scholarly journals Short-Term Outcomes of Mirogabalin in Patients with Peripheral Neuropathic Pain: A Retrospective Study

2020 ◽  
Author(s):  
Tomoko Tetsunaga ◽  
Tomonori Tetsunaga ◽  
Keiichiro Nishida ◽  
Haruo Misawa ◽  
Tomoyuki Takigawa ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Adverse Events ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Duration Of Action ◽  
Peripheral Neuropathic Pain ◽  
Long Duration ◽  
Α2δ Subunit ◽  
The Mean ◽  
Post Hoc

Abstract Background: Mirogabalin, which is approved for the treatment of peripheral neuropathic pain in Japan, is a ligand for the α2δ subunit of voltage-gated calcium channels. Both pregabalin and mirogabalin act as nonselective ligands at the α2δ-1 and α2δ-2 subunits. Mirogabalin has a unique binding profile and long duration of action. Pregabalin has been reported to produce intolerable adverse effects in some patients. This study investigated outcomes associated with mirogabalin administration in patients with peripheral neuropathic pain who ceased treatment with pregabalin.Methods: We retrospectively assessed peripheral neuropathic pain using the neuropathic pain screening questionnaire (NeP score) in 187 patients (58 men, 129 women) who were treated with mirogabalin. All patients had switched from pregabalin to mirogabalin due to lack of efficacy or adverse events. Differences in the treatment course (i.e., numeric rating scale (NRS) scores) were compared using one-way analysis of variance with Bonferroni post hoc tests.Results: The mean age of the patients was 72.3 years (range, 30–94 years), and the mean duration of disease was 37 months (range, 3–252 months). After treatment with mirogabalin for 1 week, NRS scores significantly decreased compared with baseline and continued to decrease over time. After 8 weeks, NRS scores improved by ³30% from baseline in 113 patients (69.3%). Twenty-four patients (12.8%) stopped mirogabalin treatment due to adverse events. Somnolence (26.7%), dizziness (12.3%), edema (5.9%), and weight gain (0.5%) were noted as adverse events of mirogabalin.Conclusions: The results of this investigation indicate that mirogabalin is safe and effective for reducing peripheral neuropathic pain.

scholarly journals Short-Term Outcomes of Mirogabalin in Patients with Peripheral Neuropathic Pain: A Retrospective Study

2020 ◽  
Author(s):  
Tomoko Tetsunaga ◽  
Tomonori Tetsunaga ◽  
Keiichiro Nishida ◽  
Haruo Misawa ◽  
Tomoyuki Takigawa ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Adverse Events ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Duration Of Action ◽  
Peripheral Neuropathic Pain ◽  
Long Duration ◽  
Α2δ Subunit ◽  
Duration Of Disease ◽  
Numeric Rating

Abstract Background: Mirogabalin, which is approved for the treatment of peripheral neuropathic pain in Japan, is a ligand for the α2δ subunit of voltage-gated calcium channels. Both pregabalin and mirogabalin act as nonselective ligands at the α2δ-1 and α2δ-2 subunits. Mirogabalin has a unique binding profile and long duration of action. Pregabalin has been reported to produce intolerable adverse effects in some patients. This study investigated outcomes associated with mirogabalin in patients with peripheral neuropathic pain who withdrew from treatment with pregabalin. Methods: We retrospectively assessed peripheral neuropathic pain in 187 patients (58 men, 129 women) who were treated with mirogabalin. All patients had been treated with pregabalin and withdrew from therapy due to lack of efficacy or adverse events. The mean age of patients was 72.3 years (range, 30–94 years), and mean duration of disease was 37 months (range, 3–252 months). Results: After treatment with mirogabalin for 1 week, numeric rating scale (NRS) scores decreased significantly compared with baseline, and continued to decrease over time . After 8 weeks, NRS scores improved by ³30% from baseline in 113 patients (69.3%). Twenty-four patients (12.8%) stopped mirogabalin treatment due to adverse events. Somnolence (26.7%), dizziness (12.3%), edema (5.9%), and weight gain (0.5%) were noted as adverse events of mirogabalin. Conclusions: The results of this investigation indicate that mirogabalin is safe and effective for reducing peripheral neuropathic pain.

Effect of Minocycline on Lumbar Radicular Neuropathic Pain

2015 ◽  
Vol 122 (2) ◽  
pp. 399-406 ◽  
Author(s):  
Pascal Vanelderen ◽  
Jan Van Zundert ◽  
Tamás Kozicz ◽  
Martine Puylaert ◽  
Pieter De Vooght ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Adverse Events ◽  
Confidence Interval ◽  
Rescue Medication ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Pain Questionnaire ◽  
Numeric Rating

Abstract Background: Less than 50% of patients experience sufficient pain relief with current drug therapy for neuropathic pain. Minocycline shows promising results in rodent models of neuropathic pain but was not studied in humans with regard to the treatment of neuropathic pain. Methods: In this randomized, double-blind, placebo-controlled clinical trial, patients with subacute lumbar radicular pain received placebo, amitriptyline 25 mg, or minocycline 100 mg once a day (n = 20 per group) for 14 days. Primary outcome measure was the pain intensity in the leg as measured by a numeric rating scale ranging from 0 to 10 on days 7 and 14. Secondary outcome measures were the reduction of neuropathic pain symptoms in the leg as determined with a neuropathic pain questionnaire, consumption of rescue medication, and adverse events on days 7 and 14. Results: Sixty patients were randomized and included in an intention-to-treat analysis. After 14 days, patients in the minocycline and amitriptyline groups reported a reduction of 1.47 (95% confidence interval, 0.16–2.83; P = 0.035) and 1.41 (95% confidence interval, 0.05–2.78; P = 0.043), respectively, in the numeric rating scale compared to the placebo group. No differences were seen in the neuropathic pain questionnaire values at any time point during treatment between the three groups. The rate of adverse events in the amitriptyline group was 10% versus none in the minocycline and placebo groups. No differences were noted in the consumption of rescue medication. Conclusions: Although both groups differed from placebo, their effect size was small and therefore not likely to be clinically meaningful.

scholarly journals An Assessment of Clinically Important Differences on the Worst Pain Severity Item of the Modified Brief Pain Inventory in Patients with Diabetic Peripheral Neuropathic Pain

2018 ◽  
Vol 2018 ◽  
pp. 1-8
Author(s):  
James Marcus ◽  
Kathryn Lasch ◽  
Yin Wan ◽  
Mei Yang ◽  
Ching Hsu ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Rating Scale ◽  
Roc Curves ◽  
Brief Pain Inventory ◽  
Pain Severity ◽  
Double Blind ◽  
Peripheral Neuropathic Pain ◽  
Intensity Rating ◽  
Global Impression Of Change ◽  
Post Hoc

Objectives. Using patient global impression of change (PGIC) as an anchor, an approximately 30% reduction on an 11-point numeric pain intensity rating scale (PI-NRS) is considered a clinically important difference (CID) in pain. Our objective was to define the CID for another pain measure, the worst pain severity (WPS) item of the modified Brief Pain Inventory (m-BPI). Methods. In this post hoc analysis of a double-blind, placebo-controlled, phase 2 study, 452 randomized patients with diabetic peripheral neuropathic pain (DPNP) were followed over 5 weeks, with m-BPI data collected weekly and PGIC at treatment conclusion. Receiver operating characteristic (ROC) curves (via logistic regression) were used to determine the changes in the m-BPI-WPS score that best predicted ordinal clinical improvement thresholds (i.e., “minimally improved” or better) on the PGIC. Results. Similar to the PI-NRS, a change of −3 (raw) or −33.3% from the baseline on the m-BPI-WPS optimized prediction for the “much improved” or better PGIC threshold and represents a CID. There was a high correspondence between observed and predicted PGIC categories at each PGIC threshold (ROC AUCs were 0.78–0.82). Conclusions. Worst pain on the m-BPI may be used to assess clinically important improvements in DPNP studies. Findings require validation in larger studies.

scholarly journals Differential response to scrambler therapy by neuropathic pain phenotypes

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Young Gi Min ◽  
Hyun Seok Baek ◽  
Kyoung-Min Lee ◽  
Yoon-Ho Hong
Keyword(s):  
Neuropathic Pain ◽  
Treatment Outcome ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Brief Pain Inventory ◽  
Differential Response ◽  
Open Label ◽  
Numerical Rating ◽  
Scrambler Therapy ◽  
Post Hoc

AbstractScrambler therapy is a noninvasive electroanalgesia technique designed to remodulate the pain system. Despite growing evidence of its efficacy in patients with neuropathic pain, little is known about the clinical factors associated with treatment outcome. We conducted a prospective, open-label, single-arm trial to assess the efficacy and safety of scrambler therapy in patients with chronic neuropathic pain of various etiologies. A post-hoc analysis was performed to investigate whether cluster analysis of the Neuropathic Pain Symptom Inventory (NPSI) profiles could identify a subgroup of patients regarding neuropathic pain phenotype and treatment outcome. Scrambler therapy resulted in a significant decrease in the pain numerical rating scale (NRS) score over 2 weeks of treatment (least squares mean of percentage change from baseline, − 15%; 95% CI − 28% to − 2.4%; p < 0.001). The mean score of Brief Pain Inventory (BPI) interference subdimension was also significantly improved (p = 0.022), while the BPI pain composite score was not. Hierarchical clustering based on the NPSI profiles partitioned the patients into 3 clusters with distinct neuropathic pain phenotypes. Linear mixed-effects model analyses revealed differential response to scrambler therapy across clusters (p = 0.003, pain NRS; p = 0.072, BPI interference subdimension). Treatment response to scrambler therapy appears different depending on the neuropathic pain phenotypes, with more favorable outcomes in patients with preferentially paroxysmal pain rather than persistent pain. Further studies are warranted to confirm that capturing neuropathic pain phenotypes can optimize the use of scrambler therapy.

scholarly journals Comparative Effectiveness of Papaya Leaf Stew (Carica Papaya Linn) With Turmeric Acid (Curcuma Domestica Val-Tamarindus Indica) Against Primary Dysmenorrhea

2018 ◽  
Vol 1 (2) ◽  
pp. 120-127
Author(s):  
Yunita Liana
Keyword(s):  
Young Women ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Average Score ◽  
Control Group ◽  
P Value ◽  
Primary Dysmenorrhea ◽  
Control Group Design ◽  
Before And After ◽  
The Mean

Young women often feel primary dysmenorrhoea because the hormonal cycles experienced are not stable, this can disrupt the concentration and activity of young women. The principle of back to nature is increasingly popular today, the side effects of chemical drugs can cause new problems, it is one of the driving force of the development of traditional medicine. Papaya leaves contain Vitamin E which can reduce dysmenorrhea. In addition, turmeric acids also contain curcumine and anthocyanins that inhibit cyclooxygenase, thereby reducing the occurrence of inflammation during uterine contractions. The aim of this research is to know the effectiveness of papaya leaf stew with acidic turmeric to primary dysmenorrhea. Type of Research is an experimental study with a Pretest-Posttest Control Group Design design. The sample is 30 people. The research was conducted on December 27, 2017 s.d February 24, 2018 at SMP Negeri 46 Palembang. Instrument to measure pain Numeric Rating Scale. The statistical test used by Wilcoxon and Mann Whitney U. Average score of pain before papaya leaves stem 5.40 ± 0.73 while the mean score of pain after given turmeric acid 5.33 ± 0.61 The mean score of pain after being given papaya leaves stew 3.60 ± 0.91 while the mean score of pain after given turmeric acid 4.06 ± 0.79. There was a difference of mean score of dysmenorrhea pain before and after given papaya leaf stem p value = 0.000. There is difference of mean score of dysmenorrhea pain before and after given turmeric acid p value = 0,002. There was no difference of mean score of dysmenorrhea pain before and after given papaya leaf sting and turmeric acid p value = 0,217. The decoction of papaya leaf and turmeric acid have the same effectiveness in reducing primary dysmenorrhea pain.

scholarly journals Effect of Patiromer in Hyperkalemic Patients Taking and Not Taking RAAS Inhibitors

2018 ◽  
Vol 23 (6) ◽  
pp. 524-531 ◽  
Author(s):  
Robert A. Kloner ◽  
Coleman Gross ◽  
Jinwei Yuan ◽  
Ansgar Conrad ◽  
Pablo E. Pergola
Keyword(s):  
Adverse Events ◽  
Serum Potassium ◽  
Common Adverse Event ◽  
Open Label ◽  
Serious Adverse Events ◽  
End Point ◽  
The Mean ◽  
Baseline Characteristics ◽  
Raas Inhibitors ◽  
Post Hoc

Introduction: Hyperkalemia (potassium >5.0 mEq/L) affects heart failure patients with renal disease regardless of the use of renin–angiotensin–aldosterone system inhibitors (RAASi). The open-label TOURMALINE study showed that patiromer, a sodium-free, nonabsorbed potassium binder, lowers serum potassium of hyperkalemic patients similarly when given with or without food; unlike prior studies, patients were not required to be taking RAASi. We conducted post hoc analyses to provide the first report of patiromer in patients not taking RAASi. Methods: Hyperkalemic patients received patiromer, 8.4 g/d to start, adjusted to achieve and maintain serum potassium of 3.8 to 5.0 mEq/L. If taking RAASi, stable doses were required. The primary end point was the proportion of patients with serum potassium 3.8 to 5.0 mEq/L at week 3 or 4. This analysis presents data by patients taking or not taking RAASi. Results: Demographics and baseline characteristics were similar in patients taking (n = 67) and not taking RAASi (n = 45). Baseline mean (SD) serum potassium was 5.37 (0.37) mEq/L and 5.42 (0.43) mEq/L in patients taking and not taking RAASi, respectively. Mean (SD) daily patiromer doses were similar (10.7 [3.2] and 11.5 [4.0] g, respectively). The primary end point was achieved in 85% (95% confidence interval [CI]: 74-93) of patients taking RAASi and in 84% (95% CI: 71-94) of patients not taking RAASi. From baseline to week 4, the mean (SE) change in serum potassium was −0.67 (0.08) mEq/L in patients taking RAASi and −0.56 (0.10) mEq/L in patients not taking RAASi (both P < .0001 vs baseline, P = nonsignificant between groups). Adverse events were reported in 26 (39%) patients taking RAASi and 25 (54%) not taking RAASi; the most common adverse event was diarrhea (2% and 11%, respectively; no cases were severe). Five patients (2 taking RAASi) reported 6 serious adverse events; none considered related to patiromer. Conclusions: Patiromer was effective and generally well-tolerated for hyperkalemia treatment, whether or not patients were taking RAAS inhibitors.

Differences in calculated percentage improvement versus patient-reported percentage improvement in pain scores: a review of spinal cord stimulation trials

2021 ◽  
pp. rapm-2020-102238
Author(s):  
Jonathan M Hagedorn ◽  
Timothy R Deer ◽  
Nicholas C Canzanello ◽  
Stephen M Covington ◽  
Darrell R Schroeder ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Pain Scale ◽  
Concordance Correlation ◽  
Percentage Improvement ◽  
Patient Reported ◽  
The Mean ◽  
Numeric Rating

IntroductionSpinal cord stimulation is frequently used for the treatment of intractable chronic pain conditions. Trialing of the spinal cord stimulator device is recommended to assess the patient’s response to neurostimulation before permanent implantation. The trial response is often assessed by Numeric Rating Scale changes and patient-reported percentage pain improvement. Using number rating scale changes between prespinal and postspinal cord stimulation trial, a calculated percentage pain improvement can be obtained. The aim of this study was to assess the difference between calculated and patient-reported percentage improvement in pain scale during spinal cord stimulation trials.MethodsThis study was a retrospective single center review of all spinal cord stimulation trials from January 1 2017 to July 1 2019. A total of 174 patients were included. The paired t-test was used to compare numeric pain scores obtained prestimulation versus poststimulation. The mean difference between methods (patient-reported minus calculated) was compared with zero using the 1-sample t-test. Lin’s concordance correlation coefficient was computed with a 95% CI, calculated using Fisher z-transformation; and a bootstrapping approach was used to compare the concordance correlation coefficient between groups. In all cases, two-tailed tests were used with p<0.05 considered statistically significant.ResultsBased on prestimulation and poststimulation numeric rating scale scores, the mean±SD calculated percentage improvement in pain scale was 54±28. The mean±SD patient-reported percentage improvement in pain scale was 59±25. The overall 95% limits of agreement for the two methods are −30% to +41%. The overall concordance correlation coefficient was 0.76 (95% CI 0.69 to 0.81).ConclusionAlthough the two methods are highly correlated, there is substantial lack of agreement between patient-reported and calculated percentage improvement in pain scale, suggesting that these measures should not be used interchangeably for spinal cord stimulator trial outcome assessment. This emphasizes the need for improved metrics to better measure patient response to neuromodulation therapies. Additionally, patient-reported percentage improvement in pain was found to be higher than calculated percentage improvement in pain, potentially highlighting the multidimensional experience of pain and the unpredictability of solely using Numeric Rating Scale scores to assess patient outcomes.

Effect of Pregabalin on Radiotherapy-Related Neuropathic Pain in Patients With Head and Neck Cancer: A Randomized Controlled Trial

2019 ◽  
Vol 37 (2) ◽  
pp. 135-143 ◽  
Author(s):  
Jingru Jiang ◽  
Yi Li ◽  
Qingyu Shen ◽  
Xiaoming Rong ◽  
Xiaolong Huang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Event ◽  
Neuropathic Pain ◽  
Rating Scale ◽  
Short Form ◽  
Controlled Trial ◽  
Numeric Rating Scale ◽  
Mood States ◽  
Numeric Rating

Purpose Neuropathic pain is an unavoidable treatment-related adverse event among patients with head and neck cancer who are undergoing radiotherapy. We aimed to test the efficacy and safety of pregabalin versus placebo in the treatment of radiotherapy-related neuropathic pain. Patients and Methods This randomized, double-blind, placebo-controlled trial was conducted in four centers in China. Eligible patients with a mean pain intensity score of 4 or more on an 11-point numeric rating scale were randomly assigned to receive either active treatment with a flexible dose of pregabalin or placebo for 16 weeks. The primary efficacy outcome was pain reduction measured on the numeric rating scale. Result There were 128 patients who received treatment as randomly assigned. Pain intensity reduction was 2.44 in the pregabalin arm and 1.58 in the placebo arm at week 16, yielding an adjusted mean difference of 0.87 (95% CI, 0.30 to 1.44; P = .003). In the pregabalin arm, 38 patients (59.4%) achieved at least 30% pain relief versus 21 (32.8%) in the placebo arm ( P = .006). Nineteen patients (29.7%) in the pregabalin group and five (7.8%) in the placebo group achieved 50% or greater pain relief ( P = .003). Total scores on the Profile of Mood States-Short Form, pain severity and functional interference of Brief Pain Inventory-Short Form, as well as the physiology and psychology domain of the WHO Quality of Life-BREF all were reduced significantly at week 16 in patients who received pregabalin compared with those who received placebo. There was no significant difference ( P = .29) in the incidence of experiencing at least one adverse event in the pregabalin arm (n = 35; 54.7%) versus the placebo arm (n = 29; 45.3%). Conclusion Patients treated with pregabalin with radiotherapy-related neuropathic pain had greater pain alleviation, better mood states, and higher quality of life compared with patients in the placebo group, with a good tolerability.

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