Pilot Double-blind Placebo-controlled Trial Research Articles

Dronabinol increases pain threshold in patients with functional chest pain: a pilot double-blind placebo-controlled trial.

Noncardiac chest pain is associated with poor quality of life and high care expenditure. The majority of noncardiac chest pain is either gastresophageal reflux disease related or due to esophageal motility disorders, and the rest are considered functional chest pain (FCP) due to central and peripheral hypersensitivity. Current treatment of FCP improves 40-50% of patients. Cannabinoid receptors 1 (CB1) and 2 (CB2) modulate release of neurotransmitters; CB1 is located in the esophageal epithelium and reduces excitatory enteric transmission and potentially could reduce esophageal hypersensitivity. We performed a prospective study to evaluate its effects on pain threshold, frequency, and intensity in FCP. Subjects with FCP received dronabinol (5mg, twice daily; n=7; average age, 44years; mean body mass index, 26.7) or placebo (n=6; average age, 42years; mean body mass index, 25.9) for 28days (4weeks). Chest pain, general health, and anxiety/depression questionnaires were assessed at baseline and at 4weeks. Subjects underwent an esophageal balloon distention test prior to treatment and on last day of the study. Dronabinol increased pain thresholds significantly (3.0 vs. 1.0; P=0.03) and reduced pain intensity and odynophagia compared to placebo (0.18 vs. 0.01 and 0.12 vs. 0.01, respectively, P=0.04). Depression and anxiety scores did not differ between the groups at baseline or after treatment. No significant adverse effects were observed. In this novel study, dronabinol increased pain threshold and reduced frequency and intensity of pain in FCP. Further, large scale studies are needed to substantiate these findings.

Cognitive–behavioural therapy with post-session d-cycloserine augmentation for paediatric obsessive–compulsive disorder: pilot randomised controlled trial

A partial N-methyl-D-aspartate agonist, D-cycloserine, enhances fear extinction when given before or shortly after exposure to feared stimuli in animals. In this pilot double-blind placebo-controlled trial (trial number: ISRCTN70977225), 27 youth with obsessive-compulsive disorder were randomised to either 50 mg D-cycloserine or placebo administered immediately after each of ten cognitive-behavioural therapy (CBT) sessions, primarily consisting of exposure and ritual prevention. Both groups improved significantly and maintained their gains at 1-year follow-up, with no significant advantage of D-cycloserine over placebo at any time point. The effects of CBT may not be augmented or accelerated when D-cycloserine is administered after sessions.

Biosafety, Antioxidant Status, and Metabolites in Urine after Consumption of Dried Cranberry Juice in Healthy Women: A Pilot Double-Blind Placebo-Controlled Trial

This study assessed the effect of an 8 week consumption of dried cranberry juice (DCJ) on 65 healthy young women. Basic biochemical and hematological parameters, antioxidant status, presence of metabolites in urine, and urine ex vivo antiadherence activity were determined throughout the trial. A 400 mg amount of DCJ/day had no influence on any parameter tested. A 1200 mg amount of DCJ/day resulted in a statistically significant decrease in serum levels of advanced oxidation protein products. This specific protective effect against oxidative damage of proteins is described here for the first time. Urine samples had an inhibitory effect on the adhesion of uropathogenic Escherichia coli strains, but no increase in urine acidity was noted. Hippuric acid, isomers of salicyluric and dihydroxybenzoic acids, and quercetin glucuronide were identified as the main metabolites. In conclusion, cranberry fruits are effective not only in the prevention of urinary tract infection but also for the prevention of oxidative stress.