盆腔炎1号方对湿热瘀结型慢性盆腔炎患者的临床观察

目的:探讨盆腔炎1号方对湿热瘀结型慢性盆腔炎患者临床疗效以及生活质量的影响。方法:收集湿热瘀结型慢性盆腔炎患者120例作为研究对象,根据就诊序列号进行随机分组,其中对照组60例使用常规方法治疗,治疗组60例在对照组基础上联合盆腔炎1号方治疗,比较两组患者的临床治疗效果及生活质量情况。结果:两组治疗前IL-2、TNF-a、疼痛值无显著性差异,P0.05,治疗后两组均有好转,但治疗组数据和对照组有显著性差异,P0.05,有统计学意义;治疗组疗效优良率、生活质量评价LSR、LSI、LSIB分数显著高于对照组,且均具有显著性差异。结论:给予湿热瘀结型慢性盆腔炎患者在常规治疗基础上联合盆腔炎1号方治疗可显著改善临床症状、降低疼痛感,对于提高临床疗效和生活质量具有积极意义。     

Efficacy and safety of Xinfeng capsule in the treatment of osteoarthritis:a multicenter,randomized, double-blinded,controlled trial

OBJECTIVE: To evaluate the efficacy and safety of Xinfeng capsule(XFC) in patients with osteoarthritis(OA).METHODS: This was a multicenter, double-blinded,randomized, controlled, clinical trial. Patients with OA were assigned to the XFC group [treated with XFC and a glucosamine(GS) placebo, n = 129] or the GS group(treated with GS and an XFC placebo,n = 126). Both groups were treated for 4 weeks. The primary endpoint was the difference between the two groups in the Western Ontario and Mc Master ...     

Effectiveness of flesh-moistening paste in psoriasis vulgaris patients with symptom pattern of blood stasis: a randomized and parallel-controlled trial

OBJECTIVE: To evaluate the efficacy and safety of flesh-moistening paste for treating psoriasis vulgaris in patients with blood stasis pattern in terms of Traditional Chinese Medicine(TCM).METHODS: Eudipleural rashes on both the left and right side of the same patients with psoriasis vulgaris, diagnosed via TCM as blood stasis pattern,were selected as the targeted skin lesions. A randomized, double-blind, parallel-controlled, multicenter controlled trial was conducted. The targeted skin lesions ...     

针刺联合西药治疗盆腔炎性疾病后遗症慢性盆腔痛:多中心随机对照研究

目的:比较针刺联合布洛芬缓释胶囊与单纯口服布洛芬缓释胶囊治疗盆腔炎性疾病(PID)后遗症慢性盆腔痛(CPP)的疗效。方法:将144例患者随机分为观察组(72例,脱落10例)和对照组(72例,脱落9例)。对照组予口服布洛芬缓释胶囊治疗,每次1粒;观察组在对照组基础上行针刺治疗,穴取关元、水道、归来、肾俞、次髎,其中水道、归来、肾俞、次髎行电针疗法。两组均于月经来潮前10 d开始治疗,每日1次,每个月经周期治疗10 d,共治疗3个月经周期,随访3个月经周期。记录两组患者治疗前后及随访时下腹部、腰骶部视觉模拟量表(VAS)评分和治疗前后局部体征评分、生活质量量表(WHOQOL-BREF)评分。结果:与治疗前比较,两组患者治疗后及随访时下腹部、腰骶部VAS评分均降低(P<0.05),且观察组患者治疗后及随访时VAS评分均低于对照组(P<0.05)。与治疗前比较,除对照组宫骶韧带触痛评分外,两组治疗后局部体征评分均降低(P<0.05),且观察组附件区压痛评分及局部体征总评分均低于对照组(P<0.05)。与治疗前比较,两组WHOQOL-BREF生理领域评分均升高(P<0.05),观察组心理、社会关系、环境领域评分升高(P<0.05),且观察组生理领域评分高于对照组(P<0.05)。结论:针刺联合布洛芬缓释胶囊可有效改善盆腔炎性疾病所致慢性盆腔痛患者疼痛症状、体征,提高其生活质量,其疗效优于单纯口服布洛芬缓释胶囊。     

苓芍枣仁配方颗粒治疗女性膀胱过度活动症临床研究

目的 评价苓芍枣仁配方颗粒治疗女性膀胱过度活动症(overactive bladder,OAB)的疗效.方法 将符合入选标准的女性OAB患者60例,采用随机、对照、双盲的原则分为2组,每组30例.对照组采用酒石酸托特罗定缓释片联合苓芍枣仁配方颗粒安慰剂治疗,治疗组采用酒石酸托特罗定缓释片联合苓芍枣仁配方颗粒治疗,2组均治疗4周.采用膀胱过度活动症症状量表(Overactive Bladder Symptom Scale,OABSS)判定OAB严重程度.结果 治疗后14、28d,OABSS量表评分治疗组[(5.3±2.3)分、(1.4±1.2)分比(8.4±2.4)分,F=137.209]、对照组[(7.8±1.9)分、(6.8±1.4)分比(8.6±2.6)分,F=8.927]均低于同组治疗前(P<0.01),治疗组治疗后14、28d的OABSS量表评分低于对照组(t值分别为4.668、15.678,P值均<0.01);治疗组疼痛症状评分[(5.9±1.9)分、(2.7±1.1)分比(9.5±2.3)分,F=108.819]低于同组治疗前(P<0.01),治疗组治疗后14、28d疼痛症状评分低于对照组(t值分别为6.342、14.812,P值均<0.01);小腹不适评分治疗组[(1.9±1.4)分、(1.1±1.0)分比(3.3±1.1)分,F=28.762]、对照组[(2.7±1.0)、(2.4±0.8)分比(3.4±1.2)分,F=12.103]均低于同组治疗前(P<0.01),治疗组治疗后14、28d小腹不适评分低于对照组(t值分别为2.521、5.041,P<0.05或P<0.01).结论 苓芍枣仁配方颗粒可明显降低女性OAB患者OABSS评分、疼痛症状评分、小腹不适症状评分,改善临床症状.     

清利活血法治疗慢性盆腔炎30例

采用清热利湿、活血化瘀法治疗 30例慢性盆腔炎 ,痊愈 12例、显效 16例、无效 2例 ,总有效率为93% ,提示该法有较好疗效。     

Efficacy and safety of Wuling capsule,a single herbal formula,in Chinese subjects with insomnia: A multicenter,randomized, double-blind,placebo-controlled trial

Ethnopharmacological relevance

Wuling Capsule is a single herbal formula from mycelia of precious Xylaria nigripes (Kl.) Sacc and its pharmacological function have a tranquilizing effect on the central nervous system. The aim of the study to evaluate the efficacy and safety of Wuling capsule in treatment of insomnia.

Materials and methods

We performed a multicenter, randomized, double-blind, placebo-controlled study. The participants received either placebo (n=92) or Wuling capsule (n=94) for 4 weeks and a follow-up period for 2 weeks.

Results

Compared between pre-treatment and post-treatment, the global Pittsburgh sleep quality index (PSQI) scores in both Wuling capsule group and placebo group improved significantly (P<0.01). However, there was no significant difference between Wuling capsule group and placebo group (P>0.05). Scores of clinical global impressions scale (CGI-I) at each week in Wuling capsule group was similar to those in placebo group (P>0.05). Compared between pre-treatment and post-treatment, scores of the four components of world health organization on quality of life brief scale (WHOQOL-BREF) in both Wuling capsule group and placebo group improved significantly (P<0.01). However, there were no difference between the two groups (P>0.05). The rate of adverse events was 10.10% in Wuling group, and 6.73% in placebo group (P>0.05).

Conclusions

Wuling capsule can improve insomnia when compared with pre-treatment for 4 weeks and be a well tolerated by all the patients at the 6 weeks of study period. However, there are no significant in the results of the variables tested when compared with placebo control. Further additional rigorous randomized clinical trials are still required.     

Effects of Qizhukangxian granules on idiopathic pulmonary fibrosis: a randomized,double blind,placebo-controlled and multicenter clinical pilot trial

OBJECTIVE: To evaluate the effects of Qizhukangxian granules(QG) on idiopathic pulmonary fibrosis(IPF).METHODS: This is a randomized, double blind,placebo-controlled and multicenter clinical pilot trial. Six medical centers in Tianjin, China, participated in the study. A total of 120 IPF patients were enrolled and randomized into two groups,with 60 patients in each group. The treatment group was treated with QG, while the control group received a Qizhukangxian placebo. The pharmacological treatment lasted for 48 weeks from the enrollment date. The indexes of patients were recorded on the admission day and at the end of the 24 th and 48 th weeks. Data were analyzed to study the effects of QG; forced vital capacity, change in forced vital capacity and maximal 6-min walk test(6 MWT) distance were the primary endpoints. Secondary endpoints were percentage of patients with episodes of acute exacerbation of IPF, pulmonary function, changes in pulse oxygen saturation during the 6 MWT, dyspnea score, St. George's respiratory questionnaire score, arterial blood gas analyses and the total Traditional Chinese Medicine symptom pattern score.RESULTS: After 24 weeks of treatment, QG showed greater efficacy than the placebo in certain parameters, including the dyspnea score, Traditional Chinese Medicine symptom pattern score and some indicators in the St. George's respiratory questionnaire score. Analysis of the indexes obtained from all patients at the end of the 48 th week showed that the therapeutic effects in the treatment group were significantly better than those in the control group because remarkable differences were observed in most of the primary and secondary endpoints between the two groups, except for the maximal distance of the 6 MWT and arterial blood gas analyses. No adverse reaction was observed in either group during the 48-week trial treatment period.CONCLUSION: QG could effectively treat IPF patients by ameliorating pulmonary function, improving the quality of life and lowering the percentage of acute exacerbations.     

Optimized project of traditional Chinese medicine in treating chronic kidney disease stage 3: a multicenter double-blinded randomized controlled trial

Ethnopharmacological relevance

Stage 3 is the key phase of chronic kidney disease. Traditional Chinese medicine (TCM) has been used for the treatment of chronic kidney disease. But a large sample trial is desirable.

Materials and methods

A total of 578 Chinese patients with primary glomerulonephritis in CKD stage 3 were randomly assigned to three groups: patients received TCM (TCM group), benazepril (Ben group), TCM combined with benazepril (TCM + Ben group). Patients were followed up for 24 weeks. The primary endpoint was the time to the composite of 50% increased of serum creatinine, end stage renal disease or death.

Results

eGFR in the TCM and the TCM + Ben group were improved (week 24 vs. baseline, P < 0.05) while eGFR in the Ben group was decreased (week 24 vs. baseline, P > 0.05). 24 h urinary protein excretion (UP) and urinary albumin/creatinine (UAlb/Cr) were decreased in the TCM + Ben (week 24 vs. baseline, P < 0.05) and the Ben group (week 24 vs. baseline, P > 0.05). UP and UAlb/Cr were increased in the TCM group to week 12, then were stable (week 24 vs. baseline, P < 0.05). The hemoglobin in the TCM group was also improved (week 24 vs. baseline, P < 0.05). The accumulative survival rate in the TCM + Ben group was higher than that in the TCM group and the Ben group (P = 0.044). Side effects in the TCM group were the lowest in these groups (P < 0.05). The patients with dry cough in the TCM + Ben group and the Ben group were increased as compared with the TCM group (P < 0.05). Hyperkalemia happened less frequently in the TCM group as compared with the other two groups (P = 0.052).

Conclusions

For the patients with CKD stage 3, TCM can improve eGFR and hemoglobin with lower side effects. Benazepril significantly decreased the proteinuria. Chinese medicine integrated with benazepril can ameliorate renal function and decrease proteinuria synergistically.     

Chinese herbal medicine for chronic heart failure: a multicenter,randomized, double-blind,placebo-controlled trial

ObjectiveThe purpose of this study was to assess the efficacy and safety of Chinese herbal medicine (CHM) in the treatment of chronic heart failure (CHF) patients according to syndrome differentiation.MethodsIn this multicenter, randomized, double-blind, placebo-controlled clinical trial, a total of 220 CHF patients were assigned to receive CHM or placebo granules without decoction according to syndrome differentiation in addition to their standard western treatment for 4 weeks. The change in the left ventricular ejection fraction (LVEF) was the primary outcome, and the changes in the TCM syndrome scores (TCM-SS) and New York Heart Association functional classification (NYHA-FC) were the secondary outcomes.ResultsAfter 4 weeks of treatment, the mean changes in the LVEF (13.1 ± 9.78 vs. 7.34 ± 7.40, P < 0.001) and the TCM syndrome scores (−34.2 ± 24.6 vs. −23.5 ± 25.2, P = 0.002) were better in the CHM group than in the placebo group. After two weeks of treatment, the mean changes in the LVEF (9.26 ± 7.83 vs. 4.72 ± 5.60, P < 0.001) and the TCM syndrome scores (−23.5 ± 18.6 vs. −14.0 ± 15.9, P < 0.001) were better in the CHM group than in the placebo group. In addition, repeated-measures analysis of variance (ANOVA) indicated significant time course effects of CHM versus placebo in the LVEF and TCM syndrome cores (P < 0.001 for all). The distention of the jugular vein (P = 0.021), expectoration (P = 0.044), abdominal distention (P = 0.004), and rib pain (P = 0.005) were significantly less in the CHM group than in the placebo group after two weeks of treatment. Fatigue (P = 0.001), less gas and lazy words (P = 0.001), dizziness (P = 0.003), gasping for breath (P = 0.027), abdominal distention (P = 0.011), nausea (P = 0.001) and emesis (P = 0.012) were significantly less in the CHM group than in the placebo group after treatment for four weeks. After four weeks of treatment, the change in the NYHA functional classification in the CHM group was better than that in the placebo group (P < 0.001). There was one death in the placebo group, and one patient in the CHM group experienced atrial fibrillation.ConclusionCHM treatment according to syndrome differentiation effectively improved the LVEF, TCM-SS, and NYHA-FC in patients with CHF and also appeared to be safe. Thus, CHM treatment could be used as an adjuvant therapy in the treatment of CHF (Clinical trial registration: NCT01939236).     

Treatment with rhubarb improves brachial artery endothelial function in patients with atherosclerosis: a randomized, double-blind, placebo-controlled clinical trial

Rhubarb has been used to decrease plasma cholesterol levels and reduce vascular endothelial cellular damage in recent years. However, it is not known whether reported lipid-lowering effects are associated with the improvement of endothelial function. This work aimed to elucidate the therapeutic effects of rhubarb on serum lipids and brachial artery endothelial function, as well as to investigate the relationship between them. One hundred and three patients with atherosclerosis were randomly divided into two groups: patients in the control and the trial group received a placebo and rhubarb, respectively, in addition to the 6 month baseline therapy. Serum lipids and brachial artery endothelial functions were measured in all patients before and after treatment. A total of 83 patients completed the 6-month follow-up protocol. Serum total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) in the trial group decreased significantly and LDL-C was significantly lower than that in the control group. Flow-mediated dilation (FMD) in the trial group was significantly higher after treatment in comparison to the baseline and to the control group. Improvement in FMD correlated with the decreased magnitude of TC and LDL-C levels. The results obtained appeared to confirm that rhubarb significantly improves endothelial function mainly due to lipid-lowering effects in patients with atherosclerosis.     

Effects of 650 nm - 10.6 μm Combined Laser Acupuncture- Moxibustion on Knee Osteoarthritis： A Randomized,Double-blinded and Placebo-controlled Clinical Trial

目的：观察650nm-10．6μm复合激光治疗膝骨关节炎患者的有效性以及与红光照射相比，在减轻疼痛和改善关节功能方面是否具有更好疗效。方法：48名膝骨关节炎患者被随机分到两组（每组24人），分别接受650nm-10．6μm复合激光或红光照射犊鼻穴，每次治疗20min，第一疗程（共2星期）每星期治疗3次，第二疗程（共4星期）每星期治疗2次。主要结果采用McMaster大学关节炎量表（Western Ontario and McMaster Universities Osteoarthritis Index，WOMAC）进行打分。并对患者关于疗效的自评、治疗的副作用及盲法的有效性进行统计分析。结果：所有患者均完成了第一疗程，但有12名患者在第二疗程脱落。由于第二疗程的脱落率较高，故只对第一疗程的数据进行分析。治疗前，两组患者一般情况及WOMAC得分无显著性差异（P〉0．05）。治疗后，复合激光组及红光照射组患者WOMAC得分与基线期相比均有显著降低（P〈0．01）。两组患者WOMAC得分改善率比较无显著性差异（P〉0．05）。两组患者对疗效的自评及脱落率比较均无统计学差异（P〉0．05）。两组患者对自己所属分组的猜测无统计学差异（P〉0．05），且两组患者对自己所属分组的猜测未对其WOMAC得分改善率及对疗效的自评产生影响（P〉0．05）.结论：复合激光和红光照射犊鼻穴对膝骨关节炎患者均有疗效，需扩大样本量，控制脱落率，以进一步观察两者的差异。     

Immunomodulatory effects of saffron: a randomized double-blind placebo-controlled clinical trial

Saffron is the dried stigmata of the flowers of saffron (Crocus sativus L.). Saffron is rich in carotenoids and carotenoids affect immunity. Thus, in this randomized double‐blind placebo‐controlled clinical trial with healthy men aged 21.4 ± 0.8 years (mean ± SE), the effects of taking one 100 mg saffron tablet daily for 6 weeks on the blood serum levels of IgG, IgM, IgA, C₃ and C₄ complements, counts and percentages of white blood cells, platelets, neutrophils, eosinophils, basophils, lymphocytes and monocytes, levels of some hematological parameters and levels of creatinine, SGOT and SGPT were evaluated in 45 subjects and compared with the placebo group (n = 44). After 3 weeks, saffron increased the IgG level and decreased the IgM level compared with the baseline and placebo (p < 0.01), decreased the percentage of basophils and the count of platelets compared with baseline, but increased the percentage of monocytes compared with placebo (p < 0.05). However, these parameters returned to the baseline levels after 6 weeks. Saffron did not have any significant effects on the other parameters. No adverse effects were reported. The results suggest that the sub‐chronic daily use of 100 mg saffron has temporary immunomodulatory activities without any adverse effects. Copyright © 2011 John Wiley & Sons, Ltd.     

Heyan Kuntai capsule versus dehydroepiandrosterone in treating Chinese patients with infertility caused by diminished ovarian reserve: a multicenter,randomized controlled trial

OBJECTIVE: To evaluate the clinical efficacy and safety of Heyan Kuntai capsule(HYKT) in treating women with infertility caused by diminished ovarian reserve(DOR).METHODS: One hundred eight eligible patientsfrom three Chinese hospitals were randomly divided into an HYKT treatment group(n = 55) or a dehydroepiandrosterone(DHEA) treatment group(n =53). Patients in the HYKT group were treated orally with four 0.5 g HYKT three times a day; patients in the DHEA group were treated with one 25.0 mg DHEA capsule three times a day. All patients were treated for 3 months and followed up over a3-month period.RESULTS: Of 108 patients, 12 dropped out: six from the HYKT group, and six from the DHEA group. Eleven patients got pregnant during the treatment. Serum anti-Müllerian hormone levels and antral follicle counts increased significantly in both groups after treatment(P 0.05) especially in the HYKT group(P 0.05). Serum follicle stimulating hormone(FSH) levels and FSH/luteinizing hormone ratios decreased(P 0.05) with no significant difference between the two groups. Estradiol levels in the HYKT group and DHEA-sulfate levels in the DHEA group both increased(P 0.05). The spontaneous pregnancy rates were 12% and 11% in the HYKT and DHEA groups, respectively(not significant). During the follow-up period, 16 patients in the HYKT group underwent in vitro fertilization-embryo transfer(IVF-ET) and the number of retrieved oocytes was(5.1 ± 1.8). In DHEA group, 20 patients underwent IVF-ET and the number of retrieved oocyte was(4.2 ± 1.9)(not significant); clinical pregnancy rates were 38% in the HYKT group and 20%in DHEA group(not significant). No significant adverse reactions were observed.CONCLUSION: HYKT can improve the ovarian re-serve and hormone levels in patients with infertility caused by DOR. Pregnancy rates after HYKT treatment were similar to those of DHEA treatment.HYKT might be an alternative to the treatment of infertility caused by DOR.     

The effects of fenugreek seed extract supplementation in patients with Alzheimer's disease: A randomized,double-blind,placebo-controlled trial

The aim of the current randomized control trial (RCT) study was to investigate the effects of fenugreek seed extract on memory, depression, quality of life, blood pressure, and serum malondialdehyde (MDA) and total antioxidant capacity (TAC) levels in adult AD patients. This randomized clinical trial was conducted in geriatric homes in Iran. The study participants included 82 AD patients with mild-to-moderate memory deficit. Patients in the intervention group received 5 cc of fenugreek seed extract for 4 months and subjects in the control group received a placebo. Memory, depression, quality of life, and BP levels, as well as serum MDA and TAC, were assessed before and after the intervention. There was a significant increase in serum levels of TAC (p < 0.001) and a reduction in serum MDA status (p < 0.001) after 4 months of fenugreek seed extract supplementation. In addition, increasing levels of memory (p < 0.001) and quality of life (p < 0.001), as well as reduction of depression (p = 0.002), systolic BP (p < 0.001), and diastolic BP (p < 0.001) levels were detected in the intervention group compared with baseline. Fenugreek seed extract supplementation in AD patients shows promising positive effects on memory, quality of life, BP, and selective oxidative indices levels.     

穴位埋线治疗胃热湿阻型单纯性肥胖:随机对照研究

目的:观察穴位埋线治疗胃热湿阻型单纯性肥胖的疗效与安全性。方法:将144例胃热湿阻型单纯性肥胖患者随机分为穴位埋线组(72例,脱落3例,剔除1例)和假埋线组(72例,脱落6例,剔除3例)。两组在生活方式干预的前提下,穴位埋线组于天枢、中脘、肝俞、水道等穴采用PGLA线进行埋线;假埋线组,取穴及操作同穴位埋线组,但不埋入线体。两组均2周1次,连续治疗12周,并于治疗后3个月随访。治疗前后和随访时,观察两组患者肥胖程度指标[体质量指数(BMI)、腰围(WC)、腰臀比(WHR)和脂肪百分率(F%)];治疗前后,观察两组患者血糖和胰岛素指标[空腹血糖(FBG)、空腹胰岛素(FINS)、胰岛素抵抗指数(HOMA-IR)]、脂肪细胞因子指标[脂联素、瘦素(LP)、丝氨酸蛋白酶抑制剂(Vaspin)]、炎性因子指标[肿瘤坏死因子α(TNF-α)、白细胞介素1β(IL-1β)和白细胞介素6(IL-6)],并比较两组疗效及安全性。结果:治疗后和随访时,除假埋线组WC、WHR外,两组BMI、WC、WHR和F%均较治疗前降低(P<0.01,P<0.05),且穴位埋线组均低于假埋线组(P<0.01)。治疗后,除假埋线组FBG、LP和Vaspin外,两组FBG、FINS、HOMA-IR、LP和Vaspin均较治疗前降低(P<0.01,P<0.05),脂联素较治疗前升高(P<0.01,P<0.05),且穴位埋线组以上指标均优于假埋线组(P<0.01)。治疗后,穴位埋线组血清TNF-α、IL-1β、IL-6水平较治疗前及假埋线组降低(P<0.01)。穴位埋线组总有效率为89.7%(61/68),高于假埋线组的19.0%(12/63,P<0.01)。两组均无严重不良反应发生。结论:PGLA线穴位埋线治疗胃热湿阻型单纯性肥胖可减轻患者肥胖程度,调节糖代谢和脂肪细胞因子,改善胰岛素抵抗,抑制促炎性因子表达,具有较好的安全性。     

Yukmijihwang-tang derivatives enhance cognitive processing in normal young adults: a double-blinded, placebo-controlled trial

Yukmijihwang-tang (YMJ), also known as Luweidihuang-tang in China, has been widely used as a general herbal tonic for hundreds of years in many Asian countries. This study examines whether YMJ derivatives (YMJd) enhance cognitive ability in normal human subjects and discusses its potential as treatment for dementia patients with deficient cognitive ability. Subjects were divided into two groups, the placebo-treated group (n = 15) and the YMJd-treated group (n = 20). K-WAIS tests, a Korean version of an individual intelligence quotient (IQ) test, and a P300 latency assessment of event-related potential (ERP) were conducted in order to measure changes in cognitive ability before and after 6 weeks of YMJd treatment. The K-WAIS mean scores of the group treated with YMJd were significantly higher than those of the placebo group (p < 0.05), and their mean P300 latency was substantially shorter (p < 0.005). These results suggest that YMJd treatment accelerates the speed of information processing and enhances cognitive ability. YMJd treatment may help dementia patients or the elderly recover from cognition deficiencies or degeneration in clinic.     

不同剂量桂枝茯苓胶囊治疗原发性痛经疗效探索研究

评价不同剂量桂枝茯苓胶囊治疗原发性痛经的临床有效性及安全性.将240例年龄18~30岁的原发性痛经患者按1∶1∶1的比例随机分为试验高剂量组、试验低剂量组和安慰剂组,每组各80例,连续治疗3个月经周期并随访3个月经周期,采用视觉模拟标尺法(VAS)对痛经疼痛程度进行比较.治疗期试验高剂量组、试验低剂量组、安慰剂组治疗期有效率分别为68.42%,67.57%,47.89%,试验组均优于安慰剂组(P<0.001);随访期试验高剂量组、试验低剂量组、安慰剂组有效率分别为73.68%,72.97%,53.52%,试验组均优于安慰剂组(P<0.005);治疗期试验高剂量组、试验低剂量组、安慰剂组疼痛持续时间分别下降57.88%,46.17%,30.40%;随访期试验高剂量组、试验低剂量组和安慰剂组疼痛持续时间分别下降67.93%,53.56%,47.46%,试验组疼痛持续时间下降率均优于安慰剂组,差异有显著性统计学意义(P<0.000 1),试验高剂量组疼痛持续时间下降率优于低剂量组,差异有统计学意义(P<0.05).试验高剂量组与低剂量组疗效呈现出一定的量效趋势,均无严重不良反应.桂枝茯苓胶囊高剂量组及低剂量组均能够显著缓解患者疼痛、改善患者症状,减少疼痛持续时间,对原发性痛经患者具有较好的总体治疗效果和远期治疗效应.     

Efficacy and tolerability of a standardized willow bark extract in patients with osteoarthritis: randomized placebo-controlled, double blind clinical trial.

This study assessed the clinical efficacy of a chemically standardized willow bark extract in the treatment of osteoarthritis. Willow bark extract, in a dose corresponding to 240 mg salicin/day, was compared with placebo in a 2-week, double-blind, randomized controlled trial. The primary outcome measure was the pain dimension of the WOMAC Osteoarthritis Index. Secondary outcome measures included the stiffness and physical function dimensions of the WOMAC, daily visual analogue scales (VAS) on pain and physical function, and final overall assessments by both patients and investigators. A total of 78 patients (39 willow bark extract, 39 placebo) participated in the trial. A statistically significant difference between the active treatment and the placebo group was observed in the WOMAC pain dimension (d = 6.5 mm, 95% C.I. = 0.2-12.7 mm, p = 0.047); the WOMAC pain score was reduced by 14% from the baseline level after 2 weeks of active treatment, compared with an increase of 2% in the placebo group. The patient diary VAS confirmed this result, and likewise the final overall assessments showed superiority of the willow bark extract over the placebo (patients' assessment, p = 0.0002; investigators' assessment, p = 0.0073). It is concluded that the willow bark extract showed a moderate analgesic effect in osteoarthritis and appeared to be well tolerated.