Summary of clinical trials with fatigue as an outcome in SLE.
| Authors | Data Collection | Scale | Intervention | Followup, weeks | N | Findings | Country |
|---|---|---|---|---|---|---|---|
| Greco, et al19 | 2004–2006 | FSS | Acupuncture vs minimal needling | 5–6 | 24 | No difference detected | USA |
| Avaux, et al21 | 2012–2013 | FSS | Exercise vs controls | 12 | 45 | Clinically significant improvement* | Belgium |
| Davies, et al22 | Published 2012 | FSS | Low GI diet and LC diet vs placebo | 6 | 23 | Clinically significant improvement with GI diet*, but only statistically significant improvement with LC diet (did not meet MCID) | UK |
| Bogdanovic, et al20 | Published 2015 | FSS | Aerobic and isotonic exercise | 6 | 60 | Clinically significant improvement* | Serbia |
| Arriens, et al17 | Published 2015 | FSS | Fish oil vs PBO | 26 | 50 | No difference | USA |
| Strand, et al13 | 2007–2010 | FACIT-Fatigue | Belimumab or PBO | 52 (n = 865); 76 (n = 819) | 1684 | Clinically significant improvement* | Multicenter |
| Petri, et al14 | 2010–2012 | FACIT-Fatigue | Blisibimod or PBO | 24 | 57 | Clinically significant improvement* | USA and Brazil |
| Uppal, et al12 | Published 2009 | VAS | Standard therapy ± infliximab (anchor not specified) | 24 | 27 | No difference detected | Kuwait |
| Merrill, et al11 | Published 2010 | VAS | Abatacept vs placebo (anchor not specified) | 52 | 175 | Clinically significant improvement* | Multicenter |
| Hartkamp, et al18 | Published 2010 | MFI | DHEA vs PBO | 52 | 60 | No difference detected | the Netherlands |
| Lai, et al16 | 2009–2011 | FAS | PBO vs escalating doses of N-acetylcysteine | 12 | 36 | Statistically significant improvement | USA |
| Merrill, et al15 | 2011–2014 | BFI | Tabalumab vs PBO | 52 | 1124 | No difference detected | Multicenter |
↵* Met MCID (therefore both statistically and clinically significant difference detected). MCID: minimal clinically important difference; FSS: Krupp Fatigue Severity Scale; GI: glycemic index; LC: low-calorie; FACIT-F: Functional Assessment of Chronic Illness Therapy-Fatigue Scale; PBO: placebo; VAS: visual analog scale; MFI: Multidimensional Fatigue Inventory; DHEA: dehydroepiandrosterone; BFI: Brief Fatigue Inventory; FAS: Fatigue Assessment Scale; SLE: systemic lupus erythematosus.