Table 1.
Clinical Trials in SLE involving Dehydroeipandrosterone.
| Author & year | Design | N | Patients | Dose + time | Outcome | Result |
|---|---|---|---|---|---|---|
| van Vollenhoven et al., 1994 [30] | Single center Open label Uncontrolled |
10 | Female | 200 mg | SLEDAI Patient assessment (0–100) Physician assessment (0 –100) |
SLEDAI: decreased (non significant) Physician assessment: improved (P = 0.04) Patient assessment: unchanged |
| van Vollenhoven et al., 1999 [31] | Number of centers not stated, in San Fransisco area. Double-blind Randomized Placebo-controlled |
21 | Female’Severe’ | 200mg/placebo 6 months, 6 months open label extension |
‘Responder analysis’ SLEDAI SLAM BMD |
Responder: DHEA 7/9 achieved response, placebo 4/10 (non- significant). SLEDAI: No significant change SLAM: No significant change BMD: Non significant increase in lumbar spine. |
| Petri et al., 2002 [32] | Multi-center Double-blind Randomized Placebo-controlled |
191 | Female Prednisone 10–30 mg |
100mg/200mg/ placebo 7–9 months |
Sustained reduction <7.5 mg prednisone SLEDAI SF-36 KFSS Damage index |
No reduction in prednisone dose. 200 mg: 55% responder 100 mg: 44% Placebo:41% SF-36: Non significant KFSS: Non significant change |
| Chang et al., 2002 [33] | Multicenter Randomized Double blind Placebo controlled |
120 | Female | 200 mg/placebo 24 weeks |
SLAM Flare SLEDAI |
SLAM: Non significant Flare: 16% decrease Patient global: Improved −5.5 versus 5.4; P = 0.005 |
| Chang et al., 2004 [22] | Single center Randomized Double blind Placebo controlled (subgroup of Chang et al., 2002(22)) |
32 | Female Active SLE Chinese |
200mg/placebo | Il 10 Il 1β TNFα |
IL 10: Reduced (9.21–1.89 pg/ ml with DHEA) IL1β: UnchangedTNFα: Undectable |
| Petri et al., 2004 [145] | Multicenter Randomized Double-blind Placebo-controlled |
381 | Female SLAM >7 SLEDAI >2 (n = 293) |
200mg/placebo | SLEDAI SLAM KFSS Patient global Time to flare |
ITT analysis: No difference SLEDAI: >2 Response: 58.5% versus 44.5% (P = 0.017) Flare: Less with SLEDAI>2 Patient global: Less worsening SLEDAI: Less worsening |
| Hartkamp et al., 2004 [34] | 2 centers Randomized Double-blind Placebo-controlled |
58: Initial DEXA 56: Both baseline and follow up DEXA |
Female ≤ 10 mg prednisone |
200 mg/placebo 12 months |
BMD SLEDAI |
BMD: No significant difference (Postmenopausal mean change was 1.80% with DHEA, −2.32% with placebo. Premenopausal: No change) SLEDAI: No change |
| Mease et al., 2005 [35] | Multicenter Double- blind Randomized Placebo-controlled |
66: Initial DEXA 55: Both baseline and follow up DEXA |
Female SLE ≤10 mg prednisone: (≥6 months) |
200mg/placebo 12 months |
BMD (% change) SLEDAI SLAM KFSS SLICC damage index Patient VAS Physician VAS |
BMD: Lumbar spine, gain in BMD of 1.7% in versus loss of −1.1% (P = 0.003). Total hip, 2.0% gain versus a loss of −0.3% with placebo (p = 0.013) No significant change in other outcomes |
| Nordmark et al., 2005 [37] | 2 centers Double-blind Randomized Placebo-controlled |
41 | Female >5 mg prednisone Age 20–65 |
200mg/placebo 6 months with 6 month open extension |
SF-36 BMD Body composition SLEDAI/mSLEDAI MCS HSCL-56 PGWB |
SF-36: Improved emotional components BMD: No increase Body composition: Increased waist hip ratio SLEDAI: No change mSLEDAI: No change MCS: Improved (unsustained) HSCL-56: Improved PGWB: Nonsignificant |
| Hartkamp et al., 2010 [146] | 2 centers Double-blind Randomized Placebo-controlled |
60 | Female No prednisone |
200mg/placebo 12 months |
Fatigue: MFI Depression: Zung self-rating scale SF-36 Pain VAS SLEDAI |
Fatigue: No change Depression: No change Well-being: No change |
| Sanchez-Guerrero et al., 2008 [36] | Multicenter Double-blind Randomized Placebo-controlled |
155 | Female >5 mg prednisone No osteoporosis/ bisphosphonate |
200mg/placebo in phase 1, then 200mg/100 mg in extension phase Calcium Vitamin D |
BMD | BMD: Increased at lumbar spine, 200 mg dose, (non- significant at 6 months, significant at 18 months). Maintenance of BMD at hip. (100 mg no effect) |
SLEDAI: Systemic lupus erythematosus disease activity index, DHEA: Dehydroeipandrosterone SLAM: Systemic lupus activity measure, BMD: Bone mineral density, SF-36: Short form health survey, KFSS: Krupps fatigue severity scale, DEXA: Dual-energy X-ray absorptiometry, mSLEDAI: Modified systemic lupus erythematosus disease activity index, MCS: Mental component summary, HSCL-56: Hopkins symptom check list, PGWB: Psychological general wellbeing index, MFI: Multidimensional fatigue inventory, VAS: Visual analogue scale.