| Background:Because of its prompt, positive and relatively safe effects, the benzodiazepines (BZDs) has become one of the most widely used drug clinically. It is also the drug of choice for insomnia. But in recent years some surveys show that the use of BZDs by many patients and even doctors on is not standardized, which has made BZDs ranking first of drug abuse in China. The improper use of BZDs will lead to drug dependence, cumulative poisoning and other serious consequences. Withdrawal syndrome appears after reducing the dosage or drug withdrawal, which made the majority of patients intolerable and unable to get rid of drugs. This is called drag dependence.Drug dependence is not only a medical problem, but also a social problem. Besides biological factors, its occurrence, development and prognosis has close relationship with psychosocial factors. Therefore, the psychological treatment plays an important role in the treatment of sleeping pills withdrawal. At present, most of the reported psychotherapy is cognitive behavior therapy. But because of the difference of culture, its application in China has certain limitation. Patients have difficulties to accept it. The possibility of using psychological therapy to treat sleeping pills’dependence based on the Chinese native culture has become the focus of attention.Traditional Chinese medicine contains abundant knowledge of psychology and unique psychological or psychosomatic therapies. Thoughts Imprint Psychotherapy in Lower Resistance State(TIP) which based on the clinical practice, contains rich contents of traditional Chinese medicine, modern psychology, psychosomatic medicine and behavioural medicine. It is an important part of traditional Chinese medical non-drug therapies. We have accumulated rich clinical experience to apply it in the treatment of insomnia. The techniques of TIP applied in the treatment of sleeping pills withdrawal has becoming more and more standardized. Through this research, we want to further verify TIP’s effect to sleeping pills’dependence insomnia and provide the basis for clinical application.Object:To observe the effect of TIP to reducing sleeping pills, withdrawal syndrome, objective and subjective sleep quality, traditional Chinese medicine syndrome and mental state on the sleeping pills’dependence insomnia and to evaluate the safety of its clinical application.Methods:To divide70out-patients who took with liver stagnation transforms fire syndrome of Estazolam’s dependence insomnia into two groups, namely TIP group and the controlled group. Each group has35patients. The TIP group received TIP treatment. The controlled group received supervised BZDs withdrawal treatment. The intervention period was4weeks, and with4weeks of follow-up. All the patients were recorded and measured by Estazolam’s dose and BWSQ in their pretreatment,1week,2weeks,3weeks,4weeks and8weeks after treatment.All the patients were measured by PSQI and calculated of Estazolam’s decreasing dosage rate according to the Estazolam’s dosage in their pretreatment,4weeks and8weeks after treatment. All the patients were measured by traditional Chinese medicine syndrome evaluation, SCL-90and PSG in their pretreatment and4weeks after treatment. All the statistics are analyzed by software SPSS17.0.Results:70patients were recruited.60patients were included into the FAS and58patients were included into the PPS.1. The effect to reducing sleeping pills and withdrawal syndrome(Estazolam’s dosage, Estazolam’s decreasing dosage rate and BWSQ)The maximum dose for all the patients were4mg. Only3patients taken more than routine dosage. The average dosage was1.31mg. Therefore, the sleeping pills’ dependence in this research belongs to dependence caused by therapeutic dosage.Estazolam’s dosageComparison among groups After1week and2weeks of intervention, there was no significant change among groups (P>0.05).After3weeks and4weeks of intervention, Estazolam’s dosage was reduced significantly in the TIP group compared to the controlled group (P<0.05).The effect was stable with4weeks’ follow-up.Comparison within group After1week,2weeks,3weeks and4weeks of intervention, Estazolam’s dosage was reduced significantly in both groups (P<0.05). The effect was stable with4weeks’follow-up. Estazolam’s decreasing dosage rateComparison among groups After4weeks of intervention, Estazolam’s decreasing dosage rate was significantly higher in the TIP group compared to the controlled group (P<0.05).The effect was stable with4weeks of follow-up.Comparison within group After4weeks of follow-up, there was no significant change within the TIP group (P>0.05). The effect was stable in te TIP group. After4weeks of follow-up, Estazolam’s decreasing dosage rate was reduced significantly in the controlled group (P<0.05)Analysis of clinical efficacy After4weeks of intervention, there were22patients cured clinically,9patients treated effectively and1patient treated ineffectively in the TIP group. The effective rate was96.9%. There were10patients cured clinically,6patients treated effectively and12patient treated ineffectively in the controlled group. The effective rate was57.1%. The clinical efficacy was significantly higher in the TIP group compared to the controlled group (P<0.01).After4weeks of follow-up, there were8patients cured clinically and2patients treated ineffectively in the TIP group. The effective rate was93.8%. There were3patients cured clinically,3patients treated effectively and22patient treated ineffectively in the controlled group. The effective rate was21.4%. The clinical efficacy was significantly higher in the TIP group compared to the controlled group (P<0.01)BWSQComparison among groups After1week and2weeks of follow-up, there was no significant change between the two groups (P>0.05).After3weeks and4weeks of intervention, the total score of BWSQ was significantly lower in the TIP group compared to the controlled group (P<0.05).The effect was stable with4weeks of follow-up.Comparison within group After1week,2weeks,3weeks of intervention, the total score of BWSQ was significantly higher compared to before within the TIP group (P<0.05).After4weeks of intervention and4weeks of follow-up, there was no significant change compared to before within the TIP group (P>0.05). After2weeks,3weeks,4weeks of intervention and4weeks of follow-up, the total score of BWSQ was significantly lower compared to1weeks of intervention within the TIP group (P<0.05). After1week,2weeks,3weeks,4weeks of intervention and4weeks of follow-up, the total score of BWSQ was significantly higher compared to before within the controlled group (P<0.05).After2weeks,3weeks,4weeks of intervention and4weeks of follow-up, the total score of BWSQ was significantly lower compared to1weeks of intervention within the controlled group (P<0.05)2Objective and subjective sleep quality(PSQI, PSG)PSQIComparison among groups After4weeks of intervention, the global sum of PSQI, subjective sleep quality, sleep duration, habitual sleep efficiency and daytime dysfunction were significantly lower in the TIP group compared to the controlled group (P<0.05). After4weeks of follow-up, the global sum of PSQI, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, use of sleep medication and daytime dysfunction were significantly lower in the TIP group compared to the controlled group (P<0.05)Comparison within group After4weeks of intervention, the global sum of PSQI, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, use of sleep medication were significantly lower compared to before within the TIP group (P<0.05). After4weeks of follow-up, the global sum of PSQI and Severn domains were all significantly lower compared to before within the TIP group (P<0.05). After4weeks of intervention, the global sum of PSQI, subjective sleep quality and use of sleep medication were significantly lower compared to before within the controlled group (P<0.05). After4weeks of follow-up, the global sum of PSQI, subjective sleep quality, sleep latency and use of sleep medication were significantly lower compared to before within the controlled group (P<0.05)Analysis of clinical efficacy After4weeks of intervention, there were1patients cured clinically,15patients treated significantly effectively,9patient treated effectively and7patients treated ineffectively in the TIP group. The effective rate was78.1%. There were5patients treated significantly effectively,8patients treated effectively and15patient treated ineffectively in the controlled group. The effective rate was46.4%. The clinical efficacy was significantly higher in the TIP group compared to the controlled group (P<0.01).After4weeks of follow-up, there were 5patients cured clinically,16patients treated significantly effectively,10patients treated effectively and1patient treated ineffectively in the TIP group. The effective rate was96.9%. There were3patients treated significantly effectively,9patients treated effectively and16patient treated ineffectively in the controlled group. The effective rate was42.9%. The clinical efficacy was significantly higher in the TIP group compared to the controlled group (P<0.01)PSGComparison among groups After4weeks of intervention, sleep stages of3and4, and REM sleep were significantly more in the TIP group compared to the controlled group (P<0.05). The percentage of stages of3and4and REM sleep were significantly higher in the TIP group compared to the controlled group (P<0.05)Comparison within group After4weeks of intervention, the sleep duration, sleep efficiency stages of3and4, percentage of stages of3and4, REM sleep percentage of REM sleep and the number of REM sleep were significantly increased compared to before within the TIP group (P<0.05). The awake time was significantly decreased compared to before within the TIP group (P<0.05). There was no significant change within the controlled group (P>0.05)3Traditional Chinese medicine syndrome(Integral of syndrome, main symptoms, minor symptoms, tongue and pulse)Comparison among groups After4weeks of intervention, integral of syndrome, insomnia, Irritability, red eye, bitter taste in the mouth, constipation and tongue were significantly lower in the TIP group compared to the controlled group (P<0.05).Comparison within group After4weeks of intervention, integral of syndrome, insomnia, Irritability, red eye, bitter taste in the mouth, yellow urine, constipation, tongue and pulse were significantly lower compared to before within the TIP group (P<0.05). The insomnia and thirsty were significantly lower compared to before within the controlled group (P<0.05)Analysis of clinical efficacy After4weeks of intervention, there were4patients treated significantly effectively,22patient treated effectively and6patients treated ineffectively in the TIP group. The effective rate was81.3%. There were1patients treated significantly effectively,9patients treated effectively and18patient treated ineffectively in the controlled group. The effective rate was35.7%. The clinical efficacy was significantly higher in the TIP group compared to the controlled group (P<0.01)4Mental state(SCL-90)Comparison among groups After4weeks of intervention, the global sum of SCL-90, somatization and anxiety were significantly lower in the TIP group compared to the controlled group (P<0.05)Comparison within group After4weeks of intervention, the global sum of SCL-90, somatization, obsessive-compulsive, anxiety, hostility, interpersonal sensitivity and depression were significantly lower compared to before within the TIP group (P<0.05). The global sum of SCL-90, interpersonal sensitivity and anxiety were significantly lower compared to before within the controlled group (P<0.05)5Safety evaluationDuring the4weeks of intervention, the adverse events happened in the two groups were all related to the withdraw syndrome. Feeling weak was the most common symptoms. It happened on15patients in TIP group and22patients in controlled group, which was significantly lower in the TIP group compared to the controlled group (P<0.05)Conclusion:1The sleeping pills’ dependence in this research belongs to dependence caused by therapeutic dosage. The results suggest that TIP may help the patients to reduce or stop taking sleeping pills, improve withdraw syndrome and get rid of dependence, which is better than supervised BZDs withdrawal treatment. After a period of follow-up, the effect was stable in the TIP group. TIP has lower recurrence compared to supervised BZDs withdrawal treatment.2TIP has better effect compared to supervised BZDs withdrawal treatment on the objective and subjective sleep quality, which including subjective sleep quality, sleep latency, sleep duration, stage3and4, REM sleep, traditional Chinese medicine syndrome, somatization and anxiety. After a period of follow-up, the effect was stable in the TIP group. 3Both TIP and supervised BZDs withdrawal treatment have good safety applied to sleeping pills’dependence caused by therapeutic dosage.All the above three points suggest that TIP may help to reduce or stop taking sleeping pills, improve withdraw syndrome, subj ective and obj ective sleep quality, traditional Chinese medicine syndrome and mental state and has good compliance and safety. TIP has certain clinical application value. |
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