scholarly journals A comparative prospective open label randomized controlled 8 week study in patients of depression treated with vilazodone and sertraline

2020 ◽  
Vol 7 (4) ◽  
pp. 643
Author(s):  
Nirmal Arya ◽  
Anuradha Nischal ◽  
Anil Nischal ◽  
Manu Agarwal

Background: Depression is a mood disorder treated with various antidepressant such as SSRIs due to lesser toxicity and improved safety profile.Methods: This was an eight week randomised active controlled parallel group study. 54 patients were allocated in two group. Group A received vilazodone while group B received sertraline. Assessment done at baseline, 2, 4 and 8 weeks on the basis of clinical efficacy, sexual dysfunction, side effects and weight gain using Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), Arizona Sexual Experience Scale (ASEX) and UKU Side Effect Rating Scale.Results: HAM-D score of group A was 18.78±1.78 and 7.67±1.66 while in group B was 19.04±2.12 and 8.15±1.77 at baseline and 8 weeks respectively. HAM-A score of group A was 15.44±1.50 and 6.63±1.39 while in group B was 15.26±1.83 and 7.07±1.14 at baseline and 8 weeks. ASEX total score of group A was 15.63±1.28 and 14.63±1.33 while group B was 15.52±1.37 and 16.41±1.12 at baseline and 8 weeks. ASEX desire score of group A was 9.63±0.93 and 8.67±0.88 while of group B was 9.59±0.93 and 10.07±0.92 at baseline and 8 weeks. UKU side effect rating at 2 and 8 weeks of group A was 0.22±0.42, 1.04±0.76 while in group B was 0.37±0.49, 1.89±0.85.Conclusions: Vilazodone and Sertraline are equally efficacious in treatment of depression and associated anxiety. When side effect profile were compared Vilazodone is found superior to Sertraline

2014 ◽  
Vol 2014 ◽  
pp. 1-11 ◽  
Author(s):  
D. D. Rajgor ◽  
N. J. Gogtay ◽  
V. S. Kadam ◽  
M. M. Kocharekar ◽  
M. S. Parulekar ◽  
...  

Background. Efficacy of standard dose of primaquine (PQ) as antirelapse for P. vivax has decreased. We aimed to assess efficacy of different PQ regimens. Methods. It was an open label, randomized, controlled, parallel group, assessor blind study comparing antirelapse efficacy of 3 PQ regimens (B=15 mg/day × 14 days, C=30 mg/day × 7 days, and D=30 mg/day × 14 days) with no PQ group (A) in P. vivax patients. Paired primary and recurrence samples were subjected to 3 methods: (i) month of recurrence and genotyping, (ii) by PCR-RFLP, and (iii) PCR sequencing, to differentiate relapse and reinfection. The rates of recurrence relapse and reinfection were compared. Methods were compared for concordance between them. Results. The recurrence rate was 16.39%, 8.07%, 10.07%, and 6.62% in groups A, B, C, and D, respectively P=0.004. The relapse rate was 6.89%, 1.55%, 4%, and 3.85% as per the month of recurrence; 8.2%, 2%, 4.58%, and 3.68% P=0.007 as per PCR-RFLP; and 2.73%, 1.47%, 1.55%, and 1.53% as per PCR sequencing for groups A, B, C, and D, respectively. The concordance between methods was low, 45%. Conclusion. The higher recurrence rate in no PQ as compared to PQ groups documents PQ antirelapse activity. Regimens tested were safe. However, probable resistance to PQ warrants continuous monitoring and low concordance and limitations in the methods warrant caution in interpreting.


Author(s):  
Mohit Trivedi ◽  
Vishal Dixit ◽  
Syed Esam Mahmood ◽  
Sunil Kumar Mishra ◽  
S. S. Keshari

Background: Propranolol and flunarizine have proven to be useful tools in migraine prophylaxis. This trial aims the comparison of the efficacy of flunarizine, flunarizine and placebo and flunarizine and panchgavya ghrit in migraine prophylaxis.Methods: The present study was a prospective, randomized, open-label, blinded-endpoint trial. Patients with chronic migraine were randomized (1:1:1) to flunarizine and flunarizine and placebo and flunarizine and panchgavya ghrit in three treatment groups. The study was carried out in outdoor patients in the department of Psychiatry, T.S. Mishra Medical College and Hospital, Lucknow and K.G.M.U, Ayush Department, Lucknow after clearance from Institutional Ethical Committee. Data was analysed using SPSS software.Results: The prevalence of migraine was found to be higher in the age group greater than 30 years and females. Overall there was more reduction in CGI scores in flunarizine with panchgavya ghrit and the other two groups equally at the end of 4, 6 8 and 10 weeks. Decrease in MIDAS score was observed after the therapy. Clinical Global Impression rating scale employed revealed that to start with subjects scored 7 which stands for pathology interfering in many life functions which reduced drastically in Group C as compared to Group B and Group A in descending order. Pain scales namely VAS (visual analogue scale), NPRS (Numeric Pain Rating Scale), VRS (verbal rating scale) when employed denoted there was decreased migraine frequency, decreased perception of pain, less intake of abortive medication consumed by subjects implying there were reduction in number of migraine days and there was decrease in the abortive medications taken for the same. Group C scored better on pain scales followed by Group B and Group A. Lower proportion of individuals in group C had Behavioural Toxicity and Neurological Side effects as compared to Group A and B.Conclusions: Panch gavya ghrit when administered along with flunarizine was more efficacious and safe when compared with other two groups. However large multicentric RCTs of long duration and involving more number of subjects are required to ascertain these facts.


2021 ◽  
Vol 15 (9) ◽  
pp. 2995-2998
Author(s):  
Abdulrahman Alharbi

Background: Current treatments for neuropathic pain (NeP) are tricyclic antidepressants (TCA), such as pregabalin and gabapentin are first-line drugs for the management of NeP complaints. Current treatment for the management of neuropathic pain is often sub-standard. Methods: It's a three-arm, prospective, comparative, open-label study. A total of 270 patients with persistent lumbar radiculopathy were randomized into three groups based on clinical examination, symptoms, X-rays, and MRI scans of the lumbosacral spine. Patients in Groups A and B got Gabapentine 300 mg, Pregabaline 75 mg, and Amitriptyline 75 mg, respectively. Results: The mean NPRS score at two months was 3.72 ± 2.65 for Group A, 3.63 ± 2.65 for Group B, and 5.21 ± 2.65 for Group C. The F-value was 6.63, and the p-value was 0.001, which was statistically significant. As compared to the other two treatment groups, the subjects in Group 3 saw a significant difference. ‎ The adverse effects reported occurrence of dizziness was significantly more in group B with 21 patients (23.33%) as compared to group A with 11 patients (12.22%) and group C with 4 patients (4.44%), [p=0.041). The sedation occurred in 28 patients of group B (31.11%), which was significantly more than group A i,e, in 23 patients (25.55%) and group C, i.e., 22 patients (24.44%), [P=0.036]. Conclusions: In patients with NeP Thus, in conclusion, three groups Gabapentine, Pregabaline, and Amitriptyline, are equally efficacious in relieving pain in NeP. Pregabalin has advantages in terms of Numeric pain rating scale (NPRS) score over the Gabapentine and Amitriptyline. Gabapentine has fewer reported adverse effects and hence better patient compliance on long-term use. Keywords: Gabapentine, Amitriptyline, Pregabalin, Neuropathic pain


2022 ◽  
Vol 2022 ◽  
pp. 1-7
Author(s):  
Dong Weiwei ◽  
Wu Bei ◽  
Wang Hong ◽  
Wu Cailan ◽  
Shao Hailin ◽  
...  

Purpose. This study aimed to determine whether and how stress-induced thyroid hormone changes occur during the COVID-19 pandemic in the northern area of Tianjin. Methods. This study comprised two groups of study subjects in Tianjin: before (2019) and during (2020) the COVID-19 outbreak. Subjects were included if they had FT3, FT4, and TSH concentrations and thyroid TPOAb or TgAb information available. People who were pregnant, were lactating, or had mental illness were excluded. We used propensity score matching to form a cohort in which patients had similar baseline characteristics, and their anxiety level was measured by the Hamilton Anxiety Rating Scale (HAMA). Results. Among the 1395 eligible people, 224 in Group A and 224 in Group B had similar propensity scores and were included in the analyses. The detection rate of abnormal thyroid function was decreased in pandemic Group B (69.2% vs. 93.3%, χ2 = 42.725, p < 0.01 ), especially for hypothyroidism (14.29% vs. 35.71%, χ2 = 27.429, p < 0.01 ) and isolated thyroid-related antibodies (25.89% vs. 38.39%, χ2 = 8.023, p < 0.01 ). The level of FT4 (z = −2.821, p < 0.01 ) and HAMA score (7.63 ± 2.07 vs. 5.40 ± 1.65, t = 16.873, p < 0.01 ) went up in Group B; however, TSH (z = −5.238, p < 0.01 ), FT3 (z = −3.089, p = 0.002 ), TgAb (z = −11.814, p < 0.01 ), and TPOAb (z = −9.299, p < 0.01 ) were lower, and HAMA was positive with FT3 (r = 0.208, p < 0.01 ) and FT4 (r = 0.247, p < 0.01 ). Conclusion. People in the northern area of Tianjin during the COVID-19 outbreak were at an increased risk of higher FT4, lower FT3, and lower TSH. The HAMA scores increased in emergency situations and were positively correlated with the levels of FT3 and FT4.


Vascular ◽  
2021 ◽  
pp. 170853812110100
Author(s):  
Mohamed Shukri Abdelgawad ◽  
Amr M El-Shafei ◽  
Hesham A Sharaf El-Din ◽  
Ehab M Saad ◽  
Tamer A Khafagy ◽  
...  

Background Venus ulcers developed mainly due to reflux of incompetent venous valves in perforating veins. Patients and methods In this randomized controlled trial, 119 patients recruited over two years, with post-phelebtic venous leg ulcers, were randomly assigned into one of two groups: either to receive radiofrequency ablation of markedly incompetent perforators (Group A, n = 62 patients) or to receive conventional compression therapy (Group B, n = 57 patients). Follow-up duration required for ulcer healing continued for 24 months post randomization. Results Statistically significant shorter time to healing (ulcer complete healing or satisfactory clinical improvement) between both groups (56 patients, 90.3% of cases in Group A versus 44 patients 77.2% of cases in Group B) over the follow-up period of 24 months was attained ( p  = 0.001). Also, significantly different ulcer recurrence was recorded between both groups, 8 patients (12.9%) in Group A versus 19 patients (33.3%) in Group B ( p = 0.004). Conclusion In absence of deep venous obstruction, the monopolar radiofrequency ablation for incompetent perforators is a feasible and effective method that surpasses the traditional compression protocol for incompetent perforator-induced venous ulcers in terms of time required for healing even in the presence of unresolved deep venous valvular reflux.


2021 ◽  
Vol 10 (3) ◽  
pp. 526
Author(s):  
Jakub Kwiatek ◽  
Aleksandra Jaroń ◽  
Grzegorz Trybek

Introduction: The most important factor which is responsible for the positive course of implant treatment is the process of osseointegration between the implant structure and the host’s bone tissue. The aim of this study was to assess what effect the 25-hydroxycholecalciferol concentration and vitamin D deficiency treatment have on changes in the bone level at the implant site during the process of osseointegration in the mandible. Materials and Methods: The study was with 122 people qualified for implant surgery, who were assigned to three research groups (A, B, and C). Laboratory, clinical, and radiological tests were performed on the day of surgery, and after 6 and 12 weeks. The bone level in the immediate proximity of the implant was determined by radiovisiography (RVG). Results: The bone level after 12 weeks in Groups B and C was significantly higher than after 6 weeks. The bone level in the study Group B was significantly higher than in Group A. The study showed that the higher the levels of 25-hydroxycholecalciferol were observed on the day of surgery, the higher was the level of bone surrounding the implant after 6 and 12 after surgery. Conclusion: The correct level of 25-hydroxycholecalciferol on the day of surgery and vitamin D deficiency treatment significantly increase the bone level at the implant site in the process of radiologically assessed osseointegration.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Bing-xin Kang ◽  
Hui Xu ◽  
Chen-xin Gao ◽  
Sheng Zhong ◽  
Jing Zhang ◽  
...  

Abstract Background We aimed to determine the efficacy and safety of multiple doses of intravenous tranexamic acid (IV-TXA) on perioperative blood loss in patients with rheumatoid arthritis (RA) who had undergone primary unilateral total knee arthroplasty (TKA). Methods For this single-center, single-blind randomized controlled clinical trial, 10 male and 87 female participants with RA, aged 50–75 years, who underwent unilateral primary TKA were recruited. The patients received one dose of 1 g IV-TXA 10 min before skin incision, followed by articular injection of 1.5 g tranexamic acid after cavity suture during the surgery. The patients were randomly assigned (1:1) into two groups and received an additional single dose of IV-TXA (1 g) for 3 h (group A) or three doses of IV-TXA (1 g) for 3, 6, and 12 h (group B) postoperatively. Primary outcomes were total blood loss (TBL), hidden blood loss (HBL), and maximum hemoglobin (Hb) level decrease. Secondary outcomes were transfusion rate and D-dimer levels. All parameters were measured postoperatively during inpatient hospital stay. Results The mean TBL, HBL, and maximum Hb level decrease in group B (506.1 ± 227.0 mL, 471.6 ± 224.0 mL, and 17.5 ± 7.7 g/L, respectively) were significantly lower than those in group A (608.8 ± 244.8 mL, P = 0.035; 574.0 ± 242.3 mL, P = 0.033; and 23.42 ± 9.2 g/L, P = 0.001, respectively). No episode of transfusion occurred. The D-dimer level was lower in group B than in group A on postoperative day 1 (P <  0.001), and the incidence of thromboembolic events was similar between the groups (P > 0.05). Conclusion In patients with RA, three doses of postoperative IV-TXA further facilitated HBL and Hb level decrease without increasing the incidence of adverse events in a short period after TKA. Trial registration The trial was registered in the Chinese Clinical Trial Registry (ChiCTR1900025013).


2021 ◽  
Vol 15 (7) ◽  
pp. 1801-1803
Author(s):  
Nazia Sajjad ◽  
Sara Qadir ◽  
Rukhsana Kasi ◽  
Tayyaba Rasheed ◽  
Fozia Unar ◽  
...  

Objectives: To compare the frequency of satisfactory quality of life between vaginal hysterectomy and abdominal hysterectomy. Study Design: Randomized controlled trial. Place and Duration of Study: Department of Obstetrics and Gynecology, Niazi Medical & Dental College, Sargodha from 1st April 2020 to 31st December 2020. Methodology: Ninety patients were comprised and they were divided in two groups; group A (vaginal hysterectomy) and Group B (abdominal hysterectomy) were performed. Hysterectomies (vaginal or abdominal) were performed by consultant gynecologist having experience at having least 5 years). Results: Mean age of the patients was 49.82±3.207 years, mean age of the patients of group A was 49.82±3.193 years and mean age of the patients of group B was 49.82±3.256 years. Satisfactory quality of life was noted in 38 (84.44%) patients of study group A and 29 (64.44%) patients of study group B. Statistically significant (P = 0.051) difference between the frequency of satisfactory quality of life between the both groups was noted. Conclusion: Results of this study reveals that post hysterectomy quality of life found more satisfactory in vaginal hysterectomy group as compared to abdominal hysterectomy group. Insignificant association of post hysterectomy quality of life with age group, marital status, parity and socio-economical status was found. Findings of this study also revealed that post hysterectomy satisfactory quality of life is not associated with education of the patients. Key words: Hysterectomy, Quality of life, abdomen, vagina, WHO, Uterus


Author(s):  
Priti A. Mehendale ◽  
Mayur T. Revadkar

Background: There is evidence regarding beneficial use of Transcutaneous Electrical Nerve Stimulation (TENS) on post Lower Segment Caesarean Section (LSCS) incision pain. However, efficacy of different types of TENS following C section pain has not yet been explored adequately.Methods: 96 women who had recently undergone LSCS were included for the study. The subjects were in the age group of 20 to 40 years (25.84±3.96); having pain intensity 4 or more on Numerical Pain Rating Scale (NPRS). They were divided into three groups by random allocation method; namely Group A: Acupuncture (Low/Motor) TENS, Group B: Conventional (High/Sensory) TENS and Group C: Control group. Group A and B received specific type of TENS twice a day for 15 minutes. Control group C did not receive any TENS intervention. All subjects received standard post-operative medications and physiotherapy. Pain intensity was recorded on NPRS pre and post intervention.Results: Both Acupuncture TENS and Conventional TENS significantly decreased post-operative pain intensity as compared to control group (p value <0.0001).Conclusions: Both, acupuncture and conventional TENS are equally effective in reducing post LSCS incision pain at a strong and non-painful intensity.


2018 ◽  
Vol 10 (1) ◽  
pp. 37-43
Author(s):  
Farshad Nouri ◽  
Seyed Ahmad Raeissadat ◽  
Dariush Eliaspour ◽  
Seyed Mansoor Rayegani ◽  
Maryam Sadat Rahimi ◽  
...  

Introduction: In this study, a single-blind and randomized controlled trial (RCT) for assessing the effectiveness of high-power (up to 12 W) laser therapy (HPLT) on patients with patellofemoral pain syndrome (PFPS) was carried out. Methods: Forty-four patients were randomly assigned to two treatment groups by generating random numbers with MATLAB 2014b software, where odd and even numbers were attributed to sham laser group (group A) and actual laser group (group B), respectively. Group B patients underwent HPLT with total dose of 300 J/session for 5 consecutive sessions separated by a 2-day interval. On the other hand, sham laser was applied to group A patients. Both groups had the same exercise therapy programs during the study period (3 months). The exercise therapy program included isometric knee exercise for 3 sets per day and 10 times in each set, with duration of 10 seconds per time and straight leg raise for 15 seconds 10 times a day. The group codes of patients were not revealed to subjects and data analyzer until completion of the study. Kujala, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and visual analog scale (VAS) questionnaires were chosen as outcome measures. These questionnaires were completed at three points during the study; at the beginning of the study to obtain the pre-therapy conditions and one month and three months after the start of the study to evaluate post-therapy conditions. Results: Two main analyses were conducted: within-group and between-group analyses. Withingroup analyses indicated significant improvements in respect to all measurements where pretherapy and post-therapy comparisons were conducted in both groups (P < 0.05). On the other hand, between-group comparisons did not reveal any statistically significant functional difference between group A and group B regarding the evaluative criteria (P > 0.05) except for pain VAS (P < 0.05). Conclusion: This study indicated that short-term HPLT accompanied by appropriate exercise regimen significantly decreased pain in patients with PFPS. But it was not recommended as an efficient modality in functional improvement. Also, it was observed that, in the short-term period of study, HPLT was a safe modality.


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