Carmenini 1994

Methods	79 subjects were randomized to receive phosphocreatinine or placebo for 6 months; check were performed on subjective and objective symptomatology and echocardiographic parameters were performed at three and at six months after the study started. There was no follow‐up period after withdrawal of treatment with phosphocreatinine.
Participants	79 patients affected by dilatative myocardiopathy, functional class II‐III NYHA
Interventions	Six months treatment with oral phosphocreatinine 1 gram daily (n=39) vs placebo (n=40) added to standard therapy.
Outcomes	Outcomes on death, total myocardial infarction, hospitalization for heart failure and changes in blood pressure were not reported. Ejection fraction was significantly improved from 35.9% at baseline and 40.5% after six months in the intervention group. This improvement was significantly different from the compared to the placebo group (p < 0.001). The other outcomes reported were subjective and objective symptomatology and echocardiographic parameters of heart failure. Subjective and objective symptomatology and other echocardiographic parameters of heart failure showed a significant improvement after 3 and 6 months of treatment.
Notes	Cuore 1994. 11(2) (pp 187‐193).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "divisi at random in due gruppi." Another quote:"per quanto riguarda il tipo di trattamento effettuato per ciascun paziente sulla base della lista di randomizzazione (a randomization list was used)". Patients were randomly divided in groups with a randomization list.
Allocation concealment (selection bias)	High risk	They used a randomization list, so probably not done.
Blinding (performance bias and detection bias) All outcomes	Low risk	Quote: "in doppio cieco (double‐blind)". Placebo: secondo modalita di trattamento analogo
Incomplete outcome data (attrition bias) All outcomes	Low risk	Drop‐out from creatine phosphate group: 5 cases, placebo group: 2 cases. Reasons are mentioned. Four cases due to personal reasons, 2 no show cases and 1 due to insufficient cardiac function.
Selective reporting (reporting bias)	Low risk	All outcomes reported.
Other bias	High risk	(Side) effect attribution difficult because simultaneous usage of standard therapy.