Background and aims: Muscle cramps adversely influence the quality of life of patients with liver cirrhosis. Indeed, to date, a well-established therapy for this complication is still lacking. This is the first randomized placebo-controlled trial of baclofen in the treatment of muscle cramps in patients with liver cirrhosis.
Patients and methods: A total of 100 patients with liver cirrhosis and muscle cramps signed an informed consent to participate in this study. They were recruited from the Department of Tropical Medicine-Tanta University Hospital. They were randomized to receive either baclofen or placebo for 3 months. Patients were followed monthly and 1 month after withdrawal. At each visit, the clinicoepidemiological data were recorded, the muscle cramp questionnaire was filled, and any drug-related side effects were reported.
Results: In the baclofen group, the frequency of muscle cramps decreased significantly after 1 and 3 months of treatment (P<0.005), with a significant relapse after withdrawal (P<0.001). Patients receiving baclofen showed a significant decrease in the severity and duration of muscle cramps (P<0.001). After 3 months of baclofen therapy at a dose of 30 mg/day, muscle cramps disappeared completely in 72%, reduced in 20%, and led to no change in 8% of patients. No significant changes in the frequency, severity, and duration of muscle cramps were noted in the placebo group. There were few but nonsignificant side effects in the baclofen group compared with the placebo group.
Conclusion: Baclofen was well tolerated, safe, and effective in the treatment of muscle cramps in patients with liver cirrhosis.