Examination of the Significant Placebo Effect in the Treatment of Interstitial Cystitis/Bladder Pain Syndrome
Examination of the Significant Placebo Effect in the Treatment of Interstitial Cystitis/Bladder Pain Syndrome
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DOI：
10.1016/j.urology.2014.04.011
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发表时间：
2014-08-01
期刊：
影响因子：
2.1
通讯作者：
Bosch, Philip C.
中科院分区：
文献类型：
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作者：
Bosch, Philip C.
目的 在一项随机、双盲、安慰剂对照的间质性膀胱炎/膀胱疼痛综合征试验中检验显着的“安慰剂效应”。随机临床试验是治疗影响评估的参考标准。然而，由于安慰剂干预的显着效果，通过严格的安慰剂对照试验来证明间质性膀胱炎/膀胱疼痛综合征治疗的疗效是很困难的。 方法 间质性膀胱炎/膀胱疼痛综合征患者被随机分为每 2 周皮下注射阿达木单抗或皮下安慰剂，持续 12 周，并评估结果指标。 结果 在 43 名患者中，21 名接受阿达木单抗治疗，22 名接受安慰剂治疗。在接受安慰剂的患者中，间质性膀胱炎症状和问题指数显着改善，为-8.1（95%置信区间[CI]，3.0-13.2），间质性膀胱炎症状指数为-3.7（95% CI，0.9-6.5），间质性膀胱炎问题指数为-4.4（95% CI， 2.0-6.8），与基线相比，第 12 周时盆腔疼痛、紧迫性、频率量表为 -6.9（95% CI，2.8-11.0）。大多数显着改善的安慰剂患者认为他们的改善是因为他们在研究中更加认真地遵循医生的建议并且感觉压力较小。 结论 患有中度至重度间质性膀胱炎/膀胱疼痛综合征的患者在仅接受建议和支持后有显着改善。这种干预是无风险且廉价的。在开始药物治疗之前，医生应查看所有间质性膀胱炎/膀胱疼痛综合征患者的标准建议。 (C) 2014 年爱思唯尔公司。
OBJECTIVE To examine the significant "placebo effect" in a randomized, double-blind, placebo-controlled interstitial cystitis/bladder pain syndrome trial. Randomized clinical trials are the reference standard for therapeutic impact assessment. However, proving efficacy of treatments for interstitial cystitis/bladder pain syndrome with rigorous placebo-controlled trials is difficult due to a significant effect of the placebo intervention.METHODS Interstitial cystitis/bladder pain syndrome patients were randomized to receive subcutaneous adalimumab or subcutaneous placebo every 2 weeks for 12 weeks and outcome measures were assessed.RESULTS Of the 43 patients, 21 received adalimumab and 22 received placebo. Of the patients who received placebo, there was a statistically significant improvement demonstrated in the Interstitial Cystitis Symptom and Problem Indexes of -8.1 (95% confidence interval [CI], 3.0-13.2), Interstitial Cystitis Symptom Index of -3.7 (95% CI, 0.9-6.5), Interstitial Cystitis Problem Index of -4.4 (95% CI, 2.0-6.8), and Pelvic Pain, Urgency, Frequency scale of -6.9 (95% CI, 2.8-11.0) at week 12 compared with baseline. Most of the significantly improved placebo patients felt their improvement was because they were more conscientious about following physician advice and feeling less stress while in the study.CONCLUSION Patients with moderate to severe interstitial cystitis/bladder pain syndrome had significant improvement after receiving only advice and support. This intervention is risk free and inexpensive. Physicians should review standard advice with all interstitial cystitis/bladder pain syndrome patients before starting medical therapy. (C) 2014 Elsevier Inc.