This study aimed to evaluate the therapeutic effect of traditional Chinese medicine (TCM) by observing the changes in CD4 T-lymphocyte cell count of 110 cases with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) treated continuously with TCM for 84 months. Information of 110 HIV/AIDS patients from 19 provinces and cities treated with TCM from 2004 to 2013 was collected. Changes in the indexes of CD4 counts (≤200, 201–350, 351–500 and>500 cells/mm³) at five time points (0, 12, 36, 60 and 84 months) and different treatments [TCM and TCM plus antiretroviral therapy (ART)] were compared. Repeated measures test indicated no interaction between group and time (P>0.05). Degrees of increasing and decreasing CD4 count of the two groups at four different frames were statistically significant compared with the baseline. The CD4 count between the two groups was not statistically significant. For CD4 count of≤200 cells/mm³, the mean CD4 count changes were 21 and 28 cells/mm³ per year for the TCM group and TCM plus ART group, respectively. For CD4 count of 201–350 cells/mm³, the mean CD4 count changes were 6 and 25 cells/mm³ per year for the TCM group and TCM plus ART group, respectively. For CD4 count of 351–500 cells/mm³, the mean CD4 count changes were -13 and -7 cells/mm³ per year for the TCM group and TCM plus ART group, respectively. For CD4 count of>500 cells/mm³, the mean CD4 count changes were -34 and -17 cells/mm³ per year for the TCM group and TCM plus ART group, respectively. Long-term use of TCM could maintain or slow the pace of declining CD4 counts in patients with HIV/AIDS, and may achieve lasting effectiveness.