摘錄:
這篇新聞所提到的研究是用疼痛的程度來分程度, 不是用健保局規定的X光分級來分. 所以標題"葡萄糖胺和軟骨素 對中重度關節炎 確有療效"所謂的"中重度關節炎"定義似乎不太明確. 查原文它是用"疼痛程度"來分級的. 所以應該說"葡萄糖胺和軟骨素 對關節炎中重度疼痛 確有療效"(新聞的內文寫得比較正確). 但問題是輕度疼痛原本可能改變的範圍就不大, 所以對"中重度疼痛"的改變才有辦法分出一點差距. 由此得到 "葡萄糖胺和軟骨素 對中重度關節炎 確有療效" 似有點混洮的感覺. 因為一般來說, 嚴重程度到需要做人工關節的OA, 吃葡萄糖胺是無效的. 但是這種重度OA的疼痛可否用葡萄糖胺來改善仍有疑問. 如今看到這標題讓人以為新的研究推翻了以前的觀念. 但事實可能不是如此吧.◎葡萄糖胺和軟骨素的臨床療效
醫學證據大多支持葡萄糖胺和軟骨素的臨床療效，然而有些研究報告並無法支持，這種前後不一致的結果，造成治療上的迷思。
為此，由美國風濕病學家克萊格主持進行大規模的研究，共蒐集1583名退化性膝關節炎病患，其結果是葡萄糖胺和軟骨素合用，或單獨使用，整體而言，無法有效改善患者的膝關節疼痛；但對於膝蓋疼痛在中到重度的關節炎患者，則有較明顯的改善效果。
不過葡萄糖胺的療效, 有些研究說其實是一種消炎止痛的效果, 不是原先所強調的"軟骨修補". 如果是透過消炎止痛的作用, 那與 NSAIDs 比起來又如何? 用在非關節炎的止痛也有效嗎? 這似乎也是可以好好研究的課題.
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原文: (僅有摘要) 我把它分段比較好讀:
http://repositories.cdlib.org/postprints/1503/
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Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis
D O. Clegg, et. al
ABSTRACT:
BACKGROUND:
Glucosamine and chondroitin sulfate are used to treat osteoarthritis.
The multicenter, double-blind, placebo- and celecoxib-controlled Glucosamine/chondroitin Arthritis Intervention Trial (GAIT) evaluated their efficacy and safety as a treatment for knee pain from osteoarthritis.
METHODS:
We randomly assigned 1583 patients with symptomatic knee osteoarthritis to receive
1500 mg of glucosamine daily,
1200 mg of chondroitin sulfate daily,
both glucosamine and chondroitin sulfate,
200 mg of celecoxib daily, or
placebo
for 24 weeks.
Up to 4000 mg of acetaminophen daily was allowed as rescue analgesia.
Assignment was stratified according to the severity of knee pain (mild [N=1229] vs. moderate to severe [N=354]).
The primary outcome measure was a 20 percent decrease in knee pain from baseline to week 24.
RESULTS:
The mean age of the patients was 59 years, and 64 percent were women.
Overall, glucosamine and chondroitin sulfate were not significantly better than placebo in reducing knee pain by 20 percent.
As compared with the rate of response to placebo (60.1 percent),
the rate of response to glucosamine was 3.9 percentage points higher (P=0.30),
the rate of response to chondroitin sulfate was 5.3 percentage points higher (P=0.17), and
the rate of response to combined treatment was 6.5 percentage points higher (P=0.09).
The rate of response in the celecoxib control group was 10.0 percentage points higher than that in the placebo control group (P=0.008).
For patients with moderate-to-severe pain at baseline, the rate of response was significantly higher with combined therapy than with placebo (79.2 percent vs. 54.3 percent, P=0.002).
Adverse events were mild, infrequent, and evenly distributed among the groups.
CONCLUSIONS:
Glucosamine and chondroitin sulfate alone or in combination did not reduce pain effectively in the overall group of patients with osteoarthritis of the knee.
Exploratory analyses suggest that the combination of glucosamine and chondroitin sulfate may be effective in the subgroup of patients with moderate-to-severe knee pain.
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維基百科也有提到這一份研究.
http://en.wikipedia.org/wiki/Glucosamine
Clinical studies
There have been multiple clinical trials of glucosamine as a medical therapy for osteoarthritis, but results have been conflicting. The evidence both for and against glucosamine's efficacy has led to debate among physicians about whether to recommend glucosamine treatment to their patients.[31]
Multiple clinical trials in the 1980s and 1990s, all sponsored by the European patent-holder, Rottapharm, demonstrated a benefit for glucosamine. However, these studies were of poor quality due to shortcomings in their methods, including small size, short duration, poor analysis of drop-outs, and unclear procedures for blinding.[32][33] Rottapharm then sponsored two large (at least 100 patients per group), three-year-long, placebo-controlled clinical trials of the Rottapharm brand of glucosamine sulfate. These studies both demonstrated a clear benefit for glucosamine treatment.[34][35] There was not only an improvement in symptoms but also an improvement in joint space narrowing on radiographs. This suggested that glucosamine, unlike pain relievers such as NSAIDs, can actually help prevent the destruction of cartilage that is the hallmark of osteoarthritis. On the other hand, several subsequent studies, independent of Rottapharm, but smaller and shorter, did not detect any benefit of glucosamine.[36][37]
Due to these controversial results, some reviews and meta-analyses have evaluated the efficacy of glucosamine. Richy et al. performed a meta-analysis of randomized clinical trials in 2003 and found efficacy for glucosamine on VAS and WOMAC pain, Lequesne index and VAS mobility and good tolerability.[38]
Recently, a review by Bruyere et al. about glucosamine and chondroitin sulfate for the treatment of knee and hip osteoarthritis concludes that both products act as valuable symptomatic therapies for osteoarthritis disease with some potential structure-modifying effects.[39]
This situation led the National Institutes of Health to fund a large, multicenter clinical trial (the GAIT trial) studying reported pain in osteoarthritis of the knee, comparing groups treated with chondroitin sulfate, glucosamine, and the combination, as well as both placebo and celecoxib.[40] The results of this 6-month trial found that patients taking glucosamine HCl, chondroitin sulfate, or a combination of the two had no statistically significant improvement in their symptoms compared to patients taking a placebo.[41] The group of patients who took celecoxib did have a statistically significant improvement in their symptoms. These results suggest that glucosamine and chondroitin did not effectively relieve pain in the overall group of osteoarthritis patients, but it should be interpreted with caution because most patients presented only mild pain (thus a narrow margin to appraise pain improvement) and because of an unusual response to placebo in the trial (60%). However, exploratory analysis of a subgroup of patients suggested that the supplements taken together (glucosamine and chondroitin sulfate) may be significantly more effective than placebo (79.2% versus 54%; p = 0.002) and a 10% higher than the positive control, in patients with pain classified as moderate to severe (see testing hypotheses suggested by the data).
In an accompanying editorial, Dr. Marc Hochberg also noted that "It is disappointing that the GAIT investigators did not use glucosamine sulfate ... since the results would then have provided important information that might have explained in part the heterogeneity in the studies reviewed by Towheed and colleagues"[42][43] But this concern is not shared by pharmacologists at the PDR who state, "The counter anion of the glucosamine salt (i.e. chloride or sulfate) is unlikely to play any role in the action or pharmacokinetics of glucosamine".[44] Thus the question of glucosamine's efficacy will not be resolved without further updates or trials.
In this respect, a 6-month double-blind, multicenter trial has been recently performed to assess the efficacy of glucosamine sulfate 1500 mg once daily compared to placebo and acetaminophen in patients with osteoarthritis of the knee (GUIDE study). The results showed that glucosamine sulfate improved the Lequesne algofunctional index significantly compared to placebo and the positive control. Secondary analyses, including the OARSI responder indices, were also significantly favorable for glucosamine sulfate.[45]
A subsequent meta-analysis of randomized controlled trials, including the NIH trial by Clegg, concluded that hydrochloride is not effective and that there was too much heterogeneity among trials of glucosamine sulfate to draw a conclusion.[46] In response to these conclusions, Dr. J-Y Reginster in an accompanying editorial suggests that the authors failed to apply the principles of a sound systematic review to the meta-analysis, but instead put together different efficacy outcomes and trial designs by mixing 4-week studies with 3-year trials, intramuscular/intraarticular administrations with oral ones, and low-quality small studies reported in the early 1980s with high-quality studies reported in 2007.[47]
However, currently OARSI (OsteoArthritis Research Society International) is recommending glucosamine as the second most effective treatment for moderate cases of osteoarthritis. Likewise, recent European League Against Rheumatism practice guidelines for knee osteoarthritis grants to glucosamine sulfate the highest level of evidence, 1A, and strength of the recommendation, A.
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健保的給付規定：
『3.3.3. Glucosamine sulfate給付規定：（88/9/1、93/8/1）
1.需符合下列各項條件：
(1)六十歲以上之膝關節炎病患，其放射線分期(依
Ahlback分期) stage III(含III)以下(stage I, II, III須
於病歷中記載或附報告)。
(2)膝關節炎症狀達六個月以上，其Lequesne’s
severity index for knee OA至少7 points。
2.原則上每日最大劑量為750 mg；若病情需要增加劑
量，則需事前審查核准後使用。每一療程最長十二
週，每次處方均需記錄用藥史及Lequesne’s
severity index，療程結束後評估療效，其效果不佳
者應即停用；如症狀確有改善，須停藥三個月，方
可開始另一療程；每年最多使用二療程。
3.開刀置換人工膝關節後，不得使用glucosamine製劑。』
. At 1 year, the mean RMDQ scores were 4.8 (95% CI, 3.9-5.6) for glucosamine and 5.5 (95% CI, 4.7-6.4) for the placebo group. No statistically significant difference in change between groups was found when assessed after the 6-month intervention period and at 1 year: RMDQ (P = .72), LBP at rest (P = .91), LBP during activity (P = .97), and quality-of-life EQ-5D (P = .20). Mild adverse events were reported in 40 patients in the glucosamine group and 46 in the placebo group (P = .48).