Efficacy of Zhenjingdingzhi decoction in treating insomnia with Qi-deficiency of heart and gallbladder: a randomized, double-blind, controlled trial

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1 Online Submissions: J Tradit Chin Med 5 August 5; 5(): - info@journaltcm.com ISSN 55-5 JTCM. All rights reserved. CLINICAL STUDY TOIC Efficacy of Zhenjingdingzhi decoction in treating insomnia with Qi-deficiency of heart and gallbladder: a randomized, double-blind, controlled trial Ye Qing, Zhou Jie, Yuan Xiaolei, Yuan Canxing, Yang Xuming aa Ye Qing, Zhou Jie, Yuan Xiaolei, Yuan Canxing, Neurology Department of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China Yang Xuming, College of Acumox and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China Supported by Special Research Foundation of Selection and Cultivation for Outstanding Young Teacher of Shanghai University (Clinical Research on Zhenjingdingzhi Mixture for Insomnia, No. szy); the National Natural Science Foundation of China (Effect of Dopamine D/D Receptor-MAK/ ERK Signal Transduction in D Levodopa-induced Dyskinesias with Shudi ingchan Tang, No. ); -Year Action lan for Shanghai Municipal Chinese Medicine Development roject (Clinical Succession Base of Ding's Medicine, No. ZYSNXD-CC-HGC-JD-) Correspondence to: rof. Yuan Canxing, Neurology Department of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China. canxing@hotmail.com; rof. Yang Xuming, College of Acumox and Tuina, Shanghai University of TCM, Shanghai, China. fslbest@.com. Telephone: +-; +-55 Accepted: November, Abstract OBJECTIVE: To evaluate the clinical efficacy of Zhenjingdingzhi decoction in treating insomnia with Qi-deficiency of heart and gallbladder. METHODS: We conducted a double-blind, randomized, controlled trial involving patients with insomnia of Qi-deficiency of heart and gallbladder. atients were randomly divided into the treatment group (n = 5) and the control group (n = 5) according to a random number table. The treatment group was given Zhenjingdingzhi decoction, while the control group was treated with Suanzaoren decoction. the pharmacological treatment lasted for weeks. The clinical efficacy was assessed by using Spiegel scale, ittsburgh sleep quality index (SQI) and Traditional Chinese Medicine (TCM) syndrome scores. RESULTS: Comparing Spiegel scores between the two groups at and weeks, the differences in curative effect between the two groups were both significant (both <.5). The total effective rate was % in the treatment group and 7.7% in the control group at weeks, and % and 5.% at weeks, respectively; After weeks, SQI scores showed that the total effective rates differed significantly between the two groups ( <.): % in the treatment group and 5.% in the control group; In improving sleep quality and sleep duration, the curative effect of the treatment group was better than that of the control group ( <.5). TCM syndrome, especially insomnia and palpitation, was improved better in the treatment group after weeks as compared to that in the control group ( <.5). The total effective rate of the two groups was % and %, respectively. CONCLUSION: Zhenjingdingzhi decoction is effective and safe for the treatment of insomnia with Qi-deficiency of heart and gallbladder, especially for improving sleep quality and sleep duration. 5 JTCM. All rights reserved. Key words: Sleep initiation and maintenance disor- JTCM www. journaltcm. com August 5, 5 Volume 5 Issue

2 ders; Shyness; Heart Qi deficiency; Zhenjingdingzhi decoction; Randomized controlled trial; Double-blind method INTRODUCTION Studies by the World Health Organization have shown that almost % people in the world suffer from insomnia. Insomnia is recognized as one of the global public health issues which are not fully appreciated or well solved. According to epidemiological studies, the incidence rate of insomnia in China is % to %. In view of these facts, the late rofessor Jianhua Hu, Shanghai famous specialist of Traditional Chinese Medicine (TCM), extracted Zhenjingdingzhi decoction to treat insomnia on basis of TCM theory, with reference to non-prescription medicine and literature, after decades of clinical trial and error. Zhenjingdingzhi decoction is modified from Ganmaidazao decoction, added Tiannanxing (Rhizoma Arisaematis Erubescentis), Shichangpu (Rhizoma Acori Tatarinowii), Zhenzhumu (Concha Margaritifera Usta), Yuanzhi (Radix alygalae) and Danshen (Radix Salviae Miltiorrhizae). It has the effects of melting hlegm, regulating Qi, supplementing Qi and nourishing heart to calm mind. In order to further verify the clinical efficacy of this decoction on insomnia, we observed and analyzed the therapeutic effect by comparing with Suanzaoren decoction,5 which is widely approved at home and abroad - to provide the basis for the clinical treatment of insomnia and further explore the new direction of treating sleep disorders in TCM. MATERIALS AND METHODS Diagnostic standards Diagnostic standards of insomnia in Western Medicine are stipulated by Chinese Classification of Mental Disorders Third Edition (CCMD-) (F5.). In reference to Guidelines for Diagnosis and of Common Internal Diseases in Chinese Medicine Symptoms of Chinese Medicine, 7 standard for diagnosing in TCM defines main syndromes as difficulty in falling asleep, or waking up easily, or waking up frequently during the night with difficulty of returning to sleep, or keeping sleepless all night, and symptoms persisting for more than weeks. Also we adopted accompanying symptoms as follows: dreaminess, vexation, dizziness and headaches, palpitation and amnesia, fatigue and lassitude, without other organic disease or inducement that violate sleep. The main syndromes of Qi-deficiency of heart and gallbladder type referring to Clinic Terminology of Traditional Chinese Medical Diagnosis and -Syndromes GB/T75.-7, includes palpitation and timidity, inability to fall asleep, festless sleep, and the secondary syndromes includes being susceptible to fright, shortness of breath and lassitude, lack of strength and spontaneous perspiration. And main feature of tongue and pulse diagnosis: whitish tongue and white fur, stringy-thready pulse. Inclusion standards atients were included if they: (a) conformed to the above-mentioned diagnostic standards; (b) were -5 years old; (c) suffer from insomnia over weeks. All patients volunteered for this trial and provided written informed consent. The study was approved by Medical Ethics Committee, Shanghai Longhua Hospital Affiliated to Shanghai University of TCM. Exclusion standards atients were excluded if they: (a) did not conform the diagnostic standards of insomnia or Qi-deficiency of heart and gallbladder; (b) were < years old or > 5 years old; (c) were pregnant or lactating; (d) had diabetes, psychiatric disorder or serious suicidal tendency. Eliminating cases and standards of dropout atients were eliminated if they: (a) stopped the treatment halfway due to adverse reactions or non-efficacy reasons; (b) added other drugs; (c) provided incomplete data that couldn't be counted; (d) did not complete the therapy as planned; (e) did not conform to inclusion standards but were included by mistake. atients were considered dropouts of the study if they had poor compliance, serious adverse reactions, complications or special physiological changes that made them inappropriate to continue the trial during the therapy. When data were statistically analyzed, adverse reactions should be recorded in the statistics of adverse reaction and patients who had completed / of the therapy should be evaluated the efficacy. Randomization, double-blind method From October to September, a cohort of insomnia patients who visited Neurology Department of Longhua Hospital Affiliated to Shanghai University of TCM was recruited and divided randomly into two groups of 5 by their visiting sequence. The medicine of the two groups was uniformly decocted, packaged by the Department of harmaceutical reparation of Longhua Hospital Affiliated to Shanghai University of TCM, Shanghai, China. According to a random number table, each study decoction was randomly numbered and indicated on the package. The researchers issued the study decoction on the basis of the subjects visiting sequence which was consistent with that on the decoction package. At the end of the trial, we entered the observation data into the established database. rimary unblinding was executed when the data was locked by the statistics professional. And A group and B group were established. Secondary unblinding was executed when the statistics was completed, and the treatment group and the control group were definite. JTCM www. journaltcm. com August 5, 5 Volume 5 Issue

3 Therapy Before the trial was started, all the patients were included after one-week washout period. The treatment group was given Zhenjingdingzhi decoction, which consisted of Tiannanxing (Rhizoma Arisaematis Erubescentis), Shichangpu (Rhizoma Acori Tatarinowii), Zhenzhumu (Concha Margaritifera Usta), Yuanzhi (Radix alygalae), Danshen (Radix Salviae Miltiorrhizae), Fuxiaomai (Fructus Tritici Levis), Dazao (Fructus Jujubae), and Gancao (Radix Glycyrrhizae). The control group was treated with Suanzaoren decoction which consisted of Fuling (oria), Zhimu (Rhizoma Anemarrhenae), Chuanxiong (Rhizoma Chuanxiong), Suanzaoren (Semen Ziziphi Spinosae) and repared Gancao (Radix Glycyrrhizae). The above herbs were decocted for min and concentrated to 5 ml juice twice. The two juices were mixed together. The dosage of herbal decoction was ml every day with 5 ml taken orally in the morning and evening for weeks. All the medicine of the two groups was uniformly decocted, packaged by the Department of harmaceutical reparation of Longhua Hospital Affiliated to Shanghai University of TCM. Rules of drug combinations: patients were not allowed to take other hypnotic, antipsychotics, antidepressant, hypnotic drugs and any drug that causes insomnia. Efficacy evaluation Clinical indexes: we recorded Spiegel scale, ittsburgh sleep quality index (SQI) and TCM syndrome score at weeks, and. And we assessed the clinical efficacy based on reduction rate. Clinical recovery was defined as reduction rate 75%. If the reduction rate was between 5% and 7%, then the clinical efficacy was marked effective. If the reduction rate was between 5% and %, then it was effective. Recovery was invalid if the reduction rate was less than 5%. Reduction rate = (score before treatment score after treatment) / score before treatment %. Safety evaluation Blood routine, urine routine, hepatic and renal function including aspartate transaminase (AST), alanine aminotransferase (ALT), creatinine (Cr), blood urea nitrogen (BUN), and electrocardiogram were detected before and after treatment. Adverse events were observed and recorded during the treatment. Statistical methods All the data were analyzed with SSS. software packet (Chicago, IL, USA). Measurement data was expressed with mean ± standard deviation ( xˉ ± s). Group t-test was used when measurement data was normal distribution and homogeneity of variance, otherwise t-test was used. χ test was used for enumeration data, and rank-sum test was used for ranked data. A <.5 was considered to be statistically significant. RESULTS Comparison of the general statistics before treatment A hundred patients were recruited and divided randomly into the treatment and the control group with 5 patients in each. During the trial, of the patients were lost. Of the lost, discontinued for poor compliance and for side effects like headache and vertigo. They were all from the control group. Finally, 7 patients completed the trial, 5 in the treatment group and in the control group. The flow diagram of the trial is shown in Figure. All the data from these participants were excluded from the statistical analysis. The two groups had no significant differences in age, gender, duration of symptoms, SQI scores or Spiegel scores before treatment (all >.5) as shown in Table. The two groups were comparable. Comparison of Spiegel scores before and after treatment The total effective rate was % in the treatment group and 7.7% in the control group after weeks of treatment, and % and 5.% after weeks, respectively. The statistical test showed that the differences in curative effect were both significant ( <.5). The curative effect in the treatment group was superior to that in the control group. Table Comparison of the general statistics before treatment ( xˉ ± s) Item (n=5) (n=5) t/χ /Z Age (years) 5± ±.7. Gender (Female/Male) / /.7. Duration of symptoms (years) 7±7 7± SQI score 5± ±. Spiegel score ±7 5±7. TCM syndrome score ± ± Notes: SQI: ittsburgh sleep quality index; TCM: Traditonal Chinese Medicine. -.. JTCM www. journaltcm. com August 5, 5 Volume 5 Issue

4 Assessed to eligibility (n = ) Randomized Base line group (n = 5) group (n = 5) Follow-up at weeks Analyzed (n = 5) Analyzed (n = ) were lost to follow-up Follow-up at weeks Analyzed (n = 5) Analyzed (n = ) Figure Flow diagram of the trial Table Comparison of curative effects in Spiegel scores between the two groups after and weeks Time Group n Ineffective Improved Obvious effective Recovery Total effective rate (%) After weeks a After weeks 5 7 Notes: the treatment group was given Zhenjingdingzhi decoction (5 ml, each time, twice a day) and the control group was treated with Suanzaoren decoction (5 ml, each time, twice a day). a <.5 as compared with the data of control group a Comparison of SQI scores before and after treatment After weeks, the total effective rate was % in the treatment group and.% in the control group. There was no statistical difference ( >.5) between the two groups. After weeks, the total effective rate was % in the treatment group and 5.% in the control group. The curative effect of the treatment group was obviously better than that of the control group ( <.). In improving sleep quality and sleep duration, the curative effect of the treatment group was better than that of the control group ( <.5). The mean ranks of the treatment group and the control group were 55. and 5.,. and.7, respectively (Table, ). Comparison of TCM syndrome scores before and after treatment The total effective rate was % in the treatment group and % in the control group after weeks of treatment, and % and 5.% after weeks, respectively. After weeks, there was no obvious difference ( >.5) between the two groups. However, the total effective rate in the treatment group was much higher than that in the control group ( <.). TCM syndrome, especially insomnia and palpitation, was improved better in the treatment group after weeks as compared to that in the control group ( <.5). The mean ranks of the treatment group and the control group were. and.5, 55. and., respectively (Table 5, ). Safety Before and after treatment in the two groups, blood routine, urine routine, electrocardiogram examination, hepatic and renal function revealed no abnormal changes in any patients in either group. This indicated that Zhenjingdingzhi decoction was safe. Among pa- JTCM www. journaltcm. com August 5, 5 Volume 5 Issue

5 Table Comparison of curative effects in SQI scores between the two groups after weeks and weeks Time Group n Ineffective Improved Obvious effective Recovery Total effective rate (%) After weeks After weeks a Notes: the treatment group was given Zhenjingdingzhi decoction (5 ml, each time, twice a day) and the control group was treated with Suanzaoren decoction (5 ml, each time, twice a day). a <. compared with the data of control group. SQI: ittsburgh sleep quality index. Table Comparison of curative effects in each item of SQI after weeks Ineffective Improved Obvious Item Group n effective Sleep quality 5 Time to fall asleep Sleep duration Sleep efficiency Sleep disorder Hypnotics Daytime functions Recovery 5 Mean rank a..7 a Notes: the treatment group was given Zhenjingdingzhi decoction (5 ml, each time, twice a day) and the control group was treated with Suanzaoren decoction (5 ml, each time, twice a day). a <.5 as compared with the data of control group. SQI: ittsburgh sleep quality index. Table 5 Comparison of curative effects in TCM syndrome between the two groups after and weeks Ineffective Improved Obvious Recovery Total effective Time Group n effective rate (%) After weeks 5... After weeks tients which were included in the trial, patients had adverse reactions ( in treatment group and 5 in control group). In the control group, cases withdrew from the study due to mouth and tongue sore, diarrhea 5 Notes: the treatment group was given Zhenjingdingzhi decoction (5 ml, each time, twice a day) and the control group was treated with Suanzaoren decoction (5 ml, each time, twice a day). a <. as compared with the data of control group. TCM: Traditonal Chinese Medicine. and pharyngodynia. And cases had gastrointestinal adverse reactions such as flatulence and nausea. All the adverse reactions were mild and disappeared or alleviated week after withdrawal of drug. JTCM www. journaltcm. com 5 August 5, 5 Volume 5 Issue... a

6 TCM syndrome Group Gallbladder timidity and susceptibility to fright Insomnia n Never Ye Q et al. / Clinical Study Table Comparison of curative effects in each item of TCM syndromes between the two groups after weeks Sometimes Often 5 Always 7 Mean rank a Dreaminess alpitation a Shortness of breath Shortness of breath lack of strength Anepithymia DISCUSSION With social and economic development, more people suffer from insomnia. Many western hypnotics have been developed in recent years, such as benzodiazepine derivatives, non-benzodiazepine hypnotics, and z-drugs like zolpidem, zopiclone, eszopiclone and zaleplon. - Each drug acts on neurotransmitters or receptors to produce sedative and hypnotic effects. However, the medications have short durations of action, and some have a risk of tolerance or abuse. They may also cause impairments in memory and cognitive function, especially benzodiazepine derivatives. Thus, developing effective medicines without side effects to treat insomnia is particularly urgent. Insomnia, is called Bu Mei in TCM, and early documented as mu bu ming (unclosed eyes), wo Bu An (unease sleep), bu De Wo (unable to lie down) in Huang Di Nei Jing. 5 Tai ing Sheng Hui Fang of Song Dynasty points out that insomnia due to insufficiency of the gallbladder-qi has close relation with heart. And injury of heart-qi, hidden pathogen in gallbladder and deficiency-cold of liver and gallbladder lead to difficulty in lying down. It also maintains the relationship between heart and gallbladder and began to emphasize the combination therapy for heart and gallbladder. It might be said that the book developed the new category variation for insomnia due to insufficiency of the gallbladder-qi. 7 Yi Zong Jin Jian says that insufficiency of gallbladder-qi causing timidity is essential to difficulty in Notes: the treatment group was given Zhenjingdingzhi decoction (5 ml, each time, twice a day) and the control group was treated with Suanzaoren decoction (5 ml, each time, twice a day). a <.5 as compared with the data of control group. TCM: Traditonal Chinese Medicine. lying down due to fear. As stated in the Shen Shi Zun Sheng Shu Bu Mei, timidity of heart and gallbladder and susceptibility to fright cause nightmares, dysphoria and hypersomnia. It shows that debility of heart and gallbladder leads to being vulnerable to panic and restless sleep. And sometimes tension and anxiety because of the sudden shock make decision function of gallbladder damaged which means it is easy to feel uneasy and produces symptoms like insomnia, dreaminess and easily awakened, etc. Zhu et al collected patients with insomnia and the syndrome differentiation shows that types of Qi-deficiency of heart and gallbladder, hyperactivity of fire due to Yin-deficiency and deficiency of both heart and spleen accounted for % of the subjects. Chen et al adopted a syndrome differentiation of 75 insomnia patients and the result showed that over % of the patients were the Qi-deficiency of heart and gallbladder type. Thus it can be seen that insomnia is deficiency-excess complex, but deficiency syndrome is in the majority in clinic, especially the type of Qi-deficiency of heart and gallbladder. According to its pathogenic characteristics, nourishing heart and tranquilizing mind are the main ideas for syndrome differentiation and treatment. Suanzaoren decoction obtained from Jin Kui Yao Lue of Zhangzhongjing for the treatment of insomnia with deficiency syndromes and its effectiveness had been verified by TCM doctors of past dynasties. Gu Jin Ming Yi Fang Lun 5 acclaimed it as a miraculous decoction for JTCM www. journaltcm. com August 5, 5 Volume 5 Issue 7...

7 treating consumptive disease and blood-deficiency in liver. In Ben Cao Yi Du, it is the best decoction for treating consumptive disease and insomnia with weakness and irritability. A large number of domestic and foreign clinical research and modern pharmacological experimental studies showed that Suanzaoren decoction had a better sleep improvement effect. 7- This study used Suanzaoren decoction as the control drug to evaluate the clinical efficacy of Zhenjingdingzhi decoction on treating insomnia. Zhenjingdingzhi decoction was extracted by the late rofessor Jianhua Hu, Shanghai famous specialist of TCM, originating from the therapy theory of tranquilizing mind by nourishing the heart. It was based on the famous prescription Ganmaidazao decoction from rescriptions of the Jin Kui Yao Lue Fu Ren Za Bing of Zhang Zhongjing, adding Danshen (Radix Salviae Miltiorrhizae), Shichangpu (Rhizoma Acori Tatarinowii), Yuanzhi (Radix alygalae), etc. Danshen (Radix Salviae Miltiorrhizae) has the property of nourishing blood and tranquilizing mind. Gancao (Radix Glycyrrhizae), Fuxiaomai (Fructus Tritici Levis) and Dazao (Fructus Jujubae) have the function of alleviating pain and make a good effect on nourishing heart-qi and tranquilizing mind. Shichangpu (Rhizoma Acori Tatarinowii), Yuanzhi (Radix alygalae), and Tiannanxing (Rhizoma Arisaematis Erubescentis) can eliminate phlegm for resuscitation and relieve stasis. Zhenzhumu (Concha Margaritifera Usta) has the effect on checking and descending the upward rebellious Qi. Compatibility of all the medicine makes therapeutic effect on nourishing heart, tranquilizing mind, resuscitation and relieve stasis. 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