PMID- 32017005
OWN - NLM
STAT- MEDLINE
DCOM- 20210212
LR  - 20220107
IS  - 2284-0729 (Electronic)
IS  - 1128-3602 (Linking)
VI  - 24
IP  - 2
DP  - 2020 Jan
TI  - The safety profile of probiotic VSL#3(R). A meta-analysis of safety data from 
      double-blind, randomized, placebo-controlled clinical trials.
PG  - 963-973
LID - 20082 [pii]
LID - 10.26355/eurrev_202001_20082 [doi]
AB  - OBJECTIVE: A high-concentration of a multi-strain probiotic mixture, VSL#3(R) is 
      widely used 'whenever it is useful to promote the balance of intestinal flora'. 
      As a food supplement, VSL#3(R) has been so far scarcely investigated on the aspect 
      of safety. To fill this gap, in this paper, we analyzed the adverse events (AEs) 
      recorded during the conduct of three (3) double-blind, randomized, 
      placebo-controlled trials carried out to explore the efficacy of VSL#3(R) in 
      various clinical settings. Data from a large open-label observational trial were 
      also considered. MATERIALS AND METHODS: All trials included in the analysis were 
      carried out according to good clinical practice (GCP) rules. AEs were classified 
      by System Organ Class (SOC), Preferred Term (PT) and frequency. Differences vs. 
      placebo control were considered as statistically significant if the p-value was < 
      0.05. RESULTS: A total of 120 patients were analyzed, 70 patients being included 
      in the randomized controlled trials. In this population, 45 patients had at least 
      one AE, 20 (64.5%) in the placebo group and 25 (64.1%) in the VSL#3(R) group. 29 
      patients had at least one related AE, 14 (45.2%) and 15 (38.5%) in the two 
      treatment groups, respectively. Only one AE was assessed as serious, i.e., Foetal 
      malformation, which occurred in the placebo group and was considered unrelated. 
      No significant difference was found between VSL#3(R) and placebo for any of the SOC 
      considered, with the exception of Injury, poisoning and procedural complications, 
      which was in favor of VSL#3(R). CONCLUSIONS: Based on GCP-quality data from 
      clinical trials, we conclude that VSL#3(R) is a safe and well-tolerated agent.
FAU - Panetta, V
AU  - Panetta V
AD  - L'altrastatistica S.r.l., for GB Pharma Services & Consulting S.r.l, Rome, Italy. 
      pierluigi.navarra@unicatt.it.
FAU - Bacchieri, A
AU  - Bacchieri A
FAU - Papetti, S
AU  - Papetti S
FAU - De Stefani, E
AU  - De Stefani E
FAU - Navarra, P
AU  - Navarra P
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
PT  - Retracted Publication
PL  - Italy
TA  - Eur Rev Med Pharmacol Sci
JT  - European review for medical and pharmacological sciences
JID - 9717360
SB  - IM
RIN - Eur Rev Med Pharmacol Sci. 2021 Nov;25(21):6443. PMID: 34787844
MH  - Colitis, Ulcerative/diagnosis/drug therapy/physiopathology
MH  - Double-Blind Method
MH  - Gastrointestinal Microbiome/*drug effects/physiology
MH  - Humans
MH  - Probiotics/*administration & dosage/*adverse effects
MH  - Randomized Controlled Trials as Topic/*methods
MH  - Treatment Outcome
EDAT- 2020/02/06 06:00
MHDA- 2021/02/13 06:00
CRDT- 2020/02/05 06:00
PHST- 2020/02/05 06:00 [entrez]
PHST- 2020/02/06 06:00 [pubmed]
PHST- 2021/02/13 06:00 [medline]
AID - 20082 [pii]
AID - 10.26355/eurrev_202001_20082 [doi]
PST - ppublish
SO  - Eur Rev Med Pharmacol Sci. 2020 Jan;24(2):963-973. doi: 
      10.26355/eurrev_202001_20082.