The capsaicin 8% cutaneous patch is an emergent new treatment option for patients with peripheral neuropathic pain. In randomized controlled clinical studies relevant pain relief for 12 weeks was achieved in about one third of patients following a single application. The first part of this paper is a review of the pathophysiology, pharmacology, and published clinical trials with the capsaicin 8% cutaneous patch. The second part reports on outcomes of an interdisciplinary expert workshop, where new treatment results of three major German pain centers were presented and reviewed with the objectives of obtaining responder rates for different pain syndromes, assessing maintenance of effect under real-life conditions, and giving recommendations for practical care. The 12 week responder rates with pain relief of ≥ 30% were comparable in patients with mononeuropathies (37.9%) and postherpetic neuralgia (38.8%). Similar responder rates were seen in a subgroup of patients with cervical spine radiculopathy and back pain (46.7%). In HIV-associated neuropathy the responder rates were high (47.8%) but lower in patients with other polyneuropathies (17.6%). Response rates were nearly identical after 1 week (46.6%) and 4 weeks (43.3) and dropped only slightly at 12 weeks (37.4%). In a subgroup of 54 patients who underwent a second treatment, efficacy was maintained. Response rates in patients with or without lidocaine pretreatment were comparable. Treatment with the capsaicin 8% cutaneous patch was generally safe and well tolerated. The workshop panel recommended further investigation of opportunities to improve the application procedure and to perform studies on the skin penetration and distribution of capsaicin. A modified quantitative sensory testing (QST) should be developed for clinical practice in order to better understand the correlation of sensory profiles and response to capsaicin treatment.
Our results raise questions about the long-term effectiveness of analgesic treatment regimens irrespective of analgesics type employed and call for more multidisciplinary treatment strategies.
Background and aim Strong opioids including oxycodone are amongst the most effective analgesics to combat moderate to severe pain of various aetiologies, but opioid-induced bowel dysfunction (OIBD) represents a relevant problem. The rationale for development of a prolonged-release (PR) fixed combination of oxycodone and naloxone was to counteract OIBD. Due to its negligible oral bioavailability, the μ-opioid receptor antagonist naloxone is able to selectively displace opioids from local μ-receptors in the gastrointestinal tract without affecting central opioid binding sites. Pivotal trials of PR oxycodone/naloxone not only demonstrated improved bowel function but also equivalent analgesic efficacy compared to PR oxycodone alone. Controlled clinical trials comparing PR oxycodone/naloxone with strong opioids other than oxycodone are not available. The present study is the first data set aimed at comparing pain control, bowel function, and quality of life (QoL) in patients newly treated with or switched to PR oxycodone/naloxone or other strong opioids during routine clinical practice. Methods In this three-arm, prospective observational study, 588 patients with moderate to severe pain of varying aetiologies received either PR oxycodone/naloxone (OXN group and OXN 40/20 group with indicated use of the 40 mg/20 mg dose strength at baseline) or other strong opioids (control group), dosed according to pain severity, for 4-6 weeks. Data documented include pain intensity (NRS), bowel function (Bowel Function Index, BFI), pain-related functional impairment (BPI-SF), QoL (EuroQol EQ-5D-3L), and a global assessment of treatment. Results Patients receiving PR oxycodone/naloxone experienced a clinically important reduction in pain intensity and pain-related functional impairment of approximately 40%. The reductions of pain intensity (-2.9 ± 2.3) and pain-related functional impairment (-2.4 ± 2.3) in the OXN group were significantly more pronounced than in the control group (-2.1 ± 2.1 and -1.8 ± 1.7). In the control group, mean reductions in pain intensity did not reach the threshold of ≥30% for at least moderate clinically important differences, although patients were prescribed higher doses of morphine equivalents than OXN group patients. Improvements in bowel function (OXN: -16.0 ± 27.6; control: 3.1 ± 24.4) and QoL (OXN: 20.8 ± 24.2; control: 13.2 ± 23.1) were also significantly more pronounced in the OXN group, with BFI scores reduced to a level that reflects normal bowel function. Results for the OXN 40/20 group receiving higher doses of PR oxycodone/naloxone were in line with those for the OXN group. In the control group, more frequent gastrointestinal adverse events and less favourable ratings of tolerability resulted in a higher rate of treatment discontinuations due to adverse events. Conclusions In patients receiving PR oxycodone/naloxone, more favourable outcomes compared with other strong opioids regarding pain control, bowel function, and QoL were observed. Implications The present findings underline the value of...
Effective neuropathic pain relief was observed after patch application within the innervation territories of both dorsal and ventral branches of the spinal nerve. Further controlled randomized trials are indicated.
Zusammenfassung Hintergrund Erkrankungen verursacht durch das neuartige Coronavirus (SARS-CoV-2) haben in einem sehr dynamischen Verlauf zu einer Pandemie geführt. Die epidemiologische Lage von nationaler Tragweite erforderte Infektionsschutzmaßnahmen mit dem Ziel, die Morbidität und Mortalität zu senken. Eine Überbelastung der Gesundheitssysteme sollte vermieden werden. Die Maßnahmen zur Bekämpfung der Pandemie hatten und haben Auswirkungen auf das öffentliche und private Leben. Chronisch schmerzkranke Patienten sind ebenfalls betroffen. Fragestellung Welche Auswirkungen der Pandemie auf ihre Versorgung nehmen Patienten mit chronischen Schmerzen wahr? Methode Siebzig Schmerzpatienten nach einer multimodal stationären Therapie wurden in einem standardisierten Interview telefonisch zu ihrem Befinden wie folgt befragt: Führten die Coronabedingungen zu einer Zunahme der Schmerzbelastung, verschlechterte sich die Stimmung und hatte die Pandemie einen nachteiligen Einfluss auf die schmerzmedizinische Versorgungssituation? Ergebnisse Die Veränderungen im biopsychosozialen Bereich sind für die Patienten erlebbar und wirken sich auf die Gesamtsituation aus. Chronisch schmerzkranke Patienten waren vom sogenannten Lockdown betroffen. Patienten bringen eine Verschlechterung von Stimmung und ihrer Schmerzsituation zu einem großen Anteil mit den coronabedingten Maßnahmen in Verbindung. Deutlich ist die Stimmungsverschlechterung (70 % der Befragten). Eine Schmerzzunahme wird bei 44 % der Befragten mit den durch die Pandemie verursachten Veränderungen in Zusammenhang gebracht. 39 % der Patienten geben eine Verschlechterung ihrer schmerzmedizinischen Versorgung an. Die Maßnahmen zur Bekämpfung der Pandemie hatten und haben Auswirkungen auf das Leben chronisch kranker Schmerzpatienten. Diskussion Die bestehenden, auch im Vergleich zur Situation ohne Pandemie begrenzten Möglichkeiten einer koordinierten Versorgung von Schmerzpatienten im Anschluss an einen multimodal stationären Aufenthalt auch in schwierigen Situationen beizubehalten, ist notwendig. Die negativen Auswirkungen einer Reduktion medizinischer Versorgung sind ein Argument für eine multimodal ambulante Weiterversorgung insbesondere nach erfolgter stationärer Behandlung.
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