Acupuncture as an early treatment for idiopathic sudden sensorineural hearing loss (ISSNHL) patients with flat or high-frequency drop audiograms: study protocol for a randomized controlled trial.

BACKGROUND: Idiopathic sudden sensorineural hearing loss (ISSNHL) is a common form of deafness. Acupuncture has been used as a salvage therapy for ISSNHL in China since 200 BCE. However, the efficacy of acupuncture has not been confirmed in strictly controlled trials. We designed a randomized controlled clinical trial to evaluate the efficacy and long-term effects of acupuncture in patients with early ISSNHL. METHODS/DESIGN: In this randomized controlled clinical trial, we will enroll 124 participants with ISSNHL diagnosed 2 to 4 weeks prior to enrollment, who have shown little hearing improvement after routine Western medical treatment (i.e., corticosteroids). 62 of these participants will have flat audiogram and the other 62 will have a high-frequency drop audiogram; they will all take Methycobal while half of the flat type and half of the high-frequency drop type will also receive acupuncture treatments for 4 weeks in a four-group design. The primary outcome measure will be the effective rate of hearing improvement (defined as the proportion of patients with at least 15-dB improvement in the hearing loss frequency band). The secondary outcome will measure the improvements in Pure Tone Average, Word Recognition Score, and Tinnitus Handicap Inventory. The assessments of the participants will be made at baseline, after treatment (week 4), and at follow-up (week 28). DISCUSSION: This study aims to explore the efficacy and long-term effects of acupuncture in patients with ISSNHL. This study will be a randomized controlled trial with strict methodology and few design deficits. If our study yields positive results, acupuncture could be recommended as a salvage therapy for patients with ISSNHL. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-ICR-15006787 . Registered on 12 July 2015.

[Clinical curative effect and factor analysis of depression treated by acupuncture].

OBJECTIVE: To evaluate the curative effect of primary depression treated with the main points of Back-shu points of Five-zang and Geshu (BL 17) according to the differentiation. METHODS: Sixty cases of primary depression were randomly divided into an acupuncture group (31 cases) and a western medication group (29 cases). In acupuncture group, Back-shu points of Five-zang and Geshu (BL 17) were applied as the main points, Taichong (LR 3) and Sanyinjiao (SP 6) were added for stagnation of liver qi and spleen deficiency; Shenmen (HT 7) and Sanyinjiao (SP 6) were added for deficiency of both heart and spleen according to the differentiation. In western medication group, Fluoxetine Hydrochloride capsule was taken by oral administration for 20 mg, once a day. The treatment lasted for 6 weeks in both groups. After 2, 4, and 6 weeks treatment, the clinical curative effects of both groups were assessed by Hamilton Depression (HAMD) Rating Scale, HAMD Factor Analysis and Asberg Side Effect Scale. RESULTS: After 6 weeks treatment, the total effective rate was 67.7% (21/31) in acupuncture group and 65.5% (19/29) in western medication group, indicating the close curative effects(P > 0.05). After 2, 4, and 6 weeks treatment, the HAMD score, scores of anxious somatization, sleeping and retardation factors were significantly reduced (all P < 0.01) in two groups, through the comparison at different time points between two groups, scores of anxious somatization, sleeping factors in acupuncture group were superior to those in western medication group (both P < 0.05), but score of retardation factor in western medication group was superior to that in acupuncture group (P < 0.05). The Asberg Side Effect Scale in western medication group arrived at peak at thesecond week, and then reduced slowly; the side effect in acupuncture group was low and steady, and lower than that in western medication group after 6 week treatment (P < 0.05). CONCLUSION: The curative effect of depression with acupuncture based on differentiation is equal to that of Fluoxetine Hydrochloride capsule with oral administration, while the side effect is milder than that of Fluoxetine Hydrochloride capsule.