# Abstract

 

## Background Microencapsulated sodium butyrate (MSB) has been previously associated with anti-inflammatory and regenerative properties regarding large bowel mucosa. We aimed to examine a role of MSB in patients with diverticulosis, hypothesizing its potential for reduction of diverticulitis episodes and diverticulitis prevention. 

## Methods Seventy-three patients with diverticulosis (diagnosed in colonoscopy or/and barium enema or/and CT colography) were recruited for the study and randomized. The investigated group was administered MSB 300 mg daily; the control group was administered placebo. After 12 months, a total of 52 patients completed the study and were subject to analysis (30 subjects and 22 controls). During the study, the number of episodes of diverticulitis (symptomatic diagnosis with acute pain, fever, and leukocytosis), hospitalizations, and surgery performed for diverticulitis were recorded. Additionally, a question regarding subjective improvement of symptoms reflected changes in quality of life during the analysis. 

## Results After 12 months, the study group noted a significantly decreased number of diverticulitis episodes in comparison to the control group. The subjective quality of life in the study group was higher than in the control group. There were no side effects of the MSB during the therapy. 

## Conclusions MSB reduces the frequency of diverticulitis episodes, is safe, and improves the quality of life. It can play a role in the prevention of diverticulitis. # Results Between 2011 and 2012, 92 patients were enrolled in the study. After exclusion of 19 patients who did not meet the criteria of the study, 73 patients were randomized into the treatment group or placebo group. After 12 months, a total of 52 patients concluded the study and their results were analyzed. Baseline demographic characteristics of the investigated patient groups as well as detailed results of our study are presented in Table [1](#). ::::table-wrap

::: caption
Characteristics of the investigated groups (10 years if diverticulosis
and longer) and results of the investigation at 12 months of follow-up
:::

```
                                                                                                                                                                                                          All patients   Treatment group   Placebo group   *p* value
```

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Number of patients 52 30 22\
Gender (female/male) 30/22 17/13 13/9\
Mean age of patients (years) 64.2 63.7 64.7 ns
SD 6.7 6.09 7.65\
Median 63.5 63 64\
Duration of diverticulosis (years) 9.9 10.47 9.32 ns
SD 4.46 4.18 4.82\
Median 10 8.5 10\
Clinical symptoms of diverticulitis: acute left lower quadrant pain, tenderness, fever (>3 °8C) or leukocytosis (WBC > 12,000/mm^3^), *n* (%) 9 (17.3) 2 (6.7) 7 (31.8) 0.0425
Abdominal ultrasound examinations for suspected diverticulitis, *n* (%) 6 (11.5) 1 (3.3) 5 (22.7) 0.0229
Diagnoses of diverticulitis in abdominal US, *n* (%) 6 (11.5) 1 (3.3) 5 (22.7)\
CT abdomen for suspected diverticulitis, *n* (%) 3 (5.8) 1 (3.3) 2 (9) ns (low number of events)
Diagnoses of diverticulitis in CT abdomen, *n* (%) 3 (5.8) 1 (3.3) 2 (9)\
Hospitalizations for diverticulitis, *n* (%) 4 (7.7) 1 (3.3) 3 (13.6) ns (low number of events)
Surgery (Hartmann's procedure) because of diverticulitis, *n* (%) 1 (1.9) 0 (0) 1 (4.5) ns (low number of events)
Subjective evaluation of the patients (positive answer to the question: *Did you observe adequate relief of diverticulosis related to abdominal pain or discomfort within the past 12 months?* ), *n* (%) 22 (42.3) 17 (56.7) 5 (22.7) 0.0143
Number of adverse events, *n* (%) 0 (0) 0 (0) 0 (0) ns (low number of events)

*ns* not significant:::: Mean age of patients in the treatment group (*n* = 30) was 63.7 (SD ± 6.09) and 64.7 (±7.65) in the placebo group ( *n* = 22). There were more females recruited in the study as well as more females randomized in both arms of the study. Duration of diverticular disease in the treatment group was on average 10.47 years (±4.18) and 9.32 years (±4.82) in the placebo group. The number of diverticulitis clinical symptom occurrences during 12 months of observation was 2 (6.67 %) in the MSB group and was significantly lower ( *p* = 0.0425) than the clinical symptoms of diverticulitis reported in the control group (7 occurrences, 31.8 %). In comparison to the placebo group, the number of abdominal ultrasound examinations performed for suspected diverticulitis and subsequent number of diverticulitis diagnosed based on abdominal US was significantly lower (1 vs 5, *p* = 0.0229). The number of abdominal CT imaging performed for suspected diverticulitis, number of hospitalizations for diverticulitis, and number surgical intervention for diverticulitis were reported to be higher in the treatment group (1 vs 2, 1 vs 3, and 0 vs 1, respectively) but were too low to adequately compare the investigated groups. Subjective improvement in observed symptoms based on a single closed-end question (yes or no answer): "Did you observe adequate relief of diverticulosis related to abdominal pain or discomfort within the past 12 months?" was reported to be higher in the treatment group (55.67 vs 22.73 %, *p* = 0.0143). At the time of the study as well as after the conclusion of the study, there were no adverse or side effects of MSB or placebo observed.


Extracted trial result:
Outcome: Subjective improvement in observed symptoms based on a single closed-end question (yes or no answer): "Did you observe adequate relief of diverticulosis related to abdominal pain or discomfort within the past 12 months?" (binary)
Intervention: Microencapsulated sodium butyrate (MSB) 300 mg daily
Comparator: control group was administered placebo
Intervention events: 17
Intervention group size: 30
Comparator events: 5
Comparator group size: 22
Notes: found in table 3