| ObjectiveConfronted with the worldwide problem "high relapse rate"in drug treatment, this study aims to evaluate the effect of Jitai tablet combined with psychological counseling and social support interventions in community drug treatment based on a cohort-designed community trial, combing current situations of community drug treatment in Shanghai.Specific objectives are as follows:①to understand the actual situation of Shanghai community drug treatment, including the structure network, work mechanism, staffing and workflow, etc.②to evaluate the comprehensive effect among Jitai comprehensive group (Jitai tablet+psychological counseling+social support), methadone comprehensive group (methadone+psychological counseling+social support),and Jitai pure group (Jitai tablet+social support) in community drug treatment by comparing repeated measurements of different follow-ups.③to evaluate the efficacy and safety of Jitai tablet in community drug treatment through comparing Jitai comprehensive group and methadone comprehensive group, providing reliable basis for application of Jitai tablet in community drug treatment.④preliminarily assess the effect of psychological counseling in the community drug treatment through comparing Jitai comprehensive group and Jitai pure group.MethodsA repeated measured and controlled cohort study was conducted. Eligible subjects were collected into community intervention trial according to strict inclusion and exclusion criteria. The trial consisted of three groups. Methadone comprehensive group received methadone medication combined psychological counseling and social support. Jitai comprehensive group received Jitai tablet medication combined psychological counseling and social support. Jitai pure group received Jitai tablet medication combined only social support. Treatment period of three groups was1year, including baseline visits and8week,26week and52week follow-ups. Case report form was designed to gather information. Effect evaluation index consisted of efficacy index and safety index. The main efficacy index included retention rate and relapse rate, the secondary efficacy index included anxiety, depression, psychological craving, pain degree, protracted withdrawal symptoms, addiction severity index, and health status.Safety indicators included abnormal rate of laboratory testing and incidence of adverse events.The continuous variables (expressed by geometric mean or median) were analyzed by analysis of variance or non-parametric test and frequency or proportion of the categorical variables by Χ2test or fisher’s exact test. Kaplan-Meier (K-M) survival analyses were conducted to identify retention (relapse) difference among three groups, using a log-rank test.Continuous measures taken at repeated time points during treatment were analyzed with linear mixed models (SAS MIXED procedure). Re-peated dichotomous measures were similarly analyzed with generalized linear mixed models (SAS GLM procedure). All analyses were performed using SAS version9.1and SPSS version16.0.A11of the statistical tests that we reported were two sided, and the "statistically significant "implied P<0.05.Results1. Baseline characteristic:A total of554cases of the three groups were enrolled in the study, incluing180cases of methadone comprehensive group,206cases of Jitai comprehensive group, and168cases of Jitai pure group.There were no significant differences among the groups in terms of gender, age, marriage, education, and age of initial drug use. Specific content were as follows:①most are male, account for81.11%in methadone comprehensive group,87.38%in Jitai comprehensive group, and79.26%in Jitai pure group.②average age was40years old or so, methadone comprehensive group was42.25±7.93, Jitai comprehensive group was40.98±8.02, Jitai pure groupwas40.24±8.65.③most were unmarried, married,and divorced. Account for34.44%,34.44%, and25.56%in methadone comprehensive group respectively,42.72%,24.76%, and27.18%in Jitai comprehensive group respectively,42.26%,23.81%, and25.60%in Jitai pure group respectively.④Major educational level was junior middle school, accounted for62.78%,66.50%,69.64%respectively in the three groups. Secondly was senior middle school, accounted for30.00%,28.64%,25.00%respectively in the three groups.⑤average age of initial drug use was30years old or so, methadone comprehensive group was30.02±7.88, Jitai comprehensive group was29.98±8.33, Jitai pure groupwas30.10±8.14.There were statistically significant differences in terms of employment status (in the last three years), previous medication, years of drug using and number of previous detoxification.Baseline efficacy effect:There showed no statistically significant differences of most of the baseline efficacy effect among the three groups except for4-weeks psychological craving,24-hours psychological craving, three factors of ASI including alcohol addiction,drug addiction,and legal,the factor of sleep disorder in protracted withdrawal symptoms.Baseline laboratory examination:There showed no statistically significant differences of most of the baseline laboratory indicators among the three groups except for neutrophil, lymphocyte in blood routine examination.2. Retention rate:The retention rates of methadone comprehensive group at8-week,26-week, and52-week follow-up became97.78%,91.67%,85.00%respectively. The retention rates of Jitai comprehensive group became90.78%,83.50%,74.27%respectively. The retention rates of Jitai pure group became92.26%,74.40%,63.69%respectively. Chi-square test indicated the difference of8-week retention rates among the three groups was statistically significant (P=0.015),8-week retention rate of methadone comprehensive group was higher than Jitai comprehensive group (P=0.0037) and Jitai pure group (P=0.017). There was a statistically significant difference of26-week retention rates among the three groups (P<0.0001),26-week retention rate of methadone comprehensive group was higher than Jitai comprehensive group (P=0.016) and Jitai pure group (P<0.0001),26-week retention rate of Jitai comprehensive group was higher than Jitai pure group (P=0.031). There was a statistically significant difference of52-week retention rates among the three groups (P<0.0001),52-week retention rate of methadone comprehensive group was higher than Jitai comprehensive group (P=0.010) and Jitai pure group (P<0.0001),52-week retention rate of Jitai comprehensive group was higher than Jitai pure group (P=0.027)The average maintenance time length of the three groups was333.83±6.06,307.42±7.81,289.44±8.88, respectively. By analysis of variance, there was a statistically significant difference among the three groups (P=0.000). Further pair wise comparison, the maintenance time length of methadone comprehensive group was longer than the other two groups.By the survival analysis, there was a statistically significant difference among the three groups (Log-rank P=0.000). 3. Drop out:In methadone comprehensive group, a sum of27of the patients dropped out during the52-week treatment periods,4(14.82%) of them dropped during the first8weeks,11(40.74%) of them dropped in9～26weeks,12(44.44%)of them dropped in27～52weeks.In Jitai comprehensive group, a sum of53of the patients dropped out,19(35.85%) of them dropped during the first8weeks,15(28.30%) of them dropped in9～26weeks,19(35.85%)of them dropped in27～52weeks. In Jitai pure group, a sum of61of the patients dropped out,13(21.31%) of them dropped during the first8weeks,30(49.18%) of them dropped in9～26weeks,18(29.51%)of them dropped in27～52weeks. Chi-square test indicated the difference of time dictribution among the three groups was no statistically significant (P=0.084)The first three reasons for drop out in methadone comprehensive group were being arrested for compulsory isolation (account for51.85%), participant not willing to continue (account for25.93%), side effects and adverse event (account for7.41%).The first three reasons for drop out in Jitai comprehensive group were being arrested for compulsory isolation (account for39.62%), noncompliance with research approach (account for18.87%), participant not willing to continue (account for11.32%). The first three reasons for drop out in Jitai pure group were participant not willing to continue (account for27.87%),being arrested for compulsory isolation (account for26.23%), side effects and adverse event (account for18.03%). Chi-square test indicated the difference of reasons constitute among the three groups was no statistically significant (Fisher exact test P=0.0773).4. Relapse rate:The relapse rates of methadone comprehensive group at8-week,26-week, and52-week follow-up became1.11%,2.78%,7.78%.respectively. The retention rates of Jitai comprehensive group became3.88%,6.31%,11.17%. The retention rates of Jitai pure group became0.60%,5.36%,10.71%. Chi-square test indicated the difference of8-week relapse rates among the three groups was statistically significant (P=0.045),8-week relapse of Jitai comprehensive group was higher than Jitai pure group (P=0.039). There was no statistically significant difference of26-week relapse rates among the three groups (P=0.258). There was no statistically significant difference of52-week relapse rates among the three groups (P=0.497). By the survival analysis, there was no statistically significant difference among the three groups (Log-rank P=0.325).5. Self-rating anxiety and depression. There were statistically significant differences in self-rating anxiety between the three groups at8-week,26-week, and52-week follow-ups. The findings from MIX method indicated that interaction effects, group main effect, and time main effect showed statistically significant differences. There were statistically significant differences in self-rating depression between the three groups at all time points. The findings from MIX method indicated that interaction effects, group main effect, and time main effect showed statistically significant differences.6. Craving and pain:By Wilcoxon test, there were statistically significant differences in4-weeks craving between the three groups at baseline and52-week follow-up, there showed on statistically significant differences in4-weeks craving at8-week follow-up and26-week follow-up. The findings from MIX method indicated that interaction effects and group main effect showed no statistically significant differences, time main effect showed statistically significant differences. There were no statistically significant differences in24-hours craving between the three groups at all time points. The findings from MIX method indicated that interaction effects and group main effect showed no statistically significant differences, time main effect showed statistically significant differences. There were no statistically significant differences in pain between the three groups at all time points. The findings from MIX method indicated that interaction effects and group main effect showed no statistically significant differences, time main effect showed statistically significant differences.7. Addiction Severity Index (ASI):At baseline, there were no statistically significant differences in factors of ASI except for alcohol addiction, drug addiction, and legal status. At8-week follow-up, there were statistically significant differences in factors of alcohol addiction, drug addiction, legal status, and family/social relationships. At26-week follow-up, there were statistically significant differences in factors of alcohol addiction, drug addiction, legal status, and family/social relationships. At52-week follow-up, there were statistically significant differences in factors of medical status, employment status, alcohol addiction, and legal status. The findings from MIX method indicated that interaction effects showed statistically significant differences in factors of employment status, drug addiction, and legal status.Time main effects showed statistically significant differences in all factors except for family/social relationships.8. Protracted withdrawal symptoms:At baseline, there were no statistically significant differences in factors of protracted withdrawal symptoms except for sleep disorder. At8-week follow-up, there were statistically significant differences in factors of total scores, somatic symptom, and sleep disorder. At26-week follow-up, there were no statistically significant differences in all factors of protracted withdrawal symptoms. At52-week follow-up, there were statistically significant differences in factors of total scores and sleep disorder. The findings from MIX method indicated that interaction effects showed statistically significant differences in all factors of protracted withdrawal symptoms. Time main effects showed statistically significant differences in all factors. Group main effects showed statistically significant differences in factors of total scores, somatic symptom, and sleep disorder.9. SF-36:At baseline, there were no statistically significant differences in other factors of SF-36except for social functioning. At8-week follow-up, there were statistically significant differences in factors of mental component summary, vitality, social functioning, and mental health. At26-week follow-up, there were statistically significant differences in factors of physical component summary, mental component summary, general health, vitality, and mental health. At52-week follow-up, there were statistically significant differences in factors of physical component summary, mental component summary, bodily pain, general health, vitality, and social functioning.The findings from MIX method indicated that interaction effects showed statistically significant differences in factors of general health, vitality, and mental health. Time main effects showed statistically significant differences in all factors except for physical functioning.10. Laboratory testing:Across different time points, most of items of blood routine, urine routine, blood biochemical, and electrocardiography showed no statistically significant differences among three groups except for neutrophil, lymphocyte in blood routine at baseline, white blood cells in blood routine at26-week follow-up, ketones in urine routine at baseline and26-week follow-up, electrocardiography at26-week follow-up.The findings from GLM method indicated that interaction effects showed no statistically significant differences in all items of blood routine, group and time main effects showed no statistically significant differences except for time effect in neutrophil, group effect in lymphocyte. Interaction effects, group and time main effects showed no statistically significant differences in all items of urine routine. Interaction effects, group and time main effects showed no statistically significant differences in items of blood biochemical except for time effect in blood urea nitrogen. Interaction effects, group and time main effects showed no statistically significant differences in all items of electrocardiography.11. Adverse event:until the final52-week follow-up, adverse event rates of the three groups was2.22%,12.14%,9.52%, respectively. Chi-square test indicated the difference of adverse event rates among the three groups was statistically significant(P=0.0001), adverse event rate of Jitai comprehensive group was higher than methadone comprehensive group(P=0.0002), adverse event rate of Jitai pure group was higher than methadone comprehensive group(P=0.0035).One case of serious adverse events was observed in Jitai comprehensive group, that was Surgery in hospital, and one case of serious adverse events was observed in Jitai pure group, that was laryngeal cancer. But neither of them was relevant with Jitai medication.The incidence rates of side effect maybe associated with drugs of the three groups was0.56%,7.28%,5.95%, respectively. Chi-square test indicated the difference of side effect rates among the three groups was statistically significant (P=0.005), the side effect rate of methadone comprehensive group was lower than Jitai comprehensive group (P=0.001) and Jitai pure group (P=0.004). The main possible side effect of Jitai tablets included drowsiness, dry mouth, gastrointestinal discomfort, decreased appetite, blurred vision, dizziness and sweat.98.7%of the side effects were slight,64.5%of them happened during the first month, and80.6%of them happened during the two months.12. Compliance with the intervention:100%of the participants in methadone comprehensive group,98.06%in Jitai comprehensive group, and97.02%in Jitai pure group showed good medication compliance. Chi-square test indicated the difference of medication compliance among the three groups was statistically significant (Fisher exact test, P=0.0459), methadone comprehensive group was better than Jitai pure group (Fisher exact test, P=0.0254).138participants in methadone comprehensive group took part in10group psychology sessions and above, accounting for76.67%, while153participants in Jitai comprehensive group took part in10group psychology sessions and above, accounting for74.27%. Differences between the two groups was not statistically significant (P=0.586). Social supports in methadone comprehensive group achieved661person-times,3.67per capita, Jitai comprehensive group achieved818person-times,3.97per capita, and Jitai pure group achieved751person-times,4.47per capita. Differences between the three groups was not statistically significant (P=0.257). Conclusions1. Shanghai attached great importance to the community drug treatment, preliminary formed network structure, introduced the concept of socialization and specialization, seted up a non-profit organization.Positioned drug addicts correctly and innovatived work mechanism, integrated government and social resources to promote government and non-profit organization work closely and departmental interaction within government. Strengthen grass-roots community force, ensured the personnel and funds, and leaded to synergy.2. Baseline characteristics of the three groups in this study were basically balanced and comparable. Compliance with the interventions including medication, psychological counseling and social support was good.3. The three groups including methadone comprehensive group, Jitai comprehensive group, and Jitai pure group gained good effect of maintenance and relapse prevention, decreased the level of depression and alleviated psychological craving and pain.4. JTT displayed equivalent effect of relapse prevention to methadone, and has its own advantages such as non-addictive, safe and convenient, rich in source. Jitai tablet can be recommended to clinical doctors and drug addicts.5. Combined with medication and social support, group psychological counseling showed on obvious effect in the period of1year community drug treatment.It is suggested that intervention intensity be reinforced and make further observation and evaluation.6. Social workers contributes a great share in community drug treatment, play multiple roles, such as service providers, campaigners, resources integrators and policy advisors. Construction of professional social workers team should be further strengthened in community drug treatment. |
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