醫聲論壇

從花園中的文章節錄出來的...

http://forum.doctorvoice.org/viewtopic.php?f=8&t=36372

Gascon是療效不明確的藥物嗎？？

出處：
http://www.informahealthcare.com/doi/ab ... 907X182176

Title：
Randomized, double-blind, placebo-controlled clinical trial of loperamide plus simethicone versus loperamide alone and simethicone alone in the treatment of acute diarrhea with gas-related abdominal discomfort

ABSTRACT
Objective: To compare efficacy and tolerability of a loperamide/simethicone (LOP/SIM) combination product with that of loperamide (LOP) alone, simethicone (SIM) alone, and placebo (PBO) for acute nonspecific diarrhea with gas-related abdominal discomfort.

Research design and methods: In this multicenter, double-blind, 48h study, patients were randomly assigned to receive two tablets, each containing either LOP/SIM 2mg/125mg (n = 121), LOP 2mg (n = 120), SIM 125mg (n = 123), or PBO (n = 121), followed by one tablet after each unformed stool, up to four tablets in any 24h period. The primary outcome measures were time to last unformed stool and time to complete relief of gas-related abdominal discomfort. For time to last unformed stool, an unformed stool after a 24h period of formed stools or no stools was considered a continuance of the original episode (stricter definition) or a new episode (alternate definition).

Results: A total of 483 patients were included in the intent-to-treat analysis. The median time to last unformed stool for LOP/SIM (7.6h) was significantly shorter than that of LOP (11.5h), SIM (26.0h), and PBO (29.4h) (p ≤ 0.0232 in comparison with survival curves) using the alternate definition; it was numerically but not significantly shorter than that of LOP (p = 0.0709) and significantly shorter than that of SIM and PBO (p = 0.0001) using the stricter definition. LOP/SIM-treated patients had a shorter time to complete relief of gas-related abdominal discomfort than patients who received either ingredient alone or placebo (all p = 0.0001). Few patients reported adverse events in the four treatment groups, none of which were serious in nature. Potential study limitations include the ability to generalize study results to the population at large, variability in total dose consumed, and subjectivity of patient diary data.

Conclusions: LOP/SIM was well-tolerated and more efficacious than LOP alone, SIM alone, or placebo for acute nonspecific diarrhea and gas-related abdominal discomfort.

Title：
Improving quality of colonoscopy by adding simethicone to sodium phosphate bowel preparation

http://www.pubmedcentral.nih.gov/articl ... d=19554657

Department of Medicine, Division of Gastroenterology, Faculty of Medicine Ramathibodi Hospital, Rajathevee, Bangkok, Thailand. [email protected]

AIM: To evaluate the effectiveness of simethicone in enhancing visibility and efficacy during colonoscopy.

METHODS: A prospective, double-blind, randomized, placebo-controlled study was conducted. One hundred and twenty-four patients were allocated to receive 2 doses of sodium phosphate plus 240 mg of tablet simethicone or placebo as bowel preparation. Visibility was blindly assessed for the amount of air bubbles and adequacy of colon preparation. Total colonoscopic time, side effects of the medication, endoscopist and patient satisfaction were also compared.

RESULTS: Sodium phosphate plus simethicone, compared to sodium phosphate plus placebo, improved visibility by diminishing air bubbles (100.00% vs 42.37%, P < 0.0001) but simethicone failed to demonstrate improvement in adequacy of colon preparation (90.16% vs 81.36%, P = 0.17). Endoscopist and patient satisfaction were increased significantly in the simethicone group. However, there was no difference in the total duration of colonoscopy and side effects of the medication.

CONCLUSION: The addition of simethicone is of benefit for colonoscopic bowel preparation by diminishing air bubbles, which results in enhanced visibility. Endoscopist and patient satisfaction is also increased.

Title：Functional dyspepsia - diagnosis of desperation?

http://www.springerlink.com/content/y8t1t42728607268/

[Article in German]


Liebregts T, Adam B, Holtmann G.
Department of Gastroenterology, Hepatology and General Medicine, Royal Adelaide Hospital, University of Adelaide, North Terrace, Adelaide, Australia.

Dyspepsia comprises a broad spectrum of predominantly upper abdominal symptoms, such as pain, indigestion, nausea, early satiety and bloating. While these symptoms are highly prevalent, in less than 50% of patients presenting with dyspepsia, structural lesions or biochemical abnormalities are found that explain the symptoms when routine clinical tests are used.

In patients without structural lesions the diagnosis of functional dyspepsia is justified. Exclusion of life-threatening disorders as the cause of symptoms and reassurance of the patient as well as proper explanation of the diagnosis and its underlying disease mechanisms (i.e. symptoms are due to a sensitive gut) is crucial and can be considered as an essential element of treatment.

Since there is a remarkable comorbidity of anxiety and depression, psychosomatic interventions might be necessary in selected patients. Based on controlled clinical trials few drugs, such as proton pump inhibitors, prokinetics, tricyclic antidepressants, simethicone and selected herbal preparations have been found to be effective for treatment of functional dyspepsia.

Effects of H. pylori eradication, even though strongly advocated, are most likely due to undiagnosed peptic ulcer disease in a very small group of patients. While there is currently no therapy that cures functional dyspepsia, the therapeutic target is to control symptoms.

The role of simeticone in small-bowel preparation for capsule endoscopy

http://www.thieme-connect.com/DOI/DOI?1 ... 006-944634

Deparment of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Disease, Shanghai Jiaotong University School of Medicine, Shanghai, China. [email protected]

BACKGROUND AND STUDY AIMS: Capsule endoscopy is a new diagnostic method allowing painless visualization of the entire small bowel. However, there is as yet no standardized protocol for bowel preparation before the examination. The aim of this study was to assess the effectiveness of simeticone in reducing bowel gas bubbles in patients undergoing capsule endoscopy. PATIENTS AND

METHODS: A randomized, prospective, and controlled study was conducted, including 56 patients, from March to October 2004. The patients were randomly allocated to groups receiving either simeticone or no simeticone, on the basis of a computer-generated random number table. Patients in the simeticone group (n = 28) received 300 mg simeticone for bowel preparation 20 min before capsule endoscopy, while patients in the non-simeticone group (n = 28) received no medication for bowel preparation. Two experienced endoscopists assessed and graded the visibility of the mucosa and intraluminal gas bubbles in a single-blinded fashion.

RESULTS: The visibility of the mucosa in the proximal small bowel in patients who received preparation with simeticone was considered to be better, with fewer intraluminal bubbles, than in those without bowel preparation ( P < 0.025). Interobserver agreement was excellent ( R > or = 0.8, P < 0.05). No adverse effects of simeticone were observed.

CONCLUSIONS: Simeticone administration before capsule endoscopy improves the visualization of the mucosa in the proximal small intestine.

療效不明就不要核准藥字即可
為何挖洞讓人跳

(眼汪汪) (眼汪汪) (眼汪汪) (眼汪汪) (眼汪汪)
見解不同可判生可判死
既然是簡表自行吸收何以判死
(眼汪汪) (眼汪汪) (眼汪汪) (眼汪汪) (眼汪汪)

Simethicone in the treatment of infant colic: a randomized, placebo-controlled, multicenter trial.
Pediatrics. 1994 Jul;94(1):29-34.

Metcalf TJ, Irons TG, Sher LD, Young PC.

Willow Creek Pediatrics, Salt Lake City, UT.

OBJECTIVE. To determine the efficacy of simethicone in the treatment of infant colic. DESIGN. Randomized, double blind, placebo-controlled. SETTING. Three general pediatric practices in distinct geographic regions.

PATIENTS. Eighty-three infants between 2 and 8 weeks of age with infant colic.

INTERVENTIONS. Treatment with simethicone and placebo in double blind crossover fashion.

RESULTS. A total of 166 treatment periods, ranging from 3 to 10 days, were evaluated in the 83 infants. Compared to baseline, improvement in symptoms was reported for 54% of the treatment periods, worsening was reported for 22%, and, for 24%, there was no change. The likelihood of the treatment period being rated as showing improvement, worsening, or no change was the same whether the infant was receiving placebo or simethicone. Twenty-eight percent of he infants responded only to simethicone, 37% only to placebo, and 20% responded to both. No statistically significant differences were noted among these three groups of responders. No difference could be shown even when infants with "gas-related symptoms" (by parental report) were separated out as a group.

CONCLUSION. Although both produced perceived improvements in symptoms, simethicone is no more effective than placebo in the treatment of infantile colic.

Loperamide-simethicone vs loperamide alone, simethicone alone, and placebo in the treatment of acute diarrhea with gas-related abdominal discomfort. A randomized controlled trial.

http://archfami.ama-assn.org/cgi/content/full/8/3/243

Kaplan MA, Prior MJ, Ash RR, McKonly KI, Helzner EC, Nelson EB.

Medical Department, McNeil Consumer Healthcare, Fort Washington, Pa., USA. [email protected]

CONTEXT: Acute diarrhea with gas-related abdominal discomfort is a common, usually self-limited disorder with substantial social and economic impact. OBJECTIVE: To compare the efficacy and safety of a loperamide hydrochloride-simethicone combination product with those of loperamide alone, simethicone alone, and placebo in treating acute diarrhea with gas-related abdominal discomfort. DESIGN: Randomized, placebo-controlled, double-blind trial of 48 hours' duration.

SETTING: A primary care, ambulatory practice in Acapulco, Mexico.

PATIENTS: A total of 493 outpatient adults aged 18 to 63 years, with acute nonspecific diarrhea with at least moderately severe abdominal discomfort.

INTERVENTIONS: Each patient was randomly assigned to receive 2 chewable tablets containing loperamide hydrochloride, 2 mg, and simethicone, 125 mg (n = 124); loperamide hydrochloride, 2 mg (n = 123); simethicone, 125 mg (n = 123); or placebo (n = 123). This was followed by 1 tablet after each unformed stool, up to 4 tablets in any 24-hour period.

MAIN OUTCOME MEASURES: Time to last unformed stool and time to complete relief of gas-related abdominal discomfort were the protocol-specified primary outcomes. Secondary outcomes included time to complete relief of diarrhea, number of unformed stools, and patient-assessed variables at the end of the study (overall illness relief, diarrhea relief, and abdominal discomfort relief).

RESULTS: Patients who received loperamide-simethicone had significantly (P < .001) shorter time to last unformed stool and faster relief of gas-related abdominal discomfort than patients who received loperamide, simethicone, or placebo alone. Loperamide-simethicone was significantly (P < or = .01) more effective than the other 3 treatments for all end-of-study patient-assessed outcomes and all clinically important secondary outcomes. No significant differences in adverse events were found among treatment groups.

CONCLUSIONS: The loperamide-simethicone combination chewable product provides faster and more complete relief of acute nonspecific diarrhea and associated gas-related abdominal discomfort (gas pain, cramps, gas pressure, and bloating) than either of its components or placebo. The combination is well tolerated.

Randomised double-blind comparison of simethicone with cisapride in functional dyspepsia.

http://www3.interscience.wiley.com/jour ... 1&SRETRY=0

Holtmann G, Gschossmann J, Karaus M, Fischer T, Becker B, Mayr P, Gerken G.

Division of Gastroenterology, University of Essen, Germany. [email protected]

AIM: To compare the efficacy of simethicone with cisapride in patients with functional (non-ulcer) dyspepsia.

METHODS: After standardized diagnostic work-up and at least 6-days wash-out of medication, 177 patients with functional dyspepsia were enrolled; 173 of them (age 19-71 years) were randomized and treated using a double-dummy technique with simethicone (84 mg t.d.s.) or cisapride (10 mg t.d.s.). At baseline and after 2 and 4 weeks, the intensity of the symptoms was scored from 0 (absent) to 3 (severe) using a standardized symptom questionnaire. Efficacy of the treatment was judged by the patients as 'very good', 'good', 'moderate' or 'no effect'.

RESULTS: A total of 166 patients completed the trial. After 2 and 4 weeks, 34% and 46% (respectively), of the patients treated with simethicone judged the improvement in symptoms to be excellent compared to 13% and 22% (respectively) of patients treated with cisapride (P < 0.01). After 2 weeks the difference in the improvement in the global symptom score was significantly better (Delta30.7%, P < 0.001) for simethicone than for cisapride, while this difference failed statistical significance after 4 weeks (Delta10.2%, P=0.11).

CONCLUSIONS: In patients with functional dyspepsia, simethicone relieves symptoms during the first 2 weeks of treatment significantly better than cisapride.

A randomized placebo-controlled trial of simethicone and cisapride for the treatment of patients with functional dyspepsia.
http://www3.interscience.wiley.com/jour ... 0/abstract


Holtmann G, Gschossmann J, Mayr P, Talley NJ.

Division of Gastroenterology and Hepatology, University of Essen, Germany. [email protected]

AIM: To compare the efficacy of simethicone with placebo and the prokinetic cisapride in patients with functional dyspepsia.

METHODS: One hundred and eighty-five patients with functional dyspepsia were randomized and treated in a double-dummy technique with simethicone (105 mg t.d.s.), cisapride (10 mg t.d.s.) or placebo (t.d.s.). The primary outcome measure was the O'Brien global measure of the patients' rating of 10 upper gastrointestinal symptoms (graded as absent = 0, moderate = 1, severe = 2 or very severe = 3). Outcome measures were assessed at baseline and after 2, 4 and 8 weeks of treatment (intention-to-treat).

RESULTS: At 2, 4 and 8 weeks, treatment with simethicone and cisapride yielded significantly (all P values < 0.0001) better improvement of symptoms compared to placebo. Simethicone was significantly better than cisapride after 2 weeks (P = 0.0007), but the differences were not statistically significant after 4 and 8 weeks. Patients treated with simethicone judged the efficacy of their treatment as very good in 46% of cases, compared to 15% and 16% receiving cisapride and placebo, respectively.

CONCLUSIONS: Simethicone and cisapride were significantly better than placebo for symptom control in patients with functional dyspepsia after 2, 4 and 8 weeks of treatment. Simethicone was also superior to the prokinetic cisapride in the first 2 weeks of treatment.

沒多少錢的藥，算是給他們當業績

Gascon現在健保價不是0嗎?
MK大別火了
刪藥是不須任何理由的
療效未明只是它的藉口不是理由

我哪有發火!?

這問題又不是偶提出來的...

不能夠因為健保價是0或是價格很低...

就不探討是否有效呀...

MK 寫:我哪有發火!?

這問題又不是偶提出來的...

不能夠因為健保價是0或是價格很低...

就不探討是否有效呀...

-------------------------

剛剛查了一下 gascon 明明還有健保價啊!

而且, 我記得在醫院時, 這顆藥, 並沒有說療效未明啊!
MK大, 列的papers, 也都說有效啊!
怪怪的, 應該請說沒效, 或療效未明的大大, 舉證說明一下...

MK 寫:我哪有發火!?

這問題又不是偶提出來的...

不能夠因為健保價是0或是價格很低...

就不探討是否有效呀...

抱歉沒看到前文
只看到你貼的多篇PAPER
GASCON也是老藥
如像它講的是療效未明之藥物
多年來卻仍在市場上
且許多醫師都還在使用
包括我在內
根本就是在庄肖
剛查過還剩2家有健保價
我用的這家早就歸0

MK 寫:從花園中的文章節錄出來的...

http://forum.doctorvoice.org/viewtopic.php?f=8&t=36372

Gascon是療效不明確的藥物嗎？？

Gascon屬藥效不明的藥物我也是聽說的（不少人講的，包含小兒腸胃科醫師）

也有一大堆paper也在證明化痰藥的療效，有衛生署核准的適應症，也有健保價
但你們胸腔科多不認同化痰藥的療效，不是嗎？

很巧的是，我以前在醫院遇到對gascon有意見的，也多為小兒腸胃科醫師
甚至於住院醫師都會交班某某腸胃科主治醫師的病人千萬別開gascon

docs 寫:

MK 寫:我哪有發火!?

這問題又不是偶提出來的...

不能夠因為健保價是0或是價格很低...

就不探討是否有效呀...

-------------------------

剛剛查了一下 gascon 明明還有健保價啊!

而且, 我記得在醫院時, 這顆藥, 並沒有說療效未明啊!
MK大, 列的papers, 也都說有效啊!
怪怪的, 應該請說沒效, 或療效未明的大大, 舉證說明一下...

我是說
gascon以及化痰藥最常被刪的理由就是使用療效未明之藥物
我並沒有說
gascon是沒效, 或療效未明

藥不是我刪的，理由(or藉口)也不是我給的
如果要舉證說明，可能要向審查委員要

有沒有效自已吃看看就知道
trental、transamin、化痰藥也是他們最喜歡砍殺的對象
藥會做出來賣，當然有其療效，不會無地放矢
健保局不是FDA，不要因健保核刪，就否定藥物的效果

Cate 寫:有沒有效自已吃看看就知道
trental、transamin、化痰藥也是他們最喜歡砍殺的對象
藥會做出來賣，當然有其療效，不會無地放矢
健保局不是FDA，不要因健保核刪，就否定藥物的效果

我覺得很奇怪, 刪人家的應該是大師級人物, 本身應該有足夠evidence吧 ! 怎麼他亂刪一通, 我們這些被害人, 如喪考妣去查資料, 找EBM來 defence ?
醫界大老應該跟健保局談談......要刪人家的, 必須附上EBM證據 ! 這樣被刪的我們才會心服口服呀 !
http://mypaper.pchome.com.tw/news/bear1 ... 827151641/

WINDOW 寫:

docs 寫:

MK 寫:我哪有發火!?

這問題又不是偶提出來的...

不能夠因為健保價是0或是價格很低...

就不探討是否有效呀...

-------------------------

剛剛查了一下 gascon 明明還有健保價啊!

而且, 我記得在醫院時, 這顆藥, 並沒有說療效未明啊!
MK大, 列的papers, 也都說有效啊!
怪怪的, 應該請說沒效, 或療效未明的大大, 舉證說明一下...

我是說
gascon以及化痰藥最常被刪的理由就是使用療效未明之藥物
我並沒有說
gascon是沒效, 或療效未明

藥不是我刪的，理由(or藉口)也不是我給的
如果要舉證說明，可能要向審查委員要

請審查委員们列表造冊療效未明之藥物
薦請健保局刪除其健保藥價不予給付
並昭告全國醫藥界人士知悉
以免借此設陷坑人,有損良知.
（無盡漩渦） （無盡漩渦）

chou 寫: 請審查委員们列表造冊療效未明之藥物
薦請健保局刪除其健保藥價不予給付
並昭告全國醫藥界人士知悉
以免借此設陷坑人,有損良知.
（無盡漩渦） （無盡漩渦）

健保給付項目列這麼多出來
是給保戶選民看的
很多都列假的
假裝有給付
又不能開
開了就被抽
抽了就被砍
砍了還罰百倍
這怎麼開
給付項目列這麼多只是徒增紛擾.... 讓病人在診所盧
想不被他盧就得自宮/免費贈送
有給付的又不能推自費
一整個是死路
(哭哭) (哭哭) (哭哭)


其實這跟民族性也是有關係
為什麼美國醫師很多都可以不開藥.... 都在那邊obs
可是台灣的病人卻常嫌藥不夠多、不夠飽嘴、怎麼才三顆藥呢
逼的大家得開味素藥
不然病人會換診所看醫生..... 於是劣幣逐良幣
大家還是都得開味素藥過日子
（無盡漩渦） （無盡漩渦） （無盡漩渦）