Clinical efficacy of Fuzheng Jiedu Xiaoyong granules in advanced colorectal cancer (spleen deficiency and stasis toxin syndrome)

doi:10.4251/wjgo.v18.i2.113922

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World Journal of Gastrointestinal Oncology

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1948-5204

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

Clinical Trials Study

World J Gastrointest Oncol. Feb 15, 2026; 18(2): 113922
Published online Feb 15, 2026. doi: 10.4251/wjgo.v18.i2.113922

Table 1 Comparisons of baseline data between the two groups (n = 39 in each group)

Item		Treatment group	Control group	χ²/t	P value
Sex	Male	27	25
	Female	12	14	0.058	0.81
Age (years)		60.53 ± 7.88	61.20 ± 10.00	-0.327¹	0.745
Tumor location	Colon	23	22
	Rectum	16	17	0.053	0.81
Metastatic site	Liver	26	24
	Lungs	16	14	0.013	0.908
Time since initial diagnosis (month)	> 6	11	15
	< 6	28	24	0.923	0.337
Prior treatment modalities	Surgery	16	16
	Chemotherapy	12	16	0.086	0.769

¹t value.

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Table 2 Comparisons of tumor markers before and after treatment between the two groups

Group	n	CEA (ng/mL)		P value	CA199 (U/mL)		P value
Group	n	Before treatment	After treatment	P value	Before treatment	After treatment	P value
Treatment group	36	157.80 ± 220.10	54.70 ± 132.15^a^,^b	0.023	224.09 ± 315.70	45.60 ± 77.96^a^,^b	0.009
Control group	33	185.06 ± 307.65	82.32 ± 137.10^b	0.049	213.36 ± 405.23	145.47 ± 294.89^b	0.045
P value		0.343	0.041		0.866	0.046

^aP < 0.05 vs treatment group within the same group.

^bP < 0.05 vs pre-treatment within the same group.

CEA: Carcinoembryonic antigen; CA19-9: Carbohydrate antigen 19-9.

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Table 3 Comparisons of T-lymphocyte subsets before and after treatment between the two groups

Group	n	CD3+ (%)		P value	CD4+ (%)		P value	CD8+ (%)		P value	CD4+/CD8+		P value
Group	n	Before treatment	After treatment	P value	Before treatment	After treatment	P value	Before treatment	After treatment	P value	Before treatment	After treatment	P value
Treatment group	36	68.90 ± 11.01	76.66 ± 10.20^a^,^b	0.003	32.47 ± 7.80	37.44 ± 7.27^a^,^b	0.04	31.17 ± 6.9	28.38 ± 4.51^a^,^b	0.046	1.10 ± 3.88	1.35 ± 0.34^a^,^b	0.014
Control group	33	69.05 ± 12.85	71.94 ± 8.90	0.291	31.63 ± 6.66	33.29 ± 7.27	0.347	31.97 ± 9.75	32.35 ± 7.96	0.862	1.10 ± 0.48	1.17 ± 0.44	0.791
P value		0.956	0.045		0.62	0.02		0.659	0.012		0.99	0.032

^aP < 0.05 vs treatment group within the same group.

^bP < 0.05 vs pre-treatment within the same group.

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Table 4 Comparisons of Karnofsky Performance Status score before and after treatment between the two groups

Group	n	Before treatment	After treatment	P value
Treatment group	36	70.28 ± 8.10	74.44 ± 5.58^a^,^b	0.013
Control group	33	70.91 ± 8.42	71.51 ± 5.07	0.725
P value		0.752	0.026

^aP < 0.05 vs treatment group within the same group.

^bP < 0.05 vs pre-treatment within the same group.

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Table 5 Comparisons of objective tumor responses between the two groups

Group	n	Complete response	Partial response	Stable disease	Progressive disease	Disease control rate, n (%)
Treatment group	36	0	7	26	3	33 (91.67)
Control group	33	0	6	23	4	29 (87.88)
χ²						0.015
P value						0.903

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Table 6 Comparison of traditional Chinese medicine symptom scores before and after treatment between the two groups

Group	n	Before treatment	After treatment	P value
Treatment group	36	12.33 ± 3.68	5.44 ± 2.71^b	0.00
Control group	33	11.12 ± 2.68	7.03 ± 2.72^a^,^b	0.00
P value		0.125	0.018

^aP < 0.05 vs treatment group within the same group.

^bP < 0.05 vs pre-treatment within the same group.

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Table 7 Comparisons of traditional Chinese medicine efficacy before and after treatment between the two groups

Group	n	Clinical cure	Marked improvement	Moderate improvement	Stable/deterioration	Total effective rate, n (%)
Treatment group	36	0	13	18	5	31 (86.11)^a
Control group	33	0	8	13	12	22 (66.67)
χ²						4.357
P value						0.037

^aP < 0.05 vs treatment group within the same group.

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Table 8 Incidence of adverse events in the two groups

Adverse events	Grade	0	1	2	3	4	Incidence (%)	χ²	P value
WBC reduction	Treatment group	29	5	2	0	0	19^a
WBC reduction	Control group	19	10	2	1	1	42	4.29	0.038
NE reduction	Treatment group	31	3	1	1	0	14^a
NE reduction	Control group	21	5	4	1	2	36	4.68	0.03
HGB reduction	Treatment group	21	15	0	0	0	41^a
HGB reduction	Control group	11	19	3	0	0	67	3.90	0.048
PLT reduction	Treatment group	26	10	1	0	0	31^a
PLT reduction	Control group	15	15	3	0	0	55	4.06	0.04
ALT/AST elevation	Treatment group	29	7	0	0	0	19
ALT/AST elevation	Control group	25	8	0	0	0	24	0.23	0.63
Hypertension	Treatment group	11	15	7	3	0	69
Hypertension	Control group	7	12	9	5	0	79	0.78	0.38
Nausea/vomiting	Treatment group	31	4	1	0	0	13^a
Nausea/vomiting	Control group	21	8	3	1	0	36	4.68	0.030
Diarrhea	Treatment group	28	8	0	0	0	22^a
Diarrhea	Control group	17	12	2	2	0	48	5.23	0.022
Palmar-plantar erythrodysesthesia syndrome	Treatment group	25	10	1	0	0	30
Palmar-plantar erythrodysesthesia syndrome	Control group	19	12	2	0	0	42	1.05	0.306
Paresthesia	Treatment group	27	9	0	0	0	25
Paresthesia	Control group	23	9	1	0	0	30	0.243	0.62

^aP < 0.05 vs treatment group within the same group.

WBC: White blood cells; NE: Neutrophils; HGB: Hemoglobin; PLT: Platelets; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase.

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Citation: Qin HY, Li Z, Cong PW, Mi D, Li FZ, Hu X, Li GX. Clinical efficacy of Fuzheng Jiedu Xiaoyong granules in advanced colorectal cancer (spleen deficiency and stasis toxin syndrome). World J Gastrointest Oncol 2026; 18(2): 113922
URL: https://www.wjgnet.com/1948-5204/full/v18/i2/113922.htm
DOI: https://dx.doi.org/10.4251/wjgo.v18.i2.113922