Characteristics and outcomes of peripheral neuropathic pain patients with repeated applications of high-concentration capsaicin cutaneous patch: Results of a retrospective chart review in Germany.

OBJECTIVE: The aim of this study was to evaluate patient characteristics, concomitant analgesic medication, and pain intensity in a real-world setting in Germany, focusing on the repeated application of high-concentration capsaicin patch (HCCP) for neuropathic pain. DESIGN: Data were collected from electronic medical records of patients who received at least two HCCP treatments between January 2011 and July 2022. Subgroup analyses were performed based on the number of HCCP treatments, age groups, and specific neuropathic pain conditions. SETTING: The study was conducted at an outpatient pain center in Wiesbaden, Germany. SUBJECTS: The study included 97 patients, primarily diagnosed with neuropathic back pain, postoperative or post-traumatic neuropathic pain, and postherpetic neuralgia. METHODS: The daily dose of concomitant medications (eg, opioids and anticonvulsants) at the start of capsaicin therapy was compared with the average within 2 years of capsaicin therapy. The last observation carried forward method was used if HCCP treatment was discontinued before the end of the 2-year period. RESULTS: The majority of patients received concomitant medications, with opioids, anticonvulsants, and antidepressants being the most common. The average daily morphine equivalent dose decreased significantly during HCCP treatment. Pain intensity at baseline was generally high, but substantial improvements were observed in patients who received at least three HCCP applications. CONCLUSIONS: This study provides evidence for the effectiveness of HCCP treatment in reducing pain intensity and concomitant opioid use in patients with neuropathic pain. Further research is needed to explore the long-term outcomes and optimal treatment regimens for different patient populations.

Low back pain management in routine clinical practice: what is important for the individual patient?

Chronic low back pain is a complex disorder influenced by biological, psychological, and social factors. Causes, personal circumstances and personal disease experiences are varied; patient care thus needs to be tailored to the individual. Supported by clinical study results and online patient survey data, the present paper explores factors which are important to the patient beyond pain relief and proposes topics to be raised in consultation to identify the most important treatment goals. Furthermore, the importance of communication, trust and empathy in the physician-patient relationship for effective pain management is addressed.

Effective treatment of chronic low back pain requires clear communication between patient and doctor/healthcare team. Although patients primarily expect and hope for pain relief under treatment, the reasons why they want to achieve a reduction of the pain might differ and might not even be obvious to them at the beginning of the consultation. For some patients, the pain itself might be unacceptable, for others, the issue might be restrictions in mobility or functioning in daily life because of the pain. Defining treatment goals can help identifying these underlying reasons. Using observations from his clinical pain specialist practice and supported by clinical study data and a survey of patients, the author aims to determine patients' most important treatment goals and makes suggestions on how these treatment goals can be identified in consultation with the individual patient.

Ambroxol for neuropathic pain: hiding in plain sight?

ABSTRACT: Ambroxol is a multifaceted drug with primarily mucoactive and secretolytic actions, along with anti-inflammatory, antioxidant, and local anaesthetic properties. It has a long history of use in the treatment of respiratory tract diseases and has shown to be efficacious in relieving sore throat. In more recent years, ambroxol has gained interest for its potential usefulness in treating neuropathic pain. Research into this area has been slow, despite clear preclinical evidence to support its primary analgesic mechanism of action-blockade of voltage-gated sodium (Na v ) channels in sensory neurons. Ambroxol is a commercially available inhibitor of Na v 1.8, a crucial player in the pathophysiology of neuropathic pain, and Na v 1.7, a particularly exciting target for the treatment of chronic pain. In this review, we discuss the analgesic mechanisms of action of ambroxol, as well as proposed synergistic properties, followed by the preclinical and clinical results of its use in the treatment of persistent pain and neuropathic pain symptoms, including trigeminal neuralgia, fibromyalgia, and complex regional pain syndrome. With its well-established safety profile, extensive preclinical and clinical drug data, and early evidence of clinical effectiveness, ambroxol is an old drug worthy of further investigation for repurposing. As a patent-expired drug, a push is needed to progress the drug to clinical trials for neuropathic pain. We encourage the pharmaceutical industry to look at patented drug formulations and take an active role in bringing an optimized version for neuropathic pain to market.

[Tapentadol versus classical WHO-III opioids for chronic back pain. Health services research study based on representative data from health insurance funds]. / Tapentadol versus klassische WHO-III-Opioide bei chronischen Rückenschmerzen : Versorgungsforschungsstudie auf Basis repräsentativer Krankenkassendaten.

BACKGROUND/OBJECTIVE: In clinical trials, tapentadol prolonged release (PR) showed a more favourable gastrointestinal tolerability profile compared to other strong opioids in the treatment of pain. The present analysis compared tapentadol PR and classical WHO-III PR opioids in routine clinical practice. METHOD: Retrospective cohort study (matched pair approach) using anonymised health insurance data of patients with chronic low back pain who were prescribed strong opioids following pretreatment with WHO-I/II analgesics. Data were analysed from the date of first prescription in 2015 over a maximum period of two years. The primary analysis parameter was the prescription of laxatives. RESULTS: Data of 227 patients per cohort could be included in the analysis. Significantly fewer tapentadol PR than WHO-III PR patients were prescribed laxatives (20.3% vs. 37%; p < 0.0001). In addition, laxative dosages were significantly lower in the tapentadol PR cohort (26.4 vs. 82.5 defined daily doses; p < 0.0001). A significant difference in laxative prescription was also observed under long-term treatment (tapentadol PR patients 27.7% vs. WHO-III PR patients 50%; p = 0.0029). CONCLUSION: Routine clinical practice indirectly confirmed the more favourable gastrointestinal tolerability of tapentadol PR in the treatment of chronic pain which had previously been demonstrated in clinical trials and non-interventional studies.

Oral or Topical Pain Therapy-How Would Patients Decide? A Discrete Choice Experiment in Patients with Peripheral Neuropathic Pain.

To ensure an adequate pain therapy with high patient adherence, it is necessary to know and consider patient preferences. A discrete choice experiment was used to obtain patients' preferences regarding treatment with systemic or topical pain medication. Patients with peripheral neuropathic pain (pNP) were recruited in two pain-focused practices in Germany. To identify relevant attributes of topical or systemic pain medication, a literature review and face-to-face interviews with experts for pain treatment were conducted. The attributes used in the choice scenarios were noticeable onset of effect, time spent in medical office, risk of systemic and local side effects, and impairment of daily life with regard to sleep quality and sexuality. The model was estimated with a mixed multinomial logit regression model. The study included 153 participants suffering from moderate to severe pNP. Most important attributes from patient's perspective was noticeable onset of effect (odds ratio 2.141 [95% confidence interval 1.837 to 2.494]), followed by risk of systemic side effects (2.038 [1.731 to 2.400]) and risk of sexual dysfunction (1.839 [1.580 to 2.140]), while risk of local side effects regarding skin ranked fourth (1.612 [1.321 to 1.966]). The impairment of sleep quality was also significant but less important (1.556 [1.346 to 1.798]). Local side effects were more likely to be accepted than systemic side effects. The risk of sexual dysfunction as a side effect of treatment is very important for patients, although it has received little attention in the literature.

Expert Opinion: Exploring the Effectiveness and Tolerability of Capsaicin 179 mg Cutaneous Patch and Pregabalin in the Treatment of Peripheral Neuropathic Pain.

BACKGROUND AND OBJECTIVE: Treatment of peripheral neuropathic pain (PNP) remains a challenge. In the absence of clear predictors of response, clinical decision-making involves trial and error. While many classes of pharmacological agent are used and have shown efficacy, one of the most commonly used first-line treatments is pregabalin. However, in the 60% of PNP cases in which the pain is localized, a local treatment may be more suitable. This article will summarize the evidence for the relative effectiveness and tolerability of the capsaicin 179 mg patch and pregabalin in the treatment of PNP and highlight the expert opinion of the authors based on their own clinical experiences. RESULTS: When compared in a head-to-head trial in patients with PNP, capsaicin 179 mg patch provided non-inferior pain relief compared with an optimized dose of pregabalin, as well as a reduction in dynamic mechanical allodynia, faster onset of action, fewer systemic side effects, and greater treatment satisfaction. Adverse events associated with capsaicin patch are mainly application site reactions, compared with systemic and central nervous system effects with pregabalin. Studies indicate that capsaicin 179 mg patch is associated with a lower burden of therapy than pregabalin in terms of improved tolerability, lack of a daily pill burden, lack of drug-drug interactions, and increased regimen flexibility. CONCLUSION: In localized neuropathic pain, evidence supports a pragmatic approach of using a local treatment before considering a systemic treatment. For treatment selection, the patient profile (eg, concomitant medication use, age) and the treatments' efficacy and tolerability profiles should be considered.

Tapentadol prolonged release for severe chronic osteoarthritis pain in the elderly: improvements in daily functioning and quality of life.

Background: Chronic osteoarthritis (OA) pain leads to severe impairments in physical functioning and quality of life. Patients & methods: Data of patients with severe chronic knee and/or hip OA pain were extracted from the database of a prospective, noninterventional trial to assess the benefits of tapentadol prolonged release (PR) in elderly patients (>65 years of age; n = 1162) compared with younger patients (≤65 years of age; n = 498). Results: Tapentadol PR treatment (up to 3 months) significantly reduced pain intensity and pain-related restrictions on daily functioning and significantly improved physical and mental quality of life in both patient groups. The incidence of adverse drug reactions was low. Conclusion: Tapentadol PR is a useful strong analgesic to improve pain intensity, physical functioning and quality of life in elderly OA patients.

Consensus and Controversies Between Pain and Addiction Experts on the Prevention, Diagnosis, and Management of Prescription Opioid Use Disorder.

OBJECTIVES: Prescription opioid use disorder (POUD) is an established public health crisis in many countries, and current evidence indicates it is a growing problem in Europe. Many specialists play a role, including pain and addiction medicine specialists, in the diagnosis and management of POUD, but neither group can fully address these patients' needs alone. The purpose of this consensus process was to bring together experts from pain and addiction medicine to examine the positions of both specialties. METHODS: In all, 13 international pain medicine, addiction medicine, and addiction psychiatry experts convened a meeting to formulate a set of consensus statements on the diagnosis and management of POUD. The statements were further refined by a wider group of 22 European expert clinicians. At a second meeting of all 35 participants, a set of controversy statements was also developed to recognize some of the key areas of divergent opinion. RESULTS/CONCLUSIONS: There was a high level of agreement between pain and addiction specialists. Key themes that emerged were the need to strengthen interdisciplinary communication, a desire for greater education and training for clinicians in both specialties, and mutual acknowledgment of the importance of multidisciplinary management of POUD. The blurred line between poorly managed pain and POUD was also a subject of much discussion, reflecting the difficulties in defining and diagnosing this complex condition.

Topical Ambroxol 20% for the Treatment of Classical Trigeminal Neuralgia - A New Option? Initial Clinical Case Observations.

BACKGROUND: Trigeminal neuralgia is difficult to treat and shows upregulation of sodium channels. The expectorant ambroxol acts as a strong local anesthetic, about 40 times stronger than lidocaine. It preferentially inhibits the channel subtype Nav 1.8, expressed especially in nociceptive C-fibers. It seemed reasonable to try ambroxol for the treatment with neuropathic facial pain unresponsive to other standard options. MATERIAL AND METHODS: Medical records of patients suffering from classical trigeminal neuralgia (n = 5) and successful pain reduction following topical ambroxol 20% cream in addition to standard treatment are reported. RESULTS: All patients reported pain attacks with pain intensity between 4 and 10 NRS (numeric pain scale). In all cases they could be triggered, 3 patients reported additional spontaneous pain. Attacks were reduced in all 5 patients. Pain reduction achieved following ambroxol 20% cream was 2-8 points (NRS) earliest within 15-30 minutes and lasted for 4-6 hours mostly. This was reproducible in all cases; in one case pain was eliminated after 1 week. No patient reported side effects or skin changes; oral medication was reduced in 2 patients. CONCLUSION: For the first time, a clinically significant pain relief following topical ambroxol 20% cream in patients with trigeminal neuralgia is reported. In view of the positive side effect profile, topical ambroxol for patients with such a highly impaired quality of life should be investigated further as a matter of urgency.

Successful treatment of complex regional pain syndrome with topical ambroxol: a case series.

AIM: The secretolytic drug ambroxol may be useful for the treatment of neuropathic pain due to its multiple modes of action. We hypothesized that ambroxol may be a treatment option for complex regional pain syndrome (CRPS). METHODS: Additional to standard therapy, eight CRPS-patients with symptoms of less than 12 months were treated with topical 20% ambroxol cream. Clinical courses were assessed using detailed anamnesis and clinical examination. RESULTS: Following treatment we found a reduction of spontaneous pain (6 patients), pain on movement (6 patients), edema (seven patients), allodynia (six patients), hyperalgesia (seven patients), reduction of skin reddening (four patients), improvement of motor dysfunction (six patients) and improvement of skin temperature (four patients). CONCLUSION: Topical treatment with ambroxol cream may ameliorate symptoms of CRPS.

Ambroxol for the treatment of fibromyalgia: science or fiction?

Fibromyalgia appears to present in subgroups with regard to biological pain induction, with primarily inflammatory, neuropathic/neurodegenerative, sympathetic, oxidative, nitrosative, or muscular factors and/or central sensitization. Recent research has also discussed glial activation or interrupted dopaminergic neurotransmission, as well as increased skin mast cells and mitochondrial dysfunction. Therapy is difficult, and the treatment options used so far mostly just have the potential to address only one of these aspects. As ambroxol addresses all of them in a single substance and furthermore also reduces visceral hypersensitivity, in fibromyalgia existing as irritable bowel syndrome or chronic bladder pain, it should be systematically investigated for this purpose. Encouraged by first clinical observations of two working groups using topical or oral ambroxol for fibromyalgia treatments, the present paper outlines the scientific argument for this approach by looking at each of the aforementioned aspects of this complex disease and summarizes putative modes of action of ambroxol. Nevertheless, at this point the evidence basis for ambroxol is not strong enough for clinical recommendation.

Tapentadol Prolonged Release for Chronic Pain: A Review of Clinical Trials and 5 Years of Routine Clinical Practice Data.

Tapentadol prolonged release (PR) for the treatment of moderate to severe chronic pain combines 2 modes of action. These are µ-opioid receptor agonism and noradrenaline reuptake inhibition in a single molecule that allow higher analgesic potency through modulation of different pharmacological targets within the pain transmitting systems. At the same time, this can also serve as a clue for modulation of different pain-generating mechanisms according to nociceptive, neuropathic, or mixed pain conditions. Tapentadol PR has now been on the market for 5 years, with over 4.6 million people treated worldwide. A panel of pain specialists convened in Germany to review the clinical program and to discuss the role of tapentadol PR in the management of chronic pain. The clinical study program demonstrated effective and generally well-tolerated treatment for up to 2 years in a broad range of chronic pain conditions, including those with neuropathic pain components. This was confirmed in routine clinical practice observations. Head-to-head studies with World Health Organization (WHO) III opioids such as oxycodone controlled release and oxycodone/naloxone PR showed at least comparable pain relief in the treatment of moderate-to-severe musculoskeletal pain. Rotation from poorly tolerated WHO III opioids to tapentadol PR provided effective pain relief and better symptom control for musculoskeletal pain compared to previous medication. Functionality, health status and quality of life also improved under tapentadol PR treatment. The gastrointestinal tolerability profile was more favorable compared to other tested WHO III opioids. Tapentadol PR has a good safety profile and no evidence of acquired tolerance from the long-term data so far collected. Overall, tapentadol PR represents an effective and generally well-tolerated alternative to "classical" opioidergic drugs.

Practical considerations for the use of tapentadol prolonged release for the management of severe chronic pain.

PURPOSE: Chronic pain is often challenging to address appropriately. Although patients with severe chronic pain may respond to treatment with an opioid analgesic, opioids are often associated with adverse effects that may lead patients to disrupt or discontinue therapy. In addition, opioid analgesics alone may not be effective for all types of chronic pain, including neuropathic pain. Tapentadol prolonged release (PR), a centrally acting analgesic with 2 mechanisms of action (µ-opioid receptor agonism and noradrenaline reuptake inhibition), provides strong and reliable analgesia across a range of indications, including nociceptive, neuropathic, and mixed types of chronic pain, and is associated with an improved tolerability profile relative to classic opioid analgesics. The purpose of this article was to review the recent literature on different aspects related to the clinical use of tapentadol PR. METHODS: A review was conducted of the current literature and relevant unpublished data on initiation and titration of tapentadol PR, switching from classic strong opioids, risk of withdrawal after discontinuation, long-term treatment, coadministration with other medications, and risk of abuse and diversion. FINDINGS: Tapentadol PR may provide clinically meaningful benefits over classic opioid analgesics, including ease of initiating and titrating tapentadol PR treatment in opioid-naive and opioid-experienced patients, low risk of withdrawal after cessation of tapentadol PR therapy, a favorable pharmacokinetic profile (allowing for coadministration with other medications) of tapentadol PR, and low potential for tapentadol PR abuse. IMPLICATIONS: The broad analgesic efficacy of tapentadol PR may simplify chronic pain management by allowing for the treatment of different types of pain with a single analgesic. In addition, tapentadol is associated with a low risk of pharmacokinetic interactions, which permits its use in patients taking multiple medications. Furthermore, the favorable tolerability profile of tapentadol PR may result in improved patient compliance and allow for easy titration and rotation from previous strong opioids.

[Tapentadol prolonged release improves analgesia, functional impairment and quality of life in patients with chronic pain who have previously received oxycodone/naloxone]. / Verbesserte Analgesie, Funktionalität und Lebensqualität unter Tapentadol retard.

STUDY OBJECTIVE: This subgroup analysis of a prospective, non-interventional study involving general practitioners and internists investigated the administration of tapentadol prolonged release (tapentadol PR; Palexia retard) for the treatment of patients who have previously received oxycodone/naloxone. METHODS: From the overall effectiveness sample (n = 5,002) data of all patients who were previously treated with oxycodone/naloxone in a fixed combination (n = 382) were included in this analysis. Data collection during the 3-month observation period included previous and concomitant analgesic treatment, tapentadol PR dosage, pain intensity, functional impairment, and tolerability of tapentadol PR. Health related quality of life was documented at baseline and at the end of observation by patients using the SF-12 questionnaire. RESULTS: Back pain was the most common cause of pain. Including all pain diagnoses, mixed type of pain (nociceptive and neuropathic) predominated. The oxycodone/naloxone pretreatment was multifold combined with strong opioids (10.2%), weak opioids (29.3%), non- opioids (78.3%), co-analgesics (56.0%) and analgesic rescue medication (26.9%). Switching to tapentadol PR resulted in a mean pain reduction of 3.41 points from 7.29 ± 1.40 at baseline to 3.88 ± 1.86 at end of observation (NRS 11, 11-point pain scale; descriptive p value ≤ 0.001; n = 373), using a final average daily dosage of 252.9 mg tapentadol PR. In all four categories assessing the pain-related functional impairment, significant improvements have been achieved. In addition to significantly reduced pain-related impairments of everyday activities patients' data documented significant improvements in physical and mental SF-12 total scores, which initially were already at critically low range. A good tolerability of tapentadol PR therapy was reported. CONCLUSIONS: Patients, who were previously treated with oxycodone/naloxone, benefit from a tapentadol PR therapy as well: data analysis shows a clinically relevant improvement of analgesia, functionality and quality of life. Furthermore, the previous analgesic "co"-medication could be reduced during tapentadol PR therapy.

Treatment of neuropathic pain with the capsaicin 8% patch: is pretreatment with lidocaine necessary?

The capsaicin 8% patch can effectively treat neuropathic pain, but application can cause discomfort or a burning sensation. Until March 2013, it was recommended that patients be pretreated with a topical anesthetic, for example lidocaine, before capsaicin patch application. However, speculation existed over the need for pretreatment and its effectiveness in alleviating treatment-associated discomfort. This article compares tolerability to and efficacy of the capsaicin patch in pretreated and non-pretreated patients. All patients received a single capsaicin patch application. Pretreated patients received a lidocaine plaster before and intravenous lidocaine and metamizole infusions during capsaicin patch application. Pain levels, assessed using a Numeric Rating Scale (NRS), were used to determine tolerability and efficacy. All patients (pretreated n = 32; non-pretreated n = 26) completed 100% of the intended capsaicin patch application duration. At the time of capsaicin patch removal, 69% of pretreated and 88% of non-pretreated patients reported an NRS score increase, which returned to baseline by 6 hours post-treatment. There was no significant difference in mean NRS score between patient groups at any time during or after capsaicin patch treatment. Response was similar between patient groups; capsaicin patch treatment provided rapid and significant pain reductions that were sustained over 12 weeks. The same proportion of pretreated and non-pretreated patients reported willingness to receive retreatment with the capsaicin patch. This analysis shows that the capsaicin 8% patch is generally tolerable, and the small discomfort associated with patch application is short-lived. Lidocaine pretreatment does not have a significant effect on tolerability, efficacy, or patient willingness to receive retreatment.

Is physician supervision of the capsaicin 8% patch administration procedure really necessary? An opinion from health care professionals.

Neuropathic pain is difficult to treat and can have a severe effect on quality of life. The capsaicin 8% patch is a novel treatment option that directly targets the source of peripheral neuropathic pain. It can provide pain relief for up to 12 weeks in patients with peripheral neuropathic pain. Treatment with the capsaicin 8% patch follows a clearly defined procedure, and patch application must be carried out by a physician or a health care professional under the supervision of a physician. Nonetheless, in our experience, nurses often take the lead role in capsaicin 8% patch application without the involvement of a physician. We believe that the nurse's key role is of benefit to the patients, as he or she may be better placed, because of time constraints and patient relationships, to support the patient through the application procedure than a physician. Moreover, a number of frequently prescribed drugs, including botulinum toxin and infliximab, can be administered by health care professionals without the requirement for physician supervision. Here we argue that current guidance should be amended to remove the requirement for physician supervision during application of the capsaicin 8% patch.

Can treatment success with 5% lidocaine medicated plaster be predicted in cancer pain with neuropathic components or trigeminal neuropathic pain?

An expert group of 40 pain specialists from 16 countries performed a first assessment of the value of predictors for treatment success with 5% lidocaine-medicated plaster in the management of cancer pain with neuropathic components and trigeminal neuropathic pain. Results were based on the retrospective analysis of 68 case reports (sent in by participants in the 4 weeks prior to the conference) and the practical experience of the experts. Lidocaine plaster treatment was mostly successful for surgery or chemotherapy-related cancer pain with neuropathic components. A dose reduction of systemic pain treatment was observed in at least 50% of all cancer pain patients using the plaster as adjunct treatment; the presence of allodynia, hyperalgesia or pain quality provided a potential but not definitively clear indication of treatment success. In trigeminal neuropathic pain, continuous pain, severe allodynia, hyperalgesia, or postherpetic neuralgia or trauma as the cause of orofacial neuropathic pain were perceived as potential predictors of treatment success with lidocaine plaster. In conclusion, these findings provide a first assessment of the likelihood of treatment benefits with 5% lidocaine-medicated plaster in the management of cancer pain with neuropathic components and trigeminal neuropathic pain and support conducting large, well-designed multicenter studies.

What is localized neuropathic pain? A first proposal to characterize and define a widely used term.

SUMMARY According to several guidelines, topical agents should be considered for the pharmacological management of localized neuropathic pain. As a definition for the term 'localized neuropathic pain' that might facilitate easier identification of patients who are putatively responsive to topical treatments could not be found in the literature, six pain specialists met in 2010 to address this challenging issue. The following nucleus of a definition that is based on the International Association for the Study of Pain (IASP) definition of neuropathic pain, is the most detailed that can currently be proposed: 'Localized neuropathic pain is a type of neuropathic pain that is characterized by consistent and circumscribed area(s) of maximum pain'. An extended version of this core definition and the difficulties in covering all aspects of localized neuropathic pain are presented, and discussions within the scientific community are encouraged to develop a definition that might help to identify patients who could benefit most from topical treatment.

Capsaicin 8% patch for peripheral neuropathic pain: review of treatment best practice from 'real-world' clinical experience.

SUMMARY The capsaicin 8% patch is licensed in Europe for the treatment of peripheral neuropathic pain in nondiabetic adults. In controlled trials it provided pain relief for up to 3 months with a single 30- or 60-min application. In this article, a group of pain specialists from Germany and the UK share their considerable experience of real-world use of the capsaicin 8% patch. This experience comes from treating >200 patients with a variety of neuropathic pain etiologies including postherpetic neuralgia, peripheral neuropathy and cancer-related neuropathy. These patients, a slight majority of whom were female, had experienced neuropathic pain for varied lengths of time (3 months to >15 years) and the majority were receiving concomitant medications for their pain at the time of capsaicin 8% patch treatment. Observations by the group suggest that patients with positive symptoms might respond best to therapy. To optimize response to treatment, the group reports that it is important to achieve good adhesion of the patch to the skin. The experience of the group is that the capsaicin 8% patch is a tolerable treatment and local anesthetic pretreatment may not always be required. Cooling measures used after treatments were found to be the most practical and beneficial means of relieving any treatment-related discomfort. The group observed that transient, clinically important increases in blood pressure owing to treatment-related discomfort are very rare and they have seen no correlation between treatment-related discomfort or erythema and response to treatment. In the real-life clinical setting, response to capsaicin 8% patch treatment may be higher than observed in the clinical trial program. Response to retreatment also appears to be equal to that of the first treatment, even in patients treated for the fifth time. It was also observed that patients receiving capsaicin 8% patch treatment are often able to reduce their intake of concomitant pain medications. Observations from real-life use of the capsaicin 8% patch will help to maximize its therapeutic potential.