scholarly journals Comparative Study of Magnesium, Sodium Valproate, and Concurrent Magnesium- Sodium Valproate Therapy in the Prevention of Migraine: A Randomized Controlled Double-Blind Trial.

2021 ◽  
Author(s):  
Samira Khani ◽  
Seyed Amir Hejazi ◽  
Mehdi Mehdi yaghubi ◽  
Ehsan Sharifipour
Keyword(s):  
Sodium Valproate ◽  
Migraine Prophylaxis ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Third ◽  
Parallel Group ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
Age Range

Abstract ObjectiveThis study aimed to assess the efficacy of concurrent magnesium-sodium valproate therapy and compare it with either magnesium or sodium valproate alone in the prevention of migraine prophylaxis. Materials and MethodsThis randomized single-center double-blind parallel-group controlled clinical trial study was conducted on migraine patients within the age range of 18-65 years. The subjects with at least four monthly attacks were randomly assigned to group A (n=82), group B (n=70), and group C (n=70) with the administration of sodium valproate, magnesium-sodium valproate, and magnesium, respectively. The patients passed a one-month baseline without prophylactic therapy and then received a 3-month treatment. The characteristics of migraine, including frequency, severity, duration of the attacks, and the number of painkillers taken per month, were monthly recorded in each visit. The Migraine Disability Assessment (MIDAS) and Headache Impact Test-6 (HIT-6) scores were recorded at the baseline and after 3 months of treatment in each group. Within- and between-group analyses were performed in this study. ResultsThe obtained results revealed a significant reduction in all migraine characteristics in all groups compared with baseline (P<0.001). Intragroup data analysis indicated that there was no statistically significant difference in headache frequency between groups A and B in the third month (P= 0.529); nevertheless, three other parameters showed a significant reduction in group B, compared to those reported in group A in the third month (P<0.05). On the other hand, group C could not effectively reduce measured parameters in the patients, compared to groups A and B after three months (P<0.001). Furthermore, the MIDAS and HIT-6 scores diminished significantly in groups A, B, and C compared with baseline (P<0.001), and also these changes were more significant in groups A and B than group C (P<0.001). ConclusionThe obtained results of this study revealed that magnesium could enhance the antimigraine properties of sodium valproate in combination therapy and reduce the required valproate dose for migraine prophylaxis.

scholarly journals Comparative study of magnesium, sodium valproate, and concurrent magnesium-sodium valproate therapy in the prevention of migraine headaches: a randomized controlled double-blind trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Samira Khani ◽  
Seyed Amir Hejazi ◽  
Mehdi Yaghoubi ◽  
Ehsan Sharifipour
Keyword(s):  
Sodium Valproate ◽  
Migraine Prophylaxis ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Third ◽  
Migraine Headaches ◽  
Parallel Group ◽  
Significant Difference ◽  
Group A ◽  
Group B

Abstract Objective This study aimed to assess the efficacy of concurrent magnesium-sodium valproate therapy and compare it with either magnesium or sodium valproate alone in migraine prophylaxis. Materials and methods This randomized single-center double-blind parallel-group controlled clinical trial study was conducted on migraine patients within the age range of 18–65 years. The subjects with at least four monthly attacks were randomly assigned to group A (n = 82) sodium valproate, group B (n = 70) magnesium with sodium valproate, and group C (n = 70) magnesium. The patients passed a one-month baseline without prophylactic therapy and then received a 3-month treatment. The characteristics of migraine, including frequency, severity, duration of the attacks, and the number of painkillers taken per month, were monthly recorded in each visit. The Migraine Disability Assessment (MIDAS) and Headache Impact Test-6 (HIT-6) scores were recorded at the baseline and after 3 months of treatment in each group. Within- and between-group analyses were performed in this study. Results The obtained results revealed a significant reduction in all migraine characteristics in all groups compared to those reported for the baseline (P <  0.001). Intragroup data analysis indicated that there was no statistically significant difference in headache frequency between groups A and B in the third month (P = 0.525); nevertheless, three other parameters showed a significant reduction in group B, compared to those reported for group A in the third month (P <  0.05). On the other hand, group C could not effectively reduce measured parameters in the patients, compared to groups A and B after 3 months (P <  0.001). Furthermore, the MIDAS and HIT-6 scores significantly diminished in groups A, B, and C compared to those reported at the baseline (P <  0.001), and these changes were more significant in groups A and B than in group C (P <  0.001). Conclusion The obtained results of this study revealed that magnesium could enhance the antimigraine properties of sodium valproate in combination therapy and reduce the required valproate dose for migraine prophylaxis.

scholarly journals Prospective Parallel Randomized, Double-Blind, Double-Dummy Controlled Clinical Trial Comparing Clomiphene Citrate and Metformin as the First-Line Treatment for Ovulation Induction in Nonobese Anovulatory Women with Polycystic Ovary Syndrome

2005 ◽  
Vol 90 (7) ◽  
pp. 4068-4074 ◽  
Author(s):  
Stefano Palomba ◽  
Francesco Orio ◽  
Angela Falbo ◽  
Francesco Manguso ◽  
Tiziana Russo ◽  
...  
Keyword(s):  
Polycystic Ovary ◽  
Clomiphene Citrate ◽  
Controlled Clinical Trial ◽  
Line Treatment ◽  
First Line ◽  
Ovary Syndrome ◽  
Double Blind ◽  
Group A ◽  
Group B ◽  
First Line Treatment

Abstract Context: Although metformin has been shown to be effective in the treatment of anovulation in women with polycystic ovary syndrome (PCOS), clomiphene citrate (CC) is still considered to be the first-line drug to induce ovulation in these patients. Objective: The goal of this study was to compare the effectiveness of metformin and CC administration as a first-line treatment in anovulatory women with PCOS. Design: We describe a prospective parallel randomized, double-blind, double-dummy controlled clinical trial. Setting: The study was conducted at the University “Magna Graecia” of Catanzaro, Catanzaro, Italy. Patients: One hundred nonobese primary infertile anovulatory women with PCOS participated. Interventions: We administered metformin cloridrate (850 mg twice daily) plus placebo (group A) or placebo plus CC (150 mg for 5 d from the third day of a progesterone withdrawal bleeding) (group B) for 6 months each. Mean outcome measures: The main outcome measures were ovulation, pregnancy, abortion, and live-birth rates. Results: The subjects of groups A (n = 45) and B (n = 47) were studied for a total of 205 and 221 cycles, respectively. The ovulation rate was not statistically different between either treatment group (62.9 vs. 67.0%, P = 0.38), whereas the pregnancy rate was significantly higher in group A than group B (15.1 vs. 7.2%, P = 0.009). The difference found between groups A and B regarding the abortion rate was significant (9.7 vs. 37.5%, P = 0.045), whereas a positive trend was observed for the live-birth rate (83.9 vs. 56.3%, P = 0.07). The cumulative pregnancy rate was significantly higher in group A than group B (68.9 vs. 34.0%, P &lt; 0.001). Conclusions: Six-month metformin administration is significantly more effective than six-cycle CC treatment in improving fertility in anovulatory nonobese PCOS women.

scholarly journals Effects of Dexmedetomidine on Intraoperative Hemodynamic Responses in Patients Undergoing Laparoscopic Cholecystectomy: A Randomised Double Blind Trial

2021 ◽  
Author(s):  
Dhanashree Dongare ◽  
Smita Gharde
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Base Line ◽  
Loading Dose ◽  
Double Blind Trial ◽  
Hemodynamic Responses ◽  
Double Blind ◽  
Significant Difference ◽  
Group A ◽  
American Society ◽  
Group B

Background: Dexmedetomidine is selective alpha 2 agonist with sedative sympatholytic, analgesic properties and is used as an anaesthetic adjuvant. We have evaluated the effect of dexmedetomidine on various hemodynamic responses to incidences such as laryngoscopy, endotracheal intubation, exubation and pneumoperitoneum in patients who were undergoing surgeries like laparoscopic cholecystectomy. We have used loading dose of 0.5mcg/kg of inj. Dexmedetomidine given over 10 minutes followed by infusion of a dose of 0.3mcg/kg/hour for the control of hemodynamic response to laparoscopy. Methods: Patient of either sex aged between 18-50 yrs, belongs to ASA I and II (AMERICAN SOCIETY OF ANAESTHESIOLOGY) posted for laparoscopic cholecystectomy were included. Institutional ethical committee clearance was obtained prior to study. After enrolment and valid written consent was taken. 60 patients were enrolled written valid informed consent was taken. Patients were divided into two groups 30 each with computerized randomization. Base line parameters were noted. Observer and patient was blinded for the content of syringe. Group A received injection dexmedetomidine and group B received bolus and infusion of normal saline at same rate. Routine general anaesthesia was instituted. Parameters were noted after induction, after intubation, after co2 insufflation, after 20 min, after 40 min, after co2 deflation, after extubation, after 1 and 2 hrs post-extubation. Results: Group A showed significantly less rise in HR and MAP than Group B. Requirement of intraoperative propofol was more in Group B. There was no significant difference for time taken to awakening in both groups. Conclusion: We found Injection Dexmedetomidine in given doses gave good hemodynamic control with minimal undesired effects during laparoscopy.

The role of tolvaptan in prevention of hyponatremia in patients undergoing transurethral resection of prostate surgery- A randomized double blind study

2021 ◽  
Vol 8 (2) ◽  
pp. 321-325
Author(s):  
Dinesh Kumar Singh ◽  
B B Baj ◽  
Vipin Goyal
Keyword(s):  
Transurethral Resection ◽  
Blind Study ◽  
Transurethral Resection Of Prostate ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Group A ◽  
The Mean ◽  
Group B

The aim of our study to determine the role of tolvaptan in prevention of hyponatremia in transurethral resection of prostate surgery. This is randomized double-blind study conducted in 60 ASA grade status 1 and 2 patients age group between 45-80 yrs undergoing TURP under spinal anaesthesia in urology operation theatre in Mahatma Gandhi hospital Jaipur after receiving permission from hospital ethical committee. A detailed history, complete physical examination and routine investigation were done for all patients followed by informed written consent was obtained. Patients are randomly divided into 2 groups. In group A -30 patients who received orally tab tolvaptan 15 mg and group B-30 patients who received orally tab multivitamin 2 hrs before surgery after doing electrolytes of the patients in the morning. In both groups age (in yrs), wt (in kg), ASA grade, volume of irrigating fluid (in litres), volume of prostate resected (in gm) and duration of surgery (in minutes) all demographic and surgical details data were compared. Electrolytes were compared in both groups pre and post-operatively and statistical analysis was done.There was significant difference in post-operative sodium level between the two groups (A and B). The mean level of sodium significantly reduced post-operatively in group –B (control grp). The mean level of sodium significantly increased post-operatively in group –A (tolvaptan grp). We conclude single dose of tolvaptan -15 mg found to effective in prevention of hyponatremia in patients undergoing TURP.

scholarly journals Role of Immediate Release and Delayed Release Omeprazole in Patients with Gastro Esophageal Reflux Disease

2017 ◽  
Vol 11 (2) ◽  
pp. 67-73
Author(s):  
Mahabub Rahman ◽  
Dewan Saifuddin Ahmed ◽  
Syeda Nur E Jannat ◽  
MM Shahin Ul Islam ◽  
Abu Ahmed Abdullah
Keyword(s):  
Reflux Disease ◽  
Immediate Release ◽  
Esophageal Reflux ◽  
Double Blind ◽  
Delayed Release ◽  
End Of Treatment ◽  
Significant Difference ◽  
Group A ◽  
Group B

Proton pump inhibitors are widely used for Gastro Esophageal Reflux Disease (GERD) treatment. This prospective double blind randomized cross over study was carried out in the Department of Gastroenterology, BSMMU from June 2007 to May 2008 to assess the efficacy of Immediate-release omeprazole (IR-OMEP) & Delayed-release Omeprazole (DR-OMEP) in relieving symptoms & healing of oesophagitis in GERD. All patients who fulfilled the inclusion criteria underwent upper gastrointestinal (UGI) endoscopy to be lebelled as nonerosive and erosive GERD. Among total 69 patients, 43 (62.3 %) had nonerosive and 26 (37.7 %) had erosive GERD. Patients were divided into group A (35) and group B (34) who received group A drugs (20 mg IR-OMEP bd) and group B drugs (20 mg DROMEP bd) from day 1-14 respectively. Then drugs were crossed over (group A: 20mg DR-OMEP bd; group B: 20 mg IR-OMEP bd) from day 15-28. Improvement of heartburn, regurgitation in each group were assessed in every week, during drug cross over and at the end and then compared between two groups. There was no significant difference in relieving heartburn and regurgitation between IR-OMEP and DR-OMEP either in erosive or nonerosive GERD (P>0.50). Patients with erosive GERD underwent UGI endoscopy at the end of treatment to see healing of esophagitis. Study showed significant healing of oesophagitis in group A after 4 weeks than group B (14%) (P<0.05) but there is no superiority of IR-OMEP over DR-OMEP in relieving symptoms of GERD.Faridpur Med. Coll. J. Jul 2016;11(2): 67-73

scholarly journals Inhaled Tobramycin in Children with Acute Bacterial Rhinopharyngitis

2006 ◽  
Vol 19 (1) ◽  
pp. 205873920601900 ◽  
Author(s):  
A. Varricchio ◽  
D. Tricarico ◽  
A. DE Lucia ◽  
R. Utili ◽  
M.-F. Tripodi ◽  
...  
Keyword(s):  
Nasal Obstruction ◽  
Resistant Bacteria ◽  
Double Blind ◽  
Oral Amoxicillin ◽  
Parallel Group ◽  
Blind Children ◽  
Amoxicillin Clavulanate ◽  
Group A ◽  
Adenoidal Hypertrophy ◽  
Group B

Antibiotic abuse for treating rhinopharyngitis induces the occurrence of resistant bacteria. As topical drugs might reduce this phenomenon, the aims of our study were to evaluate inhaled tobramycin in children with acute bacterial rhinopharyngitis and to compare it with oral amoxicillin/clavulanate. The trial was conducted as randomized, parallel group and double blind. Children, aged 3–6 years, with acute bacterial rhinopharyngitis were treated with 15 mg of aerosolized tobramycin (Group A) or 50 mg/Kg of amoxicillin/clavulanate (Group B) twice daily for 10 days. The following parameters were assessed: nasal obstruction, mucopurulent rhinorrhea, post-nasal drip, adenoidal hypertrophy, tympanic inflammation, tympanogramm, rhinomanometry and cultures. Of 416 patients screened, 311 children (178 females and 133 males), median age 4.5 years, completed the study: 156 in Group A and 155 in Group B. Both treatments improved all parameters (p<0.01 for all). Intergroup analysis showed that inhaled tobramycin induced a better improvement versus amoxicillin/clavulanate concerning nasal obstruction (p<0.05), adenoidal hypertrophy (p<0.01), tympanic inflammation (p<0.01), rhinomanometry (p<0.01) and cultures (p<0.05). In conclusion, inhaled tobramycin may represent a valid treatment for acute bacterial rhinopharyngitis in children, as it is effective, safe, economic and simple to use.

Oxcarbazepine as an Adjunct of Antipsychotic Therapy in Acute Schizophrenia: A Double-blind, Randomised Placebo-controlled Clinical Trial

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
D. Koethe ◽  
L. Kranaster ◽  
M. Hellmich ◽  
B.M. Nolden ◽  
J. Klosterkoetter
Keyword(s):  
Rating Scale ◽  
Rate Of Change ◽  
Controlled Clinical Trial ◽  
Antipsychotic Therapy ◽  
Double Blind ◽  
Parallel Group ◽  
Significant Difference ◽  
Mixed Regression ◽  
Psychiatric Rating ◽  
Psychiatric Rating Scale

The outcome in treatment of schizophrenia is still not satisfactorily, and using the adjunctive administration of various anticonvulsant drugs adjunctive to antipsychotics has become widely distributed. This study determines the efficacy of oxcarbazepine combined to olanzapine in treatment of schizophrenia in a double-blind, randomized, placebo-controlled, parallel-group, add-on therapy, 7 week study in 54 patients suffering schizophreniform disorder or schizophrenia. Patients were randomized to oxcarbazepine or placebo and titrated up to 1800 mg/ day in week 1 and maintained at that dose for another 6 weeks. Treatment of olanzapine started at week 2 with 5 mg/day. According to weekly improvement in Brief Psychiatric Rating Scale (BPRS), olanzapine dose was maintained constant or escalated in regular steps of 2.5 mg. Main outcome measure was the cumulative olanzapine dose from beginning administration of oxcarbazepine/placebo for a period of 42 days. Comparing treatment of oxcarbazepine and olanzapine with placebo and olanzapine, there was no difference in cumulative olanzapine doses in both groups. in the oxcarbazepine group was not significantly more rescue medication given. A mixed regression model was used to assess time trends in BPRS over the treatment period: the differences in the rate of change of BPRS in the two treatment groups suggested that the scores sank more rapidly in the oxcarbazepine group (p=0.063). Mean post-treatment aggression score also showed no significant difference. Results from this study do not support the use of OXC as an adjunct to atypical antipsychotics in patients with schizophrenia.

scholarly journals Impact of vitamin A supplementation in anaemia during pregnancy: a randomized double blind controlled clinical trial

2018 ◽  
Vol 7 (6) ◽  
pp. 2262
Author(s):  
Shakun Singh ◽  
Rachna Chaudhary ◽  
Vandana Dhama ◽  
Anu Singh ◽  
Urmila Karya
Keyword(s):  
Clinical Trial ◽  
Vitamin A ◽  
Pregnant Women ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Vitamin A Supplementation ◽  
Elemental Iron ◽  
Group A ◽  
Group B ◽  
The Impact

Background: To study the impact of Vitamin A supplementation in anaemia during Pregnancy and thus improving maternal and fetal outcome a Randomized double blind controlled clinical trial was conducted in Department of Obstetrics and Gynaecology, L.L.R.M. Medical college Meerut involving 250 pregnant women in late pregnancy 18-28 weeks with haemoglobin levels <11 g% (7-11 g%)..Methods: The study subjects were divided into two groups: Group A (n=125): Received daily supplement containing Iron (60 mg elemental iron) + Folate (500 mcg) + Vitamin A 20,000 IU weekly for a minimum of 12 weeks. Group B (n=125): Received daily supplement containing iron (60 mg elemental iron) + Folate (500 mcg) for a minimum of 12 weeks.Results: Maximum patients were uneducated belonging to low socioeconomic status. The mean haemoglobin values in Group A and Group B increased from 9.674±1.05 and 9.53±1.04 to 12.2±0.89 and 10.82±1.06 respectively after supplementation. Similarily Serum Ferritin levels increased from 15.96±2.94 and 15.70±2.83 to 78.40±17.82 and 58.64±11.93. Mean corpuscular volume, packed cell volume and red blood cell counts also increased significantly. Maximum haemoglobin levels were achieved with both vitamin A and iron supplementation. The proportion of women who became non anaemic was 97.17% in Group A vs 68.69% in Group B.Conclusions: Vitamin A supplementation improves anaemia and also dramatically improves iron stores in anaemic pregnant women.

scholarly journals Randomized Controlled Clinical Trial Comparing Transurethral Eneucleation and Resection of Prostate and Trans-urethral Resection of Prostate in the Management of Benign Prostatic Hyperplasia

2017 ◽  
Vol 7 (3) ◽  
pp. 216-220
Author(s):  
Md Mehedi Hasan ◽  
Samira Rahat Afroze ◽  
Muhammad Abdur Rahim ◽  
Muhammad Abdus Salam
Keyword(s):  
Controlled Trial ◽  
Ethical Review ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Transurethral Resection Of Prostate ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Group A ◽  
The Mean ◽  
Group B

Background: Transurethral resection of prostate (TURP) is the predominant surgical procedure for benign prostatic hypertension (BPH) but is not devoid of complications like capsular perforation, drop in Hb%, drop in Na+, residual adenoma; hence endeavors are evolving to combat such complications. A newer technique transurethral enucleation and resection of prostate (TUERP) has been devised to solve these problems. This study was designed to compare the safety and the efficacy of newer technique, TUERP with widely practiced TURP Methods: This randomized controlled trial was done at BSMMU, after getting ethical approval from the ethical review committee of the institute, from January to October, 2009. A total of 60 BPH patients were purposively enrolled in this study, after obtaining informed written consent and they were randomized as control, Group A (30 patients, underwent TURP) and experimental group, Group B (30 patients, underwent TEURP).Results: The mean preoperative Hb% level of Group A was 15.1 gm% (SD ± 0.5) and perioperative Hb% level was 13.04 gm% (SD ± 6.06). There was significant difference (P <0.05). The mean preoperative Hb% of Group B was 15.2 gm% (SD ± 0.5) and perioperative Hb% was 15.2 gm% (SD ± 0.48). There was no difference (P >0.05). The mean preoperative Na + of Group A was 140 mmol/l (SD ± 4.1) and perioperative Na+ was 126 mmol/l (SD ± 6.8). There was significant difference (P<0.01). The mean preoperative Na+ of Group B was 136 mmol/l (SD ± 4) and perioperative Na+ was 136 mmol/l (SD ± 2.70). There was no difference (P >0.05).Conclusion: TUERP eliminates drop in Hb% and Na+which are usual consequences following TURP. Thus TUERP can be advocated in the treatment of BPH as it also allows completeresection down to surgical capsule.Birdem Med J 2017; 7(3): 216-220

scholarly journals Comparing efficacy and safety of sodium valproate with propranolol in paediatric migraine prophylaxis

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Varsha Gajbhiye ◽  
Lamture Yashwant R ◽  
Sadama Quazi
Keyword(s):  
Sodium Valproate ◽  
Migraine Prophylaxis ◽  
Efficacy And Safety ◽  
Before And After ◽  
Propranolol Group ◽  
Paediatric Age ◽  
Group A ◽  
The Mean ◽  
Group B ◽  
The Brain

Migraine is a common disorder of the paediatric age group. Propranolol has been used in prophylaxis for migraine.  The use of Sodium valproate in the prophylaxis of migraine is not known. It is postulated that it increases the level of GABA in the brain that will decrease events related to migraine in the cortex. All parents of the patient were advised to keep diaries for noting time, date, severity and duration of headache during the study period, which was for a period of 6 wks. The decreased frequency of headache more than in Group A was 68% and propranolol group was 68.89%. In group A(sodium valproate), patients showed a reduction in headache duration and 52% in Group B. 20% of them headache free in Group A and 18% in Group B. Decrease in the severity of headache in Group A was 52% while 50% in Group B. The mean headache frequency before and after treatment was reduced from 8 to 2.5 attacks per month in group A and from 8.2 to 2.6 in group B. The t-value is 11 for group A. Sodium valproate is more effective and safer in migraine prophylaxis as compared with propranolol.

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