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. 2018 Oct 16;2018(10):CD009068. doi: 10.1002/14651858.CD009068.pub3

Cittadini 2003.

Methods Randomised, double‐blind, parallel‐group (pilot study)
Participants 6 participants with DMD (8 to 19 years) and 10 participants with BMD (24 to 55 years) with documented cardiac involvement
Mean age: DMD 13 years (SD 2); BMD 39 years (SD 3)
Background therapy unchanged in all participants
DMD or BMD diagnosis biopsy‐confirmed; no other inclusion/exclusion criteria specified
Interventions Weekly growth hormone 0.23 mg/kg/week (DMD) and 0.07 mg/kg/week (BMD)
Placebo
Self‐injected, subcutaneously at bedtime for 3 months
Outcomes Hormonal measures, ECG (cardiomyopathic index), ECG cardiomyopathic index (QT‐PQ ratio), echocardiography (M‐mode, 2D and echo‐Doppler), measures of left ventricular size and function, timed function tests ((timed Gowers' manoeuvre, time to climb 4 standard stairs, timed 10 metre walk, and 'dynamic index'). Pulmonary function measures comprised forced vital capacity (FVC), maximal voluntary ventilation, and maximal expiratory pressure
Funding sources Grant from Telethon
Declarations of interest None given
Notes Dates of enrollment and follow‐up not reported
Location: Italy
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Stated to be randomised but method of randomisation not described
Allocation concealment (selection bias) Unclear risk Not described
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Placebo‐controlled
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Investigators performing the echocardiographs were blind to treatment allocations
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk The manuscript did not mention if there were any dropouts or withdrawals
Selective reporting (reporting bias) High risk The report provided no numerical data for left ventricular mass index, end‐systolic stress and ejection fraction outcomes, which were presented graphically
Other bias High risk The age range of participants was wide and ranged from 8‐19 years for DMD and 24‐55 years for BMD and they were all taking multiple other treatments for cardiomyopathy
BMD: 'background' therapy including fosinopril 20 mg/day to 30 mg/day (ACE inhibitor), warfarin, magnesium supplements, pidolatum, antioxidants (vitamins E, C, glutathione, ubiquinone), furosemide, deflazacort. One participant in each group was also receiving digoxin and amiodarone.
All DMD participants were receiving deflazacort, fosinopril and antioxidants (vitamin E, glutathione and ubiquinone)