Table 3

Fragility Index of the included randomised controlled trials

First author	Outcome	Intervention	Intervention arm (n)	Events in intervention arm (n)	Control arm (n)	Events in Control arm (n)	P-value (Intervention vs control)	Fragility Index (FI)	Reverse Fragility Index (RFI)
Al Wattar58	Maternal composite outcome*	MD	486	111	500	143	0.04	2	–
	Offspring composite outcome†	MD	531	92	564	118	0.145	0	7
Assaf-Balut59	GDM incidence	MD + EVOO + Pistachio	434	74	440	103	0.012	4	–
Assaf-Balut60	Composite maternal-fetal outcome‡	MD + EVOO + Pistachio	360	32	337	87	0.0001	39	–
Babio61	Incidence of MetS	MD + EVOO	1982	29§	1934	75§	<0.001	26	–
	Incidence of MetS	MD + Nuts	1885	58	1934	75	0.186	0	7
de Lorgeril62	Composite outcome¶	MD	219	14	204	44	0.0001	17	–
de Lorgeril34	CV mortality	MD	302	6	303	19	0.01	3	–
	Non-fatal ΜΙ	MD	302	8	303	25	<0.001	5	–
de Lorgeril35 36	CV mortality	MD	302	3	303	16	0.004	4	–
	Non-fatal MI	MD	302	5	303	17	0.015	2	–
Díaz-López37 38	Diabetic retinopathy	MD + EVOO	7830	22	6856	32	0.075**	0	2
Díaz-López37 38	Diabetic retinopathy	MD + Nuts	6622	20	6856	32	0.126	0	3
Esposito31 32	Need for T2DM medication	LCMD	108	48	107	75	<0.001	14	–
Estruch18 19	Composite CV events††	MD + EVOO	11 852	96	9763	109	0.024	5	–
	Composite CV events††	MD + Nuts	10 365	83	9763	109	0.024	4	–
García-Gavilán33 53	Osteoporotic fractures	MD + EVOO	291	40	290	37	0.807	0	13
García-Gavilán33 53	Osteoporotic fractures	MD + Nuts	289	37	290	37	1	0	16
García-Layana40	Cataract surgery incidence	MD + EVOO	11 728	206	10 633	179	0.681	0	28
García-Layana40	Cataract surgery incidence	MD + Nuts	10 719	174	10 633	179	0.748	0	29
Gené Huguet41	Reversion to robustness	MD	85	14	88	1	<0.001	5	–
Greenberg57	Weight loss	MD (vs LFD)	92	41	91	35	0.454	0	8
	Weight loss	MD (vs LCD)	92	41	89	39	1	0	13
Marcos-Forniol42	Optimal CV risk factor control‡‡	MD	54	34	52	15	<0.001	7	–
Martínez-González43	Atrial fibrillation incidence	MD + EVOO	10 634	72	8851	89	0.014	7	–
Martínez-González43	Atrial fibrillation incidence	MD + Nuts	9333	92	8851	89	0.94	0	27
Papadaki44 63	Heart failure incidence	MD + EVOO	11 737	29	9664	32	0.303	0	7
	Heart failure incidence	MD + Nuts	10 279	33	9664	32	0.902	0	14
Pintó52	Presence of steatosis	MD + EVOO	34	3	30	10	0.027	1	–
	Presence of steatosis	MD + Nuts	36	12	30	10	1	0	7
Properzi45	NAFLD resolution	MD	26	3	25	9	0.046§§	0	1
Ruiz-Canela54	New symptomatic PAD cases	MD + EVOO	2539	18	2444	45	<0.001	12	–
	New symptomatic PAD cases	MD + Nuts	2452	26	2444	45	0.023	3	–
Salas-Salvadó55	Reversion of MetS	MD + EVOO	252	53	250	41	0.208	0	6
	Reversion of MetS	MD + Nuts	249	63	250	41	0.015	4	–
	New MetS Incidence	MD + EVOO	157	36	154	36	1	0	15
	New MetS Incidence	MD + Nuts	162	29	154	36	0.266	0	6
Salas-Salvadó39 46	Incidence of T2DM	MD + EVOO	570	14	515	24	0.068	0	1
Salas-Salvadó39 46	Incidence of T2DM	MD + Nuts	598	16	515	24	0.105	0	2
Salas-Salvadó47 48	New-onset of T2DM	MD + EVOO	4990	80	4271	101	0.01	9	–
Salas-Salvadó47 48	New-onset of T2DM	MD + Nuts	4876	92	4271	101	0.126	0	6
Sánchez-Villegas56	Depression	MD + EVOO	7715	88	6096	77	0.018	5	–
		MD + Nuts	6803	59	6096	88	0.003	13	–
Singh49	Total cardiac events	Indo-MD	499¶¶	39	501	76	<0.001	16	–
Toledo50	First invasive breast cancer	MD + EVOO	7031	8	5829	17	0.027	2	–
	First invasive breast cancer	MD + Nuts	5492	10	5829	17	0.253	0	4
Tuttle51	Total outcome endpoints***	MD	51	8	50	8	1	0	7

*gestational diabetes mellitus (GDM) or preeclampsia.
†Stillbirth, small-for-gestational age (SGA) fetus, or admission to the neonatal care unit.
‡Emergency caesarean section, perineal trauma, pregnancy-induced hypertension and preeclampsia, prematurity, large-for-gestational age, and SGA.
§The number of events was calculated by subtracting the baseline n from the follow-up n count.
¶Cardiac death and non-fatal myocardial infarction (MI).
**In the manuscript, the comparison is reported as ‘significant’ based on the multivariable-adjusted model; however, analysis using Fischer’s exact test does not reveal a significant difference.
††MI, stroke, or death from cardiovascular causes.
‡‡Defined as the achievement of ≥5 risk factor goals: blood pressure <140/90 mm Hg, low-density lipoprotein <2.6 mmol/L, smoking cessation, body mass index <25 kg/m², physical activity of moderate intensity >30 min/day, 3 days/wk (≥6 metabolic equivalents h/wk) and HbA_1c <7% in patients with diabetes.
§§In the manuscript, the comparison is reported as significant (p=0.046); analysis using Fischer’s exact test does not reveal a significant difference.
¶¶In the manuscript, table 4 reports that the size of the intervention group (n) was 999; instead, the count reported in the main manuscript text and the other tables was used for the calculation of the FI (n=499).
***All-cause and cardiac deaths, MI, hospital admissions for heart failure, unstable angina pectoris or stroke.
CV, cardiovascular; EVOO, extra-virgin olive oil; LCD, low-carbohydrate diet; LCMD, low-carbohydrate MD; LFD, low-fat diet; MD, Mediterranean diet; MetS, metabolic syndrome; NAFLD, non-alcoholic fatty liver disease; PAD, periphery artery disease; T2DM, type 2 diabetes mellitus.