Entry

Judgement

Description

Adequate sequence generation?

Yes.

Quote: “patients were randomly allocated.”
Comment: Probably done, since earlier reports from the same investigators clearly describe use of random sequences (Cartwright 1980). 

Allocation concealment?

No.

Quote: “...using a table of random numbers.”
Comment: Probably not done.

Blinding? (Patient-reported outcomes)

Yes.

Quote: “double blind, double dummy”; “High and low dose tablets or capsules were indistinguishable in all aspects of their outward appearance. For each drug an identically matched placebo was available (the success of blinding was evaluated by examining the drugs before distribution).”
Comment: Probably done.

Blinding? (Mortality)

Yes.

Obtained from medical records; review authors do not believe this will introduce bias.

Incomplete outcome data addressed? (Short-term outcomes (2-6 wks))

No.

4 weeks: 17/110 missing from intervention group (9 due to 'lack of efficacy'); 7/113 missing from control group (2 due to 'lack of efficacy').

Incomplete outcome data addressed? (Longer-term outcomes (>6 wks))

No.

12 weeks: 31/110 missing from intervention group; 18/113 missing from control group. Reasons differ across groups.

Free of selective reporting?

No.

Three rating scales for cognition listed in Methods, but only one reported.

Free of other bias?

No

Trial stopped early due to apparent benefit.