Effect of glucosamine hydrochloride in the treatment of pain of osteoarthritis of the knee.
Effect of glucosamine hydrochloride in the treatment of pain of osteoarthritis of the knee.
复制标题
盐酸氨基葡萄糖治疗膝骨关节炎疼痛的效果。
作者：
J. Houpt;R. McMillan;C. Wein;S. D. Paget
目的
氨基葡萄糖产品已广泛用于治疗骨关节炎（OA）疼痛。我们研究了氨基葡萄糖盐酸盐对膝关节OA疼痛和残疾的疗效。
方法
在第-2周，对受试者进行检查、随机化，并指导其仅服用处方的对乙酰氨基酚治疗疼痛。在第0周，对患者进行检查，开具对乙酰氨基酚和安慰剂或氨基葡萄糖盐酸盐（氨基葡萄糖）。在第4周，对乙酰氨基酚和安慰剂或氨基葡萄糖的处方被更新。在第4周和第8周，患者返回日记和未使用的药物，并进行检查。在第-2周、第0周和第8周进行WOMAC问卷调查。完成8周随机试验后，在8周开放标签试验中向受试者提供已知的盐酸氨基葡萄糖胶囊，并在8周开放标签试验后进行随访电话调查。
结果
未达到主要终点（第0周至第8周WOMAC疼痛评分的统计学显著差异）。然而，在24个WOMAC问题中的23个中，观察到葡萄糖胺组的积极趋势。从第5周至第8周，在膝关节检查（p = 0.026）和对每日疼痛日记问题的回答（p = 0.018）中观察到显著差异。然而，在回答“你比审判开始时好吗？40%的安慰剂组受试者和仅49%的氨基葡萄糖组受试者回答肯定（p = 0.58）。在随机试验结束时，34%的安慰剂和47%的氨基葡萄糖受试者认为他们已经服用了氨基葡萄糖。在为期8周的开放标签试验结束后，77%的受试者仍在服用氨基葡萄糖，尽管现在必须支付市售产品的费用。
结论
通过WOMAC测量，盐酸氨基葡萄糖组和安慰剂组之间的疼痛减轻无显著差异。然而，通过每日日记和膝关节检查测量的累积疼痛减轻的次要终点是有利的，表明盐酸氨基葡萄糖对一些膝关节OA患者有益。
OBJECTIVE
Glucosamine products have been used extensively for the management of pain in osteoarthritis (OA). We investigated the efficacy of the hydrochloride salt of glucosamine on pain and disability in knee OA.
METHODS
At Week -2, subjects were examined, randomized, and instructed to take only prescribed acetaminophen for pain. At Week 0 patients were examined, prescribed acetaminophen, and either placebo or glucosamine hydrochloride (glucosamine). At Week 4 the prescriptions for acetaminophen and placebo or glucosamine were renewed. At Weeks 4 and 8, patients returned diaries and unused medications, and were examined. The WOMAC questionnaire was administered at Weeks -2, 0, and 8. After completing the randomized 8 week trial, subjects were offered known glucosamine hydrochloride capsules in an 8 week open label trial, with followup telephone survey after the 8 week open label trial.
RESULTS
The primary endpoint (statistically significant difference in WOMAC pain score between Week 0 and Week 8) was not met. However, positive trends were noted for the glucosamine group in 23 of 24 WOMAC questions. A significant difference was noted from Week 5 through Week 8 in the knee examination (p = 0.026) and in the response to a daily diary pain question (p = 0.018). However, responding to the question, "Are you better than at the start of the trial?", 40% of placebo and only 49% of glucosamine subjects answered in the affirmative (p = 0.58). At the end of the randomized trial, 34% of placebo and 47% of glucosamine subjects believed that they had been given glucosamine. After the end of the 8 week open label trial, 77% of the subjects were still taking glucosamine, although now obliged to pay for commercially available products.
CONCLUSION
There was no significant difference in pain reduction between the glucosamine hydrochloride and placebo groups as measured by WOMAC. However, the secondary endpoints of cumulative pain reduction as measured by daily diary and knee examination were favorable, suggesting that glucosamine hydrochloride benefits some patients with knee OA.