本研究的目的在探討複方保健食品對精神分裂症之臨床症狀與治療副作用之效益與輔助效益。 本研究採分組開放研究，篩選年齡從18歲至65歲之男女，符合精神分裂病診斷之中重度急性住院患者，進行6週比較性實驗。實驗A組：在現行藥物治療方案上，加上保健食品，B組：採現行抗精神病藥物治療方案，C組：只使用保健食品。研究工具：精神症狀評估採國際通用之PANSS評分表 (Positive And Negative Symptoms Scales for schizophrenia)，其中並區分為正性症狀，負性症狀，一般症狀，補充症狀等四大症狀群。病患之憂鬱症狀採CDSS評分表 (Calgary Depression Scale for Schizophrenia)，藥物副作用採ESRS (Extrapyramidal Syndrome Rating Scales) 及臨床觀察紀錄，每週評分一次。 本研究共48位參與者，A B C組各16位，共48位完成。結果發現，6週後A組PANSS的總分改善百分比改變量為30.51% （組內P < 0.01），B組PANSS的總分改善百分比改變量為44.96%（組內P < 0.01），兩者在臨床上皆呈現良好之療效反應，C組PANSS的總分改善百分比改變量為24.80%（組內P < 0.01）。而三組間差異顯示，B組與A組及B組與C組之間具有顯著差異（AB組間P=0.008，BC組間P=0.001），A組與C組之間則無顯著差異。CDSS的組內和組間比較，並無顯著差異。副作用方面，嗜睡在B組較A組為多（P＝0.033）。 合併藥物與保健食品使用組(A組)與單獨使用藥物組(B組)相比，本研究所採用之保健食品並無顯著的增強效果。而單獨使用保健食品組(C組)亦未能取代藥物治療的效果。A組副作用較低，可能跟使用藥物平均劑量較少有關，但兩組用藥量比較未達顯著差異。 Objective: This study aimed to evaluate the effect of food supplement on schizophrenic patients. Methods: Patients diagnosed as moderate to severe schizophrenia within the ages of 18 to 65 were recruited into the study after informed consent was obtained. They were randomly divided into three groups. The patients in Group A received drug treatment and food supplement, Group B received drug treatment only, and Group C received food supplement only. Patients were not masked to their group assignment. The patients were evaluated every week using PANSS (Positive And Negative Symptoms Scales for schizophrenia), CDSS (Calgary Depression Scale for Schizophrenia), and ESRS (Extrapyramidal Syndrome Rating Scales) (together with a general observation questionnaire) for their psychotic symptoms, depression symptoms and side effects, respectively. Results: A total of 48 patients enrolled in the study. The percentage of improvement was 30.51% for Group A (P<0.01 for within-group comparison), 44.96% for Group B (P< 0.01 for within-group comparison), 24.80% (P< 0.01 for within-group comparison) using PANSS. There were significant differences between group B and A, as well as B and C (between-group comparison for A and B: P=0.008; for B and C: P=0.001). There were no significant differences between Group A and Group C. In addition, there were no significant differences observed in either within-group or between-group comparison using CDSS. Furthermore, the side effect of sedation was significantly higher in Group B than in Group A (P=0.033). Conclusion: The augmenting effect of using the food supplement in addition to the drug treatment was unable to be demonstrated in this study. Using the food supplement alone could not replace the therapeutic effect of the drug treatment. Lower average dose requirement of antipsychotics and fewer side effects were found in Group A compared with Group B, However, fewer side effects might be related to the lower average dose itself.
