scholarly journals Efficacy and Safety of 0.625% and 1.25% Capsaicin Patch in Peripheral Neuropathic Pain: Multi-Center, Randomized, and Semi-Double Blind Controlled Study

2017 ◽  
Vol 2 (20;2) ◽  
pp. 27-35
Author(s):  
PyungBok Lee
Keyword(s):  
Neuropathic Pain ◽  
Peripheral Neuropathy ◽  
College Teaching ◽  
Small Sample ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
High Concentration ◽  
Double Blind ◽  
Peripheral Neuropathic Pain ◽  
Topical Capsaicin

Background: Topical capsaicin therapy may be of benefit in providing pain relief in patients with peripheral neuropathy. Objectives: To investigate the efficacy and safety of 0.625% (50 µg/cm2 ) and 1.25% (100 µg/cm2 ) capsaicin patches (CPs) compared to conventional 0.075% capsaicin cream or placebo patches in patients suffering from peripheral neuropathy. Study Design: Early Phase II, multi-center, randomized, semi-double-blind, and placebocontrolled clinical trial. Setting: Two medical college teaching hospitals. Methods: Sixty patients were randomized to the 0.625% CP, 1.25% CP, placebo-controlled patch, or 0.075% capsaicin cream. The primary efficacy endpoint was the mean difference in the change of daily numerical rating scale (NRS) pain score. Secondary endpoints included values for the Daily Sleep Interference Scale, the percentage of patients achieving a ≥ 30% or ≥ 50% reduction in pain, and data for Global Impression Change (GIC) and EQ-5D. Results: Patients treated with the 0.625% CP and 0.075% capsaicin cream showed statistically significant improvements in pain after 6-weeks of test drug application. Daily sleep disorder scores were improved only for those patients applying the 0.075% capsaicin cream. For patient-derived GIC scores, the majority (11 of 12) of patients in the 0.625% CP group reported that their pain was improved. For the safety evaluation, 2 severe adverse events were reported for the 0.075% capsaicin cream group only. Repetitive patch application was related to minor skin problems such as a burning sensation, erythema, pruritus, and vesicles in 28 patients (46.67%). Limitations: The small sample size and relatively high dropout rates. Conclusion: Our data indicate that the 0.625% CP may prove to be an effective and safe alternative with which to treat patients with peripheral neuropathy and could replace the high concentration (8%) CP. Further studies are now needed to definitively establish efficacy. Key words: Capsaicin, patch, CP, topical capsaicin, neuropathic pain, peripheral neuropathic pain, PNP, high concentration CP

scholarly journals Correction to: Efficacy and safety of duloxetine and Pregabalin in Iranian patients with diabetic peripheral neuropathic pain: a double-blind, randomized clinical trial

2019 ◽  
Vol 18 (2) ◽  
pp. 583-583
Author(s):  
Khojasteh Joharchi ◽  
Moosareza Memari ◽  
Eznollah Azargashb ◽  
Navid Saadat
Keyword(s):  
Clinical Trial ◽  
Neuropathic Pain ◽  
Randomized Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Peripheral Neuropathic Pain ◽  
Iranian Patients

The article Efficacy and safety of duloxetine and Pregabalin in Iranian patients with diabetic peripheral neuropathic pain: a double-blind, randomized clinical trial, written by Khojasteh Joharchi, Moosareza Memari, Eznollah Azargashb, and Navid Saadat, was originally published.

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.

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