Meta AnalysisID 129
口服蒽醌类泻药与结直肠癌及结肠黑变病关联性的系统评价与Meta分析方案
CRD42019125414
We aim to perform a systematic review and meta-analysis of clinical trials and observational studies conducted on subjects taking anthraquinone laxatives, with the primary safety objectives of estimating the risk of colo
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Record Fields
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- Meta Analysis Id
- 129
- Evidence Id
- 8687
- Core Evidence Id
- 8687
- Source Meta Analysis Id
- 115
- Herb2 Meta Analysis Id
- HBMA000115
- Crd Id
- CRD42019125414
- Title
- Association of oral anthraquinone laxatives and colorectal cancer and melanosis coli: protocol for a systematic review and meta-analysis
- Review Question
- We aim to perform a systematic review and meta-analysis of clinical trials and observational studies conducted on subjects taking anthraquinone laxatives, with the primary safety objectives of estimating the risk of colorectal cancer and/or melanosis coli in this population. Secondary safety objectives include the evaluation of the risk of i) gastrointestinal bleeding, ii) alterations in gastrointestinal motility, and of iii) potential for dependence.
- Study Type Included
- We will consider for inclusion both clinical trials and observational studies. We will exclude reviews and meta-analyses, cross-sectional studies, letters to the editor, case reports, case series and expert opinions.
- Condition Being Studied
- Pre-clinical studies have shown a potential role of anthraquinone laxatives in both the initiation and promotion of tumorigenesis, and studies performed in humans have also suggested tumor promoting activities for these laxatives. Colorectal cancer is one of the main concerns of modern medicine, representing one of the most common type of cancer worldwide. In both sexes, colorectal cancer represents the fourth type of cancer for incidence (6.1% of the total cases) and the first for mortality (8.2% of the total cancer deaths). In high-income countries anthraquinone laxatives are used by 20% of the population, and their short-term use is generally safe. Although to date research has shown that long-term use of anthraquinones does not necessarily result in serious adverse events, it may be prudent to use such products only for short-term relief of constipation (i.e., potential for dependence, interactions, etc.), in particular when they are used as a self-medication treatment. As no firm evidence exists to the potential association between the chronic use of oral anthraquinones and the risk of colorectal cancer and/or melanosis coli, we aimed to quantify this risk.
- Participant
- We will consider studies performed on subjects taking anthraquinones as oral laxatives, excluding studies which include patients with history of any cancer. No restriction on subjects’ age will be applied.
- Animal
- Human Disease Modelled
- Intervention
- We will consider the following plants-containing anthraquinone laxatives: Cassia acutifolia, Cassia angustifolia, Frangulae cortex (Rhamnus frangula), Cascara sagrada (Rhamnus purshiana), Rhubarb (Rheum palmatum), Aloe vera. We will also consider all active anthraquinone compounds, such as: physcion, chrysophanol, rhein, dantron, emodin, aloe-emodin, and senna glycosides (sennoside A and B). Additional active compounds or interventions containing anthraquinone laxatives, not listed above and detected by screening of retrieved references or in the bibliographies of evaluated studies, will be further considered. Studies in which patients were co-treated with more than one above-mentioned anthraquinone laxatives will be included, as well.
- Comparator Control
- We will consider studies comparing the effect of the above mentioned interventions versus placebo or no treatment (considered together), or versus active control (i.e., non-anthraquinone laxatives).
- Main Outcome
- We will include studies evaluating the primary safety outcomes, i.e., colorectal cancer and/or melanosis coli. Measures of effect There will be no timing restriction. The primary safety outcomes will be the number of subjects diagnosed with colorectal cancer and/or melanosis coli, out of the total number of treated patients.
- Outcome Measure
- Additional Outcome
- In studies evaluating at least one of the above mentioned primary outcomes, also the following secondary safety outcomes will be considered (when reported): i) Gastrointestinal bleeding, ii) Alterations in gastrointestinal motility, and iii) Potential for dependence. We will also consider any other adverse events experienced by treated subjects in included studies. Adverse events will be defined based on authors’ definitions. Measures of effect There will be no timing restriction. The secondary safety outcomes will be the number of cases of gastrointestinal bleeding, alterations in gastrointestinal motility, and potential for dependence, out of the total number of treated patients.
- Study Method
- Meta-analysis, Systematic review
- Keyword
- Anthraquinones; Colonic Diseases; Colonic Neoplasms; Colorectal Neoplasms; Humans; Laxatives; Melanosis
- Contact
- Alfredo Vannacci [email protected]
- Organisational Affiliation
- University of Florence
- Funding Source
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- Italy
- Review Stage
- Review Ongoing
- First Submission Date
- 2019-02-14
- Registration Date
- 2019-03-13
- Anticipated Start Date
- 2019-02-18
- Anticipated Completion Date
- 2019-07-31
- Title Cn
- 口服蒽醌类泻药与结直肠癌及结肠黑变病关联性的系统评价与Meta分析方案
- Title En
- Association of oral anthraquinone laxatives and colorectal cancer and melanosis coli: protocol for a systematic review and meta-analysis
- Bilingual Status
- complete