Ruvolo 1994.
| Methods | DESIGN: parallel, randomised, no information on blinding DURATION: 6 months NUMBER OF STUDY CENTRES: 1 COUNTRY OF PUBLICATION: Italy SPONSOR: ‐ | |
| Participants | WHO PARTICIPATED: overweight hypertensive patients on 10 mg amlodipine daily
SETTING: outpatient clinic MAIN INCLUSION CRITERIA: BMI > 30 kg/m2, DBP > 100 mm Hg MAIN EXCLUSION CRITERIA: heart failure, coronary artery disease, diabetes mellitus NUMBER: 16 vs 16 were randomised, 16 vs 16 were analysed (dietary intervention vs no dietary intervention) GENERAL BASELINE CHARACTERISTICS (dietary intervention vs no dietary intervention): MEAN AGE [YEARS]: 53 GENDER [% MALE]: 53 NATIONALITY: Italian ETHNICITY: ‐ WEIGHT [kg]: 98 vs 97 BODY MASS INDEX [kg/m2]: 34 vs 34 SYSTOLIC BLOOD PRESSURE [mm Hg]: 178 vs 176 DIASTOLIC BLOOD PRESSURE [mm Hg]: 107 vs 106 COMORBID CONDITIONS: ‐ ANTIHYPERTENSIVE TREATMENT [%]: 100 with amlodipine 10 mg DURATION OF HYPERTENSION: ‐ SUBGROUP ANALYSES: ‐ |
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| Interventions | LENGTH OF FOLLOW‐UP: 6 months DIETARY INTERVENTION: weight‐reducing diet, no restriction on salt uptake NO DIETARY INTERVENTION: no counselling ADDITIONAL TREATMENT: amlodipine 10 mg |
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| Outcomes |
PRIMARY OUTCOMES:
1. MORTALITY: ‐
2. CARDIOVASCULAR MORBIDITY: ‐
3. ADVERSE EVENTS: reported SECONDARY OUTCOMES: 1. CHANGES IN SYSTOLIC BLOOD PRESSURE [mm Hg]: Definition:SBP change from baseline to endpoint visit 2. CHANGES IN DIASTOLIC BLOOD PRESSURE [mm Hg]: Definition: DBP change from baseline to endpoint visit 3. BODY WEIGHT [kg]: Definition: body weight change from baseline to endpoint visit ADDITIONAL OUTCOMES MEASURED IN THE STUDY: 1. Change in left ventricular dimensions 2. Change in heart rate |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: No details on sequence generation are provided |
| Allocation concealment (selection bias) | Unclear risk | Comment: Method of concealment is not described |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Comments: No description of randomisation; no information on blinding for investigators |
| Incomplete outcome data (attrition bias) All outcomes | High risk | WITHDRAWALS (dietary intervention vs no dietary intervention): 2 vs 0 REASONS/DESCRIPTIONS: ‐ |
| Selective reporting (reporting bias) | Unclear risk | Comment: No primary and secondary outcomes were defined |
| Other bias | High risk | Comments: 1. Lack of information on randomisation and concealment of allocation and blinding increases risk of bias 2. No information provided on the reason for and description of the dropout in the intervention group |