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Metaanalysis: Antibiotic Therapy for Small Intestinal Bacterial Overgrowth

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Metaanalysis: Antibiotic Therapy for Small Intestinal Bacterial Overgrowth Alimentary Pharmacology and Therapeutics Meta-analysis: antibiotic therapy for small intestinal bacterial overgrowth S. C. Shah*, L. W. Day†,‡, M. Somsouk‡ & J. L. Sewell†,‡ *Department of Medicine, University SUMMARY of California, San Francisco, CA, USA. †Department of Medicine, Center for Innovation in Access and Quality, San Background Francisco General Hospital, University Small intestinal bacterial overgrowth (SIBO) is an under-recognised diagnosis of California San Francisco, San with important clinical implications when untreated. However, the optimal Francisco, CA, USA. treatment regimen remains unclear. ‡GI Health, Outcomes, Policy and Economics (GI-HOPE) Program, Aim Division of Gastroenterology, Department of Medicine, San To perform a systematic review and meta-analysis comparing the clinical effec- Francisco General Hospital, University tiveness of antibiotic therapies in the treatment of symptomatic patients with of California San Francisco, San documented SIBO. Francisco, CA, USA. Methods Four databases were searched to identify clinical trials comparing effectiveness Correspondence to: of: (i) different antibiotics, (ii) different doses of the same antibiotic and (iii) Dr J. L. Sewell, San Francisco General antibiotics compared with placebo. Data were independently extracted accord- Hospital, Division of Gastroenterology, 1001 Potrero Ave, Unit NH 3D3, San ing to predetermined inclusion and exclusion criteria. Study quality was inde- Francisco, CA 94110, USA. pendently assessed. The primary outcome was normalisation of post-treatment E-mail: [email protected] breath testing. The secondary outcome was post-treatment clinical response. Results Publication data Of 1356 articles identified, 10 met inclusion criteria. Rifaximin was the most Submitted 15 April 2013 commonly studied antibiotic (eight studies) with overall breath test normalisa- First decision 26 May 2013 tion rate of 49.5% (95% confidence interval, CI 44.0–55.1) (44.0%–55.1%) then Resubmitted 15 August 2013 – – fi Accepted 16 August 2013 (46.7% 55.5%), then (4.6% 17.8%). Antibiotic ef cacy varied by antibiotic EV Pub Online 4 September 2013 regimen and dose. Antibiotics were more effective than placebo, with a com- bined breath test normalisation rate of 51.1% (95% CI 46.7–55.5) for antibiotics As part of AP&T’s peer-review process, a compared with 9.8% (95% CI 4.6–17.8) for placebo. Meta-analysis of four stud- technical check of this meta-analysis was ies favoured antibiotics over placebo for breath test normalisation with an odds performed by Mr M. Siddiqui. ratio of 2.55 (95% CI 1.29–5.04). Clinical response was heterogeneously evalu- ated among six studies, but tended to correlate with breath test normalisation. Conclusions Antibiotics appear to be more effective than placebo for breath test normalisa- tion in patients with symptoms attributable to SIBO, and breath test normalisa- tion may correlate with clinical response. Studies were limited by modest quality, small sample size and heterogeneous design. Additional higher quality clinical trials of SIBO therapy are warranted. Aliment Pharmacol Ther 2013; 38: 925–934 ª 2013 John Wiley & Sons Ltd 925 doi:10.1111/apt.12479 S. C. Shah et al. INTRODUCTION OR Comparative Study[ptyp] OR Randomized Controlled Small intestinal bacterial overgrowth (SIBO) is an Trial[ptyp]). For Web of Science: clinical trial AND (‘bac- under-recognised diagnosis with varied and often pro- terial overgrowth’ OR ‘small intestinal bacterial over- – tean manifestations.1 3 Because the clinical presentation growth’ OR ‘SIBO’). For Embase: ‘bacterial overgrowth’ of SIBO can range from mild, nonspecific symptoms OR sibo:ab,ti AND (‘clinical trial’/exp OR ‘controlled (such as abdominal pain, bloating and flatulence) to less study’/de OR ‘randomization’/de OR randomized:ab,ti) common but severe manifestations (such as malabsorp- AND ([humans]/lim OR patient). For Cochrane: ‘small tion, weight loss and hypoalbuminaemia), a delay in intestinal bacterial overgrowth’. We hand-searched refer- diagnosis is not uncommon.2, 4, 5 Although epidemiolog- ence lists from included studies to identify additional rel- ical data describing SIBO are limited, there appears to be evant studies for inclusion. Embase and Web of Science increased prevalence of SIBO in patients with risk factors were used to search published abstracts. Because trials of such as hypochlorhydria, gastroparesis or other motility SIBO therapy would likely be reported within several dif- disorders, anatomical abnormalities (such as small bowel ferent types of professional society meetings (i.e. gastro- diverticulosis), post-surgical state (such as ileocecal resec- enterology, infectious disease, general internal medicine, tion), small bowel mucosal disease, metabolic diseases family medicine), we did not search the proceedings of (such as diabetes) and other chronic diseases (such as any specific professional society meetings. See Figure 1 end-stage renal disease, cirrhosis, chronic pancreati- for a summary of the literature search and study selec- tis).2, 6, 7 Prevalence in the elderly may be as high as tion. 15%,3 and even higher among elderly patients with addi- Studies were eligible for inclusion if they reported pro- – tional risk factors.3, 8 10 spective clinical trials of antibiotic therapy for docu- Treatment of SIBO typically includes antibiotics and, mented SIBO among human subjects. We included trials when possible, addressing underlying predisposing con- comparing two or more antibiotics, trials comparing two ditions.11 Although a diagnosis of SIBO is often enter- or more dosing strategies for the same antibiotic, or tained and empirically treated among at-risk patients trials comparing one or more antibiotics with placebo. with gastrointestinal symptoms, comparison trials of Retrospective studies, case reports, and case series were antibiotic regimens remain disparate, and the optimal excluded due to the high risk of publication bias. antibiotic regimen is not known. To address this impor- Although we did not plan to exclude studies based on tant knowledge gap, we performed a systematic review to language, our literature search did not produce any compare the effectiveness of antibiotics for achieving non-English studies meeting inclusion criteria. Table 1 breath test normalisation among symptomatic patients details inclusion criteria, and Figure 1 describes reasons with documented SIBO. When feasible, we performed for study exclusion. meta-analyses to further characterise the role of antibiot- ics in SIBO treatment. Data abstraction The primary outcome assessed was normalisation of MATERIALS AND METHODS either lactulose or glucose breath testing. Additional data abstracted included country of origin, study design, dates Systematic review and study selection of enrolment, types of patients enrolled, antibiotic and We performed a systematic review using four primary dietary restrictions, method for diagnosing SIBO, defini- databases to identify clinical trials of antibiotic therapy tion of breath test normalisation, antibiotic regimen among symptomatic patients with documented SIBO. No used, number enrolled in each treatment arm, number restrictions were applied to language or publication date. with response/cure in each treatment arm and adverse Databases searched were as follows: (i) PubMed (original events. When both intention-to-treat and per-protocol search date July 5, 2012; updated search July 3, 2013); data were reported, we used intention-to-treat data. For (ii) Web of Science (original search date July 5, 2012; trials with more than two treatment arms, each of the updated search July 3, 2013); (iii) Embase (original treatment arms was considered separately for purposes search date July 10, 2012; updated search July 3, 2013); of pooled data analysis and possible inclusion in and (iv) Cochrane (search date July 3, 2013). Search meta-analysis. Two authors (JLS and LWD) indepen- strings were as follows. For PubMed: ‘bacterial over- dently extracted data using a set of inclusion and exclu- growth’ OR ‘small intestinal bacterial overgrowth’ OR sion criteria and pre-specified definitions. The two ‘SIBO’ AND Humans[Mesh] AND (Clinical Trial[ptyp] authors independently abstracted and entered data into 926 Aliment Pharmacol Ther 2013; 38: 925-934 ª 2013 John Wiley & Sons Ltd Meta-analysis: antibiotics for SIBO Citations identified through literature search N = 1008 Citations identified through review of Studies excluded based on review of references lists from included studies title +/– abstract N = 348 N = 1334 Full study reviewed in detail N = 22 Studies included Studies excluded after review of full article (N = 12) N = 10 Study agents did not meet inclusion criteria: 4 No comparisons made/only one treatment group: 4 Subjects not formally tested for, or diagnosed with, SIBO: 1 Normalization of breath testing not reported: 1 Outcomes not documented by treatment group: 2 Figure 1 | Results of literature search. symptoms was not possible, but we report on clinical Table 1 | Study inclusion criteria response descriptively, based on the methods used to Inclusion criteria measure clinical response in each included article. Prospective clinical trial comparing two or more antibiotics, two or more doses of the same antibiotic or Quality assessment comparing an antibiotic vs. placebo, for the treatment of We used guidance from the Cochrane Handbook for human subjects with documented SIBO Systematic Reviews of Interventions12 to assess quality Primary study goal of
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