Table 1.

Characteristics of the randomised controlled trials studies that evaluated the use of growth hormone in patients with Prader-Willi syndrome

Author/year	Age	N rhGH/control	Dose of rhGH	Period (years)	Country	Outcome
Bakker NE et al 45	6 months to 14 years	12/16	1 mg/m2/day	2	Netherlands	Z-stature and body composition (%fat mass and LBM-SDS).
Bakker NE et al 18	6–14 years	11/8	1 mg/m2/day	2	Netherlands	Quality of life (Dutch generic questionnaire-DUX25 and PWS-Dutch specific questionnaire-DUXPW questionnaires)
de Lind van Wijngaarden RFA et al 41	4, 9±3.0 years (<3 years and >3 years)	29/21	1 mg/m2/day	1;2	Netherlands	Z-stature, BMI-SDS, body composition (%fat)
Böhm B et al 33	3–11 years	19	0033 mg/kg/day	2	Sweden	Behaviour (specific test for the study) and cognition (Raven's Standard Progressive Matrices test, Arthur's adaptation of Leiter's Performance Scale; verbal comprehension test (SPIQ test), Terman’s Scale of Intelligence, Bender Gestalt test, Harris Draw-a-Man)
Lo ST et al 34	3, 5–14 years	24/18	1 mg/m2/day	1;2	Netherlands	Behaviour (Developmental Behaviour Checklist of Children with intellectual disability and Children Social Behaviour Questionnaire)
Lo ST et al 36	3, 5–14 years	41/34	1 mg/m2/day	1;2	Netherlands	VABS-II, cognitive function: Bayley Scales of Infants II- NL (BSID II), Weschsler Preschool and Primary Scale of Inteligence-Revised Dutch version
Reus L et al 37	12.9±7.1 months	10/12	1 mg/m2/day	2	Netherlands	Muscular thickness with ultrasound, muscle strength (Infant Muscle Strength metre) and motor performance (Gross Motor Function Measure)
Reus L et al 35	12.9±7.1 months	10/12	1 mg/m2/day	2	Netherlands	Cognition (BSID-II) and motor function (Gross Motor Function)
Siemensma EPC et al 14	3, 5–14 (mean 7,4 years)	29/21	1 mg/m2/day	2	Netherlands	WISC-R (vocabulary, similarities, block design and picture arrangement) and Wechsler Preschool and Primary Scale of Intelligence-Revised Dutch version
Festen DAM et al 7	3–14 years	25/25	1 mg/m2/day	2	Netherlands	Z-stature, body composition (%fat, LBM-SDS), head circumference (Z)
Festen DAM et al 16	Grupo I: 2–3 years C: 1–5 years	20/22	1 mg/m2/day	1	Netherlands	Motor and mental development (BSID-II).
Myers SE et al 44	4–37 months	12/11	1 mg/m2/day	1	USA	Z-stature, head circumference, body composition (%fat, LBM-kg), language/cognition (age of first spoken word and Capute scales of infant’s language), motor development (age of walking and Toddler and Infant Motor Evaluation)
Carrel AL et al 38	4–37 months	15/14	1 mg/m2/day	1	USA	Growth velocity, body composition and motor development (Toddler Infant Motor Evaluation)
Whitman BY et al 17	4–16 years	35/19	1 mg/m2/day	2	USA	Behaviour (Offord Survey Diagnostic Instrument and Family Inventory of Life Events)
Carrel AL et al 5	4–16 years	35/19	1 mg/m2/day	1	USA	Body composition (%fat, LBM-kg), growth velocity, BMI-kg, muscular strength and agility (agility run, broad jump, sit-ups in 20 secs and upper extremity strength)
Lindgren AC et al 6	3–12 years	15/12	0.1 IU/kg/day	1	Sweden Denmark	Z-stature, BMI-SDS, body composition (%fat, LBM-kg), growth velocity.

BMI, body mass index; LBM, lean body mass; rhGH, recombinant human GH; SDS, SD scores.