Neuropathic Pain and Sleep: A Review

Ferini‐Strambi, Luigi

doi:10.1007/s40122-017-0089-y

Cited by 49 publications

(37 citation statements)

References 32 publications

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“…We found that patients receiving TRZ reported favorable sleep outcomes (though this effect was similar across the three groups); our study, therefore, supports previous evidence showing that low doses of TRZ improve sleep. This effect might be particularly important in the clinical management of PDN, given the close association between neuropathic pain and sleep disturbances [26]. Trazodone, unique among antidepressants, has a mixed serotonergic and adrenolytic activity effective for multiple disorders including insomnia and anxiety [12,27].…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Low Doses of Trazodone in Patients Affected by Painful Diabetic Neuropathy and Treated with Gabapentin: A Randomized Controlled Pilot Study

Lipone

Ehler²,

Nastaj³

et al. 2020

CNS Drugs

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Background Painful diabetic neuropathy is an important therapeutic challenge as the efficacy of analgesic drugs in this setting is still unsatisfactory. Monotherapy with available treatments is often not sufficient and a combination of drugs is necessary. Trazodone (TRZ) is a compound with a multi-modal mechanism of action, being a serotonin-2 antagonist/reuptake inhibitor developed and approved for the treatment of depression in several countries. Previous clinical trials suggest a possible beneficial effect of low doses of trazodone for the treatment of patients affected by painful diabetic neuropathy. Objective This phase II study was designed to collect data on the efficacy and safety of low doses of TRZ combined with gabapentin after 8 weeks of treatment in patients affected by painful diabetic neuropathy. Methods This was a randomized, double-blind, placebo-controlled, multi-center, international, prospective study. Male and female diabetic patients aged 18-75 years and affected by painful diabetic neuropathy were eligible for enrollment. Subjects were randomized (1:1:1 ratio) to TRZ30 (10 mg three times daily for 8 weeks) or TRZ60 (20 mg three times daily for 8 weeks) or placebo. Gabapentin as background therapy was administered in open-label conditions to all patients. The primary endpoint was the change from baseline of the Brief Pain Inventory Short Form item 5 to week 8. Secondary endpoints included the other Brief Pain Inventory Short Form items, and the assessment of anxiety, sleep, quality of life, patient's improvement, and safety. Results One hundred and forty-one patients were included in the intention-to-treat population: 43 allocated to the TRZ30 group, 50 to the TRZ60 group, and 48 to the placebo group. After 8 weeks, the mean changes of Brief Pain Inventory Short Form item 5 from baseline were − 3.1, − 2.6, and − 2.5 in the TRZ30, TRZ60, and placebo groups, respectively. No statistically significant differences between groups were seen. Nevertheless, a better trend was observed for TRZ30 vs placebo (95% confidence interval − 1.30, 0.15; p = 0.1179), on top of the background effect of gabapentin administered to all study groups. 62.8% of patients achieved a ≥ 50% reduction in the TRZ30 group, 54% in the TRZ60 group, and 45.8% in the placebo group. At the same time, a statistically significant improvement was observed in Brief Pain Inventory Short Form item 6 for TRZ30 vs placebo (95% confidence interval − 1.54, − 0.07; p = 0.0314). No serious adverse event occurred during the trial and the most frequent treatment-emergent adverse events involved nervous system, QT prolongation, and gastrointestinal disorders. Conclusions All treatment groups showed a clinically meaningful pain improvement; nevertheless, patients in the TRZ30 treatment group reported better efficacy outcomes. This finding suggests that low doses of TRZ could be useful for treating painful diabetic neuropathy, and support further adequately powered confirmatory trials investigating the efficacy of TRZ. Clinical Trial Registratio...

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Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Low Doses of Trazodone in Patients Affected by Painful Diabetic Neuropathy and Treated with Gabapentin: A Randomized Controlled Pilot Study

Lipone

Ehler²,

Nastaj³

et al. 2020

CNS Drugs

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“…Pregabalin has shown considerable efficacy for improved sleep interference as demonstrated by an improvement in sleep quality in 77% of patients [ 96 ]. Pregabalin and gabapentin are effective in treating neuropathic pain and have a positive effect on co-morbid sleep disturbance compared with opiates and antidepressants [ 97 ]. Sleep disturbance as well as its severity correlates with the severity of neuropathic pain and is a predictor of response to pregabalin in a post hoc analysis of placebo-controlled trials [ 98 ].…”

Section: Methodsmentioning

confidence: 99%

Pregabalin in the Management of Painful Diabetic Neuropathy: A Narrative Review

et al. 2018

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Pregabalin is a first-line treatment in all major international guidelines on the management of painful diabetic neuropathy (pDPN). Treatment with pregabalin leads to a clinically meaningful improvement in pain scores, offers consistent relief of pain and has an acceptable tolerance level. Despite its efficacy in relieving neuropathic pain, more robust methods and comprehensive studies are required to evaluate its effects in relation to co-morbid anxiety and sleep interference in pDPN. The sustained benefits of modulating pain have prompted further exploration of other potential target sites and the development of alternative GABAergic agents such as mirogabalin. This review evaluates the role of pregabalin in the management of pDPN as well as its potential adverse effects, such as somnolence and dizziness, which can lead to withdrawal in ~ 30% of long-term use. Recent concern about misuse and an increase in deaths linked to its use has led to demands for reclassification of pregabalin as a class C controlled substance in the UK. We believe these demands need to be tempered in relation to the difficulties it would create for repeat prescriptions for the many millions of patients with pDPN for whom pregabalin provides benefit.Plain Language Summary: Plain language summary available for this article.

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“…Sleep disturbances decrease the quality of life and cause high health care costs and therefore, multimodal methods should be applied to improve the quality of life effectively. [33] Pregabalin is one of the most commonly prescribed analgesics for PHN. In many clinical studies, pregabalin used for PHN has been shown to reduce pain significantly, to improve sleep more compared to placebo, to have higher global efficacy, and to provide great improvement in patients with severe sleep disorders.…”

Section: Pain a Rimentioning

confidence: 99%

Evaluation of the Efficacy of Erector Spinae Plane Block and Intercostal Nerve Block in the Postherpetic Neuralgia

Hacıbeyoğlu

Arıcan

Ulukaya

et al. 2020

Agri

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The aim of this study was to compare the efficacy of an intercostal nerve block, which has been used for many years in the treatment of postherpetic neuralgia, and the more recent alternative of an erector spinae plane (ESP) block. Methods: The records of 39 patients who were treated in the algology department for postherpetic neuralgia between May 1, 2015 and May 1, 2018 were evaluated retrospectively. Patients who received an intercostal nerve block constituted Group 1 and those who received an ESP block were categorized as Group 2. The change in numeric rating scale (NRS) and Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scores in the short term and in the long term were the primary results of the study. Results: The NRS, LANSS, and sleep interference scale (SIS) scores of the patients in Group 1 and Group 2 were found to be significantly lower at the 24 th hour, week 4, and week 12 compared with the values obtained before block application. In Group 1, the scores recorded at week 4 and week 12 were significantly higher than the 24 th hour values, whereas no difference was observed between these results in Group 2. There was no significant difference between the groups in the week 4 and week 12 scores. Similarly, no significant difference was observed in the NRS, LANSS, or SIS scores before the block application or at the 24 th hour. However, the scores at week 4 and week 12 were significantly lower in Group 2 compared with Group 1. Conclusion: The results indicated that an ESP block significantly decreased neuropathic pain symptoms and the need for additional treatment in postherpetic neuralgia treatment in the long term.

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Neuropathic Pain and Sleep: A Review

Cited by 49 publications

References 32 publications

Efficacy and Safety of Low Doses of Trazodone in Patients Affected by Painful Diabetic Neuropathy and Treated with Gabapentin: A Randomized Controlled Pilot Study

Efficacy and Safety of Low Doses of Trazodone in Patients Affected by Painful Diabetic Neuropathy and Treated with Gabapentin: A Randomized Controlled Pilot Study

Pregabalin in the Management of Painful Diabetic Neuropathy: A Narrative Review

Evaluation of the Efficacy of Erector Spinae Plane Block and Intercostal Nerve Block in the Postherpetic Neuralgia

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