OBJECTIVETo compare the effect of An's Shaobei Injection ([symbols; see text]) with Xiaozhiling Injection ([symbols; see text]) in patients with internal hemorrhoids of grade I-III.

METHODSThis cohort study included 1,520 internal hemorrhoids patients with grade I-III who were scheduled for liquid injection treatment from July 2003 to July 2009. The cohort included patients who underwent either An's Shaobei Injection treatment (the treatment group, 760 cases) or Xiaozhiling Injection treatment (the control group, 760 cases). All patients were followed up regularly for 3 years; the observing indices included anal function recovery and clinical response after operation.

RESULTSAmong the 1,520 patients, 1,508 (99.2%) completed the 3-year follow-up. The efficacy rate was 97.5% in the treatment group, significantly higher than the control group (91.8%, P<0.01). The recurrence rate in the treatment group was 0.5%, significantly lower than that of the control group (1.3%, P<0.01). In addition, perianal callosity occurred in 8 cases (1.1%) and anorectal stricture in 26 cases (3.5%) after operation in the control group. There was no perianal callosity and anorectal stricture in the treatment group.

CONCLUSIONThe treatment with An's Shaobei Injection demonstrated superior clinical effect to Xiaozhiling Injection with fewer adverse effects.