LI Li-chun(李丽春)¹, LIANG Yan(梁燕)¹, HU Yong-hong(胡永红)¹, QIN Na(秦娜)¹, LI De-long (李德龙)¹, JIA Chun-sheng(贾春生)^* 2

1. Department of Acupuncture and Moxibustion, Shijiazhuang Municipal Chinese Medicine Hospital, Shijiazhuang 050021,Hebei Province, China; 2. School of Acupuncture, Moxibustion and Tuina, Hebei University of Traditional Chinese Medicine, Shijiazhuang 050020, Hebei Province, China (1．河北省石家庄市中医院针灸科，石家庄 050021，中国; 2.河北中医学院针灸推拿学院，河北石家庄 050020，中国)

ARTICLE INFO

First author: LI Li-chun, physician-in-charge.

Research field: effect specificity of acupuncture and moxibustion techniques.

E-mail: lilichun203@163.com

^*Corresponding author: JIA Chun-sheng, professor, chief physician.

Research field: effect specificity of acupuncture and moxibustion techniques.

E-mail: jia7158@163.com

*Supported by Funding project of Hebei Administration of Traditional Chinese Medicine：2015190； Funding project of Natural Science Foundation of China：81072883, 81173342, 81473773.

Accepted on November 22,2017.

ABSTRACT

Objective To observe the effect of thermosensitive moxibustion on anxiety and depression in the patients of insomnia differentiated as liver qi stagnation. Methods From January 2015 to January 2017, 60 patients of insomnia differentiated as liver qi stagnation were collected in Shijiazhuang Municipal Chinese Medicine Hospital. According to the random number table, the patients were randomized into a moxibustion group (30 cases) and an estazolam group (30 cases). In the moxibustion group, the thermosensitive moxibustion was adopted alternatively to the bilateral yuan-source points of the liver and gallbladder meridians.  In the estazolam group, estazolam, 1 mg was prescribed for oral administration before sleep every day. After 15-day treatments, the sleep quality, the severity of anxiety and depression and the therapeutic effects were observed before and after treatment in the two groups. Results Before treatment, the differences were not significant in the scores of Pittsburgh sleep quality index (PSQI), the self-rating anxiety scale (SAS) and the self-rating depression scale (SDS) between the two groups (all P>0.05). After treatment, the scores of PSQI, SAS and SDS were all reduced remarkably as compared with those before treatment in the two groups (all P<0.05). PSQI score was (6.72±2.311) points in the moxibustion group and was (5.37±2.621) points in the estazolam group. SAS score was (31.76±6.511) points in the moxibustion group and was (39.62±4.371) points in the estazolam group. SDS score was (35.98±5.161) points in the moxibustion group and was (46.38±4.971) points in the estazolam group. After treatment, the scores of PSQI, SAS and SDS in the moxibustion group were reduced more remarkably as compared with the estazolam group, indicating the significant differences (all P<0.05). After treatment, the scores of sleep efficacy and TCM symptoms were (72.65±14.36) points and (69.36±4.28) points respectively in the moxibustion group, better than the estazolam group, indicating the significant differences (all P<0.05). Conclusion The thermosensitive moxibustion at the yuan- source points of the liver and gallbladder meridians significantly improves the sleep quality, relieves the symptoms of anxiety and depression and enhances the therapeutic effects in the patients of insomnia differentiated as liver qi stagnation. Hence, this therapy deserves to be recommended in clinical practice.

KEY WORDS yuan-source points of the liver and gallbladder meridians; thermal sensitive moxibustion; insomnia differentiated as liver qi stagnation; anxiety; depression

Insomnia is one of the common diseases in modern time, manifested as difficulty in falling asleep, unsound sleep, irritability at daytime or poor memory, etc. The morbidity of insomnia is up to 10% to 20% in China ^[1], mostly associated with anxiety and depression. The anxiety and depression may aggravate insomnia. It is the vicious circle and seriously affects the normal study, work and life of the patients. The sedative-hypnotic medication is the main treatment in western medicine for the main “symptoms” of insomnia to indirectly improve sleep quality. But, it is discovered statistically ^{[2, 3]} that the recurrence rate is high and the drug dependency happens. With the acceleration of modern living rhythm and the increase of work stress, more and more people suffer from insomnia. In terms of traditional Chinese medicine (TCM), insomnia at modern time is mostly differentiated as liver qi stagnation. The dysfunction of liver in maintaining the flow of qi results in the retarded liver qi circulation and the stagnant qi activity. It is manifested as dream-disturbed sleep, difficulty in falling asleep, easy waking-up, emotional depression, distention and fullness in the chest and hypochondriac region, irritability, fear and fright, restlessness, hot temper, etc. From January 2015 to January 2017, 60 patients of insomnia differentiated as liver qi stagnation were collected in Shijiazhuang Municipal Chinese Medicine Hospital. In the research, the sleep quality and the improvements in anxiety and depression were observed after treatment with thermosensitive moxibustion at the yuan-source points of the liver and gallbladder meridians. The reports are as follows.

MATERIALS AND METHODS

General information

From January 2015 to January 2017, 60 patients of insomnia differentiated as liver qi stagnation were collected in Shijiazhuang Municipal Chinese Medicine Hospital. According to the random number table, the patients were randomized into a moxibustion group (30 cases) and an estazolam group (30 cases). In the moxibustion group, the patients were aged in the range from 29 years to 43 years and the sick duration was ranged from 6 months to 10 months. In the estazolam group, the patients were aged in the range from 28 years to 45 years and the sick duration was ranged from 5 month to 9 month. The differences were not significant in age, sick duration and gender in the patients between the two groups (P>0.05). The details are shown in Table 1.

Table 1 Comparison of the general data in the patients of insomnia between the two groups

Diagnostic criteria

（1） Diagnostic criteria of western medicine

The diagnostic criteria of western medicine were specified in reference to the diagnosis of insomnia recorded in Chinese Classification and Diagnostic Criteria of Mental Disorders ^[4]. ①Sleep disorders are almost the sole symptoms. The other symptoms are induced by insomnia, including difficulty in falling asleep, unsound sleep, dream-disturbed sleep, early waking-up and being unable to return to sleep, feeling unrefreshed upon waking, lassitude or daytime sleepiness. ②The above-mentioned sleep disorders happen at least 3 times a week, lasting for over 1 month. ③Insomnia induces serious troubles or a part of mental disorders, decreases the efficiency of activity or disturbs social function. ④It does not belong to any of somatic disorders or mental disorders.

（2）Diagnostic criteria of TCM

In reference to the diagnostic criteria of insomnia in Guidance of Clinical Research for Insomnia Treated with New Herbal Medicine ^[6] recorded in Criteria of Diagnosis and Treatment of Syndromes in Traditional Chinese Medicine ^[5] issued by the State Administration of Traditional Chinese Medicine. The diagnostic criteria includes ①Typical symptoms of insomnia, such as difficulty in falling asleep, easy waking-up, unsound sleep or being unable to return to asleep, early waking-up in the morning, failure to fall into sleep at night, sleepiness at daytime, sleep less than 6h. ② Regarding the severity of insomnia, mild degree: easy waking-up or unsound sleep, early waking-up in the morning and no disturbance to normal work; moderate degree: sleep less than 3h, and still keeping on normal work; serious degree: failure to sleep the whole night, hard to keep on normal work. Regarding the syndrome differentiation of insomnia in TCM, liver qi stagnation was differentiated, manifested as dream-disturbed sleep, difficulty in falling asleep, easy waking-up, distention and fullness in the chest and hypochondriac region, irritability, fear and fright, restlessness, hot temper, palpitation, shortness of breath, slight red tongue with thin and white tongue coating, deep or deep wiry pulse.

Inclusion criteria

①In compliance with the relevant diagnostic criteria.②Self-dissatisfied sleeping quality, obvious troubles, complaints and declined working ability. ③Never taking estazolam tablets before treatment.④Having signed the informed consent and relevant documents.

Exclusive criteria

①Intolerance to moxibustion therapy.②Insomnia caused by somatic disorders and mental disorders and alcoholic and medicinal (or drug) addiction.③Excluding the secondary insomnia induced by mental disorders and somatic disorders.④Complicated with primary diseases in cardiovascular, lung, liver and kidney as well as hematopoietic system, and unstable condition at present.

METHODS

Treatment Methods

(1) Moxibustion group

Acupoints: Taichong (太冲LR3) and Qiuxu (丘墟 GB40) were selected. The yuan-source points of the liver and gallbladder meridians on the same side were selected alternatively in each treatment (LR3 on the left side and GB40 on the left side; LR3 on the right side and GB40 on the right side). Manipulation: in reference to the techniques of thermosensitive moxibustion as detecting sensitive sites, differentiating sensitization for moxibustion, individualizing treatment and sensitive sites disappear means adequate moxibustion dose ^[7], the standard manipulation was applied to the above acupoints. The mild moxibustion was provided around LR3 and GB40 to detect the thermosensitive sites. The target manipulation was given when the reactions presented, such as preference to heat, tolerance to heat, penetration of heat and conduction of heat. The moxibustion stopped until the thermosensitive feelings disappeared, thus one treatment finished. The bilateral acupoints were used alternatively every day in the manipulation. Frequency of treatment: once a day, 5 treatments as 1 course, continuously for 3 courses.

(2) Estazolam group: taking orally estazolam tablets (Tianjin Pacific Pharmaceutical Co. Ltd., National Drug Approval No. H12020291), 1 mg, 1 h before sleep, continuously for 15 days.

Observation of clinical symptoms

(1) Pittsburgh sleep quality index ( PSQI) score

Before and at the end of treatment, PSQI ^[8] was adopted to grade the sleep quality in the patients of the two groups separately and give systematic assessment. PSQI scale is composed of 19 individual items and 5 peer items, including subjective sleep quality, sleep latency, sleep duration, sleep disturbance, sleep medication use and daytime dysfunctions. According to none, mild, moderate and severe degrees of symptoms, 0, 1, 2, and 3 scores were given in each item separately. The accumulation of them is PSQI total score. The higher the score is, the poorer the sleep quality is. The range of total score is 0 point to 21 points.

(2) SDS and SAS score

Before and after treatment, the self-rating depression scale (SDS) and the self-rating anxiety scale (SAS) were adopted for the patient assessment in the two groups. SDS contains 20 items reflecting the subjective feelings of depression. According to the occurrence frequency of the symptoms, each item is quantified in four grades. SAS contains 20 items. The total raw scores are obtained by adding the score of each item. The integral part of the result of the total raw score multiplied by 1.25 is taken as the standard score. SAS and SDS are the comprehensive assessment of anxiety and depression to analyze the subjective symptoms of patients. The higher the score is, the more severe the anxiety or depression is.

(3) TCM symptom score

The TCM symptom scores of liver qi stagnation of patients with insomnia were compared between the two groups. In reference to Guidance of Clinical Research for Insomnia Treated with New Herbal Medicine ^[6], the symptoms of liver qi stagnation were scored before and after treatment in the patients, including the scores of dream-disturbed sleep, distention and fullness in the chest and hypochondriac region, irritability, fear and fright and hot temper. Mean ± standard deviation was adopted in the statistical description of TCM syndrome score. The scores were given in compliance with patients’ symptoms and manifestation. The score of sleep efficiency is assessed comprehensively by (sleep duration ÷ time of lying in bed) ×100%.

Statistical analysis

The data were managed with x² test and variance analysis of SPSS16.0 statistical software. The measurement data were expressed with mean±SD（SE） and the symptom scores with F test. The enumeration data were analyzed with x² test and P value was obtained bilaterally.

RESUTLS

Comparison of the PSQI in the patients of insomnia in the two groups before and after treatment

Before treatment, the difference was not significant statistically in PSQI scores in the patients between the two groups (all P>0.05). After treatment, PSQI scores were reduced remarkably as compared with those before treatment in the patients of the two groups (all P>0.05). PSQI scores in the moxibustion group were higher than the estazolam group in the comparison between the two groups （Table 2）.

Table 2 Comparison of PSQI score of the patients of insomnia between the groups before and after treatment

 [mean±SD（SE）]

Comparison of the severity of anxious depression in the patients of insomnia in the two groups before and after treatment

Before treatment, the difference was not significant statistically in SAS and SDS scores in the patients between the two groups (all P>0.05), indicating the comparability between the groups. After treatment, SAS and SDS scores were reduced remarkably as compared with those before treatment in the two groups (all P<0.05). The reducing amplitudes of SAS and SDS scores in the moxibustion group were superior to that of the estazolam group (both P<0.05).

Table 3 Comparative analysis on SDS and SAS scores of the patients of insomnia between the two groups after different treatments      [mean±SD（SE）]