[No difference in efficacy of hydroquinine and placebo in restless legs syndrome].

OBJECTIVE

Determination of the efficacy of hydroquinine treatment of the restless legs syndrome.

DESIGN

Double blind cross-over trial.

SETTING

University Hospital Leiden.

PATIENTS AND METHODS

Selection through an announcement in the press and followed by structured interview. Inclusion criteria according to the international classification of sleep disorders. Exclusion criteria defined by medication risks. Patients used either hydroquinine (200 mg in the evening and 200 mg before going to bed) or placebo in the second and fourth of four periods of two weeks duration. Severity of complaints was assessed using a daily questionnaire and a Suggested Immobilization Test (SIT) twice weekly, in which they noted the severity of complaints as experienced during a 15-minute period of immobilization.

RESULTS

The study was completed by 59 out of 68 patients. Analysis of variance showed no significant differences between the two groups of patients (those starting with placebo and those starting with hydroquinine) for any of the questions of the daily questionnaire or of the SIT. McNemar's test showed no significant differences between the proportions of patients who wished to continue the use of either placebo or hydroquinine.

CONCLUSION

This study showed no significant differences between the efficacy of placebo or hydroquinine in the restless legs syndrome.