||Objective: To evaluate the clinical efficacy and quality of life of combined warming needle and patented Chinese medicine for patients with irritable bowel syndrome (IBS) due to liver-qi stagnation with spleen deficiency. Method: Sixty IBS cases were randomized into a treatment or control group by single-blind method. Warming needles on Tianshu (ST 25) and Dachangshu (BL 25) combined with patented Chinese medicine were adopted for cases in the treatment group, whereas the patented Chinese medicine alone was adopted in the control group. Results: The therapeutic efficacies in the two groups did not show substantial differences. The main symptoms were significantly improved after the treatment (P<0.01). After 2 weeks of treatment, the cases in the treatment group obtained a better improvement than the control group (P<0.01, P.<0.05) in the severity or frequency of abdominal pain, abdominal distension, restlessness, insomnia, anxiety, suspiciousness, and loose stools with a sense of incomplete emptying. The patient's quality of life was improved in both groups (P<0.01). Conclusion: Both treatment methods could improve the clinical symptoms and increase the patient's quality of life. The total effective rate in the treatment group was slightly higher than the control group. Also, the combined warming needle and Chinese herbs could improve the main symptoms in a faster way.