Improvement of symptoms of aging in males by a preparation LEOPIN ROYAL containing aged garlic extract and other five of natural medicines – comparison with traditional herbal medicines (Kampo)

Figures & data

Figure 1. Flow chart for enrollment of patients and follow-up data.

Table 1. Baseline characteristics of subjects.

	LER (n = 21)	Kampo (n = 25)	p Value
Age – years, mean (SD)	61.9 (11.4)	63.7 (12.5)	0.61†
Range	37–85	40–84
Interval of administration – day, mean (SD)	181 (15.5)	184 (35.7)	0.68†
AMS scale (total score) categories – no. (%)
Severe (score 50+)	7 (33%)	12 (48%)	0.38‡
Moderate (score 37–49)	10 (48%)	9 (36%)
Mild (score 27–36)	4 (19%)	4 (16%)
No (score ≤26)	0 (0%)	0 (0%)
IIEF-5 categories – no. (%)
Severe (score ≤7)	16 (76%)	16 (64%)	0.26‡
Moderate (score 8–11)	4 (19%)	4 (16%)
Mild to moderate (score 12–16)	1 (5%)	3 (12%)
Mild (score 17–21)	0 (0%)	2 (8%)
No ED (score 22–25)	0 (0%)	0 (0%)
SRQ-D categories – no. (%)
Masked depression (score 16+)	3 (14%)	5 (20%)	0.80‡
Borderline depression (score 11–15)	7 (33%)	5 (20%)
No (score ≤10)	11 (52%)	15 (60%)
ADAM questionnaire
Positive (“yes” to question 1 or 7 or   any 3 other questions) – no. (%)	21 (100%)	25 (100%)

The p values were calculated by t-test† or Mann–Whitney U-test‡ to compare between the groups.

LER, LEOPIN ROYAL®; AMS, Aging Males’ Symptoms; IIEF-5, International Index of Erectile Function with 5 questions; SRQ-D, Self-Rating Questionnaire for Depression; ADAM, Androgen Deficiency in Aging Males; ED, erectile dysfunction.

Table 2. Time courses of scores related symptoms of aging in males.

	Treatment	Score – mean (SD)			p Value
	group	Baseline	3 months	6 months	G	G × M
AMS scale
Somatic sub-score	LER	20.4 (5.1)	15.2 (4.1)*	13.8 (4.1)*	<0.01	<0.01
	Kampo	22.4 (5.1)	21.3 (5.5)*	20.0 (5.2)*
Psychological sub-score	LER	10.6 (3.9) †	8.5 (3.1)	8.0 (2.8)*	<0.01	0.047
	Kampo	13.2 (4.4)	13.0 (3.9)	12.7 (3.4)
Sexual sub-score	LER	15.5 (5.0)	15.2 (4.0)	14.5 (3.9)	0.47	0.79
	Kampo	15.6 (3.5)	14.8 (4.0)*	14.4 (3.7)*
Total score	LER	46.5 (11.4)	38.9 (8.9)*	36.2 (8.5)*	<0.01	0.048
	Kampo	51.2 (12.1)	49.0 (12.4)*	47.0 (11.4)*
IIEF-5 score	LER	5.6 (3.3)	8.4 (6.1)*	7.5 (5.7)	0.041	0.019
	Kampo	6.5 (5.1)	6.7 (4.6)	6.4 (5.0)
SRQ-D score	LER	10.3 (5.4)	8.8 (4.5)	9.0 (5.2)	0.50	0.55
	Kampo	9.9 (5.9)	9.3 (5.5)	9.0 (5.2)
ADAM questionnaire	LER	21 (100%)	19 (90%)	20 (95%)
Positive – no. (%)	Kampo	25 (100%)	24 (96%)	24 (96%)

The p values were calculated by the linear mixed model analysis adjusted for the baseline and age to compare between the treatment groups (G) and the group and month interaction (G × M).

†p < 0.05 compared between the two groups at the baseline by t-test.

*p < 0.05 compared with the baseline in each group by paired t-tests with the Bonferroni correction.

LER, LEOPIN ROYAL®; AMS, Aging Males’ Symptoms; IIEF-5, International Index of Erectile Function with 5 questions; SRQ-D, Self-Rating Questionnaire for Depression; ADAM, Androgen Deficiency in Aging Males.

Table 3. Endocrinologic values before and after treatments of LER and Kampo.

	Treatment	Serum level – mean (SD)
	Group	n	Baseline	6 months	p Value
Testosterone (ng/mL)	LER	18	3.28 (2.03)	3.44 (2.08)	0.51
	Kampo	14	3.60 (0.82)	3.80 (0.75)	0.17
Free testosterone (pg/mL)	LER	18	7.89 (3.73)	9.32 (6.08)	0.24
	Kampo	11	7.67 (3.28)	6.99 (3.38)	0.10
FSH (mIU/mL)	LER	17	13.0 (12.7)	12.8 (10.8)	0.66
	Kampo	15	11.0 (5.1)	10.9 (4.6)	0.77
LH (mIU/mL)	LER	16	5.41 (5.06)	5.31 (4.45)	0.85
	Kampo	11	6.70 (4.24)	6.28 (3.59)	0.48
PRL (ng/mL)	LER	13	7.56 (3.62)	8.10 (7.49)	0.83
	Kampo	12	4.85 (1.52)	4.93 (0.76)	0.89
E2 (pg/mL)	LER	5	36.0 (32.4)	32.8 (28.6)	0.18
	Kampo	10	15.8 (3.4)	16.4 (3.0)	0.44

The p values were calculated by paired t-test.

LER, LEOPIN ROYAL®; FSH, follicle-stimulating hormone; LH, luteinizing hormone; PRL, prolactin; E2, estradiol.