Clinical trial of treatment with saikokaryukotsuboreito for eugonadal patients with late-inset hypogonadism-related symptoms

Figures & data

Table I.  Components of SKRBT. Seven point five g of this product contains 4.5 g of dried extract obtained from mixed raw herbs in the preceding.

Pinellia tuber	4.0 g
Cinnamon bark	3.0 g
Poria sclerotium	3.0 g
Scutellaria root	2.5 g
Jujube	2.5 g
Ginseng	2.5 g
Oyster shell	2.5 g
Longgu	2.5 g
Ginger	1.0 g
Bupleurum root	5.0 g

SKRBT; Saikokaryukotsuboreito.

Table II.  Laboratory values before and after SKRBT treatment.

	Before	After	P
RBC (×10^6/ml)	471.5 ± 34.8	463.9 ± 39.1	NS
Hb (g/dl)	14.6 ± 1.0	14.6 ± 1.1	NS
Ht (%)	43.4 ± 2.5	42.9 ± 3.1	NS
AST (IU/l)	18.8 ± 7.1	19.6 ± 8.1	NS
ALT (IU/l)	21.5 ± 11.1	20.1 ± 9.6	NS
V-GTP (IU/l)	30.1 ± 23.3	38.0 ± 35.6	NS
T-cholesterol (mg/dl)	196.2 ± 38.1	196.8 ± 25.1	NS
triglyceride (mg/dl)	110.5 ± 54.6	127.7 ± 62.2	NS
PSA (mg/dl)	1.29 ± 0.8	1.20 ± 0.8	NS

SKRBT; Saikokaryukotsuboreito.

Table III.  Endocrinologic variables before and after SKRBT treatment.

	Before	After	P
TT (ng/ml)	4.5 ± 1.5	4.5 ± 1.2	NS
FT (pg/ml)	11.0 ± 4.8	9.6 ± 2.0	NS
cFT (pg/ml)	83.6 ± 35.8	72.5 ± 15.8	NS
cBT (ng/ml)	2.0 ± 0.8	1.7 ± 0.4	NS
E2 (pg/ml)	28.0 ± 13.3	26.1 ± 9.8	NS
LH (mIU/l)	5.5 ± 4.0	5.5 ± 4.0	NS
FSH (mIU/l)	15.0 ± 16.7	14.3 ± 17.7	NS
PRL (ng/ml)	7.3 ± 7.6	14.5 ± 18.4	NS
GH (ng/ml)	0.32 ± 0.29	0.53 ± 1.02	NS
IGF-1 (ng/ml)	177.0 ± 54.10	171.2 ± 41.1	NS
DHEA (ng/ml)	3.5 ± 3.1	3.1 ± 1.6	NS
DHEA-S (ng/ml)	1614.1 ± 994.7	1372.3 ± 883.3	NS

SKRBT; Saikokaryukotsuboreito.

Table IV.  LOH-related symptom scores before and after SKRBT treatment.

	Before	After	P
AMS	50.1 ± 11.5	42.0 ± 13.1	<0.01
psychological	14.9 ± 5.6	11.6 ± 5.3	<0.05
somatovegetative	20.5 ± 5.4	17.1 ± 5.7	<0.01
sexual	14.7 ± 3.9	13.3 ± 4.9	<0.05
SDS	47.6 ± 8.7	45.5 ± 9.9	NS
IPSS	8.3 ± 6.0	7.2 ± 6.1	NS
QOL	3.1 ± 1.3	2.7 ± 1.4	NS

LOH; late-onset hypogonadism, SKRBT; Saikokaryukotsuboreito.

Table V.  KHQ scores before and after SKRBT treatment.

KHQ-QOL	Before	After	P
general health perception	66.7 ± 25.7	50.0 ± 25.6	<0.01
impact on life	16.7 ± 17.1	8.8 ± 15.1	<0.05
role limitation	6.4 ± 11.1	6.7 ± 13.7	NS
physical limitation	4.8 ± 7.7	3.3 ± 6.9	NS
social limitation	3.2 ± 8.7	3.9 ± 11.0	NS
personal relationship	3.3 ± 8.7	4.4 ± 9.4	NS
emotion	9.5 ± 11.8	11.7 ± 15.1	NS
sleep/energy	12.7 ± 17.4	11.7 ± 15.4	NS
incontinence severity	2.5 ± 4.5	4.3 ± 7.3	NS

KHQ; the King's Health Questionnaire, SKRBT; Saikokaryukotsuboreito.