J. Acupunct. Tuina. Sci. 2010, 8 (1): 17-19 DOI: 10.

1007/s11726-010-0017-8

Special Topic Study

Clinical Study on Acupuncture and Daytime Wakefulness in Insomnia Patients

GUO Jing ()1, WANG Lin-peng ()1, WU Xi ()2 1 Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing 100010, P. R. China 2 Dongfang Hospital Affiliated to Beijing University of Traditional Chinese Medicine, Beijing 100078, P. R. China

60 2 30 30 d Epworth Sleepinss ScaleESSPittsburgh Sleep Quality IndexPSQI Abstract Objective: To observe the effect of acupuncture on daytime wakefulness in insomnia cases. Method: Sixty primary insomnia cases were randomized into a treatment and control group, 30 cases in each group. The 30 cases in the treatment group were needled on Baihui (GV 20), Shenting (GV 24), Shenmen (HT 7) and Sishencong (Ex-HN 1), whereas the 30 cases in the control group were prescribed Estazolam. After 30 d of treatment, the sleep of all cases was evaluated using the Epworth Sleepiness Scale (ESS) and Pittsburg Sleep Quality Index (PSQI). Result: The daytime wakefulness and sleep quality in the treatment group improved faster than those in the control group. Conclusion: Acupuncture has a better effect than Estazolam in the treatment of primary insomnia. Key WordsAcupuncture Therapy; Insomnia; Randomized Controlled Trial CLC NumberR246.6 Document CodeA Insomnia is becoming a more and more common problem in modern society associated with fast pace of life. Long-term insomnia may affect people both physiologically and psychologically. Furthermore, it may also cause a decline of daytime wakefulness, thus leading to daytime drowsiness, fatigue, sluggishness, indifference, dozing-off, impaired memory and reduced attention span. Numerous major accidents have been proven to be associated with impaired wakefulness. The conventional way for insomnia is to take sleeping pills. However, these pills may alter the
Fund Item: Youth Scientific Research Program by Beijing Municipal Health Bureau and Beijing Administration of Traditional Chinese Medicine Author: GUO Jing (1970- ), female, associate chief physician, doctor of medicine

normal physiological structure and decrease daytime wakefulness, which may, in turn, compromise work efficiency. Since daytime wakefulness plays a decisive role in the quality of life, other than sleep quality at night, more studies should be targeted at daytime wakefulness. Acupuncture has been reported to improve insomnia but cause no side effects. This study intends to compare the effect of treatment between acupuncture and sleeping pills using Epworth Sleepiness Scale (ESS) and Pittsburg Sleep Quality Index (PSQI).

1 Clinical Data
1.1 Inclusive criteria This is based on the diagnostic criteria of nonorganic insomnia listed in the International

Shanghai Research Institute of Acupuncture and Meridian and Springer-Verlag Berlin Heidelberg 2010 17

J. Acupunct. Tuina. Sci. 2010, 8 (1): 17-19

Classification of Diseases, Tenth Revision (ICD-10). These include: aged from 20 to 70 years; moderate or severe insomnia lasting more than 4 weeks; and never having taken or have psychoactive drugs or discontinued the administration of psychoactive drugs for more than two months. 1.2 Exclusion criteria These include women during pregnancy or lactation, cases with complication due to severe mental conditions, such as depression, anxiety or schizophrenia, cases with severe problems involving the heart, brain, kidney and liver; and cases that are not cooperative for the treatment. 1.3 Subjects All the 60 cases were from the outpatient department of Beijing Hospital of Traditional Chinese Medicine. They were randomized into two groups by the visit sequences. Of 30 cases in the treatment group, there were 14 males and 16 females, with an average age of (49.0811.57) years and mean duration of (57.6851.10) months. Of 30 cases in the control group, there were 12 males and 18 females, with an average age of (52.059.27) years and mean duration of (53.2126.35) months. Statistical analysis showed no significant difference in general data.

2.2.2 Control group Took Estazolam 1 mg orally before going to bed, once every other day. The effect was evaluated after 30 d. 2.3 Observation and evaluation indexes The ESS and PSQI evaluation. 2.4 Time frame of the observation The treatment lasted for 30 d. The evaluation was made on the 7th, 14th and 30th days of the treatment. 2.5 Statistical analysis The SPSS10.0 version software was adopted to conduct analysis. A two-sided test was adopted for all data, P<0.05 representing a significant difference. The measurement data were expressed with x s. The analysis of variance and t-test were used for inter-group comparison.

3 Results
3.1 Daytime wakefulness Comparison on total ESS scores at different time frames was shown in table 1 and the inter- group comparison before and after the treatment was shown in table 2.
Table 1. Comparison of total ESS scores at different time frames before and after the treatment ( x s) Groups Control t p n Pre-treatment 7th day 14th day 30th day Treatment 30 6.044.57 30 7.006.43 0.50 0.62 3.123.20 1.602.08 0.851.32 6.805.39 6.205.16 5.104.12 2.54 0.04
1)

2 Method
2.1 Randomization By the ratio of 1:1 and an expulsion rate of 20%, 72 envelopes were prepared with randomized numbers on them. The cases were treated according to the group code inside the envelope. 2.2 Treatment method 2.2.1 Treatment group Points: Baihui (GV 20), Shenting (GV 24), Shenmen (HT 7), Sishencong (Ex-HN 1) and Sanyinjiao (SP 6). Method: The above points were punctured with filiform needles of 0.30 mm in diameter and 40-50 mm in length, followed by even reinforcingreducing manipulation. The needles were retained for 30 min. The treatment was performed once a day. There was a 2-day interval after every 5 treatments. Ten times made up one course of treatment. The effect was evaluated after 30 d.

2.53 0.02
1)

4.76 0.00 2)

Note: Compared with the control group, 1) P<0.05, 2) P<0.01

It was seen from table 1 that there was no significant difference between the two groups prior to the treatment. After 7 d of treatment, the ESS scores in the treatment group were substantially reduced (P<0.05), and there were more significant differences between the two groups on the 14th and 30th days.
Table 2. Intergroup comparison of score decrease after the treatment ( x s) Groups Treatment Control t P n 30 30 7 d after 2.922.70 0.201.89 2.92 0.006 1) 114 d after 4.423.38 0.801.87 3.18 0.003 1) 30 d after 5.193.81 1.903.93 2.31 0.027 2)

Note: Compared with the control group, 1) P<0.01, 2) P<0.05

18

Shanghai Research Institute of Acupuncture and Meridian and Springer-Verlag Berlin Heidelberg 2010

J. Acupunct. Tuina. Sci. 2010, 8 (1): 17-19

It was seen from the table 2 that the ESS scores in the treatment group were significantly lower than the control group (P<0.01). There was still a significant difference on the 30th day of the treatment (P<0.05). 3.2 Sleep quality
Table 3. Inter-group comparison of total PSQI scores at different timeframes before and after treatment ( x s) Groups Control t p n Pre-treatment 7th day 14th day 30th day Treatment 30 13.962.37 30 13.702.91 0.28 0.78 11.032.97 8.813.48 6.382.30 11.802.49 11.32.79 10.0010.6 0.718 0.48 2.03 0.05 4.97 0.00 1)

Note: Compared with the control group, 1) P<0.01

The t test showed that there was no significant difference between the two groups prior to the treatment. However, after 30 days of treatment, the PSQI scores were significantly lower in the treatment group than in the control group (P<0.01).

4 Discussion
Insomnia is now a common problem in modern society. The global insomnia survey in 2002 showed that 43.4% Chinese people experienced varying degrees of insomnia in the previous years and 20.0% of them turned to sedative-hypnotic drugs[1]. However, these drugs often alter the physiological structure of sleep and decrease daytime wakefulness, which in turn compromise the quality of life and work. As a result, prolonged sleep time alone can no longer satisfy the clinical treatment. It is of great significance to develop an effective way that can increase sleep quality and improve daytime wakefulness. Currently, many physicians have started to evaluate the effect of hypnotic drugs on daytime dozing as well as sleep quality at night[2]. Since acupuncture has benign bi-directional regulation, it has shown considerable advantages in the treatment of insomnia for its minimal side effects, such as addiction or withdrawal syndrome[3-5]. In addition, it can improve daytime alertness as well as improving the sleep quality. In this study, the effects of acupuncture and Estazolam on daytime alertness were compared using the ESS. After 7 d of treatment, the ESS scores in the treatment group

were substantially lower than the control group, indicating a significantly higher daytime alertness. Longer treatment sessions contribute to better effects. Analysis from the score-reducing has shown that acupuncture worked substantially faster than Estazolam in improving daytime alertness. Furthermore, the total scores of PSQI in the treatment group were also significantly lower than the control group after 30 d of treatment, indicating that acupuncture worked faster in improving sleep quality. The Nei Jing (Inner Classic) recorded that disorders of the Ying-Nutritive and Wei-Defensive qi contribute to insomnia. Those with insomnia may present with restlessness at night and difficulty falling asleep, listlessness during the day, reduced attention span and impaired memory. Regarding the treatment, both the sleep quality and daytime wakefulness should be managed to regulate the "brain mind" and "heart-mind"[6]. Baihui (GV 20), Shenting (GV 24) and Sishencong (Ex-HN 1) act to calm the mind and refresh the brain; Shenmen (HT 7) acts to regulate heart-mind; and Sanyinjiao (SP 6) to balance yin and yang. Findings of this study have suggested that acupuncture has advantages in treating insomnia.

References
[1] Task Force. Consensus of Task Force on Definition and Diagnosis and of Insomnia and Drug Therapy (Draft). Chinese Journal of Neurology, 2006, 39 (2): 141. [2] KU Bao-shan. Pharmacological Study on Slow-wave Sleep. Journal of Beijing Medical University, 1999, 31(3): 204. [3] LU Jin. Clinical Observations on Treatment of Insomnia by Acupuncture Method of Harmonizing Nutrient and Defense. Shanghai Journal of Acupuncture and Moxibustion, 2008, 27(2): 6-7. [4] WANG Yu-ming, WU Hai-yan. Observation on Therapeutic Effect of Acupuncture plus Moxibustion for Insomnia. Journal of Acupuncture and Tuina Science, 2007, 5(5): 281-283. [5] YAO Xue-ying. Combined Acupuncture and Auricular Plaster Therapy for the Treatment of 202 Insomnia Cases. Shanghai Journal of Acupuncture and Moxibustion, 2007, 26 (11): 27. [6] GUO Jing, WANG Lin-peng. Significance of "Brain-mind" and "Heart-mind" in Acupuncture Treatment of Insomnia. Chinese Acupuncture & Moxibustion, 2007, 27 (suppl): 71. Translator: HAN Chou-ping () Received Date: December 15, 2009

Shanghai Research Institute of Acupuncture and Meridian and Springer-Verlag Berlin Heidelberg 2010 19