Efficacy and Safety of Wuling Capsule Combined with Fupentixol and Melitracen Tablets in Active Ulcerative Colitis Patients Accompanied with Anxiety and Depression
Psychotherapy is an important component of the treatment program for inflammatory bowel disease (IBD) , a common chronic incurable digestive system disease accompanied with psychosomatic disorder, which involves ulcerative colitis (UC) . Wuling capsule has proven to be effective in multiple gastrointestinal diseases with psychosomatic disorders, but there are rare studies about its effect on improving the condition, anxiety and depression of UC patients.
To investigate the efficacy and safety of Wuling capsule with Fupentixol and melitracen tablets in active UC patients with anxiety and depression.
A total of 120 active UC patients with anxiety and depression were selected from Gastroenterology Clinic or Inpatient Department of the Second Affiliated Hospital of Zhejiang Chinese Medical University and Zhejiang Provincial Tongde Hospital from January 2019 to December 2020, and equally, double-blindly randomized into control group, Deanxit group, Wuling capsule group and combination group, receiving Mesalazine sustained-release tablets (hereinafter referred to Mesalazine) , Mesalazine with Fupentixol and melitracen tablets, Mesalazine with Wuling capsules, Mesalazine with Fupentixol and melitracen tablets and Wuling capsules, respectively. All of the four groups were treated for 8 consecutive weeks as a course. Pre- and post-treatment main clinical symptom score, modified Mayo score, inflammatory response indicators, Zung Self-rating Anxiety Scale (SAS) score, Zung Self-rating Depression Scale (SDS) score, and Inflammatory Bowel Disease Questionnaire (IBDQ) score were compared across the four groups. Meanwhile, safety evaluation for the four treatments was conducted.
Finally, 113 cases (except Wuling capsule group containing 29 cases, other three groups containing 28 cases) who completed this study were included for analysis. Compared with other three groups, combination group showed lower post-treatment diarrhea score, mucus with blood and pus in stools score, abdominal pain score and total score of clinical symptoms, modified Mayo score, erythrocyte sedimentation rate, serum levels of C-reactive protein, tumor necrosis factor-α and interleukin-6, as well as SAS and SDS scores, and higher scores of bowel, systemic, emotional and social domains and total IBDQ score (P<0.05) . One control group case had abdominal distension and one Deanxit group case had hyposomnia during treatment, but were spontaneously relieved.
In active UC patients accompanied with anxiety and depression, Wuling capsule with Fupentixol and melitracen tablets could relieve the clinical symptoms, severity of condition, inflammatory response, anxiety and depression disorders, improve the quality of life, with relatively high safety. Therefore, Wuling capsule may be a choice for optimizing the comprehensive treatment plan of UC.
N-of-1 Trial of Jianpiqingrehuashi Granular Decoction with Mesalamine in the Treatment of Ulcerative Colitis in Remission with Spleen Deficiency-induced Damp-heat Syndrome
The patient with ulcerative colitis (UC) in remission has a long course of disease, and needs a long-term maintenance treatment. Traditional Chinese medicine (TCM) has proved to be partially effective in treating UC in remission, but the efficacy of Jianpiqingrehuashi granular decoction (JPQRHSGD) against UC in remission is not yet clear.
To evaluate the efficacy and safety of JPQRHSGD with mesalamine versus mesalamine in the treatment of UC in remission using an N-of-1 trial.
An N-of-1 trial was conducted between June 2020 and March 2021. Participant was an outpatient with UC in remission with spleen deficiency-induced dampness-heat syndrome who was selected from the First Affiliated Hospital, Guangzhou University of Chinese Medicine. The patient received a treatment program, namely four rounds of treatment without washout consisting of eight cycles〔each round includes two cycles, that was, one-month intervention treatment (use of JPQRHSGD with mesalamine) alternating with one-month control treatment (taking mesalamine only) 〕. Efficaciesof two types of treatment were evaluated by of the TCM Syndrome Score (TCMSS) , Bristol Stool Form Scale (BSFS) , visual analogue scale (VAS) for abdominal pain and diarrhea, and Short Health Scale (SHS) . Safety was also compared between the two treatments.
The total TCMSS in intervention period was significantly lower than that in control period (P<0.05) . In particular, the symptoms of diarrhea, abdominal distension and fatigue of the limbs were improved more obviouslyin intervention period (P<0.05) . The improvements of total BSFS score, and diarrhea VAS score in intervention period were better than those in control period (P<0.05) . However, abdominal pain VAS score in intervention period was worse than that in control period (P<0.05) . The improvement of SHS score in intervention period was better than those in control period (P<0.05) . No treatment-related adverse events were reported.
The JPQRHSGD with mesalamine improved the clinical symptoms of the UC patient in remission with spleen deficiency-induced dampness-heat syndrome, with relatively high safety.
Immunological Mechanism of Faecal Bacterial Transplantation in the Intervention of Ulcerative Colitis
Ulcerative colitis is listed as one of the modern refractory diseases by the World Health Organization. At present, Western medicine still has many shortcomings in its treatment, and studies have shown that fecal bacterial transplantation (FMT) has a certain effect on it, but the mechanism is not clear.
FMT was used to treat mouse ulcerative colitis model to verify the efficacy and possible mechanism of FMT.
From December 2019 to April 2020, 60 mice were divided into normal control group (Control group) , ulcerative colitis model group (Model group) , ulcerative colitis model + fecal bacteria transplantation treatment group (Model+FMT group) and ulcerative colitis model + 5-aminosalicylic acid (5-ASA) treatment group (Model+5-ASA group) by random number table method, each of 15 mice. Control group did not make any intervention; Model group prepared mouse ulcerative colitis model; after successful modeling, the Model+FMT group was given 0.2 ml of fecal bacteria solution per enema; after successful modeling, the Model+5-ASA group was given 0.019 5 g/ml 5-ASA enema. The ultrastructural changes of intestinal tissue through transmission electron microscope, flow cytometric detection of blood helper T cell (Th) -17, Th-1, Th-2, Treg cell content changes, and enzyme-linked immunosorbent assay (ELISA) were observed to detect serum interferon γ (IFN-γ) , interleukin (IL) -2, IL-17, IL-4, IL-10, transforming growth factor β (TGF-β) level changes.
Intestinal tissue transmission electron microscopy ultrastructure showed that the Model group was successfully modeled; the microvilli in the Model+FMT group and Model+5-ASA group were denser, with normal morphology, more goblet cells, slight swelling of mitochondria, and insignificant rough endoplasmic reticulum lesions. The Th17 cell content of the Model+FMT group was higher than that of the Control group and lower than that of the Model group; the Th17 cell content of the Model+5-ASA group was lower than that of Control group, Model group and Model+FMT group. The Th1 cell content of Model+FMT group and Model+5-ASA group were lower than those of Control group and Model group, respectively; Th2 cell content of Model+FMT group was lower than that of Control group and higher than that of Model group, and Th2 cell content of Model+5-ASA group was lower than that of Control group and higher than that of Model group and Model +FMT group. Treg cell content in Model+FMT group and Model+5-ASA group were lower than that of Control group and higher than that of Model group (P<0.05) . IFN-γ cell content in Model+5-ASA group was lower than that of Model group. IL-2 cell content in Model+FMT group and Model+5-ASA group was lower than that of Model group; the IL-17 cell content of Model+FMT group and Model+5-ASA group were lower than those of Control group and Model group, respectively. The IL-17 cell content of Model+5-ASA group was lower than that of Model+FMT group; the IL-4 cell content of Model+FMT group was lower than that of Control group and higher than that of Model group. The IL-4 cell content in the Model+5-ASA group was higher than that in the Model group; the IL-10 cell content in the Model+FMT group was higher than that in the Control group and the Model group, and the IL-10 cell content in the Model+5-ASA group was higher than that in the Model group; the content of TGF-β cells in the Model+FMT group and Model+5-ASA group were lower than those in the Control group and higher than those in the Model group (P<0.05) .
FMT can improve the symptoms of ulcerative colitis in mice. It is speculated that it may be achieved by adjusting the balance of Th1/Th2 cells and the ratio of Th17/Treg cells to achieve the purpose of treatment.
