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Statistic Dance on Diverticular Disease Dr Walter Elisei
U.O.C. Gastreonterologia ed Endoscopia Digestiva
ASL_Roma 6 – Albano Laziale (Roma)
Main Topics on Treatment of Diverticular Disease
How to treat Symptomatic Uncomplicated Diverticular Disease (SUDD)
How to prevent the first attack of diverticulitis ( Diverticulitis Occurrence )
How to treat Acute Uncomplicated Diverticulitis
How to prevent Acute Diverticulitis Recurrence
Main Topics on Treatment of Diverticular Disease
How to treat Symptomatic Uncomplicated Diverticular Disease (SUDD)
How to prevent the first attack of diverticulitis ( Diverticulitis Occurrence )
How to treat Acute Uncomplicated Diverticulitis
How to prevent Acute Diverticulitis Recurrence
Symptom Relief NNT:3 Complications Occurrence NNT:59
Diverticulitis Occurrence NNT:50
SUDD and Diverticulitis Occurrence_Rifaximin based treatment
3 RT Open Label
1 DB-RT_PC
(1992-2003_1660 pts)
SUDD and Diverticulitis Occurrence_Mesalamine based treatment
4 RT Open Label (1999-2007)
Mesalamine vs Other Therapy
(694 pts)
Symptom Relief
Diverticulitis Occurrence
… we still have non meta-analysis
because the data are not omogeneous…
3 RT Open Label (1999-2007)
Mesalamine vs Other Therapy
(524 pts)
SUDD and Diverticulitis Occurrence_Mesalamine based treatment
Pain control
117 pts
ITT ARR (95% CI): 7.6% (6,2 % - 29,5%)
NNT = 13.1
PP ARR (95% CI): 17.8% (0,16 % - 35,4%)
NNT = 5.6
Symptom relief
250 pts
ARR (95% CI): 39.3 % (24.7-53.9)
NNT = 2.5
Diverticulitis Occurrence (1st)
250 pts
ARR (95% CI): 12 % (2.9-21)
NNT = 8.3
Main Topics on Treatment of Diverticular Disease
How to treat Symptomatic Uncomplicated Diverticular Disease (SUDD)
How to prevent the first attack of diverticulitis ( Diverticulitis Occurrence )
How to treat Acute Uncomplicated Diverticulitis
How to prevent Acute Diverticulitis Recurrence
Antibiotics for Acute Uncomplicated Diverticulitis
Chabok A et al. Br J Surg. 2012 Apr;99(4):532-9
AVOD Trial (2012)_RCT
623 patients randomized to treatment with (314 pts) or without (309 pts) antibiotics.
CT proven diverticulitis: Ambrosetti mild
Primary Endpoint: Recovery without complications at 12 months follow-up
Complications ( 1,9% vs 1%; p= ns)
Recurrent diverticulitis at 1-year Follow-Up (16% vs 16%; p= ns).
DIABOLO Trial (2010)_RCT
528 patients randomized to treatment with or without antibiotics.
CT proven diverticulitis: Hinchey 1a or 1b
Primary Endpoint: Time-to-full-recovery al 6 months follow-up
At 6 months follow-up recovery occurred in 234 (89.3%) patients assigned to observation
and in 248 (93.2%) patients assigned to antibiotics (P=0.183).
Median time-to-recovery was comparable among observational and antibiotic treatment
strategies (14 days [IQR, 6 to 35] vs. 12 days [IQR, 7 to 30]; P=0.291 by the Log-Rank
test), with a hazard ratio for recovery of 0.910 (upper limit one-sided 95 % CI, 1.059;
P=0.151).
UEG Journal. October 2014 vol 2 n 1 suppl
Chabok A et al. Br J Surg. 2012 Apr;99(4):532-9
… it should be reserved for the treatment of complicated diverticulitis
Main Topics on Treatment of Diverticular Disease
How to treat Symptomatic Uncomplicated Diverticular Disease (SUDD)
How to prevent the first attack of diverticulitis ( Diverticulitis Occurrence )
How to treat Acute Uncomplicated Diverticulitis
How to prevent Acute Diverticulitis Recurrence
Prevention of Acute Diverticulitis Recurrence_Rifaximin
No Placebo Controlled data
Prevention of Acute Diverticulitis Recurrence_Mesalamine
PREVENT 1_2 (RT_DB_PC)
590 + 592 pts
> 1 episodes of acute diverticulitis in the previus 24 months
Mesalamine MMX vs Placebo
Mesalamine (MMX) was not superior to placebo in preventig recurrent diverticulitis.
For a portion of the study recurrence of diverticulitis was diagnosed without CT.
Raskin JB et al Gastroenterology 2014 Oct;147(4):793-802.
DIVA Trial (RT_DB_PC)
117 pts (ITT)
1-3 episodes of acute diverticulitis in the previus 14 days
3 arms: Placebo vs Mesalazine vs Mesalazine + Probiotics (12 w)
Mesalamine (MMX) was not superior to placebo in preventig recurrent diverticulitis.
The rate of complete response (GSS=0) was significantly higher with mesalamine than
placebo at weeks 6 and 52 (P
Statistical Issues in Treatment of Diverticular Disease
The published Placebo Controlled Trials were not many
The published Trials had a limited number of patients
Some enrolment criteria should be more specific for SUDD
Useful End-Points are needed
International Guidelines on Diverticular Disease
Some of them don’ t recommend treatment to prevent the first
attack of diverticulitis
Most of them don’ t recommend treatment to prevent the
Recurrence of diverticulitis.
… Only the recent guidelines suggest that antibiotics should be
used selectively, rather than routinely, in patients with acute
uncomplicated diverticulitis.
… Thank You !!!