By Hempel, S etal
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Hemmerling (2009) used the DAIDS Toxicity Table Addendum for Vaginal Microbicide Studies, WHO/CONRAD colposcopy manual 1994, and DAIDS Adult Toxicity Table (Division of AIDS, 2007) . 0 in the trial by Naito (2008). The Common Toxicity Criteria of the National Cancer Institute of Canada scale version 2 was used by Osterlund (2007) to assess and grade any adverse events. Sykora (2005) used a tool for H. pylori treatment side effects (de Boer, 1996) and assessed the causal relationship of the encountered side effects to the treatment.
The effects of long-term use of probiotics (defined as intervention durations of 1 year or more) are described in Key Question 4a. (1c) What harms are reported in case reports? In total, 43 case studies were identified that reported 1 case (Barton, 2001; Bassetti, 1998; Burkhardt, 2005; Cesaro, 2000; Cherifi, 2004; Conen, 2009; De Groote, 2005; Fredenucci, 1998; Henry, 2004; Hwang, 2009; Jensen, 1976; Ku, 2006; Ledoux, 2006; Lestin, 2003; Lolis, 2008; Lungarotti, 2003; Mackay, 1999; Munakata, 2010; Niault, 1999; Oggioni, 1998; Oh, 1979; Ohishi, 2010; Perapoch, 2000; Piarroux, 1999; Piechno, 2007; Pletinex, 1995; Presterl, 2001; Rautio, 1999; Rijnders, 2000; Tommasi, 2008; Trautmann, 2008; Viggiano, 1995; Zein, 2008; Zunic, 1991), 2 cases (Force, 1995; Kunz, 2004; Land, 2005; Riquelme, 2003), 3 cases (Kniehl, 2003; Munoz, 2005), 4 cases (Hennequin, 2000; Richard, 1988) or 6 cases (Lherm, 2002) of individuals who experienced an adverse event potentially associated with administered probiotic organisms.
Evidence Table C4, Results lists all reported events; however, the Evidence Table C3, Assessment lists the specific adverse events that were reportedly assessed according to the methods section of the publication. We noted all reported published systems used to record, categorize, and grade adverse events; however, this information was not very common in the included studies. The assessed safety parameters of controlled trials are summarized in Key Question 1a. The information on observational studies is summarized in Key Question 1d.