BackgroundIn randomised studies, the capsaicin 8% patch has demonstrated effective pain relief in patients with peripheral neuropathic pain (PNP) arising from different aetiologies.MethodsASCEND was an open-label, non-interventional study of patients with non-diabetes-related PNP who received capsaicin 8% patch treatment, according to usual clinical practice, and were followed for ≤52 weeks. Co-primary endpoints were percentage change in the mean numeric pain rating scale (NPRS) ‘average daily pain’ score from baseline to the average of Weeks 2 and 8 following first treatment; and median time from first to second treatment. The primary analysis was intended to assess analgesic equivalence between post-herpetic neuralgia (PHN) and other PNP aetiologies. Health-related quality of life (HRQoL, using EQ-5D), Patient Global Impression of Change (PGIC) and tolerability were also assessed.ResultsFollowing first application, patients experienced a 26.6% (95% CI: 23.6, 29.62; n = 412) reduction in mean NPRS score from baseline to Weeks 2 and 8. Equivalence was demonstrated between PHN and the neuropathic back pain, post-operative and post-traumatic neuropathic pain and ‘other’ PNP aetiology subgroups. The median time from first to second treatment was 191 days (95% CI: 147, 235; n = 181). Forty-four percent of all patients were responders (≥30% reduction in NPRS score from baseline to Weeks 2 and 8) following first treatment, and 86.9% (n = 159/183) remained so at Week 12. A sustained pain response was observed until Week 52, with a 37.0% (95% CI: 31.3, 42.7; n = 176) reduction in mean NPRS score from baseline. Patients with the shortest duration of pain (0–0.72 years) experienced the highest pain response from baseline to Weeks 2 and 8. Mean EQ-5D index score improved by 0.199 utils (responders: 0.292 utils) from baseline to Week 2 and was maintained until Week 52. Most patients reported improvements in PGIC at Week 2 and at all follow-up assessments regardless of number of treatments received. Adverse events were primarily mild or moderate reversible application site reactions.ConclusionIn European clinical practice, the capsaicin 8% patch provided effective and sustained pain relief, substantially improved HRQoL, improved overall health status and was generally well tolerated in a heterogeneous PNP population.Trial registration NCT01737294 Date of registration - October 22, 2012.

A 24 year-old white right handed woman with an otherwise unremarkable medical and family history was admitted with vertigo, hiccups, intractable vomiting, gait unsteadiness and oscillopsia that developed gradually over 9 months.Although initially relapsing and remitting, her manifestations became persistent approximately one month prior to her admission. Neurological examination revealed periodic alternating nystagmus, gait ataxia and bilaterally brisk tendon reflexes in upper and lower extremities and a right extensor plantar reflex. On admission brain MRI there were several lesions with increased T2/FLAIR ( Fig. 1BCD) and low T1 signal including a space-occupying lesion in the left half of the pons, extending into the left middle cerebellar peduncle, the medulla and the lower mesencephalic tectum (Fig. 1A). Lesions did not exhibit gadolinium enhancement ( Fig. 1A) but showed restricted diffusion in diffusion-weighted sequences (Fig. 1E). Spinal cord MRI was normal. CSF analysis on admission and two months later showed normal cell counts and glucose levels, increased protein (83mg/dL and 90mg/dL, respectively), normal IgG index and no oligoclonal bands. CSF flow cytometric analysis was within normal values and CSF cytology was negative for neoplastic cells in both occasions. Full blood counts, biochemistry, serum LDH, thyroid studies, coagulation profiles, ESR, CRP, autoimmune antibody screening including anti-AQP IV antibodies, plasma folate and B12 vitamin levels, plasma protein immunoelectrophoresis, complement levels, urine analysis and serology for hepatitis and HIV were normal. Bone marrow biopsy and contrast-enhanced whole body CT, upper and lower endoscopy and abdominal ultrasonography were unremarkable. Fundoscopy and slit-lamp examination were also unremarkable. Upon magnetic resonance spectroscopy findings suggestive of tumefactive demyelinating lesions, the patient was treated with two monthly courses of mitoxantrone with no apparent clinical benefit and expansion of lesions on MRI, yet still without gadolinium enhancement. A month after the second course of mitoxantrone she developed dysphagia, voice hoarseness and cachexia. Neurological examination revealed left abducens palsy, pathological left-sided cerebellar tests in addition to previous findings and posterior laryngoscopy showed left vocal cord paresis. A new CSF analysis revealed a raised protein level (130mg/dL) with normal cell counts and glucose. CSF cytology, oligoclonal bands were negative and flow cytometric analysis was within normal ranges. A new brain MRI indicated enlargement of pre-existing lesions with peripheral gadolinium enhancement of the brainstem space-occupying lesion (Fig. 1F). Stereotactic biopsy of the brainstem lesion was performed.

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