Curcuminoid Treatment for Knee Osteoarthritis: A Randomized Double‐Blind Placebo‐Controlled Trial

Treatment of osteoarthritis (OA) is challenging owing to the inefficacy and long‐term adverse events of currently available medications including non‐steroidal anti‐inflammatory drugs. Curcuminoids are polyphenolic phytochemicals with established anti‐inflammatory properties and protective effects on chondrocytes. The aim of this study is to investigate the clinical efficacy of curcuminoids in patients suffering from knee OA. A pilot randomized double‐blind placebo‐control parallel‐group clinical trial was conducted among patients with mild‐to‐moderate knee OA. Patients were assigned to curcuminoids (1500 mg/day in 3 divided doses; n = 19) or matched placebo (n = 21) for 6 weeks. Efficacy measures were changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), visual analogue scale (VAS) and Lequesne's pain functional index (LPFI) scores during the study. There was no significant difference in age, gender, body mass index, and VAS, WOMAC and LPFI scores between the study groups at baseline (p > 0.05). Treatment with curcuminoids was associated with significantly greater reductions in WOMAC (p = 0.001), VAS (p < 0.001) and LPFI (p = 0.013) scores compared with placebo. With respect to WOMAC subscales, there were significant improvements in the pain and physical function scores (p < 0.001) but not stiffness score (p > 0.05). There was no considerable adverse effect in both groups. To conclude, curcuminoids represent an effective and safe alternative treatment for OA. Copyright © 2014 John Wiley & Sons, Ltd.     

Nigella sativa Supplementation Improves Asthma Control and Biomarkers: A Randomized,Double‐Blind,Placebo‐Controlled Trial

Poor compliance with conventional asthma medications remains a major problem in achieving asthma control. Nigella sativa oil (NSO) is used traditionally for many inflammatory conditions such as asthma. We aimed to investigate the benefits of NSO supplementation on clinical and inflammatory parameters of asthma. NSO capsules 500 mg twice daily for 4 weeks were used as a supplementary treatment in a randomized, double‐blind, placebo‐controlled trial in asthmatics (clinicaltrials.gov: NCT02407262). The primary outcome was Asthma Control Test score. The secondary outcomes were pulmonary function test, blood eosinophils and total serum Immunoglobulin E. Between 1 June and 30 December 2015, 80 asthmatics were enrolled, with 40 patients in each treatment and placebo groups. After 4 weeks, ten patients had withdrawn from each group. Compared with placebo, NSO group showed a significant improvement in mean Asthma Control Test score 21.1 (standard deviation = 2.6) versus 19.6 (standard deviation = 3.7) (p = 0.044) and a significant reduction in blood eosinophils by ?50 (?155 to ?1) versus 15 (?60 to 87) cells/μL (p = 0.013). NSO improved forced expiratory volume in 1 second as percentage of predicted value by 4 (?1.25 to 8.75) versus 1 (?2 to 5) but non‐significant (p = 0.170). This randomized, double‐blind, placebo‐controlled trial demonstrated that NSO supplementation improves asthma control with a trend in pulmonary function improvement. This was associated with a remarkable normalization of blood eosinophlia. Future studies should follow asthmatics for longer periods in a multicentre trial. Copyright © 2017 John Wiley & Sons, Ltd.     

Lipid‐Lowering Effects of Curcumin in Patients with Metabolic Syndrome: A Randomized,Double‐Blind,Placebo‐Controlled Trial

Human studies of curcumin extract on lipid‐lowering effect have not been completely investigated and have had controversy results. This study tested the effect of daily curcumin extract for 12 weeks on weight, glucose, and lipid profiles in patients with metabolic syndrome. Sixty‐five patients were randomized into two groups; 33 patients taking curcumin extract capsule (630 mg thrice daily) and 32 patients taking a placebo capsule thrice daily for 12 weeks. At 12 weeks after the curcumin extract consumption, the level of high‐density lipoprotein cholesterol (HDL‐C) significantly increased from 40.96 ± 8.59 to 43.76 ± 2.79 mg/dL (p < 0.05), and the level of low‐density lipoprotein cholesterol (LDL) was significantly reduced (120.55 ± 36.81 to 106.51 ± 25.02 mg/dL, p < 0.05). The triglyceride‐lowering effect, a reduction of 65 mg/dL, was also found in this study. In subgroups analysis, the consumption of curcumin may have a lowering cholesterol effect in male patients and an increasing HDL‐C effect in female patients, both of which result in a decrease of T‐Chol/HDL‐C ratio. The intake of the curcumin extract of 1890 mg/day for 12 weeks was associated with lipid‐lowering effect but did not improve weight and glucose homeostasis in the patients with metabolic syndrome. Daily curcumin consumption may be an alternative choice to modify cholesterol‐related parameters, especially in metabolic syndrome patients. Copyright © 2014 John Wiley & Sons, Ltd.     

Investigation of the Efficacy of Adjunctive Therapy with Bioavailability‐Boosted Curcuminoids in Major Depressive Disorder

Current medications have limited efficacy in controlling the symptoms of major depressive disorder (MDD), and are associated with several adverse events on long‐term use. Curcuminoids are extremely safe and multifunctional phytopharmaceuticals that have been shown to alleviate depressive symptoms in a variety of experimental models. The present study aimed to investigate the efficacy of curcuminoids as an add‐on to standard antidepressants in patients with MDD. One hundred and eleven subjects were assigned to standard antidepressive therapy plus curcuminoids–piperine combination (1000–10 mg/day; n = 61) or standard antidepressive therapy alone (n = 50) for a period of 6 weeks. Efficacy measures were changes in the psychological status on the basis of the Hospital Anxiety and Depression Scale (HADS) and Beck Depression Inventory II (BDI‐II). The BDI‐II and HADS total and subscale scores were reduced by the end of trial in both study groups. There were significantly greater reductions in total HADS score and subscales of anxiety and depression in the curcuminoids versus control group (p < 0.001). Likewise, reductions in BDI‐II total score and scores of somatic and cognitive subscales were found to be greater in the curcuminoids compared with control group (p < 0.001). Co‐administration of curcuminoids with piperine may be used as a safe and effective add‐on to standard antidepressants in patients with MDD. Copyright © 2014 John Wiley & Sons, Ltd.     

中医五行音乐改善老年及非老年肿瘤患者生存质量随机对照研究

目的:为客观评价中医五行音乐治疗对老年及非老年晚期肿瘤患者生存质量的改善作用,完善肿瘤中医综合治疗模式,方法:按随机、单盲、平行对照设计,选取晚期肿瘤患者170例,按照70岁年龄分层,并按2∶2∶1设立治疗组,耳机聆听中医五行音乐,阳性对照组耳机聆听西洋音乐,阴性对照组只戴耳机,不接受任何音乐治疗,每次30 min,每周5次,观察期为3周,收集生存质量表、KPS评分及患者填写的症状日记等结局资料。结果:从总体上看,肿瘤生活质量指数(HQOLI-R)评分,KPS和患者症状日记评分各组组内治疗前后比较,中医五行音乐组治疗前后有统计学差异(P<0.05),西洋乐和空白对照组治疗前后无统计学差异(P>0.05)。结论:无论是老年、非老年,中医五行音乐治疗均能够提高晚期肿瘤患者生活质量,改善主观症状,但对于老年肿瘤患者症状日记评分作为一种评价生活质量的指标其敏感度仍有待考证。     

宽胸气雾剂改善冠心病PCI术后心绞痛患者生活质量随机对照研究

目的 观察宽胸气雾剂对冠心病经皮冠状动脉介入术（PCI）术后心绞痛患者临床疗效及生活质量的影响。方法 选取2022年12月—2023年9月在南方医院诊断为冠心病接受PCI治疗后仍有心绞痛的患者72例。将患者随机分为试验组和对照组,每组各36例。对照组给予常规药物治疗,试验组在常规药物治疗的基础上给予宽胸气雾剂舌下喷服,每次2喷,每日3次,连续喷服1个月。比较两组患者治疗前后的生活质量量表（SF-36）、西雅图心绞痛量表（SAQ）评分以及心绞痛缓解临床疗效。结果 最终试验组35例和对照组34例患者完成试验。与本组治疗前比较,两组治疗后心绞痛发作频次、心绞痛发作持续时间降低,SAQ各维度评分增高（P<0.05）;试验组治疗后SF-36各维度评分增高（P<0.05）;对照组治疗后SF-36躯体角色、躯体疼痛、一般健康状况、情绪角色评分增高（P<0.05）。与对照组比较,试验组治疗后心绞痛发作频次、心绞痛发作持续时间降低,SF-36和SAQ各维度评分增高（P<0.05）。两组心绞痛疗效比较,差异无统计学意义（P>0.05）,但试验组有升高趋势。结论 宽胸气雾剂能降...     

A Randomized,Double‐blind,Placebo‐controlled Clinical Trial Examining the Effects of Green Tea Extract on Systemic Lupus Erythematosus Disease Activity and Quality of Life

Antiinflammatory and immunomodulatory benefit of green tea (Camellia sinensis) in autoimmune disease has been proven in recent studies. The objective of this study was to assess the effects of green tea on disease activity and quality of life in systemic lupus erythematosus patients. A randomized controlled trial on subjects with lupus was conducted, and 68 patients in the age range of 39.1 ± 10.3 years and body mass index of 25.7 ± 5.21 kg/m² completed the 12‐week study. Patients were randomly divided into two groups of intervention (1000 mg green tea extract, two capsules/day) and control (1000 mg of starch, two capsules/day). Main outcome measure, systemic lupus erythematosus disease activity, was assessed by the systemic lupus erythematosus disease activity index at the first and after 3 months of intervention. In addition, patient's quality of life was evaluated by short form of quality‐of‐life questionnaire at baseline and after 3 months. Green tea extract supplementation significantly reduced disease activity in lupus patients (p < 0.004); in addition, it significantly increased the vitality (p < 0.006) and general health (p < 0.01). This study showed that daily consumption of green tea extracts for 12 weeks improves the systemic lupus erythematosus disease activity as well as some aspects of quality of life. Copyright © 2017 John Wiley & Sons, Ltd.     

中医药治疗冠心病的临床随机对照试验文献的质量分析

目的：评价中医药治疗冠心病的临床随机对照试验（RCT）文献的质量。方法：手工检索83种中医类杂志（1977-2002年6月）。纳入标准：中医药治疗冠心病的临床随机对照试验。结果：符合纳入标准的文献共675篇。（1）交待了随机分配方法的58篇（8.59%);(2)提到了诊断标准及研究纳入标准的637篇（94.37%);(3)无一篇提到分配隐匿;（4）使用了盲法的64篇（9.48%)。采用双盲的29篇（4.29%)。单盲的35篇（5.19%);(5)提到基线可比性的563篇（83.41%);(6)无一篇提到样本含量的估算依据;（7）12个临床研究中病人丢失,但无一在结果统计中进行intention-to-treat处理;（8）统计方法错误的24篇,占3.56%;有统计结果但没有说明方法的394篇。占58.37%;结论;迄今为止临床随机对照实试在有关中医药治疗冠心病的研究中还没有被广泛运用。我们在这一领域的临床随机对照实验中还很难见到分配隐匿,样本的估算依据。盲法与intention-to-treat的运用。一些文章还混淆了随机分配与随机抽样的概念,正确的统计学方法的运用率还比较低。总的看来,中医药治疗冠心病的RCT试验文献的质量亟待提高。     

Improved Lipid Profile in Hyperlipidemic Patients Taking Vaccinium arctostaphylos Fruit Hydroalcoholic Extract: A Randomized Double‐Blind Placebo‐Controlled Clinical Trial

Dyslipidemia is a common contributory cause of cardiovascular disease. Vaccinium arctostaphylos L. (Caucasian whortleberry) fruit is rich of anthocyanins. Anthocyanins may exert cardioprotective effects by various mechanisms such as favorably modulating dyslipidemia. Therefore, in this randomized double‐blind placebo‐controlled clinical trial with hyperlipidemic (hypercholesterolemic and/or hypertriglyceridemic) patients aged 20–60 years, the effects of taking a standardized whortleberry fruit hydroalcoholic extract (one 350 mg capsule every 8 h for 2 months) on fasting blood levels of lipids, creatinine and liver enzymes including SGOT and SGPT were evaluated in 40 patients and compared with the placebo group (n = 40). The extract lowered the blood levels of total cholesterol (P < 0.001), triglyceride (P = 0.002) and low‐density lipoprotein cholesterol (LDL‐C) (P = 0.002), but increased the blood high‐density lipoprotein cholesterol (HDL‐C) levels (P < 0.001) without any significant effects on the blood levels of SGOT, SGPT and creatinine (P > 0.05) compared with the placebo group at the endpoint. Whortleberry reduced total cholesterol, triglyceride and LDL‐C 27.6%, 19.2% and 26.3%, respectively, but increased HDL‐C 37.5% compared with baseline. No adverse effects were reported. Short‐term treatment with whortleberry fruit appears safe and improves lipid profile in hyperlipidemic patients. Copyright © 2013 John Wiley & Sons, Ltd.     

针刺治疗脑梗死恢复期神经功能评估的多中心随机对照研究

目的探讨醒脑开窍针刺治疗脑梗死恢复期的临床疗效。方法234例脑梗死恢复期患者随机分为醒脑开窍针刺组(醒脑组)和传统针刺组(传统组)。醒脑组116例接受醒脑开窍针刺和常规基础治疗,传统组118例接受传统针刺和常规基础治疗。治疗4周后,进行两组神经功能评估。结果治疗后,神经功能缺损评分(NIHSS)、斯堪的纳维亚量表(SSS)、卒中量表(CSS)、Barthel指数的改善醒脑组优于传统组(P<0.001)。结论醒脑开窍针刺在改善神经功能缺损评分和日常生活能力方面明显优于传统针刺法。     

补肾活血法治疗老年骨质疏松症100例随机对照研究

目的观察补肾活血法治疗老年骨质疏松症的疗效及安全性。方法将200例老年骨质疏松症患者随机分为治疗组和对照组各100例。治疗组给予补肾活血中药,每日1剂;对照组口服阿仑膦酸钠片70 mg,每周1次,碳酸钙D3片600 mg,每日1次。两组均治疗24周。比较两组患者治疗前后症状积分、腰椎(L1~L4)及左侧股骨颈骨密度、血清骨钙素(BGP)、骨源性碱性磷酸酶(BAP)、Ⅰ型原胶原N-端前肽(PINP)、抗酒石酸酸性磷酸酶(TRACP-5b)、Ⅰ型原胶交联C-末端肽(CTX),并检测安全性指标。治疗后评价中医证候疗效。结果治疗组中医证候疗效总有效率为92%,明显高于对照组的79%(P0.05)。两组患者治疗后症状积分、腰椎骨密度、股骨颈骨密度、BGP、BAP、TRACP-5b、PINP、CTX较治疗前均明显改善(P0.01),治疗组治疗后症状积分、腰椎骨密度、股骨颈骨密度、BGP、BAP均明显优于对照组(P0.05)。治疗期间两组患者安全性指标未见异常改变。结论补肾活血法能有效提高老年骨质疏松症患者骨密度、改善临床症状,可能与其有效调节骨转换代谢平衡相关。     

Hesperidin Supplementation Alleviates Oxidative DNA Damage and Lipid Peroxidation in Type 2 Diabetes: A Randomized Double‐Blind Placebo‐Controlled Clinical Trial

This study aimed to examine the effects of hesperidin supplement on the glycemic parameters, oxidative DNA damage, and lipid peroxidation in patients with type 2 diabetes. Sixty‐four patients were randomly allocated to receive 500 mg/day hesperidin or placebo capsules for 6 weeks. Data on glycemic parameters, total antioxidant capacity (TAC), 8‐hydroxydeoxyguanosine (8‐OHDG), and malondialdehyde (MDA) were collected at the baseline and at the end of the study. In hesperidin group, TAC increased (0.74 ± 0.16 vs. 0.82 ± 0.18), while serum froctoseamin (5.79 ± 5.86 vs. 5.01 ± 4.95; p  = 0.001), 8‐OHDG (14.32 ± 6.4 vs. 11.00 ± 7.0; p  = 0.000), and MDA (5.78 ± 1.76 vs. 4.60 ± 0.75; p  = 0.000) decreased in comparison with the baseline values. There was a significant difference in percent change of TAC (13.35 ± 19.21 vs. 3.13 ± 10.02; p  = 0.043), froctoseamin (?10.10 ± 16.84 vs. 4.27 ± 34.646), 8‐OHDG (?25.11 ± 28.23 vs. 8.69 ± 35.41; p  = 0.000), and MDA (?16.46 ± 18.04 vs. ?1.82 ± 22.63; p  = 0.007) between hesperidin and control groups following intervention in adjusted models. These results suggest that hesperidin may improve TAC and alleviate serum froctoseamin, 8‐OHDG, and MDA levels in type 2 diabetes. Copyright © 2017 John Wiley & Sons, Ltd.     

中医药治疗胃癌临床随机对照试验的中国文献评价

评价中医药治疗胃癌临床随机对照试验(randomized controlled trials,RCTs)文献的质量。方法:根据Co-chrane中心指南,机检和手检相结合检索2002年1月-2006年12月国内生物医学期刊和会议论著发表的有关中医药治疗胃癌的RCTs文献,按照临床流行病学原理及CONSORT声明,收集所有文献的信息,进行描述性分析和一致性检验。结果:共纳入RCTs文献79篇。其中7篇列举了具体纳入标准,占8.86%;3篇有排除标准,占3.79%;17篇有明确的中医证候分类,占21.52%;59篇文献提及疗效评价标准,占74.68%;无1篇文献交代样本含量估算情况;5篇报告了随机分配方法,占6.33%;2篇有随机分配隐藏的简单描述,占2.53%;42篇有基线资料的具体描述,占53.16%;2篇运用了盲法,占2.57%;45篇有统计学方法描述,占56.96%;46篇记录了副性事件,占58.23%;4篇提及治疗后的病例随访,占5.06%。结论:中医药治疗胃癌的RCTs质量还不够高,有待进一步提高。主要表现为随机分组方法没有说明或应用错误,随机分配隐藏没有得到足够重视,盲法使用过低,诊断标准以及受试者的纳入排除标准未充分报告,中医证候分类亟需规范统一,组间基线资料统计不全,样本量低且没有具体的估算方法,疗效评价标准不够统一,忽视依从性、病例脱落、随访情况的分析和伦理规范。     

Blood Pressure Lowering Effect of Nigella sativa L. Seed Oil in Healthy Volunteers: A Randomized,Double‐Blind,Placebo‐controlled Clinical Trial

Nigella sativa L. seeds (N. sativa) have been used as a traditional remedy for a wide range of diseases including hypertension. The present study was performed to explore the effects of N. sativa oil on blood pressure (BP) in healthy volunteers. In a double‐blind, randomized study, 70 healthy volunteers aged 34 to 63 years with systolic BP from 110 to 140 mmHg and diastolic BP from 60 to 90 mmHg were randomly allocated to receive 2.5 mL N. sativa oil or placebo two times a day for 8 weeks. The systolic and diastolic BPs, body mass index and blood levels of aspartate transaminase, alanine transaminase, alkaline phosphatase, creatinine and blood urea nitrogen were determined at baseline and endpoint. Results showed that in N. sativa oil treated group the systolic and diastolic BPs decreased significantly compared with baseline and placebo group at the endpoint. Other parameters did not significantly change in both groups at the endpoint. No adverse effects were reported. In conclusion, oral daily administration of 5 mL N. sativa oil to healthy volunteers for 8 weeks lowers systolic and diastolic BPs without any adverse effects. Copyright © 2013 John Wiley & Sons, Ltd.     

热毒宁注射液治疗儿童手足口病的随机对照研究

目的 研究热毒宁注射液治疗儿童手足口病普通型伴发热的临床疗效。     

中西医结合治疗对冠心病患者生存质量改善的随机对照研究

目的:编制一套有中华文化内涵的冠心病(CAD)生存质量量表,用以评价中西医结合治疗CAD的临床疗效。方法:采用随机、对照、单盲方法,将129例CAD患者分为中西医结合治疗组(简称治疗组)和常规治疗组(简称对照组),其中治疗组72例和对照组57例。对照组予常规西药如抗血小板药物、硝酸酯类药物、β-受体阻滞剂、钙离子拮抗剂、血管紧张素转化酶抑制剂(ACEI)等;治疗组在常规西药基础上辨证施治,加用中药汤剂和中成药。本研究主要观察治疗前后生存质量的改善情况。结果:(1)治疗后与治疗前相比,治疗组和对照组生存质量情况均有一定程度的改善,差异具有统计学意义(P0.05),但治疗组改善更明显;(2)治疗前,治疗组和对照组各维度计分差别无统计学意义(P0.05),治疗后,治疗组患者在"临床主要症状"、"疾病伴随情况"、"疾病认识程度"方面与对照组比较有提高,差异具有统计学意义(P0.05),而在其余"躯体活动受限程度"、"疾病发作情况"、"疾病诱发因素"、"治疗满意程度"四个方面两组差异无统计学意义(P0.05)。结论:(1)中西医结合治疗能显著改善冠心病患者的生存质量。(2)中西医结合治疗后的患者,生存质量随时间的推移改善越明显。     

A Novel Extract of Fenugreek Husk (FenuSMART™) Alleviates Postmenopausal Symptoms and Helps to Establish the Hormonal Balance: A Randomized,Double‐Blind,Placebo‐Controlled Study

Despite the widespread use of hormone replacement therapy, various reports on its side effects have generated an increasing interest in the development of safe natural agents for the management of postmenopausal discomforts. The present randomized, double‐blinded, placebo‐controlled study investigated the effect of 90‐day supplementation of a standardized extract of fenugreek (Trigonella foenum‐graecum) (FenuSMART?), at a dose of 1000 mg/day, on plasma estrogens and postmenopausal discomforts. Eighty‐eight women having moderate to severe postmenopausal discomforts and poor quality of life (as evidenced from the scores of Greene Climacteric Scale, short form SF‐36® and structured medical interview) were randomized either to extract‐treated (n = 44) or placebo (n = 44) groups. There was a significant (p < 0.01) increase in plasma estradiol (120%) and improvements on various postmenopausal discomforts and quality of life of the participants in the extract‐treated group, as compared with the baseline and placebo. While 32% of the subjects in the extract group reported no hot flashes after supplementation, the others had a reduction to one to two times per day from the baseline stages of three to five times a day. Further analysis of haematological and biochemical parameters revealed the safety of the extract and its plausible role in the management of lipid profile among menopausal women. Copyright © 2016 John Wiley & Sons, Ltd.     

针灸治疗慢性盆腔炎随机对照试验质量报告

目的:采用CONSORT声明和STRICTA标准评价国内针灸治疗慢性盆腔炎临床随机对照试验质量。方法:利用计算机检索与手工检索。检索CNKI、CBM、VIP和万方4个数据库,结合手工检索相关期刊,筛选出符合研究标准的文献,采用CONSORT声明和STRICTA标准进行质量评价。结果:共纳入合格文献85篇。大部分文献存在随机方法描述不清和无随机隐藏、盲法使用率低、无样本量计算、无意向治疗分析、针刺细节报道不充分、无针刺治疗医生的资历等问题。结论:针灸治疗慢性盆腔炎的临床随机对照试验质量普遍较低,影响报道的可靠性和同质可比性。为提高针灸临床随机试验可靠性和质量,应该将CONSORT声明和STRICTA标准引入针灸临床随机试验设计并严格执行。     

经皮穴位电刺激治疗肺癌术后早期睡眠障碍随机对照研究

目的 探讨经皮穴位电刺激（TEAS）对肺癌患者术后早期睡眠障碍的影响。方法 采用随机对照研究方法,筛选2023年3—7月期间空军军医大学唐都医院肺癌手术患者100例,纳入患者84例,采用随机数字表法分为电刺激组（TEAS组）与对照组（CON组）,每组42例。TEAS组从麻醉诱导前30 min至手术结束给予经皮穴位电刺激,穴位选用双侧神门（HT7）、内关（PC6）、三阴交（SP6）;对照组（CON组）只粘贴电极片连接电刺激仪,但不接通电源。通过记录两组术前24 h、术后24 h、术后72 h及出院前的匹兹堡睡眠指数量表（PSQI）和阿森斯失眠量表（AIS）评估睡眠情况,记录各时间点的疼痛视觉模拟评分（VAS）等;采用多因素Logistic回归方法,分析影响术后睡眠障碍的主要因素。结果 TEAS组术后24 h、术后72 h及出院前PSQI、AIS总分及VAS评分均低于CON组（P<0.05）;TEAS组术后24 h睡眠障碍发生率（58.8%）低于CON组（80.5%）。切口疼痛、不能翻身为术后睡眠障碍的危险因素（OR分别为19.584、9.745）,TEAS为保护因素（OR 0.22...     

Effect of Oral Silymarin Administration on Prevention of Radiotherapy Induced Mucositis: A Randomized,Double‐Blinded,Placebo‐Controlled Clinical Trial

Mucositis is a frequent severe complication of radiation therapy in patient with head and neck cancer. Silymarin is a polyphenolic flavonoid extracted from the milk thistle that exhibits strong antioxidant and antiinflammatory activities. In this study, we evaluate silymarin efficacy in prevention of radiotherapy induced mucositis in patients with head and neck cancer, as the first human study. During this pilot, randomized, double‐blinded, placebo‐controlled clinical trial, the effect of oral silymarin 420 mg daily in three divided doses starting at the first day of radiotherapy for 6 weeks, on oral mucositis occurrence was assessed. Twenty‐seven patients fulfilled the inclusion criteria assigned to the silymarin or placebo group. World Health Organization and National Cancer Institute–Common Terminology Criteria oral mucositis grading scale scores were recorded at baseline and weekly during these 6 weeks. The median World Health Organization and National Cancer Institute Common Terminology Criteria scores were significantly lower in silymarin group at the end of the first to sixth week (p < 0.05). The scores increased significantly in both placebo and silymarin groups during radiotherapy, but there was a delay for mucositis development and progression in silymarin group. Prophylactic administration of conventional form of silymarin tablets could significantly reduce the severity of radiotherapy induced mucositis and delay its occurrence in patients with head and neck cancer. Copyright © 2016 John Wiley & Sons, Ltd.