P126 The effectiveness of pharmacological interventions and cognitive behavioural therapy in improving sleep in fibromyalgia: a systematic review

Background/Aims Fibromyalgia (FM) is a common yet complex musculoskeletal condition. Sleep disturbance frequently coexists with FM yet optimal management of this important association is unclear. Current standard treatment for FM in general often includes a combination of pharmacological and psychological treatments - most commonly cognitive behavioural therapy (CBT). This systematic review aims to critically appraise the evidence regarding the effectiveness of these treatments at improving sleep in FM. Methods Pre-defined search terms were entered into PubMed, Cochrane CENTRAL, Embase, Medline and CINAHL. Randomised controlled trials (RCTs) studying the effectiveness of any pharmacological intervention or CBT (including electronic CBT) in managing FM-associated sleep disturbances in adults were included. Results Of 682 RCTs identified, 56 (n = 17,005; aged 18-84) met the inclusion criteria: 45 pharmacological studies assessing 24 medications and 11 CBT-based studies. Sleep assessment methods varied between studies, the most common being the visual analogue scale. The most common pharmacological interventions were pregabalin (n = 8) and milnacipran (n = 8), followed by sodium oxybate (n = 4), amitriptyline (n = 4) and fluoxetine (n = 3). Although outcome measures differed across the pregabalin studies, they all showed varying degrees of sleep improvement. Conversely, only 2/8 studies of milnacipran showed improved sleep scores. All 4 studies investigating sodium oxybate showed significant improvements in the Jenkins Sleep Scale. Only 1/4 study analysing amitriptyline and 1/3 assessing fluoxetine showed statistically significant improvement in sleep scores compared to placebo. The remaining 18 pharmacological studies included multiple antidepressants and analgesic agents, with a wide range of efficacy at improving sleep scores. The 11 CBT-based studies typically compared CBT to sleep hygiene or standard pharmacological therapies. Traditional, online and combined CBT methodologies (all n = 4), CBT for insomnia (CBT-I) (n = 7) and/or pain (CBT-P) (n = 4) were all evaluated. Studies conducting CBT-I and CBT-P showed significant improvements in the Pittsburgh Sleep Quality Index and self-reported sleep diaries. Long-term traditional CBT improved sleep in both included studies. One study using multicomponent CBT also showed significant sleep improvements. Only one study assessed online CBT, showing no significant results, though there was a trend towards improved sleep. Conclusion The optimal management of sleep disorders in FM is complex and needs to be tailored to the individual patient. We have shown that there are varying degrees of efficacy throughout a range of commonly used drugs in FM. Unfortunately, lack of consistency in outcome measures between studies makes it difficult to draw definitive conclusions pertaining to superiority between these agents. Conversely, CBT interventions appear to show consistent sleep improvement in FM. It is not clear whether this translates to online variations of CBT. We believe that a longitudinal appraisal of sleep as a primary variable, with robust consistent outcome measures, using pharmacological interventions with CBT would benefit future research. Disclosure A. Pathak: None. I. Brennan: None. R. Amarnani: None. A. Soni: Grants/research support; UCB Prize Fellowship.