Clinical Efficacy of Sedative Cataplasm for Insomnia Patients with Sub-health

Xiaoxue GONG, Qin GONG, Xi WANG

1. Shiyan Hospital of Traditional Chinese Medicine, Shiyan 442000, China; 2. Shiyan Taihe Hospital/Affiliated Hospital of Hubei University of Medicine, Shiyan 442000, China

Abstract [Objectives] This study aimed to observe the clinical efficacy of sedative cataplasm in the treatment of insomnia patients with sub-health. [Methods] A total of 90 insomnia patients with sub-health were randomly and evenly divided into treatment group and control group. The patients in the control group were given Bozi Yangxin pills orally, and those in the treatment group were treated with sedative cataplasm on Shenjue acupoint. The treatment duration was 4 weeks. The Pittsburgh Sleep Quality Index (PSQI) was used to evaluate clinical efficacy. [Results] The overall efficacy of the treatment group and control group was 91.1% and 77.1%, respectively, and the difference between the two was significant (P<0.05). After treatment, the PSQI scores of each group changed significantly (P<0.05). [Conclusions] Sedative cataplasm has a good clinical efficacy on sub-healthy insomnia patients.

Key words Sub-health, Insomnia, Sedative cataplasm, Clinical observation

1 Introduction

Sub-health refers to a state in which the human body is between health and disease, and being in a stressful environment for a long time and a fast-paced life may lead to a sub-healthy state. It is a physical and psychological state mainly manifested as insomnia, fatigue, decreased energy, decreased immunity, low physical function and decreased adaptability[1-2]. The WHO classifies sub-health as one of the greatest enemies of human health in the 21stcentury. Investigations and studies show that about 60% of people in China are currently at a sub-health state. Among the various sub-health symptoms, insomnia is the most common[3], accounting for about 42.5% of the total amount at the sub-health state[4]. Most of sub-healthy people have mild to moderate insomnia[5]. In terms of treatment of insomnia, Western medicine mainly uses hypnotics, sedatives or antidepressants. However, long-term use may lead to adverse reactions such as addiction, poisoning and resistance[6]. In recent years, traditional Chinese medicine, represented by non-drug external treatment, has made great progress and broad application prospects for sub-healthy insomnia patients[7]. In this study, Shenjue acupoint application with sedative cataplasm was used to to treat insomnia patients with sub-health, and the efficacy was satisfactory.

2 Objects and methods

2.1 General informationThe 90 cases (42 males, 48 females) were from the insomnia clinics of Shiyan Hospital of Traditional Chinese Medicine and Shiyan Taihe Hospital from March, 2016 to December, 2017, with an average age of (32.2±5.7) years, and an average disease course of (1.5±0.5) years. They were randomly and evenly divided into sedative cataplasm treatment group and Bozi Yangxin pill control group. There was no statistical difference between the two groups in general demographic data such as gender, age, and disease course.

2.2 Diagnostic criteria and exclusion criteria

2.2.1Diagnostic criteria. The diagnostic criteria of sub-health and insomnia referred to theClinicalGuidelinesofChineseMedicineonSub-health[8]andGuidingPrinciplesforClinicalStudyofNewChineseMedicines[9].

2.2.2Inclusion criteria. The inclusion criteria were as follows: meeting the above diagnostic criteria; the Pittsburgh Sleep Quality Index (PSQI) within 8-15 points; had not taken sleep-improving drugs in the past two weeks.

2.2.3Exclusion criteria. The patients with any of the following situations were excluded: chronic insomnia, secondary insomnia, alcohol and drug abuse, severe mental illness, major life events in the past half month, serious primary diseases such as physical and brain organic illness, pregnancy and lactation.

2.3 Treatment methodsThe patients in the control group were treated with Bozi Yangxin pills orally, 6 g/time, and 3 times/d.

The patients in the treatment group were given sedative cataplasm, developed by Pharmacy Department of Shiyan Hospital of Traditional Chinese Medicine, composed of Semen Ziziphi Spinosae (30 g), Fructus Schisandrae Chinensis (15 g), Flos Notoginseng (10 g), Radix Acanthopanacis Semticosi (15 g), Rhizoma Acori Tatarinowii (15 g), Radix Polygalae (10 g), Rhizoma Anemarrhenae (10 g), Rhizoma Coptidis (6 g), Radix Angelicae Sinensis (15 g), Dens Draconis (30 g), Concha Margaritifera Usta (30 g), amber powder (10 g) and cinnabar (3 g). Sedative cataplasm had a specification of 5 cm × 5 cm, and was applied on Shenjue acupoint (belly button), once a day at night. The patients in both the groups were given psychological counseling and sleep hygiene guidance. During the treatment period, drinking alcohol, coffee and strong tea was forbidden, accompanied by moderate exercise and good living habits. The course of treatment was 4 weeks. The curative effect was observed.

2.4 Indicators observed

2.4.1Efficacy evaluation. Referring to theGuidingPrinciplesforClinicalResearchofNewChineseMedicinesfortheTreatmentofInsomnia[9]formulated by Ministry of Health, China, the clinical efficacy was evaluated. For clinical recovery, sleep time returned to normal level or sleep time at night was more than 6 h; the sleep was deep; and it was energetic after waking up. For significant efficacy, sleep was obviously improved, and sleep time increased by more than 3 h; and depth of sleep increased. For efficacy, symptoms were alleviated; and sleep time increased by less than 3 h. For inefficacy, insomnia had not been improved significantly or even worsened after treatment.

2.4.2Sleep quality evaluation. The PSQI scores were used to evaluate the subject’s sleep quality before and after treatment. If the score was greater than 7, it indicates that there was a problem with the sleep quality. The greater the score, the more serious the sleep problem[10]. The scoring was performed around the treatment. Before and after treatment, blood routine, urine routine, stool routine and occult blood, liver and kidney function and electrocardiogram were checked, and all adverse reactions were recorded and their relationship with the drug tested was analyzed.

3 Results and analysis

3.1 Comparison of clinical efficacyThe overall efficacy of the treatment group and control group was 91.1% and 77.8%, respectively, and the difference between the two was significant (Table 1).

Table 1 Comparison of clinical efficacy between the two groups (n=45)

3.2 Comparison of PSQI scores between the two groups before and after treatmentSedative cataplasm significantly reduced the total PSQI scores of sub-healthy insomnia patients. The six factors of sleep quality, time to fall asleep, sleep time, sleep efficiency, daytime function, and sleep disorders all improved significantly after treatment with sedative cataplasm (P<0.01) (Table 2).

Table 2 Comparison of scores of various PSQI indices between the two groups before and after treatment

4 Discussion

As the pace of modern life is getting faster and faster, people not only have to face the pressure of work and life, and moreover, they are also faced with pressures such as complex interpersonal relationships. Being under greater psychological pressure for a long time is prone to leading to sub-health, and symptoms such as insomnia and fatigue may occur. Long-term insomnia and fatigue will make it difficult to recover energy and physical strength, which will make the physical condition worse. In response to this situation, there has been currently no exact treatment method. Considering all aspects, traditional Chinese medicine is a better way to treat sub-healthy insomnia[11].

Sedative cataplasm comes from Professor Liu Jishan’s experience in the treatment of insomnia, a famous traditional Chinese medicine master in Hubei. The prescription is a pure Chinese medicine preparation, composed of Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis, Flos Notoginseng, Radix Acanthopanacis Semticosi, Rhizoma Acori Tatarinowii, Radix Polygalae, Rhizoma Anemarrhenae, Rhizoma Coptidis, Radix Angelicae Sinensis, Dens Draconis, Concha Margaritifera Usta, amber powder and cinnabar, with functions of calming liver, clearing heat, clearing heart fire, nourishing blood, relieving convulsion and calming the nerves. Semen Ziziphi Spinosae, Fructus Schisandrae Chinensis, Flos Notoginseng, Radix Angelicae Sinensis and Radix Polygalae can tonify heart and calm the nerves; Rhizoma Coptidis, Rhizoma Anemarrhenae and Rhizoma Acori Tatarinowii can clear heat and relieve fidgetness; and Dens Draconis, Concha Margaritifera Usta, amber powder and cinnabar can tranquilize, allay excitement and soothe the nerves. The combination of the medicines above has functions of calming the liver, clearing heat, clearing away heart fire, nourishing blood, and calming the nerves. Sedative cataplasm prepared by modern technology is a non-damage, non-pain and convenient preparation for external use, characterized by large drug load, good biocompatibility with the skin, breathability, sweat resistance, no allergization, no irritation and good drug release performance. It can improve the hydration of the skin, which is conducive to the transdermal absorption of drugs. The drugs penetrate the skin through the cataplasm carrier and act directly on the skin. Thus, drug absorption is not affected by complex factors such as pH value in the digestive tract and food and drug movement time in the intestine, avoiding the first-pass effect of the drugs in the liver and gastrointestinal side effects. Therefore, there is no obvious adverse reaction. In addition, the preparation is easy to use.

The results of this study show that acupoint application of sedative cataplasm is satisfactory for sub-healthy insomnia. It can improve sleep quality without obvious side effects and is worthy of clinical promotion.