Impact of Pregabalin on gastrointestinal symptoms in generalized anxiety disorder: Results of a 6-study combined analysis

We performed a double-blind, crossover-design study to assess the tolerability and efficacy of pregabalin (PGB) in patients with essential tremor (ET). Twenty patients (11 women; mean age of 62.2 ± 12.7 years, mean ET duration of 25.5 ± 14.9 years) with ET were randomized for treatment with PGB (150–600 mg/day) or placebo, titrated over 6 weeks. Identical assessments of the Fahn–Tolosa–Marin Tremor Rating Scale (TRS) (primary endpoint), Clinical Global Impression of Change (CGI-C), Quality of Life in Essential Tremor Questionnaire (QUEST), Hamilton Anxiety Scale (HAM-A), and a sleep hygiene questionnaire (HD-16) were made at the baseline, at the end of treatment periods for both drug and placebo, and following the 2-week washout period preceding crossover. We found no improvement in any of the TRS measures and a statistically significant worsening of QUEST scores while patients were taking PGB. Adverse events were similar in frequency to previously published studies of PGB, the most common being drowsiness and dizziness.