The impact of pharmaceutical company funding on results of randomized trials of nicotine replacement therapy for smoking cessation: a meta-analysis
The impact of pharmaceutical company funding on results of randomized trials of nicotine replacement therapy for smoking cessation: a meta-analysis
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DOI：
10.1111/j.1360-0443.2007.01822.x
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发表时间：
2007-05-01
期刊：
影响因子：
6
通讯作者：
Stapleton, John
中科院分区：
文献类型：
--
作者：
Etter, Jean-Francois;Burri, Mafalda;Stapleton, John
目的探讨研究经费来源对尼古丁替代疗法（NRT）戒烟效果的影响。方法对纳入科克伦综述的所有随机对照试验进行回顾性分析。新产品的非行业试验不足，因此无法纳入。我们纳入了90项尼古丁口香糖（52）或尼古丁贴片（38）的试验。他们包括18238名治疗参与者和16235名对照参与者。49个显示了行业支持的证据（18个口香糖，31个贴片）。结果工业（31/49，63%）与非工业（7/41，17%，P < 0.001）相比，支持尼古丁贴片研究的比例更高，样本量更大（479对268，P = 0.04）。25项（51%）行业试验报告了统计学显著性（P < 0.05）结果，9项（22%）非行业试验报告了统计学显著性（OR = 3.70，95%CI = 1.46-9.35）结果。试验特征不能解释这种差异。行业支持试验的合并优势比为1.90（1.67-2.16），而其他研究的合并优势比为1.61（1.43-1.80）（卡方（2）= 3.6，P = 0.058）。在行业试验中有漏斗图不对称的证据（t = 4.35，P < 0.001），但在其他试验中没有，表明几个小的零效应行业试验可能尚未发表。插补调整后，行业试验的比值比降至1.64（1.43-1.89），总体NRT比值比从1.73（1.60-1.90）降至1.62（1.49-1.77）。结论与独立试验相比，行业支持的试验更有可能产生统计学显著性结果和更大的优势比。这些差异在调整基本试验特征后仍然存在。虽然我们没有关于每项试验的资金数额的数据，但更多的资源可能会导致更高的治疗依从性，从而在行业支持的试验中获得更高的疗效。差异也可能由发表偏倚解释，几项小型、无效的行业研究尚未发表。在对这种可能的偏倚进行调整后，行业试验的结果较低，与非行业结果相似。同样，这些产品的净效应的总体估计值降低到约5%，归因于1年的成功。这仍然对公共卫生有相当大的好处。临床试验的注册在许多国家已成为强制性的，因为这里考虑的大多数试验都是进行的，这应该会减少未来发表偏倚的可能性。
Aim To assess whether source of funding affected the results of trials of nicotine replacement therapy (NRT) for smoking cessation. Methods We reviewed all randomized controlled trials included in the Cochrane review. There were insufficient non-industry trials of the newer products for these to be included. We included 90 trials of either the nicotine gum (52) or nicotine patch (38). They comprised 18 238 treatment and 16 235 control participants. Forty-nine showed evidence of industry support (18 gum, 31 patch). Results Industry (31 of 49, 63%) compared with non-industry (seven of 41, 17%, P < 0.001) supported a higher proportion of nicotine patch studies and had larger sample sizes (479 versus 268, P = 0.04). Twenty-five (51%) industry trials reported statistically significant (P < 0.05) results, compared with nine (22%) non-industry trials (OR = 3.70, 95% CI = 1.46-9.35). This difference was not explained by trial characteristics. Industry-supported trials had a pooled odds ratio of 1.90 (1.67-2.16), compared with 1.61 (1.43-1.80) for other studies (chi(2) = 3.6, P = 0.058). There was evidence of funnel-plot asymmetry among industry trials (t = 4.35, P < 0.001), but not among other trials, indicating that several small null-effect industry trials may not have reached publication. After imputation adjustment, the odds ratio for industry trials reduced to 1.64 (1.43-1.89) and the overall NRT odds ratio reduced from 1.73 (1.60-1.90) to 1.62 (1.49-1.77). Conclusions Compared with independent trials, industry-supported trials were more likely to produce statistically significant results and larger odds ratios. These differences persisted after adjustment for basic trial characteristics. Although we had no data on the amount of funding for each trial, it is possible that more resources led to higher treatment compliance and therefore greater efficacy in industry-supported trials. Differences can also possibly be explained by publication bias with several small, null-effect industry studies not having reached publication. After adjustment for this possible bias, results for industry trials were lower and similar to non-industry results. Similarly, the overall estimate of the net effect for these products reduces to about 5% attributable 1-year successes. This remains of considerable public health benefit. Registration of clinical trials has become mandatory in many countries since most of the trials considered here were conducted, and this should reduce the potential for publication bias in future.