Patulous Eustachian Tube Treated with Chinese Medicine, Kami-Kihi-To (Jia-Wei-Gui-Pi-Tang)

Shigeru Ishikawa MD., Ph.D.

(Department of Otolaryngology, Kanazawa Municipal Hospital, Kanazawa, Japan)

Objective

To assess the efficacy of Jia-Wei-Gui-Pi-Tang therapy in the treatment of Patulous Eustachian Tube(PET)

Design

Nonrandomized trial with a follow-up period of 3 months

Setting

Kanazawa Municipal Hospital

Patients

Eighty-eight outpatients with PET

Intervention

Administration of Jia-Wei-Gui-Pi-Tang

Outcome Measures

Symptomatic and impedance-audiometric comparisons before and after therapy

Results

"Jia-Wei-Gui-Pi-Tang" was administrated in 88 patients. Therapeutic effects on symptoms were investigated by interview in 66 patients. Objective changes in impedance audiometry were also evaluated in 24 cases. After the administration of "Jia-Wei-Gui-Pi-Tang," complete relief was obtained in 36 patients (54.5%) and partial relief was obtained in 14 patients (21.2%). Abnormal tympanic membrane movements were completely improved in 8 patients (33.3%), and partially improved in 9 patients (37.5%). Side effects were noted in 3 patients (4.5%).

Conclusion

Jia-Wei-Gui-Pi-Tang therapy was considered to be an effective treatment for PET

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INTRODUCTION

Patulous Eustachian tube (PET) has been considered to be a rare condition which causes symptoms such as ear fullness, autophony and roaring tinnitus, which occurs synchronously with respiration, in the affected ear. Precise features of PET were first described by Jago in 1867. The following etiologic factors have been reported in the literature: weight loss, rheumatism, multiple sclerosis, perkinsonism, administration of sex-hormone and radiation therapy. However, a number of patients with PET lack these factors in clinical settings. Impedance audiometry has recently been used to evaluate Eustachian tube function. We can diagnose PET objectively with this method. PET has been treated with local therapy to the Eustachian tube orifice and its surrounding structures. Medical therapy has rarely been attempted for PET. The purpose of this paper is to attract attention to medical therapy for PET.

PATIENTS AND METHODS

Eighty-eight patients underwent herbal therapy for PET at the Department of Otolaryngology, Kanazawa Municipal Hospital, between February 1993 and December 1993. They consisted of 58 females and 30 males ranging from 15 to 86 years of age (51.0}16.2; mean}SD) (Fig 3). The right ear was affected in 31 patients, the left ear in 30 patients and both ears in 27 patients (Fig 4). All patients were inquired of past and present histories (weight loss, duration of symptoms and concomitant disease). A series of examinations (pure tone audiometry, tympanometry and symptomatic changes on head-down positioning) were also performed in all patients. The diagnosis of PET was made by specific symptoms and abnormal tympanic membrane movements (ATMM) detected by impedance audiometry during hyperventilation. Symptomatic grading of PET was determined based on the following scale.

Grade 0: No symptoms
Grade 1: Symptoms sometimes in the standing position
Grade 2: Symptoms always in the standing position
Grade 3: Symptoms in the supine position

Jia-Wei-Gui-Pi-Tang (Kanebo Pharmaceuticals Ltd., Japan) is spray-dried powder of a hot-water extract prepared (with 10 parts of water at 95-100 degree C for 1 hr, yield: about 19%) from a mixture of the following fourteen herbal constituents: Astragali radix: 2.0g, Ginseng radix: 3.0g, Atractylodes rhizoma: 3.0g, Hoelen: 3.0g, Polygala radix: 1.5g, Zizyphi fructus: 1.5g, Longanae arillus: 3.0g, Zizyphi spinosi Semen: 3.0g, Angelicae radix: 2.0g, Glycyrrhizae radix: 1.0g, Zingiberis rhizoma: 0.5g, Saussureae radix: 1.0g, Bupleuri radix: 3.0g, Gradeniae fructus: 2.0g. The drug was administrated three times a day, before each meal, for at least seven days. Other concomitant therapy was not combined. The efficacy of Jia-Wei-Gui-Pi-Tang was generally evaluated both subjectively (by symptomatic grading) and objectively (by impedance audiometry) 7 days after the start of the administration of Jia-Wei-Gui-Pi-Tang.

Patients were fully informed before enrollment that Chinese herbal (Jia-Wei-Gui-Pi-Tang) therapy is not an established therapy.

RESULTS

Symptomatic grading of PET was determined as Grade 1 in 30 patients, Grade 2 in 57 and Grade 3 in one before therapy. Symptomatic changes in the head-down position were evaluated in 81 cases. Transient relief was found in 65 patients and no relief in 16 patients. The range of the symptomatic duration varied from one day to ten years. Therefore, it seemed impossible to estimate the natural course of PET. Body-weight loss ranging from 1 to 6 kg was noted in 13 patients within three months before the start of therapy. As for concomitant diseases, nasal allergy, vasomotor rhinitis, hypertension, Harada disease, rheumatism, cervical vertebral disorder, diabetes, asthma, BPPV and malignant lymphoma were found. Tympanic membrane movements during hyperventilation were measured with impedance audiometry in 39 patients. ATMM was found in all the patients.
Subjective evaluation of therapeutic effects was performed in 66 patients, and objective evaluation in 24 cases. Subjectively, complete relief (grade 0) was obtained in 36 of 66 patients (54.5%), and partial relief (grade 32,1 or grade 21) in 14 patients (21.2%). The grade did not change in 16 patients (24.2%) including those with grade 3. There were no patients who showed aggravation in symptoms. The relief from symptoms started ranging from the first day to the 21st day (5.0}4.2; mean}SD) after the start of therapy in 43 of 50 patients who showed an improvement. Total relief from symptoms was noted in 8 patients and partial relief 2 of 13 patients who had weight loss before therapy. ATMM during hyperventilation disappeared in 8, decreased in 9, and did not change in 7 of 24 patients after therapy.
Fifteen of 50 patients who showed relief (complete relief in 9 and partial relief in 6) were able to be followed-up. Therapeutic effects were maintained from 3 to 9 months in all the 9 patients who showed complete relief while they were maintained for 4 months in 5 of the 6 patients who showed partial relief. Symptoms of PET prolonged for 2 months after the first therapy in the remaining one patient. However, complete relief was achieved 1 week after the second therapy.
No significant side effects were noted. However, the administration was terminated in the following 3 reasons: vertigo in one patient, itching of the upper half body 3 days after administration in one, and oligouria in one patient undergoing diuretic therapy. These adverse reactions disappeared immediately after the termination of therapy. Neither stenosis of Eustachian tube nor middle ear effusion were found after therapy.

DISCUSSION

The following 4 methods have been used in the treatments of PET:

1. attempt to narrow the lumen,
2. attempt to increase blood flow of the lumen,
3. myringotomy and
4. sedation.

Bezold`s method, diathermy, paraffin injection, Teflon injection, Gelatine sponge injection and other operative procedures on the palatal muscle are classified in the first method. These methods need skills and experiences of the practitioner. As for the second method, the stellate ganglion block was reported by Kumazawa. But the effect is transient. Myringotomy is not a radical treatment for PET. Furthermore, the effect of sedation is not clear.
Pathologic conditions indicated for the use of Jia-Wei-Gui-Pi-Tang are gastrointestinal disturbance due to neurotic disorders and neurotic disturbance due to gastrointestinal disorders. Astragali radix, Ginseng radix and Atractylodes rhizoma are thought to improve digestive function. Longanae arillus, Polygala radix, Zizyphi spinosi Semen and Angelicae radix are thought to increase peripheral blood circulation. Astragali radix and Ginseng radix are thought to increase brain activity. Hoelen, Longanae arillus, Polygala radix, Zizyphi spinosi Semen and Atractylodes rhizoma are thought to have sedative effects. Although the side effects of Jia-Wei-Gui-Pi-Tang were minute, pseudoaldosteronism has been reported after a long administration of Glycyrrhiza root. The present study revealed that Jia-We-Gui-Pi-Tang has a high possibility of efficacy in the treatment of PET. It was not clarified which ingredient of Jia-Wei-Gui-Pi-Tang improved symptoms of PET in the present study. A further medical analysis is required.

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