Kambakutaisoto Treatment for Children With Night Crying and Arousal Parasomnias Developed During Prolonged Hospitalization for Hematological and Oncological Diseases

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Journal of Child Neurology

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Figure 1

246x175mm (300 x 300 DPI)

Figure 1. Three-dimensional high-performance liquid

chromatography of kambakutaisoto extract granules.

Three-dimensional high-performance liquid chromatography was performed

using a representative lot of pharmaceutical-grade kambakutaisoto extract

granules (Tsumura & Co, Tokyo, Japan) administered in this study. This chart

was provided by Tsumura & Co.

Journal of Child Neurology

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Figure 2

146x115mm (300 x 300 DPI)

Figure 2. Cumulative incidence of night crying and non-rapid

eye movement-related parasomnias in the study cohort.

The 1-year cumulative incidence of night crying/parasomnia was 0.0832.

Journal of Child Neurology

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Figure 3

223x90mm (600 x 600 DPI)

Figure 3. Serum potassium and body weight change after

kambakutaisoto treatment.

Children receiving kambakutaisoto were followed up to monitor serum

potassium levels and body weight changes for signs of pseudo-aldosteronism.

Potassium level was essentially unchanged after 1 and 2 weeks after initiating

kambakutaisoto treatment (Wilcoxon signed-rank test, P = 1.0 and P = 1.0,

respectively). Similarly, body weight was unchanged after one and two weeks

after initiating kambakutaisoto treatment (Wilcoxon signed-rank test, P = .25 and

P = 1.0, respectively).

Journal of Child Neurology

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Table 1. Characteristics of the study cohort.

Total cohort

N = 137

4.1 (0.02Age at hospitalizaion, median year (range)

18.5)

Male, n

77

Sex

Female, n

60

Hematological malignancy

46

Disease, n

Non malignancy

28

Solid tumor

63

Operation*

41

(30%)

Invasive

procedures, n

Stem cell transplant

35 (26%)

(%)

Operation or transplant

68 (50%)

*Operations for catherter insertion or biopsy were excluded.

Night crying/parasomnia

No

Yes

n = 131

4.1 (0.0218.5)

76

55

45

26

60

39 (30%)

31 (24%)

62 (47%)

n=6

2.5 (0.310.1)

2 (33%)

4 (67%)

6 (100%)

0.230

0.086

0.573

1.000

0.037

0.013

Journal of Child Neurology

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Table 2. Clinical characteristics of children with night crying and parasomnia

ID

Age

KBT01 10.5

KBT02 3.6

Sex

Dx

PMH

Family history

of parasomnia

Invasive

proceture

AA

AA

PRES

BMT

BMT

Sleepwalking

Op

KBT03

2.0

RMS

KBT04

KBT05

KBT06

0.6

2.0

3.5

RMS

ALL

NB

Confusional arousal

Op

BMT

aPBSCT

Duration

from

Daytime

Night Confusion

Insomnia

procedur sleepiness

crying al arousal

e (wk)

17

+/12

Sleepwalking

Sleep

terrors

Dosage

of

kambakutaisoto

(g/kg/d)

Heart Blood deficiency 0.22

Heart Spleen deficiency 0.21

bid

hs

Episode

on the

start of

therapy

(/night)

Autonomi

Episode

(/night)

symptoms

Kampo dx

Heart Blood deficiency

0.15

hs

52

+/-

Heart Blood deficiency

Heart Spleen deficiency

Heart Spleen deficiency

0.19

0.13

0.20

hs

bid

bid

Duration

of

Recurrence of

Side effect

kambakuepisodes

taisoto (d)

20

+ (resolution

372

after changed to

18

bid)

56

Diarrhea improvement

Abbreviations: M, male; F, female; Dx, diagnosis; AA, aplastic anemia; RMS, rhabdomyosarcoma; ALL, acute lymphoblastic leukemia; NB, neuroblastoma; PMH, past medical history; PRES, posterior reversible encephalopathy syndrome; BMT, bone marrow transplant; aPBSCT, autologous peripheral blood stem cell transplant; Op, resection of the

tumor; bid, twice a day; hs, before sleep.

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