Study Comparing Pregabalin Alone Versus Pregabalin Combined With Venlafaxine for Treating Fibromyalgia Pain and Symptoms

What this Trial Is About

Fibromyalgia is a chronic condition marked by widespread pain, fatigue, and emotional challenges. This trial is studying whether combining pregabalin with venlafaxine provides better pain relief than pregabalin alone, as pregabalin alone offers limited relief and may cause side effects. The study is sponsored by Beijing Tiantan Hospital and focuses on improving treatment options for people with moderate to severe fibromyalgia. Participants will be randomly assigned to one of two groups. One group receives pregabalin starting at 150 mg per day, increasing to 300 mg, and possibly up to 450 mg based on response. The other group receives the same pregabalin regimen plus venlafaxine, starting at 75 mg per day and potentially increasing to 225 mg. Treatment lasts up to 12 weeks, with dosing adjusted according to tolerance and clinical response. During the study, participants will undergo pain assessments and complete questionnaires at weeks 1, 2, 4, 8, and 12 to measure pain intensity, impact on daily life, sleep quality, depression symptoms, and overall health. Researchers will monitor medication doses, adverse events, and pain reduction rates. The main outcome is average pain intensity at 4 weeks, with safety and effectiveness tracked throughout the 12-week period.

The Efficacy and Safety of Pregabalin Combined With Venlafaxine in Patients With Fibromyalgia