randomized controlled trial

Comparison of glucosamine sulfate and a polyherbal supplement for the relief of osteoarthritis of the knee: a randomized controlled trial [ISRCTN25438351].:
BMC Complement Altern Med. 2007 Oct 31;7(1):34 Authors: Mehta K, Gala J, Bhasale S, Naik S, Modak M, Thakur H, Deo N, Miller MJ

ABSTRACT: BACKGROUND: The efficacy and safety of a dietary supplement derived from South American botanicals was compared to glucosamine sulfate in osteoarthritis subjects in a Mumbai-based multi-center, randomized, double-blind study. METHODS: Subjects (n=95) were screened and randomized to receive glucosamine sulfate (n= 47, 1500 mg/day) or reparagen (n=48, 1800 mg/day), a polyherbal consisting of 300 mg of vincaria (Uncaria guianensis) and 1500 mg of RNI 249 (Lepidium meyenii) administered orally, twice daily. Primary efficacy variable was response rate based on a 20% improvement in WOMAC pain scores. Additional outcomes were WOMAC scores for pain, stiffness and function, visual analog score (VAS) for pain, with assessments at 1, 2, 4, 6 and 8 weeks. Tolerability, investigator and subject global assessments and rescue medication consumption (paracetamol) were measured together with safety assessments including vital signs and laboratory based assays. RESULTS: Subject randomization was effective: age, gender and disease status distribution was similar in both groups. The response rates (20% reduction in WOMAC pain) were substantial for both glucosamine (89%) and reparagen (94%) and supported by investigator and subject assessments. Using related criteria response rates to reparagen were favorable when compared to glucosamine. Compared to baseline both treatments showed significant benefits in WOMAC and VAS outcomes within one week (P<0.05), with a similar, progressive improvement over the course of the 8 week treatment protocol (45-62% reduction in WOMAC or VAS scores). Tolerability was excellent, no serious adverse events were noted and safety parameters were unchanged. Rescue medication use was significantly lower in the reparagen group (p <0.01) at each assessment period. Serum IGF-1 levels were unaltered by treatments. CONCLUSION: Both reparagen and glucosamine sulfate produced substantial improvements in pain, stiffness and function in subjects with osteoarthritis. Response rates were high and the safety profile was excellent, with significantly less rescue medication use with reparagen. Reparagen represents a new natural productive alternative in the management of joint health. Trial registration: Current Controlled Trials ISRCTN25438351.

PMID: 17974032 [PubMed - as supplied by publisher]

Effects of warm water sitz bath on symptoms in post-anal sphincterotomy in chronic anal fissure--a randomized and controlled study.: World J Surg. 2007 Jul;31(7):1480-4 Authors: Gupta PJ

BACKGROUND: Sitz bath is frequently recommended by physicians for a variety of anal disorders including anal fissure. The aim of the present study was to determine whether sitz bath does have any therapeutic properties improving upon a patient's postoperative symptoms after a closed lateral sphincterotomy. MATERIALS AND METHODS: Forty-six patients were randomly assigned to receive analgesics and fiber supplement alone (control patients) or a twice-daily sitz bath along with identical fiber and analgesics (sitz bath group). A 24-h pain score--post-defecation anal burning and symptom improvement--was evaluated on a visual analog scale (VAS). RESULTS: The groups were equally matched for age, gender distribution, and duration of disease. No significant difference in mean pain score between groups (p = 0.284) was noticed after one week. However, the patients from the control group experienced significant anal burning compared with patients from sitz bath group (p < 0.0001). The improvement score was higher in the sitz bath group when compared with the control group; however, it did not reached a statistically significant level. CONCLUSIONS: Patients after sphincterotomy for anal fissure receiving sitz bath experienced similar levels of pain when compared with those not receiving sitz bath. However, they reported a significant relief in anal burning and a marginally better satisfaction score and no reported adverse side effects.

PMID: 17534541 [PubMed - indexed for MEDLINE]

Phytodolor--effects and efficacy of a herbal medicine.: Wien Med Wochenschr. 2007;157(13-14):343-7 Authors: Gundermann KJ, Müller J

Herbal antirheumatics are successfully used in painful inflammatory or degenerative rheumatic diseases. One of these herbal medicines is Phytodolor (STW 1), a fixed combination of extracts from aspen leaves and bark (Populus tremula), common ash bark (Fraxinus excelsior), and golden rod herb (Solidago virgaurea). Its effects as well as those of its components have been verified in experimental and human pharmacological investigations. The mode of action of STW 1 includes antiinflammatory, antioedematous, antioxidative and analgesic properties, and it is considered to be broader than that of synthetic antirheumatics. Open clinical studies and randomised, placebo- or verum-controlled double-blind trials, performed in different subtypes of rheumatic diseases, confirm the pharmacological evidence of efficacy, such as by reducing the intake of non-steroidal antiinflammatory drugs (NSAIDs). STW 1 has a high drug safety. CONCLUSION: Phytodolor (STW 1) is a reasonable alternative to NSAIDs and to cyclooxygenase(COX)-2-inhibitors such as rofecoxib.

PMID: 17704984 [PubMed - indexed for MEDLINE]

Kava in generalized anxiety disorder: three placebo-controlled trials.: Int Clin Psychopharmacol. 2006 Sep;21(5):249-53 Authors: Connor KM, Payne V, Davidson JR

In this study, we evaluated the efficacy and safety of kava kava (Piper methysticum) in generalized anxiety disorder. Data were analyzed from three randomized, double-blind, placebo-controlled trials of kava, including one study with an active comparator (venlafaxine), in adult outpatients with DSM-IV generalized anxiety disorder. The pooled sample (n=64) included the following number of participants: kava, n=28; placebo, n=30; and venlafaxine, n=6. Given the comparability of the study designs, the data comparing kava and placebo were then pooled for further efficacy and safety analyses. No significant differences were observed between the treatment groups in any of the trials. In the pooled analyses, no effects were found for kava, while a significant effect in favor of placebo was observed in participants with higher anxiety at baseline. No evidence of hepatotoxicity was found with kava, and all of the treatments were well tolerated. Findings from these three controlled trials do not support the use of kava in DSM-IV generalized anxiety disorder.

PMID: 16877894 [PubMed - indexed for MEDLINE]

The effect of cinnamon cassia powder in type 2 diabetes mellitus.: J Med Assoc Thai. 2006 Sep;89 Suppl 3:S200-5 Authors: Suppapitiporn S, Kanpaksi N, Suppapitiporn S

BACKGROUND: Type 2 diabetes is a chronic metabolic disorder and the incidence of cardiovascular is increased two- to fourfold in its complications. Cinnamon is expected to have some degree of anti-diabetic efficacy without troublesome side effects. The objective of the present study was to investigate the anti-diabetic effect of cinnamon cassia powder in type 2 diabetic patients MATERIAL AND METHOD: Sixty type 2 diabetic patients were randomized either 1.5 g/d of cinnamon cassia powder or placebo. Both groups were in combination with their current treatment (metformin or sulfonylurea) according to single blind randomized, placebo-control trial in a 12-week period. Efficacy was evaluated by HbA1c fasting plasma glucose, Lipid profile, BUN, creatinine, liver function test and adverse effects were recorded. RESULTS: After a 12-week period, HbA1c was decreased similarly in both groups from 8.14% to 7.76% in the cinnamon group and from 8.06% to 7.87% in the placebo group. This was not found statistically significantly different. However the proportion of patients achieving HbA1c < or = 7% was also greater in patients receiving cinnamon compared with patients receiving placebo, nevertheless, it was not found statistically significantly different (35% vs 15%, x2 = 3.14, p > 0.05). No significant intergroup differences were observed in lipid profile, fasting plasma glucose except in SGOT 27.1 (8.75) to 22.1 (5) in cinnamon group and 24.08 (8.5) to 23.63 (8.88) in the placebo group (p = 0.001). CONCLUSION: The cinnamon cassia powder 1.5 g/d did not have any significant difference in reducing fasting plasma glucose, HbA1c and serum lipid profile in type 2 diabetes patients who had mean fasting plasma glucose 154.40 +/- 24.72 mg/dl.

PMID: 17718288 [PubMed - indexed for MEDLINE]

A randomized, placebo-controlled, double-blind clinical trial of curcuminoids in oral lichen planus.: Phytomedicine. 2007 Aug;14(7-8):437-46 Authors: Chainani-Wu N, Silverman S, Reingold A, Bostrom A, Mc Culloch C, Lozada-Nur F, Weintraub J

We studied the efficacy of curcuminoids in the treatment of oral lichen planus (OLP), a chronic, mucocutaneous, immunological disease. Curcuminoids are components of turmeric (Curcuma longa) that have anti-inflammatory activity. Turmeric has been used in Ayurveda (Indian traditional medicine) for centuries. A randomized, double-blind, placebo-controlled trial was conducted. In all, 100 consecutive, eligible patients with OLP presenting to the oral medicine clinic at the University of California, San Francisco, were to be selected. Two interim analyses were to be conducted during the trial. The trial was conducted between February 2003 and September 2004. The first interim analysis was conducted in October 2004 using data from the first 33 subjects. Study subjects were randomized to receive either placebo or curcuminoids at 2000 mg/day for 7 weeks. In addition, all subjects received prednisone at 60 mg/day for the first 1 week. The primary outcome was a change in symptoms from baseline. Secondary outcomes were changes in clinical signs and occurrence of side effects. The first interim analysis did not show a significant difference between the placebo and curcuminoids groups. Conditional power calculations suggested a less than 2% chance that the curcuminoids group would have a significantly better outcome as compared with the placebo group if the trial were continued to completion. Therefore, the study was ended early for futility. Reaching a conclusion regarding the efficacy of curcuminoids based on the results of this study is not possible as it was ended early for futility. Curcuminoids at this dose were well tolerated and the results suggest that for future studies a larger sample size, a higher dose and/or longer duration of curcuminoids administration should be considered; however, for the next step, an RCT of a shorter duration, using a higher dose of curcuminoids, and without an initial course of prednisone, should be considered.

PMID: 17604143 [PubMed - indexed for MEDLINE]

Ayurvedic and collateral herbal treatments for hyperlipidemia: a systematic review of randomized controlled trials and quasi-experimental designs.: Altern Ther Health Med. 2007 Jul-Aug; 13(4): 22-8 Singh BB, Vinjamury SP, Der-Martirosian C, Kubik E, Mishra LC, Shepard NP, Singh VJ, Meier M, Madhu SG

BACKGROUND: Ischemic heart disease (IHD) is a leading cause of morbidity and mortality in both developing and developed countries. An underlying cause of IHD involves retention and deposit of serum lipids in coronary arteries, decreasing blood flow. Drugs (conventional and herbal) are used to lower levels of serum cholesterol to help prevent IHD. The Ayurvedic medicine pharmacopoeia identified herbs that might contribute to a decrease in cholesterol and therefore reduce the risk of IHD. METHODS: Literature searches were conducted at 3 points: 2003, 2004, and 2007. Databases searched included PubMed, the National Library of Medicine, the National Center for Complementary and Alternative Medicine, Ovid, and EBSCO Information Services, and other search strategies also were used. Each article was assessed for quality by 3 people, and discrepancies were resolved by arbitration using a fourth person, who also read and scored each article. Additional assessments of safety using a scale and determination of reported efficacy/effectiveness of the randomized controlled trials (RCTs) and quasi-experimental designs (QEDs) were made. RESULTS: RCTs generally received high quality scores and improved by decade of publication. More than 50% of garlic, more than 80% of guggul, and 100% of Arjuna RCTs reported product effectiveness. Safety scores did not improve by decade. The QEDs received medium and high quality scores, and 93% of them reported effectiveness. The QEDs had a higher mean score for safety reporting than the RCTs. CONCLUSIONS: Many studies received high quality scores and noted safety information and reported effectiveness or efficacy in a clear manner. This finding was not consistent with other systematic reviews that have found the highest reported efficacy/ effectiveness in studies of poorer quality. Ayurvedic herbs reviewed here should be considered by physicians when trying to manage hyperlipidemia in their patients.

The special extract ERr 731 of the roots of Rheum rhaponticum decreases anxiety and improves health state and general well-being in perimenopausal women.:

Related Articles

The special extract ERr 731 of the roots of Rheum rhaponticum decreases anxiety and improves health state and general well-being in perimenopausal women.

Menopause. 2007 Mar-Apr;14(2):270-83

Authors: Kaszkin-Bettag M, Ventskovskiy BM, Kravchenko A, Rettenberger R, Richardson A, Heger PW, Heger M

OBJECTIVE: To investigate the efficacy of the special extract ERr 731 from the roots of Rheum rhaponticum compared with placebo on anxiety, health state, and general well-being in perimenopausal women. DESIGN: This study is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial, in which 109 perimenopausal women with climacteric complaints and anxiety received either 1 enteric coated tablet of ERr 731 (n=54) or placebo (n=55) daily for 12 weeks. The Hamilton Anxiety Scale, the Menopause Rating Scale II, the Women's Health Questionnaire, and the Psychological General Well-Being Index were used to measure anxiety, health state, and subjective psychological well-being. RESULTS: The results demonstrate that ERr 731 is highly effective in reducing anxiety in perimenopausal women compared with placebo. After 12 weeks, the Hamilton Anxiety Scale total score decreased significantly with ERr 731 (from 27.5+/-6.8 to 9.4+/-4.2 points) compared with placebo (from 25.1+/-6.0 to 21.6+/-8.6 points). ERr 731 also reduced the Hamilton Anxiety Scale factor scores for somatic and psychic anxiety. After 12 weeks, a reduction in the severity of anxiety from "moderate" or "severe" to "slight" was observed in 33 of 39 ERr 731 women completing the double-blind phase, which correlated well with the reduction in number and severity of hot flushes. This was reflected by a high rate of ERr 731 women reporting a marked improvement in health state and general well-being. CONCLUSIONS: ERr 731 is an effective medication for women with menopause-related anxiety and improves their health state and general well-being.

PMID: 17213754 [PubMed - indexed for MEDLINE]

Randomised clinical trial of a laxative alone versus a laxative and a bulking agent after primary repair of obstetric anal sphincter injury.: BJOG. 2007 Jun;114(6):736-40 Authors: Eogan M, Daly L, Behan M, O'Connell PR, O'Herlihy C

OBJECTIVE: To compare two postpartum laxative regimens in women who have undergone primary repair of obstetric anal sphincter injury. DESIGN: Randomised controlled trial. SETTING: National Maternity Hospital, Dublin. POPULATION: A total of 147 postpartum women who had sustained anal sphincter injury at vaginal birth. METHODS: Women were randomised to receive either lactulose alone thrice daily for the first three postpartum days followed by sufficient lactulose to maintain a soft stool over the following 10 days (lactulose group, n = 77) or the lactulose regimen combined with a sachet of ispaghula husk daily for the first 10 postpartum days (Fybogel group, n = 70). All patients kept a diary of bowel habit for the first 10 postpartum days and were invited to return for review at 3 months postpartum. MAIN OUTCOME MEASURES: Patient discomfort with first postpartum bowel motion, incidence of postnatal constipation and incontinence and incontinence score in postnatal period. RESULTS: Pain scores were similar in the two treatment groups; but incontinence in the immediate postnatal period was more frequent with the two preparations compared with lactulose alone (32.86% versus 18.18%, P = 0.03). CONCLUSIONS: This study does not support routine prescribing of a stool-bulking agent in addition to a laxative in the immediate postnatal period for women who have sustained anal sphincter injury at vaginal delivery.

AKL1, a botanical mixture for the treatment of asthma: a randomised, double-blind, placebo-controlled, cross-over study.: BMC Pulm Med. 2007;7:4 Authors: Thomas M, Sheran J, Smith N, Fonseca S, Lee AJ

BACKGROUND: Despite effective treatments, asthma outcomes remain suboptimal. Interest exists in complementary therapies, particularly in herbal remedies for asthma treatment, currently with inconclusive evidence of efficacy. The encapsulated botanical mixture AKL1 has anecdotal evidence of effectiveness in asthma. METHODS: We performed a randomised controlled cross over study comparing the effectiveness of AKL1 with indistinguishable placebo as add-on therapy in patients uncontrolled on standard asthma treatment. Thirty two adult asthmatics completed a 36 week trial consisting of a 4 week single blind run in period, during which placebo was added to usual treatment, a 12 week double blind active phase in which subjects received AKL1 or placebo, a single blind 8 week washout period receiving placebo and a final 12 week double blind cross-over active treatment phase. Daily diaries were kept of peak expiratory flow and symptoms, and spirometry, validated symptom and health status questionnaire scores and adverse events were monitored at study visits. Paired T tests were used to compare the effects of placebo and AKL1 on outcomes. Changes in outcome measures over treatment phases are presented as means and 95% confidence intervals (CI) of means. RESULTS: No significant differences in lung function (active-placebo) were found (Forced Expiratory Volume in 1 second: mean difference [95% CI] = 0.01 [-0.12 to 0.14] L, p = 0.9. Peak Expiratory Flow: -4.08 [-35.03 to 26.89]. L/min, p = 0.8).Trends to clinical improvements favouring active treatment were however consistently seen in the patient-centered outcomes: Asthma Control Questionnaire mean difference (active - placebo) [95% CI] = -0.35 [-0.78 to 0.07], p = 0.10, Asthma Quality of Life Questionnaire mean difference 0.42 [-0.08 to 0.93], p = 0.09, Leicester Cough Questionnaire mean difference 0.49, [-0.18 to 1.16], p = 0.15.Nine exacerbations occurred during placebo treatment and five whilst on AKL1. No significant adverse events were noted. CONCLUSION: AKL1 treatment was well tolerated. No significant improvements in lung function, symptoms, or quality of life were seen, although consistent trends were seen to improvements in patient-centered outcomes. Further studies are needed.