Anabolic steroids for the treatment of weight loss in HIV‐infected individuals

Karen KJ Johns; MJ Beddall; RC Corrin

doi:10.1002/14651858.CD005483

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Figure 1

Figure 1. Funnel plot of results for change from baseline in lean body mass

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Figure 2

Figure 2. Funnel plot of results for change from baseline in body weight

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Figure 3

Figure 1. Funnel plot for change from baseline in body weight with unpublished trial included

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Analysis 1.1

Comparison 1 Anabolic steroid compared to placebo ‐ primary analysis, Outcome 1 Change from baseline in lean body mass.

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Analysis 1.2

Comparison 1 Anabolic steroid compared to placebo ‐ primary analysis, Outcome 2 Change from baseline in body weight.

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Analysis 1.3

Comparison 1 Anabolic steroid compared to placebo ‐ primary analysis, Outcome 3 Deaths.

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Analysis 1.4

Comparison 1 Anabolic steroid compared to placebo ‐ primary analysis, Outcome 4 Withdrawals or discontinuations due to adverse events.

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Analysis 2.1

Comparison 2 Anabolic steroid compared to placebo ‐ subgroups by gender, Outcome 1 Change from baseline in lean body mass.

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Analysis 2.2

Comparison 2 Anabolic steroid compared to placebo ‐ subgroups by gender, Outcome 2 Change from baseline in body weight.

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Analysis 2.3

Comparison 2 Anabolic steroid compared to placebo ‐ subgroups by gender, Outcome 3 Deaths.

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Analysis 2.4

Comparison 2 Anabolic steroid compared to placebo ‐ subgroups by gender, Outcome 4 Withdrawals or discontinuations of study medication due to adverse events.

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Analysis 3.1

Comparison 3 Anabolic steroid compared to placebo ‐ men only ‐ subgroups by gonadal status, Outcome 1 Change for baseline in lean body mass.

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Analysis 3.2

Comparison 3 Anabolic steroid compared to placebo ‐ men only ‐ subgroups by gonadal status, Outcome 2 Change from baseline in body weight.

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Analysis 4.1

Comparison 4 Anabolic steroid compared to placebo ‐ subgroups by treatment duration, Outcome 1 Change from baseline in lean body mass.

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Analysis 4.2

Comparison 4 Anabolic steroid compared to placebo ‐ subgroups by treatment duration, Outcome 2 Change from baseline in body weight.

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Analysis 5.1

Comparison 5 Anabolic steroid compared to placebo ‐ subgroups by treatment dose, Outcome 1 Change from baseline in lean body mass.

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Analysis 5.2

Comparison 5 Anabolic steroid compared to placebo ‐ subgroups by treatment dose, Outcome 2 Change from baseline in body weight.

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Analysis 6.1

Comparison 6 Anabolic steroid compared to placebo ‐ subgroups by proportion of study participants on protease inhibitors, Outcome 1 Change from baseline in lean body mass.

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Analysis 6.2

Comparison 6 Anabolic steroid compared to placebo ‐ subgroups by proportion of study participants on protease inhibitors, Outcome 2 Change from baseline in body weight.

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Analysis 7.1

Comparison 7 Anabolic steroid compared to placebo ‐ subgroups by measurement technique, Outcome 1 Change from baseline in lean body mass.

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Analysis 8.1

Comparison 8 Anabolic steroid compared to placebo ‐ subgroups by methodologic quality score, Outcome 1 Change from baseline in lean body mass.

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Analysis 8.2

Comparison 8 Anabolic steroid compared to placebo ‐ subgroups by methodologic quality score, Outcome 2 Change from baseline in body weight.

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Analysis 9.1

Comparison 9 Anabolic steroid compared to placebo ‐ subgroups by adequacy of allocation concealment, Outcome 1 Change from baseline in lean body mass.

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Analysis 9.2

Comparison 9 Anabolic steroid compared to placebo ‐ subgroups by adequacy of allocation concealment, Outcome 2 Change from baseline in body weight.

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Analysis 10.1

Comparison 10 Anabolic steroid compared to placebo ‐ subgroups by score on randomization, Outcome 1 Change from baseline in lean body mass.

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Analysis 10.2

Comparison 10 Anabolic steroid compared to placebo ‐ subgroups by score on randomization, Outcome 2 Change from baseline in body weight.

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Analysis 11.1

Comparison 11 Anabolic steroid compared to placebo ‐ subgroups by score on description of withdrawals, Outcome 1 Change from baseline in lean body mass.

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Analysis 11.2

Comparison 11 Anabolic steroid compared to placebo ‐ subgroups by score on description of withdrawals, Outcome 2 Change from baseline in body weight.

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Analysis 12.1

Comparison 12 Anabolic steroid compared to placebo ‐ subgroups by total sample size of trial, Outcome 1 Change from baseline in lean body mass.

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Analysis 12.2

Comparison 12 Anabolic steroid compared to placebo ‐ subgroups by total sample size of trial, Outcome 2 Change from baseline in body weight.

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Analysis 13.2

Comparison 13 Anabolic steroid compared to placebo ‐ sensitivity analysis with unpublished trials included, Outcome 2 Change from baseline in body weight (subgroups by gender).

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Analysis 14.1

Comparison 14 Anabolic steroid compared to placebo ‐ sensitivity analysis with trials with quality score < 4 excluded, Outcome 1 Change from baseline in lean body mass.

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Analysis 14.2

Comparison 14 Anabolic steroid compared to placebo ‐ sensitivity analysis with trials with quality score < 4 excluded, Outcome 2 Change from baseline in body weight.

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Comparison 1. Anabolic steroid compared to placebo ‐ primary analysis

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Change from baseline in lean body mass Show forest plot	14	532	Mean Difference (IV, Random, 95% CI)	1.32 [0.59, 2.04]

2 Change from baseline in body weight Show forest plot	16	629	Mean Difference (IV, Random, 95% CI)	1.13 [0.29, 1.96]

3 Deaths Show forest plot	13	512	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.03, 0.03]

4 Withdrawals or discontinuations due to adverse events Show forest plot	13	597	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.02, 0.03]

Comparison 1. Anabolic steroid compared to placebo ‐ primary analysis

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Comparison 2. Anabolic steroid compared to placebo ‐ subgroups by gender

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Change from baseline in lean body mass Show forest plot	14	532	Mean Difference (IV, Random, 95% CI)	1.32 [0.59, 2.04]

1.1 Men	8	323	Mean Difference (IV, Random, 95% CI)	1.47 [0.38, 2.55]
1.2 Women	4	135	Mean Difference (IV, Random, 95% CI)	0.97 [‐0.31, 2.24]
1.3 Men and women	2	74	Mean Difference (IV, Random, 95% CI)	1.91 [0.06, 3.75]
2 Change from baseline in body weight Show forest plot	16	629	Mean Difference (IV, Random, 95% CI)	1.13 [0.29, 1.96]

2.1 Men	9	359	Mean Difference (IV, Random, 95% CI)	0.78 [‐0.28, 1.84]
2.2 Women	5	196	Mean Difference (IV, Random, 95% CI)	1.33 [‐0.40, 3.06]
2.3 Men and women	2	74	Mean Difference (IV, Random, 95% CI)	2.23 [0.62, 3.84]
3 Deaths Show forest plot	13	512	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.03, 0.03]

3.1 Men	7	275	Risk Difference (M‐H, Random, 95% CI)	‐0.00 [‐0.04, 0.04]
3.2 Women	4	148	Risk Difference (M‐H, Random, 95% CI)	0.01 [‐0.04, 0.07]
3.3 Men and women	2	89	Risk Difference (M‐H, Random, 95% CI)	0.0 [‐0.07, 0.07]
4 Withdrawals or discontinuations of study medication due to adverse events Show forest plot	13	597	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.02, 0.03]

4.1 Men	8	398	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.02, 0.03]
4.2 Women	3	110	Risk Difference (M‐H, Random, 95% CI)	0.0 [‐0.06, 0.06]
4.3 Men and women	2	89	Risk Difference (M‐H, Random, 95% CI)	0.05 [‐0.04, 0.13]

Comparison 2. Anabolic steroid compared to placebo ‐ subgroups by gender

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Comparison 3. Anabolic steroid compared to placebo ‐ men only ‐ subgroups by gonadal status

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Change for baseline in lean body mass Show forest plot	8	323	Mean Difference (IV, Random, 95% CI)	1.47 [0.38, 2.55]

1.1 Hypogonadal men	5	219	Mean Difference (IV, Random, 95% CI)	0.86 [‐0.22, 1.95]
1.2 Borderline gonadal status	1	39	Mean Difference (IV, Random, 95% CI)	0.70 [‐0.74, 2.14]
1.3 Eugonadal men	2	65	Mean Difference (IV, Random, 95% CI)	3.29 [2.11, 4.48]
2 Change from baseline in body weight Show forest plot	9	359	Mean Difference (IV, Random, 95% CI)	0.78 [‐0.28, 1.84]

2.1 Hypogonadal men	6	255	Mean Difference (IV, Random, 95% CI)	0.18 [‐1.07, 1.43]
2.2 Borderline gonadal status	1	39	Mean Difference (IV, Random, 95% CI)	1.1 [‐0.91, 3.11]
2.3 Eugonadal men	2	65	Mean Difference (IV, Random, 95% CI)	2.32 [1.04, 3.60]

Comparison 3. Anabolic steroid compared to placebo ‐ men only ‐ subgroups by gonadal status

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Comparison 4. Anabolic steroid compared to placebo ‐ subgroups by treatment duration

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Change from baseline in lean body mass Show forest plot	14	532	Mean Difference (IV, Random, 95% CI)	1.32 [0.59, 2.04]

1.1 6 months	2	97	Mean Difference (IV, Random, 95% CI)	1.33 [‐0.80, 3.46]
1.2 16 weeks	4	123	Mean Difference (IV, Random, 95% CI)	1.29 [0.18, 2.41]
1.3 12 weeks	7	290	Mean Difference (IV, Random, 95% CI)	1.16 [0.11, 2.22]
1.4 8 weeks	1	22	Mean Difference (IV, Random, 95% CI)	3.10 [1.11, 5.09]
2 Change from baseline in body weight Show forest plot	16	629	Mean Difference (IV, Random, 95% CI)	1.13 [0.29, 1.96]

2.1 6 months	3	155	Mean Difference (IV, Random, 95% CI)	0.50 [‐0.69, 1.69]
2.2 16 weeks	4	123	Mean Difference (IV, Random, 95% CI)	1.50 [‐0.64, 3.64]
2.3 12 weeks	8	329	Mean Difference (IV, Random, 95% CI)	0.96 [‐0.29, 2.21]
2.4 8 weeks	1	22	Mean Difference (IV, Random, 95% CI)	2.5 [0.47, 4.53]

Comparison 4. Anabolic steroid compared to placebo ‐ subgroups by treatment duration

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Comparison 5. Anabolic steroid compared to placebo ‐ subgroups by treatment dose

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Change from baseline in lean body mass Show forest plot	14	532	Mean Difference (IV, Random, 95% CI)	1.32 [0.59, 2.04]

1.1 Supraphysiologic dose	8	292	Mean Difference (IV, Random, 95% CI)	1.80 [0.79, 2.81]
1.2 Physiologic replacement dose	6	240	Mean Difference (IV, Random, 95% CI)	0.62 [‐0.20, 1.43]
2 Change from baseline in body weight Show forest plot	16	629	Mean Difference (IV, Random, 95% CI)	1.13 [0.29, 1.96]

2.1 Supraphysiologic dose	7	236	Mean Difference (IV, Random, 95% CI)	2.25 [1.31, 3.19]
2.3 Physiologic replacement dose	9	393	Mean Difference (IV, Random, 95% CI)	0.26 [‐0.60, 1.12]

Comparison 5. Anabolic steroid compared to placebo ‐ subgroups by treatment dose

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Comparison 6. Anabolic steroid compared to placebo ‐ subgroups by proportion of study participants on protease inhibitors

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Change from baseline in lean body mass Show forest plot	8	261	Mean Difference (IV, Random, 95% CI)	2.43 [1.67, 3.20]

1.1 Proportion on proteases inhibitors less than 60%	5	144	Mean Difference (IV, Random, 95% CI)	2.24 [1.18, 3.31]
1.2 Proportion on proteases inhibitors 60% or greater	3	117	Mean Difference (IV, Random, 95% CI)	2.82 [1.67, 3.97]
2 Change from baseline in body weight Show forest plot	9	319	Mean Difference (IV, Random, 95% CI)	1.92 [0.75, 3.08]

2.1 Proportion on protease inhibitors less than 60%	5	145	Mean Difference (IV, Random, 95% CI)	2.07 [‐0.02, 4.15]
2.2 Proportion on protease inhibitors 60% or greater	4	174	Mean Difference (IV, Random, 95% CI)	1.59 [0.57, 2.60]

Comparison 6. Anabolic steroid compared to placebo ‐ subgroups by proportion of study participants on protease inhibitors

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Comparison 7. Anabolic steroid compared to placebo ‐ subgroups by measurement technique

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Change from baseline in lean body mass Show forest plot	14	532	Mean Difference (IV, Random, 95% CI)	1.32 [0.59, 2.04]

1.1 Measurement by DEXA	9	288	Mean Difference (IV, Random, 95% CI)	1.31 [0.47, 2.14]
1.2 Measurement by BIA	5	244	Mean Difference (IV, Random, 95% CI)	1.37 [‐0.21, 2.96]

Comparison 7. Anabolic steroid compared to placebo ‐ subgroups by measurement technique

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Comparison 8. Anabolic steroid compared to placebo ‐ subgroups by methodologic quality score

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Change from baseline in lean body mass Show forest plot	14	532	Mean Difference (IV, Random, 95% CI)	1.32 [0.59, 2.04]

1.1 Quality score 5	7	228	Mean Difference (IV, Random, 95% CI)	2.23 [1.36, 3.09]
1.2 Quality score 4	6	206	Mean Difference (IV, Random, 95% CI)	0.94 [0.07, 1.82]
1.3 Quality score 3	1	98	Mean Difference (IV, Random, 95% CI)	‐0.3 [‐1.07, 0.47]
2 Change from baseline in body weight Show forest plot	16	629	Mean Difference (IV, Random, 95% CI)	1.13 [0.29, 1.96]

2.1 Quality score 5	8	286	Mean Difference (IV, Random, 95% CI)	1.57 [0.49, 2.66]
2.2 Quality score 4	6	210	Mean Difference (IV, Random, 95% CI)	1.24 [‐0.26, 2.73]
2.3 Quality score 3	2	133	Mean Difference (IV, Random, 95% CI)	‐0.48 [‐1.37, 0.40]

Comparison 8. Anabolic steroid compared to placebo ‐ subgroups by methodologic quality score

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Comparison 9. Anabolic steroid compared to placebo ‐ subgroups by adequacy of allocation concealment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Change from baseline in lean body mass Show forest plot	14	532	Mean Difference (IV, Random, 95% CI)	1.32 [0.59, 2.04]

1.1 Allocation concealment adequate	8	256	Mean Difference (IV, Random, 95% CI)	1.67 [0.67, 2.67]
1.2 Allocation concealment uncertain	6	276	Mean Difference (IV, Random, 95% CI)	0.91 [‐0.19, 2.01]
2 Change from baseline in body weight Show forest plot	16	629	Mean Difference (IV, Random, 95% CI)	1.13 [0.29, 1.96]

2.1 Allocation concealment adequate	9	318	Mean Difference (IV, Random, 95% CI)	1.31 [0.63, 2.00]
2.2 Allocation concealment uncertain	7	311	Mean Difference (IV, Random, 95% CI)	0.81 [‐0.78, 2.40]

Comparison 9. Anabolic steroid compared to placebo ‐ subgroups by adequacy of allocation concealment

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Comparison 10. Anabolic steroid compared to placebo ‐ subgroups by score on randomization

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Change from baseline in lean body mass Show forest plot	14	532	Mean Difference (IV, Random, 95% CI)	1.32 [0.59, 2.04]

1.1 Randomization score 2	8	285	Mean Difference (IV, Random, 95% CI)	1.84 [0.86, 2.81]
1.2 Randomization score 1	6	247	Mean Difference (IV, Random, 95% CI)	0.80 [‐0.15, 1.75]
2 Change from baseline in body weight Show forest plot	16	629	Mean Difference (IV, Random, 95% CI)	1.13 [0.29, 1.96]

2.1 Randomization score 2	9	343	Mean Difference (IV, Random, 95% CI)	1.42 [0.41, 2.44]
2.2 Randomization score 1	7	286	Mean Difference (IV, Random, 95% CI)	0.78 [‐0.60, 2.15]

Comparison 10. Anabolic steroid compared to placebo ‐ subgroups by score on randomization

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Comparison 11. Anabolic steroid compared to placebo ‐ subgroups by score on description of withdrawals

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Change from baseline in lean body mass Show forest plot	14	532	Mean Difference (IV, Random, 95% CI)	1.32 [0.59, 2.04]

1.1 Description of withdrawals score 1	12	377	Mean Difference (IV, Random, 95% CI)	1.60 [0.82, 2.38]
1.2 Description of withdrawals score 0	2	155	Mean Difference (IV, Random, 95% CI)	‐0.07 [‐0.71, 0.57]
2 Change from baseline in body weight Show forest plot	16	629	Mean Difference (IV, Random, 95% CI)	1.13 [0.29, 1.96]

2.1 Description of withdrawals score 1	13	439	Mean Difference (IV, Random, 95% CI)	1.54 [0.64, 2.43]
2.2 Description of withdrawals score 0	3	190	Mean Difference (IV, Random, 95% CI)	‐0.41 [‐1.24, 0.42]

Comparison 11. Anabolic steroid compared to placebo ‐ subgroups by score on description of withdrawals

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Comparison 12. Anabolic steroid compared to placebo ‐ subgroups by total sample size of trial

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Change from baseline in lean body mass Show forest plot	14	532	Mean Difference (IV, Random, 95% CI)	1.32 [0.59, 2.04]

1.1 Sample size less than 40	2	55	Mean Difference (IV, Random, 95% CI)	3.18 [2.06, 4.29]
1.2 Sample size 40 to 49	2	71	Mean Difference (IV, Random, 95% CI)	0.95 [‐0.05, 1.94]
1.3 Sample size 50 to 59	5	185	Mean Difference (IV, Random, 95% CI)	1.24 [0.03, 2.44]
1.4 Sample size 60 or greater	5	221	Mean Difference (IV, Random, 95% CI)	0.68 [‐0.39, 1.74]
2 Change from baseline in body weight Show forest plot	16	629	Mean Difference (IV, Random, 95% CI)	1.13 [0.29, 1.96]

2.1 Sample size less than 40	3	90	Mean Difference (IV, Random, 95% CI)	1.89 [‐1.25, 5.02]
2.2 Sample size 40 to 49	2	71	Mean Difference (IV, Random, 95% CI)	0.46 [‐0.84, 1.76]
2.3 Sample size 50 to 59	6	247	Mean Difference (IV, Random, 95% CI)	1.01 [0.17, 1.86]
2.4 Sample size 60 or greater	5	221	Mean Difference (IV, Random, 95% CI)	1.06 [‐0.65, 2.76]

Comparison 12. Anabolic steroid compared to placebo ‐ subgroups by total sample size of trial

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Comparison 13. Anabolic steroid compared to placebo ‐ sensitivity analysis with unpublished trials included

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2 Change from baseline in body weight (subgroups by gender) Show forest plot	17	685	Mean Difference (IV, Random, 95% CI)	1.16 [0.39, 1.93]

2.1 Men	10	415	Mean Difference (IV, Random, 95% CI)	0.87 [‐0.08, 1.83]
2.2 Women	5	196	Mean Difference (IV, Random, 95% CI)	1.33 [‐0.40, 3.06]
2.3 Men and women	2	74	Mean Difference (IV, Random, 95% CI)	2.23 [0.62, 3.84]

Comparison 13. Anabolic steroid compared to placebo ‐ sensitivity analysis with unpublished trials included

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Comparison 14. Anabolic steroid compared to placebo ‐ sensitivity analysis with trials with quality score < 4 excluded

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Change from baseline in lean body mass Show forest plot	13	434	Mean Difference (IV, Random, 95% CI)	1.48 [0.76, 2.20]

2 Change from baseline in body weight Show forest plot	14	496	Mean Difference (IV, Random, 95% CI)	1.44 [0.59, 2.30]

Comparison 14. Anabolic steroid compared to placebo ‐ sensitivity analysis with trials with quality score < 4 excluded

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