[Analysis on clinical efficacy, safety and economy of Shaobei injection and elastic band ligation in the treatment of grade II or III hemorrhoids].

Objective: Currently, various treatments such as hemorrhoidectomy, ligation and sclerotherapy injection can be applied in grade II or III hemorrhoids. This study aims to compare the clinical efficacy, safety and economy between Shaobei injection and elastic band ligation in treating patients with grade II or grade III hemorrhoids.
Methods: A retrospective cohort study was used. Clinical data of 60 patients with grade II or grade III hemorrhoids at Department of Anorectal Surgery of the Sixth Affiliated Hospital, Sun Yat-sen University between January 2019 and October 2019 were collected. Patients were divided into two groups according to surgical methods. Patients in the Shaobei group received Shaobei injection (n=28), and those in the ligation group received elastic band ligation (n=32). Inclusion criteria: (1) diagnosis of grade II or III hemorrhoid; (2) application of Shaobei injection or elastic band ligation; (3) age between 18-75 years old. Exclusion criteria: (1) comorbidity with anal fissure, anal fistula, anal sinusitis or other perianal diseases; (2) patients with mental disorder or poor compliance; (3) incomplete clinical or follow-up data. Recurrent rate, postoperative pain, anal edema, anal distension, total cost of hospitalization, length of hospitalization, and postoperative life quality EQ-5D-3L score were compared between the two groups at postoperative 6-month.
Results: No significant difference was observed in the baseline data (including Nystrom hemorrhoid symptom score) between the two groups (all P>0.05), except gender ratio [male proportion: Shaobei 75% (21/28) vs. ligation 37.5%(12/32), χ(2)=8.485, P=0.004]. No significant difference in recurrent rate was found between the two groups [14.3% (4/28) vs. 9.4% (3/32), χ(2)=0.035, P=0.851]. Compared to the ligation group, Shaobei group showed less pain at postoperative day 1 [VAS median (range): 2 (1-6) vs. 3 (1-7), Z=2.814, P=0.005] and postoperative day 7 [VAS median (range): 0 (0-2) vs. 1 (0-4), Z=3.149, P=0.002]; lower anal edema ratio at postoperative day 1 [10.7% (3/28) vs. 34.4% (11/32), Z=4.673, P=0.037]; lower anal distension ratio at postoperative day 1 [7.1% (2/28) vs. 28.1% (9/32), Z=4.391, P=0.048]; less hospitalization cost [(6343.5±1444.1) yuan vs. (10 587.1± 1719.0) yuan, t=12.515, P<0.001] and shorter postoperative hospital stay [median (range): 1 (1-5) days vs. 3 (1-6) days, Z=5.879, P<0.001]. The EQ-5D-3L scores of two groups were significantly improved six months after treatment [Shaobei group: (0.90±0.16) vs. (0.73±0.14); ligation group: (0.91±0.13) vs. (0.74±0.10); both P<0.001], while there was no statistically significant difference between the two groups (t=0.130, P=0.897). No complications such as massive hemorrhage, infection, iatrogenic anal fistula, rectal stricture and local induration occurred after the injection. Conclusions: Shaobei injection is effective and safe in treating grade II or III hemorrhoids. Compared with elastic band ligation, it can reduce morbidity of complications and hospitalization expenses.