Value of hyperbaric oxygen therapy in the management of malignant otitis externa patients

Background Malignant external otitis is a rapidly spreading bacterial infection that is aggressive in nature and may be fatal if left untreated. Hyperbaric oxygen therapy (HBOT) is a medical treatment in which the entire body is placed in an airtight chamber at increased atmospheric pressure and has been proven to be effective for a number of different medical conditions. Objective The aim of this study was to assess the usefulness of HBOT as an adjunctive treatment in patients with malignant otitis externa. Patients and methods Forty-three diabetic patients, who had malignant otitis externa, underwent control of diabetes mellitus and were treated with ciprofloxacin. HBOT was administered to 15 patients as an adjunctive treatment. All the patients were evaluated clinically (in terms of ear discharge, granulations, and pain severity) and radiologically by a temporal bone computed tomography scan. The minimum follow-up duration in both groups was 2 months. HBOT was administered in one session every other day for 2 months, resulting in a total of 30 sessions. Patient factors analyzed included age, sex, ear discharge, and pain severity. Results A total of 43 patients (28 men, 15 women) were divided into two groups: group A (28 patients) only received the antibiotic ciprofloxacin and group B (15 patients) was treated with ciprofloxacin and hyperbaric oxygen. The severity of pain improved considerably and the pain score decreased markedly from score 3 (severe) to score 0 (no pain) after 1 month in 46.7 and 93.3% of the patients by the end of the second month in comparison with patients treated only with the antibiotic: 0% after 1 month and 28.5% after 2 months. On clinical and microscopic examination, both ear discharge and granulations in the external canal had improved considerably. There was no ear discharge in 80% of patients in group B after one month treathent, 93.3% after 2 months, in comparison with 0% after 1 month, 28.5% after 2 months treatment in group A, highly statistically significant (P<0.001). Conclusion The addition of HBOT to medical treatment is highly effective and has facilitated considerable improvement in patients.


Introduction
Malignant external otitis is an infection that aff ects the external auditory canal and temporal bone. Th e causative organism is usually Pseudomonas aeruginosa, and the disease commonly manifests in elderly patients (pt) with diabetes. Th e infection begins as an external otitis that progresses to an osteomyelitis of the temporal bone. Spread of the disease outside the external auditory canal occurs through the fi ssures of Santorini and the osseocartilaginous junction [1]. Malignant external otitis is a rapidly spreading bacterial infection that accounts for a relatively small proportion of infections, but arise aggressive in nature and may be fatal if left untreated [2].
Hyperbaric oxygen therapy (HBOT) is a medical treatment in which the entire body is placed in an airtight chamber at increased atmospheric pressure. In this chamber, the patient is surrounded by and breathes 100% pure oxygen. Th is treatment has been proven eff ective for a number of diff erent medical and surgical conditions either as a primary or as an adjunctive treatment. Th e pressure can be increased to as much as three times the normal atmospheric pressure (although the usual treatment pressure is 1.5-2.0 atmospheric depending on the diagnosis). Pure, 100% oxygen is continuously maintained and circulated throughout the chamber during the treatment [3].
HBOT is an eff ective treatment for acute and chronic damaged tissue of all types -any cause, any duration, any location. Th e underlying causes can be trauma, infection, autoimmunity, ischemia, hypoxia, toxins, or something similar [4].

Value of hyperbaric oxygen therapy in the management of malignant otitis externa patients
Reda M. Sabra, Mohamed S. Taha, Ahmed G. Khafagy, Talat Elsamny Background Malignant external otitis is a rapidly spreading bacterial infection that is aggressive in nature and may be fatal if left untreated. Hyperbaric oxygen therapy (HBOT) is a medical treatment in which the entire body is placed in an airtight chamber at increased atmospheric pressure and has been proven to be effective for a number of different medical conditions.

Objective
The aim of this study was to assess the usefulness of HBOT as an adjunctive treatment in patients with malignant otitis externa.

Patients and methods
Forty-three diabetic patients, who had malignant otitis externa, underwent control of diabetes mellitus and were treated with cipro oxacin. HBOT was administered to 15 patients as an adjunctive treatment. All the patients were evaluated clinically (in terms of ear discharge, granulations, and pain severity) and radiologically by a temporal bone computed tomography scan. The minimum follow-up duration in both groups was 2 months. HBOT was administered in one session every other day for 2 months, resulting in a total of 30 sessions. Patient factors analyzed included age, sex, ear discharge, and pain severity.

Results
A total of 43 patients (28 men, 15 women) were divided into two groups: group A (28 patients) only received the antibiotic cipro oxacin and group B (15 patients) was treated with cipro oxacin and hyperbaric oxygen. The severity of pain improved considerably and the pain score decreased markedly from score 3 (severe) to score 0 (no pain) after 1 month in 46.7 and 93.3% of the patients by the end of the second month in comparison with patients treated only with the antibiotic: 0% after 1 month and 28.5% after 2 months. On clinical and microscopic examination, both ear discharge and granulations in the external canal had improved considerably. There was no ear discharge in 80% of patients in group B after one month treathent, 93.3% after 2 months, in comparison with 0% after 1 month, 28.5% after 2 months treatment in group A, highly statistically signi cant (P<0.001).
Th ese infections may be single aerobic or anaerobic, but are more often mixed infections. Th ey are often observed in compromised hosts who have diabetes or a vasculopathy of another type. Th ese infections are named on the basis of their clinical presentation and include malignant external otitis [5]. Irrespective of the depth of the tissue invasion, these infections have similar pathophysiology that includes local tissue hypoxia, which is exacerbated by a secondary occlusive endarteritis [5].
It is also used to treat many other medical conditions that are still considered experimental by the mainstream medical establishment -despite decades of reported benefi ts.
Th e aim of this article is to assess the value of hyperbaric oxygen (HBO) as an adjunctive treatment of malignant external otitis along with antimicrobial agents.

Patients' selection criteria
Th is is a retrospective study. It was carried out at the Otorhinolaryngology Department, Ain Shams University Hospitals in the period between January 2011 and December 2014 with Institutional Review Board approval. An informed written consent was obtained from all participants. Forty-three patients (pt) were examined and treated for malignant otitis externa; they all had diabetes mellitus, and were undergoing treatment for control of diabetes mellitus. Th ey were divided into two groups: group A (28 pt) only received the antibiotic ciprofl oxacin and group B (15 pt) was treated with ciprofl oxacin and HBO as an adjunctive treatment. Th e minimum follow-up duration in both groups was 2 months. Th eir ages ranged from 56 to 72 years. Both groups were similar in age, ear discharge bacteriology, and antimicrobial therapy.
Th e Student t-test was used for statistical analysis. Skewed numerical data are presented as median and interquartile range. Qualitative data are presented as number and percentage. A P value less than 0.05 was considered statistically signifi cant.

Treatment strategy
Control of diabetes: All patients were treated with insulin injections and diabetes mellitus was strictly controlled.
Ear discharge culture and sensitivity were assessed for all patients, which indicated growth of pseudomonas.
Computed tomography (CT) scan temporal bone was performed before ( Fig. 1a and b) and 2 months after treatment ( Fig. 2a and b). All patients were administered an antibiotic (ciprofl oxacin). HBOT was administered at 2.0-2.5 ATA for 90 min per session. HBOT was administered for one session every other day for 2 months. HBOT was administered in the Naser National Institute in Sechrist hyperbaric oxygen chamber (Sechrist Monoplace Hyperbaric Chambers H-Series) (Fig. 3).

Comparison criteria
Clinical microscopic examination (ear discharge, external canal edema, and granulations). Figure 4 showed granulations fi lling the external ear canal and purulent discharge (Table 1).
Pain severity (pain was scored for assessment of severity of pain and degree of improvement and cure).   with powerful analgesics), a pain scored of 1 indicated mild pain (bearable without analgesics), and a pain score of 0 indicated no pain.
Post-treatment CT scan: CT temporal bone was performed 2 months after the initiation of therapy ( Fig. 2a and b).

Results
A total of 43 patients had malignant external otitis; these patients were divided into two groups: group A (n = 28) received antibiotics only (18 men, 10 women; median age 64 years, interquartile range 58-70) and group B (n = 15) received HBO (90 min at 2.5 ATA) in addition to antibiotics (10 men, fi ve women; median age 62 years, interquartile range 56-72) ( Table 2).
A total of 43 patients were identifi ed, including 15 patients who underwent HBOT with antibiotics. Th e degree of improvement of patients after treatment with adjuvant HBOT with antibiotic was high both symptomatically and clinically, and for CT scan of temporal bone (Tables 3-6). Pain severity improved markedly and the pain score decreased considerably from 3 (severe) to 0 (no pain) after 1 month in 46.7 and 93.3% of the patients by the end of the second month in comparison with patients treated only with an antibiotic: 0% after 1 month and 28.5% after 2 months. Pain score in group B patients was greatly shifted toward score 0 (no pain) more than three to fi ve folds by the end of treatment; 93.3% were pain free in group B compared with 28.5% in group A, and this was highly statistically signifi cant (Figs. 5 and 6).
On clinical and microscopic examination, both ear discharge and granulations in the external canal were markedly improved. In group B, 80% of patients had no discharge after 1 month and 93.3% after 2 months, in comparison with 0% after 1 month and 28.5% after 2 months treatment in group A; this was highly statistically signifi cant (P < 0.001) (Figs. 7 and 8). Also, there was radiological improvement in mastoid opacity and fl uid and granulations in the mastoid and the middle ear.

Discussion
Necrotizing invasive pseudomonal infection of the external auditory canal (malignant external otitis) is an uncommon, but major disorder in the elderly. Th e high morbidity, and even mortality, of this disorder has been reduced by the early and intensive use of combination antipseudomonal antibiotics. However, in severely immunocompromised patients or in infections involving the base of the skull, multiple Hyperbaric oxygen room.

Figure 5
Pain severity after 1 month.

Figure 6
Pain severity after 2 months.

Figure 7
Ear discharge after 1 month.
cranial nerves, or the meninges, conventional therapy is prolonged, intensive, and relatively ineff ective [6]. Prompt identifi cation, antibiotic therapy, control of medical condition, and HBOT have reduced the mortality resulting from this infection. Oxygen, at increased pressures, augments tissue oxygen partial pressure, allowing increased bacterial killing by providing a substrate for the formation of oxygen free radicals and augmenting respiratory burst [16]. During the healing process, hyperoxia causes increased formation of capillaries for oxygen, nutrient, and antibiotic delivery, leading to increased effi cacy of some antibiotics in the high-oxygen environment, and possibly more rapid overall wound healing [17,18] Infections for which HBOT has been studied and is recommended by the Undersea and Hyperbaric Medicine Society include necrotizing fasciitis, gas gangrene, chronic refractory osteomyelitis (including malignant otitis externa), mucormycosis, intracranial abscesses, and diabetic foot ulcers that have concomitant infections [7]. In all of these processes, HBOT is used adjunctively along with antimicrobial agents and aggressive surgical debridement [7].
Th is study evaluates how the addition of HBOT to antibiotic treatment has aff ected improvement, cure, and infection control in these patients.
In our study, we found that the addition of HBOT to the antibiotic therapy was very benefi cial to the patients with malignant otitis externa in the control of infection, improvement of symptoms and signs, and cure of the condition. Clinically, in group B, 86.7% of the patients reported considerable improvement in pain after the fi rst month of treatment (15 sessions), with 93.3% being pain free after the second month (30 sessions). On the other hand group A showed only 32.1% improved of pain after 1 month and 28.5% free of pain after 2 months those patients treated with antibiotic only (P < 0.001). On examination, purulent ear discharge was markedly reduced with HBOT therapy, there was no ear discharge in 80% of patients after the fi rst month and in 93.3% of patients after the second month; without HBOT therapy, only 28.5% of patients were free of discharge after 2 months (P < 0.001). Radiologically, CT scan temporal bone indicated considerable improvement with HBOT treatment, with less infection, opacity, fl uid in mastoid, and osteomyelitic changes. Generally, all cases treated with antibiotic and HBOT showed considerable improvement subjectively and objectively by examination and radiology, with more than 93% of cases cured and discharged early from the hospital. In contrast, those treated only with antibiotic showed slow improvement, low percent of complete cure (less than 30%), with persistent discharge and some degree of pain, and longer duration of hospitalization. No complications were reported with this treatment.
Davis et al. [6] reported that all 16 of their patients responded promptly when a 30-day course of HBO was added to the antibiotic regimen, and all patients remained free from infection during 1 to 4 years of follow-up. No complications were noted. Pilgramm et al. [8] also showed that hyperbaric oxygenation had a positive infl uence on the reduction of P. aeruginosa in the external auditory canal and on the symptoms of pain.
Mader and Love [9] reported control of P. aeruginosa infection in their patient when adjunctive HBOT was added to the treatment regimen. Also, Gilain et al. [10] found that the addition of HBO as a complementary treatment led to the regression of clinical signs and resolution of infection.

Figure 8
Ear discharge after 2 months.
concept remained free from recurrences. Narozny et al. [12] have confi rmed the role of HBO as a valuable, benefi cial, and supporting classical treatment method in the treatment of bacterial-caused malignant otitis externa. Shupak et al. [13] treated two patients with extensive necrotizing otitis externa by hyperbaric oxygenation, followed by complete resolution, with no recurrence.
Heiden [14] confi rmed in his study that multimodal therapy, with the inclusion of HBOT, enabled a reduction in mortality compared with earlier case reports without HBOT.
In the study of Saxby et al. [15], 70% of patients were considered cured of their disease, being disease free at follow-up. HBOT confers minimal morbidity, but its role in malignant external otitis (MOE) remains uncertain. Th e high mortality of MOE despite a maximal therapeutic intervention highlights the need for more eff ective treatment protocols.

Conclusion
Th e addition of HBOT to medical treatment is highly eff ective and has led to marked improvements in patients and the time required to achieve control of infection in these patients.