Cochrane · systematic review · CD012529
Interventions to reduce acute and late adverse gastrointestinal effects of pelvic radiotherapy for primary pelvic cancers
Lawrie, TA, Green, JT, Beresford, M, et al. · Cochrane Database of Systematic Reviews · 2018 · Cochrane Library
Gynaecological, Neuro-oncology and Orphan CancerAMSTAR 2: not assessed
SoF tableOnly the outcomes this review put in its Summary of Findings table are listed (the Cochrane Handbook caps them at about seven per comparison). Its other analyses are not shown here.
Questions
113
current version
GRADE rated
41
No studies
63
Included studies
NR
No studies 63 · 55.8%Ungraded 9 · 8%Very low 10 · 8.8%Low 23 · 20.4%Moderate 6 · 5.3%High 2 · 1.8%
Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.
Questions and results
Summary of findings: Conformal RT vs conventional RT
Population: People with urological (prostate) gynaecological (cervical) cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores Summary of findings: Conformal RT vs conventional RT | no estimate extracted | 0 participants | Ungraded |
Acute and late GI toxicity grade 2+ Summary of findings: Conformal RT vs conventional RT | no estimate extracted | 2 studies · 307 participants | High |
Diarrhoea (grade 2+) Summary of findings: Conformal RT vs conventional RT | no estimate extracted | 0 participants | Ungraded |
QoL scores Summary of findings: Conformal RT vs conventional RT | no estimate extracted | 0 participants | Ungraded |
Summary of findings: IMRT vs 3DCRT
Population: People with urological (prostate) and gynaecological (cervical) cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores (EORTC‐QLQPR25 scale; lower scores better) Summary of findings: IMRT vs 3DCRT | no estimate extracted | 1 study · 181 participants | Low Downgraded: risk of bias, imprecision |
Acute and late GI toxicity Grade 2+ Summary of findings: IMRT vs 3DCRT | RR 0.48 [0.26, 0.88] | 4 studies · 444 participants | Low Downgraded: risk of bias, inconsistency |
Diarrhoea (grade 2+) Summary of findings: IMRT vs 3DCRT | RR 0.38 [0.22, 0.68] | 1 study · 72 participants | Low Downgraded: risk of bias, imprecision |
QoL scores Summary of findings: IMRT vs 3DCRT | no estimate extracted | 0 participants | Ungraded |
Summary of findings: BT vs EBRT
Population: People with urological (prostate) and gynaecological (endometrial) cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores Summary of findings: BT vs EBRT | no estimate extracted | 1 study · 348 participants | Ungraded |
Acute and late GI toxicity (grade 2+) Summary of findings: BT vs EBRT | no estimate extracted | NR | No studies |
Diarrhoea (grade 2+) Summary of findings: BT vs EBRT | no estimate extracted | 0 participants | Ungraded |
QoL scores (EORTC Q30) Summary of findings: BT vs EBRT | no estimate extracted | 1 study · 348 participants | Ungraded |
Summary of findings: Reduced dose volume vs standard dose volume
Population: People undergoing RT for pelvic cancer1
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores Summary of findings: Reduced dose volume vs standard dose volume | no estimate extracted | NR | No studies |
Acute and late GI toxicity (grade 2+) Summary of findings: Reduced dose volume vs standard dose volume | RR 1.21 [0.81, 1.81] | 1 study · 211 participants | Moderate Downgraded: imprecision |
Diarrhoea (grade 2+) Summary of findings: Reduced dose volume vs standard dose volume | no estimate extracted | NR | No studies |
QOL scores Summary of findings: Reduced dose volume vs standard dose volume | no estimate extracted | NR | No studies |
Summary of findings: Higher bladder volume vs lower bladder volume
Population: Men undergoing RT for prostate cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores (during RT) Summary of findings: Higher bladder volume vs lower bladder volume | no estimate extracted | NR | No studies |
Acute and late GI toxicity (grade 2+) Summary of findings: Higher bladder volume vs lower bladder volume | RR 2.22 [0.62, 7.93] | 1 study · 110 participants | Low Downgraded: risk of bias, imprecision |
Diarrhoea (grade 2+) Summary of findings: Higher bladder volume vs lower bladder volume | no estimate extracted | NR | No studies |
QOL scores Summary of findings: Higher bladder volume vs lower bladder volume | no estimate extracted | NR | No studies |
Summary of findings: Evening RT vs morning RT
Population: Women undergoing RT for cervical cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores Summary of findings: Evening RT vs morning RT | no estimate extracted | NR | No studies |
Acute and late GI toxicity (grade 2+) Summary of findings: Evening RT vs morning RT | RR 0.51 [0.34, 0.76] | 2 studies · 294 participants | Low Downgraded: risk of bias, imprecision |
Diarrhoea (grade 2+) (during RT) Summary of findings: Evening RT vs morning RT | no estimate extracted | 2 participants | Ungraded |
QOL scores Summary of findings: Evening RT vs morning RT | no estimate extracted | NR | No studies |
Summary of findings: Hydrogel spacer vs no intervention
Population: Men undergoing RT for prostate cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores Summary of findings: Hydrogel spacer vs no intervention | no estimate extracted | NR | No studies |
Acute and late GI toxicity (grade 2+) Summary of findings: Hydrogel spacer vs no intervention | RR 0.51 [0.08, 3.38] | 2 studies · 289 participants | Low Downgraded: risk of bias |
Diarrhoea (grade 2+) Summary of findings: Hydrogel spacer vs no intervention | no estimate extracted | NR | No studies |
QOL scores Summary of findings: Hydrogel spacer vs no intervention | no estimate extracted | NR | No studies |
Summary of findings: Endorectal balloon vs no intervention
Population: Men undergoing RT for prostate cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores Summary of findings: Endorectal balloon vs no intervention | no estimate extracted | NR | No studies |
Acute and late GI toxicity (grade 2+) Summary of findings: Endorectal balloon vs no intervention | RR 1 [0.41, 2.42] | 1 study · 48 participants | Very low Downgraded: risk of bias, imprecision |
Diarrhoea (grade 2+) Summary of findings: Endorectal balloon vs no intervention | RR 0.71 [0.37, 1.35] | 1 study · 43 participants | Very low Downgraded: risk of bias, imprecision |
QOL scores Summary of findings: Endorectal balloon vs no intervention | no estimate extracted | NR | No studies |
Summary of findings: Aminosalicylates vs placebo
Population: People undergoing pelvic radiotherapy for urological, gynaecological or colorectal cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores (IBDQ‐B) Summary of findings: Aminosalicylates vs placebo | no estimate extracted | NR | No studies |
Acute and late GI toxicity (grade 2+) Summary of findings: Aminosalicylates vs placebo | RR 1.02 [1.22, 1.45] | 2 studies · 143 participants | Moderate Downgraded: risk of bias |
Diarrhoea (grade 2+) Summary of findings: Aminosalicylates vs placebo | no estimate extracted | NR | No studies |
QOL scores Summary of findings: Aminosalicylates vs placebo | no estimate extracted | NR | No studies |
Summary of findings: Superoxide dismutase vs no intervention
Population: People with rectal cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores Summary of findings: Superoxide dismutase vs no intervention | no estimate extracted | NR | No studies |
Acute and late GI toxicity (grade 2+) Summary of findings: Superoxide dismutase vs no intervention | RR 0.2 [0.05, 0.86] | 1 study · 92 participants | Low Downgraded: risk of bias, imprecision |
Diarrhoea (grade 2+) Summary of findings: Superoxide dismutase vs no intervention | no estimate extracted | NR | No studies |
QOL scores Summary of findings: Superoxide dismutase vs no intervention | no estimate extracted | NR | No studies |
Summary of findings: Corticosteroids vs placebo
Population: Men with prostate cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores Summary of findings: Corticosteroids vs placebo | no estimate extracted | NR | No studies |
Acute and late GI toxicity (grade 2+) Summary of findings: Corticosteroids vs placebo | RR 0.85 [0.62, 1.15] | 1 study · 126 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Diarrhoea (grade 2+) Summary of findings: Corticosteroids vs placebo | no estimate extracted | NR | No studies |
QOL scores Summary of findings: Corticosteroids vs placebo | no estimate extracted | NR | No studies |
Summary of findings: Sucralfate vs placebo
Population: People undergoing pelvic radiotherapy for urological, gynaecological or colorectal cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores Summary of findings: Sucralfate vs placebo | no estimate extracted | NR | No studies |
Acute and late GI toxicity (grade 2+) [acute = during RT; late = 6 months post‐RT] Summary of findings: Sucralfate vs placebo | RR 1.07 [0.83, 1.39] | 1 study · 335 participants | Moderate Downgraded: imprecision |
Diarrhoea (grade 2+) [during RT] Summary of findings: Sucralfate vs placebo | RR 0.81 | 4 studies · 284 participants | Low Downgraded: imprecision, inconsistency |
QOL scores Summary of findings: Sucralfate vs placebo | no estimate extracted | NR | No studies |
Summary of findings: Amifostine vs no intervention
Population: People with urological, gynaecological or colorectal cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores Summary of findings: Amifostine vs no intervention | no estimate extracted | NR | No studies |
Acute and late GI toxicity (grade 2+) Summary of findings: Amifostine vs no intervention | RR 0.25 | 3 studies · 278 participants | Low Downgraded: risk of bias |
Diarrhoea (grade 2+) during treatment Summary of findings: Amifostine vs no intervention | RR 0.25 [0.06, 0.98] | 1 study · 36 participants | Very low Downgraded: risk of bias, imprecision |
QOL scores Summary of findings: Amifostine vs no intervention | no estimate extracted | NR | No studies |
Summary of findings: Sodium butyrate vs placebo
Population: Men undergoing RT for prostate cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores Summary of findings: Sodium butyrate vs placebo | no estimate extracted | NR | No studies |
Acute and late GI toxicity (grade 2+) Summary of findings: Sodium butyrate vs placebo | RR 0.91 [0.41, 1.98] | 1 study · 79 participants | Moderate Downgraded: imprecision |
Diarrhoea (grade 2+) Summary of findings: Sodium butyrate vs placebo | no estimate extracted | NR | No studies |
QOL scores Summary of findings: Sodium butyrate vs placebo | no estimate extracted | NR | No studies |
Summary of findings: Selenium vs no intervention
Population: Women undergoing RT for gynecological cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores Summary of findings: Selenium vs no intervention | no estimate extracted | NR | No studies |
Acute and late GI toxicity (grade 2+) Summary of findings: Selenium vs no intervention | no estimate extracted | NR | No studies |
Diarrhoea (grade 2+) Summary of findings: Selenium vs no intervention | RR 0.4 | 1 study · 81 participants | Low Downgraded: risk of bias |
QOL scores Summary of findings: Selenium vs no intervention | no estimate extracted | NR | No studies |
Summary of findings: Bile acid sequestrants vs no intervention
Population: People with pelvic cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores (during RT) Summary of findings: Bile acid sequestrants vs no intervention | MD 0.5 | 1 study · 33 participants | Very low Downgraded: risk of bias, imprecision |
Acute and late GI toxicity (grade 2+) Summary of findings: Bile acid sequestrants vs no intervention | RR 4.24 [1.07, 16.7] | 1 study · 33 participants | Low Downgraded: risk of bias, imprecision |
Diarrhoea (grade 2+) Summary of findings: Bile acid sequestrants vs no intervention | RR 2.82 [0.66, 12.01] | 1 study · 33 participants | Very low Downgraded: risk of bias, imprecision |
QOL scores Summary of findings: Bile acid sequestrants vs no intervention | no estimate extracted | NR | No studies |
Summary of findings: Misoprostol vs placebo
Population: Men with prostate cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcomes1 Summary of findings: Misoprostol vs placebo | no estimate extracted | NR | No studies |
Mean GI symptom scores Summary of findings: Misoprostol vs placebo | no estimate extracted | NR | No studies |
Acute and late GI toxicity (grade 2+) Summary of findings: Misoprostol vs placebo | RR 1.38 [0.76, 2.51] | 1 study · 100 participants | Low Downgraded: risk of bias, imprecision |
Diarrhoea (grade 2+) Summary of findings: Misoprostol vs placebo | RR 1 [0.46, 2.19] | 1 study · 100 participants | Very low Downgraded: risk of bias, imprecision |
QOL scores Summary of findings: Misoprostol vs placebo | no estimate extracted | NR | No studies |
Summary of findings: Magnesium oxide vs placebo
Population: Men with prostate cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores (during RT) Summary of findings: Magnesium oxide vs placebo | no estimate extracted | NR | No studies |
Acute and late GI toxicity (grade 2+) Summary of findings: Magnesium oxide vs placebo | RR 1.7 [0.87, 3.31] | 1 study · 92 participants | Moderate Downgraded: imprecision |
Diarrhoea (grade 2+) Summary of findings: Magnesium oxide vs placebo | no estimate extracted | NR | No studies |
QOL scores Summary of findings: Magnesium oxide vs placebo | no estimate extracted | NR | No studies |
Summary of findings: Octreotide vs placebo
Population: People undergoing RT for pelvic cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcomes1 Summary of findings: Octreotide vs placebo | no estimate extracted | NR | No studies |
Mean GI symptom scores Summary of findings: Octreotide vs placebo | no estimate extracted | NR | No studies |
Acute and late GI toxicity (grade 2+) Summary of findings: Octreotide vs placebo | no estimate extracted | NR | No studies |
Diarrhoea (grade 2+) Summary of findings: Octreotide vs placebo | RR 1.01 [0.76, 1.35] | 2 studies · 340 participants | Moderate Downgraded: risk of bias |
QOL scores Summary of findings: Octreotide vs placebo | no estimate extracted | NR | No studies |
Summary of findings: Diet interventions vs usual on‐treatment diet
Population: People undergoing pelvic radiotherapy for urological, gynaecological or colorectal cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Elemental diet Summary of findings: Diet interventions vs usual on‐treatment diet | no estimate extracted | NR | No studies |
Mean GI symptom scores (IBDQ‐B) (higher scores better) Summary of findings: Diet interventions vs usual on‐treatment diet | no estimate extracted | 1 study · 50 participants | Low Downgraded: risk of bias, indirectness |
Acute and late GI toxicity (grade 2+) Summary of findings: Diet interventions vs usual on‐treatment diet | no estimate extracted | NR | No studies |
Diarrhoea (grade 2+) Summary of findings: Diet interventions vs usual on‐treatment diet | RR 0.79 [0.45, 1.38] | 1 study · 50 participants | Low Downgraded: risk of bias, imprecision, indirectness |
QOL scores (IBDQ) (higher scores better) Summary of findings: Diet interventions vs usual on‐treatment diet | MD 4.6 | 1 study · 50 participants | Low Downgraded: risk of bias, indirectness |
Lactose‐restricted diet Summary of findings: Diet interventions vs usual on‐treatment diet | no estimate extracted | NR | No studies |
Diarrhoea (grade 1+) Summary of findings: Diet interventions vs usual on‐treatment diet | RR 0.74 [0.45, 1.23] | 1 study · 119 participants | Low Downgraded: risk of bias, imprecision, indirectness |
QOL scores (QLQ‐PR25) Summary of findings: Diet interventions vs usual on‐treatment diet | no estimate extracted | 1 study · 119 participants | Ungraded |
High‐fibre diet Summary of findings: Diet interventions vs usual on‐treatment diet | no estimate extracted | NR | No studies |
Low‐fibre diet Summary of findings: Diet interventions vs usual on‐treatment diet | no estimate extracted | NR | No studies |
Low‐fat diet Summary of findings: Diet interventions vs usual on‐treatment diet | no estimate extracted | NR | No studies |
Mean GI symptom scores (Vaizey scale) (higher scores better) Summary of findings: Diet interventions vs usual on‐treatment diet | no estimate extracted | 1 study · 70 participants | Low Downgraded: risk of bias, imprecision, indirectness |
Diarrhoea Summary of findings: Diet interventions vs usual on‐treatment diet | no estimate extracted | NR | No studies |
QOL scores (IBDQ) Summary of findings: Diet interventions vs usual on‐treatment diet | MD 2.4 | 1 study · 76 participants | Low Downgraded: risk of bias, imprecision, indirectness |
Prebiotic diet Summary of findings: Diet interventions vs usual on‐treatment diet | no estimate extracted | NR | No studies |
Summary of findings: Protein supplements vs no intervention
Population: Individuals undergoing RT for pelvic cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores (lower is better) Summary of findings: Protein supplements vs no intervention | no estimate extracted | NR | No studies |
Acute and late GI toxicity (grade 2+) Summary of findings: Protein supplements vs no intervention | no estimate extracted | NR | No studies |
Diarrhoea (grade 2+) Summary of findings: Protein supplements vs no intervention | RR 0.53 [0.27, 1.03] | 1 study · 74 participants | Very low |
QOL scores Summary of findings: Protein supplements vs no intervention | no estimate extracted | NR | No studies |
Summary of findings: Probiotics vs control (placebo or no intervention)
Population: People undergoing RT for pelvic cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores Summary of findings: Probiotics vs control (placebo or no intervention) | no estimate extracted | NR | No studies |
Acute and late GI toxicity (grade 2+) Summary of findings: Probiotics vs control (placebo or no intervention) | no estimate extracted | NR | No studies |
Diarrhoea (grade 2+) Summary of findings: Probiotics vs control (placebo or no intervention) | RR 0.43 [0.22, 0.82] | 5 studies · 923 participants | Low Downgraded: risk of bias, imprecision, inconsistency |
QOL scores Summary of findings: Probiotics vs control (placebo or no intervention) | no estimate extracted | NR | No studies |
Summary of findings: Proteolytic enzymes vs control (placebo or no intervention)
Population: People undergoing RT for pelvic cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores Summary of findings: Proteolytic enzymes vs control (placebo or no intervention) | no estimate extracted | NR | No studies |
Acute and late GI toxicity (grade 2+) Summary of findings: Proteolytic enzymes vs control (placebo or no intervention) | RR 0.45 [0.24, 0.88] | 1 study · 120 participants | Low Downgraded: risk of bias |
Diarrhoea (grade 2+) Summary of findings: Proteolytic enzymes vs control (placebo or no intervention) | RR 1.6 [0.89, 2.89] | 1 study · 56 participants | Very low Downgraded: risk of bias, imprecision |
QOL scores Summary of findings: Proteolytic enzymes vs control (placebo or no intervention) | no estimate extracted | NR | No studies |
Summary of findings: Glutamine vs placebo
Population: People undergoing RT for pelvic cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores Summary of findings: Glutamine vs placebo | no estimate extracted | NR | No studies |
Acute and late GI toxicity (grade 2+) Summary of findings: Glutamine vs placebo | RR 2.4 [0.68, 8.53] | 1 study · 69 participants | Low Downgraded: imprecision |
Diarrhoea (grade 2+) Summary of findings: Glutamine vs placebo | RR 0.98 [0.78, 1.24] | 4 studies · 289 participants | High |
QOL scores Summary of findings: Glutamine vs placebo | no estimate extracted | NR | No studies |
Summary of findings: Counselling vs no intervention
Population: Individuals undergoing RT for pelvic cancer
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Mean GI symptom scores (lower is better) Summary of findings: Counselling vs no intervention | MD 0.08 | 1 study · 152 participants | Low Downgraded: imprecision |
Acute and late GI toxicity (grade 2+) Summary of findings: Counselling vs no intervention | no estimate extracted | NR | No studies |
Diarrhoea (grade 2+) Summary of findings: Counselling vs no intervention | RR 0.12 [0.03, 0.47] | 1 study · 74 participants | Low Downgraded: imprecision |
QOL scores (5‐point VAS; lower is better) Summary of findings: Counselling vs no intervention | no estimate extracted | 1 study · 152 participants | Very low Downgraded: imprecision |