Ghost marketing: pharmaceutical companies and ghostwritten journal articles

The use of ghostwriters by industry is subject to increasing public attention and scrutiny. This article addresses the practice and ethics of scientific ghostwriting. We focus on the type of ghostwriting that involves a pharmaceutical company hiring a medical education and communications company to write a paper favorable of their product, who then hires a well-known academic to publish it under his or her name without disclosing the paper's true origins. We argue that this practice is harmful both to the public and to the institutions of science and that it is not justified by an analogy to accepted scientific authorship practices. Finally, we consider ways to discourage the practice.     

The vexed question of authorship: views of researchers in a British medical faculty.

OBJECTIVE: To assess knowledge, views, and behaviour of researchers on criteria for authorship and causes and control of gift authorship. DESIGN: Interview survey of stratified sample of researchers. SETTING: University medical faculty. SUBJECTS: 66 staff (94% response rate) comprising several levels of university academic and research appointments. MAIN OUTCOME MEASURES: Awareness and use of criteria for authorship, views on which contributions to research merit authorship, perceptions about gift authorship and strategies for reducing it, and experiences of authorship problems. RESULTS: 50 (76%) respondents supported criteria for authorship, but few knew about or used available criteria. Of the five people who could specify all three criteria of the International Committee of Medical Journal Editors, only one knew that all criteria had to be met. Forty one respondents (62%) disagreed with this stipulation. A range of practical and academic contributions were seen as sufficient for authorship. Gift authorship was perceived as common, promoted by pressure to publish, to motivate research teams, and to maintain working relationships. A signed statement justifying authorship and a published statement of the contribution of each author were perceived as practical ways of tackling gift authorship. Most researchers had experienced problems with authorship, most commonly the perception that authorship had been deserved but not awarded (49%). CONCLUSION: There seems to be a gap between editors'' criteria for authorship and researchers'' practice. Lack of awareness of criteria is only a partial explanation. Researchers give more weight than editors to practical research contributions. Future criteria should be agreed by researchers and not be imposed by editors.     

奥氮平联合重复经颅磁刺激或改良电休克治疗精神分裂症的疗效分析

目的:比较抗精神病药物奥氮平联合复经颅磁刺激(rTMS)或改良电休克(MECT)治疗精神分裂症的疗效。方法:将84例精神分裂症患者随机分为rTMS组(42例)与MECT组(42例),两组分别在奥氮平的基础上联合MECT或rTMS进行治疗。在治疗2、4、8周末后,采用阳性症状和阴性症状量表PANSS、治疗时出现症状量表TESS评估临床治疗效果及不良反应,同时采用修订韦氏记忆量表(WMS-RC)和威斯康星卡片分类测验(WCST)评定认知功能。结果:治疗后,两组总有效率比较无统计学差异(P0.05)。两组治疗后PANSS总分、阳性症状、阴性症状和一般病理分值均显著低于治疗前(P0.05,P0.01),但组间比较无统计学差异(P0.05)。两组TESS评分及不良反应的发生情况比较无统计学差异(P0.05)。与治疗前相比,两组患者治疗后认知功能均显著改善(P0.05,P0.01),且rTMS联合组在改善患者记忆功能、执行能力方面效果优于MTCT组(P0.05)。结论:奥氮平联合MECT或rTMS对精神分裂症状的疗效相当,但联合rTMS可更显著改善患者的认知功能。     

Comparison of One or Two Weeks of Lansoprazole, Amoxicillin, and Clarithromycin in the Treatment of Helicobacter pylori

Background The simplest, most effective, and least expensive Helicobacter pylori therapy remains to be determined. Two weeks of 30 mg lansoprazole bid, 1 gm amoxicillin bid, and 500 mg clarithromycin bid (LAC2) had been shown to be an effective therapy for H. pylori. The aim of this study was to assess whether 1 week of this regimen (LAC1) would have a similar efficacy.
Materials and Methods. H. pylori -positive patients assessed histologically, by rapid urease test, microbiologically, and by a ¹³C-urea breath test (¹³C-UBT) were randomized to receive either LAC1 or LAC2 in a single-center open study. Patients were interviewed 1 to 3 days after completion of therapy to evaluate adverse events and compliance. Efficacy was determined by ¹³C-UBT at least 4 weeks after antibiotic therapy.
Results. Seventy evaluable patients were randomized to receive LAC1 (n = 33) and LAC2 (n = 37). Of the 33 LAC1 patients, 30 (91%) were treated successfully (95% confidence interval (CI) = 76–98%), compared with 32 of 37 (86%) in the LAC2 group (95% CI = 71–96%). There was no difference in efficacy between the two groups (Fisher's exact test p = 1.0; 95% CI =–10.3%–19.2%). Patients taking LAC1 experienced significantly fewer severe adverse events than those taking LAC2 (Mann-Whitney U test). One of 64 patients had primary resistance to clarithromycin, and treatment was unsuccessful in this case. Six of the 7 remaining treatment failures developed secondary resistance to clarithromycin.
Conclusions. LAC1 is as effective as LAC2 and is associated with less toxicity. Posttreatment clarithromycin resistance is common in patients who do not experience success with therapy.     

Efficacy,safety and immunogenicity of hexavalent rotavirus vaccine in Chinese infants

A randomized, double-blind, placebo-controlled multicenter trial was conducted in healthy Chinese infants to assess the efficacy and safety of a hexavalent live human-bovine reassortant rotavirus vaccine (HRV) against rotavirus gastroenteritis (RVGE). A total of 6400 participants aged 6–12 weeks were enrolled and randomly assigned to either HRV (n = 3200) or placebo (n = 3200) group. All the subjects received three oral doses of vaccine four weeks apart. The vaccine efficacy (VE) against RVGE caused by rotavirus serotypes contained in HRV was evaluated from 14 days after three doses of administration up until the end of the second rotavirus season. VE against severe RVGE, VE against RVGE hospitalization caused by serotypes contained in HRV, and VE against RVGE, severe RVGE, and RVGE hospitalization caused by natural infection of any serotype of rotavirus were also investigated. All adverse events (AEs) were collected for 30 days after each dose. Serious AEs (SAEs) and intussusception cases were collected during the entire study. Our data showed that VE against RVGE caused by serotypes contained in HRV was 69.21% (95%CI: 53.31–79.69). VE against severe RVGE and RVGE hospitalization caused by serotypes contained in HRV were 91.36% (95%CI: 78.45–96.53) and 89.21% (95%CI: 64.51–96.72) respectively. VE against RVGE, severe RVGE, and RVGE hospitalization caused by natural infection of any serotype of rotavirus were 62.88% (95%CI: 49.11–72.92), 85.51% (95%CI: 72.74–92.30) and 83.68% (95%CI: 61.34–93.11). Incidences of AEs from the first dose to one month post the third dose in HRV and placebo groups were comparable. There was no significant difference in incidences of SAEs in HRV and placebo groups. This study shows that this hexavalent reassortant rotavirus vaccine is an effective, well-tolerated, and safe vaccine for Chinese infants.     

辛伐他汀治疗老年高血脂患者疗效与安全性的最佳剂量研究

目的:观察不同剂量辛伐他汀治疗老年高血脂患者疗效与安全性。方法:将纳入研究的80例老年高血脂患者随机分为高剂量组和低剂量组,各40例。高剂量组给予辛伐他汀剂40 mg/日,低剂量组给予20 mg/日。治疗2个月后观察疗效、血脂水平变化情况,并统计两组不良反应的发生情况。结果:高剂量组总有效率95%显著高于低剂量组的80%(P0.05);治疗后,两组TG、TC、LDL-C、HDL-C水平均有改善,与本组治疗前比较均有显著性差异(P均0.05),且高剂量组上述指标改善明显优于低剂量组(P均0.05);治疗期间两组不良反应发生率无统计学意义(P0.05)。结论:辛伐他汀高剂量(40 mg/日)治疗老年高血脂的疗效优于低剂量(20 mg/日),且不增加不良反应发生的风险。     

康莱特注射液联合放化疗治疗中晚期宫颈癌的临床研究

目的：探讨康莱特注射液联合放化疗对中晚期宫颈癌患者的疗效及对放化疗引起的毒副反应的影响。方法：选取2009年6月—2012年3月间笔者所在医院收治的经病理组织学确诊的62例局部晚期宫颈鳞癌患者,随机平均分成实验组（n=31）和对照组（n=31）,分别接受康莱特注射液+放化疗联用和单纯放化疗的治疗,考察两组受试者的临床有效率、生活质量及毒副反应。结果：实验组和对照组受试者的总有效率分别为93.6%和83.9%,无显著差异（P>0.05）;生活质量稳定和改善的比率分别为93.5%和71.0%,有显著差异（P<0.05）;实验组受试者的主要毒副反应发生率明显低于对照组（P<0.05）。结论：康莱特注射液联合放化疗能有效用于中晚期宫颈癌患者的治疗,并显著提高患者生活质量,明显减轻放化疗所致不良反应。     

缬沙坦联合吲达帕胺治疗高血压的效果观察

目的:探讨缬沙坦和吲达帕胺治疗高血压的临床效果,为临床治疗提供可借鉴的方法。方法:选取2012年4月-2014年1月在我院接受治疗的87例高血压患者的临床资料,根据治疗方式的不同将所选患者分为缬沙坦组、吲达帕胺组和联合用药组,每组27例。缬沙坦组患者采用口服缬沙坦单药治疗,吲达帕胺组患者采用口服吲达帕胺单药治疗,联合用药组采用缬沙坦+吲达帕胺缓释片治疗。观察三组患者治疗前后的血压变化、治疗总有效率及不良反应的发生情况。结果:治疗后,三组患者的血压均不同程度降低(P0.05);联合用药组患者血压下降幅度明显高于缬沙坦单药治疗组和吲达帕胺单药治疗组,差异具有统计学意义(P0.05)。联合用药组患者治疗的总有效率明显高于缬沙坦单药治疗组和吲达帕胺单药治疗组,差异具有统计学意义(P0.05)。三组患者不良反应的发生率无显著差异(P0.05)。结论:缬沙坦胶囊与吲哒帕胺缓释片联合应用治疗高血压具有显著的临床意义,能够有效的控制患者的血压,值得推广采用。     

全反式维甲酸联合化疗治疗晚期结肠癌临床观察

目的:探讨全反式维甲酸联合化疗治疗晚期结肠癌的临床疗效和安全性。方法:将2009年4月至2012年3月我院收治的178例晚期结肠癌患者随机分入试验组(全反式维甲酸联合m FOLFOx6方案化疗)和对照组(单纯m FOLFOx6方案化疗),每组89例。治疗后,观察和比较两组患者的近期疗效、疾病进展时间、总生存期、KPS评分改善情况和不良反应的发生情况。结果:试验组的近期有效率为67.8%,对照组为50.6%,显著低于试验组(P=0.021);试验组患者的KPS评分改善率为79.3%,而对照组为57.4%,显著低于试验组(P=0.002)。试验组患者的中位生存期和中位疾病进展期分别为14.784、7.502个月;对照组患者分别为13.12、6.244个月,均较试验组显著缩短(P0.05)。试验组患者恶心呕吐的发生率显著低于对照组(P=0.016),两组其它不良反应如骨髓抑制、肝肾功能损害、心脏毒性等的发生率比较差异无统计学意义(P0.05)。结论:全反式维甲酸注射液联合化疗治疗晚期结肠癌可以提高其临床疗效,延长其生存期,改善其生存质量,且能减轻消化道不良反应。     

沙利度胺联合甲氨喋呤与羟氯喹治疗类风湿关节炎的疗效分析

目的:探讨沙利度胺(THD)联合甲氨喋呤(MTX)、羟氯喹(HCQ)治疗类风湿关节炎(RA)的临床疗效。方法:82例RA患者随机分为观察组(n=41)与对照组(n=41),对照组给予MTX治疗,观察组在对照组基础上加用THD与HCQ,对比两组患者临床疗效。结果:观察组有效率为90.2%,显著高于对照组的70.7%(P0.05);治疗前、治疗后1个月两组患者肿胀关节数、压痛关节数、晨僵时间、ESR、CRP、RF、VAS比较差异无统计学意义(P0.05);治疗后2、3、4、5、6个月比较观察组各观察指标均显著优于对照组(P0.05);两组患者治疗过程中血细胞降低、消化道症状、呼吸道感染、月经紊乱、皮疹、ALT升高、头晕嗜睡、口腔溃疡等不良反应发生率比较无统计学差异(P0.05)。结论:沙利度胺联合甲氨喋呤、羟氯喹用于类风湿关节炎患者的治疗,能够有效延缓病情的进展、缓解患者痛苦,同时减少了药物的不良反应,为临床提供了新的治疗方法。     

Chronotherapeutic dose schedule of phenytoin and carbamazepine in epileptic patients

The objective of this study was to compare the efficacy and safety of a chronotherapeutic dosing schedule of phenytoin and carbamazepine versus a conventional dosing schedule for the treatment of tonic-clonic epileptic patients. Of 148 epileptic subjects found to have subtherapeutic trough drug levels (subtherapeutic group, STG), 103 subjects who completed the study were randomized to either STG I (n=51) for treatment by the conventional dosing schedule (tablet phenytoin 100-400 mg/day OD or BD, tablet carbamazepine 200-800 mg BD, or both, equally divided doses with no fixed time of drug intake), with a dose increment but no change in usual time of drug administration allowed; or to STG II (n=52), with no dose increment permitted but a shift in all or most (two-thirds or three-fourths) of the daily dose of one or both medications to 20:00 h. The 62 patients who experienced drug toxicity reactions (toxicity group, TG) and who had serum drug levels in the toxic range were assigned to TG I for dose reduction or TG II for dose reduction and drug administration at 20:00 h. Those 16 subjects in STG I and 47 subjects in STG II who initially evidenced subtherapeutic trough drug concentrations exhibited therapeutic drug levels by the end of four weeks of treatment (p<0.01). A significantly greater number of TG II, as compared to TG I, subjects who experienced toxic reactions showed improved drug tolerance. There were no poor responders and more good responders (control of epilepsy for one year) in STG II compared to STG I subjects. The findings of this study indicate that a chronotherapeutic dosing schedule of phenytoin and carbamazepine involving the administration of most or all the daily dose of medication(s) at 20:00 h can improve the response of diurnally active epileptic patients not responding to standard doses, achieve therapeutic drug levels, and reduce toxic manifestations in subjects having drug concentrations beyond the therapeutic range.     

A randomized,controlled trial of interferon-β-1a (Avonex<Superscript>®</Superscript>) in patients with rheumatoid arthritis: a pilot study [ISRCTN03626626]

The objective of this study was to evaluate the safety and possible efficacy of IFN-β-1a for the treatment of patients with rheumatoid arthritis (RA). Twenty-two patients with active RA were enrolled in a phase II randomized, double-blind, placebo-controlled trial of 30 μg IFN-β-1a by weekly self-injection for 24 weeks. The primary outcome of the study was safety. Secondary outcomes included the proportion of patients achieving an American College of Rheumatology (ACR) 20 response at 24 weeks. There were no significant differences in adverse events reported in the two groups. Fewer than 20% of patients in each arm of the study achieved an ACR 20 response at 24 weeks (P = 0.71). Sixty-nine percent of patients receiving IFN-β and 67% receiving placebo terminated the study early, most of them secondary to a perceived lack of efficacy. Overall, IFN-β-1a had a safety profile similar to that of placebo. There were no significant differences in the proportion of patients achieving an ACR 20 response between the two groups.     

A randomized, controlled trial of interferon-beta-1a (Avonex(R)) in patients with rheumatoid arthritis: a pilot study [ISRCTN03626626

The objective of this study was to evaluate the safety and possible efficacy of IFN-beta-1a for the treatment of patients with rheumatoid arthritis (RA). Twenty-two patients with active RA were enrolled in a phase II randomized, double-blind, placebo-controlled trial of 30 microg IFN-beta-1a by weekly self-injection for 24 weeks. The primary outcome of the study was safety. Secondary outcomes included the proportion of patients achieving an American College of Rheumatology (ACR) 20 response at 24 weeks. There were no significant differences in adverse events reported in the two groups. Fewer than 20% of patients in each arm of the study achieved an ACR 20 response at 24 weeks (P = 0.71). Sixty-nine percent of patients receiving IFN-beta and 67% receiving placebo terminated the study early, most of them secondary to a perceived lack of efficacy. Overall, IFN-beta-1a had a safety profile similar to that of placebo. There were no significant differences in the proportion of patients achieving an ACR 20 response between the two groups.     

补阳还五汤联合强力定眩片对后循环缺血性眩晕患者眩晕症状、氧化应激及血流指标的影响

目的:探讨补阳还五汤联合强力定眩片对后循环缺血(PCI)性眩晕患者眩晕症状、氧化应激及血流指标的影响。方法:选取中国中医科学院西苑医院于2018年12月~2019年12月间接收的80例PCI性眩晕患者,采用信封法将患者随机分为对照组(n=40,常规西医治疗)和研究组(n=40,常规西医基础上增加补阳还五汤联合强力定眩片治疗),比较两组患者临床疗效、眩晕症状、氧化应激及血流指标,记录两组治疗期间不良反应发生情况。结果:治疗2个疗程后,研究组的总有效率高于对照组(P<0.05)。两组患者治疗2个疗程后眩晕障碍量表(DHI)评分、超氧化物歧化酶(SOD)、一氧化氮(NO)水平、椎动脉平均血流速度、基底动脉平均血流速度均升高,且研究组高于对照组(P<0.05);两组丙二醛(MDA)水平、全血黏度、血浆黏度、红细胞压积均降低,且研究组低于对照组(P<0.05)。两组不良反应发生率比较无差异(P>0.05)。结论:补阳还五汤联合强力定眩片治疗PCI性眩晕患者,可改善患者眩晕症状及血流状况,降低机体氧化应激程度,疗效确切,且用药安全性较好。     

三种药物联合治疗假丝酵母菌性阴道炎的临床疗效评价

目的:研究克霉唑阴道片、硝夫太尔制霉素阴道软胶囊联合定君生栓治疗复发性假丝酵母菌性阴道炎的临床疗效,为临床治疗提供依据。方法:选取2014年9月到2015年6月我院就诊的复发性假丝酵母菌性阴道炎患者60例,按照随机数字表法将患者分为实验组和对照组,每组30例,实验组给予克霉唑阴道片、硝夫太尔制霉素阴道软胶囊联合定君生栓治疗,对照组给予克霉唑阴道片和定君生栓治疗,治疗前检测所有患者病原菌分布情况,治疗后随访3个月,分析两组临床疗效和不良反应。结果:细菌培养结果共分离出158株假丝酵母菌,其中白色假丝酵母菌最多,占66.46%;实验组总有效率为93.33%,显著高于对照组的76.67%,两组比较差异具有统计学意义(P0.05);两组不良反应发生率比较无统计学意义(P0.05)。结论:克霉唑阴道片、硝夫太尔制霉素阴道软胶囊联合定君生栓治疗复发性假丝酵母菌性阴道炎具有较好的临床疗效,且无明显不良反应。     

Efficacy and tolerance of a comfrey root extract (Extr. Rad. Symphyti) in the treatment of ankle distorsions: results of a multicenter, randomized, placebo-controlled, double-blind study.

Comfrey (Symphytum officinale L.) is a medicinal plant with anti-inflammatory, analgesic and tissue regenerating properties. In a double-blind, multicenter, randomized, placebo-controlled, group comparison study on patients suffering from unilateral acute ankle sprains (n = 142, mean age 31.8 years, 78.9% male), the percutaneous efficacy of an ointment of comfrey extract (Kytta-Salbe f, four treatments per day for 8 days) was confirmed decisively. Compared to placebo, the active treatment was clearly superior regarding the reduction of pain (tonometric measurement, p<0.0001, as the primary efficacy variable) and ankle edema (figure-of-eight method, p = 0.0001). Statistically significant differences between active treatment and placebo could also be shown for ankle mobility (neutral zero method), and global efficacy. Under active treatment, no adverse drug reactions were reported. The good local and global tolerance of the trial medication could also be confirmed. The study results are consistent with the known pre-clinical and clinical data concerning comfrey.     

文拉法辛与舍曲林治疗老年性抑郁症的效果及对认知功能的影响

目的:探讨文拉法辛与舍曲林治疗老年性抑郁症的效果及对认知功能的影响。方法:收集我院2012年6月到2014年1月收治的老年性抑郁症患者80例,按照随机数字表法分为观察组和对照组,每组40例,观察组给予盐酸文拉法辛胶囊、对照组给予舍曲林治疗。应用相应量表评价两组患者抑郁症和认知功能变化情况,并记录不良事件发生率。结果:观察组治疗有效率为90.0%,对照组为82.5%,差异无统计学意义(P0.05),治疗后观察组HAMD评分优于对照组,差异具有统计学意义(P0.05),两组治疗后与治疗前相比差异均具有显著统计学意义(P0.05)。治疗前Ra、Cc、Rc、Re、Rf、Rpe、n Rpe指标在两组间差异无统计学意义(P0.05),治疗后观察组优于对照组,差异有统计学意义(P0.05);治疗后两组不良事件发生率差异无统计学意义(P0.05),且经过对症处理均好转。结论:文拉法辛与舍曲林对老年患者抑郁症症状和认知功能改善均有一定的效果,但文拉法辛的治疗效果较舍曲林好,并且安全可靠,临床可以优先选择文拉法辛治疗。