Intermittent Directly Observed Therapy for Abdominal Tuberculosis: A Multicenter Randomized Controlled Trial Comparing 6 Months Versus 9 Months of Therapy

Makharia, Govind; Ghoshal, Uday C; Ramakrishna, B. S.; Agnihotri, Abhishek; Ahuja, Vineet; Chowdhury, Sudipta Dhar; Gupta, Siddhartha Datta; Mechenro, John; Mishra, Abhishek; Pathak, Manish; Pandey, R M; Sharma, Raju; Sharma, Surendra Kumar

doi:10.1093/cid/civ376

Cited by 40 publications

(61 citation statements)

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“…We included three RCTs which included 328 participants (Makharia 2015a; Park 2009; Tony 2008). For a summary of the included trial characteristics, see Table 1, and for a detailed description of each trial see the 'Characteristics of included studies' tables.…”

Section: Resultsmentioning

confidence: 99%

“…This is based on concerns that short-course ATT may not be long enough to eliminate slow- or non-replicating bacilli in the infected site in order to prevent relapse of the disease, and because of the difficulties in assessing treatment response in abdominal TB (Park 2009). Thus, despite the current recommendations, many clinicians still treat patients with abdominal TB for more than six months (Debi 2014; Makharia 2015a). …”

Section: Introductionmentioning

confidence: 99%

“…Some trials have reported that six-month antituberculous regimens are as effective as longer regimens in the treatment of people with abdominal TB (Balasubramanian 1997; Makharia 2015a). Long regimens are associated with poor adherence and loss of participants to follow-up, which can lead to increased relapse rates and mortality.…”

Section: Introductionmentioning

confidence: 99%

“…Few trials have assessed the effectiveness of six-month regimens versus longer regimens for the treatment of this form of TB (Makharia 2015a; Park 2009; Tony 2008). As relapse is a relatively uncommon event, large numbers of participants are required to assess this outcome, and existing trials may be underpowered to detect a difference in relapse rates.…”

Section: Introductionmentioning

confidence: 99%

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Six-month therapy for abdominal tuberculosis

Jullien

Jain

Ryan

et al. 2016

Cochrane Database of Systematic Reviews

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BackgroundTuberculosis (TB) of the gastrointestinal tract and any other organ within the abdominal cavity is abdominal TB, and most guidelines recommend the same six-month regimen used for pulmonary TB for people with this diagnosis. However, some physicians are concerned whether a six-month treatment regimen is long enough to prevent relapse of the disease, particularly in people with gastrointestinal TB, which may sometimes cause antituberculous drugs to be poorly absorbed. On the other hand, longer regimens are associated with poor adherence, which could increase relapse, contribute to drug resistance developing, and increase costs to patients and health providers.ObjectivesTo compare six-month versus longer drug regimens to treat people that have abdominal TB.Search methodsWe searched the following electronic databases up to 2 September 2016: the Cochrane Infectious Diseases Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase (accessed via OvidSP), LILACS, INDMED, and the South Asian Database of Controlled Clinical Trials. We searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov for ongoing trials. We also checked article reference lists.Selection criteriaWe included randomized controlled trials (RCTs) that compared six-month regimens versus longer regimens that consisted of isoniazid, rifampicin, pyrazinamide, and ethambutol to treat adults and children that had abdominal TB. The primary outcomes were relapse, with a minimum of six-month follow-up after completion of antituberculous treatment (ATT), and clinical cure at the end of ATT.Data collection and analysisTwo review authors independently selected trials, extracted data, and assessed the risk of bias in the included trials. For analysis of dichotomous outcomes, we used risk ratios (RR) with 95% confidence intervals (CIs). Where appropriate, we pooled data from the included trials in meta-analyses. We assessed the quality of the evidence using the GRADE approach.Main resultsWe included three RCTs, with 328 participants, that compared six-month regimens with nine-month regimens to treat adults with intestinal and peritoneal TB. All trials were conducted in Asia, and excluded people with HIV, those with co-morbidities and those who had received ATT in the previous five years. Antituberculous regimens were based on isoniazid, rifampicin, pyrazinamide, and ethambutol, and these drugs were administered daily or thrice weekly under a directly observed therapy programme. The median duration of follow-up after completion of treatment was between 12 and 39 months.Relapse was uncommon, with two cases among 140 participants treated for six months, and no events among 129 participants treated for nine months. The small number of participants means we do not know whether or not there is a difference in risk of relapse between the two regimens (very low quality evidence). At the end of therapy, there was probably no difference in the proportion o...

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Six-month therapy for abdominal tuberculosis

Jullien

Jain

Ryan

et al. 2016

Cochrane Database of Systematic Reviews

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“…Recently, vasculitis of the mesenteric vasculature due to tuberculosis has been implicated as a contributory factor 8 . The mesenteric vasculature (medium and small vessels, mostly) and endarteritis of sub-mucosal vessels was frequently involved by granulomatous inflammation, with intravascular organizing thrombus being present in 30.0% of the resected specimens with perforation [9][10] . Multiple perforations occur in 40.0% of patients and are associated with poor prognosis 9 .…”

Section: Discussionmentioning

confidence: 99%

Acute Spontaneous Multiple Ileal Tuberculosis Perforation: A Case Report

Rima

Naser

Kabir³

et al. 2017

Bangladesh J. Infect. Dis.

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A 18 years old boy presented with severe diffuse abdominal pain, constipation, abdominal distention, fever and diagnosed as a case of perforation as free gas noted under both dome of the diaphragm. After resuscitation, exploratory laparotomy was done and diagnosed as a case of multiple spontaneous leaky perforations of jejunum and ileum 25 to 30 cm from duodeno-Jejunal flexure (DJ) up to terminal ileum. Peritoneal toileting and excisional biopsy of the mesenteric lymph node were done. Operative and postoperative period were uneventful. Histopathological examination of the resected lymph node revealed granulomatous inflammation compatible with tuberculosis. Anti-tubercular therapy was started and continued for 6 months. Patient was discharged on the 12 th postoperative day in a good condition. At 3 months of follow up the patient was asymptomatic and thriving well. Free perforation is one of the most feared complications of the intestinal tuberculosis. The terminal ileum is the most common site of perforation, while the majority of (90%) perforations are solitary. [Bangladesh Journal of Infectious Diseases 2016;3(2):52-54]

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