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Table 1 Summary of non-randomized interventional human trials for cleft recurrence*

From: Oral cleft prevention program (OCPP)

Study

Intervention

Supplemented group

Control group

Reduction

# births

RR (%)

# births

RR (%)

Conway (1958)

MV and 0.5mg FA

59

0.0

78

6.4

100% (p=0.1)

Peer et al. (1964)

MV and 5mg FA and 10mg B6

176

2.2

418

4.7

53% (p=0.1)

Briggs 1976 [extension of Peer et al. (1964)]

MV and 5mg FA and 10mg B6

228

3.1

417

4.8

35% (p=0.2)

Tolarova (1982)

MV and 10mg FA

84

1.2

206

7.3

84% (p=0.02)

Tolarova and Harris (1995)

MV and 10mg FA

211

1.4

1824

4.2

66% (p=0.03)

Total**

 

498

2.01

2319

4.38

54.1%

  1. MV=multivitamin; FA=Folic acid; RR=Recurrence Rate.
  2. * Conway [8], Peer et al.[114] and Briggs [115] included mothers to children with cleft lip and/or cleft palate. Tolarova [116] included mothers to children with cleft lip with/without cleft palate (CL/P). Tolarova and Harris [117] included women with CL/P or mothers to a child with CL/P.
  3. ** The total recurrence for treated and control groups is based on total number of affected births divided by total group size (or proportion of each study’s recurrence relative to its sample size). Peer et al. [114] and Tolarova [116] are excluded as these data were included in other studies.