Efficacy and safety of thalidomide on psychological symptoms and sleep disturbances in the patient with refractory ankylosing spondylitis.

BACKGROUND

Thalidomide has been used to treat ankylosing spondylitis (AS) patients, but the efficacy and safety of thalidomide on psychological symptoms and sleep disturbances in the patient with refractory AS has not been evaluated.

METHODS

In this 6-month open study, 35 cases of patients with refractory AS were recruited, using thalidomide at a dose of 150 mg/d before sleep. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), fingertip-to-floor distance, nocturnal pain, total back pain, psychological symptoms, and sleep were assessed at baseline, 3 months and 6 months respectively.

RESULTS

Clinical parameters, included BASDAI, BASFI, fingertip-to-floor distance, nocturnal pain, total back pain, ESR, CRP, SAS, SDS and PSQI lower levels of month 3 were found when compared to initial levels (P<0.05). In the 6th month, the levels of BASDAI, fingertip-to-floor, nocturnal pain, total back pain, SDS were further lower than those in the 3rd month (P<0.05). The levels of BASMI were lower than this at baseline (P<0.05). The most tolerable common adverse reactions were drowsiness (10/35), dry mouth (8/35), constipation (8/35), dandruff (7/35), dizziness (4/35).

CONCLUSIONS

Thalidomide can improve effectiveness and safety in the treatment of physical, as well as psychological symptoms and sleep disturbances accompanying refractory AS.