Randomized Trial of Bulb Syringes for Earwax: Impact on Health Service Utilization

We thank Dr Bartels for his response and agree that safety concerns must be paramount. Our original study protocol (Ref 1) reflected both routine clinical practice and the warnings issued on bulb syringe instruction sheets by excluding patients with a history of tympanic perforation, previous tympanic or mastoid surgery, history of inner ear problems such as severe vertigo, and signs of perforation or infection.

Our study was indeed not designed to assess safety as this would have required a considerably larger study population. The systematic review with which we were involved (Ref 2) did undertake a thorough literature search and cautiously concluded that using ear drops and irrigation appear safe techniques. However we acknowledge that many otologists have experience of dealing with tympanic perforation caused by attempted removal of wax. We also take seriously Dr Bartel's concerns about the apparently greater risks of ear irrigation in patients with pre-existing ear pathology. We do not ‘discount’ those concerns but note that current ear irrigation devices work at much lower pressures than those previously in use. Moreover we have been struck by the fact that, despite the theoretical risks, reports of damage to the ear drum from the self-use of bulb syringes are elusive. We have been assured by a major US supplier of bulb syringes that they are unaware of receiving any such reports over many years. Were such events to occur in the US and European countries we would have expected this to have led to adverse publicity about the devices and restrictions on their marketing whereas they continue to be seen as acceptable to be sold over the counter in many countries. This is presumably a consequence of a common-sense approach by patients in heeding the warnings issued with the devices and, most importantly, employing caution and avoiding discomfort when using them.

We note Dr Bartel’s advocacy of the ‘Murine Earigate’ system but have no experience of the device and are unaware of any published evidence of its effectiveness or safety. His comment about Qtips echo commonly issued advice elsewhere and indeed advice we give in our clinical practice. How such advice impacts on the need for ear care by health professional might be a good subject for future research.

References 1. Coppin R, Wicke D, Little P. Managing earwax in primary care: efficacy of self-treatment using a bulb syringe. Br J Gen Pract. 2008; 58(546):44–49. 2. Clegg AJ, Loveman E, Gospodarevskaya E, et al. The safety and effectiveness of different methods of earwax removal: a systematic review and economic evaluation. Health Technol Assess. 2010;14(28):1–192.

Competing interests:   None declared

2 comments:

1) As some of the other comments have pointed out, there are some people that should not have water injected into their ears. I don't know that it is necessary to visualize everyone's ear or have an audiogram prior to irrigation, but I would think that it would be wise to exclude individuals with a history of previous perforation (if healing has not been verified in the interim) or previous ear surgery.

2) Like the other comments, I am puzzled that we were not told what drops were used. In addition, no prepartion of drops has been proven to be clearly better than plain saline or water. So, if one is attempting to control health care costs, why not prescribe a bulb syringe to be used with water rather than having to purchase drops?

Competing interests:   None declared

Several methods of ear irrigation exist and a bulb syringe is but one of them. This study has too few participants to disclose risks or risk- differences between the control and study groups. It may be a sufficiently powered study to assess the validity that self-ear irrigation can reduce visits to a primary care facility. As an otologist, I have over the last 31 years taken care of more than a half dozen persons whose tympanic membranes were perforated by ear irrigation. The authors allude to that prospect but discount it as being the result of over-powered irrigation. Neither do the authors discuss what already exists in the market that is potentially safer than a bulb syringe, the "Murine Earigate" system. The common agents for wax irrigation or wax softening are not mentioned. The major generator of deep impactions, Qtips, is not mentioned as proscribed. As well, our experience is that folks who come in for major ear cleaning have a very low risk of return as we teach them the ear's nature self-cleaning method and advise against Qtip usage. I.e., I am not convinced that teaching self-irrigation is the best thing to do though I do encourage folks to familiarize themselves with the "Murine Earigate" method. Major risk factors in relatively low power ear irrigation do exist in perhaps 0.01 to 0.03% (incidence of cholesteatoma/tympanic membrane perforation, prior mastoid cavity, recurring ear infection history, etc) of the population who have risk of infection from irrigation. The percentage who have a weak, thin area of the tympanic membrane that would be unusually subject to perforation with ear irrigation is not known. I encourage folks with these risk factors never to allow self or professionally applied ear irrigation. Do these authors assure that these risk factors have been assessed prior to encouraging home irrigation. We strictly avoid using ear irrigation in our office unless the otologist has documented the tympanic membrane to be of at least normal strength and that no aggravatable pathology exists.

Competing interests:   None declared

We thank Professor Krouse for her interest in our study and agree with her comment that a further prospective follow-up study would be useful. This also fits with the conclusions of the systematic review led by Clegg that we cited and would have the additional benefit of adding to the safety data on bulb syringes. However, from the initial study of symptoms(Ref 1) and the current prospective follow-up, we were able to document adverse events, and there were none, which suggest adverse events are likely to be rather uncommon. Also since bulb syringes are available over the counter in the US and, as described, we found no reports of adverse events, this suggests the safety profile of these devices is good.

Her comment about the group of patients benefiting most from using a bulb syringe is interesting. We noted that 49% of patients in the bulb arm of the study had no record of attending for irrigation during the 2 year follow-up but we did not analyse the characteristics of those patients. We agree that understanding which patients are most likely to benefit from using bulbs should be one of the aims of any future study.

Reference 1. Coppin R, Wicke D, Little P. Managing earwax in primary care: efficacy of self-treatment using a bulb syringe. Br J Gen Pract. 2008;58(546):44- 49.

Competing interests:   None declared

This randomized trial showed promising initial findings in patients performing self-irrigation with a bulb syringe for earwax removal. Additional follow-up studies that are prospective in nature vs. retrospective analysis would be optimal.

Practitioners prescribing self care treatments to manage earwax problems would benefit by knowing which patients (e.g. age, gender, education, and socioeconomic variables) are most likely to adhere to this treatment regimen, development of a standardized irrigation protocol that maximizes benefits, and a documented adverse risk profile. Prospective studies that build on these initial findings must be undertaken prior to advocating a recommendation that promotes self care ear-irrigation practices in lieu of clinic-based care.

Competing interests:   None declared

How can you publish a study without revealing the composition of the main treatment modality? I agree with the previous comment that the composition of these drops may significantly affect outcomes. There should at least be a reference of some sort to identify the drops (i.e. "proprietary formula", standard OTC preparation). I think the editors really dropped the ball on this one to allow the treatment methods to be published in such a vague manner.

Competing interests:   None declared