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| Research recommendation |
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| Relative values of different outcomes | The outcomes identified as critical outcomes for this review were health-related and hearing-related quality of life, any outcomes related to wax removal, for example ability or ease of removal, and adverse events such as perforations or infections. Pure tone audiometry was identified as an important outcome. |
| Quality of the clinical evidence | The evidence found was very limited with mainly single studies made up of small numbers comparing interventions. The majority of the evidence ranged from low to very low quality. This was mainly due to risk of bias in patient selection and allocation where adequate descriptions were not provided and to indirectness as several papers do not include enough detail to determine whether children were included. The guideline committee noted the majority of the studies compared 2 alternative interventions or investigated the timing or combinations of interventions rather than comparing treatment with no treatment. Only 1 study compared the use of earwax softeners to no treatment. Ear drops alone: The evidence showed that there was a clinically important benefit in using ear drops, specifically water or sodium bicarbonate, compared with no treatment to remove impacted wax. Chlorobutanol did not show a clinically important benefit. When different ear drops were compared with each other, chlorobutanol was found to have a clinically important benefit compared with almond oil and to sodium bicarbonate. Both chlorobutanol and sodium bicarbonate showed clinically important benefits compared with water and hydrogen peroxide urea was more clinically beneficial than chlorobutanol. Eardrops used to facilitate irrigation: When compared with no treatment, water, hydrogen peroxide and olive oil had a clinically beneficial effect but there was no clinically important benefit of sodium bicarbonate in facilitating immediate irrigation. When comparing ear drops against each other, the only clinically important benefit observed was when chlorobutanol was compared with saline drops prior to immediate syringing. No clinically important differences were observed when ear drops were compared with each other prior to delayed irrigation. Clinical irrigation compared with other strategies: There was a clinically important benefit for successful removal of wax when this was performed by syringing in a clinic compared with removal using home kits. Adverse events were generally not well reported but there was mostly a small or no clinically important difference between the different ear wax softeners used and when comparing removal by syringing in a clinic to home kits. On the whole, the evidence does suggest that there is a clinical benefit in using an earwax softener such as water or sodium bicarbonate either as the sole treatment, or to facilitate irrigation. However, due to the limitations of the evidence, it was difficult to conclude that there is clear advantage of using one particular softener over another. The committee noted that earwax removal may be an urgent requirement in order to exclude this as a cause of hearing loss and avoid delay in treatment of underlying pathology. The committee noted the absence of comparative evidence regarding the method of earwax removal. |
| Trade-off between clinical benefits and harms | The committee discussed the importance of managing earwax in people with hearing loss. The presence of impacted wax prevents examination of the ear, and makes it impossible to perform accurate audiometry or take an ear mould impression. People who wear hearing aids are more likely to have impacted wax due to the hearing aid preventing wax from being excreted naturally. Although the committee agreed that the evidence was weak when considering one treatment over another, it was accepted that it is standard practice to treat earwax because it is not possible to manage a person’s hearing loss clinically without removing earwax when present, nor is it safe to manage hearing loss without excluding conditions like chronic infection by examination of the eardrum. The committee considered it important to stress that the removal of earwax should be provided as part of basic management of patients, and made a consensus recommendation for the circ*mstances in which earwax should be removed. The committee agreed that wax can be removed under direct vision or a microscope using a probe in certain situations when wax build up is minimal and sited near the meatus rather than impacted earwax deep in the canal, but research and discussion should be focused towards situations where this would not be the case. The committee noted the clinical benefit of ear irrigation as opposed to ear drops alone. In current practice, wax softeners are the standard intervention in primary care, followed by irrigation if unsuccessful. Irrigation of the ear canal should be undertaken using warm water and an electronic ear irrigation machine with a variable pressure control. A jet tip is used to angle the flow of water along the top of the posterior wall. Historically ear syringing was used and this is evident in the papers reviewed. The effect is the same but irrigation is a much safer method and syringing is now contraindicated because of adverse effects, namely trauma. Ear irrigation may be unsafe for some patients. The committee noted that the NICE clinical knowledge summary on ear irrigation includes contraindications for ear irrigation, and considered it important to signpost clinicians to this resource. Contraindications include perforation of the tympanic membrane, previous ear surgery, ear infection, previous problem with irrigation, and presence of a foreign body in the ear. The evidence demonstrated the benefit of using earwax softeners before ear irrigation, however the evidence was not strong enough to recommend a specific type of softener between oil, sodium bicarbonate or water. The committee recognised that it is currently common practice to use sodium bicarbonate or olive oil, although there is wide variation in practice amongst clinicians and personal preference plays a strong role, as does the type of the earwax. The evidence indicated that water is as clinically effective as other types of softeners and could be used as an alternative. The committee considered that clinical judgement should be used to determine which softener is most appropriate for the patient. Clinicians should also consider cost as a factor in their decision-making. Adverse events (such as irritation, otitis externa and perforation of ear drum) were reported in the evidence for hydrogen peroxide before irrigation, but the committee noted that the majority of studies did not report adverse events, so no conclusions could be drawn about adverse events of other treatments. The committee noted that sodium bicarbonate can also cause irritation. In contrast, there is some evidence that favours hydrogen peroxide alone (without irrigation). The committee noted the risk of potential confounding, for example if patients have used a cotton bud at the same time as the softener. The committee confirmed that hydrogen peroxide is no longer used in most clinical settings; however, it is available in pharmacies and is commonly used by the public in self-management. There is no evidence that hydrogen peroxide is more effective than other softeners before irrigation and there is evidence of a risk of adverse events, however overall the committee did not feel that there was sufficient evidence to justify making a negative recommendation about hydrogen peroxide. There was no high quality evidence in favour of a specified time interval for administering a softener before ear irrigation, however the committee considered that this was a clinically significant issue. In the absence of evidence favouring longer periods of administration, and the impact on patients’ quality of life caused by waiting, the committee agreed by consensus to recommend a timescale of either immediately before irrigation or up to 5 days prior to irrigation. The committee noted that health professionals may not be aware that administering ear drops on the same day as irrigation is an option, and wanted to highlight this for consideration. The impact on resources was noted as additional primary and community care appointments would not be required, but in some cases this would have to be balanced against appointments taking longer if the wax is difficult to remove. There may also be implications for clinic planning, particularly in remote rural areas where patients have limited travel options and may appreciate same day treatment. Giving the patient advice or a leaflet on the correct method to instil ear drops is valuable to ensure they have effect. The committee also noted that giving advice on measures that may help prevent the build-up of wax is often welcomed by patients. The committee also noted issues around compliance and whether some patients with cognitive decline or physical limitations are able to administer earwax softeners effectively themselves. The committee suspected that some older patients in this category would not be able to self-administer this treatment, but would instead require instillation of drops by a healthcare professional in the clinic shortly before irrigation. The committee noted that no evidence was found comparing the clinical or cost effectiveness of irrigation with other mechanical methods, such as microsuction or physical removal with a probe. Microsuction is the method usually employed by ENT services because it is quick and efficient and allows the clinician a good view of the ear canal and drum. It is the method of choice if irrigation has failed or if the person has external or middle ear pathology. The technique, however, is gaining in popularity and is available in some ear care clinics. The committee wished to highlight that microsuction may be considered where available, and where appropriately trained staff can use this technique. The committee considered that ear syringing with a large metal syringe or similar obsolete equipment is potentially harmful. The design of the syringe and the inability to control the water pressure increases the risk of damage to the ear canal and tympanic membrane. This treatment should no longer be used in current practice. Irrigation using an electronic ear irrigation machine which pumps water into the ear at a controlled pressure is safer. The committee noted the lack of evidence on the harms associated with the use of cotton buds. The committee agreed cotton buds can present a potential hazard when used by patients or their carers to remove wax themselves, and the importance of highlighting this with a consensus recommendation to warn of the increased risk of infections and causing wax to become impacted by pushing it further into the ear canal. The general advice given is not to insert anything into the ear canal as it is self-cleaning and the only cleaning needed is to gently wipe the conch (bowl) of the external ear with a damp flannel over a finger in order to clean earwax away from the meatus (entrance to the ear canal). |
| Trade-off between net clinical effects and costs | One UK health economic evaluation was identified, which was carried out as part of an NIHR health technology assessment. This compared 3 options: no treatment; treatment using softeners for a week and self-irrigating (using a bulb irrigator) if the wax does not clear; using softeners for a week and returning to a GP if the wax does not clear. The study described its results as “exploratory and should not be used as a basis for changing policy and practice”. The committee noted that self-irrigation is not commonly recommended in the UK. There are concerns regarding the safety of self-irrigation, and recommending this approach would conflict with the separate recommendation to advise people not to insert objects into their ears. The committee noted that the ‘exploratory’ study showed that GP-administered irrigation was not cost effective compared with self-irrigation due to very little additional benefit to quality of life from increased effectiveness. However, the committee noted that only 1 clinical study was identified reporting adverse events for self-irrigation. The committee agreed that self-irrigation is a potential method that it needed to consider, but decided that at this stage there is too little evidence regarding its safety for the committee to be confident that such a significant change from current practice would be safe. The committee considered making a recommendation for further research. Although such research would be welcomed, the committee decided that the other questions identified in this guideline are currently higher priorities. Comparing earwax treatment to no treatment, the committee noted a significant difference in the ICERs depending on which quality of life measure is used: removal was highly cost effective at a threshold of £20,000 per QALY gained when quality of life was measured using HUI3 but not cost effective when EQ-5D was used. The committee agreed that HUI3 is a more appropriate measure of quality of life for people with hearing loss than EQ-5D (see appendix N for more discussion on this issue), and that it appears to be a more appropriate tool in this context, however the committee noted that this study had not found any measurement for a change in utility directly equivalent to the impact of having earwax, and so the results of this study cannot be relied upon. In addition to the low quality evidence that earwax removal could be cost effective, the committee also noted that current practice is to remove wax, and did not consider any treatment to be an option for consideration as this would not be acceptable to patients. Regarding the most cost-effective method of removing earwax, the committee was constrained by the lack of clinical evidence regarding methods other than irrigation (such as microsuction). Irrigation has been shown to be effective. The cost of the initial purchase of the machine (around £159) will be split over many hundreds of uses, and so is not significant. Consumables cost only £0.54 per use. Irrigation machines are currently found in some GP surgeries. The major cost involved is the healthcare professional’s time, which is dependent on the number of appointments required to remove the earwax. Microsuction machines are considerably more expensive than irrigation machines. If purchased with a microscope the combined equipment can cost from £7,500 to as much as £14,000 if a high end microscope is used. However, if a loupe (a portable microscope with lower magnification) is used instead of a microscope then the combined cost would instead be between £1,350 and £3,350. The cost of consumables is however still low, expected to be slightly under£3 peruse. In some areas there are alternative local ear care clinics providing irrigation to which people can be referred. It is not necessary and would not be appropriate to refer people with earwax, without complications, to a hospital service for earwax removal, as this would be unnecessarily more expensive than a primary or community care appointment. Consequently the committee recommended that earwax removal should be offered as it is likely to be cost effective, and that irrigation should be considered as the method of removal. Where irrigation is used, softeners should be used before irrigation to increase the rate of success of irrigation. The committee noted that various possible softeners are available that are cheap and similarly priced (all below £3 per bottle, with the cheapest below £1 per bottle). The committee therefore agreed that softeners that can be obtained at a low price and do not carry a risk of adverse effect should be preferred, such as water, sodium chloride or olive oil. Softeners such as water or sodium bicarbonate can be effective if instilled a few minutes before irrigation, or part-way through the irrigation appointment, thus reducing the need for further additional visits and also decreasing delays in care. The committee noted that no clinical or economic evidence was identified regarding microsuction compared with ear irrigation in either this review or the review of settings for earwax management, despite a common belief among clinicians that microsuction is more clinically effective. The committee also noted that, whereas ear irrigation is widely available, microsuction is less widely available and the equipment is more expensive. The committee therefore recommended that microsuction could be considered where it is already available, but that it cannot recommend that microsuction equipment be routinely purchased. |
| Other considerations | The committee also noted that there is a range of treatments available for treating earwax that are inappropriate and should not be used, for example ear candles. The committee discussed how great the impact of earwax on audibility would be. It was agreed that the measurable difference was probably not more than 10dB in most cases; a level which would give a perceived reduction in loudness of 50%. The committee however recognised that earwax can have a huge impact on quality of life, especially for certain occupations where safety is important. It is likely to have a much greater impact on those who wear hearing aids and find themselves unable to use their aids because of earwax. The committee is aware of the practice of using regular small quantities of olive or almond oil in order to keep earwax soft and in this way to try to avoid build-up of earwax. This use of oil was not researched and the committee know of no evidence to advise against this practice if it is found to help the individual. |
