Aub kq1 Evidence Table (Reference id #1767)



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AUB KQ1 Evidence Table (Reference ID #1767)

Study Description

Intervention(s)/ Comparator(s)

Patient Population

Baseline Measure(s)

Outcome Measure(s)

Overall Quality

Risk of Bias

Author:

Freeman et al., 2011


Country:

United States


Enrollment period:

December 2006 to May 2008


Intervention setting:

63 participating study sites


Funding:

Ferring Pharmaceuticals, Inc


Author industry relationship disclosures:

5/6
Study Design:

RCT
Blinding:

Patients, investigators



Intervention:

3.9 g/day tranexamic acid (1.3 g 3 times daily) for up to 5 consecutive days


Comparator:

1.95 g/day tranexamic acid (0.65 g 3 times a day) for up to 5 consecutive days


Placebo
Groups:

G1: Tranexamic acid (3.9 g)

G2: Tranexamic acid (1.95 g)

G3: Placebo
Followup:

3 cycles




Inclusion criteria:

Aged 18-49

Average MBL during two pretreatment cycles ≥80

No abnormal findings at cervical cytology screening


Exclusion criteria:

History or presence of clinically significant disease

History of bilateral oophorectomy or hysterectomy

Pregnant, breastfeeding or planning pregnancy during the study

Women with fibroids requiring surgical management
N at enrollment:

G1: 118

G2: 117

G3: 69
N at followup:

G1: 112

G2: 115

G3: 67
Age, mean years (range):

G1: 39.2 (20-50)

G2: 40.2 (20-49)

G3: 38.9 (19-48)
BMI:

NR
Parity:

NR
Race/ethnicity, n (%):

White:


G1: 77 (67.0)

G2: 76 (66.1)

G3: 43 (64.2)

Black:


G1: 34 (29.6)

G2: 31 (27.0)

G3: 22 (32.8)

Asian:


G1: 0

G2: 3 (2.6)

G3: 0

Native American:



G1: 1 (0.9)

G2: 0

G3: 0

Pacific Islander:



G1: 0

G2: 1 (0.9)

G3: 0

Other:


G1: 3 (2.6)

G2: 4 (3.5)

G3: 2 (3.0)


Bleeding:

MBL measured by alkaline hematin method, mean mL/cycle:



G1: 169.0

G2: 178.0

G3: 153.6
Duration, mean years ± SD:

G1: 11.9 ± 8.9

G2: 12.1 ± 9.4

G3: 10.0 ± 8.4


Bleeding:

MBL mean reduction from baseline, mL/cycle:



G1: 65.3

G2: 46.5

G3: 3.0

G1 vs. BL: p<0.0001

G2 vs. BL: p<0.0001

G3 vs. BL: p=NS

G1 vs. G3: p<0.0001

G2 vs. G3: p<0.0001
MBL % reduction from baseline:

G1: 38.6

G2: 26.1

G3: 1.9
Quality of life:

NR
Pain:

NR
Sexual function:

NR
Patient satisfaction:

NR
Fertility:

NR
Time to conception:

NR
Additional interventions:

NR
Adverse Events, n (%):

At least 1 adverse event:

G1: 97 (84.4)

G2: 104 (90.4)

G3: 56 (83.6)

Viral upper respiratory infection:



G1: 8 (7.0)

G2: 12 (10.4)

G3: 3 (4.5)

Fatigue:


G1: 4 (3.5)

G2: 13 (11.3)

G3: 3 (4.5)

Musculoskeletal pain:



G1: 6 (5.2)

G2: 10 (8.7)

G3: 2 (3.0)

Arthralgia:



G1: 5 (4.4)

G2: 7 (6.1)

G3: 1 (1.5)

Myalgia:


G1: 6 (5.2)

G2: 5 (4.4)

G3: 0

Nasal congestion:



G1: 3 (2.6)

G2: 8 (7.0)

G3: 0

Sinusitis:



G1: 3 (2.6)

G2: 7 (6.1)

G3: 1 (1.5)

Multiple allergies:



G1: 4 (3.5)

G2: 6 (5.2)

G3: 0

Throat irritation:



G1: 0

G2: 7 (6.1)

G3: 2 (3.0)

Anemia:


G1: 1 (0.9)

G2: 6 (5.2)

G3: 1 (1.5)

Nausea:


G1: 1 (0.9)

G2: 1 (0.9)

G3: 1 (1.5)

Diarrhea/upper abdominal pain:



G1: 0

G2: 1 (0.9)

G3: 0

Lenticular opacity:



G1: 1 (0.9)

G2: 0

G3: 0

Blurred vision:



G1: 1 (0.9)

G2: 0

G3: 1 (1.5)

Withdrawal from study for AEs not treatment relateda:



G1: 1 (0.9)

G2: 3 (2.6)

G3: 1 (1.5)

Serious AE’s not considered related to treatmentb:



G1: 1 (0.9)

G2: 1 (0.9)

G3: 0

Overall quality:

Fair
Risk of bias:

Randomization:

Unclear
Allocation concealment:

Unclear
Selective reporting:

Low
Blinding patients/personnel:

Low
Blinding outcome assessment:

Unclear
Incomplete outcome reporting:

Low
Other:

Low




Table Notes:a mild myalgia (1 subject in G1); moderate anemia, moderate menorrhagia, severe anemia (1 subject each in G2) moderate headache (1 subject in G3); b1 subject in G1 experienced severe dyspepsia, gastritis, and chest pain and 1 subject in G2 experienced severe ovarian torsion on day 56 of study


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