High-Dose Intravenous Immunoglobulin Is Effective in Painful Diabetic Polyneuropathy Resistant to Conventional Treatments. Results of a Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial

Jann, Stefano; Fazio, Raffaella; Cocito, Dario; Toscano, Antonio; Schenone, Angelo; Marfia, Gerolama Alessandra; Antonini, Giovanni; Franceschini, Luisa De Toni; Mazzeo, Anna Teresa; Grandis, Marina; Velardo, D; Mataluni, Giorgia; Peci, Erdita

doi:10.1093/pm/pnz331

Cited by 13 publications

(6 citation statements)

References 42 publications

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“…Four weeks after IVIG, ≥50% pain reduction was reported in seven of 11 patients (63.6%) in the IVIG group vs. zero of 12 in the placebo group ( P =0.0013). The only adverse effect reported in the treatment group was mild “dermatitis psoriasiform” in one patient [ 34 ].…”

Section: Resultsmentioning

confidence: 99%

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Managing Chronic Neuropathic Pain: Recent Advances and New Challenges

Hange

Poudel

Ozair

et al. 2022

Neurology Research International

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Aim. Neuropathic pain affects 7–10% of the population, with most of the patients receiving inadequate and incomplete treatment. Owing to the high financial burden and the poor quality of life of the patients and their caretakers, there is a dire need to address the challenges in diagnosing and treating chronic neuropathic pain. Methods. This literature review was conducted to review novel treatments and related challenges through a systematic search from sources such as PubMed, Google Scholar with the combination of MESH words such as neuropathic pain, management of neuropathic pain. Articles from non-English literature, reports without human subjects, animal studies, and abstracts/posters were excluded. However, human studies and studies published in English were included. Result. This review article discusses novel treatment modalities while acknowledging the challenges medical workers face while encountering neuropathic pain. Despite the recent advances in diagnosis and treatment modalities, several challenges still exist. Hence, there is still a need to explore the various treatment modalities, emphasizing the cause and underlying pathophysiology of neuropathic pain. Conclusion. We recommend integrated multimodal treatment with the current treatment facility, including various medical disciplines. However, a personalized approach would work the best depending on the ’patient’s medical history. Therefore, this article recommends an integrated, cause-specific, cost-effective approach to address this problem of chronic neuropathic pain.

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Section: Resultsmentioning

confidence: 99%

“…e only adverse e ect reported in the treatment group was mild "dermatitis psoriasiform" in one patient [34]. peripheral neuropathy in the lower extremities found a significant improvement of pain symptoms with the topical application of 250 mg CBD/3fl.…”

Section: Immunoglobulinmentioning

confidence: 90%

Managing Chronic Neuropathic Pain: Recent Advances and New Challenges

Hange

Poudel

Ozair

et al. 2022

Neurology Research International

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“…After the eligibility assessment, 175 articles were excluded. In total 5 papers met the inclusion criteria [20][21][22][23][24]. These studies were published between 2015 and 2021.…”

Section: Resultsmentioning

confidence: 99%

Immunoglobulin Use for the Management of Painful Peripheral Neuropathy: A Systematic Review and Meta-Analysis

et al. 2022

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Background: Immunoglobulins (IG) are widely used for the treatment of a variety of immunemediated diseases. The exact mechanism of action remains unknown, but IG modulate the expression and function of Fc receptors, interfere with complement activation and production of cytokines, neutralize pathogenic autoantibodies, and affect the activation and effector functions of B and T lymphocytes. Immunoglobulins are usually delivered intravenously, and are effective in ameliorating motor symptoms, and/or preventing disease progression in immune-mediated neuropathies, including Guillain-Barre ´syndrome and chronic inflammatory demyelinating polyneuropathy. Objective: The aim of this systematic review and meta-analysis was to study the potential of IG for the treatment of painful peripheral neuropathy (PPN). The outcome of interest was the percentage of patients with PPN who achieved pain relief following IG administration. Methods: We performed a systematic literature search on March 17, 2022, in the PubMed database without any publication date restrictions. We also looked for unpublished or ongoing trials in clinicaltrials.org. Pain reduction following IG treatment had to be within the aims (primary or secondary). Results: The aforementioned literature search strategy revealed five studies (two open-label, three randomized placebo-controlled) eligible to be included. The pooled estimate of the percentage of patients with PPN who received immunoglobulins and reported pain relief was found to be 65% (95% CI 58-71%). The likelihood of achieving pain relief with immunoglobulin treatment was 2.9 times higher (95% CI 1.6-5.2) compared to placebo (p = 0.0003). Conclusion:The use of IG for the treatment of pain due to peripheral neuropathy has a potential therapeutic benefit. Further studies across patients with different types of painful peripheral neuropathy are needed to better characterize this effect.Registration number on PROSPERO: CRD42022319614.

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“… 17 , 18 Some drugs and treatments require a large sample size for investigation and verification. 19–21 Therefore, it is necessary to include a large sample size to estimate the reliability and validity. In addition, single-center studies were common, and half of the clinical trials were concentrated in North America.…”

Section: Discussionmentioning

confidence: 99%

Interventional Clinical Trials on Diabetic Peripheral Neuropathy: A Retrospective Analysis

Wang¹,

Zhang

et al. 2021

JPR

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Aims/Introduction Diabetic peripheral neuropathy (DPN) is the most common complication of diabetes. At present, there is no comprehensive summary of the clinical trials related to DPN. In this article, we summarized the basic characteristics of the interventional clinical trials pertaining to DPN to determine the current status of research in this field and the existing issues. Materials and Methods We searched the World Health Organization International Clinical Trial Registration Platform (ICTRP), PubMed and Web of Science for clinical trials from 2005 to April 2021 and extracted 149 registered and 459 published clinical trials on DPN. We summarized the characteristics of the clinical trials, including the source registration, recruitment status, stage, age group, allocation method, intervention, end point classification, funding source, and treatment. Results After excluding noninterventional and nontreatment trials, 149 registered clinical trials out of 292 records from 12 registration centers and 459 published articles were included in this study. Among the registered trials, 43% had been completed, and 34.4% had been published in peer-reviewed journals. Among these trials, more than half used random allocation and blinded placebo-controlled methodologies. A total of 40.3% of the trials were multicenter studies, 63.8% of the treatments were drug therapies, and the endpoint classifications of 49% were efficacy and safety. Of the 459 published interventional clinical trials on DPN, 69.7% of the trials used drug treatments; more than half were randomized, double-blind, placebo-controlled clinical trials; 94.1% had positive outcomes; 46.4% had a target size of 50; and 22.9% were multicenter. Conclusion This paper systematically summarizes the current status of interventional trials on DPN registered in the ICTRP and published clinical trials and provides a reference for the development of high-quality intervention strategies for DPN in the future.

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High-Dose Intravenous Immunoglobulin Is Effective in Painful Diabetic Polyneuropathy Resistant to Conventional Treatments. Results of a Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial

Cited by 13 publications

References 42 publications

Managing Chronic Neuropathic Pain: Recent Advances and New Challenges

Managing Chronic Neuropathic Pain: Recent Advances and New Challenges

Immunoglobulin Use for the Management of Painful Peripheral Neuropathy: A Systematic Review and Meta-Analysis

Interventional Clinical Trials on Diabetic Peripheral Neuropathy: A Retrospective Analysis

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