scholarly journals Oxcabazepine (®Trileptal) in Anti-Epileptic Polytherapy

1990 ◽  
Vol 3 (1) ◽  
pp. 35-39 ◽  
Author(s):  
Peder Klosterskov Jensen
Keyword(s):  
Seizure Frequency ◽  
Active Metabolite ◽  
Epileptic Activity ◽  
Double Blind Study ◽  
Duration Of Treatment ◽  
Double Blind ◽  
Significant Difference ◽  
Daily Dose ◽  
Adults And Children ◽  
Clonic Seizures

The anti-epileptic activity of oxcarbazepine (OXC) was compared with that of carbamazepine (CBZ) and the primary active metabolite of OXC, a monohydroxy derivative (MHD). Altogether 255 patients receiving either OXC or MHD (192 and 63 patients respectively) were included in the analysis of efficacy. Out of these 255 patients a total of 40 were children. The duration of treatment varied between 8 and 24weeks. The daily dose of OXC or MHD varied between 600 and 5400 mg (in children 600–2400 mg). Out of five studies two were double-blind controlled studies (including a total of 105 patients) whereas the remaining three were open studies. The results of these studies indicate that, in adults with epilepsy, there is no statistically significant difference in overall seizure frequency between CBZ and OXC. In one double-blind study the number of generalized tonic-clonic seizures was significantly less frequent during treatment with OXC than with CBZ. No statistically significant difference with regard to side-effects was observed between OXC and CBZ. The results in children with epilepsy show a statistically significant difference in seizure frequency in favour of OXC, in comparison with CBZ. Overall, the polytherapy studies in adults and children support the effectiveness and safety of oxcarbazepine.

A Comparison of the Efficacy and Safety of Alprazolam and Desipramine in Depressed Outpatients

1988 ◽  
Vol 33 (7) ◽  
pp. 590-594 ◽  
Author(s):  
Ronald A. Remick ◽  
F. Douglas Keller ◽  
R.A. Buchanan ◽  
R.E. Gibson ◽  
J.A.E. Fleming
Keyword(s):  
Active Drug ◽  
Severity Of Illness ◽  
Common Side Effect ◽  
Double Blind Study ◽  
Double Blind ◽  
Drug Study ◽  
Antidepressant Effects ◽  
Significant Difference ◽  
Daily Dose ◽  
The Mean

Fifty-two adult depressed outpatients fulfilling Research Diagnostic Criteria for Definite Major Depressive Disorder were enrolled in a double-blind study comparing the antidepressant effects of alprazolam versus desipramine. Twenty-nine patients completed the seven week (one week placebo followed by six weeks of active drug) study. The mean daily dose of alprazolam and desipramine at study termination was 3.34 mg and 192 mg respectively. Based on psychometric ratings of depression (Hamilton Scale) and severity of illness (Clinical Global Impressions) there was no significant difference between alprazolam and desipramine at the end of six weeks of active drug treatment. Both medications were well tolerated with drowsiness being the most common side effect of alprazolam, and insomnia, dry mouth, and constipation, the complaints most associated with desipramine.

Sulphadiazine/Trimethoprim Once Daily in Maxillary Sinusitis: A Randomized Double-Blind Comparison with Sulphamethoxazole/Trimethoprim B.I.D.

1981 ◽  
Vol 9 (6) ◽  
pp. 478-481 ◽  
Author(s):  
Pierre Federspil ◽  
Peter Bamberg
Keyword(s):  
Maxillary Sinusitis ◽  
Favourable Result ◽  
Double Blind Study ◽  
Double Blind ◽  
Once Daily ◽  
Days Of Therapy ◽  
Significant Difference ◽  
Blind Comparison ◽  
Cure Rates

In a randomized double-blind study fifty-four patients suffering from acute maxillary sinusitis were treated for 10 days with daily doses of sulphadiazine/trimethopim (1 g) and sulphamethoxazole/trimethoprim (1.92 g), respectively. The efficacy was evaluated clinically at two follow-up visits. X-ray investigations were performed at admission and after the therapy. Of thirty-nine patients finally evaluated, thirty-seven showed a favourable result. After 6–8 days of therapy there was significant difference in cure rates in favour of sulphadiazine/trimethoprim (p < 0.05) while the outcome as evaluated after treatment was similar for both drugs.

Duloxetine augmentation in resistant obsessive compulsive disorder: Surveying a new medication for challenges in treatment of OCD

2017 ◽  
Vol 41 (S1) ◽  
pp. S415-S415
Author(s):  
A. Mowla
Keyword(s):  
Obsessive Compulsive Disorder ◽  
Primary Outcome Measure ◽  
Controlled Clinical Trial ◽  
Double Blind Study ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Compulsive Disorder ◽  
Significant Difference ◽  
Competing Interest ◽  
To Receive

IntroductionUp to 50% of patients with OCD have failed to respond in SSRI trials, so looking for pharmacological alternatives in treatment of obsessive compulsive disorder (OCD) seems necessary.ObjectivesSurveying duloxetine augmentation in treatment of resistant OCD.AimsStudy the effects of serotonin-norepinephrine enhancers for treatment of OCD.MethodsThis augmentation trial was designed as an 8-week randomized controlled, double blind study. Forty-six patients suffering from OCD who had failed to respond to at least 12 weeks of treatment with a selective serotonin reuptake inhibitor (fluoxetine, citalopram or fluvoxamine) were randomly allocated to receive duloxetine or sertraline plus their current anti OCD treatment. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) was the primary outcome measure.ResultsForty-six patients (24 of 30 in duloxetine group and 22 of 27 in sertraline group) completed the trial. Both groups showed improvement over the 8-week study period (mean Y-BOCS total score at week 8 as compared with baseline: P < 0.001 and P < 0.001) without significant difference (P = 0.861). Those receiving duloxetine plus their initial medications experienced a mean decrease of 33.0% in Y-BOCS score and the patients with sertraline added to their initial medication experienced a mean decrease of 34.5% in Y-BOCS.ConclusionsOur double blind controlled clinical trial showed duloxetine to be as effective as sertraline in reducing obsessive and compulsive symptoms in resistant OCD patients. However, it needs to be noted that our study is preliminary and larger double blind placebo controlled studies are necessary to confirm the results.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Azelastine in the Prophylactic Treatment of Bronchial Asthma: An Italian Multicentre Comparison with Ketotifen

1989 ◽  
Vol 17 (3) ◽  
pp. 218-225 ◽  
Author(s):  
L. Ambrosi ◽  
F. Bariffi ◽  
M. Carino ◽  
E. Catena ◽  
G. Ceccarelli ◽  
...  
Keyword(s):  
Bronchial Asthma ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Effective Prophylaxis ◽  
Daily Dosage Regimen ◽  
Forced Expiratory Flow ◽  
Expiratory Flow ◽  
Low Incidence ◽  
Clinical Measures

The prophylactic effectiveness of the phthalazinone derivative, azelastine was compared with ketotifen. A total of 111 patients, aged 18 – 65 years, from 10 centres was entered into this randomized, double-blind study. All patients had reversible asthma. After 1 week on placebo, patients were allocated to either 8 mg/day azelastine once or twice daily, or to 1 mg ketotifen, twice daily, for a further 12 weeks. Azelastine was more effective in improving respiratory function (forced expiratory flow in 1 s and peak expiratory flow rate) when given in the once daily regimen, whereas clinical measures (number of weekly asthma attacks) were most improved by twice daily dosing. There was no significant difference between the effectiveness of azelastine and that of ketotifen. Treatments were equally well tolerated and a low incidence of side-effects was reported. In conclusion, 8 mg/day azelastine, in either a single or twice daily dosage regimen may be regarded as providing effective prophylaxis against bronchial asthma.

scholarly journals Role of pre–extubation fentanyl in mastectomy: a randomized, controlled, double–blind study

2021 ◽  
Vol 25 (2) ◽  
Author(s):  
Ahmed Salman ◽  
Norma Osama Zayed ◽  
Ahmed Mansour ◽  
Ramy Howaidi ◽  
Ahmed Gamaleldin Foly ◽  
...  
Keyword(s):  
Short Form ◽  
Cardiovascular Responses ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Randomized Controlled ◽  
Arterial Blood ◽  
Extubation Time ◽  
Significant Difference

Background: Both tracheal intubation and extubation are associated with dangerous consequences such as tachycardia, hypertension, myocardial ischemia and arrhythmias. The aim was to evaluate pre–extubation two different doses of fentanyl on hemodynamic stabilization and delayed recovery in mastectomy. Methodology: The randomized controlled double–blind study was conducted on 126 patients aged 16–60 years, with controlled hypertension, receiving chemotherapy before surgery and underwent mastectomy for breast cancer. Patients were randomly allocated into 3 equal groups. Before extubation, patients received 10 ml saline in group (C), 1 µg/kg fentanyl in Group–F1: and 2 µg/kg fentanyl in Group–F2. Mean arterial blood pressure (MAP) and heart rate (HR) were recorded at T1 (after maintenance of anesthesia), T2 (after giving the test drug), T3 (immediately after extubation), T4 (5 min. after extubation) and T5 (15 min after extubation). Results: MAP was significantly lower in fentanyl groups compared to Group–C at T2 and T3 without significant deference between fentanyl groups. HR was significantly lower in fentanyl groups compared to Group–C and in Group–F2 compared to Group–F1 at T3, T4 and T5. Time of extubation was significantly prolonged in Group–F2 compared to Group–F1 and Group–C without a significant difference between Group–F1 and Group–C. Conclusions: Pre–extubation fentanyl 1 µg/kg blunted cardiovascular responses to extubation without respiratory depression or prolonged recovery. Pre–extubation fentanyl 2 µg/kg provide more control in HR but with delay in the extubation time compared to 1 µg/kg of fentanyl. Key words: Pre–Extubation, Fentanyl, Mastectomy, Hemodynamics, Recovery Preregistration: The study was registered in the Ethical Committee of Faculty of Medicine, Cairo University, Cairo, Egypt (approval number: 281) Citation: Salman A, Zayed NO, Mansour A, Howaidi R, Foly AG, ElSharkawy MS, Abdelgalil AS. Role of pre–extubation fentanyl in mastectomy: a randomized, controlled, double–blind study. Anaesth. pain intensive care 2021;25(2):143-149. DOI: 10.35975/apic.v25i2.1462. Abbreviations: CST=Craniosacral therapy; SMT=Sensorimotor training; NCLBP=Nonspecific chronic low back pain; VAS=Visual analogue scale; ODI=Oswestry disability index, BDI-II=Beck depression inventory-II, and SF-36=Short Form-36; CSF=cerebral spinal fluid; CSS=craniosacral system; PRM=primary respiratory movements Received: 27 June 2020, Reviewed: 24 July 2020, Accepted: 27 July 2020

scholarly journals Pull vs. wet: rendimiento diagnóstico y calidad de las muestras de las PAAF guiadas por USE en las masas sólidas del páncreas

2021 ◽  
Vol 51 (1) ◽  
Author(s):  
Cecilia Curvale ◽  
Ignacio Málaga ◽  
Paloma Rojas Saunero ◽  
Viviana Tassi ◽  
Enrique Martins ◽  
...  
Keyword(s):  
Endoscopic Ultrasound ◽  
Fine Needle Aspiration ◽  
Diagnostic Yield ◽  
Needle Aspiration ◽  
Double Blind Study ◽  
Cell Block ◽  
Ultrasound Guided ◽  
Double Blind ◽  
Fine Needle ◽  
Significant Difference

Differential diagnosis of pancreatic masses is challenging. The endoscopic ultrasound-guided fine-needle aspiration method with the highest diagnostic yield has not been established. It was realized a prospective, randomized, double-blind study of the endoscopic ultrasound-guided fine-needle aspiration in solid lesions of the pancreas to compare and evaluate diagnostic yield and aspirate quality between wet and pull technique. Forty-one patients were enrolled. The wet technique presented a sensitivity, a specificity, a positive and negative predictive value, and a diagnostic accuracy of 58.3%, 100%, 100%, 25% and 63.4%, respectively. In the capillary technique they were: 75%, 100%, 100%, 35.7% and 78.1%, respectively. Comparing the diagnostic yield between both techniques, there was no statistically significant difference (McNemar’s test p = 0.388). Regarding the cellularity of the specimen, both in cytology and the cell block samples, no significant difference was observed between the techniques (p = 0.84 and 0.61, respectively). With respect to contaminating blood in the specimen, there was no difference in cytology samples (p = 0.89) and no difference in cell block samples (p = 0.08). The suitability of cytology samples for diagnosis was similar in both techniques (wet = 57.5% and capillary = 56.7%, p = 0.94) and there was no difference in cell block samples (wet = 75% and capillary = 66.1%, p = 0.38). In this study we did not observe differences in diagnostic yield or sample quality. Since both techniques are effective, we suggest the simultaneous and alternate use of both methods.

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 Intra-articular morphine versus bupivacaine for knee motion among patients with osteoarthritis: randomized double-blind clinical trial

2008 ◽  
Vol 126 (6) ◽  
pp. 309-313 ◽  
Author(s):  
Miriam Bellini Gazi ◽  
Rioko Kimiko Sakata ◽  
Adriana Machado Issy
Keyword(s):  
Pain Clinic ◽  
Osteoarthritis Of The Knee ◽  
Double Blind Study ◽  
Double Blind ◽  
Analgesic Effects ◽  
Numerical Scale ◽  
Double Blind Clinical Trial ◽  
Significant Difference ◽  
Pain At Rest ◽  
Flexion And Extension

CONTEXT AND OBJECTIVE: Osteoarthritis causes pain and disability in a high percentage of elderly people. The aim of the present study was to assess the efficacy of intra-articular morphine and bupivacaine on the joint flexion and extension angles of patients with knee osteoarthritis. DESIGN AND SETTING: A randomized double-blind study was performed at a pain clinic of Universidade Federal de São Paulo. METHODS: Thirty-nine patients with pain for more than three months, of intensity greater than three on a numerical scale (zero to 10), were included. G1 patients received 1 mg (1 ml) of morphine diluted in 9 ml of saline, intra-articularly, and G2 patients received 25 mg (10 ml) of 0.25% bupivacaine without epinephrine. Pain was assessed on a numerical scale and knee flexion and extension angles were measured after administration of the drugs at rest and during movement. The total amount of analgesic supplementation using 500 mg doses of paracetamol was also determined. RESULTS: No significant difference in pain intensity was observed between G1 and G2. Significant decreases in pain at rest and during movement and significant increases in mean flexion and extension angles were observed in both groups, with no significant difference between the two groups. The mean total amount of paracetamol used over a seven-day period was 3578 mg in G1 and 5333 mg in G2 (P = 0.2355; Mann-Whitney test). CONCLUSION: The analgesic effects of 1 mg of morphine and 25 mg of 0.25% bupivacaine were similar among patients with osteoarthritis of the knee.

scholarly journals A Multicenter, Prospective, Randomized, Placebo-Controlled, Double-Blind Study of a Novel Pain Management Device, AT-02, in Patients with Fibromyalgia

Pain Medicine ◽  
2019 ◽  
Vol 21 (2) ◽  
pp. 326-332 ◽  
Author(s):  
Hiroshi Oka ◽  
Kenji Miki ◽  
Iwao Kishita ◽  
David F Kong ◽  
Takahiro Uchida
Keyword(s):  
Rating Scale ◽  
Numerical Rating Scale ◽  
Repeated Measure ◽  
Controlled Clinical Trial ◽  
Double Blind Study ◽  
Double Blind ◽  
Point Change ◽  
Entire Treatment Period ◽  
Magnetic Field Therapy ◽  
Significant Difference

Abstract Objectives Existing treatments for fibromyalgia have limited efficacy, and only a minority of individuals clinically respond to any single intervention. This study was a prospective, multicenter, randomized, double-blind, controlled clinical trial to evaluate the feasibility of alternating magnetic field therapy in fibromyalgia patients by comparing the Angel Touch device (AT-02) with a sham control (S-01). Methods Two sites enrolled 44 subjects with diagnosed fibromyalgia. After informed consent, subjects taking prohibited concomitant drugs underwent a washout period of two or more weeks. All subjects then began a one-week run-in period. Numerical rating scale (NRS) pain scores were collected without device intervention for one day, followed by S-01 application to four or more painful sites for 10 minutes at each site, twice daily for six days. Subjects were then randomized to AT-02 or S-01, applied to four or more painful sites for 10 minutes at each site, twice daily for eight weeks. NRS scores were obtained twice daily during the entire treatment period. Results The primary end point (change in NRS ± SD at week 8 vs baseline) was –0.94 ± 1.33 in the AT-02 group and –0.22 ± 1.38 in the S-01 group. A trend toward a between-group difference in eight-week NRS scores favored the AT-02 group (–0.73, 95% confidence interval = –1.56 to 0.11, P = 0.086). An adjusted repeated measure analysis detected a significant difference in NRS scores (P = 0.039). Conclusions The reduction in NRS scores for AT-02 relative to sham was comparable to reductions observed in meta-analyses of fibromyalgia drug therapy. The unadjusted results and the persistence of the pain score reductions remain encouraging.

Daflon 500 mg: Symptoms and Edema

Angiology ◽  
2005 ◽  
Vol 56 (6_suppl) ◽  
pp. S25-S32 ◽  
Author(s):  
Albert-Adrien Ramelet
Keyword(s):  
Quality Of Life ◽  
Controlled Study ◽  
Venous Disease ◽  
Double Blind Study ◽  
Life Questionnaire ◽  
Double Blind ◽  
Randomized Controlled ◽  
Randomized Controlled Studies ◽  
Significant Difference

Patients suffering from any class of the Clinical, Etiological, Anatomical, Pathophysiological (CEAP) classification of chronic venous disease (CVD) may be symptomatic (C0s-C6s). Leg heaviness, discomfort, itching, cramps, pain, paresthesia, and edema (C3) are the most frequent manifestations of CVD and a major reason for medical consultation. Daflon 500 mg (micronized purified flavonoid fraction [MPFF]) is an effective treatment for symptoms and edema in CVD as demonstrated in several randomized controlled studies. A 2-month, double-blind study in 40 patients established the superiority of Daflon 500 mg over placebo with regard to symptoms and objective signs. This was confirmed in another double-blind, placebo-controlled trial (2 months’ treatment, 160 patients), and in the Reflux assEssment and quaLity of lIfe improvEment with micronized Flavonoids (RELIEF) study. The latter included 5,052 patients in 23 countries, using a visual analog scale for evaluating pain, leg heaviness, cramps, and a sensation of swelling. All symptoms showed significant and progressive improvement. The quality-of-life results (scores on the ChronIc Venous Insufficiency quality of life Questionnaire [CIVIQ]) paralleled those of symptoms. The decrease in the ankle and calf circumferences was significantly greater (p<0.001) in the group of patients treated with Daflon 500 mg in two studies, and correlated well with the improvement in the sensation of swelling (p<0.001). This was confirmed with more sophisticated measurement techniques as in the RELIEF study or in a trial assessing edema with an optoelectronic volumeter in 20 patients. A further double-blind, randomized, controlled study established a statistically significant difference in favor of Daflon 500 mg in comparison with diosmin, both on symptoms and edema. The therapeutic efficacy of Daflon 500 mg on CVD symptoms and edema has been demonstrated in double-blind, randomized, controlled studies. Further studies using a new approach may define the most precise and validated methodology for application in future research in phlebology.

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