A Prospective and Retrospective Clinical Controlled Observation of Chinese Herbal Decoction (SMLJ01) for Type 1 Gastric Neuroendocrine Tumors

INTRODUCTION: Type 1 gastric neuroendocrine tumors (g-NETs) have a good prognosis but a high recurrence rate. AIM: To observe the clinical efficacy of the treatment of type 1 g-NETs with the Chinese herbal decoction SMLJ01. MATERIALS AND METHODS: A prospective and retrospective, clinical, controlled observation was conducted in 4 Chinese centers from 2012 to 2019. Patients with type 1 g-NETs were nonrandomly divided into treatment and control groups after endoscopic treatment based on herbal treatment administered according to their wishes. The treatment group received oral SMLJ01, with follow-up every 6 to 12 months, while the control group received follow-up alone. Patient follow-up (via telephone) from 2012 to 2017 was mainly retrospective. All patients after 2017 were followed prospectively. The recurrence times and rates were compared after treatment for at least 6 months. Symptom improvements were evaluated in the treatment group. The follow-up ended on October 31, 2019. RESULTS: During a median follow-up of 22 months (range: 2-86 months), the survival rate was 100%, and no metastases occurred. Twenty-one of the 82 treated patients (25.6%) had recurrence after a median of 22 months, and 22 of the 54 control patients (40.7%) had recurrence after a median of 8 months (P = .063). The Kaplan-Meier curve analysis showed that the patients in the treatment group had a significantly longer median recurrence-free survival (RFS) time than those in the control group (P = .001). The risk of recurrence in the treatment group was 0.38 relative to that in the control group (95% CI: 0.20-0.70). The symptom score of the patients after taking Chinese medicine was 19.5 (10.3, 28.0), which was significantly lower than before treatment (31.5 (19.3, 38.0)). The difference was statistically significant (P < .01). CONCLUSION: SMLJ01, with the effects of soothing the liver, strengthening the spleen, increasing acid and harmonizing the stomach, may help reduce the recurrence rate, relieve symptoms and prolong the recurrence time in patients with type 1 g-NETs and is worthy of evaluation with further randomized research with large sample sizes and longer follow-up periods.