Background The European League Against Rheumatism (EULAR) developed recommendations for the medical treatment of systemic sclerosis (SSc). However, recently, a need for standardised non-pharmacological recommendations in SSc was identified. To address this need, an overview of the current evidence on the effectiveness of non-pharmacological interventions in patients with SSc must be provided.
Objectives To summarise the evidence on the effectiveness of non-pharmacological interventions on physical functioning and psychological well-being in patients with SSc.
Methods We searched for studies reporting on the effectiveness of non-pharmacological (psychological, educational, rehabilitation) interventions for SSc in MEDLINE, EMBASE, CINAHL, PsycINFO, Scopus, Cochrane Library, and Web of Science. There were no restrictions on study design; randomised clinical trials (RCTs), controlled clinical trials (CCTs), and observational studies (ODs) with a pre-post design (≥10 clinical cases) were included. Two reviewers independently assessed the methodological quality.
Results Twenty-two studies (9 RCTs, 1 CCT, 12 ODs) met inclusion criteria. Studies assessing comparable interventions were grouped, resulting in fifteen different interventions. The total number of included patients per study ranged from 10 to 53. In total, 17 different outcome dimensions were assessed, with hand function, limitations in activities, and quality of life being assessed most frequently. Eleven studies, two of which were of high quality, assessed the effectiveness of an intervention on hand function. Positive effects on hand function were reported in 7 of these 11 studies investigating the effectiveness of two comprehensive rehabilitation programmes for the hands and/or face, aerobic training, stretching, paraffin treatment, manual lymph drainage, and ultrasound. Eight studies assessed the effectiveness of an intervention on limitations in activities, of which four reported positive effects. Two of these were high quality RCTs assessing a comprehensive rehabilitation program for physical and psychological well-being and manual lymph drainage, respectively. Eight studies aimed to improve quality of life in patients with SSc. Of those, three RCTs reported positive results, including two studies on comprehensive rehabilitation programs for the hands and face, and one high quality RCT assessing manual lymph drainage.
Conclusions The effectiveness of a wide variety of non-pharmacological approaches targeting to reduce the consequences of SSc have been studied utilizing a wide variety of outcome dimensions. The strength of evidence on the effectiveness of these interventions is limited by the heterogeneity in interventions and outcome measures, small samples sizes, and low quality of designs. Our results warrant a practice-based international consensus on the content of a limited number of non-pharmacological interventions and outcome measures, as a prerequisite to establish an international research agenda. Then, international collaborations should be established to contribute to the knowledge of non-pharmacological care and conduct high-quality RCTs for patients with SSc.
Disclosure of Interest None declared