Real-life efficacy of pregabalin for the treatment of peripheral neuropathic pain in daily clinical practice in Denmark: the NEP-TUNE study.

OBJECTIVE: The aim of this study was to provide evidence regarding the real-life efficacy of pregabalin in the treatment of peripheral neuropathic pain (NeP) in Denmark. METHODS: In this prospective, observational, noninterventional study, pregabalin (Lyrica(®)) was prescribed following usual clinical practice. Compared with baseline, the primary study end points after 3 months of observation were changes in 1) the average level of pain during the past week, 2) the worst level of pain during the past week, and 3) the least level of pain during the past week. The Wilcoxon signed-rank test was used to perform paired analyses, and a multivariate regression analysis investigated factors driving change in pain. RESULTS: A total of 86 of the 128 patients included were regarded as efficacy evaluable (those completing 3 months of pregabalin treatment). Patients (59 years) were long-time sufferers of peripheral NeP, and 38% of them had comorbidities. The majority had previously been treated with tricyclic antidepressants or gabapentin. The average dose of pregabalin was 81.5 mg/d at baseline and 240 mg/d after 3 months. A clinically and statistically significant improvement of 2.2 points in the average level of pain intensity was found after 3 months. The higher the pain intensity at baseline, the higher was the reduction of the pain score. Positive results were also found for pain-related sleep interference, patients' global impression of change, quality of life, and work and productivity impairment. Twenty-one patients reported 28 adverse events. CONCLUSION: This real-life study indicates that for some patients (two-thirds), addition of pregabalin for peripheral NeP helps to reduce their pain intensity significantly.

A randomized, double-blind, placebo-controlled multicenter trial evaluating topical zinc oxide for acute open wounds following pilonidal disease excision.

The purpose of this randomized, double-blind, placebo-controlled multicenter trial was to compare topical zinc oxide with placebo mesh on secondary healing pilonidal wounds. Sixty-four (53 men) consecutive patients, aged 17-60 years, were centrally randomized to either treatment with 3% zinc oxide (n = 33) or placebo (n = 31) by concealed allocation. Patients were followed with strict recording of beneficial and harmful effects including masked assessment of time to complete wound closure. Analysis was carried out on an intention-to-treat basis. Median healing times were 54 days (interquartile range 42-71 days) for the zinc and 62 days (55-82 days) for the placebo group (p = 0.32). Topical zinc oxide increased (p < 0.001) wound fluid zinc levels to 1,540 (1,035-2,265) microM and decreased (p < 0.05) the occurrence of Staphylococcus aureus in wounds. Fewer zinc oxide (n = 3) than placebo-treated patients (n = 12) were prescribed postoperative antibiotics (p = 0.005). Serum-zinc levels increased (p < 0.001) postoperatively in both groups but did not differ significantly between the two groups on day 7. Zinc oxide was not associated with increased pain by the visual analog scale, cellular abnormalities by histopathological examination of wound biopsies, or other harmful effects. Larger clinical trials will be required to show definitive effects of topical zinc oxide on wound healing and infection.

Pain treatment on outpatient basis utilizing extradural opiates. A Danish multicentre study comprising 105 patients.

Previous to October 1st, 1981, 8 major Danish anaesthesiological departments registered 105 patients treated with extradural opiates for a period of more than 7 days, partially or completely on outpatient basis. Ninety-four suffered from painful malignant diseases and 11 patients from various painful benign diseases. The mean period of treatment was 65 days (range: 7-283 days) and of these 49 days (2-266 days) as outpatients. The total number of inserted epidural catheters was 215, equivalent of an average of 2 per patient (range 1-5). Reasons for removing an extradural catheter were injection-related pain, difficulty in injecting the desired volume, and displacement of catheter. Morphine chloride, in a solution of 0.4 mg/ml of normal saline, was the main choice as analgesic agent (90 patients). The mean daily dose of this drug totalled 12.6 +/- 4.8 mg (S.D.) (range: 4-30 mg) distributed as 2.7 +/- 0.9 (S.D.) (range: 1-6) daily injections. Twelve patients were treated with buprenorphine extradurally. Satisfactory pain relief was achieved for 70 patients (67%) who managed with extradural opiates as sole analgesic treatment. One patient developed septicaemia with a non-fatal outcome probably originating from some other focus. Apart from this no serious side effects were reported. Medically unskilled persons or relatives were responsible for instillation of all extradural opiates with 42 patients and partially responsible with 14 patients. Eleven patients managed injections without assistance. District nurses took care of medication for 46 patients, aided by a general practitioner in 5 cases. Three patients were supplied with continuous extradural infusion by means of a Mill Hill microinfusion pump.