To study the clinical efficacy of and safety of Honghua Huayu Decoction (Safflower and Blood Stasis Decoction) combined with acupuncture in treating shoulder-hand syndrome after stroke. Methods: A hundred and twenty patients with shoulder hand syndrome after stroke were included as study subjects. After signing the informed consents, patients were randomly divided into three groups, namely Group A, B and C. Patients in group A were treated with Honghua Huayu Decoction combined with acupuncture, patients in group B only received acupuncture treatment, while patients in group C were only treated with Honghua Huayu Decoction. Movement of attacked upper limb, shoulder pain, quality of life scores and adverse reactions were observed among the three groups before and after the treatment. Results: After treatment, movement of attacked upper limb and quality of life in patients of group A were significantly improved compared with those before the treatment, as well as those in the group B and C (P<0.01). Shoulder pain scores were significantly lower than those before treatment and those of group B and C (P<0.01). Adverse reactions were significantly fewer in group, compared with group B and C (P<0.05). Conclusion: Honghua Huayu Decoction combined acupuncture may significantly improve the movement of attacked upper limb and quality of life in patients with shoulder hand syndrome after stroke, relieving shoulder pain with few and mild adverse reactions and high safety, which is worthy of wide application.