EarCare

CLINICAL STUDIES ON THE FOLLOWING INGREDIENTS:

Efficacy of naturopathic extracts in the management of ear pain associated with acute otitis media

Abstract

Objective: 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).

Design: 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.

Setting: Primary pediatric community ambulatory centers.

Participants: One hundred three children aged 6 to 18 years who were diagnosed with otalgia associated with AOM.

Results: 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).

Conclusion: 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.

Source: Sarrell EM, Mandelberg A, Cohen HA. Efficacy of naturopathic extracts in the management of ear pain associated with acute otitis media. Arch Pediatr Adolesc Med. 2001 Jul;155(7):796-9. doi: 10.1001/archpedi.155.7.796. PMID: 11434846.

Naturopathic treatment for ear pain in children

Abstract

Objective: Otitis media is 1 of the most frequent diseases of early infancy and childhood and 1 of the most common reasons for children to visit a physician. In the past 2 decades, there has been a substantial increase in the diagnosis of otitis media worldwide. In the United States, 93% of all children have had at least 1 episode of acute otitis media (AOM) by 7 years of age. Otalgia is the hallmark of AOM. Most affected children either complain of earache or manifest behavior that the parents interpret as indicating ear pain. Treatment of the ear pain early in the course of AOM decreases both parental anxiety and the child's discomfort and accelerates the healing process. The objective of this study was to determine the efficacy and tolerability of naturopathic versus traditional treatment for the management of otalgia commonly associated with AOM in children.

Methods: The study was designed as a double-blind trial in an outpatient community clinic. A total of 171 children who were aged 5 to 18 years and had otalgia and clinical findings associated with middle-ear infection were studied. The children were randomly assigned to receive treatment with Naturopathic Herbal Extract Ear Drops (NHED) or anesthetic ear drops, with or without amoxicillin. On enrollment, the children were assigned by computer-numbered randomization to receive NHED (contents: allium sativum, verbascum thapsus, calendula flores, hypericum perfoliatum, lavender, and vitamin E in olive oil) 5 drops 3 times daily, alone (group A) or together with a topical anesthetic (amethocaine and phenazone in glycerin) 5 drops 3 times daily (group B), or oral amoxicillin 80 mg/kg/d (maximum 500 mg/dose) divided into 3 doses with either NHED 5 drops 3 times daily (group C) or topical anesthetic 5 drops 3 times daily (group D). A double-blind design was used, and all ear drops were placed in identical bottles. Treatment was initiated by the nurse in all cases. A single physician (M.S.) evaluated and treated all of the patients included in the study and recorded all of the data. The presence or absence of ear pain was assessed over 3 days with a visual analog scale. Ear pain was assessed by a specially devised observational instrument based on previous reports. One side of the instrument consisted of a linear numbered scale, from 1 (no pain) to 10 (worst possible pain), and a corresponding color scale, ranging from blue to dark red. The reverse side contained a scale of 5 facial expressions, ranging from broad smile (no pain) to a sad and crying face (worst possible pain), and a corresponding color scale, ranging from blue to dark red.

Results: There were no significant between-group differences in patient age or gender, degree of fever, main symptoms, associated symptoms, and severity or laterality of acute otitis media. Each group had a statistically significant improvement in ear pain over the course of the 3 days. Patients who were given ear drops alone had a better response than patients who were given ear drops together with amoxicillin. Results were better in the NHED group than in the controls. Nevertheless, the findings indicated that the pain was mostly (80%) self-limited and could be explained simply by the time elapsed. The American Academy of Otolaryngology-Head and Neck Surgery guidelines recommend topical medications as the first line of treatment for ear pain in the absence of systemic infection or serious underlying disease. Because no evidence was found that systemic antibiotics alone improved treatment outcome, if antibiotics do not change the natural course of otitis media, then the main goal of treatment, as in the present study, should be to alleviate the ear pain. The alternative, naturopathic herbal extract medications, may offer many new possibilities in the management of ear pain associated with AOM. Primary care physicians should be aware that at least 10% of their patients may have tried 1 or more forms of alternative/complementary medicine before presenting for consultation. As it was widely reported in the medical literature, these herb, these herbal extracts have the potential to meet all of the requirements of appropriate medication that could be routinely used in the pediatric patient, namely in vitro bacteriostatic and bacteriocidal activity against common pathogens, immunostimulation ability, antioxidant activity, and anti-inflammatory effects. They are also well-absorbed with good penetration into the tissue surrounding the tympanic membrane. They have been found to enhance local immunologic activity. Finally, herbal extracts are well-tolerated (owing to their long elimination time), easy to administer, and less expensive than the new antibiotics. There are no documented side effects. On the basis of our findings that the group with the most significant treatment effects (NHED with topical anesthetic) explained only 7.3% of the total pain reduction, we propose that sometimes the general practitioner or pediatrician needs to give the human body a chance to repair itself. Nevertheless, if the physician believes that there is an indication for some treatment, especially if the parents are anxious, then a local treatment such as one used in our study might be adequate.

Conclusion: This study suggests that in cases of ear pain caused by AOM in children in which active treatment, besides a simple 2- to 3-day waiting period, is needed, an herbal extract solution may be beneficial. Concomitant antibiotic treatment is apparently not contributory.

Source: Sarrell EM, Cohen HA, Kahan E. Naturopathic treatment for ear pain in children. Pediatrics. 2003 May;111(5 Pt 1):e574-9. doi: 10.1542/peds.111.5.e574. PMID: 12728112.

The effectiveness of topical preparations for the treatment of earwax: a systematic review

Abstract

Background: Earwax is a common problem in both primary and secondary care. There is uncertainty as to the most effective topical treatment.

Aim: To assess the evidence concerning the efficacy of topical preparations used for treating earwax.

Design of study: Systematic review and meta-analysis.

Methods: Searching for randomised controlled trials (RCTs) of relevant studies. Classification of preparations into three groups, enabling pooling of data and meta-analysis.

Results: Of the 18 RCTs included in the review, four were judged to be of high quality. Fifteen preparations including saline and plain water were studied. Oil-based and water-based preparations were equally effective at clearing earwax without syringing (odds ratio [OR] = 0.9, 95% confidence interval [CI] = 0.4 to 2.3) and facilitating successful syringing (OR = 1.0, 95% CI = 0.6 to 1.6). A non-water-, non-oil-based preparation appeared more effective than an oil-based preparation at both clearing earwax without syringing, and facilitating successful syringing. Immediate syringing after application of a preparation may be as effective as using eardrops for several days and delaying syringing.

Conclusion: On current evidence, there is little to choose between water-based and oil-based preparations; non-water-, non-oil-based preparations appear promising at both clearing earwax and facilitating successful syringing, but further large trials are needed. Although immediate ear syringing is effective and convenient for patients, it may be less cost-effective than using eardrops and perhaps avoiding syringing. Most of the evidence regarding such a common and time-consuming problem is not of high quality.

Source: Hand C, Harvey I. The effectiveness of topical preparations for the treatment of earwax: a systematic review. Br J Gen Pract. 2004 Nov;54(508):862-7. PMID: 15527615; PMCID: PMC1324923.

Ear pain and hearing loss

Abstract

The pitfall for the non-ear specialist is to think that ear symptoms can only be due to ear disease—this is far from the case. Due to its complex nerve supply, pain and paraesthesia often have an origin away from the ear but symptoms are referred to the ear; consequently earache in the presence of a normal eardrum is due to a malignancy until proven otherwise. In additional to referral to the ear of symptoms from regional disease, systemic disease can also present with earache, a good example of which is Wegener’s granulomatosis and the painless deafness associated with vitamin D deficiency. While unrelenting pain with aural discharge can be a presenting symptom of life-threatening condition such as osteitis of the skull base or a malignancy of the ear, unrelenting discharge without pain can also be a sign of life-threatening disease such as cholesteatoma, tuberculosis, and tertiary syphilis. Assessment of the patient with an ear problem should include a thorough history to include symptoms of systemic and regional disease as well as auditory and neural symptoms. Examination should include the ear but also the head and neck and upper respiratory mucosal surfaces as well as looking for signs of systemic disease. Investigation should include assessment of the hearing, search for systemic conditions and local imaging of the head and neck. Treatment of hearing loss is not just confined to hearing aids but advice should be given on prevention, and the use of environmental aids or surgery considered.

Source: Hawthorne, Maurice, and Maurice Hawthorne, 'Ear pain and hearing loss', in William E. G. Thomas, Malcolm W. R. Reed, and Michael G. Wyatt (eds), Oxford Textbook of Fundamentals of Surgery, Oxford Textbooks in Surgery (Oxford, 2016; online edn, Oxford Academic, 31 Jan. 2024), https://doi.org/10.1093/med/9780199665549.003.0060_update_001, accessed 30 Sept. 2025.

Follow the Wax: The Natural Protection of the Ear Canal and Its Biome

Abstract

The external canal is a unique environment that has an elaborate mechanism for self-cleaning and protection. The fundamental basis of this is the epithelial migration of the desquamating layers of the keratinizing epithelium that lines the entire canal and ear drum. This migratory movement results in a "conveyor belt" effect where the dead skin is moved out of the bony ear canal to the cartilaginous portion, where it is lifted off with the help of glandular skin secretions and the hairs of the canal to form what we call "ear wax." The ear wax has numerous protective properties and is essential to the health of the external ear. The protective properties are due to chemical properties of the wax, in addition to intrinsic chemical secretions by the sebaceous and cerumen apocrine glands. The protection also comes from a diverse population of organisms that exist in the external ear that are usually saprophytic, commensal, and symbiotic, but in some cases, they can become parasitic and pathologic. Detection and quantification of the members of this biome has been difficult, and their overall role in the normal biome of the ear and their transition into pathogens remain an area of active research and investigation.

Source: Hanson MB, Adams M. Follow the Wax: The Natural Protection of the Ear Canal and Its Biome. Otolaryngol Clin North Am. 2023 Oct;56(5):863-867. doi: 10.1016/j.otc.2023.06.005. Epub 2023 Jul 28. PMID: 37517877.

Searching for Scientific Explanations for the Uses of Spanish Folk Medicine: A Review on the Case of Mullein (Verbascum, Scrophulariaceae)

Abstract

Verbascum species (common mullein) have been widely used in Spanish folk medicine to treat pathologies related to the musculature, skeleton, and circulatory, digestive, and respiratory systems, as well as to treat infectious diseases and organ-sense illnesses. These applications support the potential anti-inflammatory action of Verbascum phytochemicals. Based on the aforementioned facts, and following a deep bibliographic review of the chemical composition of the 10 species of Verbascum catalogued by the Spanish Inventory of Traditional Knowledge related to Biodiversity, we look for scientific evidences to correlate the traditional medical uses with the chemical components of these plants. To support these findings, in silico simulations were performed to investigate molecular interactions between Verbascum phytochemicals and cellular components. Most of common mullein traditional uses could rely on the anti-inflammatory action of phytochemicals, such as quercetin, and it could explain the employment of these plants to treat a wide range of diseases mediated by inflammatory processes such as respiratory diseases, otitis, arthrosis, and rheumatism among others.

Source: Blanco-Salas J, Hortigón-Vinagre MP, Morales-Jadán D, Ruiz-Téllez T. Searching for Scientific Explanations for the Uses of Spanish Folk Medicine: A Review on the Case of Mullein (Verbascum, Scrophulariaceae). Biology (Basel). 2021 Jul 2;10(7):618. doi: 10.3390/biology10070618. PMID: 34356473; PMCID: PMC8301161.

Antioxidants in treatment of idiopathic sudden hearing loss

Abstract

Objective: Assuming that superoxide anion radicals (O(2)-) may play a role in damage to the inner ear, the authors investigated the possible benefit of vitamin E as an antioxidant in the treatment of idiopathic sudden hearing loss.

Study design: Prospective, double-blind study.

Setting: The Department of Otolaryngology of Rambam Medical Center serves as a tertiary referral center for a population of 1.2 million people.

Patients: A total of 66 patients, aged 15 to 70 years, with diagnoses of idiopathic sudden hearing loss of less than 7 days' duration during 1998 to 2001, were included in the study. All were treated with bed rest, steroids, magnesium, and carbogen inhalation. The study group received vitamin E in addition.

Results: The recovery rate, calculated as hearing gain divided by the difference in hearing level between the affected and unaffected ear, was better than 75% in 41 of 66 (62.12%) patients. This rate was achieved in 26 (78.78%) patients in the study group treated with vitamin E, compared with 15 (45.45%) patients in the control group.

Conclusion: Patients treated with the addition of vitamin E achieved better recovery than did the control patients. Further studies should be directed toward a better understanding of the role of antioxidants in idiopathic sudden hearing loss.

Source: Joachims HZ, Segal J, Golz A, Netzer A, Goldenberg D. Antioxidants in treatment of idiopathic sudden hearing loss. Otol Neurotol. 2003 Jul;24(4):572-5. doi: 10.1097/00129492-200307000-00007. PMID: 12851547.

Verbascum Thapsus and mullein oil as an instant relief for acute suppurative otitis media in children

Abstract

Any acute complaints with pain especially in infants and children make the whole family especially the parents of the child very depressed and anxious. Such one condition is the management of acute suppurative otitis media in children which has become an essential need because the acute pain that the child suffers at most of the times is intolerable. From the most ancient days in medical field, for any acute complaints people run to various treatment of medicines which give instant relief. So, as the myth says Homoeopathic system of medicine is slow acting and not suitable for emergency conditions but here is the true side of Homoeopathy, the real fact to prove the importance of Homoeopathy in treating an acute emergency pain and give an instant relief with cure. This study can give the evidence in use of external application like ear drops is very beneficial acute aid and approach to the disease can give a immediate satisfaction and rapid relief in patients. So, the effectiveness of Homoeopathy acts well in even acute emergency conditions especially when given both internally and externally. The study concludes with the significant effect in administration of same homoeopathic medicine both as internal medicine and external application together gives better improvement.

Source: International Journal of Homoeopathic Sciences 2021; 5(4): 127-128, S Architha Aishwarya and PR Sisir DOI: https://doi.org/10.33545/26164485.2021.v5.i4b.462

References:

1. https://pubmed.ncbi.nlm.nih.gov/11434846/
2. https://pubmed.ncbi.nlm.nih.gov/12728112/
3. https://pmc.ncbi.nlm.nih.gov/articles/PMC1324923/
4. https://academic.oup.com/book/31816/chapter-abstract/483132662?redirectedFrom=fulltext
5. https://pubmed.ncbi.nlm.nih.gov/37517877/
6. https://pmc.ncbi.nlm.nih.gov/articles/PMC8301161/
7. https://pubmed.ncbi.nlm.nih.gov/12851547/
8. https://www.homoeopathicjournal.com/articles/462/5-4-7-358.pdf