EBM 討論 彰化秀傳紀念醫院 中醫部R2:王琬鈺

Scenario A 35 y/o female suffers from functional dyspepsia, and she has taken stomach medicine for a long time

PICO type : Therapy Functional dyspepsia Patient / problem（病患或問題）: Functional dyspepsia Intervention（介入處理）: Drug therapy + specific acupuncture Comparison（比較）: Drug therapy + non-specific acupuncture Outcome（臨床結果）: GSRS(Gastrointestinal Scale Related Symptoms) HADS (Hospital Anxiety and Depression Scale) SF-36 (Short-form Health Survey Quality of Life)

搜尋EBM資料庫 Cochrane Library PubMed ClinicalKey

Pubmed 搜尋歷程 (acupuncture) AND (functional dyspepsia) AND(RCT) 13 results

Pubmed

Cochrane Library搜尋歷程 (acupuncture) AND (functional dyspepsia) 1 results

Cochrane Library

Clinicalkey (acupuncture) AND (functional dyspepsia) AND(RCT) Last 12 months 13 results

Clinicalkey

選定評讀論文 Arq Gastroenterol v. 50 no. 3-jul./set. 2013 ACUPUNCTURE EFFECTIVENESS AS A COMPLEMENTARY THERAPY IN FUNCTIONAL DYSPEPSIA PATIENTS Flávia Altaf da Rocha LIMA, Lincoln Eduardo Villela Vieira de Castro FERREIRA and Fábio Heleno de Lima PACE

證據等級 Level 1b

Objective Evaluate the effectiveness of acupuncture as a complementary to conventional treatment in functional dyspepsia patients

Methods RCT

Results After 4 weeks of treatment there was improvement of gastrointestinal symptoms in Group I (55 ± 12 vs 29 ± 8.8; P = 0.001) and Group II (50.5 ± 10.2 vs 46 ± 10.5; P = 0.001). Quality of life was significantly better in Group I than group II (93.4 ± 7.3 vs 102.4 ± 5.1; P = 0.001). Anxiety (93.3% vs 0%; P = 0.001) and depression (46.7% vs 0%; P = 0.004) were significantly lower in Group I than group II. When comparing the two groups after 4 weeks of treatment, gastrointestinal symptoms (29 ± 8.8 vs 46 ± 10.5; P<0.001) and quality of life (102.4 ± 5.1 vs 96 ± 6.1; P = 0.021) were significantly better in Group I than group II.

Results Three months after the treatment, gastrointestinal symptoms remained better only in Group I, when compared to the pre-treatment values (38 ± 11.3 vs 55 ± 12; P = 0.001).)

Conclusion In patients with functional dyspepsia the complementary acupuncture treatment is superior to conventional treatment. Further studies with more patients are needed to confirm these findings.

文獻評讀 Critical appraisal topic

Critical Appraisal Skills Programme (CASP) 1. Did the study ask a clearly-focused question? Q : Yes,本篇文章為有functional dyspepsia困擾的患者，比較同樣在服用西藥(PPD type: domperidone 10 mg / EP type: omeprazole 20 mg)之下，再搭配針灸輔助性療法，是否具有改善消化功能不佳的症狀及改善生活品質和負面情緒的作用，且分組方式為randomized controlled design的方式。

2. Was this a randomised controlled trial (RCT) and was it appropriately so? Q : Yes. 本篇文章提及「 The patients by simple random sampling, were divided into two groups: Group I (GI - drug therapy associated with a specific acupuncture) and Group II (GII - drug therapy associated with non-specific acupuncture) 」且是藉由臨床實證來了解，有效針刺在具有調節腸胃功能的穴道上，是具緩解functional dyspepsia的療效，符合這份study想要探討的模式。

Detailed Questions

3. Were participants appropriately allocated to intervention and control groups? Q:Yes. 本篇文章提及「 The patients by simple random sampling, were divided into two groups: Group I (GI - drug therapy associated with a specific acupuncture) and Group II (GII - drug therapy associated with non-specific acupuncture) 」，代表實為隨機方式來分組。

3. Were participants appropriately allocated to intervention and control groups? 此次試驗的對象來源為Gastroenterology outpatient clinic of the University Hospital ，且在文章中有提及「The groups were similar in relation to gender, marital status and educational Level .The mean age of patients in the GI was significantly lower than GII. As to the type of FD, 11 patients (36.7%) were classified as dyspepsia type DPP and 19 (63.3%) as the EP (P = 0.705). Anxiety disorder was more common among the patients of, whereas the presence of depressive disorder showed no difference. The mean of the gastrointestinal symptom indices and quality of life was similar in both groups 」 代表這兩個群組除了年齡G2組較高之外，其餘條件在接受試驗沒有顯著的特質差異。

3.Were participants appropriately allocated to intervention and control groups? General characteristics of the sample

4. Were participants, staff and study personnel ‘blind’ to participants’ study group? Q : It can’t tell us about this question in detail. 本篇研究終點GSRS、QOL等皆用量表測量，未做到雙盲可能會有bias產生。而治療方法難以做到雙盲可說是此類研究的固有限制之一。

5. Were all of the participants who entered the trial accounted for at its conclusion? Q : Yes. 在本試驗中一開始即徵求30個受試者，而將他們隨機分為兩組，在最後評估數據統計值時的人數也依舊為30人，代表所有的受試者皆有完整參與此試驗，且其數據皆列入統計分析。 對照組和實驗組之n值皆為15人

6. Were the participants in all groups followed up and data collected in the same way?-1 Q : Yes. 在文中使用到三種評量表:GSRS、HADS和SF-36，而在文中提及「 Each of the scales was applied at three distinct times: immediatelly before (time 1), on the day following the end of treatment (time 2) and 3 months after the treatment (time 3). The form responses were completed by the patient (self-reporting).」即在這三個不同的評估時間點，無論是哪一組中的哪個受試者所接受的評估表單及數據收集的方式皆是相同的。 The medication treatment lasted four weeks and was established according to the FD type. For patients with functional dyspepsia PPD type domperidone 10 mg was prescribed, 30 minutes before main meals (breakfast, lunch and dinner) For patients with functional dyspepsia EP type, omeprazole 20 mg, 30 minutes before breakfast. Both groups were instructed as to the dietary and behavioral modifications.

6. Were the participants in all groups followed up and data collected in the same way?-2 G1 V.S. G2 The acupuncture treatment was conducted during 4 weeks, concomitant drug therapy, in twelve sessions, three times per week, with approximate 40 minutes duration Having as reference points used by classical literature (according to the principles of TCM) and current for FD treatment, two treatment plans involving 10 acupoints were prepared. GI: The points were active in the reduction of referred symptoms (PC6, LI4, CV12, ST36, L3, ST44) GII: The 10 acupoints were on the same meridian, but with one less measure at the location (points without primary FD indications: PC5, LI3, CV11, ST35, L2, ST43).

Q: It can’t tell about this. 7. Did the study have enough participants to minimise the play of chance? Q: It can’t tell about this. 在文中只提及收案30名受試者，但未陳述如何估算收案的受試者人數及其所代表之統計意義。

8. How are the results presented and what is the main result? Q:由下方圖表顯示，接受適當的針灸穴位輔助療法後，G1組 其GSRS (55 ± 12 vs 29 ± 8.8) 、Quality of life(93.4 ± 7.3 vs 102.4 ± 5.1)及anxiety(93.3% vs 0%)/depression(46.7% vs 0%)數值都有明顯改善。與對照組(G2)相比，其實驗組(G1)在每項數值的改善成效都明顯優於G2，故代表採用針灸作為輔助療法對於有functional dyspepsia的患者來說，具有一定的療效。 There was improvement of gastrointestinal symptoms in GI and. In group I the quality of life showed a significant increase compared to the while in GII no significant difference was observed. The frequency of anxiety disorder and depression was significantly lower in patients undergoing in the group I. In the GII the anxiety and depressive disorder were similar in the two moments, respectively

8. How are the results presented and what is the main result? Q:由下方圖表顯示，接受適當的針灸穴位輔助療法三個月後，G1 (29 ± 8.8 vs 38 ± 11.3; P = 0.002)和G2 (46 ± 10.5 vs 54.5 ± 16.4; P = 0.001)的療效都無法有效維持，但接受針灸治療後的G1組，雖然症狀還是會復發，但症狀較未接受治療前有所減緩(38 ± 11.3 vs 55 ± 12; P = 0.001) 。G2組則無明顯改善GII (54.5 ± 16.4 vs 50.5 ± 10.2; P = 0.067)。

9. How precise are these results? Q : 基本上此試驗為RCT(single-blinded)的試驗，在操作及統計數據的過程中，無論對照組或實驗組都是一致的，收案的受試者在兩組的特質傾向，除了G2年齡稍長，其餘也沒有顯著的差異。 且在結果中顯示一開始兩組間的GSRS數值比較是無顯著差異(P-value＞0.05)的；而在接受治療之後的立即GSRS指數評估、及治療後三個月的GSRS指數評估，兩組間皆有顯著差異((P-value＜0.05)。 故我認為適當針灸穴位介入，在改善消化功能症狀這一塊，此結果可以作為一個decision。

10. Were all important outcomes considered so the results can be applied? Q :Yes. 這個試驗就不同的症狀表現，將functional dyspepsia 再進一步分成兩型，EP和PPD type，探討在使用西藥之下，針刺在相關穴位上是否有所幫助。而當中所選取的穴位，皆是中醫書籍上常提及調整加強腸胃功能的穴道，且在治療之後，皆有令人滿意的療效，這同時也肯定了中醫對於功能性消化不良的患者，能起到一定的幫助。故我認為有functional dyspepsia的患者，可以以衛教方式推廣自行穴道按摩，平時在家自我保健，來達到協助改善症狀的目的。

如何應用於病人身上 腸胃道疾患，是現在社會的文明病，很多人因為工作因素，使得三餐進食不正常，進食速度過快或外食多烤炸辣食品，這些都可能導致腸胃功能不適，舉凡胃食道逆流、腹痛、便秘、腹瀉等等，最常見也最容易被人忽略的就是功能性消化不良，常以腹脹、腹痛來作表現，而許多患者往往在就診時，也已經吃了很多相關藥物，對於吃藥會有顧忌或習慣服用西藥，故查閱關於針灸這方面的期刊報告，以RCT的方式來證明針刺相關的腸胃道穴位，的確能改善功能性消化不良。為患者提供另一個治療模式。 對於這個結論的應用，對於長期有功能性消化不良症狀的患者，可能先排除掉因器質性問題而出現的類似症狀(eg:腹痛)。而後患者在門診若是不願意服用中藥，或長期習慣服用多樣西藥，為免過多藥物造成負擔，即可提供患者採用針灸治療，並同時衛教指導患者自行在家做按摩，以延長鞏固其療效。

療效評估 在門診遇到一些吃完飯後，容易腹脹不適的患者，有的長時間服用西藥，症狀仍舊反覆發作，有些因腹脹不適，甚而影響到食慾，胃口變差，體力下降，若患者能接受針灸治療，都會建議使用針灸像是足三里、內關等穴位作處理(通常腸胃功能不佳者，其相關穴位按壓都會異常酸楚)，有患者表示針完當下其腹脹痛不適症狀會有緩解改善，腸胃蠕動狀況也變好，而後追蹤觀察其症狀復發頻率，也較之前緩解。 若患者屬於常食用冷飲生食者，除了針刺在穴位上，若再加上艾灸，其改善程度也會較明顯。除了治療之外，首要還是需衛教患者平常少吃冰飲生食，有良好的飲食習慣，腸胃功能本身較差者，盡量食用較易消化的食物，教導患者自行按摩腸胃道相關穴位，讓患者對自己身體狀況有更多認識，也能更積極配合治療。 

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