OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of tramadol in a 6-month open extension following a 6-week double-blind randomized trial. RESEARCH DESIGN AND METHODS: Patients with painful diabetic neuropathy who completed the double-blind study were eligible for enrollment in an open extension of up to 6 months. All patients received tramadol 50-400 mg/day. Self-administered pain intensity scores (scale 0-4; none to extreme pain) and pain relief scores (scale -1-4; worse to complete relief) were recorded the first day of the open extension (last day of the double-blind phase) and at 30, 90, and 180 days. RESULTS: A total of 117 patients (56 former tramadol and 61 former placebo) entered the study. On the first day of the study, patients formerly treated with placebo had a significantly higher mean pain intensity score (2. 2+/-1.02 vs. 1.4+/-0.93, P<0.001) and a lower pain relief score (0. 9+/-1.43 vs. 2.2+/-1.27, P<0.001) than former tramadol patients. By Day 90, both groups had mean pain intensity scores of 1.4, which were maintained throughout the study. Mean pain relief scores (2. 4+/-1.09 vs. 2.2+/-1.14) were similar after 30 days in the former placebo and former tramadol groups, respectively and were maintained for the duration of the study. Four patients discontinued therapy due to ineffective pain relief; 13 patients discontinued due to adverse events. The most common adverse events were constipation, nausea, and headache. CONCLUSIONS: Tramadol provides long-term relief of the pain of diabetic neuropathy.

Adult↗

PubMedDate not supplied

Time and frequency dependence of disposable ECG electrode-skin impedance.

The magnitude and phase of disposable electrode-skin impedance were studied as functions of time, 0-48 hours, and frequency, 1 Hz-1 kHz. For both unabraded and mildly abraded skin, the impedance decreased as a function of time steadily or exponentially with time constants of several hours. Impedance decreased as a function of frequency by factors of 2 to 20 with greatest change at low frequencies. For heavily abraded skin, the impedance decreased slightly and then increased as a function of time especially at low frequencies. Impedance imbalance between pairs of identical electrodes applied in a like manner to the forearm were often greater than k omega, nearly equal to individual electrode-skin impedances, and decreased with time. Electrode impedance imbalance is particularly important because it affects noise levels in ECG recordings.

Chlorides↗

PubMedDate not supplied

The duration of response to norgestimate and ethinyl estradiol in the treatment of acne vulgaris.

OBJECTIVE: This was a postmarketing, retrospective, exploratory analysis to investigate the duration of response to a triphasic combination oral contraceptive (OC) (Ortho Tri-Cyclen; Ortho-McNeil Pharmaceutical, Raritan, NJ) [norgestimate-ethinyl estradiol]) in the treatment of moderate acne vulgaris. PROCEDURES: Healthy women with moderate acne vulgaris were enrolled in two 6-month, multicenter, randomized, double-blind, placebo-controlled clinical trials. Subjects received either 3 weeks of active OC treatment (i.e., 0.035 mg ethinyl estradiol plus increasing doses of norgestimate [0.180 mg, 0.215 mg, 0.250 mg]) and 1 week of inactive tablets, or 4 weeks of color-matched placebo tablets. RESULTS: A total of 507 subjects were enrolled in the study. Duration of response was analyzed in subjects with at least slight improvement in global progress of treatment from the earliest cycle showing response (n = 305) and in subjects with at least slight improvement at or before cycle 3 (n = 276); the duration of response was statistically significant in favor of the norgestimate-ethinyl estradiol group in both cases (P < or = .001). The variability of mean percent change in lesions was also statistically significantly greater in the placebo group than in the OC group for total lesions (P < or = .001) and inflammatory lesions (P < or = .001). CONCLUSION: A triphasic combination of norgestimate and ethinyl estradiol lengthens the time interval to recurrence of acne lesions.

Acne Vulgaris↗