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Steroid Treatments Equally Effective Against Sudden Deafness | National Institutes of Health (NIH) - Steroids for Hearing Loss or Vertigo
RACGP - Oral corticosteroids for painful acute otitis externa
The oral steroid patients experienced typical symptoms, such as sleep, mood and appetite changes. The injected steroid patients had pain at the injection site and vertigo; a few had ear infections and a perforated eardrum. Most symptoms cleared up by 6 months. Nevertheless, the difference showed that while the treatments were equally effective, they might not be equally appropriate for every patient.
People with sudden deafness should discuss the risks and benefits of both treatments with their doctor. Site Menu Home. Search Health Topics. Download File. Call Us Corticosteroid Therapy for Inner Ear Disorders. Who is this information for? Corticosteroids are man-made drugs that work like cortisol, a natural steroid hormone in your body. These medicines reduce inflammation and alter the immune system.
They can be taken as tablets, or injected into the blood-stream or body tissues. Common examples of corticosteroids include: Prednisolone e. Sensorineural hearing loss new onset or sudden deterioration of pre-existing SNHL should be confirmed with an Audiogram prior to commencing CT. However, the study indicates that the measuring tools worked well, the intervention was accepted by patients and the sample size calculation is likely to be adequate. Although we did not plan this to be a pilot study, and it should be classified as an underpowered RCT, our outcomes are useful to inform a larger study in a similar manner to a pilot study.
Therefore, these potentially interesting results should be confirmed in a larger, properly funded clinical trial before applying the results in the routine healthcare setting. Shortening the duration of intense pain by 1. Therefore, pursuing this research with a follow-up study adequately powered to measure complete resolution of pain as an outcome makes sense.
However, for a larger study to be feasible, reasonable funding for reimbursement for healthcare providers and participating patients is likely to be required. A future study with a larger number of patients available for statistical analysis could also investigate the extent to which the effect of oral corticosteroids is influenced by baseline pain, sleep disturbance due to symptoms, occlusion of the ear canal or initial cleaning of the ear canal using suction under microscope.
Did you know you can now log your CPD with a click of a button? Background and objectives Acute otitis externa is often painful. The aim of this study was to evaluate the efficacy of 10 mg oral prednisolone twice daily for four days in addition to conventional therapy.
Methods Patients attending general practice clinics in Far North Queensland, Australia, for acute painful otitis externa were given a study capsule with either 10 mg prednisone or placebo. Results Seventy-three patients were randomised. Results from 19 patients in the intervention group and 11 patients in the control group were analysed.
However, this result needs to be confirmed in a larger trial. Study objectives Primary research questions and subsequent data collection aimed to comply with the only published validated questionnaire for acute otitis externa. Will oral corticosteroids increase patient satisfaction concerning: burning or stinging feeling post-administration of topical treatment itching post-administration of topical treatment time to resolution of pain time to resolution of itching time to resolution of swelling time to resolution of discharge?
Secondary research questions were: Will oral corticosteroids reduce the need for: unplanned revisits exclusion due to worsening of symptoms? Will oral corticosteroids increase patient satisfaction concerning time to resolution of normal activities? Patients and recruitment Sixteen primary healthcare centres and 19 adjacent pharmacies in tropical Far North Queensland, Australia, agreed to participate. Data collection Age, gender, ethnicity and initial ear pain was noted at baseline. Visual analogue scale Randomisation Randomisation was achieved using random numbers generated by the ResearchRandomizer website www.
Blinding Medical practitioners, participating pharmacists, patients, staff telephoning patients and the person doing statistical analysis were all unaware of group allocation.
Intervention The pharmacist checked inclusion criteria for a second time and provided study tablets to patients accepting participation.
Statistical analysis All patients fulfilling inclusion criteria and with data available were analysed as follows: Time to resolution of pain: groups were compared using a log rank test.
Cox regression was used in case clinically relevant baseline differences existed between groups. This test was chosen as the data were ordinal Satisfaction with symptom resolution: patient satisfaction was compared between groups using a Mann-Whitney U test. Patient satisfaction was analysed using a Mann-Whitney U test. Sample size calculation Sample size calculations were based on the primary research questions and made two-tailed to avoid the assumption that a difference between groups would always favour the intervention group.
Patient and public involvement Patients or the public were not involved in the design of this study. Results One hundred and sixty-four patients were screened for eligibility between 28 October and 19 June Table 1. Table 2. Table 3. Limitations The main limitations of this study were recruitment of participants and loss to follow-up of included participants.
The following potential problems were identified: The researchers noted that the wet seasons in —16 and —17 were unusually dry, resulting in fewer than expected cases of otitis externa.
Many GPs in the participating clinics also expressed there were fewer cases than usual. There is always a time pressure in primary healthcare, and actions linked with financial remuneration are often given some priority.
Remuneration for participating practitioners, pharmacists or patients was not available in this study because of the limited funding allocated. After discussions with colleagues, the researchers first believed recruitment would work well without remuneration.
Afterwards, it became evident that this assumption was incorrect, and remuneration to medical practitioners and pharmacists for each included patient, and a small remuneration to patients for returned surveys, may have reduced the recruitment problem and loss to follow-up. Each can containing study tablets had a unique identifying number, which pharmacists were instructed to note on the survey handed out to patients.
Many pharmacists failed to do so, and these returned surveys could therefore not be linked with the correct patient. A checklist was introduced for pharmacists halfway through the study, and this problem was significantly reduced.
Generalisability This study was planned as a randomised controlled trial RCT but, most likely because of insufficient funding, failed to recruit enough patients to be adequately powered to assess the proposed outcomes. This is a card that contains 6 days of steroids, with less provided each day. The gradual decrease in the amount of steroids each day is called a "taper".
The reason to do this is to allow the patient's adrenal glands, which are usually suppressed by the steroids, to gradually return to supplying steroids to the patient on their own.
Medrol is slightly stronger than prednsone, so to convert this into "prednisone", when using the 4 mg dose-pack, one just has to multiple by 5. In other words, the medrol dose pack is the equivalent of 30 mg of prednisone, tapering down to 0 over a week. For persons in whom a larger amount of steroids is indicated a longer protocol and more intense protocol is selected.
Longer pulses require longer tapers. Checking the blood pressure to make sure it is not dropping too low and follow up visits during the taper period are often required. Some patients are "steroid dependent". For example, whenever the steroid dose is decreased below a threshold, hearing starts to deteriorate again. In patients like this, an attempt is made to find a steroid sparing replacement drug such as methotrexate or Enbrel , but in the meantime, the steroids are reduced to as low an amount as is practical.
Steroids have many side effects, that are more common with longer administration. Common ones in the short run i.
It is a common problem for which patients present to general practitioners GPsparticularly in coastal temperate and tropical climates. Its monthly incidence in the USA increases during the summer season from 0. However, in tropical parts of Australia the annual incidence is likely to be much higher than 1. The skin in the external ear canal of a healthy ear has a thin protective coating of cerumen, a mixture of secretions from apocrine and sebaceous glands mixed with desquamated epithelial cells.
An infectious organism cannot be found in at least one-third of patients with otitis externa. A secondary infection is likely in severe cases, and common organisms found are Pseudomonas spp. Common consequences for patients with otitis externa are pain, sleep disturbance, temporary loss of hearing, pharmaceutical and consultation expenses, and potentially loss of income. Initial symptoms at presentation to medical practices range from mild irritation with almost no pain to the strongest pain imaginable as measured by a pain scale.
As well as pain, other consequences are costs for healthcare and sometimes also loss of productivity. Most patients fully recover after 5—14 days. Infection may also spread to deeper structures such as the inner ear and the brain, which can be potentially life-threatening.
The treatment for otitis externa is usually topical; in selected cases, oral antibiotics are prescribed. Prednisone or prednisolone is used in doses ranging from 20 to 75 mg daily for 3—5 days. Corticosteroids reduce the immune response. Therefore, corticosteroids given to a patient who has a severe infection could theoretically be detrimental. However, it has previously been shown that corticosteroids can be given safely and with beneficial effect to patients with ongoing infection of low or moderate virulence.
Examples are patients with croup 14 and sore throat. Acute otitis externa is in most cases either an aseptic inflammation that is simultaneously colonised by bacteria, or an infection of low-to-moderate virulence.
In these situations, corticosteroids could theoretically be beneficial. Current evidence indicates that a topical steroid is beneficial to patients with otitis externa. We were unable to identify a published clinical trial evaluating the effect of oral corticosteroids in patients with otitis externa. Giving oral corticosteroids to patients with otitis externa could be beneficial or harmful. It may be that oral corticosteroids in the lower dose range are beneficial while using higher doses could add side effects and risks without benefit.
If a short course of low-dose oral corticosteroids 20 mg prednisone daily is beneficial, then this finding is useful for practitioners currently prescribing a higher dose. If a benefit of oral corticosteroids is not proven, then physicians currently prescribing it need to be advised of this finding.
The objective of this study was to assess the efficacy of low-dose oral prednisolone for four days in addition to conventional therapy in the management of painful acute otitis externa. Primary research questions and subsequent data collection aimed to comply with the only published validated questionnaire for acute otitis externa. Sixteen primary healthcare centres and 19 adjacent pharmacies in tropical Far North Queensland, Australia, agreed to participate. Consecutive patients attending participating primary healthcare centres for otitis externa were asked by the medical practitioner if they accepted screening in relation to inclusion criteria:.
Patients fulfilling all inclusion criteria were referred to one of the participating pharmacies, where further information was given, consent forms were signed and the study medication was dispensed. A website was created as an ongoing resource for GPs and pharmacists www. Furthermore, GP clinics and pharmacies were visited regularly to ensure they adhered to the agreed study protocol.
Age, gender, ethnicity and initial ear pain was noted at baseline. Initial ear pain was measured using a VAS of 10 cm Figure 1. The VAS, subsequent diary and final survey after symptom resolution or up to 10 days after enrolment adhered to the validated VAS, diary and survey published by Shikiar et al in Figure 1.
Visual analogue scale. Randomisation was achieved using random numbers generated by the ResearchRandomizer website www.
Medical practitioners, participating pharmacists, patients, staff telephoning patients and the person doing statistical analysis were all unaware of group allocation. The pharmacist checked inclusion criteria for a second time and provided study tablets to patients accepting participation. The intervention was a study capsule taken twice daily for four days in addition to any other treatment prescribed by the medical practitioner.
Capsules with the active ingredient contained 10 mg of prednisone packed in an opaque gelatine capsule. The remaining space was filled with lactose. Capsules with placebo contained lactose packed in a gelatine capsule which was identical in appearance to capsules with the active ingredient. The lactose content was considered insignificant for patients with lactose intolerance. All patients fulfilling inclusion criteria and with data available were analysed as follows:. The analysis was done as intention to treat.
Intention to treat was defined as all patients fulfilling the inclusion criteria with follow-up data available, making analysis possible irrespective of whether they adhered to the allocated treatment arm. Imputation of data for patients lost to follow-up was not made.
Sample size calculations were based on the primary research questions and made two-tailed to avoid the assumption that a difference between groups would always favour the intervention group. Sample size calculations for survival analysis used the statistical software PASS version We calculated that patients would be sufficient to answer all primary research questions.
We expected that some patients would be lost to follow-up so we aimed to include patients. A more detailed description of the sample size calculation is described in the full study protocol. Patients with any type of side effect mentioned above were instructed in the written information to immediately contact their GP or nearest emergency department if their GP was unavailable. The patient information also outlined that those patients must immediately stop taking the study tablets.
Furthermore, they were instructed to notify the steering committee. Patients were also withdrawn from the study if it was their wish. Detailed rules for discontinuation of the study are presented in the study protocol.
The funder, Cairns Hospital Foundation, did not participate in planning, analysing data or writing of the manuscript. One hundred and sixty-four patients were screened for eligibility between 28 October and 19 June Seventy-three patients were randomised and given instructions with surveys to return and a can containing the study tablets.
Forty-three of these patients could not be analysed, while 30 patients submitted identifiable surveys and were included in the final analysis Figure 2. Figure 2. This study did not find evidence that the intervention and control groups differed statistically at baseline Table 1. Two patients in the intervention group stated they took only 3—4 out of eight study tablets.
No reason for this was given. All other patients included in the final analysis stated they took all eight study tablets. It took an average of 5. Lost hours as a result of otitis externa were similar in both groups Table 2. Side effects during treatment were expected and similar in both groups Table 3. None of these revisits were considered unexpected or serious, and all four patients became completely pain-free in an average of 4. No patient was excluded as a result of worsening of symptoms.
The influence of ethnicity was not analysed because most patients were of Caucasian ethnicity Table 1. Patient satisfaction after treatment was similar in both groups Table 3.
It took an average of 3. However, oral corticosteroids did not reduce the time to reporting being completely pain-free complete resolution of pain. The main limitations of this study were recruitment of participants and loss to follow-up of included participants. Recruitment was slower than anticipated, and fewer than half of the patients who were screened were suitable for inclusion. The target was never reached: after 20 months of recruiting, the study was terminated because of slow recruitment of patients.
Fewer than half of the randomised patients returned identifiable surveys. The following potential problems were identified:. A formal process evaluation 24 to see if further lessons could be learnt was not done because of lack of funding.
Clinical follow-up by the medical practitioner on days three and six would have added useful information. However, this would have required substantial funding that was not available. This study was planned as a randomised controlled trial RCT but, most likely because of insufficient funding, failed to recruit enough patients to be adequately powered to assess the proposed outcomes. However, the study indicates that the measuring tools worked well, the intervention was accepted by patients and the sample size calculation is likely to be adequate.
Although we did not plan this to be a pilot study, and it should be classified as an underpowered RCT, our outcomes are useful to inform a larger study in a similar manner to a pilot study.
Therefore, these potentially interesting results should be confirmed in a larger, properly funded clinical trial before applying the results in the routine healthcare setting. Shortening the duration of intense pain by 1. Therefore, pursuing this research with a follow-up study adequately powered to measure complete resolution of pain as an outcome makes sense.
However, for a larger study to be feasible, reasonable funding for reimbursement for healthcare providers and participating patients is likely to be required. A future study with a larger number of patients available for statistical analysis could also investigate the extent to which the effect of oral corticosteroids is influenced by baseline pain, sleep disturbance due to symptoms, occlusion of the ear canal or initial cleaning of the ear canal using suction under microscope.
Did you know you can now log your CPD with a click of a button? Background and objectives Acute otitis externa is often painful.
The aim of this study was to evaluate the efficacy of 10 mg oral prednisolone twice daily for four days in addition to conventional therapy. Methods Patients attending general practice clinics in Far North Queensland, Australia, for acute painful otitis externa were given a study capsule with either 10 mg prednisone or placebo. Results Seventy-three patients were randomised. Results from 19 patients in the intervention group and 11 patients in the control group were analysed.
The glucocorticoids, prednisolone and dexamethasone, were the most effective in our study in reducing middle ear inflammation in response to bacterial challenge. Prednisone (1 mg / kg / day) or Dexamethasone (10mg / day) should be used for at least days, with a tapering of the dose over a similar time period. The glucocorticoids, prednisolone and dexamethasone, were the most effective in our study in reducing middle ear inflammation in response to bacterial challenge. Otitis media with effusion is the most common cause of acquired hearing loss Management of chronic middle ear effusion with prednisone combined with. Most patients fully recover after 5–14 days.4 In rare cases, severe damage to the pinna, outer ear and middle ear may result in significant hearing loss. For Sudden Sensorineural Hearing Loss, corticosteroid use should start ideally within 72 hours of deafness onset 1and can be offered within 2 weeks of symptom onset as a primary treatment. J Physiol ; Pt 1 Fewer than half of the randomised patients returned identifiable surveys. Systematic review of topical antimicrobial therapy for acute otitis externa. An infectious organism cannot be found in at least one-third of patients with otitis externa. Salvage treatment, which is given to patients who did not receive or did not respond to primary treatment, is typically delivered weeks after the onset of symptoms.More ». June 6, Injecting steroids into the middle ear works just as well as taking them orally when it comes to restoring hearing for sudden deafness patients. This finding, the result of a large clinical trial comparing the therapies, will help doctors choose the best treatment for patients with this condition.
Sudden deafness, also called sudden sensorineural hearing loss, is an emergency medical condition that affects several thousand people annually, usually between the ages of 40 and It often arises without an obvious cause and occurs in one ear all at once or over a period of up to 3 days. Oral steroids, such as prednisone, are usually prescribed over the course of 2 weeks to restore hearing.
There is only a 2- to 4-week window of time for treatment before hearing loss becomes permanent. Recently, doctors have started injecting steroids directly into the middle ear — a procedure called intratympanic treatment.
This technique is thought to deliver more of the drug to the ear and to avoid some of the side effects that can come along with oral steroids.
The side effects of oral therapy can be mild, like weight gain, mood changes and sleep disruption, or more serious, like high blood pressure and elevated blood sugar. Side effects of injected steroids are usually local, such as ear infection and vertigo.
However, up until now, no study had compared the 2 treatments to see whether direct injection worked as well as oral steroids. To investigate, Dr. Steven Rauch of Harvard Medical School and the Massachusetts Eye and Ear Infirmary led a team of investigators from 16 medical centers nationwide in a clinical trial involving more than patients. The results were published in the May 25, , issue of the Journal of the American Medical Association.
The study tested the treatments as they are usually given in the clinic. For oral steroid therapy, patients received 60 milligrams of prednisone for 14 days, followed by a tapering-off period of 5 days.
The other group was given 40 milligrams of methylprednisolone injected directly through the eardrum 4 times over the course of 2 weeks.
The study followed the recovery of these patients for 6 months, measuring the success of the treatments based on hearing tests at the first and second weeks, and months 2 and 6. Under both regimens, patients recovered their hearing to about the same extent at 2 and 6 months. The oral steroid patients experienced typical symptoms, such as sleep, mood and appetite changes. The injected steroid patients had pain at the injection site and vertigo; a few had ear infections and a perforated eardrum.
Most symptoms cleared up by 6 months. Nevertheless, the difference showed that while the treatments were equally effective, they might not be equally appropriate for every patient. People with sudden deafness should discuss the risks and benefits of both treatments with their doctor. Site Menu Home. Search Health Topics. Search the NIH Guide.
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