Scharf 1999.
| Methods | Double blind randomised control trial, 25 weeks | |
| Participants | 27 participants (12 intervention, 15 placebo) who had a diagnosis of AD according to DSM‐4 criteria that was of mild to moderate severity, defined by a MMSE score of 11‐25, aged >/= 50 years, were out‐patient in Australia | |
| Interventions | Intervention: Unknown dose of diclofenac and misoprostol oral Control: Placebo |
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| Outcomes | Cognition (ADAScog 0‐70 lower score = improvement) at 12, 25 weeks (MMSE 0‐30 higher score = improvement) at 12, 25 weeks Clinical global impression of change at 12, 25 weeks (GDS lower score = improvement) at 12, 25 weeks (CGIC lower score = improvement) at 12, 25 weeks Behavioral disturbance (ADAS‐noncog lower score = improvement) at 12, 25 weeks (ADAS‐total lower score = improvement) at 12, 25 weeks Activity of daily living (IADL lower score = improvement) at 12, 25 weeks Quality of life (PSMS lower score = improvement) at 12, 25 weeks Caregiver burden (CGIC lower score = improvement) at 12, 25 weeks |
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| Notes | source of funding from postgraduate medical research scholarship | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk |
Quote: Randomization was performed by the manufacturer of the medication before delivery to the study centre. For patients 1 to 20, 50% received diclofenac/misoprostol (D/M) and 50% placebo; for patients 21‐41, two thirds received D/M and one third placebo. Comment: Sequence generated by some rule based on hospital or clinic record number |
| Allocation concealment (selection bias) | Low risk |
Quote: The identity code was concealed in sequentially numbered opaque envelopes. Quote 2: The medication and envelopes were stored in a pharmacy separate from the study site. The medication was supervised and dispensed by independent pharmacist trained in the conduct of randomised double‐blind clinical trials. Quote 3: Medication codes were broken after completion of the trial or if a patient was withdrawn prematurely due to an adverse event. Comment: Done |
| Blinding (performance bias and detection bias) All outcomes | Low risk |
Quote 1: Patients were randomly assigned in a double‐blind fashion to receive either D/M as a single table twice a day or identical placebo twice daily for 25 weeks. Comment: Blinding of participants ensured and unlikely that the blinding could have been broken |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Side effects are more significant in D/M group. Comment: Reasons for missing outcome data unlikely to be related to true outcome |
| Selective reporting (reporting bias) | Low risk | Report all outcome state in methodology Comment: The study protocol is not available, but all of the study’s pre‐specified outcomes have been reported in the pre‐specified way in methodology |
| Other bias | High risk |
Comment: Selection bias: baseline are different between intervention and placebo |