ABSTRACT
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.
Subject(s)
Capsaicin/therapeutic use , Neuralgia/drug therapy , Pain Management , Sensory System Agents/therapeutic use , Transdermal Patch , Adolescent , Adult , Child , Child, Preschool , Female , Germany , Humans , Male , Middle Aged , Practice Guidelines as Topic , Time FactorsABSTRACT
The fentanyl transdermal therapeutic system (fentanyl-TTS;Durogesic) has a distinct route of administration and safety profile compared with other opioids used in the treatment of moderate to severe pain.These aspects are likely to have an impact on patient acceptance and functioning as well as efficacy. We compared the cost-utility of fentanyl-TTS and controlled-release morphine (cr-morphine) in the treatment of moderate to severe nonmalignant pain in outpatients in Germany. A 1-year, three-phased decisionanalytic model was constructed, incorporating estimates of a variety of aspects of pain control.Use of fentanyl-TTS was predicted to incur higher costs than cr-morphine over 1 year of treatment (DM 6950 vs.DM 6186, respectively) but was associated with a higher number of quality-adjusted life days (234 vs. 216, respectively), thus achieving an incremental cost-utility ratio of DM 15,960 per quality-adjusted life-year gained.The results of the decision-analytic model support the use of fentanyl-TTS as a favorable cost-effective option for the treatment of moderate to severe nonmalignant pain.
ABSTRACT
BACKGROUND: In chronic pain patient's diagnostic and therapy planning many complex information must be evaluated and analysed. The variety of data cannot be mastered without assistance of a database tool adapted to these special need. DATABASE ENVIRONMENT: On the base of FileMaker Pro 5.0, a user-friendly and analysis-oriented database environment for documentation and quality assurance in pain therapy (QUAST) has been developed. QUAST has been tested for 2 years by 23 pain clinics in Germany including data of more than 14.000 patients. Among patients'demographic and clinical data all 335 fields of the validated German pain questionnaire are included in QUAST together with psychometric test procedures (CES, SES, PDI, SF-36). We developed a outcome questionnaire for the evaluation of treatment - related changes of outcome variables (103 fields), a daily questionnaire (11 fields) and a protocol to assess the effects of neural and other blockades (144 fields). All data of therapy and outcome can be documented (total number of the fields: 2661). The test results (e. g. in the form of total or compound scores) can be analysed and printed. For pain related diagnoses, procedures, blockades, drugs, expected and unexpected events hierarchical coding systems (altogether 72,157 data records) have been developed. These can be assigned automatically to coding systems like ICD-10 or ICP-M. CONCLUSION: Due to its ability of export into other databases and already enclosed routines QUAST permits an internal assurance of quality of process and outcome in pain management. It also can be an instrument of an external quality assurance. QUAST is at present the only computer system available in Germany, to fulfil the required prerequisites for adequate quality control.
