A new 72-hour transdermal fentanyl matrix patch has been designed, which has a 35%-50% reduction of the absolute fentanyl content compared with other currently available transdermal fentanyl patches that are using the matrix technology. The new patch has previously been shown to be pharmacokinetically bioequivalent to the marketed fentanyl patch. To determine noninferiority in efficacy in cancer patients and to compare safety, a clinical trial comparing the new fentanyl patch with standard oral or transdermal opioid treatment was planned. The design was an open, parallel group, multicenter trial, in which 220 patients were randomized to receive either the fentanyl patch or standard opioid treatment for 30 days. The primary efficacy variable, pain intensity (PI) on a 0-10-point numerical rating scale, was recorded once daily. The primary endpoint was the relative area under the curve of PI expressed as a percentage of the maximum possible PI area under the curve. Any adverse events were recorded; four tolerability endpoints, constipation, nausea, daytime drowsiness, and sleeping disturbances, were assessed daily. Noninferiority was shown; the upper 95% confidence interval limits of the mean difference in relative PI area under the curve between the fentanyl patch and standard opioid treatment were less than 10% for both the intention-to-treat and per-protocol populations. Scores for the tolerability endpoints were similar in the treatment groups. The new fentanyl matrix patch with a lower drug load was found noninferior and as safe as established standard oral and transdermal opioid treatment.
The prevalence of abnormal ECG recordings should be considered in the pain management of these patients. General ECG screening in this population should be discussed. Future studies should examine a larger population to identify potential risk factors (e.g., medication).
Acupuncture is being increasingly used as one of the most important non-pharmacological therapies in treatment of chronic pain. Chronic headache, especially migraine and tension headache are diseases frequently encountered. In their treatment acupuncture is a method with very few side effects and is a remarkable alternative or addition in the whole concept of treatment. Open and placebo-controlled studies have shown that acupuncture reduces the frequency and intensity of headache in many patients, as well as the use of drugs. The success rates achieved of about 50-85% are comparable to the results of other methods. In the case of migraine, especially good results are archived by prophylactic treatment with acupuncture during the pain-free period. The concept of treatment depends on the basic rules of traditional Chinese medicine (TCM). Selection of the acupuncture points is primarily determined by the pain site. Long-term success could be confirmed by follow-up examinations six to eighteen months after end of the therapy.
Epidural steroid injections are frequently used in the conservative treatment of backache, although they are still subject to critical discussion. Relief of pain is attributed to the anti-inflammatory effect of the steroid. During a 3-year period, 53 patients with back pain or differing aetiology were treated with one or more epidural injections of 14 mg betamethasone (2 ml Celestan) in a prospective and retrospective fashion. Patients were followed up for 1 year. Immediately after the injection 68% free of pain. Freedom from pain or improvement totally free of pain. Freedom from pain or improvement was reported by 39% of patients after 2 weeks and by 31% after 6 months to 1 year. Patients with acute pain (up to 6 months) responded better than patients with chronic symptoms. No significant correlations were detected between response and other characteristics, e.g. age, sex, number of injections, type of pain, intensity of pain, or psychological overlay. For patients with acute pain epidural steroid injections seem to be a safe, appropriate and promising procedure.
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