scholarly journals Palmitoylethanolamide, a Special Food for Medical Purposes, in the Treatment of Chronic Pain: A Pooled Data Meta-analysis

2016 ◽  
Vol 19 (2;2) ◽  
pp. 11-24 ◽  
Author(s):  
Giustino Varrassi
Keyword(s):  
Chronic Pain ◽  
Neuropathic Pain ◽  
Mast Cells ◽  
Pain Intensity ◽  
Meta Analysis ◽  
Open Label ◽  
Double Blind ◽  
Pooled Data ◽  
Kaplan Meier ◽  
Variance Explained

Background: A growing body of evidence suggests that neuroinflammation, which is characterized by infiltration of immune cells, activation of mast cells and glial cells, and production of inflammatory mediators in the peripheral and central nervous systems, has an important role in the induction and maintenance of chronic pain. These findings support the notion that new therapeutic opportunities for chronic pain might be based on anti-inflammatory and pro-resolving mediators that act on immune cells, in particular mast cells and glia, to mitigate or abolish neuroinflammation. Among anti-inflammatory and pro-resolving lipid mediators, palmitoylethanolamide (PEA) has been reported to down-modulate mast cell activation and to control glial cell behaviors. Objective: The aim of this study was to perform a pooled meta-analysis to evaluate the efficacy and safety of micronized and ultra-micronized palmitoylethanolamide (PEA) on pain intensity in patients suffering from chronic and/or neuropathic pain. Study Design: Pooled data analysis consisting of double-blind, controlled, and open-label clinical trials. Methods: Double-blind, controlled, and open-label clinical trials were selected consulting the PubMed, Google Scholar, and Cochrane databases, and proceedings of neuroscience meetings. The terms chronic pain, neuropathic pain, and micronized and ultra-micronized PEA were used for the search. Selection criteria included availability of raw data and comparability between tools used to diagnose and assess pain intensity. Raw data obtained by authors were pooled in one database and analyzed by the Generalized Linear Mixed Model. The changes in pain over time, measured by comparable tools, were also assessed by linear regression post-hoc analysis and the Kaplan-Meier estimate. Twelve studies were included in the pooled meta-analysis, 3 of which were double-blind trials comparing active comparators vs placebo, 2 were open-label trials vs standard therapies, and 7 were open-label trials without comparators. Results: Results showed that PEA elicits a progressive reduction of pain intensity significantly higher than control. The magnitude of reduction equals 1.04 points every 2 weeks with a 35% response variance explained by the linear model. In contrast, in the control group pain, reduction intensity equals 0.20 points every 2 weeks with only 1% of the total variance explained by the regression. The Kaplan-Meier estimator showed a pain score ≤ 3 in 81% of PEA treated patients compared to only 40.9% in control patients by day 60 of treatment. PEA effects were independent of patient age or gender, and not related to the type of chronic pain. Limitations: Noteworthy, serious adverse events related to PEA were not registered and/or reported in any of the studies. Conclusion: These results confirm that PEA might represent an exciting, new therapeutic strategy to manage chronic and neuropathic pain associated with neuroinflammation. Key words: Chronic pain, neuropathic pain, neuroinflammation, astrocytes, glia, mast cells, microglia, micronized and ultra-micronized palmitoylethanolamide

621 PL02.05 LONG-TERM TREATMENT OF PATIENTS WITH EOSINOPHILIC GASTRITIS AND/OR EOSINOPHILIC DUODENITIS WITH LIRENTELIMAB, A MONOCLONAL ANTIBODY AGAINST SIGLEC-8

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Kathryn Peterson ◽  
Mirna Chehade ◽  
Joseph Murray ◽  
Gary Falk ◽  
Nirmala Gonsalves ◽  
...  
Keyword(s):  
Mast Cells ◽  
Common Adverse Event ◽  
Symptom Improvement ◽  
Duration Of Treatment ◽  
Open Label ◽  
Double Blind ◽  
Long Term Treatment ◽  
Patient Reported ◽  
Symptom Scores

Abstract   Eosinophilic esophagitis (EoE), gastritis (EG), and/or duodenitis (EoD) are associated with accumulation and activation of eosinophils and mast cells in the esophagus, stomach, and/or duodenum, respectively. Lirentelimab (AK002), an antibody against siglec-8, depletes eosinophils and inhibits mast cells. We performed an open-label extension (OLE) study of subjects who completed ENIGMA (a randomized, double-blind, placebo-controlled phase 2 study of lirentelimab in adults with symptomatic, biopsy-confirmed EG and/or EoD, with or without EoE) to evaluate long-term responses. Methods Subjects who received 4 monthly infusions of lirentelimab or placebo during ENIGMA (n = 59) were eligible for the OLE; they received monthly, escalating doses of lirentelimab (0.3 or 1 mg/kg escalating to 3 mg/kg). Symptoms were assessed weekly using an electronic daily patient-reported outcome questionnaire and total symptom scores (TSS) were calculated. Patients underwent upper endoscopy with biopsy at screening and at the end of ENIGMA (day 99, week 16, blinded); in the OLE, endoscopies were performed on day 323 (30 weeks after the first dose in the OLE). Histopathology was assessed by a single pathologist. Results Fifty-eight subjects entered the OLE; 45 completed ≥52 weeks lirentelimab (including exposure during ENIGMA) and 29 completed 70 weeks. Mean TSS improved through week 70 (Figure 1). Subjects receiving 70 weeks lirentelimab (ENIGMA+OLE) had further improvements in TSS from baseline (mean reductions: 68% at weeks 29–30, 70% at weeks 51–52, 75% at weeks 69–70). Symptom scores (abdominal pain, nausea, vomiting, early satiety, appetite loss, abdominal cramping, bloating, diarrhea) decreased significantly from baseline. Treatment response was not associated with concomitant EoE. The most common adverse event was mild to moderate infusion-related reactions, usually with the first infusion. Conclusion In the OLE of the ENIGMA study, patients with EG and or EoD (with or without concomitant EoE) who received lirentelimab had sustained tissue eosinophil depletion and significant long-term symptom improvement. Symptoms continued to improve with duration of treatment. Lirentelimab appears to be a promising targeted treatment for EG and/or EoD.

Placebos in chronic pain: evidence, theory, ethics, and use in clinical practice

BMJ ◽  
2020 ◽  
pp. m1668 ◽  
Author(s):  
Ted J Kaptchuk ◽  
Christopher C Hemond ◽  
Franklin G Miller
Keyword(s):  
Chronic Pain ◽  
Clinical Practice ◽  
Predictive Coding ◽  
Evidence Theory ◽  
Placebo Treatment ◽  
Placebo Effects ◽  
Unified Framework ◽  
Open Label ◽  
Double Blind ◽  
Bayesian Brain

ABSTRACTDespite their ubiquitous presence, placebos and placebo effects retain an ambiguous and unsettling presence in biomedicine. Specifically focused on chronic pain, this review examines the effect of placebo treatment under three distinct frameworks: double blind, deception, and open label honestly prescribed. These specific conditions do not necessarily differentially modify placebo outcomes. Psychological, clinical, and neurological theories of placebo effects are scrutinized. In chronic pain, conscious expectation does not reliably predict placebo effects. A supportive patient-physician relationship may enhance placebo effects. This review highlights “predictive coding” and “bayesian brain” as emerging models derived from computational neurobiology that offer a unified framework to explain the heterogeneous evidence on placebos. These models invert the dogma of the brain as a stimulus driven organ to one in which perception relies heavily on learnt, top down, cortical predictions to infer the source of incoming sensory data. In predictive coding/bayesian brain, both chronic pain (significantly modulated by central sensitization) and its alleviation with placebo treatment are explicated as centrally encoded, mostly non-conscious, bayesian biases. The review then evaluates seven ways in which placebos are used in clinical practice and research and their bioethical implications. In this way, it shows that placebo effects are evidence based, clinically relevant, and potentially ethical tools for relieving chronic pain.

scholarly journals Effect of preoperative gabapentin on pain intensity and development of chronic pain after carpal tunnel syndrome surgical treatment in women: randomized, double-blind, placebo-controlled study

2016 ◽  
Vol 134 (4) ◽  
pp. 285-291 ◽  
Author(s):  
Eduardo Jun Sadatsune ◽  
Plínio da Cunha Leal ◽  
Rachel Jorge Dino Cossetti ◽  
Rioko Kimiko Sakata
Keyword(s):  
Chronic Pain ◽  
Neuropathic Pain ◽  
Surgical Treatment ◽  
Postoperative Pain ◽  
Carpal Tunnel Syndrome ◽  
Carpal Tunnel ◽  
Postoperative Analgesia ◽  
Pain Syndrome ◽  
Double Blind ◽  
Tunnel Syndrome

ABSTRACT CONTEXT AND OBJECTIVES: Effective postoperative analgesia is important for reducing the incidence of chronic pain. This study evaluated the effect of preoperative gabapentin on postoperative analgesia and the incidence of chronic pain among patients undergoing carpal tunnel syndrome surgical treatment. DESIGN AND SETTINGS: Randomized, double-blind controlled trial, Federal University of São Paulo Pain Clinic. METHODS: Forty patients aged 18 years or over were randomized into two groups: Gabapentin Group received 600 mg of gabapentin preoperatively, one hour prior to surgery, and Control Group received placebo. All the patients received intravenous regional anesthesia comprising 1% lidocaine. Midazolam was used for sedation if needed. Paracetamol was administered for postoperative analgesia as needed. Codeine was used additionally if the paracetamol was insufficient. The following were evaluated: postoperative pain intensity (over a six-month period), incidence of postoperative neuropathic pain (over a six-month period), need for intraoperative sedation, and use of postoperative paracetamol and codeine. The presence of neuropathic pain was established using the DN4 (Douleur Neuropathique 4) questionnaire. Complex regional pain syndrome was diagnosed using the Budapest questionnaire. RESULTS: No differences in the need for sedation, control over postoperative pain or incidence of chronic pain syndromes (neuropathic or complex regional pain syndrome) were observed. No differences in postoperative paracetamol and codeine consumption were observed. CONCLUSIONS: Preoperative gabapentin (600 mg) did not improve postoperative pain control, and did not reduce the incidence of chronic pain among patients undergoing carpal tunnel syndrome surgery.

Amitriptyline in Neuropathic Cancer Pain in Patients on Morphine Therapy: A Randomized Placebo-controlled, Double-blind Crossover Study

2002 ◽  
Vol 88 (3) ◽  
pp. 239-242 ◽  
Author(s):  
Sebastiano Mercadante ◽  
Edoardo Arcuri ◽  
Walter Tirelli ◽  
Patrizia Villari ◽  
Alessandra Casuccio
Keyword(s):  
Quality Of Life ◽  
Neuropathic Pain ◽  
Adverse Effects ◽  
Cancer Pain ◽  
Pain Intensity ◽  
Cancer Patients ◽  
Double Blind ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study

Aims and Background Amitriptyline is the most common analgesic adjuvant used in cancer patients with neuropathic pain, even though no specific studies have demonstrated a benefit. A randomized placebo-controlled, double-blind crossover study was designed to evidence the effects of amitriptyline in patients with neuropathic cancer pain. Methods Sixteen advanced cancer patients with neuropathic pain on systemic morphine therapy, no longer receiving oncologic treatment, presenting moderate pain (about 4 or more, but less than 7, on a numerical scale of 0-10) in the last week, and given a stable morphine dose in the last 2 days were admitted to the study. During the first week of study, patients were administered 25 mg of amitriptyline or equivalent drops of placebo at night for 3 days and 50 mg for the following 4 days. Doses for patients aged more than 65 years were 15 mg (first 3 days) and 30 mg (3 days after). After a week, a crossover took place for the second week, with the other treatment at an inverse sequence. Opioid consumption, pain intensity, symptoms and adverse effects, mood, sleep, patient's preference, quality of life before starting the study, the first week after and the second week after were recorded. Results No significant benefits in analgesia were found in the global pain intensity of the previous week of treatment, the least pain intensity or the pain evaluated just after a week of treatment, at the moment of the visit, when amitriptyline was compared with placebo. A significant difference was evidenced for the worst pain (P < 0.035). No differences in opioid doses during the period of study were found. Drowsiness, confusion and dry mouth were significantly more intense with amitriptyline than with placebo (P < 0.036, 0.003, and 0.034, respectively). There were no substantial differences between the two treatments in Spitzer's quality of life score and for each item. No differences in patients' preference for the two treatment periods were found. The analgesic effects of amitriptyline were slight and associated with adverse effects. Conclusions In light of the results obtained in the study, the extensive use of the drug for cancer pain should be questioned.

Validation of Painreportit Neuropathic Pain Scale in African American Adults with Sickle Cell Disease

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3525-3525 ◽  
Author(s):  
Keesha Roach ◽  
Robert E Molokie ◽  
Zaijie Jim Wang ◽  
Mariam O Ezenwa ◽  
David Shuey ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Neuropathic Pain ◽  
Pain Intensity ◽  
Sickle Cell ◽  
Pain Scale ◽  
Moderate Correlation ◽  
Cell Disease ◽  
Weak Correlation ◽  
Average Pain Intensity ◽  
Average Pain

Abstract Background: Pain in sickle cell disease (SCD) has been thought to be episodic, but more recent evidence has shown that individuals in this population also suffer from chronic pain likely resulting from central or peripheral neural damage (neuropathic pain). There is accumulating evidence from human and animal studies indicating potential neuropathic pain in SCD. A number of valid and reliable measures of neuropathic pain have been used to differentiate neuropathic from non-neuropathic types of pain. PAINReportIt, which takes about 10 to 18 minutes to complete, is a computer based self-report pain assessment tool based on the 1970 version of the McGill Pain Questionnaire. From PAINReportIt, a new subscale has been proposed as a measure of neuropathic pain that sums the number of neuropathic pain quality words selected. The PAINReportIt number of neuropathic pain (PR-NNP) scale, however, lacks validation in patients with SCD. Aim: The purpose of this study was to determine the construct validity for the PR-NNP by examining the associations between the PR-NNP and other valid and reliable measures of neuropathic pain (self-administered Leeds Assessment of Neuropathic Symptoms and Signs [S-LANSS] and the Neuropathic Pain Symptom Inventory [NPSI]) among adults with SCD. We hypothesized that the PR-NNP scores would be significantly correlated with S-LANSS and NPSI scores. Methods: This prospective instrument validation study was conducted in an ambulatory research setting with 79 adults diagnosed with SCD who had chronic pain within the prior 12 months (>3 on a 0-10 pain scale). The sample mean age was 36.0 ± 11.5 [ranged from 19-74 years], 63% were female, and 97% reported they were African American. The participants were asked to complete self-reported pain measures (PR-NNP, S-LANSS, NPSI, and PR-NNoc [number of nociceptive pain words]). Descriptive, correlational, and regression analyses were used. Results: Mean scores for average pain intensity, PR-NNP, NSPI, S-LANSS, and PR-NNoc appear in Table 1. Bivariate results indicated moderate correlation between the two validated measures of neuropathic pain (NPSI and S-LANSS; r= .57, p=.000). The NPSI was moderately correlated with PR-NNP (r= .43, p=.000), and weakly correlated with PR-NNoc (r=.35, p=.002). For S-LANSS, there was a moderate correlation with PR-NNP (r=0.41, p=.000) and a weak correlation with PR-NNoc (r=.30, p=.007). There was a weak correlation between average pain intensity and NPSI and S-LANSS, r=.37, p=.001 and r=.36, p=.001, respectively. Regression analysis including average pain intensity, PR-NNP, and PR-NNoc as predictors showed that controlling for PR-NNP and average pain, PR-NNoc was not significantly associated with either NPSI (p=.930) or S-LANSS (p=.731), while each point of increase in PR-NNP was associated with an increase of 1.9 (p=.004) in NPSI and of 0.8 (p=.003) in S-LANSS. The same analysis showed that a one point increase in the average pain intensity was associated with an increase of 2.7 (p=.001) in NPSI and of 1.0 (p=.001) in S-LANSS. Conclusions: Both average pain intensity and PR-NNP but not PR-NNoc have unique explanatory properties of both indicators of neuropathic pain (NPSI and S-LANSS). These findings support the construct validity of the PR-NNP as a potential screening tool for neuropathic pain in patients with SCD. Validation of PR-NNP is important for future neuropathic pain research in the sickle cell population, particularly in cases of multi-site trials, and in cases where the practitioner can detect the potential presence of neuropathic pain without use of expensive equipment. These findings are important because pain management in the sickle cell population often includes opioids, but easy and early detection of neuropathic pain could result in an opioid sparing pain management approach in this population. Disclosures No relevant conflicts of interest to declare.

Efficacy variables in patients with cancer versus patients without cancer treated with methylnaltrexone or placebo: An analysis of two placebo-controlled studies.

2018 ◽  
Vol 36 (34_suppl) ◽  
pp. 1-1
Author(s):  
Bruce Chamberlain ◽  
Michelle Rhiner ◽  
Neal E Slatkin ◽  
Nancy Stambler ◽  
Robert Joseph Israel
Keyword(s):  
Opioid Use ◽  
Advanced Illness ◽  
Open Label ◽  
Double Blind ◽  
Patients With Cancer ◽  
Pooled Data ◽  
Bowel Movements ◽  
Open Label Extension ◽  
Post Hoc ◽  
Clinical Trial Information

1 Background: A post-hoc analysis of pooled data from two randomized, double-blind studies and their open-label extensions evaluated whether baseline characteristics and efficacy endpoints differ between cancer and noncancer adults with advanced illness and opioid-induced constipation treated with methylnaltrexone (MNTX) or placebo. Methods: Patients received SC MNTX 0.15 mg/kg or placebo (study 302) and SC MNTX 8 mg (38≤62 kg), 12 mg (≥62 kg), or placebo (study 4,000) every other day for two weeks and received the same doses of MNTX as needed during the first 2 weeks of the open-label extensions. Double-blind populations were stratified by those with/without cancer. Efficacy endpoints included rescue-free bowel movements (RFBMs) within 4 hours after each dose for ≥2 of the first 4 doses; time to rescue-free laxation; rescue laxatives use; and ≥3 RFBMs/week and ≥1 RFBM/week in ≥3 of 4 weeks. Results: Median baseline opioid use (mg/day) was greater in cancer (187.9 placebo [n=114]; 180.0 MNTX [n=116]) versus noncancer patients (80.0 placebo [n=71]; 120.0 MNTX [n=62]). MNTX significantly ( P<0.0001) improved the proportion of cancer (56.9%) and noncancer (58.1%) patients with an RFBM within 4 hours after each dose for ≥ two of the first four doses versus placebo (5.3% cancer; 11.3% noncancer). Median time to laxation was significantly ( P≤0.0002) shorter in cancer (0.96 hours) and noncancer (1.25 hours) patients 24 hours after the first dose of MNTX versus placebo (22.53 and >24 hours, respectively). Rescue laxatives were used by 39.7% of cancer and 30.6% of noncancer MNTX patients versus 51.8% of cancer and 39.4% of noncancer placebo patients. Of 108 open-label extension double-blind MNTX patients, 79 (73.1%) achieved ≥3 RFBMs/week with ≥1 RFBM/week increase in ≥ three of four weeks versus 48 (46.6%) of 103 double-blind placebo patients (data from double-blind and first two weeks of open-label). Conclusions: MNTX treatment improved the laxation response, with a faster onset of laxation in patients with and without cancer, and reduced the need for rescue laxatives vs placebo. Improvements over placebo continued into the first two weeks of the open-label extensions for MNTX-treated patients. Clinical trial information: NCT00672477, NCT00402038.

scholarly journals Combination Therapy for Neuropathic Pain. A Systematic Review

2021 ◽  
Author(s):  
Ancor Serrano Afonso ◽  
Thiago Carnaval ◽  
Sebastiá Videla Cés
Keyword(s):  
Systematic Review ◽  
Neuropathic Pain ◽  
Combination Therapy ◽  
Meta Analysis ◽  
Complete Analysis ◽  
Secondary Outcome ◽  
Double Blind ◽  
Adult Participants ◽  
Drop Outs ◽  
Quality Evidence

Pharmacological treatment is poorly effective for neuropathic pain (NP). A progressive decrease in the estimated effect of NP drugs has been reported, giving rise to an increase in multimodal analgesic approach. We performed a systematic review to assess whether there is more and better-quality evidence available since the last review. We evaluated the efficacy, tolerability and safety of double-blind randomized controlled trials involving only adult participants comparing combination therapy (CT: &ge; 2 drugs) to placebo and/or at least one other comparator with NP indication. The primary outcome was the proportion of participants reporting &ge; 50% pain reduction from baseline. Secondary outcome was the proportion of drop-outs due to treatment-emergent-adverse-events. After removing duplicates, 2323 citations were screened. 164 articles were assessed for eligibility, from which 16 were included for qualitative analysis. From the latter, only 5 lasted for at least 12 weeks and only 6 complied with required data for complete analysis, but not for meta-analysis. CT has been adopted for years without robust evidence. Efforts to achieve better quality evidence have not improved over the years. In this regard, guidelines for NP should attempt to make recommendations on CT research, prioritizing which combinations to analyze.

scholarly journals Chronic Pain in the Elderly: The Case for New Therapeutic Strategies

2015 ◽  
Vol 5;18 (5;9) ◽  
pp. E863-E876
Author(s):  
Giustino Varrassi
Keyword(s):  
Chronic Pain ◽  
Neuropathic Pain ◽  
Immune System ◽  
Mast Cells ◽  
Elderly Patients ◽  
Elderly Population ◽  
Neuronal Cells ◽  
Neuronal Cell ◽  
The Elderly ◽  
Narrative Review

Background: Elderly patients in general exhibit a higher incidence of chronic and neuropathic pain conditions. This group poses a particular clinical challenge due to age-related pharmacokinetic and pharmacodynamic issues, comorbid conditions, and polypharmacy, as well as frailty and cognitive decline. Poor control of pain has consistently been identified as an issue for older people. The identification of safe and efficacious treatments for chronic pain remains a critical public health concern, especially considering the progressive increase of the world’s elderly population. Objectives: This narrative review deals with the principal alterations of the somatosensory system together with changes in non-neuronal cells in the course of aging. The possibility to control chronic pain based on an innovative strategy which addresses non-neuronal cell dysregulation control will also be discussed. Study Design: Narrative review. Results: Peripheral nerves display functional, structural, and biochemical changes with aging that mainly involve Aδ fibers. Alteration in the responses to heat pain in the middle insular cortex and primary somatosensory cortex are also observed in the elderly. In general, pain threshold increases with age while the threshold of pain tolerance remains unchanged or decreases. Additionally, other important modifications of the pain perception system in this age group consist in a clear reduction in the descending inhibitory capacity with an associated increase in central sensitization. Furthermore, different changes concern immune system cells, such as mast cells and microglia, that with age show an increase in their sensitivity to noxious stimuli and a decreased capability to be regulated by homeostatic endogenous systems. Since these cells are the primary interlocutors for pain neurons, their alterations lead to changes that promote persistent neuroinflammation, thereby impacting pain neuronal cell functionality. Limitation: This review is not an exhaustive review for the current evidence supporting the role of immune cells in influencing pain somatosensory neuron functions. It is also important to stress the small number of studies designed to determine the efficacy and safety of anti-pain therapies in elderly patients. Conclusion: Non-neuronal cells of immune system origin such as microglia and mast cells, along with astrocytes, are capable of influencing pain somatosensory neuron functions. These nervous system non-neuronal cells may thus be viewed as innovative targets for persistent pain control. Among therapies aiming at preserving the functionality of non-neuronal cells, palmitoylethanolamide, with its high efficacy/risk ratio, may be an excellent co-treatment for the ever-growing elderly population with chronic pain. Key words: Elderly, chronic and neuropathic pain, mast cells, glial cells, neuroinflammation, micronized and ultra-micronized palmitoylethanolamide

scholarly journals Evidence for Dietary Agmatine Sulfate Effectiveness in Neuropathies Associated with Painful Small Fiber Neuropathy. A Pilot Open-Label Consecutive Case Series Study

Nutrients ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 576 ◽  
Author(s):  
Michael L. Rosenberg ◽  
Vahid Tohidi ◽  
Karna Sherwood ◽  
Sujoy Gayen ◽  
Rosina Medel ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Pain Intensity ◽  
Treatment Options ◽  
Case Series ◽  
Small Fiber Neuropathy ◽  
Consecutive Case ◽  
Open Label ◽  
Small Fiber ◽  
Case Series Study ◽  
Series Study

Peripheral neuropathies associated with painful small fiber neuropathy (SFN) are complex conditions, resistant to treatment with conventional medications. Previous clinical studies strongly support the use of dietary agmatine as a safe and effective treatment for neuropathic pain. Based on this evidence, we conducted an open-label consecutive case series study to evaluate the effectiveness of agmatine in neuropathies associated with painful SFN (Study Registry: ClinicalTrials.gov, System Identifier: NCT01524666). Participants diagnosed with painful SFN and autonomic dysfunctions were treated with 2.67 g/day agmatine sulfate (AgmaSet® capsules containing G-Agmatine® brand of agmatine sulfate) for a period of 2 months. Before the beginning (baseline) and at the end of the treatment period, participants answered the established 12-item neuropathic pain questionnaire specifically developed to distinguish symptoms associated with neuropathy and to quantify their severity. Secondary outcomes included other treatment options and a safety assessment. Twelve patients were recruited, and 11 patients—8 diagnosed with diabetic neuropathy, two with idiopathic neuropathy and one with inflammatory neuropathy—completed the study. All patients showed improvement in neuropathic pain to a varied extent. The average decrease in pain intensity was 26.0 rating points, corresponding to a 46.4% reduction in overall pain (p < 0.00001). The results suggest that dietary agmatine sulfate has a significant effect in reducing neuropathic pain intensity associated with painful SFN resistant to treatment with conventional neuropathic pain medications. Larger randomized placebo-controlled studies are expected to establish agmatine sulfate as a preferred treatment.

scholarly journals Assessment of Pain Anxiety, Pain Catastrophizing, and Fear of Pain in Children and Adolescents With Chronic Pain: A Systematic Review and Meta-Analysis

2017 ◽  
Vol 43 (3) ◽  
pp. 314-325 ◽  
Author(s):  
Emma Fisher ◽  
Lauren C Heathcote ◽  
Christopher Eccleston ◽  
Laura E Simons ◽  
Tonya M Palermo
Keyword(s):  
Systematic Review ◽  
Chronic Pain ◽  
Pain Intensity ◽  
Pain Catastrophizing ◽  
Meta Analysis ◽  
Anxiety And Depression ◽  
Generalized Anxiety ◽  
Evidence Based ◽  
Fear Of Pain ◽  
Pain Anxiety

Abstract Objective To conduct a systematic review of pain anxiety, pain catastrophizing, and fear of pain measures psychometrically established in youth with chronic pain. The review addresses three specific aims: (1) to identify measures used in youth with chronic pain, summarizing their content, psychometric properties, and use; (2) to use evidence-based assessment criteria to rate each measure according to the Society of Pediatric Psychology (SPP) guidelines; (3) to pool data across studies for meta-analysis of shared variance in psychometric performance in relation to the primary outcomes of pain intensity, disability, generalized anxiety, and depression. Methods We searched Medline, Embase, PsycINFO, and relevant literature for possible studies to include. We identified measures studied in youth with chronic pain that assessed pain anxiety, pain catastrophizing, or fear of pain and extracted the item-level content. Study and participant characteristics, and correlation data were extracted for summary and meta-analysis, and measures were rated using the SPP evidence-based assessment criteria. Results Fifty-four studies (84 papers) met the inclusion criteria, including seven relevant measures: one assessed pain anxiety, three pain catastrophizing, and three fear of pain. Overall, five measures were rated as “well established.” We conducted meta-analyses on four measures with available data. We found significant positive correlations with the variables pain intensity, disability, generalized anxiety, and depression. Conclusion Seven measures are available to assess pain anxiety, pain catastrophizing, and fear of pain in young people with chronic pain, and most are well established. We present implications for practice and directions for future research.

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