Clinical efficacy of Japanese traditional herbal medicine (Kampo) in patients with late-onset hypogonadism

Figures & data

Table I.  The excess (Shi/Jitsu)−insufficiency (Xu/Kyo) scoring system questionnaire for decisions regarding patient's pathogenic alteration.

Each patient answered 10 questions according to their condition at their option. Total score was calculated. Patient's pathogenic alteration was determined per these scores as follows: excess; score of 55 to 100, intermediate; 45 to 54; insufficiency; 0 to 44.

Table II.  Composition of the six Japanese traditional herbal medicines for LOH treatment.

7.5 g of Keishibukuryogan (TJ-25) extractgranules contains 1.75 g of a dried extract of the following mixed crude drugs.		7.5 g of Kamishoyosan (TJ-24) extractgranules contains 4.0 g of a dried extract of the following mixed crude drugs.		7.5 g of Tokishakuyakusan (TJ-23) extractgranules contains 4.0 g of a dried extract of the following mixed crude drugs.
Cinnamon bark	3.0 g	Bupleurum root	3.0 g	Peony root	4.0 g
Peony root	3.0 g	Peony root	3.0 g	Atractylodes lancea rhizome	4.0 g
Peach kernel	3.0 g	Atractylodes lancea rhizome	3.0 g	Alisma rhizome	4.0 g
Poria sclerotium	3.0 g	Japanese angelica root	3.0 g	Poria sclerotium	4.0 g
Mountain bark	3.0 g	Poria sclerotium	3.0 g	Cnidium rhizome	3.0 g
		Gardenia fruit	2.0 g	Japanese angelica root	3.0 g
		Moutan bark	2.0 g
		Glycyrrhiza	1.5 g
		Ginger	1.0 g
		Mentha herb	1.0 g
7.5 g of Hachimijiogan (TJ-7) extractgranules contains 4.0 g of a dried extract of the following mixed crude drugs.		7.5 g of Hochuekkito (TJ-41) extractgranules contains 5.0 g of a dried extract of the following mixed crude drugs.		7.5 g of Saikokaryukotsuboreito (TJ-12) extractgranules contains 4.5 g of a dried extract of the following mixed crude drugs.
Rehmannia root	6.0 g	Astragalus root	4.0 g	Bupleurum root	5.0 g
Cornus fruit	3.0 g	Atractylodes lancea rhizome	4.0 g	Pinellia tuber	4.0 g
Dioscorea rhizome	3.0 g	Ginseng	4.0 g	Cinnamon bark	3.0 g
Alisma rhizome	3.0 g	Japanese angelica root	3.0 g	Poria sclerotium	3.0 g
Poria sclerotium	3.0 g	Bupleurum root	2.0 g	Scutellaria root	2.5 g
Moutan bark	2.5 g	Jujube	2.0 g	Jujube	2.5 g
Cinnamon bark	1.0 g	Citrus unshiu peel	2.0 g	Ginseng	2.5 g
Powdered processed aconite root	0.5 g	Glycyrrhiza	1.5 g	Oyster shell	2.5 g
		Cimicifuga rhizome	1.0 g	Longgu	2.5 g
		Ginger	0.5 g	Ginger	1.0 g

Table III.  Index for the selection of Japanese traditional herbal medicine corresponding to the conditions of patients with LOH.

• Keishibukuryogan (TJ-25)

Strong build, ruddy face, substantial abdomen, lower abdominal defiance; Excess

• Kamishoyosan (TJ-24)

Infirm, shoulder stiffness, fatigue, anxiety; Intermediate

• Tokishakuyakusan (TJ-23)

Weak muscle, fatigue, sensitive to cold (lumber∼lower extremities); Insufficiency

• Hachimijiogan (TJ-7)

Severe fatigue, pollakisuria, erectile; Insufficiency

• Hochuekkito(TJ-41)

Lower digestive function, severe lower extremities fatigue, infirm; Insufficiency

• Saikokaryukotsuboreito (TJ-12)

Good∼fair physical strength, palpitation, sleep disturbance, irritated; Excess∼intermediate

Table IV.  SMI for evaluation of LOH symptom severity.

Symptoms	Severity of symptoms				Score
	Severe	Moderate	Mild	Absent
1. Hot flash	10	6	3	0
2. Tendency to sweet	10	6	3	0
3. Sensation of chilling in hip and extremities	14	9	5	0
4. Shortness of breath, palpitation	12	8	4	0
5. Difficulty of sleep, or lack of deep sleep	14	9	5	0
6. Predisposition to anger, easily irritated	12	8	4	0
7. Anxious, occasionally depressed	7	5	3	0
8. Often has headache, dizziness and/or vomiting	7	5	3	0
9. Fatigability	7	4	2	0
10. Shoulder stiffness, lumber pain, pains in the extremities	7	5	3	0
			Total score

Each patient answered 10 questions in terms of their LOH symptoms. Higher scores represented severe LOH symptoms; an SMI score >50 indicated serious LOH symptoms.

Table V.  The pre-treatment values of several parameters obtained from 151 patients with LOH, such as age, pathogenic alternation score, SMI, IIEF 5, AMS total and free testerone levels and IPSS were indicated.

	Mean ± SD	Range
Age	55.4 ± 10.1	31–86
Excess – insufficiency score	47.4 ± 10.2	10–73
SMI	59.2 ± 15.2	20–100
IIEF 5	9.6 ± 6.6	1–24
AMS	52.6 ± 9.8	34–75
Total testosterone (ng/mL)	3.64 ± 1.34	0.58–10.6
Free testosterone (pg/mL)	7.5 ± 2.0	2.0–11.7
Total IPSS	11.0 ± 8.5	1–28

Figure 1.  The rate of Japanese traditional herbal medicine administration. More than half of patients with LOH received Kamishoyosan (TJ-24), followed by Hachimijiogan (TJ-7) and Tokishakuyakusan (TJ-23).

Figure 2.  The mean score of SMI of patients with LOH decreased significantly four weeks after Japanese traditional herbal medicine administration. (*p < 0.0001; Student t test).

Figure 3.  The efficacy of Japanese traditional herbal medicine for LOH was 41.8, 29.1, and 29.1% in the Excellent, Fair, and Poor response groups, respectively. Accordingly, 70.9% of patients with LOH treated with Japanese traditional herbal medicine experienced favorable effects.

Table VI.  The efficacy rate of Kampo for 151 patients with LOH according to their pathogenic alteration.

	Excellent	Fair	Poor	Efficacy rate (%)
Excess	15	8	3	23/26 (88.5)
Intermediate	36	18	19	54/73 (74.0)
Insufficiency	12	18	22	30/52 (57.7)
Total	63	44	44	107/151 (70.9)

Table VII.  The efficacy rate of six Japanese traditional herbal medicines (Kampo) for 151 patients with LOH.

	Excellent	Fair	Poor	Efficacy rate (%)
Keishibukuryogan (TJ-25)	9	3	3	12/15 (80.0)
Kamishoyosan (TJ-24)	40	25	23	65/88 (73.9)
Tokishakuyakusan (TJ-23)	4	6	10	10/20 (50.0)
Hachimijiogan (TJ-7)	8	8	8	16/24 (66.7)
Hochuekkito (TJ-41)	0	2	0	2/2 (100)
Saikokaryukotsuboreito (TJ-12)	2	0	0	2/2 (100)
Total	63	44	44	107/151 (70.9)

Figure 4.  Pathogenic alteration scores in Excellent response group patients were significantly higher than those in the Fair and Poor response groups (*p = 0.0497, +p = 0.0035; ANOVA Scheffe's procedure).

Figure 5.  SMI scores in Excellent response group patients were significantly lower than those in the Poor response group (*p = 0.0092; ANOVA Scheffe's procedure).