Maggi 1990

Methods	A randomized trial with 90 subjects with heart failure, NYHA II en III, comparing L‐carnitine (30 patients), phosphocreatinine (30 patients) and placebo (30 patients) addition to the conventional treatment for 3 months. At baseline and after 3 months clinical parameters of heart failure, laboratory parameters, ECG parameters and echocardiographic parameters were evaluated. There was no follow‐up period after withdrawal of treatment with phosphocreatinine.
Participants	90 subjects, aged 61,9 ± 5 years, 57 men and 33 women, with established heart failure (class II and III NYHA scale) on medical treatment in form of cardiokinetic (digitalis) and/or diuretic drugs.
Interventions	Thirty subjects were given 500 mg phosphocreatinine twice a day per os, a second group of thirty subjects was given 1 gram L‐carnitine per os twice a day, and the control group was given a placebo twice a day per os during 3 months.
Outcomes	Outcomes on death, total myocardial infarction, hospitalization for heart failure, or changes in blood pressure were not reported. In the phosphocreatinine group there was a significant improvement of ejection fraction in the intervention group; increasing from 42.46% at baseline to 47.36% after three months (p < 0.01). Other outcome measures: reported symptoms, blood parameters, ECG measurements and echocardiography. With all three treatment, significant control and reduction of all cardiopathology symptoms was reached (p < 0.01). No differences in symptoms between treatments were reported except for the sense of dyspnoea in favour for phosphocreatinine compared to the L‐carnitine and placebo group. On the electrocardiogram (no time of measurement mentioned) the amount of first degree bundle branch blocks and arrhythmias was less in the phosphocreatinine (50%) and L‐carnitine (43%) group, but also in the control group (30%).
Notes	Maggi et al., Acta toxicologica et therapeutica, 1990, 11 (pp173‐184).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Lo studio policentrico e stato condotto in doppio cieco randomizzato (this is a double‐blind randomized multicenter tial)". Further methods of randomization are not mentioned. So it's unclear if this was adequate.
Allocation concealment (selection bias)	Unclear risk	Method not mentioned.
Blinding (performance bias and detection bias) All outcomes	Low risk	Quote: "double‐blind", "the boxes containing the three products in use were identical and indistinguishable from each other".
Incomplete outcome data (attrition bias) All outcomes	Low risk	Two drop‐outs mentioned, reason: lack of compliance.
Selective reporting (reporting bias)	Low risk	All end points detailed.
Other bias	High risk	Continuous scale used for overall opinion of participant and doctor: very subjective outcome measurement. (Side) effect attribution difficult because simultaneous usage of standard therapy. Possible baseline imbalance because of different baseline medication. Three treatment groups.