Hemorrhoids are a highly prevalent disease, which have been a health challenge to people for a long time, seriously affecting the life, work, study, and the quality of life. The development of hemorrhoids is closely related to the imbalance of the mucosal barrier function of the anal cushion and the destruction of the mucus barrier and the mucosal barrier. How to treat hemorrhoids simply and efficiently has become a concern of clinicians.

To comprehensively assess the clinical efficacy of mussel adhesive protein (MAP) with fumigation and sitz bath with Tongyangxiao Lotion (a traditional Chinese medicine) in the treatment of grades 1 and 2 mixed hemorrhoids.

A prospective, randomized, single-blind, controlled study design was used. 298 anorectal outpatients with grades 1 and 2 hemorrhoids were selected from Hebei University of Chinese Medicine in 2021, and equally randomized into an experimental group and a control group. All patients were given general treatment such as diet and life guidance, and a 10-day fumigation and sitz bath with Tongyangxiao Lotion. The experimental group additionally received a 10-day treatment with topical use of MAP concurrently. The primary efficacy indicators include the response level (cure, marked response, response, non-response) and recurrence rate. The secondary efficacy indicators include the visual analogue scale (VAS) score, clinical symptom score, quality of life score, and safety index.

276 patients actually completed this study, including 140 in the experimental group and 136 in the control group; 135 males and 141 females, with a median age of 38 (29, 48) years. There were no significant differences between two groups in gender ratio, mean age, distribution of course, and grade of mixed hemorrhoids, VAS score, clinical symptom score, anal mean canal resting pressure, hemorrhoid disease and the Crohn's Anal Fistula Quality of Life (CAF-QoL) score and past history (P>0.05). The VAS score, clinical symptom score, hematochezia score, rectal tenesmus score, hemorrhoid mucosa score, hemorrhoid nucleus size score of the two groups differed between two groups on the 4th, 7th or 10th day of follow-up (P<0.05). On the 10th day of follow-up, the VAS score, clinical symptom score, hematochezia score and hemorrhoid size score of the experimental group were lower than those in the control group (Z=-4.681, -3.784, -1.994, -3.411, P<0.05). The VAS score, clinical symptom score, anal canal resting pressure and CAF-QoL score decreased in both groups after treatment (P<0.05). The post-treatment VAS score (Z=-4.681), clinical symptom score (Z=-3.784), anal canal resting pressure (t=2.566), and CAF-QoL score (t=6.827) in the experimental group were lower than those in the control group (P<0.05). The experimental group had higher overall response rate (96.43% vs 91.18%) than the control group (χ²=8.557, P=0.036). The experimental group also had higher cure rate (84.28% vs 69.85%) (χ²=8.157, P=0.004). No complications and adverse reactions were found in both groups during the treatment period. There was no significant difference in the recurrence rate between the experimental group and control group (3.23% vs 5.33%) (P>0.05) .

MAP combined with sitz bath with Tongyangxiao Lotion acted rapidly, which had better performance in repairing the barrier function of the anal cushion, improving the clinical symptoms, reducing the tension of the internal anal sphincter, and improving the quality of life in patients with grades 1 and 2 mixed hemorrhoids.