Background: cervical cancer (cancer of the neck of the womb) is the fourth most common cancer among women throughout the world, accounting for about 569,847 new detected cases and 311,365 deaths every year. Women more commonly present with advanced disease in the developing (low-income) world, where access to cervical screening programmes is limited. Advanced cancer of the cervix may not be curable and women often need treatment to control distressing symptoms (palliation), such as vaginal bleeding. Bleeding can be severe enough to be life threatening in women with advanced cervical cancer. Management of vaginal bleeding often poses a challenge, especially in the developing world, where access to radiotherapy is limited. Options for palliative treatment of severe vaginal bleeding include interventional radiology treatment (using x-rays to guide the insertion of 'plugs' into blood vessels supplying the cancer) or vaginal packing (where gauze is compacted into the vagina to absorb the blood and apply pressure directly to the cervix), although these are often only partly effective and may cause harm. Vaginal packs can be soaked with formalin, which is a preservative chemical. Other options for treating severe vaginal bleeding include tranexamic acid (a medicine that reduces bleeding that can be given by mouth or by injection) and radiotherapy (high-energy x-ray treatment).
Review question: the aim of this review was to compare tranexamic acid, vaginal packing (with or without formalin-soaked packs), interventional radiology or other interventions versus radiotherapy treatment to control vaginal bleeding in cervical cancer.
Main findings: the searches were updated to March 2018. We found no randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) for inclusion, so there is an absence of evidence that tranexamic acid, vaginal packing (with or without formalin-soaked packs), interventional radiology techniques or other interventions are as effective or safe as radiotherapy for palliative control of bleeding from the vagina in advanced cervical cancer. There is a need for randomised controlled trials or good-quality non-randomised comparative studies to determine the effectiveness and safety of these interventions when compared with radiotherapy in terms of symptom control, quality of life and side events.
Certainty of the evidence: no studies fulfilled the inclusion criteria and so there is no good-certainty evidence.
Since the last version of this review we found no new studies. There is no evidence from controlled trials to support or refute the use of any of the proposed interventions compared with radiotherapy. Therefore, the choice of intervention will be based on local resources. Radiotherapy techniques for managing vaginal bleeding are not readily available in resource-poor settings, where advanced cases of cervical cancer are predominant. Thus, this systematic review identified the need for a randomised controlled trial assessing the benefits and risks of palliative treatments for vaginal bleeding in women with advanced cervical cancer.
This is an updated version of the original Cochrane review published in Issue 5, 2015.
Cervical cancer is the fourth most common cancer among women worldwide, with estimated 569,847 new diagnoses and 311,365 deaths per year. However, incidence and stage at diagnosis vary greatly between geographic areas and are largely dependent on the availability of a robust population screening programme. For example, in Nigeria, advanced-stage disease at presentation is common (86% to 89.3% of new cases), whereas in the UK, only 21.9% of women present with International Federation of Gynaecology and Obstetrics (FIGO) stage II+ disease. Women with advanced cancer of the cervix often need palliation for distressing symptoms, such as vaginal bleeding. Vaginal bleeding can be life threatening in advanced disease, with an incidence ranging from 0.7% to 100%. Bleeding is the immediate cause of death in 6% of women with cervical cancer and its management often poses a challenge.
Thus, vaginal bleeding remains a common consequence of advanced cervical cancer. Currently, there is no systematic review that addresses palliative interventions for controlling vaginal bleeding caused by advanced cervical cancer. A systematic evaluation of the available palliative interventions is needed to inform decision-making.
To evaluate the efficacy and safety of tranexamic acid, vaginal packing (with or without formalin-soaked packs), interventional radiology or other interventions compared with radiotherapy for palliative treatment of vaginal bleeding in women with advanced cervical cancer.
The search for the original review was run in 23 March 2015, and subsequent searches for this update were run 21 March 2018. We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 3) in the Cochrane Library; MEDLINE via Ovid to March week 2, 2018; and Embase via Ovid to March week 12, 2018. We also searched registers of clinical trials, abstracts of scientific meetings and reference lists of review articles, and contacted experts in the field. We handsearched citation lists of relevant studies.
We searched for randomised and non-randomised comparative studies that evaluated the efficacy and safety of tranexamic acid, vaginal packing (with or without formalin-soaked packs), interventional radiology or other interventions compared with radiotherapy techniques for palliative treatment of vaginal bleeding in women with advanced cervical cancer (with or without metastasis), irrespective of publication status, year of publication or language in the review.
Two review authors independently assessed whether potentially relevant studies met the inclusion criteria. We found no studies for inclusion and, therefore, we analysed no data.
The search strategy identified 1522 unique references of which we excluded 1330 on the basis of title and abstract. We retrieved the remaining 22 articles in full, but none satisfied the inclusion criteria. We identified only observational data from single-arm studies of women treated with formalin-soaked packs, interventional radiology or radiotherapy techniques for palliative control of vaginal bleeding in women with cervical cancer.