Clinical Observation On The Efficacy Of Acupuncture Treatment For Tinnitus

Back ground:Tinnitus terminologically is from the Latin "tinnere" meaning to ring and can be described as the conscious perception of sound or noise without external acoustic stimulation.Tinnitus is described in most cases as subjective-meaning that it cannot be heard by anyone other than patient.Actually most commonly used term in the recent literature is "subjective idiopathic Tinnitus”.For the patients the sound is real but in fact that is a "phantom sensation".Primary idiopathic Tinnitus is the situation that Tinnitus is idiopathic and there is no detectable cause for it to be developed.It may be associated with sensory neural hearing loss(SNHL).In the majority of patients Tinnitus is accompanied by SNHL.Although primary idiopathic Tinnitus is still pathologically unknown,probable mechanisms contain cochlear and somatic modifications.Some researchers have figured out that tinnitus-like phenomenon can be induced to normal people(without any auditory problem)by placing them in a complete calm environment so they concluded it is a natural entity in some special conditions.In patients suffered from hearing loss,decreased neural input from cochlea toward cortex and prolonged decrease in afferent neural activity lead to alteration in brain activity and the final result is Tinnitus.Although a wide range of therapies has been used,there is no cure for primary Tinnitus.These therapies include:medications,auditory therapies,specific forms of sound therapy,cognitive behavioral treatment(CBT),transcranial magnetic stimulation(TMS)and so on.Because of variety in Tinnitus etiologies,responses vary widely to different therapies.Therefore most of the methods don't work universally and each option must match individually.Acupuncture is one of the most often-used option in Tinnitus treatment that some studies have shown it is able to relieve loudness and disturbing quality of Tinnitus immediately.Basically the method must be done according to Chinese medicine theory and syndrome differentiation.Objective:To evaluate the efficacy of Acupuncture treatment for TinnitusMaterial and methods:A pilot randomized clinical trial(RCT)performed at the school of Acupuncture,Moxibustion and Tuina in Beijing University of Chinese Medicine,China,with cooperation of Isfahan University of Medical Science,Iran.from June 2017 to March 2018.People who took part in this study,have recalled by one of the faculty members in the ENT and head and neck surgery department of Isfahan University of medical science,Iran.Through the summon,87 patients were referred to Acupuncture clinic and were interviewed.Of these 87 assessed patients,11 patients had not meeting inclusion criteria,7 patients declined to participate and 5 patients did not appear for the evaluation appointment.Therefore,total of 64 participants of both genders,aged between 25 and 75 years,who were not undergoing another treatment for Tinnitus and suffered from Tinnitus more than two month,were included in the study.After participants complete a baseline evaluation,all of 64 participants were randomly divided into one of the two groups of this study:The first group was received Acupuncture treatment and second group was received Nicotinic Acid and Vitamin E that was called Medication group.Outcome measurement was divided into two types;Subjective and objective outcomes.In this study we used two standard questionnaires[Tinnitus handicap inventory(THI)and Visual analogue scale Loudness(VAS Loudness)]as subjective outcome measurement,for assessment one day before treatment(baseline),at the end of treatment and one more time four weeks later.Indeed a Pure tone audiometry(PTA)as objective outcome measurement was done one day before treatment(baseline)and at the end of treatment.An expert medical statistician used SPSS sofftware to analysis data.each participants as a measurable value.P-value<0.05 was considered statistically significant.This study analyzed difference in intensity and loudness of Tinnitus and hearing level between two groups.Independent-t test for quantitative variables and Chi-square test for nominal qualitative variables was used.Kolmogorov-Smimov test was used to compare distribution of age parameter between two groups.To determine if hearing level for the left and right ear in two groups of treatment have the same distribution,Mann-Whitney test was used.Wilcolon test was used to compare hearing level before and after intervention in each group.Repeated measure ANOVA test was used to determine if there is a significant difference for the THI and VAS Loudness in different times.The post hoc LSD test,compares variables in each group between different times.Independent-t test,compare the mean scores of VAS Loudness and THI between the two groups at different times.ANCOVA test by ignoring bias factors,compare the mean scores of VAS Loudness and THI between the two groups of this study at different times.· Schedule for study was as followFirst step:Screening consist of standard interview,take history,physical examination,imaging(MRI and CT-scan)and laboratory tests,PTA,filling THI and VAS Loudness questionnaires.Second step:Treatment initiation,in Acupuncture group,patients was received Acupuncture for 4 weeks(three time per week)and in Medication group,patients was received Nicotinic Acid Tablet(25 mg)three times per day and Vitamin E Pearl(400 mg)per day for,4 weeks.Third step:At the end of 4th week of intervention,PTA and filling THI and VAS Loudness questionnaires for second time.Forth step:Follow up(4 weeks after last session of treatment),filling THI and VAS Loudness questionnaires for third time.In the Acupuncture group,the participants received treatment that followed an Acupuncture program using according to TCM technique.Acupuncture points were selected as follows:Three group of basic points(according to the World Health Organization(WHO)format)were used including local points,general points and modification points.Local points include YiFeng(SJ 17),TingHui(GB 2),JiaChe(ST 6),XiaGuan(ST 7),and general points composed of YangLingQuan(GB34),WaiGuan(SJ 5),FengChi(GB 20),SiShenCong(Ex-HN 1)and perform bloodletting from apex of ear;Modification points for liver fire are TaiChong(LIV3),JiaXI(GB43),for excess heat are HeGu(LI 4),QuChi(LI 11),for kidney essence deficiency is ZhaoHai(KI 6)and for phlegm heat are NeiGuan(PC 6),ZhongWan(REN 12)and FengLong(ST 40)were added accordingly.In the case of deficiency syndrome,we used reinforcing technique at general points and reducing technique for excess syndrome;for local points we used only reducing technique.The intervention in Medication group lasted 4 weeks,patients was received three tab Nicotinic Acid 25 mg per day and one pearl Vitamin E 400 mg per day.Result:Final data were imported and analyzed by an expert medical statistician who was blinded to study grouping.Statistical analysis was performed by using the SPSS version 18.0 for Windows.Eighty-seven subjects were evaluated regarding the study eligibility criteria Of these,23(26.44%)were excluded and 64(73.56%)participated in the study.Only 47 participants(73.43%)completed the treatment(Acupuncture group,30;Medication group,17).Of the 17 participants in Medication group,10(58.8%)were male and 7(41.2%)were female,with an average age of 52.35 ± 11.25 years.Thirty participants were allocated to Acupuncture group,19(61.3%)were male and 11(38.7%)were female,with an average age of 50.61 ± 11.29 years.No difference in sex,age,hearing level were detected between two groups.After medication,in compare with pre-intervention,statistically hearing level is improved in left and right ears(P-value=0.040),the same result is reached in Acupuncture group so that for left ear(P-value=0.002)and for right ear(P-value=0.003).In Medication group,According to repeated measure ANOVA test in three times,before intervention(Mean ± SD= 8.35± 1.656),after last session of treatment(Mean ± SD= 7.41 ±1.97)and after 4 weeks follow up(Mean ± SD= 7.88± 1.833)resulted in no statistically significant change in mean of VAS Loudness(P-value=0.092)but in Acupuncture group before intervention(Mean ± SD= 6.87± 1.945),after last session of treatment(Mean ± SD= 5.52 ±2.236)and after 4 weeks follow up(Mean ± SD= 5.23 ± 2.404)heralded statistically decrease in VAS Loudness(P-value<0.001).Independent-t test showed difference in mean value of VAS Loudness before intervention in Medication group(Mean ± SD= 8.35 ± 1.656)and Acupuncture group(Mean ±SD= 6.87± 1.945)is statistically significant(P-value<0.010).Therefore we used ANCOVA test to ignore this confounding factor when interpreting the effect of intervention.ANCOVA test showed that mean values of VAS Loudness after intervention between Medication group(Mean ± SD= 7.41 ±1.97)and Acupuncture group(Mean ± SD= 5.52 ±2.236)is not statistically significant(P-value=0.140)but 4 weeks after intervention,difference in mean value of VAS Loudness between Medication group(Mean ± SD= 7.88± 1.833)and Acupuncture group(Mean ± SD= 5.23 ± 2.404)is statistically significant(P-value=0.009)and decrease in mean of VAS Loudness in Acupuncture group had been more than Medication group.Post hoc LSD test showed that,difference in mean value of VAS Loudness in Acupuncture group,for the time before intervention(Mean± SD= 6.87±1.945)and after last session of intervention(Mean ± SD= 5.52 ±2.236)is statistically decreased(P-value=0.001),and also difference in mean value between the time before intervention(Mean ± SD= 6.87± 1.945)and after 4 weeks follow up(Mean ± SD= 5.23 ± 2.404)are statistically decreased(P-value<0.001),but after last session of intervention(Mean ± SD= 5.52 ±2.236)and after 4 weeks follow up(Mean ± SD= 5.23 ± 2.404)is not statistically significant(P-value=0.100).Mean of VAS Loudness before treatment,after the last session of treatment and 4 weeks after last session as follow up is different in both groups,but in acupuncture group is much more significant.In Medication group,According to repeated measure ANOVA test in three times,before intervention(Mean ± SD= 74.47± 21.360),after last session of treatment(Mean ± SD= 66±20.530)and after 4 weeks follow up(Mean ± SD= 69.06 ± 19.289)resulted in no statistically significant change in mean of THI(P-value= 0.339)but in Acupuncture group before intervention(Mean ± SD= 60.39 ± 23.991),after last session of treatment(Mean ± SD= 43.61 ± 24.414)and after 4 weeks follow up(Mean ± SD= 42± 24.133)heralded statistically decrease in THI(P-value<0.001).Independent-t test showed difference in mean value of THI before intervention in Medication group(Mean ± SD= 74.47± 21.360)and Acupuncture group(Mean ± SD= 60.39 ±23.991)is statistically significant(P-value=0.049).Therefore we used ANCOVA test to ignore this confounding factor when interpreting the effect of intervention.ANCOV A test showed that mean values of THI after intervention between Medication group(Mean± SD= 66± 20.530)and Acupuncture group(Mean ± SD= 43.61 ± 24.414)is statistically significant(P-value= 0.02)and decrease in mean of THI in Acupuncture group had been more than Medication group.Also 4 weeks after intervention,difference in mean value of THI between Medication group(Mean ± SD=69.06 ± 19.289)and Acupuncture group(Mean ± SD= 42± 24.133)is statistically significant(P-value= 0.001)and decrease in mean of THI in Acupuncture group had been more than Medication group.Post hoc LSD test showed that,difference in mean value of THI in Acupuncture group,for the time before intervention(Mean± SD= 60.39 ± 23.991)and after last session of intervention(Mean ± SD= 43.61 ± 24.414)is statistically decreased(P-value<0.001),and also difference in mean value between the time before intervention(Mean ± SD= 60.39 ± 23.991)and after 4 weeks follow up(Mean ± SD= 42± 24.133)are statistically decreased(P-value<0.001),but after last session of intervention(Mean ± SD= 43.61±414)and after 4 weeks follow up(Mean ± SD=42± 24.133)is not statistically significant(P-value= 0.42).Mean of THI before treatment,after the last session of treatment and 4 weeks after last session as follow up is different in both groups,but in acupuncture group is much more significant.Changes in acupuncture group is much more significant than Medication group before treatment,after the last session of treatment and 4 weeks after that about mean of THI.Conclusion:This study revealed more efficacy for Acupuncture on relieving Tinnitus compared to routine medication therapy and the effect was stable up to 4 weeks after treatment sessions had finished.