title: Non surgical interventions for late radiation proctitis in patients who have received radical radiotherapy to the pelvis.
abstract: BACKGROUND
  Chronic radiation proctitis (inflammation of the rectum) may develop after the completion of pelvic radiotherapy. Presently there is no recommended standard management.
  
  
  OBJECTIVE
  To assess the effects of various non-surgical treatment options for the management of late chronic radiation proctitis.
  
  
  METHODS
  We searched the Cochrane Controlled Trials Register, issue 1, 2001, MEDLINE 1966 to 2001, EMBASE 1980 to 2001, CANCERCD 1980 to 2001, Science Citation Index 1991 to 2001, CINAHL 1982 to 2001, as well as sources of grey literature. We also hand searched relevant textbooks and contacted experts in the field.
  
  
  METHODS
  Studies (preferentially randomised controlled trials) of interventions for the non-surgical management of late radiation proctitis in patients who have undergone pelvic radiotherapy as part of their cancer treatment.
  
  
  METHODS
  The inclusion criteria were independently applied by two of the reviewers (AD and EJM) and where there was disagreement this was resolved by involving a third reviewer to form a consensus.
  
  
  RESULTS
  Six randomised controlled trials were included. None of the trials compared anti-inflammatories with placebo. However rectal sucralfate showed greater clinical improvement for proctitis than anti-inflammatories (odds ratio 14.00, 95% confidence interval 1.46 to 134.26; n=1 study), though no difference was seen for endoscopic improvement (odds ratio 2.74, 95% confidence interval 0.64 to 11.76, n=1 study). The addition of metronidazole to the anti-inflammatory regime also appeared to improve the response rate, as measured by the reduction in rectal bleeding, diarrhoea, erythema and ulceration (n=1 study). Similarly rectal hydrocortisone appeared to be more effective than rectal betamethasone for clinical improvement although no difference was seen in endoscopic improvement (n=1 study). Short chain fatty acid enemas did not appear to be effective compared to placebo (n=2 studies). In the comparison of the heater probe and bipolar electrocautery (n=1 study), there was no discernible difference for severe bleeding after one year, but the heater probe demonstrated a greater increase in the haematocrit and reduced transfusion requirements.
  
  
  CONCLUSIONS
  Late radiation complications are a relatively rare manifestation, with many potential carers and poor diagnostic criteria. Although certain interventions look promising and may be effective (such as rectal sucralfate, adding metronidazole to the anti-inflammatory regime and heater probes), single small studies (even if well conducted) provide insufficient evidence. The episodic and variable nature of late radiation proctitis also requires placebo controlled studies to establish whether particular treatments are effective. Regional or centralised registers of radiation toxicity should be established so that interventions can be administered in the setting of multi-centre trials with specific entry criteria, formal baseline and therapeutic assessments providing standardised outcome data including quality of life evaluations.
authors.affiliation: Centre for Cancer Treatment, Mount Vernon Hospital, Rickmansworth Rd, Northwood, Middlesex, UK, HA6 2RN. 101501.2532@compuserve.com
authors.forename: A
authors.initials: A
authors.lastname: Denton
authors.forename: A
authors.initials: A
authors.lastname: Forbes
authors.forename: J
authors.initials: J
authors.lastname: Andreyev
authors.forename: E J
authors.initials: EJ
authors.lastname: Maher
mesh_terms: D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D004564:Electrocoagulation; D005227:Fatty Acids / Q000627:therapeutic use; D005557:Formaldehyde / Q000627:therapeutic use; D006801:Humans; D006931:Hyperbaric Oxygenation; D010386:Pelvic Neoplasms / Q000532:radiotherapy; D011349:Proctitis / Q000628:therapy*; D011832:Radiation Injuries / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic
chemical_list: D000893:Anti-Inflammatory Agents; D005227:Fatty Acids; D005557:Formaldehyde