotavirus. In developing countries,trimetroprim-sulfamethoxazole (TMP-SMP) is effective in 80%of children with bloody diarrhea.Objective To determine the efficacy of trimethoprim-sulfa-methoxazole (TMP-SMX) treatment in children with acute bloodydiarrhea.Methods A randomized double blind clinical trial was conductedin Adam Malik Hospital and Dr. Pirngadi Hospital Medan duringSeptember 2003-March 2004. Children aged 2-24 months oldwith diagnosis of acute bloody diarrhea were randomized into twogroups to either receive TMP-SMX or placebo for 5 days.Microscopic fecal analysis was performed on the first, second,fifth and twelfth day, and the results were compared.Results A total of 68 children consisted of 48 (71%) boys and 20(29%) girls were enrolled. Each group had 34 participants.Analysis of the first day showed leukocyte and erythrocyte in thestool specimens, which were all absent on the twelfth day in bothgroups. There was no difference in stool analysis between TMP-SMX and placebo group in day two (P=0.758), day five (P=0.341)and day twelve. Diarrhea duration in TMP-SMX and placebogroup was 7.18 days and 6.65 days, respectively. This differentwas statistically not significant (P=0.385).Conclusion There is no difference in the efficacy of trimethoprim-sulfamethoxazole treatment compared to placebo in children withacute bloody diarrhea.

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.

SYMPHYTUM OFFICINALE IN THE TREATMENT OF PLANTAR KERATOSIS IN DIABETIC PATIENTS: DOUBLE BLIND RANDOMIZED CLINICAL TRIAL

2021 ◽  
pp. 62-64
Author(s):  
Beatriz Bertolaccini Martínez ◽  
Elisa Coutinho Moura
Keyword(s):  
Clinical Trial ◽  
Salicylic Acid ◽  
Statistical Analysis ◽  
Diabetic Patients ◽  
Type 2 Diabetic Patients ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Before And After ◽  
Type 2 Diabetic

PURPOSE: To compare the efcacy between SO and salicylic acid SA in the treatment of plantar keratosis of diabetic patients. METHODS: Randomized, double-blind clinical trial, with 47 type 2 diabetic patients, both sexes and with plantar keratosis. Patients were randomized into 2 groups: G1 (n = 48; treated with 15% SO extract) and G2 (n = 46; treated with 10% AS). The feet were photographed before (D0) and after the treatment (D30) and keratosis areas were measured using the Image J software. For each patient, a lesion in each foot was analyzed. The results were expressed by median. In the statistical analysis, the Wilcoxin test was used to compare the lesion areas before and after treatments and the Mann-Whitney test was used to compare the regression of the lesion areas between the two groups. P <0.05 was adopted. RESULTS: G1 (D0 = 2 8.156 vs D30 = 2.226; p <0.0001) and G2 (D0 = 4.835 vs D30 = 2.059; p <0.0001) showed a difference between the areas (cm ) of the keratosis, 2 before and after the treatment. There was a difference in the regression of the areas (cm ) of keratosis, between G1 and G2, respectively (4.540 vs 1.171, p <0.0001). CONCLUSION: Symphytum ofcinale proved to be more effective than Salicylic Acid in the treatment of plantar keratosis in diabetic patients.

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