scholarly journals A Multi-centered Study to Evaluate the Efficacy and Safety of Amitriptyline and Mecobalamine in the Management of Neuropathic Pain

2019 ◽  
Vol 4 (01) ◽  
Author(s):  
Dr. Mayuresh Dilip Kiran ◽  
Shaheen Naseem Sheikh ◽  
Lalit Jeeevan Pawaskar
Keyword(s):  
Neuropathic Pain ◽  
Adverse Events ◽  
Risk Reduction ◽  
Safety Assessment ◽  
Moderate Intensity ◽  
Efficacy And Safety ◽  
Vas Score ◽  
Efficacy Assessment ◽  
The Central Nervous System ◽  
Patients Experience

Introduction: Neuropathic Pain (NP) is known as ‘nerve pain’- is a type of chronic pain that occurs when nerve in the central nervous system becomes damage or injured. An FDC of Amitriptyline a neuroanalgesia and Mecobalamine (Vitamin B12) a damage nerve rejuvenator have an important role in management of NP. Methodology: Of 786 registered, 666 patients completed the study. Efficacy assessment was made by reduction in mean VAS score and ≥50% reduction in NP was calculated at conclusion visit and used to determine the corresponding NNT which was calculated by using risk reduction. Safety assessment was made by inspecting the adverse events during trial. Results: Reduction in mean VAS score was from 7.3 (baseline) to 5.6 (day 30) and 3.9 (day 45). Nearly all the patients had experience ≥50% reduction in NP and NNT score of 1.21 which was calculated by using risk reduction parameter at conclusion visit. Overall 236 patients experience adverse events and were of mild to moderate intensity, sedation and drowsiness being dominantly seen. Conclusion: A combination of Amitriptyline and Mecobalamine was efficacious, safe and well-tolerated in management of Neuropathic pain (NP).

Efficacy and Safety of a Combination of Cinnarizine and Dimenhydrinate in the Treatment of Vertigo

2018 ◽  
Vol 3 (01) ◽  
Author(s):  
Dr. Mayuresh Kiran ◽  
Mr. Lalit Pawaskar
Keyword(s):  
Clinical Study ◽  
Adverse Events ◽  
Calcium Antagonists ◽  
Safety Assessment ◽  
Channel Blocker ◽  
Medical Condition ◽  
Age Group ◽  
Efficacy And Safety ◽  
Efficacy Assessment ◽  
Antihistaminic Drug

Introduction and Background: Vertigo is a medical condition where a person feels as he/ she or the objects around them are moving when they are stable and not moving. Antihistamines, Calcium antagonists, histamine analogs (eg, betahistine derivatives), diuretics, neuroleptics as well as other psychotherapeutic drugs, corticosteroids agents and hemorheologics can be used for the treatment of Vertigo. Combination of Cinnarizine which is a selective calcium-channel blocker and Dimenhydrinate which is an H 1 antihistaminic drug can be used in combination for the treatment of vertigo. This clinical study was conducted to evaluate the efficacy and safety of combination of Cinnarizine 20 mg and Dimenhydrinate 40 mg in patients of vertigo of age group 18 to 65 years. Methodology: Out of total 216 patients, 168 completed the study. Efficacy assessment was made by analysing the reduction in vertigo symptom score (VSS). Safety assessment was made by analysing the adverse events experienced by the patient or observed by the investigator during trial. Results: Reduction in VSS from 7.277 (baseline) to 3.975 (day 3) and 0.987 (day 5). At visit 2 and visit 3 there was reduction of 45.373 % and 86.426 % in mean VSS score. Conclusion: A combination of Cinnarizine 20 mg and Dimenhydrinate 40 mg is safe and efficacious in the treatment of vertigo.

Safety and Efficacy of a Combination of Chloramphenicol, Polymyxin-B and Dexamethasone in Ocular Infection with Inflammation

2018 ◽  
Vol 3 (01) ◽  
Author(s):  
Dr. Mayuresh Dilip Kiran ◽  
Shaheen Naseem Sheikh, Lalit Jeevan Pawaskar
Keyword(s):  
Adverse Events ◽  
Analogue Scale ◽  
Safety Assessment ◽  
Polymyxin B ◽  
Fixed Dose ◽  
Ocular Infection ◽  
Vas Score ◽  
Efficacy Assessment ◽  
Dose Combination ◽  
Ocular Discharge

Introduction: Ocular infection with inflammation is very common in developing countries like India. Multi-drug therapy is used in the treatment of Ocular infection with inflammation. We studied the safety as well as efficacy of one such combination anti-bacterial (Chloramphenicol and Polymyxin -B) and corticosteroid (Dexamethasone) in the treatment of Ocular infection with inflammation especially mild keratitis and conjunctivitis. Methodology: Out of 151 patients, 117 were completed the study. Efficacy assessment was made by reduction in Visual Analogue Scale (VAS) Score of Ocular hypermia, Ocular discharge, Keratitis and Conjunctivitis related to Ocular infection with inflammation. Safety assessment was made by inspecting the adverse events during the study. Results: Reduction in mean VAS score was analysed from 4.47 (baseline) to 2.76 (day 3) to 0.55 (day 5) of ocular hypermia, from 3.42 (baseline) to 2.03 (day 3) to 0.24 (day 5) of ocular discharge, 3.57 (baseline) to 1.89 (day 3) to 0.21 (day 5) of keratitis and from 3.84 (baseline) to 2.10 (day 3) to 0.20 (day 5) of conjunctivitis. Majority of patients had more than 90% reduction in their VAS score at conclusion visit in all the parameters. 8.54% of adverse events of mild intensity was observed. Conclusion: A fixed dose combination of Chloramphenicol, Polymyxin-B and Dexamethasone of is safe and effective in the treatment of Ocular infection with inflammation.

scholarly journals Review of Efficacy and Safety of Duloxetine 40 to 60 mg Once Daily in Patients with Diabetic Peripheral Neuropathic Pain

2012 ◽  
Vol 2012 ◽  
pp. 1-12 ◽  
Author(s):  
Vladimir Skljarevski ◽  
Elijah P. Frakes ◽  
Doron Sagman ◽  
Sarah Lipsius ◽  
Alexandra N. Heinloth ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Adverse Events ◽  
Brief Pain Inventory ◽  
Primary Outcome Measure ◽  
Pain Severity ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Peripheral Neuropathic Pain ◽  
Once Daily

We summarize efficacy and safety findings from 4 double-blind, placebo-controlled, 12-week studies and 1 open-label, uncontrolled, 34-week maintenance-of-effect (MOE) study that examine duloxetine 40 and 60 mg once daily (QD) in patients with diabetic peripheral neuropathic pain (DPNP). In all placebo-controlled studies, duloxetine showed significantly (P≤.01) greater reduction in pain severity (weekly mean of 24-hour average pain severity ratings, primary outcome measure) compared with placebo. In all placebo-controlled studies, duloxetine showed significantly (P≤.05) greater improvement on brief pain inventory-Interference ratings. Patient global impression of improvement ratings were superior to placebo (P≤.01) for duloxetine patients in all placebo-controlled studies. Response rates (based on 30% pain reduction) ranged from 57% to 68% for duloxetine and from 35% to 47% for placebo and were statistically significantly different (P≤.01) between treatment groups in 3 out of 4 studies. The open-label study showed maintenance of analgesic effect of duloxetine in DPNP. In the duloxetine groups, 4.3% to 14.9% of patients discontinued because of adverse events (placebo groups: 2.6% to 7.4%). Most commonly reported treatment-emergent adverse events were nausea, somnolence, and headache. Duloxetine 40 and 60 mg QD was efficacious and well tolerated in the management of DPNP.

scholarly journals A randomized, double-blind, comparative study for efficacy assessment of two hyaluronic acid nasolabial fillers

2018 ◽  
Vol 3 (2) ◽  
Author(s):  
Saman Ahmad Nasrollahi ◽  
Mansour Nassiri Kashani ◽  
Taraneh Yazdanparast ◽  
Setareh Ameri ◽  
Alireza Firooz
Keyword(s):  
Hyaluronic Acid ◽  
Safety Assessment ◽  
Clinical Signs ◽  
P Value ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Efficacy Assessment ◽  
Spss Software ◽  
Nasolabial Folds ◽  
Better Than

<p class="Default">Hyaluronic acid fillers are considered safe for use in cosmetics as described in the safety assessment. This study was aimed to assess and compare the efficacy and safety of two hyaluronic acid (HA) fillers on mild nasolabial folds. Ten women aged 30-50 years with mild nasolabial folds participated for injection of A and B gels into right or left nasolabial folds. The volume and surface of nasolabial folds were measured by CSI software and the density and thickness of dermis assessed by skin ultrasonography before and 2, 12, and 24 weeks after injection. The data were analyzed using SPSS software version 20, and p-value &lt;0.05 were considered as significant. Global assessment showed over 50% improvement in patients injected with both gel A and B. At 2 weeks after injecting gel A the volume and surface of wrinkles decreased significantly. In the side injected with gel B, this reduction was significant at 2 and 12 weeks after injection. In addition, 24 weeks after injection of both gels the dermis echo-density increased and the dermis thickness decreased.  This study indicated the significant positive filling effect of both HA fillers in decreasing the clinical signs of wrinkles at nasolabial folds. Comparing both fillers, there were not any statistically significant differences in any of measurements, but the persistence of gel B to improve the wrinkle appearance was slightly better than gel A. </p>

Almotriptan is an Effective and Well-Tolerated Treatment for Migraine Pain: Results of A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Cephalalgia ◽  
2002 ◽  
Vol 22 (6) ◽  
pp. 453-461 ◽  
Author(s):  
AJ Dowson ◽  
H Massiou ◽  
JM Laínez ◽  
X Cabarrocas
Keyword(s):  
Adverse Events ◽  
Standard Treatment ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Migraine Pain ◽  
Significant Difference ◽  
Severe Intensity ◽  
Efficacy Assessment ◽  
Better Than

Almotriptan is a novel and specific serotonin 5-HT1B/1D agonist for the acute treatment of migraine. This randomized, single-dose, double-blind, multicentre, study assessed the efficacy and safety of oral almotriptan (12.5 mg and 25 mg) in patients with migraine, and compared it with the standard treatment (sumatriptan 100 mg) and placebo. A total of 668 patients treated one migraine attack of moderate or severe intensity with study medication. The primary efficacy assessment was migraine pain relief, improvement from severe or moderate pain to mild or no pain, at 2 h after treatment. Response rates, stratified for variation in baseline pain levels, for both almotriptan doses were equivalent to sumatriptan and significantly better than placebo. Other efficacy assessments confirmed the equivalence of the almotriptan groups with the sumatriptan group. Almotriptan 12.5 mg was as well tolerated as placebo ( P = 0.493) and significantly better tolerated than sumatriptan ( P < 0.001), in terms of the overall incidence of adverse events. There was no statistically significant difference in the incidence of adverse events between almotriptan 25 mg and sumatriptan 100 mg ( P = 0.376). The results from this large clinical study indicate that the new, specific 5-HT1B/1D agonist, almotriptan, is an effective and well-tolerated treatment for migraine pain.

Deep brain stimulation of the posterior limb of the internal capsule in the treatment of central poststroke neuropathic pain of the lower limb: case series with long-term follow-up and literature review

2020 ◽  
Vol 133 (3) ◽  
pp. 830-838 ◽  
Author(s):  
Andrea Franzini ◽  
Giuseppe Messina ◽  
Vincenzo Levi ◽  
Antonio D’Ammando ◽  
Roberto Cordella ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Lower Limb ◽  
Internal Capsule ◽  
Posterior Limb ◽  
Vas Score ◽  
The Mean ◽  
Deep Brain ◽  
Stimulation Of

OBJECTIVECentral poststroke neuropathic pain is a debilitating syndrome that is often resistant to medical therapies. Surgical measures include motor cortex stimulation and deep brain stimulation (DBS), which have been used to relieve pain. The aim of this study was to retrospectively assess the safety and long-term efficacy of DBS of the posterior limb of the internal capsule for relieving central poststroke neuropathic pain and associated spasticity affecting the lower limb.METHODSClinical and surgical data were retrospectively collected and analyzed in all patients who had undergone DBS of the posterior limb of the internal capsule to address central poststroke neuropathic pain refractory to conservative measures. In addition, long-term pain intensity and level of satisfaction gained from stimulation were assessed. Pain was evaluated using the visual analog scale (VAS). Information on gait improvement was obtained from medical records, neurological examination, and interview.RESULTSFour patients have undergone the procedure since 2001. No mortality or morbidity related to the surgery was recorded. In three patients, stimulation of the posterior limb of the internal capsule resulted in long-term pain relief; in a fourth patient, the procedure failed to produce any long-lasting positive effect. Two patients obtained a reduction in spasticity and improved motor capability. Before surgery, the mean VAS score was 9 (range 8–10). In the immediate postoperative period and within 1 week after the DBS system had been turned on, the mean VAS score was significantly lower at a mean of 3 (range 0–6). After a mean follow-up of 5.88 years, the mean VAS score was still reduced at 5.5 (range 3–8). The mean percentage of long-term pain reduction was 38.13%.CONCLUSIONSThis series suggests that stimulation of the posterior limb of the internal capsule is safe and effective in treating patients with chronic neuropathic pain affecting the lower limb. The procedure may be a more targeted treatment method than motor cortex stimulation or other neuromodulation techniques in the subset of patients whose pain and spasticity are referred to the lower limbs.

Efficacy and Safety of Antigen-specific Immunotherapy in the Treatment of Patients with Non-small-cell Lung Cancer: A Systematic Review and Meta-analysis

2019 ◽  
Vol 19 (3) ◽  
pp. 199-209 ◽  
Author(s):  
Bing-Di Yan ◽  
Xiao-Feng Cong ◽  
Sha-Sha Zhao ◽  
Meng Ren ◽  
Zi-Ling Liu ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Systematic Review ◽  
Adverse Events ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Specific Immunotherapy ◽  
Meta Analysis ◽  
Small Cell ◽  
Efficacy And Safety ◽  
Small Cell Lung

Background and Objective: We performed this systematic review and meta-analysis to assess the efficacy and safety of antigen-specific immunotherapy (Belagenpumatucel-L, MAGE-A3, L-BLP25, and TG4010) in the treatment of patients with non-small-cell lung cancer (NSCLC). </P><P> Methods: A comprehensive literature search on PubMed, Embase, and Web of Science was conducted. Eligible studies were clinical trials of patients with NSCLC who received the antigenspecific immunotherapy. Pooled hazard ratios (HRs) with 95% confidence intervals (95%CIs) were calculated for overall survival (OS), progression-free survival (PFS). Pooled risk ratios (RRs) were calculated for overall response rate (ORR) and the incidence of adverse events. </P><P> Results: In total, six randomized controlled trials (RCTs) with 4,806 patients were included. Pooled results showed that, antigen-specific immunotherapy did not significantly prolong OS (HR=0.92, 95%CI: 0.83, 1.01; P=0.087) and PFS (HR=0.93, 95%CI: 0.85, 1.01; P=0.088), but improved ORR (RR=1.72, 95%CI: 1.11, 2.68; P=0.016). Subgroup analysis based on treatment agents showed that, tecemotide was associated with a significant improvement in OS (HR=0.85, 95%CI: 0.74, 0.99; P=0.03) and PFS (HR=0.70, 95%CI: 0.49, 0.99, P=0.044); TG4010 was associated with an improvement in PFS (HR=0.87, 95%CI: 0.75, 1.00, P=0.058). In addition, NSCLC patients who were treated with antigen-specific immunotherapy exhibited a significantly higher incidence of adverse events than those treated with other treatments (RR=1.11, 95%CI: 1.00, 1.24; P=0.046). </P><P> Conclusion: Our study demonstrated the clinical survival benefits of tecemotide and TG4010 in the treatment of NSCLC. However, these evidence might be limited by potential biases. Therefore, further well-conducted, large-scale RCTs are needed to verify our findings.

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