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1.
A double-blind, randomized pilot study for comparison of Melissa officinalis L. and Lavandula angustifolia Mill. with Fluoxetine for the treatment of depression.
Araj-Khodaei, M, Noorbala, AA, Yarani, R, Emadi, F, Emaratkar, E, Faghihzadeh, S, Parsian, Z, Alijaniha, F, Kamalinejad, M, Naseri, M
BMC complementary medicine and therapies. 2020;(1):207
Abstract
BACKGROUND Depression has rapidly progressed worldwide, and the need for an efficient treatment with low side effect has risen. Melissa officinalis L and Lavandula angustifolia Mill have been traditionally used in Asia for the treatment of depression. Many textbooks of traditional Persian medicine refer to these herbs for the treatment of depression while there are no adequate clinical trials to support this claim. The present study aimed to evaluate the efficacy of M. officinalis and L. angustifolia compared to fluoxetine for the treatment of mild to moderate depression in an 8-week randomized, double-blind clinical trial. METHODS Forty-five adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) for major depression, were randomly assigned to 3 groups to daily receive either M. officinalis (2 g) or L. angustifolia (2 g) or fluoxetine (20 mg) and were assessed in weeks 0, 2, 4 and 8 by the Hamilton Rating Scale for Depression (HAM-D) including 17 items. RESULTS Our study showed that M. officinalis and L. angustifolia effect similar to fluoxetine in mild to moderate depression. (F = 0.131, df = 2,42, p = 0.877). CONCLUSION Due to some restrictions in this study including absence of placebo group, large-scale trials are needed to investigate the anti-depressant effect of these two herbs with more details. TRIAL REGISTRATION IRCT2014061718126N1 . Registration date: 2015-06-04-"Retrospectively registered".
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2.
Multicenter Clinical Trials Analyzing Efficacy and Safety of Topical Cortex Phellodendri Compound Fluid in Treatment of Diabetic Foot Ulcers.
Liu, Y, Li, Y, Du, Y, Huang, T, Zhu, C
Medical science monitor : international medical journal of experimental and clinical research. 2020;:e923424
Abstract
BACKGROUND The aim of this study was to analyze the clinical application of cortex phellodendri compound fluid (CPCF) in the treatment of diabetic foot ulcers. MATERIAL AND METHODS From January 2012 to December 2015, a total of 720 cases of diabetic foot ulcers (DFU) were randomly assigned into an experimental group (n=540) that was treated by CPCF and a control group (n=180) that was treated by a Kangfuxin solution (KFS). After 4 weeks of treatment, their ulcer area, serum growth factor, clinical total effective rate, and incidence of adverse events were assessed. RESULTS There were 720 patients who completed the trial. The experimental group was superior to the control group in reducing ulcer area, increasing growth factor content, and total effective rate (P<0.05). There was no significant difference in the adverse events rates between the 2 groups. CONCLUSIONS CPCF external treatment of diabetic foot ulcer can promote ulcer healing and increase the concentration of growth factors, and it is safe and reliable.
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3.
HL301 versus Umckamin in the treatment of acute bronchitis: a phase III, randomized, controlled, double-blind, multicenter study.
Kim, WY, Park, MJ, Rhee, CK, Lee, SY, Kim, DJ, Kim, DG, Choi, CM, Kim, DK, Kim, YH, Yoon, HJ, et al
Current medical research and opinion. 2020;(3):503-508
Abstract
Objective: HL301 is a combination product of seven medicinal plants that has been proven effective in acute bronchitis by two phase II studies. In the present study, its efficacy and safety compared with those of Umckamin in the treatment of acute bronchitis were evaluated in phase III, randomized, controlled, double-blind, multicenter trial design.Methods: A total of 246 acute bronchitis patients were randomized to receive either HL301 (600 mg/day) or Umckamin (333 mg/day) for seven days. The primary outcome was the difference in their baseline (visit 2) and end of treatment (visit 3) bronchitis severity score (BSS). Other efficacy variables included the change in each BSS component (cough, sputum, dyspnea, chest pain, and crackle), response rate, improvement rate, and satisfaction rate with treatment.Results: A full analysis set and per protocol set analysis of both groups revealed that the difference of BSS between visit 2 and visit 3 in the HL301 and Umckamin group was not significantly different (4.58 ± 1.79 versus 4.29 ± 1.88, p = .37 and 4.60 ± 1.81 versus 4.33 ± 1.88, p = .42, respectively). The change in five BSS components (cough, sputum, dyspnea, chest pain, and crackle) of the HL301 and Umckamin groups did not differ after treatment. HL301 or Umckamin treated participants showed an equal level of response, improvement, and satisfaction rates with treatment. Both the HL301 group and Umckamin group showed the same safety profile.Conclusions: HL301 (600 mg/day) was as effective and safe as Umckamin (333 mg/day) in treating acute bronchitis.
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4.
Medicinal plants brought by Indian indentured immigrants: A comparative review of ethnopharmacological uses between Mauritius and India.
Mahomoodally, MF, Protab, K, Aumeeruddy, MZ
Journal of ethnopharmacology. 2019;:245-289
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE Mauritius is famous for its floricultural diversity and traditions practiced across the island by various ethnic groups. During the British rule in the 1835s, Indian indentured labourers migrated to Mauritius and played a very important role in shaping the Mauritian culture. They brought along their high heritage of traditional knowledge of certain medicinal herbs and spices. Nonetheless, there has been no comparative study to investigate whether these past traditional knowledge are still preserved in Mauritius and India. AIM OF THE STUDY To document and compare the traditional uses of medicinal herbs and spices brought by Indian indentured labourers with their current uses in Mauritius and India, and to review pharmacological studies of such plants. MATERIALS AND METHODS Locally published textbooks, research dissertations, and relevant records from the 'Mauritiana' section of the University of Mauritius library were scrutinised for possible early records of such herbs and spices brought by Indian indentured immigrants. Field trips and site visits to Mauritius Herbarium and The National Folk Museum were conducted to gather data on their traditional uses as practiced by the Indian indentured immigrants. A literature search was performed to gather the current ethnomedicinal uses of these plants in Mauritius and India using key databases such as ScienceDirect and PubMed, as well as thesis from local university website. Pharmacological studies on these plants were also reviewed in an attempt to compare the ethnomedicinal uses against reported ailments. RESULTS Indian labourers brought 18 medicinal plants for medicinal purposes as documented at the folk museum of Indian Immigration. Piper betle L., Azadirachta indica A. Juss., and Curcuma longa L. were common plants used by Indian indentured immigrants against a wide range of ailments. Data obtained from recent ethnomedicinal surveys revealed that A. indica and C. longa were the most traditionally used plants in India, while in Mauritius, C. longa was the most popular plant followed by Allium sativum L. and Ocimum tenuiflorum L. It was also found that all these plants are currently being used against a wide range of diseases in both countries. In addition, several studies have highlighted the pharmacological properties such as analgesic, anti-inflammatory, anti-microbial, anti-pyretic, and anti-diabetic for some plants. CONCLUSION This investigation can be considered as a first attempt to document and compare traditional knowledge of medicinal plants brought by Indian immigrants. We observed that some of these knowledge are preserved and still practiced in Mauritius. It is anticipated that this study will revive the interest in safeguarding and promoting the ancestral knowledge on the uses of such plants.
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5.
Standardised versus individualised multiherb Chinese herbal medicine for oligomenorrhoea and amenorrhoea in polycystic ovary syndrome: a randomised feasibility and pilot study in the UK.
Lai, L, Flower, A, Prescott, P, Wing, T, Moore, M, Lewith, G
BMJ open. 2017;(2):e011709
Abstract
OBJECTIVES To explore feasibility of a randomised study using standardised or individualised multiherb Chinese herbal medicine (CHM) for oligomenorrhoea and amenorrhoea in women with polycystic ovary syndrome (PCOS), to pilot study methods and to obtain clinical data to support sample size calculations. DESIGN Prospective, pragmatic, randomised feasibility and pilot study with participant and practitioner blinding. SETTING 2 private herbal practices in the UK. PARTICIPANTS 40 women diagnosed with PCOS and oligomenorrhoea or amenorrhoea following Rotterdam criteria. INTERVENTION 6 months of either standardised CHM or individualised CHM, 16 g daily taken orally as a tea. MAIN OUTCOME MEASURES Our primary objective was to determine whether oligomenorrhoea and amenorrhoea were appropriate as the primary outcome measures for the main study. Estimates of treatment effects were obtained for menstrual rate, body mass index (BMI), weight and hirsutism. Data were collected regarding safety, feasibility and acceptability. RESULTS Of the 40 participants recruited, 29 (72.5%) completed the study. The most frequently cited symptoms of concern were hirsutism, weight and menstrual irregularity. Statistically significant improvements in menstrual rates were found at 6 months within group for both standardised CHM (mean difference (MD) 0.18±0.06, 95% CI 0.06 to 0.29; p=0.0027) and individualised CHM (MD 0.27±0.06, 95% CI 0.15 to 0.39; p<0.001), though not between group (p=0.26). No improvements were observed for BMI nor for weight in either group. Improvements in hirsutism scores found within group for both groups were not statistically significant between group (p=0.09). Liver and kidney function and adverse events data were largely normal. Participant feedback suggests changing to tablet administration could facilitate adherence. CONCLUSIONS A CHM randomised controlled trial for PCOS is feasible and preliminary data suggest that both individualised and standardised multiherb CHMs have similar safety profiles and clinical effects on promoting menstrual regularity. These data will inform the design of a study in primary care that will incorporate an appropriate control. TRIAL REGISTRATION NUMBER ISRCTN 31072075; Results.
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6.
Randomized double-blind controlled clinical trials with herbal preparations of Serenoa repens fruits in treatment of lower urinary tract symptoms : An overview.
Görne, RC, Wegener, T, Kelber, O, Feistel, B, Reichling, J
Wiener medizinische Wochenschrift (1946). 2017;(7-8):177-182
Abstract
In this review, results of randomized double-blind controlled clinical trials (RCTs) with extracts of Serenoa repens fruits at a dose of 320 mg/d for the treatment of lower urinary tract symptoms (LUTS) are assessed. Of the RTCs conducted for up to 6 months, a benefit was seen in three of three RTCs with ethanolic, in eight of nine RTCs with hexane, and in one of two RTCs with CO2 extracts. Of the RTCs conducted for more than 6 months, a benefit was seen in two RTCs with hexane and in one RTC with CO2 extracts, whereas one RTC with an ethanolic, two RTCs with hexane, and one RTC with CO2 extracts did not show positive results. As LUTS are dynamic conditions with strong spontaneous fluctuation over time, the majority of patients might expect improvement of single symptoms and thus of quality of life, particularly as the extracts are well tolerated even in long-term treatment.
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7.
Double-blind randomized phase III study comparing a mixture of natural agents versus placebo in the prevention of acute mucositis during chemoradiotherapy for head and neck cancer.
Marucci, L, Farneti, A, Di Ridolfi, P, Pinnaro, P, Pellini, R, Giannarelli, D, Vici, P, Conte, M, Landoni, V, Sanguineti, G
Head & neck. 2017;(9):1761-1769
Abstract
BACKGROUND There is no widely accepted intervention in the prevention of acute mucositis during chemoradiotherapy for head and neck carcinoma. In the present double-blind study, we tested 4 natural agents, propolis, aloe vera, calendula, and chamomile versus placebo. METHODS Patients undergoing concomitant chemo-intensity-modulated radiotherapy (IMRT) were given natural agent or matched placebo; grade 3 mucositis on physical examination according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was the primary endpoint. Various covariates were tested at logistic regression, including the individual amount of mucosa receiving at least 9.5 Gy per week (V9.5w). RESULTS One hundred seven patients were randomized from January 2011 to July 2014, and 104 were assessable (51%-49% were assigned to the placebo group and 53%-51% were assigned to the natural agent). Overall, 61 patients developed peak grade 3 mucositis with no difference between arms (P = .65). Conversely, V9.5w (P = .007) and primary site (P = .037) were independent predictors. CONCLUSION The selected natural agents do not prevent mucositis, whereas the role of V9.5w is confirmed.
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8.
[A Multi-arm Placebo-controlled Study with Glutamic Acid Conducted in Rostock in 1953/1954].
Häßler, F, Weirich, S
Praxis der Kinderpsychologie und Kinderpsychiatrie. 2017;(7):516-525
Abstract
A Multi-arm Placebo-controlled Study with Glutamic Acid Conducted in Rostock in 1953/1954 Glutamic acid was commonly used in the treatment of intellectually disabled children in the 50s. Koch reported first results of an observation of 140 children treated with glutamic acid in 1952. In this line is the multi-arm placebo-controlled study reported here. The original study protocols were available. 58 children with speech problems who attending a school of special needs received glutamic acid, or vitamin B, or St.-John's-wort. The effect of glutamic acid was in few cases an improvement of attention. On the other hand restlessness and stutter increased. The majority of all reported a weight loss. The treatment with vitamin B showed a positive effect concerning concentration. The treatment with St.-John's wort was stopped caused by headache and vomiting in eight of nine cases. The results of the study reported here are unpublished. The reason may be that until the 60s the effects of glutamic acid in the treatment of intellectually disabled children were in generally overestimated.
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9.
Tripterygium wilfordii Hook. f. versus azathioprine for prevention of postoperative recurrence in patients with Crohn's disease: a randomized clinical trial.
Zhu, W, Li, Y, Gong, J, Zuo, L, Zhang, W, Cao, L, Gu, L, Guo, Z, Li, N, Li, J
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver. 2015;(1):14-9
Abstract
BACKGROUND Tripterygium wilfordii Hook. f. (TwHF) has been used for many years to induce the remission of Crohn's disease in China. AIMS To compare TwHF versus azathioprine for the prevention of postoperative recurrence in Crohn's disease. METHODS 90 Crohn's disease patients who had undergone resection were treated with TwHF 1.5mg/kg/day or azathioprine 2.0 mg/kg/day. The primary endpoint was clinical recurrence, and the secondary endpoint was endoscopic recurrence. RESULTS 47 patients completed the trial. Clinical recurrence was observed in 6/45 patients in the TwHF group and 4/45 patients in the azathioprine group at week 26 (P=0.74). At week 52, 8/45 azathioprine patients and 12/45 TwHF patients had clinical recurrence (P = 0.45). During the first 26 weeks, 56.8% of the patients in the TwHF group versus 47.7% in the azathioprine group experienced endoscopic recurrence (P = 0.52). However, at week 52, 74.4% of patients in the TwHF group and 50% in the azathioprine group had endoscopic recurrence (P = 0.03). CONCLUSIONS TwHF was less effective in maintaining endoscopic remission at week 52, even though TwHF was comparable to azathioprine for preventing postoperative clinical recurrence.
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10.
Comparative evaluation of terminalia chebula extract mouthwash and chlorhexidine mouthwash on plaque and gingival inflammation - 4-week randomised control trial.
Gupta, D, Gupta, RK, Bhaskar, DJ, Gupta, V
Oral health & preventive dentistry. 2015;(1):5-12
Abstract
PURPOSE The present study was conducted to assess the effectiveness of Terminalia chebula on plaque and gingival inflammation and compare it with the gold standard chlorhexidine (CHX 0.2%) and distilled water as control (placebo). MATERIALS AND METHODS A double-blind randomised control trial was conducted among undergraduate students who volunteered. They were randomly allocated into three study groups: 1) Terminalia chebula mouthwash (n = 30); 2) chlorhexidine (active control) (n = 30); 3) distilled water (placebo) (n = 30). Assessment was carried out according to plaque score and gingival score. Statistical analysis was carried out to compare the effect of both mouthwashes. ANOVA and post-hoc LSD tests were performed using SPSS version 17 with p ≤ 0.05 considered statistically significant. RESULTS Our result showed that Terminalia chebula mouthrinse is as effective as chlorhexidine in reducing dental plaque and gingival inflammation. The results demonstrated a significant reduction of gingival bleeding and plaque indices in both groups over a period of 15 and 30 days as compared to the placebo. CONCLUSION The results of the present study indicate that Terminalia chebula may prove to be an effective mouthwash. Terminalia chebula extract mouthrinse can be used as an alternative to chlorhexidine mouthrinse as it has similar properties without the side-effects of the latter.