A comparison of the efficacy of two ear drop preparations ('Audax' and 'Earex') in the softening and removal of impacted ear wax. The effectiveness of topical treatment in discharging ears with in-dwelling ventilation tubes. Efficacy of naturopathic extracts in the management of ear pain associated with acute otitis media. Randomized clinical trial of docusate, triethanolamine polypeptide, and irrigation in cerumen removal in children. [Double-blind comparative study of trimethroprim-sulphacetamide-polymyxin b and gentamicin in the treatment of otorrhoea (author's transl)]. A comparison of cortisporin and ciprofloxacin otic drops as prophylaxis against post-tympanostomy otorrhea.
Thirty-six patients with symptoms of impacted ear wax were recruited to an open, randomized, parallel group study of 'Audax' ear drops and 'Earex' ear drops. Patients had had their symptoms for several weeks and they were assessed on entry for the degree of impaction in each ear. After using the drops, morning and evening for 4 days, they were assessed on the fifth day for degree of impaction, ease of syringing, side-effects or discomfort, and the investigator's and patient's own global impression of efficacy of the ear drops. A trend was seen showing less impaction post-treatment in the 'Audax' group than in the 'Earex' group although the difference did not reach statistical significance. A significant difference was seen in favour of 'Audax' for the frequency and ease of syringing (p < 0.005). No patients in the 'Audax' group reported any side-effect or discomfort although 1 patient using 'Earex' reported slight irritation whilst another found the smell unacceptable. The results of the investigators' and patients' own global impression of efficacy were significantly in favour of 'Audax' ear drops (p < 0.01). The efficacy and tolerability of topical treatment (both drops and spray) in the treatment of otorrhoea in those ears with ventilation tubes in-situ was studied. Sixty patients were randomised into two treatment groups. One group used an antibacterial/anti-inflammatory ear drop preparation (Otosporin) and the other group a similar preparation administered as an ear spray (Otomize). A 'blind' clinical assessment was made one and three weeks after commencing treatment. Both treatments (drops and spray) significantly improved patients' symptoms and signs after one week (p < 0.001). The spray was significantly easier to administer (p < 0.01) and caused less discomfort on application (p < 0.02). To determine the efficacy and tolerance of Otikon Otic Solution (Healthy-On Ltd, Petach-Tikva, Israel), a naturopathic herbal extract (containing Allium sativum, Verbascum thapsus, Calendula flores, and Hypericum perforatum in olive oil), compared with Anaesthetic (Vitamed Pharmaceutical Ltd, Benyamina, Israel) ear drops (containing ametocaine and phenazone in glycerin) in the management of ear pain associated with acute otitis media (AOM).
                Children between the ages of 6 and 18 years who experienced ear pain (otalgia) and who were diagnosed with eardrum problems associated with AOM were randomly assigned to be treated with Otikon or Anaesthetic ear drops, which were instilled into the external canal(s) of the affected ear(s). Ear pain was assessed using 2 visual analog scales: a linear scale and a color scale. Pain assessment took place throughout the course of 3 days. The mean score of pain reduction was used to measure outcome.
                Primary pediatric community ambulatory centers.
                One hundred three children aged 6 to 18 years who were diagnosed with otalgia associated with AOM.
                Each of the 2 treatment groups were comparable on the basis of age, sex, laterality of AOM, and the effectiveness of ameliorating symptoms of otalgia. The 2 groups were also comparable to each other in the initial ear pain score and in the scores at each application of Otikon or Anaesthetic drops. There was a statistically significant improvement in ear pain score throughout the course of the study period (P =.007).
                Otikon, an ear drop formulation of naturopathic origin, is as effective as Anaesthetic ear drops and was proven appropriate for the management of AOM-associated ear pain. Cerumen obstructing visualization of the tympanic membrane in children is a common and frustrating problem. Docusate sodium, triethanolamine polypeptide, and saline were compared to determine their effectiveness in relieving cerumen obstruction in children.
                A randomized, controlled, double-blind trial was performed on pediatric patients aged 6 months through 5 years with cerumen obstruction. The enrolling physician determined whether the cerumen completely or partially obstructed visualization of the tympanic membrane. One milliliter of docusate sodium, triethanolamine polypeptide, or normal saline as control was placed into the patient's ear canal. If the tympanic membrane was not completely visualized after 15 minutes, the ear was irrigated with 50 mL of tepid water. Irrigation was repeated a second time if needed. The main outcome was the proportion of tympanic membranes that were completely visualized after cerumeno-eblytic agents or control saline, alone or with irrigation if needed.
                Of 92 patients enrolled, 34 received docusate sodium; 30, triethanolamine polypeptide; and 28, saline. Mean +/- SD patient age was 34.7 +/- 18.1 months, and 50 (54%) of the patients were girls. Groups were similar in age, race, sex, ear enrolled, wax consistency, and degree of obstruction. There was no significant difference in the proportion of tympanic membranes completely visualized after treatment with docusate (18/34; 53%), triethanolamine polypeptide (13/30; 43%), or saline (19/28; 68%) (P =.17).
                Application of docusate sodium or triethanolamine polypeptide did not significantly improve the proportion of tympanic membranes that were completely visualized vs application of the saline control. A double-blind comparative study of the use of Garamycine (gentamicin) ear drops and TSP (trimethroprim-sulphacetamide-polomyxin B) ear drops in the treatment of 100 cases of otorrhoea due to external otitis, a recurrent otitis media accompanied by perforation of the drum, an infection of the mastoid cavity or a postoperative infection, provided evidence of the effectiveness of both medications. TSP ear drops gave positive results in 42 out of 50 cases treated, whilst for gentamicin aural solution results were positive for 46 out of 50 cases. Gentamicin gave a successful result in 5 of the 8 failures with TSP, whilst TSP cured the four original failures with gentamicin. There were no signs of ototoxicity, of excessive fungal proliferation nor of any local sensitivity to the ear drops. It would seem that these aural preparations are complementary, capable of resulting in the disappearance of the majority of bacterial agents responsible for pathogenic otorrhoea. Myringotomy and tube insertion, a common pediatric surgical procedure, is frequently complicated by purulent otorrhea. Many otolaryngologists routinely use topical antibiotics as prophylaxis against post-tympanostomy otorrhea. The aminoglycosides (neomycin sulfate, tobramycin and gentamicin) contained in commonly used topical antibiotics as well as components of the solutions have been shown to be ototoxic in animal studies. Although little reported evidence of ototoxicity in humans exists, sporadic reports of sensorineural hearing loss linked to topical antibiotic use do exist, and the potential for sensorineural hearing loss must be considered. The purpose of this study is to compare the rate of post-tympanostomy otorrhea in a double-blinded randomized trial using either topical Ciprofloxacin, with no reported ototoxicity, or Cortisporin as prophylaxis. One hundred patients (200 ears) between ages 7 months and 11 years with a diagnosis of recurrent otitis media or chronic otitis media undergoing tympanostomy tube insertion were randomized into two equal groups. Three drops of either drop A or B were placed into each ear at the time of tube insertion and then three times daily for 3 days. Patients were examined at 3 weeks and details of otorrhea were obtained. The rate of otorrhea was analyzed using chi-square. The overall rate of otorrhea was 39 ears (19.5%), 17 (17%) ears for the Cortisporin group and 22 (22%) for the Ciprofloxacin group. The difference in rate of otorrhea was not statistically significant (P=0.372, 95% confidence interval equals -6-16%). Our data suggest that topical Cortisporin offers no benefit over Ciprofloxacin for post-operative otorrhea prophylaxis. Therefore we recommend topical quinolone prophylaxis, which should eliminate concerns about ototoxicity, without sacrificing efficacy.
Trials have been heterogeneous and generally of low or moderate quality, making it difficult to offer any definitive recommendations on the effectiveness of cerumenolytics for the removal of symptomatic ear wax. Using drops of any sort appears to be better than no treatment, but it is uncertain if one type of drop is any better than another. Future trials should be of high methodological quality, have large sample sizes, and compare both oil-based and water-based solvents with placebo, no treatment or both.