Background: This study was conducted to compare the pharmacokinetics of caffeine delivered using caffeinated chewing gum to that delivered using a marketed caffeinated beverage (instant coffee) in 16 healthy adult volunteers.Materials and Methods: This was a controlled open-label, randomized, two-period crossover study. Caffeinated chewing gum and a serving of instant coffee, each containing ∼50 mg caffeine, were administered with blood samples collected before and up to 24 hours after administration starts. Plasma caffeine levels were analyzed using validated liquid chromatography coupled with tandem mass spectrometry methodology.Results: There were no statistical differences between the two caffeine products in tmax (p = 0.3308) and ka (p = 0.3894). Although formulated at ∼50 mg caffeine each, mean dose released from chewing gum was ∼18% less than beverage. Dose-normalized area under the concentration–time curve (AUC)0-t, AUC0-∞, and Cmax was similar between products. Although the criteria were not set a priori and the study was not powered for concluding bioequivalence, the 90% confidence intervals fell within the bioequivalence limit of 80% to 125%.Conclusions: Existing scientific literature on caffeine, based mostly on data from caffeinated beverages, can be leveraged to support the safety of caffeine delivered by chewing gum and current maximum safe caffeine dose advice should be applicable irrespective of delivery method.
A double-blind, crossover study was undertaken in general practice to compare the efficacy and tolerability of a new controlled-release indomethacin with sustained-release diclofenac sodium in patients with osteoarthritis. Eighty-four patients were randomly allocated to receive controlled-release indomethacin tablets (75 mg) or sustained-release diclofenac sodium tablets (100 mg) at night for a period of 4 weeks before being crossed-over to receive the alternative treatment for a further 4 weeks. Pain scores for day and night, duration of morning stiffness, requirement for escape analgesia, and treatment preference were similar for both treatments. There was no significant difference between treatments for incidence and severity of side-effects. It was concluded that controlled-release indomethacin tablets (75 mg) given as a single night-time dose were as efficacious and well tolerated as sustained-release diclofenac sodium (100 mg).
A reflective piece on introducing mindfulness into counselling practice, with special attention given to the effect on the therapist. The writer explores his own experience of regular mindfulness practice and offers some introductory thoughts on the importance of counsellor embodiment in client work.
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