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1.
Multicenter, Prospective, Controlled Double-Blind Study Comparing Fib-19-01, A Phytotherapy Treatment, To A Dietary Supplement And To Conventional Care In Patients Suffering From Fibromyalgia.
Barmaki, M, Maindet-Dominici, C, Nizard, J, Baron, D, Russ, I, Fardellone, P, Ginies, P, Marc, JF, Conrozier, T, Bertin, P
Alternative therapies in health and medicine. 2019;(4):46-53
Abstract
BACKGROUND Current therapeutic modalities for fibromyalgia (FM) do not provide satisfactory results and new approaches have to be explored. OBJECTIVES To assess efficacy and safety of adding a phytotherapy treatment (Fib-19-01) to the current therapeutic regimen in patients with FM. METHODS Double-blind controlled trial: women with active FM (Fibromyalgia Index Questionnaire FIQ > 40) were randomised to receive Fib-19-01 or a food supplement (FS) undistinguishable from Fib-19-01 or no supplementary treatment (NoST). All continued the conventional therapy throughout the 6 month follow-up. Primary endpoint: change in FIQ between Day 0 and month 6 (M6). Secondary Criteria: variation over time FIQ ( repeated measurements), change in Pichot fatigue scale, Pittsburgh Sleep Quality Index (PSQI), SF-12 and Hospital Anxiety and Depression (HAD) scales. RESULTS 100 patients (Intent-To-Treat population) were analyzed. FIQ decreased significantly only in the Fib-19-01 group (P < .001) at both week 12 and 24. Improvement was higher for Fib-19-01 (-13.4 ± 18.9) than in the 2 other groups (-5.5 ± 15.6 and -5.6 ± 11.3) despite there was no statistical between-group difference at week 24 in FIQ score (P = .08 and P = .09 respectively). Analysis of variance in repeated measurements of FIQ showed a significant difference between Fib-19-01 and FS throughout the follow-up period (P = .03). Fib-19-01 was superior to both FS and NoST for Pichot scale decrease over time: -4.6 (range -6.9; -2.28), -0.29 (-2.7; 2.1) and -0.72 (-3.1; 1.66) (P = .013 and 0.023 respectively), mental and social SF12 [+8.1 (range 3.5; 12.6), -0.27(range -5.3; 4.8 ) and -0.02 (range -5.0; 4.9 ) P = .02 and 0.018)],HAD depression [-2.0 (range -3.3; -0.7), +0.5 (range -0.9; 1.9 ) and +0.71 (range -0.7; 2.1) P = .013 and 0.007]. No significant difference was found between FS and NoST groups for any outcome. All treatments were well and similarly tolerated. CONCLUSIONS In patients with FM taking conventional therapy, Fib-19-01 has a therapeutic effect on fatigue, emotion and social life, and depression associated with the disease.
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2.
Hypoglycemic and hypolipidemic activities of crude seeds of Centratherum anthelminticum in healthy volunteers and type 2 diabetic patients.
Mudassir, HA, Qureshi, SA, Azmi, MB, Ahsan, M, Kamran, M, Jafar, S
Pakistan journal of pharmaceutical sciences. 2018;(3(Supplementary)):1061-1065
Abstract
This study first time reports the hypoglycaemic activity of crude seeds powder (CSP) of Centratherum anthelminticum in healthy and type 2 diabetic volunteers. In addition, hypolipidemic effect of same CSP was also determined in healthy volunteers. Healthy individuals were divided into control and two test groups T1 and T2 treated with 200 & 400mg of CSP. Similarly, type 2 diabetic patients were also divided into positive control (PC) treated with metformin 600mg and two test groups DT1 (CSP 400mg + metformin 600mg) & DT2 (CSP 400mg). Each group has 6 individuals and each treatment was done orally. CSP 400mg was found more hypoglycaemic on all time intervals from 30 to 120min when oral glucose tolerance test was conducted in healthy volunteers. Both test quantities of CSP 200 & 400 mg were found successful in same healthy persons in decreasing the levels of triglycerides & total cholesterol (p<0.05), low & very low density lipoprotein cholesterols (p<0.01) and keeping the level of high density lipoprotein cholesterol as same as it was observed in control group. Similarly, CSP 400mg along with metformin and alone was also found helpful in lowering the fasting blood glucose levels in type 2 diabetic patients (DT1 & DT2) -24.99% and -20.62% respectively as compared to diabetic group only treated with metformin (PC), (p<0.01). Therefore, CSP of C antheminticum proves effective hypoglycaemic and hypolipidemic agent by possibly inducing glucose tolerance in healthy individuals and type 2 diabetic patients.
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3.
Comparison of tripterygium wilfordii multiglycosides and tacrolimus in the treatment of idiopathic membranous nephropathy: a prospective cohort study.
Liu, S, Li, X, Li, H, Liang, Q, Chen, J, Chen, J
BMC nephrology. 2015;:200
Abstract
BACKGROUND Idiopathic membranous nephropathy (IMN) is a major cause of nephrotic syndrome among adults. Considering the natural course of IMN, when to treat and with which immunosuppressive treatment need to be carefully considered in such patients. A combination of tripterygium wilfordii multiglycosides (TWG) and prednisone may be an effective option for treating patients with IMN. METHODS In this prospective cohort study, we enrolled patients with biopsy-proven IMN at our kidney centre. One cohort received TWG combined with prednisone, whereas another cohort received tacrolimus (TAC) combined with prednisone, for 36 weeks. The primary outcome was the remission rate, whereas the secondary outcomes included the time to remission, relapse rate, changes in serum albumin levels and daily urinary protein levels, estimated glomerular filtration rate, and adverse events. RESULTS A total of 53 patients with IMN met the criteria for enrollment, and all patients completed the therapy. At the end of the 36-week therapy, remission (either partial remission [PR] or complete remission [CR]) was observed in 20 patients (86.9 %) receiving TWG and in 27 patients (90.0 %) receiving TAC (p > 0.05), whereas CR was noted in 12 patients (52.2 %) receiving TWG and 14 patients (46.7 %) receiving TAC (p > 0.05). The probability of remission was similar for both the TWG and TAC groups (p > 0.05, by log-bank test). The mean time for achieving remission was 11.8 ± 12.5 weeks in the TWG group and 8.5 ± 9.1 weeks in the TAC group (p > 0.05). CONCLUSIONS The combination of TWG and predisone is an effective and safe therapy for IMN.
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4.
A prospective study on the safety of herbal medicines, used alone or with conventional medicines.
Jeong, TY, Park, BK, Cho, JH, Kim, YI, Ahn, YC, Son, CG
Journal of ethnopharmacology. 2012;(3):884-8
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE Along with increase of herbal medicine use worldwide, the safety of traditional herbal medicines frequently becomes a medical issue. AIM OF THE STUDY This study aimed to investigate the incidence of herbal medicine-induced adverse effects on liver functions. SUBJECTS AND METHODS A prospective study was performed with 313 inpatients (87 male and 226 female) receiving herbal prescriptions during hospitalization. The patients were classified into two groups based on their treatments: one group received herbal medicines only (57 patients), and another received herbal and conventional medicines concurrently (256 patients). All patients were given liver and renal function tests at the start of hospitalization (baseline) and at approximately 2-week intervals thereafter, until discharge. RESULTS Six of the 313 patients showed abnormal liver function without related clinical symptoms (1.9%, 95% CI 0.38-3.41); none of the patients in the herbal group had abnormal result in liver function tests (0% of 57 patients) while all six had received a combination of herbal and conventional medicines (2.3% of 256 patients, 95% CI 0.46-4.14). CONCLUSION Our findings indicate that herbal drugs used alone are relatively safe, but the risk for adverse reactions may increase when herbal and conventional drugs are taken concurrently.
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5.
[A prospective cohort study on the influence of high doses of herbs for clearing heat and resolving stasis on survival rates in patients with hepatitis B-related acute-on-chronic liver failure].
Hu, XY, Zhang, Y, Chen, G, Zhong, S, Fan, XJ
Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine. 2012;(2):176-85
Abstract
BACKGROUND Hepatitis B-related acute-on-chronic liver failure (ACLF) is a severe clinical syndrome characterized by jaundice, coagulopathy, ascites and hepatic encephalopathy and with a high mortality rate of 65% to 93%. It involves significant ethical issues when a randomized, double-blinded, placebo-controlled clinical study is conducted to such a serious disease. Therefore, a prospective cohort study design was utilized to explore a new treatment modality of applying integrated traditional Chinese and Western medicine. OBJECTIVE To evaluate the efficacy, safety and recent survival rates of high-dose herbs with the function of clearing heat and resolving stasis, named Qingre Huayu, in patients with hepatitis B-related ACLF with heat toxin stagnation syndrome. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS A matched, prospective cohort study was conducted. Participants who met the inclusion criteria were recruited from the Department of Infectious Diseases, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine. Patients were assigned to either an integrated medicine group or a Western medicine group according to their own preference and received either a regime of classic Western medical treatment (control group) or a regime of classic Western medical treatment plus Qingre Huayu herbs (treatment group). The regimes were conducted for 12 weeks. MAIN OUTCOME MEASURES Survival rates of non-liver transplantation patients were evaluated after 12-week treatment. The levels of total bilirubin (TBiL), albumin (ALB), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and prothrombin activity (PTA) were detected at baseline and weeks 4, 8 and 12. Scores of traditional Chinese medicine (TCM) syndrome and complications were evaluated at baseline and study completion. Adverse events were recorded. RESULTS All patients were followed up to the deadline for this study. There were 21 cases (31.8%) who died in the treatment group (n=66) and 19 cases (59.4%) in the control group (n=32). Significant difference (X(2)=6.775, P<0.01) was found in comparing the survival and death rates between the two groups by X(2) test. At 12 weeks, mean survival time of the two groups was 69.9 and 47.2 d respectively; cumulative survival rate of patients in the treatment group was higher than that of patients in the control group (P<0.01). Levels of TBiL, ALT, AST, ALB and PTA at weeks 4, 8 and 12 in the treatment group were superior to those in the control group with statistical significance (P<0.01 or P<0.05). In comparison of the TCM syndrome scores at week 12, the average score of the TCM syndrome of the treatment group (n=45) was 7.52±2.41, lower than 18.34±4.36 of the control group (n=13), and the difference was significant (t=8.784, P<0.01). Complication incidences after 12 weeks of treatment were statistically different between the treatment group (n=45) and the control group (n=13) by X(2) test (P<0.05 or P<0.01). Incidence rates of ascites, infection and hepatic encephalopathy accounted for 22.22%(10/45) and 69.23% (9/13), 8.89% (4/45) and 53.85% (7/13), and 11.11% (5/45) and 46.15% (6/13) in the two groups respectively. The incidence rates of adverse events in the treatment group and the control group were 0.00% and 12.50% respectively and the difference was statistically significant (X(2)=5.705, P<0.05). No drug-related adverse events were found in blood, urine and stool routine tests, renal function test and electrocardiography. CONCLUSION High doses of Qingre Huayu herbs can significantly improve liver function and coagulation function, reduce complications, and reduce mortality in patients with hepatitis B-related ACLF.
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6.
Use of prunes as a control of hypertension.
Ahmed, T, Sadia, H, Batool, S, Janjua, A, Shuja, F
Journal of Ayub Medical College, Abbottabad : JAMC. 2010;(1):28-31
Abstract
BACKGROUND Fruits and vegetables are shown to reduce blood pressure. It is not merely the antioxidants contained in fruits and vegetables that have health benefits such as lowered systolic and diastolic blood pressures. This study was undertaken to see the cardiovascular protective effects of prunes. METHODS A placebo controlled clinical trial study was designed to see the effects of Prunus domestica on blood pressure in 259 pre-hypertensive (Systolic BP = 120-139 mmHg, diastolic BP = 80-89 mmHg) volunteers. Treated groups drank prune juice and ate the whole fruit (dried plums) while either 3 (about 11.5 gm) or 6 prunes were soaked overnight in a glass of water whereas control group took only a glass of plain water early in the morning on empty stomach. Blood pressure was recorded fortnightly for 8 weeks, and blood samples were taken at 0 and 8 weeks. RESULTS There was significant reduction of blood pressure by single dose of prunes daily group and the controls (p < 0.05). With the double dose of prunes, only systolic BP was reduced significantly (p < 0.05). Control group had significantly increased serum HDL whereas test groups had significantly reduced serum cholesterol and LDL (p < 0.05). Data was analysed by paired-sample t-test with 95% confidence interval. CONCLUSION The data predicts cardiovascular protective effects of prunes.
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7.
The homeopathic preparation Neurexan vs. valerian for the treatment of insomnia: an observational study.
Waldschütz, R, Klein, P
TheScientificWorldJournal. 2008;:411-20
Abstract
Insomnia is prevalent and complementary therapies are common, but data are lacking on the effectiveness and tolerability of preparations beyond valerian. Here we report on an open-label, prospective cohort study in 89 German centers offering both conventional and complementary therapies. Subjects received the homeopathic preparation Neurexan or valerian for 28 days. Doses were at physicians' judgments. Sleep duration and latency were evaluated based on patients' sleep diaries over 14 days; sleep quality was evaluated at 28 +/- 1 days. A total of 409 subjects were enrolled. The groups were balanced at baseline for age, sex, weight, and sleep disturbances. At day 14, both groups reported improved sleep latency and duration; latency was reduced from baseline by 37.3 +/- 36.3 min with Neurexan and by 38.2 +/- 38.5 min with valerian. The duration of sleep increased by 2.2 (+/-1.6) h in the Neurexan group and by 2.0 (+/-1.5) h in the valerian group. Differences between the groups in improvement on sleep duration were significantly in favor of Neurexan therapy at days 8, 12, and 14. At day 28, quality of sleep was improved in both groups with no significant differences between the treatments. Significantly more patients reported lack of daytime fatigue with Neurexan than with valerian therapies (49% vs. 32%; p < 0.05 for the comparison). For patients favorable towards a CAM-based therapy, Neurexan might be an effective and well-tolerated alternative to conventional valerian-based therapies for the treatment of mild to moderate insomnia.
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8.
Protein and ginger for the treatment of chemotherapy-induced delayed nausea.
Levine, ME, Gillis, MG, Koch, SY, Voss, AC, Stern, RM, Koch, KL
Journal of alternative and complementary medicine (New York, N.Y.). 2008;(5):545-51
Abstract
BACKGROUND Nausea that develops during the period that begins 24 hours after the administration of chemotherapy is called delayed nausea, and occurs in many patients with cancer. Meals high in protein decrease the nausea of motion sickness and pregnancy, possibly by reducing gastric dysrhythmias. Ginger also has antinausea properties. OBJECTIVES To explore the use of protein meals with ginger for the treatment of the delayed nausea of chemotherapy. DESIGN Twenty-eight (28) patients with cancer receiving chemotherapy for the first time were assigned to 1 of 3 groups. For 3 days beginning the day after their chemotherapy, Control Group patients continued with their normal diet, Protein Group patients consumed a protein drink and ginger twice daily, and High Protein Group patients consumed a protein drink with additional protein and ginger twice daily. OUTCOME MEASURES Patients recorded in a diary each day whether they had experienced nausea, whether their nausea had been frequent, whether their nausea had been bothersome, and whether they had needed any antiemetic medication. Gastric myoelectrical activity was assessed in 5 patients before and after ingestion of a high protein meal and ginger. RESULTS Reports of nausea, frequent nausea, and bothersome nausea were significantly less common among High Protein Group patients than among Control and Protein Group patients. Furthermore, significantly fewer patients in the High Protein Group used antiemetic medication. Differences between the Protein and Control groups were not statistically significant. In the 5 patients who had tests of gastric myoelectrical activity performed, a significant decrease in gastric dysrhythmia occurred after ingestion of the protein and ginger. CONCLUSIONS High protein meals with ginger reduced the delayed nausea of chemotherapy and reduced use of antiemetic medications. Protein with ginger holds the potential of representing a novel, nutritionally based treatment for the delayed nausea of chemotherapy.
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9.
Safety and efficacy of oral HD-03/ES given for six months in patients with chronic hepatitis B virus infection.
Rajkumar, JS, Sekar, MG, Mitra, SK
World journal of gastroenterology. 2007;(30):4103-7
Abstract
AIM: To investigate the safety and efficacy of the formulation HD-03/ES capsules in the management of patients with chronic hepatitis B infection. METHODS A total of 25 patients were recruited to the study and were given HD-03/ES, two capsules twice daily for six months. Clinical assessment of symptoms and signs were done using the " clinical observation table" once a month before and after the treatment. Biochemical investigations of total bilirubin, ALT, AST, serum protein for liver function tests were done every month after initiating treatment. Serum was analyzed for HBV markers for HBsAg, HBeAg and HBV DNA at baseline, 4 and 6 mo after therapy using ELISA kits from Roche. RESULTS After 6 mo of therapy with HD-03/ES, a significant reduction of ALT values from 66.5 +/- 11.1 to 39.1 +/- 5.2 (P < 0.01) and a significant HBsAg loss (52%, P < 0.001), HBeAg loss (60%, P < 0.05) and HBV DNA loss (60%, P < 0.05) was observed. Adverse effects were mild and never warranted withdrawal of the drug. CONCLUSION The results of this pilot study indicate that HD-03/ES might be a safe and effective treatment for chronic hepatitis B infection and a long-term multicentric comparator trial is warranted and under way.
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10.
The mushroom Agaricus Blazei Murill in combination with metformin and gliclazide improves insulin resistance in type 2 diabetes: a randomized, double-blinded, and placebo-controlled clinical trial.
Hsu, CH, Liao, YL, Lin, SC, Hwang, KC, Chou, P
Journal of alternative and complementary medicine (New York, N.Y.). 2007;(1):97-102
Abstract
BACKGROUND Complementary and alternative medicine use in adults with type 2 diabetes is popular. Although most of the herbs and supplements appear to be safe, there is still insufficient evidence that demonstrates their definitive beneficial effects. This study was done to determine whether the supplement of Agaricus blazei Murill extract improves insulin resistance in type 2 diabetes. MATERIALS AND METHODS This study was a clinical randomized, double-blind, placebo-controlled trial. Of a population of 536 registered diabetes patients with 72 subjects (1) aged between 20 and 75 years, (2) being Chinese, (3) having type 2 diabetes for more than 1 year, and (4) having been taking gliclazide and metformin for more than 6 months were enrolled in this study. The enrolled patients were randomly assigned to either receiving supplement of Agaricus blazei Murill (ABM) extract or placebo (cellulose) 1500 mg daily for 12 weeks. Homeostasis model assessment for insulin resistance (HOMA-IR) was used as the major outcome measurement. RESULTS At the end of the study, subjects who received supplement of ABM extract (n = 29) showed significantly lower HOMA-IR index (3.6[standard deviation, 2.5] versus 6.6[standard deviation, 7.4], p = 0.04) than the control group (n = 31). The plasma adiponectin concentration increased 20.0(standard deviation, 40.7)% in the ABM group after 12 weeks of treatment, but decreased 12.0(20.0)% among those taking the placebo (p < 0.001). CONCLUSIONS Supplement of ABM extract improves insulin resistance among subjects with type 2 diabetes. The increase in adiponectin concentration after taking AMB extract for 12 weeks might be the mechanism that brings the beneficial effect. Studies with longer periods of follow-up should be conducted in the future.