Suan Zao Ren Tang as an original treatment for sleep difficulty in

得意仁琮治療電年斯緝世唾 ~fî禮磁立毒縱觀察研究〉
Suan Zao Ren Tang as an original treatment for
sleep difficulty in climacteric women:a prospective
clinical observation
2
1
Chia-Hao Yeh1 . , ]ung-Nein Lai , 3*
lInstitute of Traditional Medicine, School of Medicine, National Yang-Ming University
2 0 epar加lent of Chinese Medicine, Taipei City Hospital, Yang Ming Branch
30epartment of Obstetric and Gynecology, Taipei Ci ty Hospital, Yang Ming Branch, Taipei,
Taiwan
Background
Little scientific evidence supports the efficacy of herbal rnedicines in the
treatrnent of wornen with sleep difficulty during the clirnacteric period. The purpose
of this study is to evaluate both the efficacy and safety of a finished Chinese herbal
preparation Suan Zao Ren Tang(SZRT)in reducing the irnpact of sleep disturbance on
clirnacteric wornen.
Methods
A prospective follow-up study was carried out in Yang Ming branch of Taipei
City Hospital between April 2008 and Decernber 2009. Fifty-two clirnacteric wornen
with sleep
difficuli旬，
received SZRT at a rate of 4.0 g , thrice daily for four weeks.
Baseline scores were rneasured on the Pittsburg Sleep Quality Index(PSQI) , followed
by further rneasures at the end ofweeks 1, and 4. The Menopause Rating Scale(MRS)
were undertaken as secondary outcornes. Regression rnodels were constructed to
explore the score differences between the baseline and at weeks 1 and 4 by various
deterrninants including age , body rnass index(BMI) , and severity of baseline
rnenopausal syrnptorns.
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φ 醫藥研究論叢
Results
Arn ong 78 surveyed patients , 52 and 42 were screened for intention to treat(ITT)
and per-protocol population set analysis, respectively. There were statistically
significant reductions in the PSQI index scores on the fourth week. By week 4, the
mean PSQI scores had fallen from 13.5(+2 .2 )to
9.8( 士 3.2)(95%
confidence interval
[CI] 2.57 , 4.59)for total score , from 2 .4( + 0.5)to 1. 6( + 0.8)(95% CI
for subjective sleep quality, from 2 .4( + 0.8)to
1. 9( 士 0.9)(95%
0.51 月 .99)
CI 0.21 ,0.75)for
sleep latency, and from 2. O( + 1. 1)to 1. 1(士1. 1)(95% CI 0.56 , 1. 17)for habitual sleep
efficiency. There were no significant improvement in scores of subjective disturbance
and daytime dysfunction at weeks 4 among intention-to-treat population. Further
analyses showed that SZRT might not be as effective in treating poor sleepers with
severe menopausal
symptoms(MRS 孟 16) ，
compared with those with mild and
moderate symptoms. Five adverse drug reactions were detected: three events of acid
regurgitation , headache , chest pain, and two events of stomach ache.
Discussion
Excluding women with past history of heartburn or acid regurgitation, four
weeks of therapy with the Chinese herbal preparation SZRT appears to be a relatively
safe and effective short-term therapeutic option for climacteric women with poor
sleep quality, and may be considered to ease women's transition into menopause.
Keywords
Suan Zao Ren Tang , climacteric , Pittsburg Sleep Quality Index , sleep difficulty
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