ROLE OF VITAMIN E IN THE TREATMENT OF MUSCLE CRAMPS IN CIRRHOTIC PATIENTS

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ROLE OF VITAMIN E IN THE TREATMENT OF MUSCLE CRAMPS IN CIRRHOTIC PATIENTS

P Tan, E Alhamar, P Marotta
Dept of Gastroenterology, London Health Sciences Centre, London, Ontario

BACKGROUND: Muscle cramps in patients with chronic liver disease is common. While vitamin E is used anecdotally in several centres, there have been no published randomized controlled trials to evaluate the role of vitamin E in cirrhotic patients with painful muscle cramps.
PURPOSE: To assess the efficacy and safety of vitamin E in treating muscle cramps in patients with cirrhosis.
METHODS: As a pilot study, nine biopsy-proven cirrhotic patients were enrolled in the prospective double-blind randomized placebo-controlled crossover pilot trial. All patients were recruited from University Hospital of London Health Sciences Centre. Patients were evaluated over a four-week 'run-in' period in which they documented their symptoms with a daily diary: (1) number of cramps; (2) severity of cramps (mild, moderate, severe); (3) need for analgesia (yes, no); and (4) maximum duration of cramps (<10 sec, 10-60 sec, >60 sec). At the end of the run-in period, those patients who were compliant (³60% completion of the diary) were randomized to receive either vitamin E 800 IU once daily or placebo for four weeks. The patients were then crossed over to use the other treatment for four more weeks, after a 'washout' period of four weeks. The patients continued their daily diary throughout the study and documented any adverse effects.
RESULTS: A total of nine patients completed the study. Baseline characteristics at study entry revealed a mean age of 44 (23-52), a mean MELD score of 13 (7-19), a mean baseline serum vitamin E level of 22 (17-55), and 5 patients (56%) were on diuretics. Outcome measures demonstrated that more patients on vitamin E, compared with placebo, experienced increased frequency of muscle cramps (6 vs 3 patients, P=0.98), greater duration of cramps (5 vs 4 patients, P=0.93), and increased severity of cramps (5 vs 4 patients, P=0.57). In contrast, more patients on placebo, compared with vitamin E, had greater requirements for analgesia (6 vs 3 patients, P=0.31). In regards to adverse effects, three patients (33%) reported symptoms, with no increased frequency of adverse effects seen in patients on vitamin E.
CONCLUSION: The use of vitamin E for the treatment of muscle cramps in cirrhotic patients is associated with a trend toward greater frequency, duration and severity of muscle cramps, but a decreased requirement for analgesia. Therefore, this pilot study will facilitate larger prospective trials of vitamin E in establishing and validating an objective measurement tool for the evaluation of the common yet complex problem of painful muscle cramps in cirrhosis.

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