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 | Â | ||
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 | Â | ||
22% of the patients reported an EPIC score above eighty in the bowel domain | Â | ||
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 | Â |
 |  | 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% | Â |
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 | Â |
 |  | 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% | Â |
 |  | 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 15Â months, of which 9 patients received a second HBOT course that helped 8 patients At 1Â year, the haematuria-free survival rate was 70% | Â |
 |  | 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 55.5Â months was 91.4% | Â |
 |  | 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 |