| 摘要: | 背景: 臨床統計17~20%的成人有耳鳴，其中約有四分之一的病患會影響生活，並常伴隨沮喪、憂鬱、失眠等。目前西醫針對耳鳴的藥物治療並無定論，過去的研究發現抗焦慮藥及抗憂鬱劑，可降低病患中特定族群對其耳鳴的不良感受，但這類型的西藥多有成癮與戒斷不易等副作用，本試驗欲藉由中藥複方柴胡加龍骨牡蠣湯，改善病患失眠、焦慮的症候，期能達到改善耳鳴之功效，並建立中西醫結合治療的臨床實證。
方法：本試驗設計為隨機分配、開放式的研究，受試者為二十歲以上的成人，患有持續性主觀性的耳鳴，已發作超過三個月，共收集24人，分為兩組，實驗組以西藥併中藥複方柴胡加龍骨牡蠣湯治療，對照組只以西藥治療，主要結果為耳鳴殘疾量表(Tinnitus Handicap Inventory)，匹茲堡睡眠量表(Pittsburgh Sleep Quality Index)，並以視覺類比量表(Visual Analogue Scale)來比較病患對於耳鳴的主觀感受，包括耳鳴音響度及耳鳴困擾度的評估。次要結果為純音聽力檢查(pure tone audiometry)，語言聽力檢查(speech reception threshold)。
結果: 本試驗納入收案的24位中，有21位完成試驗，試驗的結果顯示在耳鳴殘疾量表及匹茲堡睡眠量表方面，實驗組的改善比對照組都較為明顯，且具有統計上的意義。以視覺類比量表來比較病患對於耳鳴的主觀感受，包括耳鳴音響度及耳鳴困擾度的評估，試驗前後實驗、對照兩組的改善結果並無統計上的差異，但實驗組中有改善的人數有八至九成，相對於對照組只有不到六成的人有改善。
結論: 本試驗的結果顯示西藥結合中藥複方柴胡加龍骨牡蠣湯治療耳鳴可降低病患主觀的不良感受，但試驗存在有安慰劑效果、群組數不夠、人為的介入或其他因素的干擾，有待進一步以隨機雙盲對照試驗研究，期能確認柴胡加龍骨牡蠣湯的療效，並建立中西醫結合治療的臨床實證。
Background
It is estimated that approximately 20% of adults suffer from tinnitus at some point in their lives; further, approximately a quarter of these individuals have severe tinnitus, which affects their daily activities. Moreover, medications for the treatment of tinnitus have not been successful. Only drugs that improve sleep quality or that have an antidepressant or anti-anxiety effect have been proved to be useful. However, these drugs have several side effects such as the risk of dependency on these drugs.
Among herbal medicines, Chai Hu Jia Long Gu Mu Li Tang is the most preferred; it is widely used for tinnitus as it improves emotional health and sleep quality. In this study, we have aimed to establish the basic clinical efficacy and safety data for the use of Chai Hu Jia Long Gu Mu Li Tang in adult patients with chronic tinnitus.
Methods
This study was a randomized, open-label, controlled trial. Twenty-four adult patients with constant tinnitus who had suffered from tinnitus for more than 3 months were included in this study. Participants in the experimental group were administered western medicine in addition to the Chinese herbal formula, Chai Hu Jia Long Gu Mu Li Tang; whereas, those in the control group were administered only western medicine. The primary outcome measures that were included were the Tinnitus Handicap Inventory, Pittsburgh Sleep Quality Index, and visual analogue scale. The secondary outcome measures to be included were pure tone audiometry and speech reception threshold.
Results
Ten of the 12 participants in the experimental group and 11 of the 12 in the control group completed the study. Based on the Tinnitus Handicap Inventory and Pittsburgh Sleep Quality Index, the outcome of the experimental group was statistically superior to that of the control group. There was no significant difference between the groups regarding the visual analogue scale. However, 80%–90% of the experimental group participants experienced a reduction in the loudness and annoyance of their tinnitus; whereas, less than 60% of the control group participants showed improvement.
Conclusion
This study reveals that individuals who suffered from chronic tinnitus benefitted from the combined treatment with western medicine and the Chinese herbal formula, Chai Hu Jia Long Gu Mu Li Tang. However, these results were influenced strongly by the placebo effect. Further double-blinded, placebo-controlled trials are required to validate these results. |
