Efficacy Of Hyperbaric Oxygen Research Articles

Hyperbaric oxygen (HBO2) therapy in thermal burn injury revisited. Pressure does matter. Review.

Throughout more than five decades a multitude of experimental and clinical studies has shown predominantly positive, but also controversial results on the efficacy of hyperbaric oxygen (HBO2) therapy in burns. Aim of the study was to define a common denominator or constellations, respectively, linked to the effects of HBO2 in burns with special focus on dosage parameters. Based on original work since 1965, species, number of individuals, type of study, percentage of total body surface area (TBSA), region, depth of burn, causative agent, interval between burn and first HBO2 session, pressure, duration of individual session, number of HBO2 sessions per day, cumulative number of HBO2 sessions and type of chamber were assessed. Out of 47 publications included, 32 were animal trials, four were trials in human volunteers and 11 clinical studies. They contained 94 experiments whose features were processed for statistical evaluation. 64 (67.4%) showed a positive outcome, 16 (17.9%) an ambiguous one and 14 (14.7%) a negative outcome. The only factor independently influencing the results was pressure with ATA (atmospheres absolute) lower than 3 ATA being significantly associated with better outcome (p=0.0005). There is a dire need for well-designed clinical studies in burn centers equipped with hyperbaric facilities to establish dedicated treatment protocols.

Efficacy of hyperbaric oxygen after microtia reconstruction using costal cartilage: A retrospective case-control study

Introduction: Microtia reconstruction with autologous costal cartilage framework grafting is challenging because the three-dimensional structure of the ear is highly complex, and meeting the high aesthetic demands of patients can be difficult. If the skin flap overlying the framework is thinned to achieve a smooth and accentuated outline, a poor blood supply in the thin skin flap may lead to skin necrosis, exposure of the framework, and poor surgical results. Hyperbaric oxygen (HBO2) therapy can promote the healing of complex wounds and flaps. This study sought to determine the effectiveness of HBO2 therapy for prevention of postoperative complications after framework grafting in microtia reconstruction. Methods: We retrospectively evaluated postoperative complications and compared outcomes in pediatric patients who underwent costal cartilage grafting for microtia reconstruction at our institution between 2011 and 2015 according to whether or not they received postoperative HBO2 therapy. HBO2 therapy was applied once daily for a total of 10 sessions starting on the first postoperative day. Results: During the study period, eight patients received HBO2 therapy after costal cartilage grafting and 12 did not. There was no significant difference in the incidence of postoperative ulcers. However, the incidence of framework exposure was lower and the healing time was shorter in patients who received HBO2 therapy than in those who did not. Discussion: HBO2 therapy can be used safely in pediatric patients to reduce postoperative complications and improve the aesthetic outcome of microtia reconstruction. After costal cartilage grafting, HBO2 therapy should be considered as adjuvant therapy.

Efficacy of hyperbaric oxygen after microtia reconstruction using costal cartilage: A retrospective case-control study

Introduction: Microtia reconstruction with autologous costal cartilage framework grafting is challenging because the three-dimensional structure of the ear is highly complex, and meeting the high aesthetic demands of patients can be difficult. If the skin flap overlying the framework is thinned to achieve a smooth and accentuated outline, a poor blood supply in the thin skin flap may lead to skin necrosis, exposure of the framework, and poor surgical results. Hyperbaric oxygen (HBO2) therapy can promote the healing of complex wounds and flaps. This study sought to determine the effectiveness of HBO2 therapy for prevention of postoperative complications after framework grafting in microtia reconstruction. Methods: We retrospectively evaluated postoperative complications and compared outcomes in pediatric patients who underwent costal cartilage grafting for microtia reconstruction at our institution between 2011 and 2015 according to whether or not they received postoperative HBO2 therapy. HBO2 therapy was applied once daily for a total of 10 sessions starting on the first postoperative day. Results: During the study period, eight patients received HBO2 therapy after costal cartilage grafting and 12 did not. There was no significant difference in the incidence of postoperative ulcers. However, the incidence of framework exposure was lower and the healing time was shorter in patients who received HBO2 therapy than in those who did not. Discussion: HBO2 therapy can be used safely in pediatric patients to reduce postoperative complications and improve the aesthetic outcome of microtia reconstruction. After costal cartilage grafting, HBO2 therapy should be considered as adjuvant therapy.

Efficacy of Hyperbaric Oxygen on Idiopathic Sudden Sensorineural Hearing Loss and Its Correlation with Treatment Course: Prospective Clinical Research

Objectives: This study was conducted to explore the effectiveness of hyperbaric oxygen (HBO) in the treatment of idiopathic sudden sensorineural hearing loss (ISSNHL) and recommend the appropriate course of treatment. Methods: 102 patients (105 diseased ears) with ISSNHL were recruited from the Department of Neurology and Otorhinolaryngology, West China Fourth Hospital, Sichuan University, between January 2018 and September 2020. Of them, 45 patients (group A) received intravenous steroid (IVS), and the remaining patients (group B) received IVS and HBO therapy (HBOT). Pure-tone audiometry (PTA) was performed twice at baseline and 10 days after treatment. Patients in group B were subdivided into group 1 (≤10 sessions) and group 2 (>11 sessions) to verify the correlation between the efficacy and course of HBOT, at the follow-up endpoint, the PTA was performed again. The multivariate logistical regression model was used to analyze the related factors of prognosis. Results: Compared with the control group, significantly larger hearing gains and better hearing recovery rate were observed in the IVS + HBOT group (p < 0.05). The time of treatment and course of HBOT were significantly correlated with the hearing threshold after treatment (p < 0.05) and had no significant relationship with tinnitus and age (p > 0.05). Conclusion: HBOT + IVS is an effective method for ISSNHL, especially for the recovery of low-frequency hearing and initial hearing levels of severe and profound. Tinnitus is the most common concomitant symptom of ISSNHL, and prolonging the course of HBOT did not significantly improve it. Initiating HBOT within 7 days for 10–25 sessions of treatment was more beneficial.

P-256 Efficacy of Hyperbaric Oxygen in the Treatment of Osteoradionecrosis of the Mandible. Results from the combined clinical trials DAHANCA-21 and NWHHT2009-1

P-256 Efficacy of Hyperbaric Oxygen in the Treatment of Osteoradionecrosis of the Mandible. Results from the combined clinical trials DAHANCA-21 and NWHHT2009-1

Efficacy of hyperbaric oxygen combined with escitalopram in depression and its effect on cognitive function.

Objective:To investigate the efficacy of hyperbaric oxygen (HBO) combined with escitalopram in patients with depression and its effect on cognitive function.Methods:From 2016 to 2018, seventy patients with depression aged 18-65 years treated in Affiliated Hospital of Hebei University were selected. Seventy patients with depression meeting the diagnostic criteria of ICD-10 were selected and randomly divided into control group and observation group using a random number table, with 35 patients in each group. The control group was treated with escitalopram, while the observation group was additionally treated with HBO on this basis. The patients were assessed using the Hamilton Depression Scale (HAMD) and Montreal Cognitive Assessment Scale (MoCA) before treatment and two, four and six weeks after treatment.Results:Two weeks after treatment, HAMD score showed a statistically significant difference between the two groups (P < 0.05). No statistically significant differences were found in HAMD score between the two groups four and six weeks after treatment (P > 0.05). Four and six weeks after treatment, MoCA score presented statistically significant differences between the two groups (P < 0.05).Conclusion:Escitalopram combined with HBO in the treatment of depression presents rapid efficacy and a certain effect in improving cognitive function.

Efficacy of hyperbaric oxygenation in the complex treatment of women suffering interstitial cystitis/painful bladder

Introduction. Interstitial cystitis/painful bladder (IC / BMP) is a rare, chronic, and disabling disease. Treatment of IC / BMP is empirical in the scope of physiotherapy procedures, taking antidepressants, pentosan sodium salt sulfate, intravesical administration of lidocaine and heparin, as well as various types of surgical interventions — mainly aimed at relieving the symptoms of the disease. The effectiveness of the latter does not exceed 60%, and symptoms return even when a period of remission seems to have occurred. The article presents the experience of our clinic in treating women with IC / BMP using hyperbaric oxygenation (HBO).Purpose of the study. To study the effectiveness of HBO in complex therapy patients suffering IC / BMP in the form of ulcerative lesions.Materials and methods. The study included 40 women, average age 60.1 ± 10.5 years, with the classic form of IC / BMP. All patients were examined and included in the study according to the NIDDK criteria. The patients were divided into 2 groups: Group I — women who received complex therapy with HBO (n = 20), Group II — only complex therapy (n = 20). Group I women received treatment: transurethral coagulation of Gunner's lesion zones, bladder hydrodistension, tricyclic antidepressants, intravesical instillations of lidocaine, dimethylsulfoxide, and a course of HBO. HBO consisted of 10 sessions (40 min, 2 ATM). Group II patients received the same IC / BMP therapy as the group I women, to the same extent, but without HBO.Results. Indicators of the PUF scale after 6 months of therapy in Groups I and II were 14.2 and 21.2 points, respectively. The average score in Group I was 3.48, in Group II — 5.13 according to the visual analogue pain scale. The cystometric capacity of the bladder in both groups after treatment was stable, its value was at least 320 ml. The number of urinations after combined therapy with HBO after 1, 3 and 6 months was 12 times a day. Whereas it was 14 times a day in Group II after 1 month, and it was 15 times a day after 3 and 6 months.Conclusions. The index of IC assessment, indicators of the visual-analogue pain scale, the cystometric capacity of the bladder, and the number of urinations improved after standard treatment but were significantly worse than in patients who received HBO additionally. Treatment with HBO leads to a statistically significant improvement, only in combination with the therapy, both according to questionnaires, and the function of accumulation and emptying of the bladder. For patients with IC/BMP who had ineffective standard treatment, it makes sense to conduct HBO, which can be an important stage of therapy and contribute to a longer remission of the disease. 

The therapeutic efficacy of hyperbaric oxygen in the treatment of non-arteritic anterior ischemic optic neuropathy

Objective To observe and explore the therapeutic efficacy of hyperbaric oxygen (HBO) in the treatment of non-arteritic anterior ischemic optic neuropathy (NAION). Methods A total of 139 NAION patients were randomly divided into a control group of 72 and a hyperbaric oxygen group of 67. Both groups were given conventional drugs including prednisolone, mecobalamin and compound anisodine, while the hyperbaric oxygen group was additionally provided with hyperbaric oxygen treatment at a pressure of 0.2MPa once a day for 30 days. Each day′s treatment lasted for 110 minutes, including 20 minutes at increasing pressure, 20 minutes decreasing and 60 minutes with the pressure stable at 0.2MPa. Before and after the 30-day treatment, the visual acuity and visual mean sensitivity (MS) of the two groups were observed and compared. Results There was no significant difference between the control group and the hyperbaric oxygen group in terms of average visual acuity or visual MS before the treatment. Afterward the average visual acuity (4.88±0.25) and visual MS (16.68±1.19) of the hyperbaric oxygen group were significantly higher than before the treatment and significantly better than those of the control group. The total effective rate of the hyperbaric oxygen group was 91%, significantly higher than that of the control group (75%). Conclusions Conventional treatment combined with hyperbaric oxygen therapy can significantly promote the visual acuity and visual MS of NAION patients. Key words: Optic neuropathy; Ischemia; Hyperbaric oxygen therapy; Field of view; Visual sensitivity

EFFECTS OF HYPERBARIC OXYGEN THERAPY ON THE POST-OPERATIVE PERIOD IN PATIENTS WITH A DIFFERENT FUNCTIONAL STATUS

Aim. To evaluate the effi cacy of hyperbaric oxygenation (HBO) in patients with a different functional status (FS) after the elimination of acute colonic obstruction (ACO).Materials and methods. A retrospective analysis of 210 medical records of patients who had undergone emergency surgical interventions aimed at ACO elimination was carried out. Based on the value of the direct current potential (DCP), the patients were divided into three groups: 1st (n = 96) with the DCP value from –30 mV and below — FS subcompensation; 2nd (n = 60) with average negative DCP values from –15 to –29.9 mV — FS compensation; 3rd (n = 54) with low negative and positive DCP values from –14.9 mV and higher — FS decompensation. The correlation between patients’ FS and the incidence of postoperative complications was studied, and independent predictors of fatal outcomes were identifi ed. Subsequently, a quantitative analysis of complications and mortality was carried out in each group depending on the use of HBO sessions in the postoperative period, followed by an assessment of their effi cacy.Results. According to the number of perioperative complications and mortality, risk groups in terms of the unfavourable course of the postoperative period were identifi ed: patients with high negative DCP values, for whom the arterial hypotension and acute kidney injury (AKI) could serve as the independent predictors of death; and patients with low negative and positive DCP values, for whom the statistically signifi cant predictors of mortality were shown to be the DCP level, hypotension, AKI and pneumonia. HBO sessions in the postoperative period allow the number of complications in the general population to be reduced: pneumonia by 7%, delirium by 8.8%, AKI by 6.3%, intestinal dysfunction for more than 3 days by 7.3%. In addition, HBO contributed to a 2.9% decrease in suppurative diseases. The analysis of the data on the HBO application in the general population and FS information showed HBO to have a positive effect on the general somatic status of ACO patients. In addition, HBO treatment is shown to decrease the incidence of complications in the early postoperative period. The effi cacy of HBO is found to be higher in the cohort of the most severe patients with decompensated FS, where such complications as delirium, pneumonia and gastrointestinal paresis were decreased by 22.2%, 13% and 18.5%, respectively. As a result, in this group of patients, a signifi cant decrease of 11.1% in 30-day mortality was achieved.Conclusion. The postoperative period depends on the actual FS. The conducted analysis of HBO therapy has convincingly confi rmed its effi cacy in the combined treatment of patients after the elimination of ACO. 

Protocol for prospective randomised assessor-blinded pilot study comparing hyperbaric oxygen therapy with PENtoxifylline+TOcopherol± CLOdronate for the management of early osteoradionecrosis of the mandible

IntroductionOsteoradionecrosis (ORN) of the mandible is a painful and debilitating condition occurring after radiotherapy to the head and neck to treat cancer. For decades, hyperbaric oxygen (HBO) has formed the...

Hyperbaric oxygen therapy in treatment of sudden sensorineural hearing loss: finding for the maximal therapeutic benefit of different applied pressures

We compared the efficacy of hyperbaric oxygen (HBO2) therapy used in the treatment of sudden sensorineural hearing loss (SSNHL) as a supplementary therapy to the first-line medical treatment according to the different applied pressures used in HBO2 treatment while maintaining the same number of sessions, periodicity and exposure times. We evaluated data from 115 patients suffering from SSNHL within seven days of hearing loss: 35 patients received the standard treatment protocol (control group), and 80 individuals were treated with additional application of HBO2 therapy pressured to 2.0 ATA (H2.0; n=49) or 2.5 ATA (H2.5; n=31), respectively. Treatment success was assessed using pre- and post-treatment audiograms. We found significant differences in both HBO2 groups compared to the control group. In low frequencies the most significant differences can be seen in both H2.0 and H2.5. In spoken speech frequencies only the H2.0 group was statistically significant. In high frequencies the therapeutic benefits were the lowest. Furthermore, we found a notable difference in the therapeutic effect of HBO2 therapy according to the different applied pressure. At low frequencies, the use of 2.5 ATA pressure was more efficient. However, in the higher frequency ranges, the better hearing gains were obtained at the 2.0 ATA pressure. Our results support the possibility of optimizing treatments individually, depending on the type and frequency range of hearing impairment (shape of the audiogram) in favor of using the 2.0 ATA. This is important in terms of an individual approach to each patient as well as to minimize the burden of a patient in order to obtain the maximum therapeutic effect.

Hyperbaric oxygen for the treatment of patients of optic nerve injury with craniocerebral trauma

Objective To observe the efficacy of hyperbaric oxygen for the treatment of patients of optic nerve injury with severe craniocerebral trauma. Methods The data of 84 eyes of 84 cases of optic nerve injury with craniocerebral trauma were collected and all cases were randomly divided into two groups, 42 eyes of 42 cases in each group. The control group received routine treatment and observation group received routine treatment combined with hyperbaric oxygen treatment. The follow-up time was 6 months. After treatment, the efficacy and visual acuity were compared and analyzed between the two groups. Results The total effective rate was 95.24% of observation group and 73.81% of the control group, the difference was statistically significant (χ2=7.3716, P=0.0066). After treatment, the visual acuity of two groups were improved, and the visual acuity in obsenvation group was better than that of the control group, the difference was statistically significant (t=0.1265, P=0.0000). Conclusion Routine treatment combined with hyperbaric oxygen treatment for optic nerve injury with craniocerebral trauma is effective. Key words: Optic nerve injury; Craniocerebral trauma, severe; Hyperbaric oxygen; Visual acuity

A critical look at the effect of hyperbaric oxygen on the ischemic nipple following nipple sparing mastectomy and implant based reconstruction: a case series.

Nipple preservation provides superior aesthetic results as well as patient satisfaction in patients treated with both therapeutic and prophylactic mastectomy. Post-operative nipple ischemia and necrosis presents a unique clinical challenge that may be treated with hyperbaric oxygen therapy or conservative measures alone. To date, the efficacy of hyperbaric oxygen on post-operative nipple ischemia has yet to be evaluated. A retrospective review of patients treated with either hyperbaric oxygen or conservative management was performed. Post-operative photographs were evaluated using a novel imaging data pathway to in both groups to determine rates of healing. Although patients treated with hyperbaric oxygen experienced rates of healing nearly twice those of patients treated with conservative measures alone, no statistical significance was found between groups in this series. No significance difference was found between groups treated with hyperbaric oxygen or conservative management in this series. Further large scale, multi-center studies are warranted to further determine clinical utility and cost-effectiveness of hyperbaric oxygen for nipple ischemia following nipple sparing mastectomy (NSM) and implant based reconstruction.

Successful treatment with hyperbaric oxygen therapy for pneumatosis cystoides intestinalis as a complication of granulomatosis with polyangiitis: a case report

BackgroundAlthough gastrointestinal involvement in patients with granulomatosis with polyangiitis is uncommon, it is associated with mild to severe life-threatening complications. We present a case of pneumatosis cystoides intestinalis in a patient with granulomatosis with polyangiitis that was treated successfully with hyperbaric oxygen.Case presentationA 70-year-old Japanese man with a 3-year history of granulomatosis with polyangiitis consulted our hospital with a complaint of severe back pain. Computed tomography showed a large amount of gas located in his bowel wall and mesentery. He underwent urgent exploratory laparotomy, which led to a diagnosis of pneumatosis cystoides intestinalis without intestinal perforation or necrosis. He consequently underwent 13 sessions of hyperbaric oxygen therapy and was discharged from our hospital without complications.ConclusionsSeveral previous reports have supported the efficacy of hyperbaric oxygen for treating pneumatosis cystoides intestinalis. The present case, however, is the first in which pneumatosis cystoides intestinalis in a patient with granulomatosis with polyangiitis was successfully treated with hyperbaric oxygen. We therefore suggest that hyperbaric oxygen therapy could be a candidate treatment for pneumatosis cystoides intestinalis in patients with granulomatosis with polyangiitis.

Hyberbaric oxygen as sole treatment for severe radiation - induced haemorrhagic cystitis.

ABSTRACTPurpose To examine the safety and efficacy of hyperbaric oxygen as the primary and sole treatment for severe radiation-induced haemorrhagic cystitis.Materials and methods Hyperbaric oxygen was prospectively applied as primary treatment in 38 patients with severe radiation cystitis. Our primary endpoint was the incidence of complete and partial response to treatment, while the secondary endpoints included the duration of response, the correlation of treatment success-rate to the interval between the onset of haematuria and initiation of therapy, blood transfusion need and total radiation dose, the number of sessions to success, the avoidance of surgery and the overall survival.Results All patients completed therapy without complications with a mean follow-up of 29.33 months. Median number of sessions needed was 33. Complete and partial response rate was 86.8% and 13.2%, respectively. All 33 patients with complete response received therapy within 6 months of the haematuria onset. One patient needed cystectomy, while 33 patients were alive at the end of follow-up.Conclusions Our study suggests the early primary use of hyperbaric oxygen for radiation-induced severe cystitis as an effective and safe treatment option.

Hyperbaric oxygen for experimental intracerebral haemorrhage: Systematic review and stratified meta-analysis

ABSTRACTObjective: Hyperbaric oxygen (HBO) is widely used in treating various neurological diseases. However, HBO for treatment of intracerebral haemorrhage (ICH) remains controversial, in either animal or clinical studies. Therefore, we conducted this systematic review and meta-analysis on studies describing the efficacy of HBO in animal models of ICH.Methods: Studies were identified by searching mainstream databases through November 2015. The efficacy of HBO in animal models of ICH was assessed by changes in the brain water content (BWC), neurobehavioural outcome (NO) or both. Subgroup analyses were performed according to different design characteristics.Results: In total 15 studies met our inclusion criteria. HBO can reduce the BWC (−0.982, 95% CI, −1.148 to −0.817; P < 0.01; 57 comparisons), and improve NO (−0.767, 95% CI, −1.376 to −0.159; P < 0.01; eight comparisons). HBO was most effective in reducing BWC when given 72 h after ICH for a 4- to 5-day consecutive treatment at the chamber pressure of 3.0 atmosphere absolute. Efficacy was higher with phenobarbital anaesthesia, the blood infusion model and in rabbits.Conclusion: Although HBO was found to be effective in experimental ICH, additional confirmation is needed due to possible publication bias, poor study quality and the limited number of studies conducting clinical trials.

The efficacy of hyperbaric oxygen in hemorrhagic stroke: experimental and clinical implications.

Hemorrhagic stroke, accounting for 10–30% of stroke cases, carries high rates of morbidity and mortality. This review presents the current knowledge on the efficacy of hyperbaric oxygen (HBO)-based modalities in the preclinical research on hemorrhagic stroke. Both preconditioning and post-treatment with HBO are considered as prospective therapeutic options. High efficacy of HBO therapy (HBOT) for brain hemorrhage has been noted. We found that moderate hyperbaric pressures appear optimal for therapeutic effect, while the therapeutic window of opportunity is short. HBO preconditioning offers more modest neuroprotective benefit as compared to HBO post-treatment for experimental intracerebral hemorrhage. We advocate for mandatory calculations of percent changes in the experimentally investigated indexes of HBO effectiveness and stress the need to design new clinical trials on HBO for hemorrhagic stroke.

The Efficacy of Hyperbaric Oxygen in the Treatment of Chronic Ulcers

The Efficacy of Hyperbaric Oxygen in the Treatment of Chronic Ulcers

Hyperbaric oxygen therapy in branch retinal artery occlusion in a 15-year-old boy with methylenetetrahydrofolate reductase mutation.

Purpose. To report the efficacy of hyperbaric oxygen (HBO) therapy in a case of branch retinal artery occlusion (BRAO) in a 15-year-old boy. Methods. We report a 15-year-old boy with sudden loss of vision due to BRAO. Examination included laboratory evaluation for systemic risk factors. Follow-up exams included visual acuity, fundus examination, fundus fluorescein angiography, and visual field testing. HBO therapy was employed for treatment. Results. Medical history was positive for isolated glucocorticoid deficiency. Laboratory evaluation disclosed hyperhomocysteinemia and methylenetetrahydrofolate reductase (MTHFR) mutation. The visual acuity 0.05 at presentation improved to 0.8 after 20 days of HBO therapy. There was no change on visual fields. Conclusion. In this pediatric case, HBO therapy was useful in the treatment of BRAO.

Is there a role for hyberbaric oxygen as primary treatment for grade IV radiation-induced haemorrhagic cystitis? A prospective pilot-feasibility study and review of literature.

To examine the safety and efficacy of hyperbaric oxygen as the primary treatment for Grade IV radiation-induced haemorrhagic cystitis. Hyperbaric oxygen was prospectively applied as a primary treatment option in 11 patients with Grade IV radiation cystitis. Primary endpoint was the incidence of complete and partial response to treatment. Secondary endpoints included the duration of response, the correlation of treatment success-rate to the interval between the onset of haematuria and initiation of therapy, blood transfusion need and total radiation dose, the number of sessions to success, the avoidance of surgery and the overall survival. All patients completed therapy without complications for a mean follow-up of 17.82 months (range 3 to 34). Mean number of sessions needed was 32.8 (range 27 to 44). Complete and partial response rate was 81.8% and 18.2%, respectively. However, in three patients the first treatment session was not either sufficient or durable giving a 72.7% rate of durable effect. Interestingly, all 9 patients with complete response received therapy within 6 months of the haematuria onset compared to the two patients with partial response who received therapy at 8 and 10 months from the haematuria onset, respectively (p = 0.018). The need for blood transfusion (p = 0.491) and the total radiation dose (p = 0.259) were not correlated to success-rate. One patient needed cystectomy, while all patients were alive at the end of follow-up. Early primary use of hyperbaric oxygen to treat radiation-induced grade IV cystitis is an effective and safe treatment option.