Coppin et al conducted a blinded study of adults with cerumen impaction to assess the efficacy of bulb syringe irrigation compared with standard care.1
The authors recruited patients from 7 practices in England. To be eligible for the study, patients had to have symptoms of blockage and visible occluding ear wax. The researchers assessed 434 patients and randomized 237; of these, only 3 were lost to follow-up.
Using concealed allocation, a nurse randomly gave all the patients identical-looking envelopes. Half of the envelopes contained ear drops and instructions in usual care (ear irrigation by a clinician after the use of ear drops). The other half contained ear drops and a 25-mL ear bulb syringe (not available over the counter in the United Kingdom). Instructions provided with the syringes indicated that they could be cleaned and reused, but did not specifically instruct patients as to when to use them. Baseline characteristics were balanced between the 2 groups.
After 2 weeks, the nurse reassessed the patients and irrigated the ears of any patient with evidence of occlusion. The authors used National Health Service computerized records to track ear wax–related visits over the next 2 years for participants in both groups.
During the 2-year follow-up, more of the patients in the control group returned to the clinic with episodes of ear wax compared with those in the intervention group (73% vs 60%; risk ratio=1.21; 95% confidence interval [CI], 1.01-1.37; P=.038).
This RCT is the first to provide evidence that some patients do not need to spend time (or money) on an office visit for ear wax irrigation.
The researchers also found that, among the returnees, patients in the control group had, on average, 50% more visits. That is, for every 2 patients who were given a bulb syringe, there was one less visit (incidence rate ratio=1.79; 95% CI, 1.05-3.04; P=.032). A secondary analysis found no significant difference in adverse events between the intervention and the control groups.