Effect of Combined Acupuncture and Shen Zao An Shen Tang on Sleep Quality of Insomnia Patients Due to Deficiency of the Heart and Spleen

1 The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin 150001, China

2 Atlantic Institute of Oriental Medicine, Florida 32424, USA

3 Harbin Chinese Medicine Hospital, Harbin 150001, China

CLINICAL STUDY

Effect of Combined Acupuncture and Shen Zao An Shen Tang on Sleep Quality of Insomnia Patients Due to Deficiency of the Heart and Spleen

Kou Ji-you1, Wei Yan1, Tong Xin2, Yang Long3

1 The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin 150001, China

2 Atlantic Institute of Oriental Medicine, Florida 32424, USA

3 Harbin Chinese Medicine Hospital, Harbin 150001, China

Author: Kou Ji-you, M.D., associate chief physician

Objective: To observe the clinical efficacy of acupuncture combined withShen Zao An Shen Tangfor insomnia due to deficiency of the heart and spleen, investigate the law of treating insomnia based on syndrome differentiation, and thus provide evidence for treatment based on differentiation of insomnia in traditional Chinese medicine.

Methods: A total of 62 cases with insomnia due to deficiency of the heart and spleen were randomized into a combined acupuncture and Chinese herbal formula group and a Western medication group, 31 cases in each group. Acupuncture and self-madeShen Zao An Shen Tangwere employed in the former, while Estazolam was used in the latter. After a 28-day treatment, the clinical efficacy, sleep efficiency, sleep dysfunction rating scale (SDRS) and adverse reactions in the two groups were observed and compared.

Results: The total effective rate in the combined acupuncture and Chinese herb formula group was 96.8%, versus 74.2% in the Western medication group, showing a statistically significant difference (P＜0.05). After treatment, the sleep efficiency ratios in both groups were significantly increased (P＜0.01,P＜0.05), and there was a between-group statistically significant difference (P＜0.05). Also, the SDRS scores in both groups were decreased (P＜0.01,P＜0.01) and there was a between-group statistically significant difference (P＜0.01). In addition, the adverse reaction rate in the combined acupuncture and Chinese herb formula group was significantly lower than that in the Western medication group (P＜0.05).

Conclusion: Combining acupuncture and Chinese herb formula can obtain a substantial clinical efficacy for insomnia due to deficiency of the heart and spleen and improve the patients’ sleep quality. Compared with Estazolam, it is better in effect and less in adverse reactions.

Acupuncture Therapy; Acupuncture Medication Combined;Shen Zao An Shen Tang; Insomnia; Heart-spleen Deficiency; Syndrome Differentiation Treatment

Insomnia refers to inability to fall asleep or remain asleep for an adequate duration of time. It can greatly affect patients’ work and life. Most patients with insomnia can experience symptoms such as fatigue, lassitude, drowsiness, poor concentration, slow reaction and anxiety. It’s estimated that there will be up to 0.7 billion insomnia sufferers till 2020[1]. In Chinese medicine, insomnia is also known as sleeplessness. According to Chinese medicine, insomnia is located in the heart but associated with the spleen, stomach, liver, gallbladder and kidney. One of the most common patternsis deficiency of the heart and spleen due to excessive thinking[2-3]. To explore patterns of insomnia and provide practical evidence for treatment based on pattern identification, we’ve observed the effect of acupuncture combined with Chinese herbal formula for insomnia due to deficiency of the heart and spleen. The results are now summarized as follows.

1 Clinical Materials

1.1 Diagnostic criteria

1.1.1 Diagnostic criteria in Western medicine

The diagnostic criteria were made according to the third edition ofChinese Classification and Diagnostic Criteria of Mental Disorders(CCMD-3)[4]. Predominant complaint of insomnia, including difficulty initiating sleep, difficulty maintaining sleep, frequent waking, early morning awakening, problems returning to sleep after awakening, feeling unrefreshed, fatigue or daytime drowsiness; preoccupation with the sleeplessness and excessive concern over its consequences; the sleep disturbance causeing clinically significant distress or impairment in social functioning; the sleep disturbance occurring at least three times per week for at least 1 month.

1.1.2 Diagnostic criteria in Chinese medicine

This was made according to theGuiding Principles for Clinical Study of New Chinese Medicines[5]. In mild cases, patients may experience difficulty falling asleep, frequent awakening and inability to return to sleep after awakening. In severe cases, patients cannot sleep throughout the night. Insomnia is typically accompanied by headache, dizziness, palpitations, poor memory and dreams.

Pattern identification of insomnia due to deficiency of the heart and spleen: insomnia, dream-disturbed sleep, palpitations, poor memory, dizziness, blurred vision, mental fatigue, a lusterless complexion, a pale tongue with white coating and a thready weak pulse.

1.2 Inclusion criteria

Those who met the above diagnostic criteria in both Western and Chinese medicine; those who met the criteria for deficiency of the heart and spleen; aged between 18 and 65; the sleep disturbance lasted for at least 1 month; those who haven’t taken any psychoactive drugs or discontinued psychoactive drugs for at least two weeks; agreed to participate in the study and signed the informed consent.

1.3 Exclusion criteria

Having complications of severe diseases involving the cardiovascular, lung, liver, kidney and hematopoietic systems, hemophilia or other hemorrhagic diseases, nervous system conditions, mental disorders, tumor, and pregnant or breast-feeding women; having a history of epilepsy, sleep apnea syndrome, chronic obstructive pulmonary disease (COPD) and restless leg syndrome; having fever or contracted infection over the last week or having taken some medicine that can affect sleep; those who didn’t meet the inclusion criteria or comply with the treatment that made therapeutic efficacy and safety evaluation impossible.

1.4 General data

A total of 62 insomnia cases were treated in Acupuncture Outpatient Department, the Second Affiliated Hospital of Heilongjiang University of Chinese Medicine between July 2012 and April 2013. They were randomly allocated into a combined acupuncture and Chinese herbal formula group and a Western medication group, 31 in each group. There were no statistical differences in gender, age and duration between the two groups (P＞0.05), indicating that the two groups were comparable (Table 1).

Table 1. Between-group comparison of general data

2 Treatment Methods

2.1 Combined acupuncture and Chinese herbal formula group

2.1.1 Acupuncture therapy

Points: Baihui (GV 20), Sishencong (EX-HN 1), Shenting (GV 24), Fengchi (GB 20), Xinshu (BL 15), Pishu (BL 20), Shenmen (HT 7), Neiguan (PC 6), Zusanli (ST 36), Sanyinjiao (SP 6) and Zhaohai (KI 6).

Method: Puncture the above points using filiform needles of 0.35 mm in diameter and 40 mm in length. Apply reinforcing manipulation to Xinshu (BL 15), Pishu (BL 20), Sanyinjiao (SP 6) and Zhaohai (KI 6). Apply even reinforcing-reducing manipulation to the rest points. Manipulate once every 10 min. Retain the needles for 30 min.

The acupuncture treatment was done once a day, 6-day makes up one treatment course. There was a 2-day interval between two courses. The patients were treated for a total of 4 courses.

2.1.2 Chinese herbal formula

Ingredients in the self-madeShen Zao An Shen Tang:Dang Shen(Radix Codonopsis),Suan Zao Ren(Semen Ziziphi Spinosae),Bai Zhu(Rhizoma Atractylodis Macrocephalae),Huang Qi(Radix Astragali),Fu Shen(Sclerotium Poriae Pararadicis),Yuan Zhi(Radix Polygalae),Long Yan Rou(Arillus Longan),Bai Zi Ren(Semen Platycladi),Ye Jiao Teng(Caulis Polygoni Multiflori),Fu Ling(Poria),Dang Gui(Radix Angelicae Sinensis),Chen Pi(Pericarpium Citri Reticulatae),Cu Chai Hu(vinegar-processed Radix Bupleuri),Yu Jin(Radix Curcumae) andGan Cao(Radix et Rhizoma Glycyrrhizae). The patients took one dose (500 mL) twice a day, once before breakfast and once after dinner.

2.2 Western medication group

The patients took 1 mg of Estazolam every day before going to bed, for a total of 28 d.

3 Therapeutic Efficacy Observation

3.1 Observation indexes

In order to observe the patients’ sleep quality, sleep duration, awakening and mental status after awakening, they were asked to fill in the sleep dysfunction rating scale (SDRS) 1 d before treatment and 2 d after treatment.

3.1.1 Sleep efficiency ratio

The sleep efficiency ratio was calculated by using the internationally recognized formula.

Sleep efficiency ratio ＝ Time asleep ÷ Actual time spent in bed × 100%.

3.1.2 SDRS

Currently, SDRS is reliable and valid for insomnia evaluation. This scale classifies insomnia into early, middle and late stages and analyzes each stage respectively. Using this scale, we can evaluate the sleep quality, duration and mental status upon awakening. The score ranged from 0 to 40. A higher score indicates a poorer sleep quality and shorter sleep duration.

3.1.3 Adverse reactions

During treatment, adverse reactions have been documented and compared between the two groups.

3.2 Therapeutic efficacy criteria

These were made according to theGuiding Principles for Clinical Study of New Chinese Medicines[5].

Clinical recovery: Patients restore to normal sleep or have more than 6 h of sound refresh sleep.

Marked effect: Patients have better sleep quality and the sleep time is increased by over 3 h.

Improvement: The sleep time is increased by less than 3 h.

Failure: Insomnia remains unchanged or becomes worse.

3.3 Statistical methods

The SPSS 19.0 version statistical software was used for statistical analysis, mean ± standard deviationfor expression of measurement data, independent staplet-test for inter-group comparison, paired samplet-test for intra-group comparison, Chi-square test for numeration data. APvalue of＜0.05 indicates a statistical significance.

3.4 Results

3.4.1 Between-group comparison of clinical efficacy

The total effective rate of the combined acupuncture and Chinese herbal formula group was 96.8%, versus 74.2% in the Western medication group. Chi-square test showed a statistical significance (P＜0.05), (Table 2).

Table 2. Between-group comparison of clinical efficacy

3.4.2 Between-group comparison of sleep rate

Before treatment, there was no statistical significant difference in sleep rate between the two groups (P＞0.05). After 4 weeks of treatment, the sleep rates in both groups were substantially improved (P＜0.01,P＜0.05); there was a statistical significant difference in sleep rate between the two groups (P＜0.05), showing a better result in the combined acupuncture and Chinese herbal formula group than that in the Western medication group (Table 3).

3.4.3 Between-group comparison of SDRS score

Before treatment, there was no statistical significant difference in SDRS score between the two groups (P＞0.05). After 4 weeks of treatment, the intra-group and inter-group comparisons bothshowed significant differences in SDRS score (P＜0.01), (Table 4).

Table 3. Between-group comparison of sleep rate (%)

3.4.4 Between-group comparison of adverse reactions after treatment

During the treatment, no adverse reactions occurred in the combined acupuncture and Chinese herbal formula group except 1 patient fainted from needling. As for the Western medication group, one patient experienced headache, four experienced dizziness, 2 experienced a dry mouth and two experienced fatigue. Chi-square test suggested that the adverse reaction rate was substantially lower in the observation group than that in the Western medication group, showing a statistical significance (P＜0.05), (Table 5).

Table 4. Between-group comparison of SDRS score (point)

Table 4. Between-group comparison of SDRS score (point)

Note: CACHF=Combined acupuncture and Chinese herbal formula group; WM=Western medication group; intra-group comparison before and after treatment, 1) P＜0.01; compared with Western medication group after treatment, 2) P＜0.01

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Table 5. Between-group comparison of adverse reactions (case)

4 Discussion

In Chinese medicine, insomnia falls under the category of ‘sleeplessness’. Contributing factors may include disharmony between Ying-Nutrient and Wei-Defensive due to internal or external pathogens and deficiency of yin, yang, qi and blood of the Zang-fu organs. Acupuncture has a long history of good effects for insomnia[6-9]. As for insomnia due to deficiency of the heart and spleen, excessive worries may consume heart blood and at the same time affect the spleen’s function in transportation and transformation, leading to a poor appetite and subsequent insufficiency of Ying-Nutrient blood, which in turn fails to nourish the heart mind. As a result, blood deficiency is the root cause of insomnia, and too much thinking is the inducing factor. Clinically, the liver needs to be regulated. The treatment principles for this pattern are to tonify heart blood, strengthen spleen qi, regulate the liver and calm the mind. Xinshu (BL 15), Pishu (BL 20), Neiguan (PC 6), Zusanli (ST 36) and Sanyinjiao (SP 6) were selected to strengthen spleen qi and tonify heart blood; Baihui (GV 20), Sishencong (EX-HN 1), Shenting (GV 24) and Shenmen (HT 7) to benefit the brain and calm the mind. Fengchi (GB 20), a crossing point between The Gallbladder Meridian and the Yang Link Vessel, is a common point for insomnia. Reducing manipulation on Fengchi (GB 20) can soothe the liver and gallbladder, inhibit liver wind and calm the mind[10]. Zhaohai (KI 6) can nourish kidney yin, guide Wei-Defensive qi into yin and calm the mind. However, regulation of deficiency and excess using needles is limited by individual constitutions. Therefore, we combined self-madeShen Zao An shen Tangto consolidate the effect of tonifying qi and blood, regulating the liver and tranquilizing the mind.

This study has proven that acupuncture combined with self-madeZao Ren An Shen Tangcan effectively improve the patients’ sleep quality and efficiency, thus obtain significantly better overall effective rate than Estazolam. In addition, no obvious adverse reactions have been found. This method deserves further clinical application.

Conflict of Interest

There is no conflict of interest in this article.

Acknowledgments

This work was supported by Heilongjiang Administration of Traditional Chinese Medicine (No. ZHY12-Z030).

Statement of Informed Consent

All the patients signed the informed consent.

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Wei Yan, M.D., associate chief physician.

E-mail: weiyan76424@163.com

R246.6

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r:Han Chou-ping

Date:December 12, 2013