Area Editoriale
Due trials controllati contro placebo (uno sul trattamento della malattia di Crohn in fase attiva con Bidifobacterium Longum e Synergy 1 ed uno sul trattamento con VSL#3 nei pazienti con colite ulcerosa attiva) che, nonostante le conclusioni degli autori, ancora una volta danno risultati cui è difficile attribuire una rilevanza clinica. Entrambi infatti mostrano differenze statisticamente significative fra trattamento attivo e placebo nella riduzione media degli indici di attività ma non nella percentuale dei pazienti che raggiungono una remissione clinica.
Steed H, Macfarlane GT, Blackett KL, Bahrami B, Reynolds N, Walsh SV, Cummings JH, Macfarlane S.Clinical trial: the microbiological and immunological effects of synbiotic consumption - a randomized double-blind placebo-controlled study in active Crohn's disease. Aliment Pharmacol Ther. 2010;32:872-83.
BACKGROUND: Crohn's disease is an inflammatory illness in which the immune response against gut microorganisms is believed to drive an abnormal immune
response. Consequently, modification of ucosal bacterial communities, and the
immune effects they elicit, might be used to modify the disease state. AIM: To investigate the effects of synbiotic consumption on disease processes in patients with Crohn's disease. METHODS: A randomized, double-blind placebo-controlled trial was conducted involving 35 patients with active Crohn's disease, using a synbiotic comprising Bifidobacterium longum and Synergy 1. Clinical status was scored and rectal biopsies were collected at the start, and at 3- and 6-month intervals. Transcription levels of immune markers and mucosal bacterial 16S rRNA gene copy numbers were quantified using real-time PCR. RESULTS: Significant
improvements in clinical outcomes occurred with synbiotic consumption, with reductions in both Crohn's disease activity indices (P = 0.020) and histological scores (P = 0.018). The synbiotic had little effect on mucosal IL-18, INF-gamma and IL-1beta; however, significant reductions occurred in TNF-alpha expression in synbiotic patients at 3 months (P = 0.041), although not at 6 months. Mucosal bifidobacteria proliferated in synbiotic patients. CONCLUSION: Synbiotic
consumption was effective in improving clinical symptoms in patients with active Crohn's disease.
Tursi A, Brandimarte G, Papa A, Giglio A, Elisei W, Giorgetti GM, Forti G, Morini
S, Hassan C, Pistoia MA, Modeo ME, Rodino' S, D'Amico T, Sebkova L, Sacca' N, Di
Giulio E, Luzza F, Imeneo M, Larussa T, Di Rosa S, Annese V, Danese S, Gasbarrini
A. Treatment of relapsing mild-to-moderate ulcerative colitis with the probiotic VSL#3 as adjunctive to a standard pharmaceutical treatment: a double-blind, randomized, placebo-controlled study. Am J Gastroenterol. 2010;105:2218-27
OBJECTIVES: VSL#3 is a high-potency probiotic mixture that has been used successfully in the treatment of pouchitis. The primary end point of the study was to assess the effects of supplementation with VSL#3 in patients affected by relapsing ulcerative colitis (UC) who are already under treatment with 5-aminosalicylic acid (ASA) and/or immunosuppressants at stable doses. METHODS: A total of 144 consecutive patients were randomly treated for 8 weeks with VSL#3 at a dose of 3,600 billion CFU/day (71 patients) or with placebo (73 patients).
RESULTS: In all, 65 patients in the VSL#3 group and 66 patients in the placebo group completed the study. The decrease in ulcerative colitis disease activity index (UCDAI) scores of 50% or more was higher in the VSL#3 group than in the placebo group (63.1 vs. 40.8; per protocol (PP) P=0.010, confidence interval (CI)₉₅(%) 0.51-0.74; intention to treat (ITT) P=0.031, CI₉₅(%) 0.47-0.69). Significant results with VSL#3 were recorded in an improvement of three points or
more in the UCDAI score (60.5% vs. 41.4%; PP P=0.017, CI₉₅(%) 0.51-0.74; ITT
P=0.046, CI₉₅(%) 0.47-0.69) and in rectal bleeding (PP P=0.014, CI₉₅(%) 0.46-0.70; ITT P=0.036, CI₉₅(%) 0.41-0.65), whereas stool frequency (PP P=0.202, CI₉₅(%) 0.39-0.63; ITT P=0.229, CI₉₅(%) 0.35-0.57), physician's rate of disease activity (PP P=0.088, CI₉₅(%) 0.34-0.58; ITT P=0.168, CI₉₅(%) 0.31-0.53), and endoscopic scores (PP P=0.086, CI₉₅(%) 0.74-0.92; ITT P=0.366, CI₉₅(%) 0.66-0.86) did not show statistical differences. Remission was higher in the VSL#3 group than in the placebo group (47.7% vs. 32.4%; PP P=0.069, CI₉₅(%) 0.36-0.60; ITT P=0.132, CI₉₅(%) 0.33-0.56). Eight patients on VSL#3 (11.2%) and nine patients on placebo (12.3%) reported mild side effects. CONCLUSIONS: VSL#3 supplementation is safe and able to reduce UCDAI scores in patients affected by relapsing mild-to-moderate UC who are under treatment with 5-ASA and/or immunosuppressants. Moreover, VSL#3 improves rectal bleeding and seems to reinduce remission in relapsing UC patients after 8 weeks of treatment, although these parameters do not reach statistical significance.