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1.
The efficacy and safety of SKI306X, an herbal anti-arthritic agent, was compared with that of diclofenac sodium for the treatment of osteoarthritis of the knee. In a randomized, double-blind, active comparator-controlled trial, a total of 249 patients were randomly assigned to receive either 200 mg of SKI306X three times daily or 100 mg of diclofenac sustained release (SR) once daily. Clinical efficacy variables (visual analog scale, Lesquesne index and global satisfaction score) and adverse events were monitored at baseline and 2nd and 4th weeks of treatment. SKI306X demonstrated efficacy statistically comparable to that of diclofenac, as assessed by the VAS and patients' and investigators' global satisfaction score. Both treatments were well tolerated, however, the SKI306X treatment group experienced less heartburn (4.0% versus 13.7%, p = 0.015, chi-square test). In this four-week trial, SKI306X was well tolerated and demonstrated clinical efficacy comparable to that of diclofenac SR.  相似文献   

2.
Clematis mandshurica protected to apoptosis of rat chondrocytes   总被引:2,自引:0,他引:2  
OBJECTIVE: To investigate the effect of SKI 306X, a purified extract from the mixture of three herbs, i.e. Clematis mandshurica, Trichosanthes kirilowii and Prunella vulgaris, on apoptosis in chondrocytes. DESIGN: Rat chondrocyte cell line RCJ3.1C.18 cells were incubated with 1 microM staurosporin and SKI 306X or each of its components. Cell viability was determined by trypan blue exclusion assay. Induction of apoptosis was determined by nuclear condensation or fragmentation after Hoechst staining. Amount of apoptosis was quantified both by nuclear morphology and flow cytometry. Expression level of Bcl-2, and caspase-3 and PARP activations were assayed by Western blot. RESULTS: SKI 306X significantly prevented staurosporin-induced apoptosis. Among its three components, only Clematis mandshurica significantly decreased the amount of staurosporin-induced apoptosis. Although the level of Bcl-2 expression was decreased after staurosporin treatment, it was sustained after the combination treatment with Clematis mandshurica. Whereas staurosporin induced the degradation of 32 kDa caspase-3 precursor and the production of 85-kDa cleavage products of PARP in a time-dependent fashion, Clematis mandshurica treatment prevented those manifestations. CONCLUSIONS: Pharmacological efficacy of SKI 306X protecting osteoarthritis in part may result from the inhibition of apoptosis in chondrocytes by Clematis mandshurica.  相似文献   

3.
Herbal medicinal products (HMPs) are used in a variety of oral and topical forms for the treatment of osteoarthritis. The aim of this study was to update a previous systematic review published in 2000. We searched electronic databases (MEDLINE, EMBASE, CISCOM, AMED, CINAHL, Cochrane registers) to June 2007, unrestricted by date or language, and included randomized controlled trials that compared HMPs with inert (placebo) or active controls in patients with osteoarthritis. Five reviewers contributed to data extraction. Disagreements were discussed and resolved by consensus with reference to Cochrane guidelines and advice from the Cochrane Collaboration. Thirty‐five studies (30 studies identified for this review update, and 5 studies included in the original review) evaluating the effectiveness of 22 HMPs were included. However, due to differing HMPs, interventions, comparators, and outcome measures, meta‐analysis was restricted to data from studies of three HMPs: topical capsaicin, avocado‐soybean unsaponifiables, and the Chinese herbal mixture SKI306X showed benefit in the alleviation of osteoarthritic pain. Several studies investigating products from devil's claw, and a powder from rose hip and seed, reported favorable effects on osteoarthritic pain, whereas two studies of a willow bark extract returned disparate results. Three studies of Phytodolor NR were of limited use because doses and measures were inconsistent among trials. The remaining single studies for each HMP provided moderate evidence of effectiveness. No serious side effects were reported with any herbal intervention. Despite some evidence, the effectiveness of none of the HMPs is proven beyond doubt. The obvious potential benefits of HMPs in the treatment of osteoarthritis are reduced reliance on synthetic medications with the associated risks of harmful adverse events, but further clinical trials are necessary before HMPs can be adopted in osteoarthritis treatment guidelines. Copyright © 2009 John Wiley & Sons, Ltd.  相似文献   

4.
The clinical efficacy of a herbomineral formulation containing roots of Withania somnifera, the stem of Boswellia serrata, rhizomes of Curcuma longa and a zinc complex (Articulin-F), was evaluated in a randomized, double-blind, placebo controlled, cross-over study in patients with osteoarthritis. After a one-month single blind run-in period, 42 patients with osteoarthritis were randomly allocated to receive either a drug treatment or a matching placebo for a period of three months. After a 15-day wash-out period the patients were transferred to the other treatment for a further period of three months. Clinical efficacy was evaluated every fortnight on the basis of severity of pain, morning stiffness, Ritchie articular index, joint score, disability score and grip strength. Other parameters like erythrocyte sedimentation rate and radiological examination were carried out on a monthly basis. Treatment with the herbomineral formulation produced a significant drop in severity of pain (P less than 0.001) and disability score (P less than 0.05). Radiological assessment, however, did not show any significant changes in both the groups. Side effects observed with this formulation did not necessitate withdrawal of treatment.  相似文献   

5.
A double‐blind, placebo‐controlled human trial was conducted to evaluate the safety and efficacy of a standardized oral supplementation of Boswellin®, a novel extract of Boswellia serrata extract (BSE) containing 3‐acetyl‐11‐keto‐β‐boswellic acid (AKBBA) with β‐boswellic acid (BBA). A total of 48 patients with osteoarthritis (OA) of the knee were randomized and allocated to the BSE and placebo groups for intervention. Patients were administered BSE or placebo for a period of 120 days. The trial results revealed that BSE treatment significantly improved the physical function of the patients by reducing pain and stiffness compared with placebo. Radiographic assessments showed improved knee joint gap and reduced osteophytes (spur) confirming the efficacy of BSE treatment. BSE also significantly reduced the serum levels of high‐sensitive C‐reactive protein, a potential inflammatory marker associated with OA of the knee. No serious adverse events were reported. This is the first study with BSE conducted for a period of 120 days, longer than any other previous clinical trial on patients with OA of the knee. The findings provide evidence that biologically active constituents of BSE, namely, AKBBA and BBA, act synergistically to exert anti‐inflammatory/anti‐arthritic activity showing improvement in physical and functional ability and reducing the pain and stiffness.  相似文献   

6.
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.  相似文献   

7.
BACKGROUND: Intermittent allergic rhinitis (IAR) causes patients distress and impairs their work performance and quality of life. A variety of medicines are used by sufferers whose anguish frequently leads to trying new treatments, increasingly from herbal sources. METHODS: Prospective, randomized, double-blind, parallel group comparison study of Butterbur extract (Ze 339; 8 mg total petasine; one tablet thrice-daily), fexofenadine (Telfast 180, one tablet once-daily) and placebo in 330 patients. Protocol and analysis were according to the latest guidelines on new treatments for allergic rhinitis. The primary efficacy variable was a change in symptoms from baseline to endpoint during daytime. The secondary efficacy variables were: (a) as per primary variable (evening/night); (b) Physician's global assessment; (c) Responder rates. Safety was closely monitored. FINDINGS: Both active treatments were individually significantly superior to placebo (p<0.001) in improving symptoms of IAR, while there were no differences between the two active treatments (p=0.37). Superiority to placebo was similarly shown during the evening/night (p<0.001), by physicians' own assessment and by responder rates. Both treatments were well tolerated. INTERPRETATION: Butterbur Ze 339 and Fexofenadine are comparably efficacious relative to placebo. Despite being a herbal drug, Butterbur Ze 339 has now been subject to a series of well controlled trials and should be considered as an alternative treatment for IAR.  相似文献   

8.
Andrographis paniculata Wall (Acanthaceae) is becoming more recognized for its anti‐inflammatory and antioxidant properties. A randomized, double‐blind, placebo‐controlled study was conducted to assess the efficacy of an andrographolide‐containing supplement, ParActin® (300 and 600 mg daily), on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain reduction in patients with knee osteoarthritis. Joint stiffness, physical function, changes in the SF‐36 quality of life questionnaire, a fatigue scale, and safety were also evaluated. A total of 103 male and female patients with I‐II osteoarthritis of the knee joint were assessed. Patients treated with 300 or 600 mg/day of ParActin® showed a significant reduction in pain at days 28, 56, and 84 compared with a placebo group. WOMAC stiffness scores, physical function score, and the fatigue score showed a significant improvement in both ParActin®‐treated groups compared with the placebo group. At the end of the study, the quality of life (SF‐36 questionnaire) and Functional Assessment of Chronic Illness Therapy (FACIT) scores showed significant improvements in both ParActin®‐treated groups compared with the placebo group. Overall, it can be concluded that ParActin® in 300 and 600 mg/day dosages were found to be effective and safe in reducing pain in individuals suffering from mild to moderate knee osteoarthritis.  相似文献   

9.
目的:探讨肾康注射液联合血液透析治疗慢性肾功能衰竭(CRF)患者的临床疗效。方法:将41例慢性肾衰终末期维持血透患者随机分成肾康注射液治疗组(简称治疗组)19例和单纯血透治疗对照组(简称对照组)22例,两组均进行标准的透析方法,在对症处理相同的条件下维持血透治疗。对照组每周3次血液透析治疗,治疗组在进行对症治疗的基础上,每周透析2次,每次透析完后给予肾康注射液。分别观察两组患者血肌酐(Scr)和血尿素氮(BUN)水平、透析充分性、营养状况、中医证候等方面的变化。结果:治疗组与对照组在肾功能、透析充分性、营养指标及电解质方面均无显著差异(P>0.05);治疗组中医证候疗效总有效率84.21%,对照组45.45%,治疗组优于对照组(P<0.05);两组肌肤甲错、肢体麻木、大便干结症状改善不明显,差异无统计学意义(P>0.05);倦怠乏力、气短懒言、食少纳呆、头晕、头痛、腰痛、自汗症状改善明显,差异有统计学意义(P<0.05),治疗组优于对照组。两组在治疗前后均进行了三大常规、心电图、肝功能、肾功能、电解质检查,无异常表现。治疗组患者在使用肾康注射液期间,未发现有明显不良反应,安全性较好。结论:肾康注射液联合血液透析治疗慢性肾功能衰竭,能够改善患者的临床症状,提高患者的生活质量。在达到充分透析的情况下,肾康注射液有可能减少每周的透析次数。  相似文献   

10.
运用膝关节熏洗器中药熏洗治疗膝骨关节炎的临床研究   总被引:1,自引:0,他引:1  
目的观察运用膝关节熏洗器中药熏洗治疗膝骨关节炎的临床疗效。方法将120例膝骨关节炎患者随机分为治疗组和对照组各60例,对照组采用中药热敷加红外光治疗,治疗组运用膝关节熏洗器进行中药熏洗治疗,2组疗程均为3周。观察2组治疗后VAS疼痛评分和Lequesne指数改善情况、临床疗效、舒适率和不良反应发生情况。结果 2组治疗后VAS疼痛评分、Lequesne功能指数、临床疗效及舒适率比较均有显著性差异,治疗组无明显不良反应。结论运用膝关节熏洗器中药熏洗治疗膝骨关节炎疗效显著,舒适性和安全性好,值得推广应用。  相似文献   

11.
目的观察运用膝关节熏洗器中药熏洗治疗膝骨关节炎的临床疗效。方法将120例膝骨关节炎患者随机分为治疗组和对照组各60例,对照组采用中药热敷加红外光治疗,治疗组运用膝关节熏洗器进行中药熏洗治疗,2组疗程均为3周。观察2组治疗后VAS疼痛评分和Lequesne指数改善情况、临床疗效、舒适率和不良反应发生情况。结果 2组治疗后VAS疼痛评分、Lequesne功能指数、临床疗效及舒适率比较均有显著性差异,治疗组无明显不良反应。结论运用膝关节熏洗器中药熏洗治疗膝骨关节炎疗效显著,舒适性和安全性好,值得推广应用。  相似文献   

12.
BackgroundOral mucositis (OM) is one of the most common complications of mucotoxic cancer therapy. Mucositis induces clinically significant pain, increases the risk of infections and affects the patients’ quality of life.ObjectiveThis study investigated the effects of an herbal preparation from Plantago ovata hydrocolloid in the prevention and treatment of OM, in breast cancer patients undergoing chemotherapy with a regimen including adriamycin.Design, setting, participants, and interventionsThis research was a double-blind, randomized, controlled crossover trial. The herbal compound consisted of a mixture of 500 mg of P. ovate husk in 30 mL water plus three drops of vinegar per dose, which was used as a mouthwash. Phytochemical and physicochemical tests of the compound were also performed. Twenty-eight patients who developed mucositis during the chemotherapy screening cycle were randomized to the herbal compound (n = 14) and placebo (n = 14) groups. They received herbal compound or placebo three times per day during their next chemotherapy cycle (cycle 1 of treatment). Patients were crossed over during cycle 2 of treatment and received the alternative therapy. An oral care protocol was prescribed to all patients in cycles 1 and 2 of the treatment.Main outcome measuresThe patients were visited at baseline, the end of the first and second weeks of the screening cycle, and the end of the first and second weeks of each of two treatment cycles. The degree of mucositis was used as the main treatment outcome. Other indexes, such as the severity of pain, xerostomia grade and the quality of life were also measured.ResultsCompared with the placebo, the herbal compound significantly reduced the degree of mucositis, the severity of pain and the xerostomia grade; it also improved the patients’ quality of life (P < 0.05). Comparison between the screening cycle and placebo treatment group showed that the oral care protocol had a significant effect in the reduction of OM (P < 0.05).ConclusionThe oral care protocol and the herbal compound based on P. ovata are effective ways for preventing and treating OM in patients undergoing mucotoxic cancer therapy.Trial registrationIranian registry of clinical trials IRCT20180923041093N1.  相似文献   

13.
The study was designed to investigate efficacy and safety of Astragalus membranaceus (AM) in the treatment of patients with seasonal allergic rhinitis (SAR). AM is an active component in the herbal and mineral complex (HMC) registered in Croatia as a food supplement Lectranal®. The study was designed as a 6‐weeks, double‐blind, placebo‐controlled clinical trial and conducted in 48 adult patients with a moderate to severe SAR. The treatment efficacy was evaluated by the mean change in the symptom score (TSS), quality of life (QoL), specific serum IgE and IgG, nasal eosinophils, and physicians' and patients' global evaluation. Compared to placebo, HMC significantly decreased the intensity of rhinorrhea while for other primary efficacy variables the treatment groups did not differ. In contrast, investigators and patients equally judged the treatment with HMC as more efficacious. In addition, the analysis of changes from baseline inside the groups for TSS, QoL, and 4 main symptoms of SAR were strikingly in favor of the active treatment. In patients with SAR due to weed pollen allergy HMC significantly improved primary variables, reflective TSS and QoL. The study revealed a significant number of positive signals indicating the therapeutic effectiveness of the HMC in patients with SAR which should be further tested in larger, multicentre trials with more patients. Copyright © 2009 John Wiley & Sons, Ltd.  相似文献   

14.
中西医结合治疗膝关节骨性关节炎32例   总被引:1,自引:1,他引:1  
左可斌  张琳 《西部中医药》2010,23(10):29-30
目的:观察"输液式"关节冲洗配合中药内服外洗治疗膝关节骨性关节炎的疗效。方法:采用关节冲洗配合内服仙灵骨葆及外用中药熏洗治疗膝关节骨性关节炎32例。结果:32例经治疗总有效率为93%。结论:"输液式"关节冲洗术配合中药内服外洗治疗膝骨性关节炎创伤小、操作简便、安全可靠、疗效肯定。  相似文献   

15.
目的:探讨手法为主四联疗法治疗膝骨性关节炎的临床效果。方法:将膝骨性关节炎患者240例,随机分为两组,对照组120例单纯采用玻璃酸钠膝关节腔内注射,每周1次,5次为1疗程;治疗组120例为手法为主的四联疗法组,施行中医推拿手法为主,我院自拟中药方内服加外熏洗,以及玻璃酸钠膝关节腔内注射四联治疗方案,1月为1疗程。分别于治疗前及治疗后1月、3个月、随访12个月对膝关节进行评分,包括膝关节功能指数、疼痛、肿胀各项指标,对所得数据进行统计学分析。结果:治疗组总有效率为95.8%,对照组总有效率为70.8%,两组比较差异有统计学意义(P〈0.01)。结论:采用中医推拿手法为主,自拟中药方内服加外熏洗,玻璃酸钠膝关节腔内注射四联疗法治疗膝骨性关节炎具有良好的临床效果,值得推广应用。  相似文献   

16.
The purpose of this study is to explore the psychological efficacy of Xinwei Decoction, a traditional Chinese herbal medicine, to treat functional dyspepsia (FD) accompanied with depression and anxiety. Seventy-three subjects, divided into three groups, had been given herbal medicine (Xinwei Decoction), prokinetic agent (Domperidone) and placebo, respectively for 8 weeks. Before and after treatment, all subjects were examined with FD symptom scale, Hamilton Depression Scale (HAMD) and Hamilton Anxiety Scale (HAMA). As a result, the total scores of the three groups in FD symptom scale, HAMD and HAMA after treatment decreased in different levels, with the decrease in the herbal group more significant than the other two groups (p < 0.01), indicating the efficacy of the herbal medicine. The total effective rates of the herbal, Domperidone and placebo groups were 90%, 67% and 31%, respectively, which indicated significant effect differences between Xinwei Decoction and Domperidone (p < 0.05) and between Xinwei Decoction and placebo (p < 0.01), showing that the efficacy of herbal therapy was superior to that of the other two therapies. Furthermore, there was no one in the Domperidone and placebo groups being cured of depression and anxiety, while the curing rate in the herbal group was about 70%, indicating the efficacy of herbal medicine in comparison to that of Domperidone and placebo for anti-depression and anti-anxiety. The result demonstrated that Xinwei Decoction could not only alleviate FD symptoms but also relieve depression and anxiety.  相似文献   

17.
A randomized, double‐blind, comparative clinical study was conducted to compare the safety and efficacy of castor oil with diclofenac sodium in patients with knee osteoarthritis. Subjects with symptoms of knee osteoarthritis were given a castor oil capsule 0.9 mL (n = 50) thrice daily for 4 weeks or a capsule of diclofenac sodium (n = 50), 50 mg thrice daily for 4 weeks. The subjects completed an overall evaluation of symptom relief at 2 weeks and 4 weeks of completed treatment. The subjects were evaluated by clinical, routine laboratory and radiographic investigations for improvement of disease conditions and also for adverse drug reaction. On completion of 4 weeks treatment it was observed that both drugs were significantly effective in the treatment of knee osteoarthritis (p < 0.001) and adverse drug reactions were high with diclofenac sodium, whereas with castor oil there were no adverse effects reported. The present study indicates that castor oil can be used as an effective therapy in primary knee osteoarthritis. Copyright © 2009 John Wiley & Sons, Ltd.  相似文献   

18.
中药外敷为主治疗膝骨关节炎疗效观察   总被引:4,自引:0,他引:4  
目的观察中药外敷配合透明质酸钠凝胶注射治疗膝骨关节炎的疗效。方法将135例患者随机分为治疗组72例,对照组63例,治疗组采用中药外敷配合透明质酸钠凝胶注射,对照组口服芬必得配合推拿局部。结果治疗3星期后治疗组有效率91.67%,对照组为52.38%,经χ^2检验P〈0.01,差异有统计学意义。结论中药外敷配合透明质酸钠凝胶注射治疗膝骨关节炎疗效优于芬必得。  相似文献   

19.
The aim of this double-blind, placebo-controlled study was to evaluate the efficacy of 100 mg Pycnogenol daily (oral capsules) in a 3 month study in patients with osteoarthritis (OA). OA symptoms were evaluated by WOMAC scores, mobility by recording their walking performance (treadmill). Treatment (77 patients) and placebo group (79) were comparable for age, sex distribution, WOMAC scores, walking distances and use of antiinflammatory drugs. The global WOMAC score decreased by 56% (p < 0.05) in the treatment group versus 9.6% in the placebo group. Walking distance in the treadmill test was prolonged from 68 m at the start to 198 m after 3 months treatment (p < 0.05), under placebo, from 65 m to 88 m (NS). The use of drugs decreased by 58% in the treatment group (p < 0.05) versus 1% under placebo. Gastrointestinal complications decreased by 63% in the treatment group, but only 3% under placebo. Overall, treatment costs were reduced significantly compared with placebo. Foot edema was present in 76% of the patients of the treatment group at inclusion and in 79% of the controls. After 3 months edema decreased in 79% of Pycnogenol patients (p < 0.05) vs 1% in controls. In conclusion, Pycnogenol offers an option for reduction of treatment costs and side effects by sparing antiinflammatory drugs.  相似文献   

20.
OBJECTIVE:To evaluate the efficacy and safety of sugarcane bagasse dietary fiber as an adjuvant therapy for improving quality of life in patients with stable chronic obstructive pulmonary disease(COPD).METHODS:This was a multicenter,randomized,double-blind,placebo-controlled trial.A total of196 participants were randomized into a trial group(treated with 6 g/day sugarcane bagasse plus conventional treatment,n = 98) and a control group(treated with placebo plus conventional treatment,n = 98).All efficacy analyses were performed according to the intention-to-treat(ITT) principle.A per-protocol analysis set(PPS) was used to analyze the cases that completed the clinical trial with good compliance.The trial period was 30 days,with a 6-month follow-up.Pre-and post-treatmentpulmonary symptom scores(cough,sputum,wheezing,and dyspnea) were recorded for both groups.The St.George's Respiratory Questionnaire(SGRQ) and the modified Medical Research Council(m MRC) dyspnea scale were assessed before treatment and at the end of the 6-month follow-up.RESULTS:The ITT population was 178 and the PPS population was 166.Post-treatment pulmonary clinical symptoms and severity of dyspnea(m MRC and SGRQ evaluation) were significantly improved in both the trial group and the control group(ITT and PPS:P 0.05).However,there was no statistical difference between the two groups in post-treatment pulmonary symptoms and m MRC.There was a greater reduction in the SGRQ subscales of activity,effect and total score in the trial group compared with the control group(ITT and PPS:P 0.01).There was no statistical difference in pre-and post-treatment safety variables in either group.CONCLUSION:Sugarcane bagasse combined with conventional treatment improved quality of life in patients with stable COPD.Sugarcane bagasse appears to be a safe herbal medicine with potential for treating patients with stable COPD when taken orally as an adjuvant therapy.  相似文献   

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