Evidence Table H3: DISCRETE outcomes for class ANTI-BACTERIAL (ORAL).

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

H.01.01 Clindamycin Vehicle

Side effects Severe diarrhea (withdraw) 1

Mild diarrhea 8

Stomach gas 1

Stomach ache (mild) 0

Severe diarrhea (withdraw) 0

Mild diarrhea 1

Stomach gas 0

Stomach ache (mild) 1

Heartburn (mild) 0

Urinary frequency (mild) 1

Morbilliform rash (withdraw) 0

56

Parallel 

Mod/sev

N=98

Long (13

Heartburn (mild) 1

Urinary frequency (mild) 0

morbilliform rash (withdraw) 1

H.01.02 Clindamycin Tetracycline

Esophagitis Present 1

Absent 24

Present 0

Absent 23

265

Parallel Mod

N=48

È Mid (8)

Mild diarrhea and cramping Present 1

Absent 24

Present 0

Absent 23

Mid (8)

Overall change/physician Much improved 13

Improved 9

Same 3

Worse 0

Much improved 16

Improved 6

Same 1

Worse 0

Mid (8)

H.01.02 Clindamycin hydrochloride Tetracycline hydrochloride

Overall change/patient (vas) Worse 0

Same 1

Improved 12

Much improved 1

Worse 0

Same 1

Improved 13

Much improved 2

275

Parallel Sev

N=47

Í Mid (10.

Diarrhea Mid (11) Withdraw 2 Withdraw 0

Lesions change 25% or less decrease 2

More than 25% decrease 12

25% or less decrease 2

More than 25% decrease 14

Mid (11)

H.02.01 Demethylchlortetracycline Placebo

Adverse effects Photosensitivity 11 0.01

GI disturbance 2

Photo-onycholysis 2

Photosensitivity 0

GI disturbance 0

Photo-onycholsis 0

162

Parallel 

Mod/sev

N=37

È Mid (9)

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 H DISCRETE: Page 1 of 14

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 change Excellent or good 16 0.01

Poor 5

Excellent or good 5

Poor 11

162

Parallel 

Mod/sev

N=37

È Mid (9)

Overall change/physician Good 29 NS

Fair 3

Poor 5

Questionable 3

Good 23

Fair 5

Poor 3

Questionable 3

192

Parallel 

N=74

Short (3)

Overall change/physician, patient Declo preferred 20 0.01

Placebo preferred 6

Equally good 7

Neither good 3

Declo preferred 20

Placebo preferred 6

Equally good 7

Neither good 3

Questionable 1

193

Cross-over 

N=74

Short (3)

Questionable 1

Overall change/physician Improved 5 NS

No change 10

Worse 0

Not assessed 3

Improved 3

No change 13

Worse 0

Not assessed 6

312

Parallel 

Mild/mod/sev

N=66

È Short (4)

H.02.01 Demethylchlortetracycline Vehicle

Severity change Worse 8 NS

No change after good response 3

No change 5

Slight 11

Worse 10

No change after good response 2

No change 9

Slight 11

Good 7

Excellent 3

71

Cross-over 

N=150

Short (4)

Good 4

Excellent 11

Side effects Short (4) Photoreactivity 15 Photoreactivity 1

H.02.02 Demethylchlortetracycline Phenethicillin

Overall change/physician Improved 5 NS

No change 10

Worse 0

Not assessed 3

Improved 5

No change 10

Worse 1

Not assessed 4

312

Parallel 

Mild/mod/sev

N=66

È Short (4)

H.02.03 Demethylchlortetracycline Tetracycline hydrochloride

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 H DISCRETE: Page 2 of 14

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 change Worse 8 NS

No change after good response 3

No change 5

Slight 11

Worse 10

No change after good response 3

No change 6

Slight 15

Good 4

Excellent 3

71

Cross-over 

N=150

Short (4)

Good 4

Excellent 11

Side effects Short (4) Photoreactivity 15 Photoreactivity 3

H.02.03 Demethylchortetracycline Tetracycline

Overall change/physician Poor 0 0.01

Fair 1

Good 21

Excellent 12

Poor 0

Fair 3

Good 28

Excellent 19

70

Parallel 

N=100

È Long (13

Side effects Diarrhea 0 0.05

Nausea 0

Pruritus ani 0

Diarrhea 4

Nausea 1

Pruritus ani 1

Long (13

Relapse Long (15 Relapse 0 Relapse 8

H.03.01 Doxycycline Placebo

Comedones (discretized %) Poor 47

Better than poor 15

Poor 47

Better than poor 15

273

Cross-over 

Mild

N=62

Í Short (4)

Cysts Good/excellent 16

Fair/poor/worse 46

Good/excellent 11

Fair/poor/worse 51

Short (4)

Inflammatory (discretized %) Excellent 8

Good 13

Fair 7

Poor 20

Excellent 4

Good 11

Fair 5

Poor 21

Worse 21

Short (4)

Worse 14

Papules change Good/excellent 26

Fair/poor/worse 36

Good/excellent 12

Fair/poor/worse 50

Short (4)

Pustules Good/excellent 25

Fair/poor/worse 37

Good/excellent 15

Fair/poor/worse 47

Short (4)

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 H DISCRETE: Page 3 of 14

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

Side effects Diarrhea 0

Nausea 0

Photoxicity 0

Diarrhea 0

Nausea 0

Photoxicity 0

273

Cross-over 

Mild

N=62

Í Short (4)

H.03.02 Doxycycline Fusidic acid cream

Overall change/investigator Cured 14

Improved 19

No effect 14

Cured 18

Improved 29

No effect 9

1

Parallel 

Mild/mod

N=110

È Mid (10)

Overall change/patient Cured 14 NS

Improved 19

No effect 14

Cured 16

Improved 30

No effect 10

Mid (10)

Side effects Unpleasant smell 0

Smarting of eyes 0

Discontinued due to nausea 1

None 46

Unpleasant smell 2

Smarting of eyes 2

Discontinued due to nausea 0

None 52

Mid (10)

H.03.04 Doxycycline Minocycline

Side effects GI pain/nausea 2

Constipation 1

Tired 1

None 4

GI pain/nausea 0

Constipation 0

Tired 0

None 8

311

Parallel 

Mild/mod

N=18

Mid (12)

H.03.04 Doxycycline + placebo Minocycline + placebo

Withdrawal due to side effects Dyspepsia 1

Headache 1

Nausea 0

Vertigo 0

Dyspepsia 1

Headache 0

Nausea 1

Vertigo 1

257

Parallel 

Mod/sev

N=79

Mid (12)

H.04.03 Erythromycin Tetracycline

Severity change Very good 10

Good 3

Moderate 4

Poor 3

Very good 8

Good 10

Moderate 1

Poor 1

6

Parallel 

N=40

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 H DISCRETE: Page 4 of 14

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

Side effects Diarrhea 0

Nausea 1

Pruritus ani 0

Vomiting 1

Diarrhea 1

Nausea 1

Pruritus ani 1

Vomiting 0

6

Parallel 

N=40

È

H.04.03 Erythromycin + placebo Tetracycline + placebo

Side effects Side effects leading to withdrawal 7

GI distress 4

Vaginal candidiasis 0

Pseudotumor cerebri 0

Side effects leading to withdrawal 2

GI distress 4

Vaginal candidiasis 1

Pseudotumor cerebri 1

Rash 0

125

Parallel 

Mild/mod

N=178

È

Rash 1

Overall change/patient Improved or markedly improved 77 NS

Worse or unchanged 23

Improved or markedly improved 89

Worse or unchanged 11

Mid (12)

H.04.03 Erythromycin acistrate Tetracycline

Side effects Any event 11

None 18

Any effect 9

None 20

36

Parallel 

Mod/sev

N=60

È Mid (12)

Side effects Any effect 3

None 18

Any effect 3

None 18

Long (24

H.04.05 Roxithromycin (150) Roxithromycin (300)

Severity change (akamatsu) Worsening 2

No change 1

Slight improvement 1

Moderate improvement 10

Worsening 0

No change 2

Slight improvement 2

Moderate improvement 7

Good improvement 4

4

Parallel 

N=30

È Mid (8)

Good improvement 1

H.04.06 Oleandomycin Triacetyl-oleandomycin

Overall change/physician Excellent 11

Good 23

Negative 19

Excellent 28

Good 44

Negative 17

247

Parallel 

N=142

Short (6)

H.05.01 Minocycline Placebo

Side effects Vertigo (withdraw) 1

Urticaria (withdraw) 1

Vertigo (withdraw) 0

Urticaria (withdraw) 0

161

Cross-over 

N=43

È Short (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 H DISCRETE: Page 5 of 14

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

H.05.02 Minocycline Clindamycin

Overall change/patient Much improved/ improved 37

Not changed/ worse/ much worse 1

Much improved/improved 40

Not changed/ worse/ much worse 2

268

Parallel 

Mod/sev

N=80

È Mid (12)

Side effects Facial allergy (withdraw) 0

Urticaria (withdraw) 1

Impetiginisation 0

Dryness 0

Facial allergy (withdraw) 1

Urticaria (withdraw) 0

Impetiginisation 1

Dryness 1

Diarrhea/ ahd 0

Mid (12)

Diarrhea/ ahd 1

H.05.02 Minocycline + placebo Clindamycin phosphate + placebo

307 Facial stinging Present 1 Present 1

Parallel 

Mod/sev

N=64

È Mid (12)

H.05.04 Minocycline Tetracycline

Side effects Vaginal candidiasis (withdraw) 1

Persistent headache (withdraw) 1

Dizzy/loss of vision (withdraw) 0

Vaginal canididiasis (withdraw) 1

Persistent headache (withdraw) 0

Dizzy/loss of vision (withdraw) 1

72

Parallel 

Mod/sev

N=100

È Long (19

GI symtoms Mild nausea 1

Moderate nausea 1

Moderate pain 0

None 28

Mild nausea 2

Moderate nausea 0

Moderate pain 1

None 29

298

Parallel 

Mod/sev

N=62

Mid (12)

Vaginal infection Mild 0 NS

Moderate 0

None 30

Mild 2

Moderate 2

None 28

Mid (12)

H.06.01 Oxytetracycline Placebo

250 Side effects Present 0 Present 0

Cross-over 

Mod/sev

N=76

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 H DISCRETE: Page 6 of 14

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 change [phase i] Excellent 31

Good 20

Fair 3

Poor 1

Excellent 1

Good 5

Fair 10

Poor 5

Unchanged 0

250

Cross-over 

Mod/sev

N=76

Mid (10)

Unchanged 0

Severity change [phase ii] Excellent 13

Good 7

Fair 1

Poor 0

Excellent 2

Good 8

Fair 25

Poor 13

Unchanged 4

Mid (10)

Unchanged 0

H.06.02 Oxytetracycline (oral) + vehicle Benzoyl peroxide + placebo (oral)

Side effects Severe facial reaction 0

GI symptoms 2

Vaginal candidiasis 0

Severe facial reaction 1

GI symptoms 2

Vaginal candidiasis 1

255

Parallel Mod

N=69

Mid (12)

Oxytetracycline + vehicle Benzoyl peroxide + metronidazole 

+ placebo

H.06.03

Overall change/patient Much worse 0 NS

Worse 1

Unchanged 3

Somewhat improved 4

Much worse 0

Worse 0

Unchanged 1

Somewhat improved 2

Improved 8

Much improved 12

123

Parallel 

Mod/sev

N=52

Short (6)

Improved 6

Much improved 9

Overall change/physician 0-25% 2 NS

26-50% 4

51-75% 6

76-100% 11

0-25% 1

26-50% 2

51-75% 8

76-100% 12

Short (6)

Severity change/photo 0-25% 3 NS

26-50% 4

51-75% 4

76-100% 12

0-25% 1

26-50% 3

51-75% 10

76-100% 9

Short (6)

Oxytetracycline (oral) + vehicle Tetracycline (topical) + placebo 

(oral)

H.06.05

Side effects Severe facial reaction 0

GI symptoms 2

Vaginal candidiasis 0

Severe facial reaction 0

GI symptoms 2

Vaginal candidiasis 0

255

Parallel Mod

N=69

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 H DISCRETE: Page 7 of 14

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

H.06.06 Oxytetracycline Trimethoprim + sulfamethoxazole

Overall change/matched (vas) Co-tri better 3 NS

Oxytet better 2

Both the same 2

Co-tri better 3

Oxytet better 2

Both the same 2

152

Parallel 

Mild/mod/sev

N=16

È Short (4)

Inter-treatment severity comparison Papules 2

Pustules 2

Papules 6

Pustules 6

Mid (12)

Overall change/matched (vas) Co-trimax better 2 NS

Oxytet better 2

Both the same 4

Co-trimax better 2

Oxytet better 2

Both the same 4

Mid (12)

Severity change/photo Considerable 4

Partial 2

None 2

Considerable 5

Partial 3

None 0

Mid (12)

Side effects Flatulence/ abdominal pain 1

None 7

Flatulence/ abdominal pain 0

None 8

Mid (12)

H.06.07 Oxytetracycline Trimethoprim

Overall change/patient Excellent 1 NS

Good 1

Fair 18

No change 3

Excellent 0

Good 7

Fair 11

No change 3

Worse 0

128

Parallel Mild

N=45

È Short (4)

Worse 1

Side effects Bad enough to withdraw 0

Headache/abd pain 3

None 

Bad enough to withdraw 2

Headache/abd pain 0

None 

Short (4)

Overall change/patient Excellent 0 NS

Good 8

Fair 15

No change 1

Excellent 2

Good 10

Fair 5

No change 3

Worse 1

Mid (8)

Worse 0

H.07.01 Trimethporim-sulfamethoxazole Placebo

223 Dizziness and headaches Dizziness and headaches 1 Dizziness and headache 0

Cross-over 

N=40

È Short (4)

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 H DISCRETE: Page 8 of 14

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

Red macular rash Macular rash (withdraw) 1

No rash 39

Macular rash (withdraw) 0

No rash 33

223

Cross-over 

N=40

È Short (4)

H.07.02 Sulfadimethoxine Placebo

Inter-treatment preference/physician More effective 75

Equally effective 37

Less effective 22

More effective 22

Equally effective 37

Less effective 75

41

Cross-over 

Sev

N=134

È Mid (10)

H.08.01 Tetracycline Placebo

Clinical change (grouped) Improved 23 0.01

No change 0

Worse 1

Improved 15

No change 4

Worse 8

201

Parallel 

N=51

È Mid (12)

Clinical change/photo (grouped) Improved 18 0.01

No change 5

Worse 1

Improved 9

No change 14

Worse 4

Mid (12)

Clinical improvement/photo (grouped) Improvement 13 0.01

No change 11

Worse 0

Improved 2

No change 20

Worse 5

Mid (12)

Side effects Nausea 0

Pruritis ani 0

Contact lens discomfort 1

Nausea 0

Pruritis ani 0

Contact lens discomfort 0

Mid (12)

H.08.01 Tetracycline Topical treatment

Improvement Much improvement 36

Little improvement 18

Much improvement 2

Little improvement 12

69

Parallel 

N=68

Í Long (16

Side effects Long (16 Diarrhea & GI problems 2 Diarrhea & GI problems 0

Tetracycline (oral) + vehicle 

(topical)

H.08.01 Vehicle (topical) + placebo (oral)

Severity change > 1 unit decrease 12 NS

< 1 unit decrease 1

No change 5

> 1 unit decrease 6

< 1 unit decrease 4

No change 7

10

Parallel Mod

N=60

Mid (8)

H.08.01 Tetracycline + vehicle Vehicle (oral) + vehicle (topical)

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 H DISCRETE: Page 9 of 14

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

33 Diarrhea Present 1 Present 1

Parallel Mild

N=87

Mid (8)

Overall change/patient Marked improvement 11

Improved 10

No change 7

Worse 1

Marked improvement 0

Improved 1

No change 20

Worse 8

Mid (8)

Overall change/physcian Excellent 11

Good 6

Fair 8

Poor 4

Excellent 0

Good 0

Fair 4

Poor 25

Mid (8)

H.08.01 Tetracycline hydrochloride Vehicle

Severity change Worse 10 NS

No change after good response 3

No change 6

Slight 15

Worse 10

No change after good response 2

No change 9

Slight 11

Good 7

Excellent 3

71

Cross-over 

N=150

Short (4)

Good 4

Excellent 3

Side effects Short (4) Photoreactivity 3 Photoreactivity 1

H.08.02 Tetracycline + vehicle Clindamycin + vehicle

33 Diarrhea Present 1 Present 1

Parallel Mild

N=87

Mid (8)

Overall change/patient Marked improvement 11

Improved 10

No change 7

Worse 1

Marked improvement 19

Improved 3

No change 7

Worse 0

Mid (8)

Overall change/physcian Excellent 11

Good 6

Fair 8

Poor 4

Excellent 17

Good 6

Fair 1

Poor 5

Mid (8)

Tetracycline hydrochloride + 

placebo

H.08.02 Clindamycin + placebo

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 H DISCRETE: Page 10 of 14

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

Side effects Erythema 1

Gastrointestinal upset 1

Diarrhea 1

Erythema 0

Gastro-intestinal upset 0

Diarrhea 1

186

Parallel Mod

N=44

Í

Tetracycline hydrochloride + 

placebo (topical)

H.08.03 Erythromycin + placebo (oral)

Overall change/physician, patient Excellent 5

Good 13

Fair 6

Poor 1

Excellent 2

Good 13

Fair 8

Poor 2

Worse 0

279

Parallel 

Mod/sev

N=54

È Short (4)

Worse 0

Closed comedones severity change (vas) Mid (12) >50% reduction 6 >50% reduction 12

Open comedones severity change (vas) Mid (12) >50% reduction 14 >50% reduction 19 NS

Overall change/physician, patient Excellent 4 NS

Good 10

Fair 5

Poor 3

Excellent 17

Good 12

Fair 6

Poor 0

Worse 0

Mid (12)

Worse 0

Papules severity change (vas) Mid (12) >50% reduction 15 >50% reduction 19 NS

Pustules severity change (vas) Mid (12) >50% reduction 14 >50% reduction 20 NS

Withdrawals due to side effects Mid (12) Withdraw 2 Withdraw 0

Tetracycline (oral) + vehicle 

(topical)

Tetracycline (topical) + placebo 

(oral)

H.08.04

Severity change > 1 unit decrease 12 NS

< 1 unit decrease 1

No change 5

> 1 unit decrease 14

< 1 unit decrease 3

No change 2

10

Parallel Mod

N=60

Mid (8)

H.08.05 Tetracycline + placebo Azelaic acid + placebo

Abdominal pain Present 1

Absent 21

Present 0

Absent 23

22

Parallel 

Mod/sev

N=45

Í Long (24

H.08.05 Tetracycline hydrochloride Azelaic acid + placebo

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 H DISCRETE: Page 11 of 14

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/physician Excellent/good 127

Other 42

Excellent/good 115

Other 49

166

Parallel 

Mild/mod

N=333

È Mid (12)

Overall change/physician Excellent/good 145 NS

Other 24

Excellent/good 134

Other 30

Long (20

Tetracycline hydrochloride + 

placebo

H.08.05 Azelaic acid + placebo

Overall change/patient Good or excellent 82

Other 53

Good or excellent 78

Other 48

167

Parallel 

Mod/sev

N=261

È Long (24

H.08.08 Tetracycline Tetracycline + proteolytic enzymes

Severity change Much improved 13 NS

Not improved 12

Much improved 18

Not improved 8

317

Parallel Sev

N=51

È Mid (12)

H.08.08 Tetracycline (sustained release) Tetracycline hydrochloride

Overall change/physician Improved 11 NS

No change 10

Worse 0

Improved 11

No change 5

Worse 2

212

Parallel 

N=55

È Short (4)

Overall change/physician Improved 15 NS

No change 6

Worse 0

Improved 13

No change 5

Worse 0

Mid (12)

Side effects Diarrhea 1

Sore mouth 1

Diarrhea 0

Sore mouth 0

Mid (12)

H.08.085 Tetracycline + sodium novobiocin Placebo

Overall change/physician Improved 18 0.04

Not improved 5

Improved 9

Not improved 10

299

Parallel 

Mod/sev

N=42

È Short (4)

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 H DISCRETE: Page 12 of 14

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

Side effects Diarrhea 0

Dryness of oral mucous 0

Headache 1

Low seeing theshold 1

Diarrhea 1

Dryness of oral mucous 1

Headache 0

Low seeing theshold 0

Macular drug reaction 0

299

Parallel 

Mod/sev

N=42

È Short (4)

Macular drug reaction 1

H.08.14 Povidone-iodine + tetracycline Tetracycline + vehicle

236 Itching Itching 0 Itching 0

Parallel 

Mod/sev

N=30

Í Long (14

Overall change/physician Improved or much improved 10

No change or worse 3

Improved or much improved 12

No change or worse 2

Long (14

H.09.01 Dapsone Placebo

Severity change Greatly improved 9 0.05

Improved 3

Not improved 9

Greatly improved 3

Improved 2

Not improved 18

293

Parallel 

Mild/mod/sev

N=46

È

Severity change [female] Greatly improved 5 0.01

Improved 2

Not improved 2

Greatly improved 1

Improved 1

Not improved 14

Severity change [male] Greatly improved 4

Improved 1

Not improved 7

Greatly improved 2

Improved 1

Not improved 4

Side effects Present 6 Present 3

Side effects [Female] Present 4 Present 0 0.1

Side effects [Male] Present 2 Present 3

H.09.02 Phenethicillin Placebo

Overall change/physician Improved 5 NS

No change 10

Worse 1

Not assessed 4

Improved 3

No change 13

Worse 0

Not assessed 6

312

Parallel 

Mild/mod/sev

N=66

È Short (4)

H.09.04 Sodium fusidate (oral) Sodium fusidate (topical)

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 H DISCRETE: Page 13 of 14

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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

Overall change/physician No effect 14

Improved 22

Completely resolved 1

No effect 13

Improved 18

Completely resolved 0

344

Parallel 

Mild/mod/sev

N=70

È Short (2)

Severity change/photo Improved 11

Worse 6

No difference 19

Improved 11

Worse 2

No difference 15

Short (2)

Side effects Short (2) Gastric irritation 7 Gastric irritation 0

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 H DISCRETE: Page 14 of 14

ÈÍ