| Methods |
Randomized, double‐blind, placebo‐controlled cross‐over trial. Wash‐out period = 15 days. Conducted in Venezuela |
| Participants |
Mild to moderate BP (cut‐offs not defined). Patients either never received antihypertensive treatment before or in the 3 months prior to entering the trial. Mean age 48 years (range: 20 to 70). Males 33%. Baseline sitting (standing) BP was 147.2/103.7 (149.5/102.1) mmHg in the treatment group and 140.0/100.6 (142.9/100.8) mmHg in the control group |
| Interventions |
Indapamide 2.5 mg/d or placebo. N = 24 patients randomized. Each treatment period = 8 weeks (2 periods in all with a 4‐week wash‐out period in between) |
| Outcomes |
Trough mean sitting and standing SBP and DBP; biochemical data including serum potassium, sodium, uric acid and lipids; heart rate; body weight |
| Notes |
A sample size calculation was not provided. Total withdrawals and WDAEs reported for periods I and II combined. Mortalities and SAEs were not reported and data for total AEs not useable. BP variability was given as standard error of the mean (SEM), not standard deviation |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
"The patients were randomised to group A (indapamide followed by placebo) or group B (placebo followed by indapamide), following a 15‐day washout period." (line 12 under "Patients and Methods" p.164). No further information was provided |
| Allocation concealment (selection bias) |
Low risk |
"The codes of the active drug and the placebo were kept at the laboratory supplying the tablets." (line 15 under "Patients and Methods" p.164) |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
"The study was conducted according to a double‐blind, crossover, placebo‐controlled methodology..." (line 11 under "Patients and Methods" p.164). No further information was given |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
It is not known if the study was based on an intention‐to‐treat (ITT) or per‐protocol technique
Attrition: a total of 3/24 patients (12.5%) withdrew from the study early; 2 patients while receiving indapamide due to severe faintness and 1 patient while receiving placebo due to severe hypertension
WDAEs: 3/24 (12.5%) |
| Selective reporting (reporting bias) |
Unclear risk |
Variability was not given for heart rate, biochemical data or body weight. BP, biochemical data and vital signs were presented separately (not combined) for each group of patients (group A and group B) as well as for the indapamide and placebo treatment phase. Therefore, both indapamide and placebo represent 2 data sets. Mortalities and SAEs were not reported. Total AEs were presented for group A and B separately, however there is no information indicating which treatment (IND or PLB) the patient was receiving at the time the adverse event was reported |
