Houwing 2003.
Methods | Randomised clinical trial, the Netherlands | |
Participants | 103 hospitalised adults admitted for hip fracture and PO‐score > 8, at nutritional risk due to being frail elderly Male:Female = 19:84 Mean age = 81 years Exclusion criteria: Terminal care, metastatic hip fracture, insulin‐dependent diabetes, renal disease (creatinine > 176 mmol/l), hepatic disease, morbid obesity (BMI > 40), need for therapeutic diet incompatible with supplementation, and pregnancy or lactating |
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Interventions | Experimental group: 400 ml high‐protein nutritional supplement enriched with arginine, zinc and antioxidants with energy: 500 kcal, 40 g of protein (n = 51) Control group: 400 ml placebo (non‐caloric, water‐based drink only sweeteners, colourants and flavourings) Look and taste of the supplements were not exactly identical, but were given in similar, blinded packages to mask the differences. Participants received 400 ml daily between regular meals of either the study or placebo supplement starting immediately postoperatively for a period of 4 weeks or until discharge. (n = 52) Co‐intervention: regular diet (oral) |
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Outcomes | Incidence of pressure ulcers and maximum wound size | |
Study dates | Between April 1998 and December 1999 | |
Notes | We contacted the authors by Linkedin. We received an initial response but no further response. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The control group received a placebo drink. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | It was unclear how the outcome assessment was performed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were below 5% dropouts and participants with incomplete data. |
Selective reporting (reporting bias) | Unclear risk | No protocol could be obtained, and the trial did not report all‐cause mortality or serious adverse events. |
For‐profit bias | High risk | The trial was funded by a company that might have conflict of interest (Numico). |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |