scholarly journals Comparative Efficacy, Safety and Tolerability of Olanzapine and Blonanserin in Patients with Schizophrenia: A Parallel Group Study

2021 ◽  
Vol 48 (2) ◽  
pp. 45-52
Author(s):  
S. Chattopadhyay ◽  
U. Roy ◽  
S. Biswas ◽  
P. Roy ◽  
P. Mandal
Keyword(s):  
Rating Scale ◽  
Statistical Tests ◽  
Vital Signs ◽  
P Value ◽  
First Line ◽  
Medical College ◽  
Parallel Group Study ◽  
Parallel Group ◽  
Haematological Profile ◽  
Safety Parameters

Abstract Background The antipsychotic olanzapine is a first-line drug in the treatment of schizophrenia while blonanserin is indicated in resistant cases of schizophrenia when the first line antipsychotics have failed. There are very limited studies available world-wide as well as in India that compare blonanserin with other antipsychotics in the setting of schizophrenia. Aims To study the efficacy, safety and tolerability of olanzapine and blonanserin in Schizophrenia. Settings and Design: The study was a prospective, observational, parallel group study done on schizophrenia patients aged between 18-50 years of both sexes at an outpatient Department of Psychiatry, in a tertiary medical college. The study was conducted from February 2015 to October 2016, with follow ups at weeks 4, 8 and 12. Materials and Methods The efficacy parameters were measured by the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impression (CGI) rating. The safety parameters included the vital signs, haematological profile, lipid profile, blood sugar monitoring. Adverse drug reactions and compliance to therapy was observed through-out the study period. Appropriate statistical tests were applied to detect any significant within and between group differences using Microsoft Excel 2007 and SPSS version 17. Results There was significant decrease in the mean total score on the BPRS and CGI-S in the blonanserin arm at the 2nd and last follow up visit (p value < 0.001). Compliance was good in both groups (≤ 20% missed pills). Overall, 77 treatment-emergent adverse events were present from 56 patients. Twenty three subjects of the blonanserin arm and 33 subjects in the olanzapine arm at least experienced one adverse event (p = 0.006), metabolic adverse effects were more common with olanzapine, whereas insomnia, headache and somnolence were more often seen with blonanserin. Conclusions In the present study, blonanserin provided significantly better outcomes than olanzapine with respect to BPRS, CGI-S scores.

scholarly journals A comparative study of the efficacy of amisulpride and olanzapine in patients with schizophrenia attending the outpatient Department of Psychiatry in a tertiary care hospital, Silchar, Assam, India

2019 ◽  
Vol 8 (2) ◽  
pp. 284
Author(s):  
Ali N. Yashin ◽  
Dolly Roy ◽  
Prosenjit Ghosh
Keyword(s):  
Atypical Antipsychotics ◽  
Rating Scale ◽  
Tertiary Care ◽  
P Value ◽  
Care Hospital ◽  
Brief Psychiatric Rating Scale ◽  
Parallel Group ◽  
Psychiatric Rating ◽  
Psychiatric Rating Scale

Background: Schizophrenia is one of the most commonly encountered psychiatric disorders. It is characterized by impairment in perception or expression of reality, leading to occupational and social dysfunction. Now a day’s mainstay of treatment of schizophrenia is by using atypical antipsychotics. Amisulpride and olanzapine are atypical antipsychotics which are commonly used in treatment of schizophrenia. The current study is undertaken to assess the efficacy of amisulpride which is a relatively newer antipsychotics against existing antipsychotic olanzapine.Methods: This was designed as a single-blind, prospective, parallel-group, observational study. Eighty adult patients of either sex were randomized to receive standard doses of the two drugs orally for 12 weeks, with follow up at 4 and 8 weeks. Effectiveness was assessed by change in the score of Brief Psychiatric Rating Scale (BPRS) and Clinical Global Impression (CGI) score during the treatment period. Data were entered in Microsoft excel and statistical analysis were done using graph pad and p value <0.05 considered to be statistically significant.Results: Out of 80 adults patients 76 patients were evaluated by dividing into two groups, 38 patients were included in each group. Final BPRS score was less for olanzapine as compared to amisulpride (p<0.001). Improvement in CGI score is more in olanzapine group than amisulpride group which became statistically significant from 8th weeks onwards.Conclusions: Both amisulpride and olanzapine are very effective in controlling the symptoms of schizophrenia which is evident by significant decrease in BPRS, CGI-S and CGI-I score, but efficacy of amisulpride is still inferior to olanzapine.

Efficacy, tolerability, and biomarker analyses from a phase III, randomized, placebo-controlled, parallel group study of gefitinib as maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC; INFORM; C-TONG 0804).

2011 ◽  
Vol 29 (18_suppl) ◽  
pp. LBA7511-LBA7511
Author(s):  
L. Zhang ◽  
M. Shenglin ◽  
X. Song ◽  
B. Han ◽  
Y. Cheng ◽  
...  
Keyword(s):  
Maintenance Therapy ◽  
Objective Response ◽  
Locally Advanced ◽  
Phase Iii ◽  
Chinese Patients ◽  
Symptom Improvement ◽  
First Line ◽  
Parallel Group Study ◽  
Parallel Group ◽  
Platinum Based Chemotherapy

LBA7511 Background: INFORM (a phase III, randomized, multicenter, parallel group study; NCT00770588 ) investigated the efficacy, safety and tolerability of gefitinib (G) vs. placebo (P) as maintenance therapy in pts with locally advanced/metastatic NSCLC following standard first-line platinum based chemotherapy. Methods: Pts (≥18 years, with stage IIIB/IV NSCLC and WHO performance status 0-2) had completed 4 cycles of first-line platinum based doublet chemotherapy without progression/unacceptable toxicity. Pts were randomized 1:1 to G 250mg/day or P on discontinuation of first-line therapy. Progression-free survival (PFS; primary endpoint) was assessed in the intent to treat population (Cox proportional hazards adjusted for histology [adenocarcinoma vs. non-adenocarcinoma], smoking status [never-smoker vs. smoker], EGFR mutation status [positive vs. negative vs. unknown] and best response to first-line chemotherapy [complete response/partial response vs. stable disease]). PFS was considered superior with gefitinib if the G:P hazard ratio (HR) upper confidence interval (CI) was <1.00. Secondary endpoints included overall survival (OS), objective response rate, disease control rate, symptom improvement and tolerability. Results: 296 pts (n=148 G, n=148 P) were randomized (27 centers in china; 26 September 2008-10 August 2009). PFS data cutoff on 24 January 2011. Median duration of follow-up was 16.8 months: 91% pts progressed; 59% deaths. Demography was balanced between treatments; overall, 54.1% pts were never-smokers, 70.6% had adenocarcinoma, and 40.9% were female. For G vs. P, PFS HR=0.42; 95% CI 0.32-0.54; p<0.0001; median PFS 4.8 vs. 2.6 months. Most common AEs (any grade) with G were rash (49.7%), diarrhea (25.2%), and ALT increase (21.1%) which were generally mild/moderate. Overall incidence of serious AEs: G (6.8%); P (3.4%). Other secondary endpoint data (including OS and biomarkers) will be presented. Conclusions: PFS was significantly longer with G compared with P as maintenance therapy in Chinese patients with locally advanced NSCLC.

Clinical outcome for continuous versus intermittent chemotherapy for unresectable metastatic colorectal cancer: Comparative analysis after first-line therapy.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 825-825
Author(s):  
Nadine Abdallah ◽  
AMR Mohamed ◽  
Hibah Ismail ◽  
Wei Chen ◽  
Alaa Akhras ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Statistical Tests ◽  
Random Effect ◽  
Random Effect Model ◽  
Primary Objective ◽  
Induction Treatment ◽  
P Value ◽  
First Line ◽  
Free Interval ◽  
Significant Difference

825 Background: Colorectal cancer (CRC) is the third most common and second most lethal cancer in the U.S, with almost 50% of patients developing metastatic disease. Although survival of metastatic CRC (mCRC) has improved significantly, current treatment strategies are associated with many adverse effects. With no prospect of cure, goals of treatment should consider both quantity and quality of life. Interruption of chemotherapy after induction can represent a means to achieve this balance. Methods: The primary objective of this meta-analysis is to assess the effect of continuation vs interruption of systemic therapy in terms of survival in patients with unresectable mCRC after first line treatment. Among 15 prospective studies published from 2009-2017, 9 qualified for inclusion. Random-effect model was used for pooled effects within two main categories: continuous chemotherapy vs chemotherapy-free interval after first line induction. Studies with maintenance fluoropyrimidine and/or bevacizumab were excluded. Primary endpoint was median progression free survival (PFS) and secondary endpoint was median overall survival (OS). z statistics were used for comparing subgroups. All statistical tests were two-sided. P values < 0.05 were considered significant. Results: 1366 patients (55% males) were included in the final analysis. Induction treatment was 5-FU or capecitabine-based chemotherapy with either oxaliplatin or irinotecan with or without bevacizumab. After stratifying for induction status, there was no statistically significant difference in median PFS between continuous vs chemotherapy free interval [Median PFS 4.74-month (95% CI 3.87-5.61) vs 3.52 month (95% CI 2.97-4.07), z-test adjusted p value 0.1383]. No significant difference in median OS between both groups [Median OS 16.95-month (95% CI 15.40-18.50) vs 18.35 month (95% CI 15.17-21.54)]. Conclusions: In mCRC patients, the superiority of continuous chemotherapy was not demonstrated. Further studies should shed light on patient and tumor characteristics most likely to benefit from continuous chemotherapy to limit delivery of cytotoxic therapy to this subset of patients.

scholarly journals Lamotrigine versus Valproic Acid as First-line Monotherapy in Newly Diagnosed Typical Absence Seizures: An Open-label, Randomized, Parallel-group Study

Epilepsia ◽  
2004 ◽  
Vol 45 (9) ◽  
pp. 1049-1053 ◽  
Author(s):  
Giangennaro Coppola ◽  
Gianfranca Auricchio ◽  
Rosario Federico ◽  
Marco Carotenuto ◽  
Antonio Pascotto
Keyword(s):  
Valproic Acid ◽  
Newly Diagnosed ◽  
First Line ◽  
Open Label ◽  
Absence Seizures ◽  
Parallel Group Study ◽  
Parallel Group

Efficacy and Safety of Intravenous Acetylsalicylic Acid Lysinate Compared To Subcutaneous Sumatriptan and Parenteral Placebo in the Acute Treatment of Migraine. A Double-Blind, Double-Dummy, Randomized, Multicenter, Parallel Group Study

Cephalalgia ◽  
1999 ◽  
Vol 19 (6) ◽  
pp. 581-588 ◽  
Keyword(s):  
Adverse Events ◽  
Acetylsalicylic Acid ◽  
Rating Scale ◽  
Double Blind ◽  
Efficacy Analysis ◽  
Parallel Group Study ◽  
Parallel Group ◽  
Significant Difference ◽  
Lysine Acetylsalicylate ◽  
Subcutaneous Sumatriptan

Two-hundred-and-seventy-eight patients with acute migraine attacks with or without aura were treated in 17 centers with 1.8 g lysine acetylsalicylate i.v. (Aspisol®;=1 g acetylsalicylic acid), 6 mg sumatriptan s.c. or placebo using a double-blind, double-dummy, randomized, multicenter parallel group study design. Two-hundred-and-seventy-five of them fulfilled the criteria for efficacy analysis, corresponding to 119 patients treated with lysine acetylsalicylate (L-ASA), 114 with sumatriptan and 42 with placebo injections. Both treatments were highly effective compared to placebo ( p <0.0001) in decreasing headache from severe or moderate to mild or none (verbal rating scale, VRS, placebo=23.8%). Sumatriptan showed a significantly ( p=0.001) better response (91.2%) compared to L-ASA (response 73.9%). Of the patients in the L-ASA-group, 43.7% were pain-free after 2 h; 76.3% after sumatriptan and 14.3% after placebo. It took patients on average 12.6 (L-ASA), 8.2 (sumatriptan), and 19.4 h (placebo) to be able to work again. There was no significant difference between treatment groups in recurrence of headache in responders within 24 h (18.2% L-ASA, 23.1% sumatriptan, 20% placebo). Accompanying symptoms (nausea, vomiting, photophobia, phonophobia, and visual disturbances) improved with both verum treatments to a similar extent. L-ASA was significantly better tolerated than sumatriptan (adverse events L-ASA 7.6%, sumatriptan 37.8%). In conclusion, subcutaneous sumatriptan and lysine acetylsalicylate i.v. are effective treatments for patients suffering from migraine attacks. Sumatriptan is more effective, but resulted in more adverse events.

scholarly journals Comparative Efficacy of Tamsulosin Versus Tamsulosin Plus Finasteride in Patients with Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hypertrophy, a Randomized Open Label Parallel Group Study

2021 ◽  
Vol 14 (4) ◽  
pp. 2205-2219
Author(s):  
Cijoy Jose P ◽  
V.P. Karthik ◽  
Vasanthi Vasanthi ◽  
Punnagai guna
Keyword(s):  
Urinary Tract ◽  
Lower Urinary Tract Symptoms ◽  
Lower Urinary Tract ◽  
Benign Prostatic Hypertrophy ◽  
Prostatic Hypertrophy ◽  
P Value ◽  
Parallel Group Study ◽  
Parallel Group ◽  
Urinary Tract Symptoms ◽  
Lower Urinary

Background: Benign prostatic hypertrophy (BPH) is a common entity among elderly men and is responsible for significant disability. Medical treatment for BPH has played a major role in improving the symptoms associated with bladder outlet obstruction. Recent guidelines recommend the combination of an alpha-1 blocker and a 5-ARI as first-line treatment of men with moderate-to-severe LUTS. There is limited study data to support which is the effective therapy for BPH/LUTS in a tertiary care hospital in India. Methods: A randomized, open labelled, double blind, active control parallel group study comparing the safety and efficacy of tamsulosin versus tamsulosin+finasteride in subjects with lower urinary tract symptoms secondary to benign prostatic hypertrophy. The subjects were randomized after obtaining written informed consent. The subjects were recruited from the patient population that was attending the Out-Patient department of Urology, Sri Ramachandra Medical College & Research Institute, Sri Ramachandra University. Results: A total sample of 60 subjects, 30 into each group was enrolled. In the tamsulosin group, according to IPSS score, 11 patients who had moderate symptoms (36.7%) became mild, and among 19 patients who had severe symptoms (63.3%), 12 patients became mild (40%) and 7 patients became moderate (23.3%) with a p value of 0.021 which is statistically significant. In the tamsulosin+ finasteride group, according to IPSS score, 10 patients who had moderate symptoms (33.3%) became mild, and among 20 patients who had severe symptoms (66.7%), 12 patients became mild (40%) and 8 patients became moderate (26.7%) with a p value of 0.020 which is statistically significant. When comparing between the two groups, 76.7% attained mild symptoms in group 1 and 73.3% patients attained mild symptoms in group 2 with a p value of 0.766 which is statistically not significant. Conclusion: To conclude tamsulosin 0.4mg is as effective as the combination therapy of tamsulosin 0.4mg and finasteride 5mg in the treatment of lower urinary tract symptoms secondary to Benign prostatic hypertrophy.

scholarly journals Complimentary Feeding Practices in Under-2 Children

2014 ◽  
Vol 13 (3) ◽  
pp. 35-41 ◽  
Author(s):  
Shanjoy Kumar Paul ◽  
Quazi Rakibul Islam ◽  
Sunirmal Roy ◽  
Pranab Kumar Rudra
Keyword(s):  
Statistical Tests ◽  
Statistical Significance ◽  
Feeding Practices ◽  
Cross Sectional Study ◽  
P Value ◽  
Cross Sectional ◽  
Medical College ◽  
Data Collection Sheet ◽  
Appropriate Practices ◽  
Detrimental Impact

Background: Complimentary feeding (CF) practices are quiet frustating in our country. Innaproprite foods in first two years of life have detrimental impact on health and growth of children. The aim of the study was to see the present pattern of CF practices, to identify wrong practices and to  develop awareness among medical professionals so that they may encourage appropriate practices more vigorously for reducing child mortality and morbidity.Methods: A cross-sectional study was conducted from October, 2011 to December, 2011 in the Pediatric department (indoor and outdoor) of Sir Salimullah Medical College Mitford Hospital, Dhaka and in a private chamber of a district town of Bangladesh. Four hundred motherchild pairs were selected by non-random convenience sampling method. 6-24 months old children and children under six months (if was on complimentary feeding) were included. Data was collected from the mothers/caregivers of the children in a pretested semi-structured data collection sheet and analyzed by SPSS version 12. Appropriate statistical tests were done. Statistical significance was considered if p value was <0.05. Results: Early initiation was very high (49.25%). Most common first complimentary food was rice gruel with milk (26.56%). Most common current main complimentary food (25.52%) and most common main complimentary food fed in last 24 hours (26.82%) was also rice gruel with milk. Amount of complimentary food per feed was inappropriate in most cases. Frequency of CF was not appropriate in many cases. Fast foods and commercial cereal  were given to 54.8% & 33.33% children respectively. Only 1% mothers/caregivers had sound knowledge about CF. Positive support from family regarding practicing appropriate CF was found in 24.75% cases. Feeding practices were mostly influenced by relatives (25%).Conclusion: CF practices are still not ideal in our country. So, all possible interventions should be applied to improve it and thus to improve child survival.DOI: http://dx.doi.org/10.3329/cmoshmcj.v13i3.21020

scholarly journals An open label study on Depression Patient's Disability Outcomes: Comparative Evaluation of Escitalopram and Amisulpride

2016 ◽  
Vol 5 (2) ◽  
pp. 37-42
Author(s):  
Vijay Kaul ◽  
Shaktibala Dutta ◽  
Mirza Atif Beg ◽  
Nand Kishore Singh ◽  
Shalu Bawa ◽  
...  
Keyword(s):  
Rating Scale ◽  
Public Health Problem ◽  
P Value ◽  
Disability Assessment ◽  
Global Public Health ◽  
Open Label ◽  
Medical College ◽  
Group I ◽  
Intergroup Comparison ◽  
Significant Difference

Background Depression is an important global public health problem due to its relatively high lifetime prevalence and significant disability caused by it. The present study was conducted to compare improvement in disability outcome by Amisulpride and Escitalopram among depression patients using WHO-Disability Assessment Schedule (WHO-DAS).Materials and Methods The study was conducted in depression patients for 1 year in the Department of Neuropsychiatry, Nepalgunj Medical College & Teaching Hospital. A total of 117 depression patients were divided into 2 groups. Group I (58 patients) received Amisulpride tablet at a dose of 50 mg/day and Group II (59 patients) were given Escitalopram at a dose of 10 mg/day. The patients were required to follow up at 4 weeks, 8 weeks and at 15 weeks. The efficacy of the drugs was calculated by Hamilton depression rating scale (HAM-D). The improvement in functional outcome was compared between the two groups by using WHO-Disability Assessment Schedule (WHO-DAS). Appropriate statistical tools using GraphPadInstat 3.0 were used for analysis. p value < 0.05 was considered significant.Results HAM-D score in group receiving Amisulpride at 0 and 15 weeks was 16.92±0.35 and 7.87±0.29 (p<0.0001). HAM-D score in group receiving Escitalopram at 0 and 15 weeks was 17.09±0.39 and 6.63±0.39 (p<0.0001). WHO-DAS score in group receiving Amisulpride at 0 and 15 weeks was 112.54±0.82 and 43.08±1.41 (p<0.0001) respectively. WHO-DAS in group receiving Escitalopram at 0 and 15 weeks was 113.73±1.92 and 40.69±1.49 (p<0.0001) respectively. Intergroup comparison at 15 weeks was insignificant (p>0.05). Gastrointestinal disturbances, sexual disturbances, amenorrhea, lactation, agitation and insomnia were the commonly encountered adverse drug reactions.Conclusion Both Amisulpride and Escitalopram showed improvement in WHO Disability Assessment Score (WHO-DAS) at the end of study period. But intergroup comparison showed no significant difference in the two groups. Journal of Nobel Medical College Vol.5(2) 2016; 37-42

scholarly journals The effect of Lavender Aromatherapy on labor pain among delivery women

2020 ◽  
pp. 13
Author(s):  
Aqliya Nursahidah ◽  
Shinta Novelia ◽  
Anni Suciawati
Keyword(s):  
Rating Scale ◽  
Statistical Tests ◽  
Stress Hormones ◽  
Active Phase ◽  
Numeric Rating Scale ◽  
Labor Pain ◽  
Control Group ◽  
P Value ◽  
Control Group Design ◽  
Post Test

This study aims to find out the effect of aromatherapy lavender on labor pain,  Labor pain is a manifestation of cervical nerve compression. When there is pain, stress hormones cause the opening of the cervix is ​​inadequate, so that labor can increase in time. The way to deal with labor pain, which is one of them with non-pharmacological methods, aromatherapy lavender is known to contain linalool, the main active ingredient that plays a role in the relaxing effect to reduce pain and anxiety. This research using the quasi-experiment, with a post-test only control group design, with the first group or 15 respondent given lavender aromatherapy while the second group or 15 respondent was not given, the sample in this study were 30 respondents in the first phase of active labor. Labor pain assessment using a Numeric Rating scale. Statistical tests using the Mann Whitney test showed that the P value was 0.002<0.05, so it can be concluded that there was an effect of lavender aromatherapy on labor pain during the first of the active phase at the Afifah Clinic in Bandung Regency.

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