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Table 3 Results and significance level of pelvic radiotherapy

From: Hyperbaric oxygen treatment for late radiation-induced tissue toxicity in treated gynaecological cancer patients: a systematic review

Study, year

Percentage of gynaecological cancers

Results

Significance level

Oscarsson et al., 2013 [14]

5.1%

Relative improvement of the EPIC score urinary domain immediately after treatment was 22% and after six to twelve months follow-up the relative improvement was 21%

p-value EPIC urinary score relative increase < 0.001

29% improvement EPIC score urinary domain in early state and after six to twelve months follow-up in patients with an EPIC score below eighty. In the patients with an EPIC score below eighty before HBOT, 76% of the patients improved after HBOT and 24% did not respond to HBOT

Improved EPIC score p-value < 0.001

31% of the patients reported an EPIC score above eighty after HBOT in the urinary domain

 

Relative improvement EPIC score bowel domain immediately after treatment was 24% and after six to twelve months follow-up was 21%

p-value EPIC bowel score relative increase < 0.001

41% increasement of EPIC score bowel domain early after HBOT and 39% increasement of EPIC score bowel domain six to twelve months after HBOT in patients with an EPIC score below eighty

Improved EPIC score p-value < 0.001

89% of patients had an increase in EPIC score after HBOT and 11% of patients did not respond to HBOT in the patients with an EPIC score below eighty

 

22% of the patients reported an EPIC score above eighty in the bowel domain

 

Glover et al., 2016 [15]

45.2%

Absolute difference between treatment group and control group in improvement of at least one point in IBDQ rectal bleeding score after twelve months: 7.6%

p-value absolute difference IBDQ-score = 0.58

95% CI = −20.3 to 35.5

Insignificant difference in improvement of overall bowel function after twelve months between treatment and control group (Mann–Whitney U-score: 0.67)

U-score bowel function p-value = 0.50

  

Insignificant difference in rectal bleeding after twelve months between treatment and control group (Mann-Whitney U-score: 1.69)

U-score rectal bleeding p-value = 0.092

  

The improvement from baseline to twelve months was consistent with the ITT analysis and differed with a U score of 0.71 for overall bowel function and a U score of 2.06 for rectal bleeding between the control and treatment group

U-score bowel function ITT p-value = 0.48

U-score rectal bleeding ITT p-value = 0.040

  

PP-analyses were consistent with the ITT analysis with a U score of 0.94 for overall bowel function and a U score of 1.44 for rectal bleeding

U-score bowel function PP p-value = 0.35

U-score rectal bleeding PP p-value = 0.15

  

LENT-SOMA rectal bleeding score: 100% of the patients increased in the control group and 31% of the patients increased in the treatment group

 
  

Insignificant improvement in rectum and intestine LENT-SOMA score in the control and treatment group. The U-score of rectal LENT-SOMA was 1.62 and the U-score of intestinal LENT-SOMA was -1.41

p-value U-score rectal = 0.11

p-value U-score intestinal = 0.16

  

No difference between treatment and control group in CTCAE grades after treatment

 
  

Subgroup analyses reported that the IBDQ scores between the treatment and control group did not change in patients who had completed radiotherapy one to five years before HBOT

 
  

The U score for overall bowel function was 0.59 and the U score for rectal bleeding was 1.57

p-value bowel function = 0.56

p-value rectal bleeding = 0.12

  

Difference in rectal bleeding was reported in the subgroup analyses of patients treated in a monoplace chamber with a U score of 2.9. The difference for overall bowel function in the subgroup analyses of patients treated in a monoplace chamber was insignificant with a bowel function U score of -0.31

p-value rectal bleeding monoplace = 0.004

p-value bowel function monoplace = 0.76

Oscarsson et al., 2019 [16]

25.3%

73% of the patients had an improvement, 23% of the patients did not change and 5% decreased in the treatment group of the EPIC total urinary score

 
  

34% of the patients had an improvement, 54% of the patients did not change and 11% decreased in the control group of the EPIC total urinary score

 
  

40% of the patients in the treatment group and 9% of the patients in control group reported an EPIC score above eighty at the end of the study

 
  

64% of the patients had an improvement, 28% of the patients did not change and 8% had decreased LRMGS grades in the treatment group

p-value differences between groups = 0.0012

  

18% of the patients had an improvement, 53% of the patients did not change and 29% had decreased LRMGS grades in the control group

 
  

10.1 points significant difference in mean EPIC urinary total score between treatment and control group (ITT analysis)

95% CI = 2.2–18.1

ITT analysis p-value = 0.013

11.4 points significant difference mean EPIC urinary total score between treatment and control group in urinary domain (PP analysis)

95% CI = 3.5–19.2

PP analysis p-value = 0.0047

8.33 points significant difference mean EPIC bowel total score between treatment and control group

95% CI = 1.15—15.54

p-value = 0.024

  

11.5 points significant difference in the EPIC sub score of urinary bother between treatment and control group

95% CI = 2.7—20.3

p-value = 0.012

  

12.1 points significant difference in the EPIC sub score of urinary incontinence between treatment and control group

95% CI = 4.3—19.9

p-value = 0.0031

  

Significant improvement in mean SF-36 score for general health in the treatment group of 13.2 points.

95% CI SF-36 score = 6.0—20.4

p-value = 0.0006

  

No significant change in the control group for the mean SF-36 score

 

Clarke et al., 2008 [19]

86.7%

88.9% of the patients recovered or experienced some improvement in the treatment group and 62.5% experienced some improvement in the control group. The calculated absolute difference was 26.4%

 

The treatment group reported significantly greater healing/improvement compared to the control group

Fisher’s exact test p = 0.0009

Logistic regression analysis p = 0.0011

2.39 points absolute difference in improvement of the LENT-SOMA score between treatment and control group. Improvement in treatment group was greater than in the control group

p-value absolute difference < 0.0001

greater decrease p-value = 0.0019

  

Treatment group had a lower mean score than the control group after initial allocation with a difference of 1.93

95% CI = 0.38–3.48

p-value difference in mean score = 0.0150

  

No differences were reported after the crossover

p-value after crossover = 0.6594

  

Odds ratio for some improvement was 5.93

95% CI = 2.04–17.24

  

Significant better outcomes were reported more often in the treatment group

An absolute risk reduction of 0.32 (32%) was recorded in the clinical evaluation outcomes, which corresponds to a number needed to treat of 3

Improvement in treatment group for bowel bother was 14% and for bowel function 9%.

Improvement in control group for bowel bother was 5% and for bowel function 6% The control group had an improvement of 13.6 for bowel bother and 10% for bowel function after cross-over

p-value Jockheere Terpstra = 0.0008

  

A significant improvement was reported between initialization and randomization in the treatment group for the bowel bother subscale with a change of 14.14

p-value = 0.0007

  

The control group had an insignificant improvement between initialization and randomization for the bowel bother subscale with a change of 5.75

p-value = 0.1521

  

The control group had a significant improvement after crossover with a change of 14.27

p-value = 0.0002

Jones et al., 2006 [23]

60.0%

44.5% complete recovery of rectal bleeding, 33.3% decrease in frequency and severity of rectal bleeding

11.1% of the patients had a decrease in the rectal bleeding

60.0% rectal pain recovery and 20.0% of the patients reported an improvement in rectal pain

20.0% of the patients reported full recovery of diarrhea and 60.0% reported an improvement

NR

Bui et al., 2004 [27]

NR

100% overall improvement

NR

Andren et al., 2020 [28]

13.5%

Significant mean LENT-SOMA score reduction for all patients of 3.7

95% CI mean reduction = 2.6–4.8

p-value mean reduction < 0.001

  

Significant mean LENT-SOMA score reduction in the subgroup analysis for proctitis of 3.8

95% CI reduction proctitis = 1.4–6.10

p-value reduction proctitis = 0.004

  

Significant mean LENT-SOMA score reduction in the subgroup analysis for cystitis of 3.7 (2.4–5.0)

p-value reduction cystitis < 0.001

  

Significant association between severity of LRITT and improvement in LENT-SOMA scores

p-value severity of LRITT = 0.003

  

Insignificant association between improvement of LENT-SOMA scores and the number of treatments, number of comorbidities and age

p-value number of treatments = 0.71

p-value number of comorbidities = 0.50

p-value of age = 0.21

Ngoo et al., 2018 [29]

NR

The bleeding resolved in 77.8% of the patients

 
  

This percentage was associated with a shorter time between radiotherapy and the first cystitis episode and was associated with lower transfusion requirements before treatment

p-value interval = 0.018

p-value lower transfusion requirements = 0.012

Lin et al., 2017 [30]

92.9%

Macroscopic hematuria resolved in 83.3% of the patients after an average of 38 sessions and macroscopic hematuria decreased in 7.1% of the patients

NR

  

Three patients (7.1%) had frequent urination and urgency without significant hematuria, with symptoms resolved after HBOT

 
  

One patient (2.4%) did not respond to HBOT

 
  

One patient underwent an urodynamic test with the following results: urine peak flow from 12.8 ml/s before HBOT to 15.0 ml/s after HBOT, urine mean flow from 6.5 ml/s before HBOT to 8.9 ml/s after HBOT, urine voiding time of 40.0 s before HBOT to 28.0 s after HBOT, time to peak flow from 15.0 s before HBOT to 8.0 s after HBOT and voided volume from 251 mL before HBOT to 248 mL after HBOT

 

Ribeiro de Oliveira et al., 2015 [31]

61.4%

67% of the patients recovered completely from hematuria and 22.7% of the patients recovered partially from hematuria

10.2% of the patients did not recover from hematuria of which 9.1% of these patients had an absence of variation of hematuria and 1.1% of these patients had aggravation of hematuria

After a mean follow-up period of twelve months, the recurrence rate of hematuria was 15.2%

 
  

No significant difference of hematuria resolution between sex groups

p-value = 0.738

  

No significant difference in hematuria resolution between uterine cervix cancer patients and prostate cancer patients

p-value = 0.228

  

Significant difference for the need of transfusion support in the group with hematuria resolution and the group without hematuria resolution. 82.9% of the patients in the group with hematuria resolution did not use transfusion therapy and 61.1% of the patients in the group without hematuria resolution did not use transfusion therapy

p-value = 0.026

  

Insignificant difference in hematuria resolution depending on the differences in time between radiotherapy and hematuria, time between hematuria and HBOT and time between radiotherapy and HBOT

p-value radiotherapy and hematuria = 0.236

p-value hematuria and HBOT = 0.199

p-value radiotherapy and HBOT = 0.44

  

Significant difference in hematuria resolution depending on the number of treatments

p-value number of treatments = 0.042

Mougin et al., 2016 [32]

8.5%

Haematuria had completely resolved in 52.1% of the patients

In 12.7% of the patients, haematuria had partially resolved

No improvement was registered in 35.2% of the patients

26.8% of the patients had a recurrence of haematuria after a median follow-up of 15 months, of which 9 patients received a second HBOT course that helped 8 patients

At 1 year, the haematuria-free survival rate was 70%

 
  

The hematuria grade of less than 3 made a significant difference for successful therapeutic outcome with a hazard ratio of 4.4 (univariate analysis)

p-value = 0.01

  

The hematuria grade of less than 3 at the time of diagnosis made a significant difference for successful therapeutic outcome with a hazard ratio of 3.6 (multivariate analysis)

p-value = 0.027

  

The anticoagulant therapy made a significant difference for treatment failure with a hazard ratio of 0.3

p-value = 0.03

Ferreira et al., 2014 [33]

51.4%

The response rate of resolution or improvement of haematuria after a median follow-up period of 55.5 months was 91.4%

 
  

Haematuria persisted in 6 patients, of which 5 patients had undergone cystectomy

 
  

Median difference in subjective score of dysuria before and after HBOT was 1 (1–1.5)

p-value < 0.001

  

Median difference in subjective score of frequency before and after HBOT was 0.5 (0.5–1.5)

p-value = 0.016

  

Median difference in subjective score of haematuria before and after HBOT was 2.5 (2–2.5)

p-value < 0.001

  

Median difference in subjective score of incontinence before and after HBOT was 0.5 (0–1)

p-value = 0.003

  

Median difference in subjective score of decreased stream before and after HBOT was 0 (0–1)

p-value = 0.14

  

The median difference in sum of all subjective scores before and after HBOT was 5 (5–6)

p-value < 0.001

  

Significant difference was reported between haematuria response and the time interval between the first episode of haematuria and HBOT

p-value < 0.05

  1. NR = not reported