WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Orally administered synthetic cannabinoids (nabilone and dronabinol) have been shown to be superior to dopamine receptor antagonists in preventing chemotherapy-induced nausea and vomiting (CINV).• There is no information on the tolerability of an acute dose titration of a whole-plant cannabis-based medicine (CBM).• The efficacy of cannibidiol with tetrahydrocannabinol added to the current standard therapy in the control of CINV after moderately emetic cancer chemotherapy (MEC) administration has not been established.
WHAT THIS STUDY ADDS• This is the first controlled study assessing the tolerability of an acute dose titration of a CBM.• The results suggest that rapid titration of a CBM appeared to be well tolerated by most patients and efficacious in reducing the incidence of delayed CINV.
AIMSDespite progress in anti-emetic treatment, many patients still suffer from chemotherapy-induced nausea and vomiting (CINV). This is a pilot, randomized, double-blind, placebo-controlled phase II clinical trial designed to evaluate the tolerability, preliminary efficacy, and pharmacokinetics of an acute dose titration of a whole-plant cannabis-based medicine (CBM) containing delta-9-tetrahydrocannabinol and cannabidiol, taken in conjunction with standard therapies in the control of CINV.
METHODSPatients suffering from CINV despite prophylaxis with standard anti-emetic treatment were randomized to CBM or placebo, during the 120 h post-chemotherapy period, added to standard anti-emetic treatment. Tolerability was measured as the number of withdrawals from the study during the titration period because of adverse events (AEs). The endpoint for the preliminary efficacy analysis was the proportion of patients showing complete or partial response.
RESULTSSeven patients were randomized to CBM and nine to placebo. Only one patient in the CBM arm was withdrawn due to AEs. A higher proportion of patients in the CBM group experienced a complete response during the overall observation period [5/7 (71.4%) with CMB vs. 2/9 (22.2%) with placebo, the difference being 49.2% (95% CI 1%, 75%)], due to the delayed period. The incidence of AEs was higher in the CBM group (86% vs. 67%). No serious AEs were reported. The mean daily dose was 4.8 sprays in both groups.
CONCLUSIONCompared with placebo, CBM added to standard antiemetic therapy was well tolerated and provided better protection against delayed CINV. These results should be confirmed in a phase III clinical trial.
Pelegrí, Carme, Jordi Vilaplana, Cristina Castellote, Manel Rabanal, À ngels Franch, and Margarida Castell. Circadian rhythms in surface molecules of rat blood lymphocytes.
Background/Aims: In prepubertal short children with idiopathic growth retardation, growth hormone (GH) peak after GH release stimuli classifies patients as growth hormone- deficient (GHD) or non-GHD. This study compared a 2-year growth response to GH therapy in 318 prepubertal short children. Methods: Patients were classified as: severe GHD (GH peaks <5 ng/ml after 2 stimuli; n = 54), mild GHD (GH peaks <10 ng/ml, but one or two between 5 and 10 ng/ml; n = 140), dissociated GH release (GH peak ≧10 ng/ml after 1 stimulus and <10 ng/ml after the other; n = 89), and normal GH release (GH peaks ≧10 ng/ml after 2 stimuli; n = 35). Results: Two-year height gain did not differ statistically among the 4 groups: 1.39 ± 0.51 SD, 16.4 ± 2.3 cm; 1.23 ± 0.56 SD, 15.8 ± 2.1 cm; 1.18 ± 0.53 SD, 15.3 ± 2.0 cm, and 1.14 ± 0.53 SD, 15.4 ± 2.0 cm, respectively, as was also the case for bone age gain: 2.5 ± 0.6, 2.4 ± 0.7, 2.6 ± 0.7 and 2.3 ± 0.5 years, respectively. Conclusions: Our results suggest that GH release stimuli are of little help for deciding on GH therapy in the clinical management of prepubertal short children with idiopathic growth retardation, while well-defined anthropometric and biochemical criteria may be useful.
The misuse of medicines is a global public health concern that needs to be taken into consideration and requires actions across all government sectors and society. The aim of this study is to identify trends of drug abuse in Catalonia, a region of Spain located in the South of Europe. For this purpose, a questionnaire-based detection tool was created and implemented in 60 community pharmacies. Out of 548 questionnaires (98.4%), 64.2% of participants were men and the highest age proportion was 25–35 years (31.4%). Potential drug abuse was the highest in urban pharmacies (84.9%). The main drug class involved were benzodiazepines (31.8%), codeine (19.3%), tramadol (7.5%), methylphenidate (5.8%), gabapentinoids (5.8%), cycloplegic drops (4.4%), z-drugs (2.6%), piracetam (2.2%), dextromethorphan (1.6%) and clomethiazole (1.1%). The majority of drugs were requested without prescription (58.6%) and through probably forged prescriptions (23.7%). Slightly less than half (49.8%) of the patients request frequently to the pharmacist, especially in rural and mountain pharmacies (73.3% and 88.5%, respectively). A small proportion (10.8%) were requested with intimidation. Pharmacists only supplied in 21.7% of the cases. This study has demonstrated the suitability of the new detection system, being a useful approach to replicate in other locations with similar needs.
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