Prediction of treatment response to capsaicin 8% patch: Lessons to be learned from daily clinical practice

Prediction of treatment response to capsaicin 8% patch: Lessons to be learned from daily clinical... In this issue of the Scandinavian Journal of Pain, Gustorff et al. have carefully examined neuropathic pain patients treated with the capsaicin 8% patch and have identified possible predictors for treatment response [1].Neuropathic pain is often a chronic disabling condition. First-line analgesic treatments include antidepressants and gabapentin or pregabalin, but treatment often provides only partial relief or may be associated with intolerable side effects [2]. Randomized controlled trials (RCTs) have shown that patients tend to have either minimal pain relief or very good pain relief from a given drug. Unfortunately, RCTs rarely include characterizations of patients who respond to the treatment, and thus little is known about the predictors of response to various treatments. As a consequence, treatment continues to be a trial-and-error process.In the past 10 years, different topical treatments for peripheral neuropathic pain have been introduced. The most important treatment options are lidocaine and capsaicin patches and also intradermal injections of botulinum toxin type A. Qutenza, a cutaneous patch of capsaicin 8%, has been given marketing authorization in Europe with the indication: “treatment of peripheral neuropathic pain in non-diabetic adults” and FDA approval for postherpetic neuralgia. Capsaicin 8% patches are applied to the pain area for 30 or 60 minutes, and the treatment can be repeated after 3 months. This is usually done in a hospital setting. The first studies on the high-concentration capsaicin path (NGX-4010) emerged in 2008 [3,4]. Subsequent studies have confirmed the effect of highdose capsaicin in postherpetic neuralgia, but one study failed to reproduce the positive findings in HIV neuropathy [5]. No published RCTs have tested the capsaicin 8% patch in other neuropathic pain conditions. Since the application of the capsaicin 8% patch is painful, a low-dose capsaicin application has been used as an active control to ensure blinding in RCTs. The treatment is generally well tolerated and apart from the pain experienced during the application, it has limited side effects, although little is still known about the long-term effect and safety of repeated applications.The effect of the capsaicin 8% patch is modest, but as for other analgesic treatments some patients seem to obtain a good effect, while other patients fail to respond, and it would be extremely valuable to be able to predict the treatment response. Gustorff and colleagues are to be congratulated for having systematically assessed the patients before the treatment with the capsaicin 8% patch and examined factors related to treatment response. In this observational study, 57 patients with postherpetic neuralgia, peripheral nerve injury or polyneuropathy were carefully assessed with quantitative sensory testing before treatment with capsaicin 8% patches. Patients with ≥30% pain reduction by day 7/10 were classified as responders. The etiology of the neuropathic pain did not predict the response to treatment, but there was one variable in the quantitative sensory testing that predicted response. Perhaps surprisingly, non-responders had significantly worse dynamic mechanical allodynia at baseline than responders. We can only speculate on the mechanisms underlying the neuropathic pain in patients with allodynia and the lack of effect of capsaicin patches, but it provides useful information for the clinical treatment of neuropathic pain patients.Is this result from a non-placebo controlled exploratory observational study useful, considering the sometimes very large placebo responses in pain treatment? Yes, it is. The hypothesis generated from this careful examination of patients will of course need to be tested in an RCT, but at least now we have a hypothesis. Maybe of even more importance, the knowledge that allodynia may predict non-response to the capsaicin 8% patch will hopefully prevent researchers from including only patients with allodynia in their trials, which is the case in some RCTs, although rarely justified.References[1]Gustorff B, Poole C, Kloimstein H, Hacker N, Likar R. Treatment of neuropathic pain with the capsaicin 8% patch: using quantitative sensory testing to investigate predictors of response to treatment. Scand J Pain 2013;4:138–45.Gustorff BPooleCKloimsteinHHackerNLikarR.Treatment of neuropathic pain with the capsaicin 8% patch: using quantitative sensory testing to investigate predictors of response to treatmentScand J Pain2013413845[2]Dworkin RH, O’Connor AB, Backonja M, Farrar JT, Finnerup NB, Jensen TS, Kalso EA, Loeser JD, Miaskowski C, Nurmikko TJ, Portenoy RK, Rice AS, Stacey BR, Treede RD, Turk DC, Wallace MS. Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain 2007;132:237–51.http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000251572400006&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=b7bc2757938ac7a7a821505f8243d9f31792077010.1016/j.pain.2007.08.033DworkinRHO’ConnorABBackonjaMFarrarJTFinnerupNBJensenTSKalsoEALoeserJDMiaskowskiCNurmikkoTJPortenoyRKRiceASStaceyBRTreedeRDTurkDCWallaceMS.Pharmacologic management of neuropathic pain: evidence-based recommendationsPain200713223751[3]Backonja M, Wallace MS, Blonsky ER, Cutler BJ, Malan Jr P, Rauck R, TobiasJ. NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study. Lancet Neurol 2008;7:1106–12.10.1016/S1474-4422(08)70228-Xhttp://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000261396000016&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=b7bc2757938ac7a7a821505f8243d9f318977178BackonjaMWallaceMSBlonskyERCutlerBJMalan JrPRauckRTobiasJ.NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind studyLancet Neurol20087110612[4]Simpson DM, Brown S, Tobias J. Controlled trial of high-concentration capsaicin patch for treatment of painful HIV neuropathy. Neurology 2008;70:2305–13.10.1212/01.wnl.0000314647.35825.9chttp://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000257060000008&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=b7bc2757938ac7a7a821505f8243d9f318541884SimpsonDMBrownSTobiasJ.Controlled trial of high-concentration capsaicin patch for treatment of painful HIV neuropathyNeurology200870230513[5]Clifford DB, Simpson DM, Brown S, Moyle G, Brew BJ, Conway B, Tobias JK, Vanhove GF. A randomized, double-blind, controlled study of NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy. J Acquir Immune Defic Syndr 2012;59:126–33.2206766110.1097/QAI.0b013e31823e31f7CliffordDBSimpsonDMBrownSMoyleGBrewBJConwayBTobiasJKVanhoveGF.A randomized, double-blind, controlled study of NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathyJ Acquir Immune Defic Syndr20125912633 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Scandinavian Journal of Pain de Gruyter

Prediction of treatment response to capsaicin 8% patch: Lessons to be learned from daily clinical practice

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de Gruyter
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© 2013 Scandinavian Association for the Study of Pain
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1877-8860
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1877-8879
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10.1016/j.sjpain.2013.05.003
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Abstract

In this issue of the Scandinavian Journal of Pain, Gustorff et al. have carefully examined neuropathic pain patients treated with the capsaicin 8% patch and have identified possible predictors for treatment response [1].Neuropathic pain is often a chronic disabling condition. First-line analgesic treatments include antidepressants and gabapentin or pregabalin, but treatment often provides only partial relief or may be associated with intolerable side effects [2]. Randomized controlled trials (RCTs) have shown that patients tend to have either minimal pain relief or very good pain relief from a given drug. Unfortunately, RCTs rarely include characterizations of patients who respond to the treatment, and thus little is known about the predictors of response to various treatments. As a consequence, treatment continues to be a trial-and-error process.In the past 10 years, different topical treatments for peripheral neuropathic pain have been introduced. The most important treatment options are lidocaine and capsaicin patches and also intradermal injections of botulinum toxin type A. Qutenza, a cutaneous patch of capsaicin 8%, has been given marketing authorization in Europe with the indication: “treatment of peripheral neuropathic pain in non-diabetic adults” and FDA approval for postherpetic neuralgia. Capsaicin 8% patches are applied to the pain area for 30 or 60 minutes, and the treatment can be repeated after 3 months. This is usually done in a hospital setting. The first studies on the high-concentration capsaicin path (NGX-4010) emerged in 2008 [3,4]. Subsequent studies have confirmed the effect of highdose capsaicin in postherpetic neuralgia, but one study failed to reproduce the positive findings in HIV neuropathy [5]. No published RCTs have tested the capsaicin 8% patch in other neuropathic pain conditions. Since the application of the capsaicin 8% patch is painful, a low-dose capsaicin application has been used as an active control to ensure blinding in RCTs. The treatment is generally well tolerated and apart from the pain experienced during the application, it has limited side effects, although little is still known about the long-term effect and safety of repeated applications.The effect of the capsaicin 8% patch is modest, but as for other analgesic treatments some patients seem to obtain a good effect, while other patients fail to respond, and it would be extremely valuable to be able to predict the treatment response. Gustorff and colleagues are to be congratulated for having systematically assessed the patients before the treatment with the capsaicin 8% patch and examined factors related to treatment response. In this observational study, 57 patients with postherpetic neuralgia, peripheral nerve injury or polyneuropathy were carefully assessed with quantitative sensory testing before treatment with capsaicin 8% patches. Patients with ≥30% pain reduction by day 7/10 were classified as responders. The etiology of the neuropathic pain did not predict the response to treatment, but there was one variable in the quantitative sensory testing that predicted response. Perhaps surprisingly, non-responders had significantly worse dynamic mechanical allodynia at baseline than responders. We can only speculate on the mechanisms underlying the neuropathic pain in patients with allodynia and the lack of effect of capsaicin patches, but it provides useful information for the clinical treatment of neuropathic pain patients.Is this result from a non-placebo controlled exploratory observational study useful, considering the sometimes very large placebo responses in pain treatment? Yes, it is. The hypothesis generated from this careful examination of patients will of course need to be tested in an RCT, but at least now we have a hypothesis. Maybe of even more importance, the knowledge that allodynia may predict non-response to the capsaicin 8% patch will hopefully prevent researchers from including only patients with allodynia in their trials, which is the case in some RCTs, although rarely justified.References[1]Gustorff B, Poole C, Kloimstein H, Hacker N, Likar R. Treatment of neuropathic pain with the capsaicin 8% patch: using quantitative sensory testing to investigate predictors of response to treatment. Scand J Pain 2013;4:138–45.Gustorff BPooleCKloimsteinHHackerNLikarR.Treatment of neuropathic pain with the capsaicin 8% patch: using quantitative sensory testing to investigate predictors of response to treatmentScand J Pain2013413845[2]Dworkin RH, O’Connor AB, Backonja M, Farrar JT, Finnerup NB, Jensen TS, Kalso EA, Loeser JD, Miaskowski C, Nurmikko TJ, Portenoy RK, Rice AS, Stacey BR, Treede RD, Turk DC, Wallace MS. Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain 2007;132:237–51.http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000251572400006&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=b7bc2757938ac7a7a821505f8243d9f31792077010.1016/j.pain.2007.08.033DworkinRHO’ConnorABBackonjaMFarrarJTFinnerupNBJensenTSKalsoEALoeserJDMiaskowskiCNurmikkoTJPortenoyRKRiceASStaceyBRTreedeRDTurkDCWallaceMS.Pharmacologic management of neuropathic pain: evidence-based recommendationsPain200713223751[3]Backonja M, Wallace MS, Blonsky ER, Cutler BJ, Malan Jr P, Rauck R, TobiasJ. NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study. Lancet Neurol 2008;7:1106–12.10.1016/S1474-4422(08)70228-Xhttp://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000261396000016&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=b7bc2757938ac7a7a821505f8243d9f318977178BackonjaMWallaceMSBlonskyERCutlerBJMalan JrPRauckRTobiasJ.NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind studyLancet Neurol20087110612[4]Simpson DM, Brown S, Tobias J. Controlled trial of high-concentration capsaicin patch for treatment of painful HIV neuropathy. Neurology 2008;70:2305–13.10.1212/01.wnl.0000314647.35825.9chttp://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000257060000008&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=b7bc2757938ac7a7a821505f8243d9f318541884SimpsonDMBrownSTobiasJ.Controlled trial of high-concentration capsaicin patch for treatment of painful HIV neuropathyNeurology200870230513[5]Clifford DB, Simpson DM, Brown S, Moyle G, Brew BJ, Conway B, Tobias JK, Vanhove GF. A randomized, double-blind, controlled study of NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy. J Acquir Immune Defic Syndr 2012;59:126–33.2206766110.1097/QAI.0b013e31823e31f7CliffordDBSimpsonDMBrownSMoyleGBrewBJConwayBTobiasJKVanhoveGF.A randomized, double-blind, controlled study of NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathyJ Acquir Immune Defic Syndr20125912633

Journal

Scandinavian Journal of Painde Gruyter

Published: Jul 1, 2013

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