LipoCol Forte capsules reduce the risk of liver cancer: A propensity score-matched, nationwide, population-based cohort study

doi:10.4251/wjgo.v15.i5.828

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World Journal of Gastrointestinal Oncology

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Retrospective Cohort Study

World J Gastrointest Oncol. May 15, 2023; 15(5): 828-842
Published online May 15, 2023. doi: 10.4251/wjgo.v15.i5.828

Table 1 Demographic characteristics and comorbidities for non-LipoCol Forte capsules users and LipoCol Forte capsules user populations in Taiwan between 2010 and 2017

Variables	Non-LFC users (n = 33231)		LFC users (n = 33231)		SMD
Variables	n	%	n	%	SMD
Sex
Female	15869	47.75	15798	47.54	0.004
Male	17362	52.25	17433	52.46	0.004
Age (yr)
20-29	300	0.90	319	0.96	0.006
30-39	1434	4.32	1545	4.65	0.016
40-49	3677	11.07	3816	11.48	0.013
> 50	27820	83.72	27551	82.91	0.022
mean (SD)	63.22	13.60	62.75	13.62	0.035
Comorbidities
Hypertension	21195	63.78	20825	62.67	0.023
Coronary heart disease	11255	33.87	10972	33.02	0.018
Ischemic stroke	6902	20.77	6784	20.41	0.009
Hemorrhagic stroke	816	2.46	939	2.83	0.023
Diabetes mellitus	12348	37.16	12172	36.63	0.011
Hyperlipidemia	16793	50.53	16196	48.74	0.036
Renal insufficiency	4028	12.12	4007	12.06	0.002
Cirrhosis	2585	7.78	2643	7.95	0.007
Alcoholic liver damage	2554	7.69	2606	7.84	0.006
Nonalcoholic fatty liver disease	1648	4.96	1825	5.49	0.024
HBV infection	3239	9.75	3342	10.06	0.010
HCV infection	2061	6.20	2196	6.61	0.017
Medications
Statin	12008	36.13	11666	35.11	0.022
Non-statin lipid-lowering drug	6339	19.08	6161	18.54	0.014
Aspirin	15564	46.84	15330	46.13	0.014
HBV treatment	1531	4.61	1572	4.73	0.006
HCV treatment	7	0.02	10	0.03	0.006
Metformin	8674	26.10	8469	25.49	0.014
Thiazolidinediones	2533	7.62	2483	7.47	0.006

Student’s t-test. LFC: LipoCol Forte capsules; SMD: Standardized mean difference (a standardized mean difference of 0.05 or less indicates a negligible difference); SD: Standard deviation; HBV: Hepatitis B virus; HCV: Hepatitis C virus.

Table 2 Incidence rates, hazard ratios and 95% confidence intervals of liver cancer, stratified by sex, age, comorbidities and medications, comparing LipoCol Forte capsules users with non-LipoCol Forte capsules users

	Non-LFC users			LFC users			Crude			Adjusted
Variable	Event	Person-years	IR	Event	Person-years	IR	cHR	95%CI	P value	aHR¹	95%CI	P value
Overall	3848	186604	20.62	3700	192122	19.26	0.89	(0.85, 0.94)^c	< 0.001	0.91	(0.86, 0.95)^c	< 0.001
Sex
Female	1416	91487	15.48	1267	94190	13.45	0.83	(0.77, 0.9)^c	< 0.001	0.87	(0.8, 0.94)^c	< 0.001
Male	2432	95117	25.57	2433	97932	24.84	0.93	(0.88, 0.99)^a	0.014	0.93	(0.87, 0.98)^b	0.008
Age (yr)
20-29	11	1884	5.84	9	2054	4.38	0.67	(0.27, 1.68)	0.396	0.61	(0.24, 1.59)	0.313
30-39	68	8881	7.66	77	9854	7.81	0.96	(0.69, 1.34)	0.827	0.79	(0.56, 1.11)	0.178
40-49	285	22392	12.73	290	23617	12.28	0.95	(0.8, 1.12)	0.508	0.91	(0.77, 1.07)	0.249
> 50	3484	153447	22.71	3324	156597	21.23	0.89	(0.85, 0.94)^c	< 0.001	0.91	(0.87, 0.95)^c	< 0.001
Comorbidities
Hypertension
No	1169	69398	16.85	1281	73107	17.52	1	(0.92, 1.08)	0.910	0.93	(0.86, 1.01)	0.090
Yes	2679	117206	22.86	2419	119015	20.33	0.85	(0.81, 0.9)^c	< 0.001	0.89	(0.84, 0.94)^c	< 0.001
Coronary heart disease
No	2455	124923	19.65	2413	130037	18.56	0.9	(0.85, 0.95)^c	< 0.001	0.88	(0.84, 0.94)^c	< 0.001
Yes	1393	61681	22.58	1287	62085	20.73	0.89	(0.83, 0.96)^b	0.004	0.94	(0.87, 1.02)	0.143
Ischemic stroke
No	3002	149577	20.07	2983	154633	19.29	0.92	(0.87, 0.97)^b	0.001	0.91	(0.86, 0.96)^c	< 0.001
Yes	846	37027	22.85	717	37489	19.13	0.8	(0.73, 0.89)^c	< 0.001	0.9	(0.81, 0.99)^a	0.033
Hemorrhagic stroke
No	3738	182382	20.50	3586	187046	19.17	0.89	(0.85, 0.94)^c	< 0.001	0.9	(0.86, 0.95)^c	< 0.001
Yes	110	4222	26.05	114	5076	22.46	0.86	(0.66, 1.12)	0.265	1	(0.76, 1.32)	0.992
Diabetes mellitus
No	2023	119363	16.95	1972	124172	15.88	0.9	(0.84, 0.96)^c	< 0.001	0.89	(0.84, 0.95)^c	< 0.001
Yes	1825	67241	27.14	1728	67950	25.43	0.9	(0.84, 0.96)^b	0.001	0.92	(0.86, 0.98)^a	0.010
Hyperlipidemia
No	1986	92314	21.51	1980	98628	20.08	0.9	(0.84, 0.96)^c	< 0.001	0.89	(0.83, 0.94)^c	< 0.001
Yes	1862	94290	19.75	1720	93494	18.40	0.89	(0.83, 0.95)^c	< 0.001	0.93	(0.87, 1)^a	0.040
Renal insufficiency
No	3319	165852	20.01	3221	170964	18.84	0.9	(0.86, 0.95)^c	< 0.001	0.9	(0.85, 0.94)^c	< 0.001
Yes	529	20752	25.49	479	21158	22.64	0.86	(0.76, 0.97)^a	0.016	0.96	(0.85, 1.1)	0.580
Cirrhosis
No	2514	174893	14.38	2314	180074	12.85	0.84	(0.8, 0.89)^c	< 0.001	0.83	(0.79, 0.88)^c	< 0.001
Yes	1334	11711	113.91	1386	12048	115.04	0.98	(0.91, 1.06)	0.606	1	(0.93, 1.08)	0.921
Alcoholic liver damage
No	3297	173575	19.00	3164	178842	17.69	0.89	(0.84, 0.93)^c	< 0.001	0.88	(0.84, 0.93)^c	< 0.001
Yes	551	13029	42.29	536	13281	40.36	0.95	(0.85, 1.07)	0.432	1	(0.88, 1.13)	0.970
Nonalcoholic fatty liver disease
No	3553	177753	19.99	3404	182155	18.69	0.89	(0.85, 0.94)^c	< 0.001	0.9	(0.86, 0.94)^c	< 0.001
Yes	295	8851	33.33	296	9967	29.70	0.86	(0.73, 1.01)	0.06	0.92	(0.78, 1.09)	0.322
HBV infection
No	2604	170246	15.30	2501	175001	14.29	0.89	(0.84, 0.94)^c	< 0.001	0.88	(0.83, 0.93)^c	< 0.001
Yes	1244	16359	76.05	1199	17121	70.03	0.89	(0.82, 0.96)^b	0.003	0.91	(0.84, 0.99)^a	0.025
HCV infection
No	2784	176772	15.75	2658	181323	14.66	0.89	(0.84, 0.94)^c	< 0.001	0.88	(0.83, 0.93)^c	< 0.001
Yes	1064	9832	108.22	1042	10799	96.49	0.85	(0.78, 0.92)^c	< 0.001	0.9	(0.82, 0.98)^a	0.016
Medication
Statins
No	2693	120440	22.36	2681	125954	21.29	0.91	(0.87, 0.97)^b	0.001	0.91	(0.86, 0.96)^c	< 0.001
Yes	1155	66164	17.46	1019	66168	15.40	0.84	(0.77, 0.92)^c	< 0.001	0.92	(0.84, 1)	0.058
Non-statin lipid-lowering drugs
No	3203	151343	21.16	3080	157120	19.60	0.89	(0.85, 0.93)^c	< 0.001	0.9	(0.86, 0.95)^c	< 0.001
Yes	645	35261	18.29	620	35003	17.71	0.92	(0.82, 1.03)	0.135	0.94	(0.84, 1.05)	0.295
Aspirin
No	1947	101738	19.14	1935	105708	18.31	0.91	(0.86, 0.97)^b	0.004	0.88	(0.83, 0.94)^c	< 0.001
Yes	1901	84866	22.40	1765	86414	20.43	0.88	(0.82, 0.94)^c	< 0.001	0.93	(0.87, 1)^a	0.043
HBV treatment
No	2971	179610	16.54	2788	184920	15.08	0.87	(0.82, 0.91)^c	< 0.001	0.83	(0.79, 0.88)^c	< 0.001
Yes	877	6994	125.40	912	7203	126.62	0.97	(0.89, 1.07)	0.592	0.99	(0.9, 1.09)	0.807
HCV treatment
No	3843	186594	20.60	3697	192084	19.25	0.89	(0.86, 0.94)^c	< 0.001	0.91	(0.87, 0.95)^c	< 0.001
Yes	5	10	487.00	3	39	77.83	0.21	(0.04, 1.07)	0.060	NA	NA	1
Metformin
No	2471	140106	17.64	2413	145474	16.59	0.9	(0.85, 0.96)^c	< 0.001	0.9	(0.85, 0.95)^c	< 0.001
Yes	1377	46498	29.61	1287	46648	27.59	0.89	(0.82, 0.96)^b	0.002	0.92	(0.85, 0.99)^a	0.033
Thiazolidinediones
No	3453	173105	19.95	3331	178541	18.66	0.89	(0.85, 0.94)^c	< 0.001	0.91	(0.87, 0.95)^c	< 0.001
Yes	395	13499	29.26	369	13581	27.17	0.9	(0.78, 1.04)	0.141	0.89	(0.77, 1.03)	0.110

¹Adjusted in multivariate analysis by sex, age, comorbidities and medications.

^aP < 0.05.

^bP < 0.01.

^cP < 0.001.

LFC: LipoCol Forte capsules; IR: Incidence rate per 1000 person-years; cHR: Crude hazard ratio; aHR: Adjusted hazard ratio; HBV: Hepatitis B virus; HCV: Hepatitis C virus; NA: Not available.

Table 3 Incidence and hazard ratios of liver cancer, stratified by the duration of LipoCol Forte capsules use

Variable	n	PY	IR	cHR	95%CI	P value	aHR¹	95%CI	P value
Non-use of LipoCol Forte capsules as reference	3848	186604	20.621	1.00	Reference		1.00	Reference
LipoCol Forte capsules
< 28 d	3115	161794	19.253	0.9	(0.86, 0.94)^c	< 0.001	0.94	(0.89, 0.98)^b	0.006
28-84 d	533	27871	19.124	0.87	(0.79, 0.95)^b	0.002	0.79	(0.72, 0.87)^c	< 0.001
> 84 d	52	2457	21.165	0.99	(0.75, 1.3)	0.925	0.64	(0.48, 0.84)^b	0.001

¹Adjusted in multivariate analysis by sex, age, comorbidities and medications.

^aP < 0.05.

^bP < 0.01.

^cP < 0.001.

PY: Person-years; IR: Incidence rate per 1000 person-years; cHR: Crude hazard ratio; aHR: Adjusted hazard ratio.

Table 4 Cox proportional hazard model estimated hazard ratio among cumulative dose of LipoCol Forte capsules

Variable	n	PY	IR	cHR	95%CI	P value	aHR¹	95%CI	P value
Non-use of LFC as reference	3848	186604.2	20.6212	1.00	(Reference)	-	1.00	(Reference)	-
LFC dose (g)
< 91	3182	158379	20.09	0.94	(0.9, 0.98)^b	0.0089	0.98	(0.94, 1.03)	0.4435
91-179	366	21568	16.97	0.77	(0.69, 0.86)^c	<0.001	0.69	(0.62, 0.77)^c	< 0.001
> 179	152	12175	12.48	0.55	(0.47, 0.65)^c	<0.001	0.46	(0.39, 0.55)^c	< 0.001

¹Adjusted in multivariate analysis by sex, age, comorbidities and medications.

^aP < 0.05.

^bP < 0.01.

^cP < 0.001.

LFC: LipoCol Forte capsules; PY: Person-years; IR: Incidence rate per 1000 person-years; cHR: Crude hazard ratio; aHR: Adjusted hazard ratio.

Table 5 The risk of liver cancer by stratified follow-up years

Follow-up time	Non-LFC users			LFC users			cHR	95%CI	aHR¹	95%CI
Follow-up time	n	PY	IR	n	PY	IR	cHR	95%CI	aHR¹	95%CI
2-3 yr	1367	93294	14.65	1332	92819	14.35	0.98	(0.91, 1.06)	1.01	(0.93, 1.09)
4-6 yr	1554	63868	24.33	1401	64063	21.87	0.9	(0.84, 0.97)^b	0.92	(0.86, 0.99)^a
> 6 yr	927	29442	31.49	967	35241	27.44	0.77	(0.7, 0.84)^c	0.75	(0.68, 0.82)^c

¹Adjusted in multivariate analysis by sex, age, comorbidities and medications.

^aP < 0.05.

^bP < 0.01.

^cP < 0.001.

LFC: LipoCol Forte capsules; PY: Person-years; IR: Incidence rate per 1000 person-years; cHR: Crude hazard ratio; aHR: Adjusted hazard ratio.

Citation: Lai HC, Lin HJ, Shih YH, Chou JW, Lin KW, Jeng LB, Huang ST. LipoCol Forte capsules reduce the risk of liver cancer: A propensity score-matched, nationwide, population-based cohort study. World J Gastrointest Oncol 2023; 15(5): 828-842
URL: https://www.wjgnet.com/1948-5204/full/v15/i5/828.htm
DOI: https://dx.doi.org/10.4251/wjgo.v15.i5.828