OBJECTIVE: To observe effects of syndrome-differentiation acupuncture on life quality in patients with functional dyspepsia (FD) in order to evaluate its clinical efficacy. METHODS: One hundred and five cases of FD were randomly divided into a syndrome-differentiation acupuncture group, a regular acupuncture group and a non-acupoint group, 35 cases in each one. Zhongwan (CV 12), Tianshu (ST 25), Zusanli (ST 36) were selected as main acupoints in the syndrome-differentiation acupuncture group. After syndrome differentiation, Danzhong (CV 17) and Zhangmen (LR 13) were added for those with stagnation of liver qi; Pishu (BL 20) and Weishu (BL 21) were added for those with deficiency of spleen-stomach qi; Qimen (LR 14) and Taichong (LR 3) were added for liver-qi invading stomach and Yinlingquan (SP 9) and Neiting (ST 44) were added for dampness-heat blocking stomach. The selection of acupoints in the regular acupuncture group was the same as main acupoints in the syndrome-differentiation acupuncture group. The points 10 mm lateral to the main acupoints were selected in the non-acupoint group. The treatment was given once a day, six days as a treatment course and totally two courses were required. The symptom total score, health-related quality of life survey (SF-36) and Nepean dyspepsia index (NDI) were evaluated before and after the treatment as well as one month after the treatment (follow-up visit), respectively. The efficacy was also assessed. RESULTS: After the treatment, the total effective rate was 87.5% (28/32) in the syndrome-differentiation acupuncture group, which was superior to 74.2% (23/31) in the regular acupuncture group and 20.7% (6/29) in the non-acupoint group (P < 0.05, P < 0.01). Compared before the treatment, the SF-36, NDI and symptom total score after the treatment and in the follow-up visit were all obviously improved in the syndrome-differentiation acupuncture group and regular acupuncture group (all P < 0.05), which was the most obvious in the syndrome-differentiation acupuncture group [after the treatment, SF-36: 84.54 +/- 5.93 vs 81.44 +/- 6.22, 63.46 +/- 6.59; NDSI: 18.94 +/- 9.30 vs 21.23 +/- 8.39, 43.93 +/- 11.26; NDLQI: 71.42 +/- 7.23 vs 63.11 +/- 7.06, 54.87 +/- 6.00; symptom total score: 22.06 +/- 15.80 vs 32.52 +/- 16.88, 47.97 +/- 10.92]; the improvement in the regular acupuncture group was more obvious than that in the non-acupoint group (P < 0.01, P < 0.05). Compared before the treatment, only NDSI score was improved in the non-acupoint group after the treatment (P < 0.05). CONCLUSION: The syndrome-differentiation acupuncture could obviously improve patient's life quality in the treatment of FD, which is an effective therapy for FD.