Herbal medicine Ninjinyoeito ameliorates ribavirin-induced anemia in chronic hepatitis C: A randomized controlled trial

Table 1 Patients’ characteristics before therapy

	NYT	Control	P
Age (yr)	46.3 ± 14.3	54.9 ± 10.3	0.113
Gender (M/F)	9/1	8/5	0.123
Body weight (kg)	65.2 ± 9.8	60.6 ± 9.1	0.291
ALT (U/L)	74.9 ± 38.2	58.1 ± 25.1	0.457
Hb ( g/dL)	14.3 ± 1.4	14.0 ± 1.6	0.709
HCVRNA (kIU/mL)	553.5 ± 315.0	637.6 ± 314.0	0.673
HCV serotype (1/2)	8/2	9/4	0.377

Table 2 Virological and biochemical results

	NYT (%)	Control (%)	P
Enrolled cases	10	13
Normal ALT at the end of therapy	7 (70.0)	6 (46.2)	0.253
Negative HCVRNA at the end of therapy	8 (80.0)	7 (53.8)	0.192
Normal ALT 6 mo after therapy	8 (80.0)	4 (30.8)	0.489
Negative HCVRNA 6 mo after therapy	4 (40.0)	4 (30.8)	0.645

Table 3 Hematological and immunological results

	NYT	Control	P
Max△RBC (× 103)	868 ± 474	1.244 ± 419	0.178
Max△Hb (g/dL)	2.59 ± 1.10	3.71 ± 0.97	0.026
min Hb (g/dL)	11.66 ± 1.78	10.10 ± 1.08	0.079
WBC (wk 24)	3 444 ± 1731	3 204 ± 1143	0.894
Plts (wk 24, × 104)	14.69 ± 5.52	12.77 ± 4.22	0.709
Th1 (wk 4, %)	27.29 ± 11.6	30.20 ± 8.66	0.480
Th2 (wk 4, %)	2.77 ± 1.06	2.30 ± 1.09	0.232
Th1/Th2 (wk 4)	10.89 ± 5.68	15.48 ± 6.87	0.130
GP×[wk 4, nmol/(min·mL)]	76.41 ± 31.79	78.96 ± 31.96	0.522

GPx: glutathione peroxidase.

Table 4 Multiple regression analysis

Variable	Parameter estimate	Standard error	P
Intercept	-1.61742	1.12391	0.1707
NYT administration	1.47645	0.43746	0.0042
Serum creatinine (wk 0)	-3.05400	1.57891	0.0722

Maximal hemoglobin decrease = 1.477 × [NYT administration] -3.054× [serum creatinine at wk 0]-1.617 (NYT administration: the NYT group, 1; the control group, 2) Adjusted R square: 0.3923.

Table 5 Comparison of NYT and other drugs which were reported to be effective for RBV-induced anemia

	Action	Mechanisms	Indication for anemia in health	Form	Adverse reactions	Daily cost
			insurance system of Japan			(yen)
NYT	Promotion of erythropoiesis,	Activation of immature	Anemia in	Granule	Abdominal discomfort	227.7
	protection of erythrocytic	erythroid cells,	general,		(frequency unknown)
	membrane, improvement of	antioxidant effect
	erythrocytic deformability
EPA	Increase in erythrocyte	Increase in EPA content in	None	Capsule	Jaundice, gynecomastia	353.4
	deformability	erythrocytic membrane			(frequency unknown),
		phospholipids			hemorrhagic tendency,
					liver injury (< 0.1%)
EPO	Increase in erythropoiesis	Stimulation of stem cell	Renal anemia	Vial for	Thromboembolism,	1643
		differentiation to		injection	cerebral hemorrhage,	(750 IU)
		erythroid cells			shock (frequency unknown),
					high blood pressure, liver
					injury (0.1-< 5%)