Arzneimittel Forsch
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Arzneimittel Forsch · Jun 1999
Clinical TrialLong-term intraspinal infusions of opioids with a new implantable medication pump.
Experiences with long-term intraspinal infusion of opioid drugs using the new implantable medication pump VIP 30 in patients with chronic non-malignant pain are reported. During a 19-month period 10 patients with chronic pain--mainly mixed nociceptive-neuropathic pain--underwent implantation of the medication pump for long-term treatment. The mean follow-up period was 9.5 months. ⋯ Technical problems (catheter dislocation) developed in 1/10 patients could be surgically corrected. One pump including catheter was explanted because of an infected seroma within the pocket area. Long-term intrathecal application of opioids with the VIP 30 pumps is an effective and safe treatment in patients with chronic non-malignant pain.
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Arzneimittel Forsch · May 1999
ReviewPlacebo--efficacy and adverse effects in controlled clinical trials.
The therapeutic efficacy of placebo in a series of diseases has long been known. It is less well known, however, that treatment with placebo can also produce significant adverse drug reactions. Therefore, the placebo drug reactions from controlled trials were studied for the first time systematically. ⋯ Treatment with placebo is frequently effective and cannot therefore be considered as "non-treatment". Placebo effects can only be quantified by direct comparison with "non-treatment". Like active treatment, treatment with placebo is frequently accompanied by adverse drug reactions. Placebo adverse effects are often disease- and active treatment-specific. The effects and adverse effects of a placebo need to be known before the effects of active treatment in controlled clinical trials can be assessed. The mechanisms of placebo effects are many and varied (e.g. endorphin release, conditioning). Since the use of drugs without regard to evidence-based medicine (prescription of drugs without proven efficacy = pseudoplacebos) may clearly also result in serious adverse effects, such practice may not only be non-beneficial but may even be harmful.
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Arzneimittel Forsch · Apr 1999
Randomized Controlled Trial Clinical TrialDimethindene maleate in the treatment of sunburn. A double-blind, placebo-controlled pilot study.
The efficacy of topical dimethindene maleate (DMM, CAS 31614-69-5, Fenistil Gel) in the treatment of sunburn was evaluated in a placebo-controlled, 1-period crossover trial in 24 healthy volunteers. An UV-erythema (sunburn) of a well-defined intensity and extent was experimentally induced on three different skin test-areas by means of UV-A/B irradiation with three times the minimal erythema dose (MED). About 24 h after irradiation, one skin test-area was subjected to a 1-h occlusive treatment with DMM gel, the second test area was subjected to treatment with a placebo gel and the third one remained untreated. ⋯ With regard to subjective sensations of pain, itching and tenderness assessed by means of visual analogue scales (VAS), no clinically relevant differences between treatments were observed after sole UV-irradiation. After additional laser stimulation tenderness was--objectively but not subjectively--decreased on the DMM-area versus placebo. Both gel preparations were well tolerated.
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Arzneimittel Forsch · Apr 1999
Randomized Controlled Trial Clinical TrialStudy on local inflammatory reactions and other parameters during subcutaneous mistletoe application in HIV-positive patients and HIV-negative subjects over a period of 18 weeks.
Subcutaneous injections of fermented and unfermented aqueous extracts of Viscum album L. result in a local inflammatory reaction at the injection site. In this trial, the symptoms associated with this local reaction were investigated. Furthermore the occurrence of local reactions was tried to correlate with an increase in CD3/25- and CD8/38-positive lymphocyte counts, with eosinophilic granulocyte numbers, and with the formation of mistletoe lectin antibodies. ⋯ There were no changes in eosinophilic granulocytes or CD8/38-positive lymphocyte populations. For evaluation of the therapeutic applications of mistletoe extracts in HIV-positive patients it is advisable to assess primarily activation of CD3-positive lymphocytes and the patient response on the basis of the local reaction. The local inflammatory reaction at the injection site is desirable and well tolerated if the reaction is smaller than 5 cm in diameter.
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Arzneimittel Forsch · Mar 1999
Effects of propofol (intravenous propofol emulsion) on cell membranes measured by electrofusion and electroporation.
The influence of propofol (CAS 2078-54-8 (intravenous propofol emulsion) on cell membrane properties was investigated in vitro with techniques of cell electrofusion and cell electroporation. Human lymphoma cells and plant protoplasts were chosen as a model system. Propofol (intravenous propofol emulsion) decreased the electrofusion yield of the cells and their membrane permeability. ⋯ The effects of electroporation were highly reversible. Propofol (intravenous propofol emulsion) was more effective than tetracaine. These sensitive techniques are suitable for the investigation of interactions between anesthetic drugs and the cell membrane.