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Comparison 1 Disease Activity, Outcome 1 SLEDAI.
Figuras y tablas -
Analysis 1.1

Comparison 1 Disease Activity, Outcome 1 SLEDAI.

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Comparison 2 Quality of Life, Outcome 1 Patient Global.
Figuras y tablas -
Analysis 2.1

Comparison 2 Quality of Life, Outcome 1 Patient Global.

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Comparison 2 Quality of Life, Outcome 2 Physician Global.
Figuras y tablas -
Analysis 2.2

Comparison 2 Quality of Life, Outcome 2 Physician Global.

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Comparison 3 Adverse events, Outcome 1 Acne.
Figuras y tablas -
Analysis 3.1

Comparison 3 Adverse events, Outcome 1 Acne.

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Comparison 3 Adverse events, Outcome 2 Hirsutism.
Figuras y tablas -
Analysis 3.2

Comparison 3 Adverse events, Outcome 2 Hirsutism.

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Comparison 3 Adverse events, Outcome 3 Menstrual change.
Figuras y tablas -
Analysis 3.3

Comparison 3 Adverse events, Outcome 3 Menstrual change.

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Table 1. Summary of quality assessment of included studies

Study id

Assignment

Alloc concealment

Baseline

ITT

Dropouts

Outcome Blind

Chang 2002

Yes

Probably Adequate

No detail presented

Yes

Yes (7/120)

Yes

Hartkamp 2004

Unclear

Adequate

No (postmenopausal status higher in active arm; oestrogen use lower in active arm)

No (2 declined final dexa scan excluded

Yes (2/60)

Yes

Nordmark 2005

Unclear

Unclear

Similar (DHEA treatment group had slightly more active disease

Unclear

Yes (3/41)

Yes

Petri 2002

Unclear

Probably Adequate

Yes

Yes

No (49/191)

Yes

Petri 2004

yes

Adequate

yes (although Anti dsDNA higher in active treatment group)

Yes

Yes (115/381)

Yes

Van Vollenhoven 1995

Unclear

Unclear

Yes

No

Yes (2/28)

Yes

Van Vollenhoven 1999

Yes

Probably Adequate

No Males in placebo group only, organs effected differed.Some differences in baseline activity scores with DHEA group tending to be higher (none statistically significant)

No

Yes (2/21)

Yes

KEY

Assignment random

Allocation concealed

Baseline characteristics similar

Intention to treat analysis

drop outs described

Outcomes blinded
Figuras y tablas -
Table 1. Summary of quality assessment of included studies
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Table 2. Summary of Disease activity: SLEDAI (0‐105) (individual studies)

Study

no. participants

placebo (SEM)

DHEA (SEM)

change vs placebo

Mild/Moderate

Chang 2002*

Placebo: 59; DHEA 61

‐1.4 (4.6)

‐1.2 (5.4)

p=0.7

Hartkamp 2004

Placebo: 30; DHEA 30

+0.3 (na)

+0.43 (na)

p=0.79

Nordmark 2005

Placebo: 17 DHEA 20

reported as "no significant change"

Petri 2002

Placebo 64; DHEA 100 63; DHEA 200 64

measured but not reported for all participants

Petri 2004

Placebo: 192 (146 reported) DHEA 189 (147 reported)

17.8% deteriorated

9.5% deteriorated

p=0.04 not reported for all participants ‐ only those with "active disease"

van Vollenhoven 1995*

Placebo: 14 DHEA 14

+0.79 (0.75)

‐1.71 (1.18)

p=0.09

*Summarised in Meta‐analysis

Severe

van Vollenhoven 1999*

Placebo: 10 DHEA 9

‐3.9 (1.4)

‐10.3 (3.1)

p=0.07

*Summarised in Meta‐analysis
Figuras y tablas -
Table 2. Summary of Disease activity: SLEDAI (0‐105) (individual studies)
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Table 3. Summary of Disease activity: SLAM (0‐84) (individual studies)

Study

No. participants

placebo (SEM)

DHEA (SEM)

change vs. placebo

Mild/Moderate Disease at baseline

Chang 2002*

Placebo: 59; DHEA 61

‐2.0 (0.49)

‐2.6 (0.44)

p=0.355

Petri 2004

Placebo: 192 (146 reported) DHEA 189 (147 reported)

10.3% deteriorated

6.8% deteriorated

p= 0.29 Not reported for all participants ‐ only those with "active disease"

Severe disease at baseline

van Vollenhoven 1999

Placebo: 10 DHEA: 9

‐2.4 (2.0)

‐5.4 (2.34)

p=0.41
Figuras y tablas -
Table 3. Summary of Disease activity: SLAM (0‐84) (individual studies)
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Table 4. Summary of Health Related Quality of Life: Patient Global (0‐100) (ind.studies)

study

No. Participants

placebo (SEM)

DHEA (SEM)

change vs. placebo

Mild to Moderate disease

Chang 2002

Placebo 59: DHEA 61

+5.4 (2.56)

‐5.5 (3.46)

p=0.005 (adjusted for treat centre and treatment, no unadjusted presented) [95% CI from crude analysis ‐76.1 to 54.3]

Hartkamp 2004

Placebo 30: DHEA 30

measured but not reported

Nordmark 2005

Placebo 17: DHEA 20

not measured

Petri 2002

Placebo 64: DHEA 100mg 62: DHEA 200mg 64

measured but not reported

Petri 2004

Placebo 192 (reported 146): DHEA 189 (reported 147)

22.6% deteriorated

10.9% deteriorated

p=0.007 Not reported for all participants, only those with "active disease"

van Vollenhoven 1995

Placebo 14: DHEA 14

+2.4 (7.0)

‐11.5 (5.7)

unadjusted 0.138, P vs placebo adjusted 0.022

*Summarised in Meta‐analysis

Severe Disease

van Vollenhoven 1999

Placebo 10: DHEA 9

‐23.5 (2.4)

‐23.7 (4.8)

p= 0.53
Figuras y tablas -
Table 4. Summary of Health Related Quality of Life: Patient Global (0‐100) (ind.studies)
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Table 5. Adverse events

Adverse events

Chang 2002

Hartkamp 2004

Petri 2002

Petri 2004

van Vollenhoven 1995

van Vollenhoven 1999

Nordmark 1002

No. Participants

DHEA:61; Placebo:59

DHEA:30; Placebo:30

DHEA 100mg:63; DHEA 200mg: 64; Placebo:64

DHEA:192; Placebo: 189

DHEA:14; Placebo:14

DHEA:10; Placebo:10

DHEA: 20; Placebo:17

Serious AEs

DHEA: 7 (11.5); Placebo: 18 (30.5)

DHEA: 33 (17); placebo: 27 (14)

DHEA: 1; placebo: 1

DHEA: 1; placebo: 2

Withdrawal due to AE

DHEA 100: 4 (6); DHEA 200: 6 (9); placebo:3 (5)

DHEA: 11 (5.7); placebo:27 (14.3)

DHEA: 0; placebo: 0

Acne

DHEA: 59%; placebo: 29%

DHEA 100: 26 (41); DHEA 200: 26 (41); placebo:12 (19)

DHEA: 63 (33.3); placebo: 27 (14.1)

DHEA:8 (57); placebo: 1 (7)

DHEA: 6; placebo:3

Hirsutism

DHEA 100: 7 (11); DHEA 200:5 (7.8); placebo: 3 (4.7)

DHEA: 31 (16.4); placebo: 3 (1.6)

DHEA: 2 (14); placebo:4 (28)

DHEA:4; placebo:2

Weight Gai

DHEA: 2(14); placebo:1 (7)

Rash

DHEA 100: 3 (4.8); DHEA 200: 7 (11); placebo: 3 (4.7)

DHEA: 62 (32.3); placebo: 75 (39.7)

DHEA :0 ; placebo: 2 (14)

Menarrhagia

DHEA 100:5 (7.9); DHEA 200: 5 (7.8); placebo: 3 (4.7)

DHEA: 1 (7); placebo: 2 (14)

DHEA: 8; placebo :3

Headache

DHEA 100: 3 (4.8); DHEA 200: 4 (6.3); placebo:1 (1.6)

DHEA: 56 (29.2); placebo:42 (22.2)

DHEA:4 ; placebo: 4

Abdominal Pain

DHEA 100: 3 (4.8); DHEA 200: 5 (7.8); placebo:0

DHEA: 30 (25.6); placebo: 27 (14.3)

Chest Pain

DHEA: 22 (10.4); placebo: 14 (7.4)

Arthralgia

DHEA:71 (37.0); placebo: 68 (36)

Asthenia

DHEA 100: 4 (6.3); DHEA 200: 3 (4.7); placebo:3 (4.7)

DHEA: 51 (26.6); Placebo45 (23.8)

Myalgia

DHEA: 69 (35.9); placebo: 42 (22.2)

flu like symptoms

DHEA: 42 (21.9); placebo: 39 (20.6)

Stomatitis

DHEA: 44 (22.9); placebo: 28 (14.8)

Mood Change

DHEA: 30 (15.6); placebo:28 (14.8)

DHEA; 1 (7); placebo: 0

DHEA:1; placebo:3

Alopecia

DHEA: 39 (20.3); placebo: 28 (14.8)

DHEA: 0; placebo:1

Fever

DHEA: 28 (14.6); placebo: 22 (11.6)

Perihperal vascular disease

DHEA: 20 (10.4); placebo: 19 (10.1)

Sinusitis

DHEA: 21 (10.4); placebo: 17 (9)

Insomnia

DHEA 100: 4 (6.3); DHEA 200: 3 (4.7); placebo:2 (3.1)

DHEA: 2; placebo:1
Figuras y tablas -
Table 5. Adverse events
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Table 6. Clinical Relevance Table ‐ Summary of Meta‐analysis: Benefits

Outcome

# patients(# trials)

Control baseline m

Wt absolute change

Relative % change

NNT (B) or NNT (H)

Statistical Sig

Quality of Evidence

SLEDAI (mild/moderate) (0‐105)

148(2)

6.55*

0.6% reduction (0.6 points less on a scale of 0‐105)

9.3% improvement

NA

not statistically significant

Gold

95% confidence interval

‐2.12 to 0.89

SLEDAI (severe) (0‐105)

19(1)

9.4

6% reduction (6.4 points less on a scale of 0‐105)

68% improvement

3

borderline statistically significant

Silver

95% confidence interval

‐13.12 to 0.32

HRQoL (mild/moderate) Patient Global (0‐100)

148 (2)

28.5

11.5% reduction (11.5 point reduction on a scale of 0‐100)

40.4% improvement

5

statistically significant

Gold

95% confidence interval

‐19.1 to ‐3.8

HRQoL (severe) (0‐100)

19 (1)

52.6

0.2% reduction (0.2 point reduction on a scale of 0‐100)

0.4% improvement

NA

not statistically significant

Silver

95% confidence interval

‐3.7 to 3.3

Legend:

SLEDAI ‐ SLE disease activity index
HRQOL ‐ Health Related Quality of Life

NA=not applicable
Figuras y tablas -
Table 6. Clinical Relevance Table ‐ Summary of Meta‐analysis: Benefits
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Table 7. Clinical Relevance Table: Summary Meta‐analysis table: adverse events

Outcome

# patients (#trials)

Event rate (placebo)

Event rate (treated)

Relative risk

Absolute risk dif

NNH

Adverse Events (mild/moderate): Acne

657 (4)

56/326 (17.2%)

123/331 (37.2%)

2.2

0.2

5

95% confidence interval

1.65 to 2.83

0.13 to 0.26

Adverse Events (mild/moderate): Menstrual Change

276 (3)

5/137 (3.6%)

6/139 (4.3%)

1.2

0.1

not statistically significant

95% confidence interval

0.38 to 3.77

‐0.04 to 0.05
Figuras y tablas -
Table 7. Clinical Relevance Table: Summary Meta‐analysis table: adverse events
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Comparison 1. Disease Activity

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 SLEDAI Show forest plot

3

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

1.1 Mild to moderate SLE

2

148

Mean Difference (IV, Fixed, 95% CI)

‐0.61 [‐2.12, 0.89]

1.2 Severe SLE

1

19

Mean Difference (IV, Fixed, 95% CI)

‐6.4 [‐13.12, 0.32]
Figuras y tablas -
Comparison 1. Disease Activity
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Comparison 2. Quality of Life

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Patient Global Show forest plot

3

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

1.1 Mild to Moderate SLE

2

148

Mean Difference (IV, Fixed, 95% CI)

‐11.46 [‐19.08, ‐3.84]

1.2 Severe SLE

1

19

Mean Difference (IV, Fixed, 95% CI)

‐0.20 [‐3.67, 3.27]

2 Physician Global Show forest plot

3

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

2.1 Mild to moderate SLE

2

148

Mean Difference (IV, Fixed, 95% CI)

‐3.16 [‐8.12, 1.80]

2.2 Severe SLE

1

19

Mean Difference (IV, Fixed, 95% CI)

‐9.80 [‐40.36, 20.76]
Figuras y tablas -
Comparison 2. Quality of Life
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Comparison 3. Adverse events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Acne Show forest plot

5

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 Mild to moderate SLE

4

657

Risk Ratio (M‐H, Fixed, 95% CI)

2.16 [1.65, 2.83]

1.2 Severe SLE

1

20

Risk Ratio (M‐H, Fixed, 95% CI)

2.0 [0.68, 5.85]

2 Hirsutism Show forest plot

5

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2.1 Mild to moderate SLE

4

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Severe SLE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Menstrual change Show forest plot

4

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 Mild to moderate SLE

3

276

Risk Ratio (M‐H, Fixed, 95% CI)

1.2 [0.38, 3.77]

3.2 Severe SLE

1

20

Risk Ratio (M‐H, Fixed, 95% CI)

2.67 [0.98, 7.22]
Figuras y tablas -
Comparison 3. Adverse events
Ir a la tabla de la revisión