A Randomized Clinical Trial Of Alprazolam Plus Cognitive-Behavioral Therapy (CBT) Versus CBT Only In Cancer Patients With Insomnia And Psychopathology Distress

PURPOSE:Persistent insomnia is common complaint in cancer survivors. When sleepdisturbances combined with already high levels of cancer-related psychologicaldistress, may place cancer survivors at a higher risk of future psychopathology andpoor quality of life. The aim of this study was to investigate the effectiveness ofalprazolam as an adjuvant drug to Cognitive-Behavioral Therapy(CBT) for thetreatment of Insomnia and distress in cancer survivors.PATIENTS AND METHODS:Randomized, single-blind, controlled clinical trial conducted at a single cancercenter, with recruitment from Autumn2011to January2012.110cancer patients metentry levels of Insomnia and distress and100of them completed the study.55wererandomized to Alprazolam plus CBT group,55to placebo plus CBT group. Studylasted8weeks. The content of intervention mainly included mainly includes everyfive individual interventions of CBT in one week on both group patients andAlprazolam0.8-1.2mg/d/d1-14on A+CBT group. Longitudinal assessment wereperformed at baseline and2,5,8weeks thereafter. Treatments were administered oncetwo days for4weeks. Observations including the clinical effectiveness assessed byClinical Global Impression on psychological distress, the assessment scores ofHamilton Depression Rating Scale for Depression, HRSD, Hamilton Anxiety Scale,HAMA and Hospital Anxiety and Depression Scale, HADS; the clinical effectiveness,the assessment scores of Pittsburgh sleep quality index (PSQI). All the data wereprocessed by SPSS17.0soft ware for windows.RESULTS:1. After all treatment period, There’s significant difference in the in-classcomparison of HAMA and HRDS score. These indicated that both two groupsimproved the anxiety and depression emotion of the patients. And The inter-classcomparison shows that the A+CBT group is superior to the CBT group in thedecrease on the score of HAMA. But there is no significant difference on HRDS between two groups. At the first follow up time, HADS, HAMA, HAMA-PH,HRSD,HRSD-A/S score were significantly decreased and anxiety and depressionsymptoms have been obviously alleviated in A+CBT group.2．CGI global improvement scores indicated that Patients in each study arm havegot significantly improvement on GI score of anxiety and depression after treatment,and there have significant difference between the two groups (P<0.001) at the firstfollow up point. However, There have no statistically significant differences betweenthe two groups in CGI global improvement scores of anxiety and depression at thesecond and third follow up point.3. After all treatment period, There’s significant difference in the in-classcomparison of PSQI and HRDS-IN score. These indicated that both two groupsimproved insomnia. And The inter-class comparison shows that the A+CBT group issuperior to the CBT group shows that in factors of hours of sleep, daytime function,sleep efficiency and sleep quality, but they have similar curative effects in otherfactors. Comparing two groups’ clinical effective showed no significant differences.CONCLUSION:Patients with cancer who had symptoms of insomnia and distress, use ofalprzolam plus CBT strategy was rapidly work. Hours of sleep, daytime function,sleep efficiency and sleep quality were significantly improved, and anxious anddepressive symptoms were rapidly reduced. the combination of treatments could helpto improve the compliance of patients and increase the efficacy of CBT...