Evidence Table M3: DISCRETE outcomes for class ANTI-ANDROGEN.

Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

M.01.02 Cyproterone + ethinyl estradiol Minocycline hydrochloride

GI+other side effects Heartburn/ depression 0 NS

Diarrhea 0

Nausea/vomiting/giddness 2

Bleeding problems 4

Heartburn/ depression 4

Diarrhea 4

Nausea/vomiting/giddness 3

Bleeding problems 1

Headaches 3

245

Parallel 

Mild/mod

N=98

Í

Headaches 4

Gyn side effects White vaginal discharge 1 NS

Weight gain 5

Painful/swollen breasts 3

Vaginal irritation 0

White vaginal discharge 0

Weight gain 1

Painful/swollen breasts 0

Vaginal irritation 1

Headaches/giddiness/fluid retention 

0

Headaches/giddness/fluid retention 

1

Skin side effects Dry skin 1 NS

Spider nevus on nose 1

Hair falling out 0

Itching 0

Dry skin 0

Spider nevus on nose 0

Hair falling out 1

Itching 1

Anxiety, depression Anxiety, depression 

Overall change/patient Some improvement 36 NS

Complete improvement 7

Other 6

Some improvement 34

Complete improvement 8

Other 7

Long (24

Cyproterone + ethinyl estradiol 

+ placebo

M.01.03 Tetracycline + placebo

Systemic reactions Chest pain 0

Headache 0

Menstrual irregularity 0

Breast tenderness 0

Chest pain 0

Headache 0

Menstrual irregularity 0

Breast tenderness 0

Hypertension 0

Dysmenorrhoea 0

137

Parallel 

N=92

È Long (24

Hypertension 1

Dysmenorrhoea 1

Cyproterone + ethinyl estradiol 

(0.05)

Levonorgestrel + ethinyl estradiol 

(0.030)

M.01.05

48 Discontinuation due to side effects Discontinuation 5 Discontinuation 6

Parallel 

N=133

È

TRIAL: -presence of positive or negative methodological features (see Summary Table). "Mild/mod," etc., -our assessment of entry severity of study patients. "P"- to parallel study, "S"-split face design. BETWEEN 

P-VALUE: comparison between Target and Comparator arms.

Evidence Table M DISCRETE: Page 1 of 7

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Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

Total lesions change

Between P-value: vs levonorgestrel

> 75% reduction 30 0.001

No change or worse 2

Else (total-1-2) 13

>75% reduction 9

No change or worse 6

Else (total-1-2) 21

48

Parallel 

N=133

È Long (24

Cyproterone + ethinyl estradiol 

(0.035)

M.01.07 Desogestrel + ethinyl estradiol

Back improvement Yes 41 NS

No 38

Yes 38

No 45

103

Parallel 

N=162

Í Mid (12)

Chest improvement Yes 43 NS

No 36

Yes 42

No 41

Mid (12)

Complete healing Yes 28

No 51

Yes 20

No 63

Mid (12)

Face improvement Yes 46 0.05

No 33

Yes 32

No 51

Mid (12)

Back improvement Yes 66 NS

No 13

Yes 68

No 15

Long (32

Chest improvement Yes 68 NS

No 11

Yes 65

No 18

Long (32

Complete healing Yes 46

No 33

Yes 62

No 21

Long (32

Face improvement Yes 64 0.05

No 15

Yes 52

No 31

Long (32

Side effects Headache 75 0.05

Reduced libido 5

Breast tenderness 19

Nervousness 21

Headache 76

Reduced libido 29

Breast tenderness 58

Nervousness 48

Depression 45

Edema 22

Long (32

Depression 9

Edema 29

Cyproterone + ethinyl estradiol 

(0.035)

Levonorgestrel + ethinyl estradiol 

(0.030)

M.01.08

48 Discontinuation due to side effects Discontinuation 6 Discontinuation 6

Parallel 

N=133

È

TRIAL: -presence of positive or negative methodological features (see Summary Table). "Mild/mod," etc., -our assessment of entry severity of study patients. "P"- to parallel study, "S"-split face design. BETWEEN 

P-VALUE: comparison between Target and Comparator arms.

Evidence Table M DISCRETE: Page 2 of 7

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Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

Total lesions change

Between P-value: vs levonorgestrel

>75% reduction 27 0.001

No change or worse 2

Else (total-1-2) 15

>75% reduction 9

No change or worse 6

Else (total-1-2) 21

48

Parallel 

N=133

È Long (24

Cyproterone (.05 mg) + ethinyl 

estradiol

Norethisterone + placebo + ethinyl 

estradiol

M.01.09

Systemic reactions I > once Tiredness/lassitude 3

Loss of libido 1

Headaches 3

Dizziness/ giddiness 0

Tiredness/lassitude 4

Loss of libido 0

Headaches 3

Dizziness/ giddiness 1

Breast soreness 2

Urinary urgency 0

Depression 1

Nausea/vomiting 2

237

Parallel 

Mod/sev

N=90

Long (26

Breast soreness 2

Urinary urgency 1

depression 1

Nausea/vomiting 2

Systemic reactions I once only Tiredness/lassitude 1

Loss of libido 1

Headaches 4

Dizziness/giddiness 4

Tiredness/lassitude 1

Loss of libido 1

Headaches 2

Dizziness/giddiness 3

Breast soreness 3

Urinary urgency 3

Depression 3

Nausea/vomiting 6

Long (26

Breast soreness 4

Urinary urgency 3

depression 3

Nausea/vomiting 2

Systemic reactions II > once Abnormal uterine bleeding 1

Aching legs 0

Consipation 0

Abdominal pain 0

Abnormal uterine bleeding 0

Aching legs 0

Consipation 0

Abdominal pain 0

Benign breast tomor 0

Vaginal discharge 0

Long (26

Benign breast tomor 0

Vaginal discharge 0

Systemic reactions II once only Abnormal uterine bleeding 4

Aching legs 3

Constipation 0

Abdominal pain 0

Abnormal uterine bleeding 3

Aching legs 1

Constipation 3

Abdominal pain 0

Benign breast tumor 0

Vaginal discharge 0

Long (26

Benign breast tumor 0

Vaginal discharge 0

M.02.01 Desogestrel + ethinyl estradiol Gestodene + ethinyl estradiol

TRIAL: -presence of positive or negative methodological features (see Summary Table). "Mild/mod," etc., -our assessment of entry severity of study patients. "P"- to parallel study, "S"-split face design. BETWEEN 

P-VALUE: comparison between Target and Comparator arms.

Evidence Table M DISCRETE: Page 3 of 7

ÈÍ
Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

Severity (pillsbury) Absent 0

Minimal 3

Minor 2

Mild 6

Absent 1

Minimal 1

Minor 2

Mild 4

Moderate 0

225

Parallel 

Mild/mod

N=24

Í Mid (12)

Moderate 0

Severity change (pillsbury) Absent 2

Minimal 8

Minor 1

Mild 0

Absent 3

Minimal 2

Minor 1

Mild 2

Moderate 0

Long (36

Moderate 0

Systemic adverse effects Present 6

Absent 5

Present 4

Absent 4

Long (36

M.02.02 Desogestrel + ethinyl estradiol Levonorgestrel + ethinyl estradiol

Side effects Worse acne & drop out 2

Irregular bleed 2

Worse acne & drop out 4

Irregular bleed 3

263

Parallel 

N=54

Severity change Improved 9 0.05

No improvement 1

Improved 5

No improvement 4

Long (24

M.03.01 Spironolactone Placebo

Change (count) Improved 15 0.001

Unchanged 5

Worse 0

Improved 4

Unchanged 9

Worse 7

249

Cross-over 

Mild/mod

N=58

È Mid (12)

Overall change/patient Proportion improved 18 0.001

Proportion unchanged 3

Proportion worse 0

Proportion improved 5

Proportion unchanged 9

Proportion worse 7

Mid (12)

Positive side effects Decreased oily skin 9

Breast enlargement 2

Decreased oily skin 0

Breast enlargement 0

Mid (12)

Severity/photo Improved 11 0.02

Unchanged 7

Worse 1

Improved 4

Unchanged 12

Worse 3

Mid (12)

TRIAL: -presence of positive or negative methodological features (see Summary Table). "Mild/mod," etc., -our assessment of entry severity of study patients. "P"- to parallel study, "S"-split face design. BETWEEN 

P-VALUE: comparison between Target and Comparator arms.

Evidence Table M DISCRETE: Page 4 of 7

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Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

Side effects Menstrual irregularity 11

Severe nausea (drop out) 2

Nausea 1

Dizziness 1

Menstrual irregularity 0

Severe nausea (drop out) 0

Nausea 0

Dizziness 0

249

Cross-over 

Mild/mod

N=58

È Mid (12)

M.04.01 Delta-0.2%-chlormadione Vehicle

Overall change/patient Change in acne 0

No change in acne 10

Change in acne 0

No change in acne 20

2

Parallel split 

face 

N=20

È Mid (7)

Overall change/physician Change in acne 0

No change in acne 10

Change in acne 0

No change in acne 20

Mid (7)

M.04.02 Delta-5%-chlormadione Vehicle

Overall change/patient Change in acne 0

No change in acne 10

Change in acne 0

No change in acne 20

2

Parallel split 

face 

N=20

È Mid (7)

Overall change/physician Change in acne 0

No change in acne 10

Change in acne 0

No change in acne 20

Mid (7)

M.04.03 Delta-0.2%-chlormadione Delta-5%-chlormadione

Overall change/patient Change in acne 0

No change in acne 10

Change in acne 0

No change in acne 10

2

Parallel split 

face 

N=20

È Mid (7)

Overall change/physician Change in acne 0

No change in acne 10

Change in acne 0

No change in acne 10

Mid (7)

M.04.04 16-epiestriol-3-allyl ether Placebo

Oiliness No change 30 NS

Improved 19

Marked improvement 17

No change 35

Improved 24

Marked improvement 9

19

Parallel 

N=134

Mid (12)

Severity change No change 31 NS

Improved 19

Marked improvement 16

No change 34

Improved 26

Marked improvement 8

Mid (12)

TRIAL: -presence of positive or negative methodological features (see Summary Table). "Mild/mod," etc., -our assessment of entry severity of study patients. "P"- to parallel study, "S"-split face design. BETWEEN 

P-VALUE: comparison between Target and Comparator arms.

Evidence Table M DISCRETE: Page 5 of 7

ÈÍ
Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

M.04.05 Epiestriol Vehicle

Inter-treatment severity change Better 9

Same 23

Better 23

Same 8

295

Parallel split 

face 

N=50

È Mid (12)

Overall change/physician Worse 7

Unchanged 18

Improved 19

Worse 7

Unchanged 18

Improved 19

Mid (12)

M.04.06 Inocoterone acetate Vehicle

Local adverse reactions Burning 32 NS

Stinging 18

Itching 10

Redness 19

Burning 24

Stinging 24

Itching 6

Redness 15

Peeling 12

213

Parallel Mod

N=153

È

Peeling 27

Norgestimate + ethinyl estradiol 

+ inactive drug

M.04.09 Placebo

Overall change/investigator Excellent 30 0.001

Good 28

Fair 16

No change 3

Excellent 15

Good 24

Fair 14

No change 20

Worse 8

218

Parallel Mod

N=257

È Long (26

Worse 2

Overall change/patient Much improved 34 0.001

Somewhat improved 39

Not improved 5

Worse 1

Much improved 18

Somewhat improved 40

Not improved 19

Worse 4

Long (26

Adverse events Discontinued therapy 13

Other 113

Discontinued therapy 5

Other 119

280

Parallel Mod

N=250

È

Overall change/investigator Excellent 22 0.001

Good 32

Fair 16

No change 9

Excellent 6

Good 25

Fair 19

No change 25

Worse 5

Long (24

Worse 5

TRIAL: -presence of positive or negative methodological features (see Summary Table). "Mild/mod," etc., -our assessment of entry severity of study patients. "P"- to parallel study, "S"-split face design. BETWEEN 

P-VALUE: comparison between Target and Comparator arms.

Evidence Table M DISCRETE: Page 6 of 7

ÈÍ
Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

Overall change/patient Much improved 30 0.001

Somewhat improved 38

Not improved 10

Worse 5

Much improved 10

Somewhat improved 28

Not improved 37

Worse 5

Much worse 0

280

Parallel Mod

N=250

È Long (24

Much worse 0

M.04.11 Serum gonadotrophin Placebo

Overall change/patient with physician Improved 8

No change 9

Worse 2

Improved 9

No change 9

Worse 3

271

Parallel 

Mild/mod/sev

N=40

È Mid (12)

TRIAL: -presence of positive or negative methodological features (see Summary Table). "Mild/mod," etc., -our assessment of entry severity of study patients. "P"- to parallel study, "S"-split face design. BETWEEN 

P-VALUE: comparison between Target and Comparator arms.

Evidence Table M DISCRETE: Page 7 of 7

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