TABLE 3-4 Benzodiazepines

Study

Populationa

Arm (N)

Handling of Dropouts and % Completed Tx by Arm

PTSD Outcome Measure

Braun et al., 1990

Sex NR, combat (40%), accidental injury

Total (16)

Not clear

PTSD Scale

Alprazolam (7)

57%

PL (9)

67%

Crossover Study

 

 

 

 

aIn the population column, male alone or female alone denotes that at least 80% of the study population was male or female. If only one trauma type is listed, at least 80% of the study population reported that type of trauma.

bPTSD outcome measure change data were obtained either directly from the study, when

these trials ranged from 26 to 73 years. One study reported duration of of illness and time since exposure was not reported in the other studies. Race/ethnicity was only reported in one study, and participants were predominantly white (88 percent) (Kosten et al., 1991).

The treatment period for these studies ranged from 5 weeks to 14 weeks. None of the studies conducted follow-up after completion of treatment. Two studies measured adverse events associated with the treatment condition (Baker et al., 1995; Katz et al., 1994). The main PTSD outcome measures used in the MAOI studies were CAPS-Total, Impact of Events Scale (IES), and the PTSD Scale.

One of the phenelzine trials failed to show a significant benefit, but it was extremely small, and dropouts were high with weak treatment of missing values (Shestatzky et al., 1988). The second study of phenelzine was larger and showed significant benefit, but dropouts approached 50 percent with weak treatment of missing values (Kosten et al., 1991). The two studies of brofaromine (Baker et al., 1995; Katz et al., 1994) had a primary PTSD outcome, and both failed to show a beneficial effect. However, because study designs were weak in the treatment of missing values to address the substantial dropout rates, the committee could not conclude that brofaromine was ineffective.


Synthesis: The committee found the overall body evidence regarding MAOIs to be scant and low quality. The committee is uncertain about the presence of an effect, and believes that future well-designed studies will have an important impact on confidence in the effect and the size of the effect.



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