New antiquack blog

[vaidya]

and here's some studies for Azadirachta indica (note that I am still searching for human clinical trials, not the many many more animal research trials):

1: J Commun Dis. 1999 Dec;31(4):241-5.

Field evaluation of herbal mosquito repellents.

Das NG, Nath DR, Baruah I, Talukdar PK, Das SC.

Repellent properties of Zanthoxylum armatum DC. Syn. Z. alatum Roxb. (Timur), Curcuma aromatica (Jungli haldi) and Azadirachta indica (Neem) oils were evaluated against mosquitoes in mustard (Brassica sp.) and coconut (Cocos sp.) oil base and compared with synthetic repellent. Dimethyl phthalate (DMP) as standard. Timur and jungli haldi afforded better protection in the both the base at all the concentrations. Tepellents in mustard oil gave longer protection time than those in coconut oil. At 0.57 mg/cm2 concentration timur oil gave significantly higher protection both in mustard (445 min) as well as coconut oil (404 min) than the other repellents and DMP.

Publication Types: Clinical Trial Comparative Study

PMID: 10937301 [PubMed - indexed for MEDLINE]

2: Indian J Dent Res. 2001 Jul-Sep;12(3):133-44.

Erratum in: Indian J Dent Res 2001 Oct-Dec;12(4):193.

The effect of indigenous Neem Azadirachta indica [correction of (Adirachta indica)] mouth wash on Streptococcus mutans and lactobacilli growth.

Vanka A, Tandon S, Rao SR, Udupa N, Ramkumar P.

Dept. of Pedodontics & Preventive Dentistry, College of Dental Surgery, Manipal 570 119, India.

Neem is one of the most widely researched tropical tree, with almost all it's parts being put for a variety of uses. In the present study, the antibacterial effect of Neem mouthwash against salivary levels of streptococcus mutans and lactobacillus has been tested over a period of 2 months. Also it's effect in reversing incipient carious lesions was assessed. While streptococcus mutans was inhibited by Neem mouthwashes, with or without alcohol as well as chlorhexidine, lactobacillus growth was inhibited by chlorhexidine alone. The initial data appears to prove it's effect in inhibiting S. mutans and reversing incipient carious lesions, longer term clinical trials are essential.

Publication Types: Clinical Trial Comparative Study Randomized Controlled Trial

PMID: 11808064 [PubMed - indexed for MEDLINE]

3: J Ethnopharmacol. 2004 Jan;90(1):99-103.

Evaluation of antiplaque activity of Azadirachta indica leaf extract gel--a 6-week clinical study.

Pai MR, Acharya LD, Udupa N.

Department of Pharmaceutics, College of Pharmaceutical Sciences, Manipal Academy of Higher Education, 576119, Manipal, India

Various chemical agents have been evaluated over the years with respect to their antimicrobial effects in the oral cavity; however, all are associated with side effects that prohibit regular long-term use. Therefore, the effectiveness of neem (Azadirachta indica A. Juss) leaf extract against plaque formation was assessed in males between the age group of 20-30 years over a period of 6 weeks. Present study includes formulation of mucoadhesive dental gel containing Azadirachta indica leaf extract (25 mg/g). A 6-week clinical study was conducted to evaluate the efficacy of neem extract dental gel with commercially available chlorhexidine gluconate (0.2% w/v) mouthwash as positive control. Microbial evaluation of Streptococcus mutans and Lactobacilli species was carried out to determine the total decrease in the salivary bacterial count over a period of treatment using a semi-quantitative four quadrant streaking method. The results of the study suggested that the dental gel containing neem extract has significantly (P<0.05) reduced the plaque index and bacterial count than that of the control group.

Publication Types: Clinical Trial Randomized Controlled Trial

PMID: 14698516 [PubMed - indexed for MEDLINE]

4: Life Sci. 2004 Oct 29;75(24):2867-78.

Clinical studies on the effect of Neem (Azadirachta indica) bark extract on gastric secretion and gastroduodenal ulcer.

Bandyopadhyay U, Biswas K, Sengupta A, Moitra P, Dutta P, Sarkar D, Debnath P, Ganguly CK, Banerjee RK.

Department of Physiology, Indian Institute of Chemical Biology, 4, Raja S. C. Mullick Road, Kolkata, 700032, India. ubandyo_1964@yahoo.com

We have shown earlier that Neem (Azadirachta indica) bark aqueous extract has potent antisecretory and antiulcer effects in animal models and has no significant adverse effect (Bandyopadhyay et al., Life Sciences, 71, 2845-2865, 2002). The objective of the present study was to investigate whether Neem bark extract had similar antisecretory and antiulcer effects in human subjects. For this purpose, a group of patients suffering from acid-related problems and gastroduodenal ulcers were orally treated with the aqueous extract of Neem bark. The lyophilised powder of the extract when administered for 10 days at the dose of 30 mg twice daily caused a significant (p < 0.002) decrease (77%) in gastric acid secretion. The volume of gastric secretion and its pepsin activity were also inhibited by 63% and 50%, respectively. Some important blood parameters for organ toxicity such as sugar, urea, creatinine, serum glutamate oxaloacetate transaminase, serum glutamate pyruvate transaminase, albumin, globulin, hemoglobin levels and erythrocyte sedimentation rate remained close to the control values. The bark extract when taken at the dose of 30-60 mg twice daily for 10 weeks almost completely healed the duodenal ulcers monitored by barium meal X-ray or by endoscopy. One case of esophageal ulcer (gastroesophageal reflux disease) and one case of gastric ulcer also healed completely when treated at the dose of 30 mg twice daily for 6 weeks. The levels of various blood parameters for organ toxicity after Neem treatment at the doses mentioned above remained more or less close to the normal values suggesting no significant adverse effects. Neem bark extract thus has therapeutic potential for controlling gastric hypersecretion and gastroesophageal and gastroduodenal ulcers.

Publication Types: Clinical Trial Comparative Study Research Support, Non-U.S. Gov't

PMID: 15454339 [PubMed - indexed for MEDLINE]

5: Trans R Soc Trop Med Hyg. 2005 Oct;99(10):769-74.

Phase I safety study of Praneem polyherbal vaginal tablet use among HIV-uninfected women in Pune, India.

Joshi SN, Katti U, Godbole S, Bharucha K, B KK, Kulkarni S, Risbud A, Mehendale S.

National AIDS Research Institute, Epidemiology Department, MIDC, Bhosari, Pune, Maharashtra, India. sjoshi@nariindia.org

Praneem polyherbal formulations containing purified extracts of Azadirachta indica (neem tree) have shown activity against HIV and sexually transmitted disease pathogens in studies in vitro. The product also has contraceptive properties. This has prompted its development as a possible microbicide. We evaluated the safety of Praneem polyherbal tablet use among HIV-uninfected women. Twenty eligible women were enrolled in a Phase I open-label study requiring 14 days of consecutive intravaginal use of Praneem polyherbal tablets. Nine (45%) participants experienced 17 episodes of genital irritation. Transient genital itching was reported by eight (40%) participants, burning micturation by two (10%) and lower abdominal pain, genital burning and intermenstrual spotting by one (5%) each. On colposcopy, petechial haemorrhage was observed in two participants, one on day 7 and the other on day 14, and both were resolved without any treatment. There were no serious adverse events. Praneem polyherbal tablets were found to be safe for once daily intravaginal use for 14 consecutive days in sexually active HIV-uninfected women and a Phase II study may be taken up as a priority.

Publication Types: Clinical Trial, Phase I

PMID: 16084547 [PubMed - indexed for MEDLINE]

6: Parasitol Res. 2007 Jan;100(2):329-32. Epub 2006 Aug 10.

Efficacy of neem seed extract shampoo on head lice of naturally infected humans in Egypt.

Abdel-Ghaffar F, Semmler M.

Zoology Department, Faculty of Science Cairo University, Giza, Egypt.

Sixty heavily lice-infested male and female children (4-15 years) were selected and subjected to the treatment with a neem seed extract shampoo. Twenty to thirty milliliter of the shampoo were thoroughly mixed with completely wet hair and rubbed in to reach the skin of the scalp. After 5, 10, 15 and 30 min, the shampoo was washed out and the hair basically combed. Head lice were collected and examined. The neem seed extract shampoo proved to be highly effective against all stages of head lice. No obvious differences regarding the efficacy of the shampoo were observed between an exposure time of 10, 15 or 30 min. No side effects, such as skin irritation, burning sensations, or red spots on the scalp, forehead or neck, respectively, were observed.

Publication Types: Clinical Trial

PMID: 16900389 [PubMed - indexed for MEDLINE]

7: Am J Ther. 2007 Jul-Aug;14(4):369-74.

Fractionated neem leaf extract is safe and increases CD4+ cell levels in HIV/AIDS patients.

Mbah AU, Udeinya IJ, Shu EN, Chijioke CP, Nubila T, Udeinya F, Muobuike A, Mmuobieri A, Obioma MS.

Department of Pharmacology and Therapeutics, College of Medicine, University of Nigeria, Enugu Campus, Enugu, Nigeria.

The safety and effect of an acetone-water neem leaf extract (IRAB) on CD4 cells was investigated in 60 HIV/AIDS patients as part of an ongoing study to determine the influence of neem on immunity and viral load in HIV/AIDS. Patients were confirmed as HIV I or II positive, as having CD4 cell count, less than 300 cells/microL, and as antiretrovirally naïve. They were given oral IRAB (1.0 g daily for 12 weeks). Clinical and laboratory tests were carried out at baseline and at 4 weekly intervals. Thus, the patients served as their own controls. Sixty patients completed treatment. Fifty (83.33%) were completely compliant with respect to laboratory tests. Increase in mean CD4 cells, 266 cells/microL (159%), for the 50 patients was significant (P < 0.001) between baseline and week 12. Erythrocyte sedimentation rate (64 mm/hr at baseline) was 16 mm/hr at week 12, whereas total number of incidences of HIV/AIDS-related pathologies decreased from 120 at baseline to 5. Mean bodyweight, hemoglobin concentration, and lymphocyte differential count increased significantly by 12% (P < 0.05), 24% (P < 0.0001), and 20% (P < 0.0001), respectively. There were no adverse effects and no abnormalities in kidney and liver function parameters. The results support the safety of IRAB in HIV/AIDS, and its significant influence on CD4 cells may be useful in the formulation of multidrug combination therapies for HIV/AIDS. However, its antiretroviral activity is being evaluated in our laboratory.

Publication Types: Clinical Trial Multicenter Study

PMID: 17667213 [PubMed - indexed for MEDLINE]

 

[vaidya]

and here are some studies on Centella asiatica and venous insufficiency... you see guys, lots of info - you just need a little experience:

1: Minerva Cardioangiol. 1992 Apr;40(4):137-43.

[Activity of Centella asiatica in venous insufficiency]

[Article in Italian]

Cesarone MR, Laurora G, De Sanctis MT, Belcaro G.

Clinica Cardiovascolare, Università degli Studi G. D'Annunzio, Chieti.

In this a review concerning TTFCA, its effects on metabolism in the connective tissue of the vascular wall and on the microcirculation are presented and discussed. This compound is effective in venous insufficiency, reducing ankle edema, foot swelling, capillary filtration rate and by improving microcirculatory parameters (RF, VAR PO2-PCO2). TTFCA displays a significant activity in venous hypertensive microangiopathy and its effects are dose-dependent.

Publication Types: Clinical Trial Comparative Study English Abstract

PMID: 1528498 [PubMed - indexed for MEDLINE]

2: Haematologica. 1991 May-Jun;76(3):256-9.

Centella Asiatica Triterpenic Fraction (CATTF) reduces the number of circulating endothelial cells in subjects with post phlebitic syndrome.

Montecchio GP, Samaden A, Carbone S, Vigotti M, Siragusa S, Piovella F.

Clinica Medica II, IRCCS Policlinico San Matteo, Pavia, Italy.

Here we report a study performed in order to assess the number of circulating endothelial cells (EC) in normal subjects and in patients with postphlebitic syndrome (PPS), and the effect of treatment with Centella Asiatica Triterpenic Fraction (CATTF), a drug which has been demonstrated to be effective in promoting wound healing in vivo. EC counts were determined by means of differential centrifugation and phase contrast microscopy. Patients with PPS showed an increased number of circulating EC in comparison to normal subjects (3.8 +/- 1.2 cells versus 1.5 +/- 0.6 per counting chamber). Treatment for three weeks with CATTF caused a statistically significant reduction of circulating EC (1.80 +/- 0.6 cells per counting chamber).

Publication Types: Clinical Trial

PMID: 1743599 [PubMed - indexed for MEDLINE]

3: Angiology. 1990 Jan;41(1):12-8.

Capillary filtration and ankle edema in patients with venous hypertension treated with TTFCA.

Belcaro GV, Rulo A, Grimaldi R.

Cardiovascular Clinic, University G. D'Annunzio, Chieti, Italy.

The variation of capillary filtration rate (CFR), ankle circumference (AC), and ankle edema (AE) was evaluated in three groups of patients with venous hypertension (ambulatory venous pressure greater than 42 mmHg) and in a group of normal subjects before and after treatment for four weeks with Total Triterpenic fraction of Centella Asiatica (TTFCA), a venoactive drug acting on the microcirculation and on capillary permeability. Group A (20 patients) was treated with TTFCA 60 mg tid; Group B (20 patients) was treated with 30 mg tid; Group C (12 patients) was treated with placebo; and Group D (10 normal subjects) was treated with TTFCA 60 mg tid in an open study. Capillary filtration rate was assessed by venous occlusion plethysmography, ankle edema by a new system called AECT (Ankle edema coin tester). Subjective symptoms of venous hypertension were assessed by an analogue scale line considering four symptoms: swelling sensation, restless lower extremity, pain and cramps, and tiredness. CFR, AC, and AE were significantly higher in patients in comparison with normal subjects. After four weeks of TTFCA treatment there was a significant decrease of the abnormally increased CFR, AC, and AECT time in patients. This was also greater in the higher dose group. No significant change was observed in the placebo group and in normal subjects treated with TTFCA. Symptoms were also significantly improved in the two groups treated with the active drug according to the dose. No significant changes were observed in the placebo group.(ABSTRACT TRUNCATED AT 250 WORDS)

Publication Types: Clinical Trial Comparative Study Controlled Clinical Trial

PMID: 2305995 [PubMed - indexed for MEDLINE]

4: Angiology. 1987 Jan;38(1 Pt 1):46-50.

Titrated extract of Centella asiatica (TECA) in the treatment of venous insufficiency of the lower limbs.

Pointel JP, Boccalon H, Cloarec M, Ledevehat C, Joubert M.

Ninety-four patients suffering from venous insufficiency of the lower limbs participated in a multicenter, double-blind versus placebo study. After randomization, they were allotted for a treatment period of two months to one of three groups: TECA 120 mg/day, TECA 60 mg/day, or placebo. A significant difference (p less than 0.05) in favor of TECA was shown for the symptoms of heaviness in the lower limbs and edema, as well as for the overall evaluation by the patient. The venous distensibility measured by a mercury strain gauge plethysmograph at three occlusion pressures was improved for the TECA groups but aggravated for the placebo group.

Publication Types: Clinical Trial Comparative Study Randomized Controlled Trial

PMID: 3544968 [PubMed - indexed for MEDLINE]

5: Minerva Cardioangiol. 1994 Jun;42(6):299-304.

[The microcirculatory activity of Centella asiatica in venous insufficiency. A double-blind study]

[Article in Italian]

Cesarone MR, Laurora G, De Sanctis MT, Incandela L, Grimaldi R, Marelli C, Belcaro G.

Istituto di Clinica Cardiovascolare, Università degli Studi G. D'Annunzio, Chieti.

In 87 patients with chronic venous hypertensive microangiopathy the efficacy of oral FTTCA (Centella asiatica) administered for 60 days was tested. The microcirculatory effects of two dosages (30 mg bid and 60 mg bid) versus placebo was assessed in a double blind study. The compound was well tolerated and no unwanted effects were observed. Microcirculatory parameters--peri-malleolar skin flux at rest (RF) and transcutaneous PO2 and PCO2--improved as did the abnormally increased RF, PCO2 decreased and PO2 increased in comparison with values measured at inclusion. These results confirm the efficacy of FTTCA in venous hypertensive microangiopathy. Furthermore the effects of FTTCA appear to be dose-related.

Publication Types: Clinical Trial Comparative Study English Abstract Randomized Controlled Trial

PMID: 7936334 [PubMed - indexed for MEDLINE]

6: Angiology. 2001 Oct;52 Suppl 2:S15-18.

Effects of the total triterpenic fraction of Centella asiatica in venous hypertensive microangiopathy: a prospective, placebo-controlled, randomized trial.

Cesarone MR, Belcaro G, De Sanctis MT, Incandela L, Cacchio M, Bavera P, Ippolito E, Bucci M, Griffin M, Geroulakos G, Dugall M, Buccella S, Kleyweght S, Cacchio M.

Irvine Vascular Laboratory, St Mary's Hospital and Imperial College, London, UK.

The aim of this study was to demonstrate whether total triterpenic fraction of Centella asiatica (TTFCA), was effective in improving the microcirculation in venous hypertension and microangiopathy. Forty patients with severe venous hypertension, ankle swelling, lipodermatosclerosis were included. After informed consent, patients were randomized into a treatment and a placebo group: those in the treatment group received TTFCA (tablets, 60 mg, twice daily for 8 weeks). The two groups of subjects were comparable for age and sex distribution. The mean age was 48 years (SD 9; M:F= 11:11) in the treatment group (22 patients) and 47.6 (SD 7; M:F= 10:8) in the placebo group (18 patients). There were no differences between placebo and treatment group at inclusion; there was no change between inclusion and measurements at 8 weeks in the placebo group. A decrease (p < 0.05) in RF (flux at rest) and RAS (rate of ankle swelling) were observed in the treatment group. The decrease in capillary filtration was associated with improvement in signs and symptoms (p < 0.05). The difference in flux, signs and symptoms, and filtration was clinically important at 8 weeks. No side effects were observed. In conclusion venous microangiopathy was improved by TTFCA treatment.

Publication Types: Clinical Trial Randomized Controlled Trial

PMID: 11666117 [PubMed - indexed for MEDLINE]

7: Angiology. 2001 Oct;52 Suppl 2:S19-25.

Increase in echogenicity of echolucent carotid plaques after treatment with total triterpenic fraction of Centella asiatica: a prospective, placebo-controlled, randomized trial.

Cesarone MR, Belcaro G, Nicolaides AN, Geroulakos G, Bucci M, Dugall M, De Sanctis MT, Incandela L, Griffin M, Sabetai M.

Irvine Vascular Laboratory, St Mary's Hospital and Imperial College, London, UK.

The aim of this study was to evaluate whether total triterpenic fraction of Centella asiatica (TTFCA), was effective in modulating collagen production over 12 months, by producing an increase in echogenicity in echolucent carotid plaques. Part I was a pilot study aimed at evaluating the effects of TTFCA on different types of plaques. Part II was a prospective, randomized, placebo-controlled trial aimed at evaluating the effects of TTFCA on hypoechoic-echolucent plaques. The sonographic examination of carotid plaques was made with high-resolution ultrasound. Capturing, digital image processing, and normalization were standardized, interobserver, intrascanner, gain-level variability were standardized using as reference blood (black) for the most echolucent parts of the plaque and the adventitia (white) as the most echogenic part. Normalization of echo texture was obtained and plaque characterization differentiated echo-texture of plaque associated with events and those that did not cause embolization, thrombosis, or cardiovascular events. After identifying plaques at higher risk, patients were treated with TTFCA (oral tablets, 60 mg, thrice daily for 12 months) to evaluate whether this compound, by modulating collagen synthesis, could increase the echogenicity and therefore the stability of echolucent plaques. Part II was aimed at evaluating the effects of TTFCA on hypoechoic-echolucent plaques. Asymptomatic patients with echolucent plaques (GSM<18) were treated with TTFCA (60 mg, oral tablets three times daily for 12 months) or with comparable placebo after informed consent. All patients were also treated with antiplatelet agents. In part 1, at inclusion the GSC in the hypoechoic group was 15 (range, 12-18) while in the hyperechoic group it was 26 (range, 24-31); at 6 months it was increased in the hypoechoic group and at 12 months the increase was significant (19.5; p<0.05). There was a minor increase in GSM in the hyperechoic group (30; ns). In part II in the treatment group there was a significant difference in GSM (increase) at 12 months (p<0.05), improvement in texture (p<0.05) and a nonsignificant decrease in stenosis. No changes were observed in the placebo group. Events were observed in 6.5% of patients in the TTFCA group and in 11% in the control group (p<0.05). In conclusion these observations suggest a positive action of TTFCA on the stabilization of hypoechoic, low-density carotid plaques.

Publication Types: Clinical Trial Randomized Controlled Trial

PMID: 11666118 [PubMed - indexed for MEDLINE]

8: Angiology. 2001 Oct;52 Suppl 2:S27-31.

Treatment of diabetic microangiopathy and edema with total triterpenic fraction of Centella asiatica: a prospective, placebo-controlled randomized study.

Incandela L, Belcaro G, Cesarone MR, De Sanctis MT, Nargi E, Patricelli P, Bucci M.

Irvine Vascular Laboratory, St Mary's Hospital and Imperial College, London, UK.

The aim of this study was to demonstrate in a prospective, placebo-controlled, randomized study, whether total triterpenic fraction of Centella asiatica (TTFCA) is effective in improving the microcirculation in diabetic microangiopathy and neuropathy, Patients with severe diabetic microangiopathy, neuropathy, and edema; patients with microangiopathy without neuropathy; and healthy subjects were included. Microangiopathy was defined by laser Doppler and capillary filtration (rate on ankle swelling). Inclusion criteria were increase in resting flux and rate of ankle swelling; decrease in venoarteriolar response (VAR) and alteration in flux increase with temperature. Patients were randomized: the treatment group received TTFCA (tablets, 60 mg twice daily for 12 months); those in the placebo group received similar tablets. Healthy controls were followed up as a reference. Groups were comparable; there were no dropouts. There were no differences in the treatment and placebo groups at inclusion. Treatment was well tolerated; no side effects were reported. No variations were observed in normals at 12 months. In the neuropathy A-group, decreases (p<0.05) in RF and RAS were observed in the two treatment groups. The decrease in RAS was associated with a decrease in edema (p<0.05) in both treatment groups. The differences in flux (38%) and in VAR (38%) were associated with a decrease (28%) in the rate of ankle swelling (p<0.05). In patients without neuropathy (B-group) the decrease in flux was 22%, the VAR increased 22.7%, and the RAS decreased 9.5% at 12 months. The variations in normals and the progressive deterioration observed in untreated patients in both groups indicates the difference between treatment and placebo. In conclusion, the decrease in capillary filtration and edema is associated with symptomatic improvement. The action on edema is beneficial for the evolution of neuropathy. The effects of TTFCA on flux, RAS, and edema are important in early stages of microangiopathy to avoid progression to clinical stages.

Publication Types: Clinical Trial Randomized Controlled Trial

PMID: 11666119 [PubMed - indexed for MEDLINE]

9: Angiology. 2001 Oct;52 Suppl 2:S33-7.

Flight microangiopathy in medium- to long-distance flights: prevention of edema and microcirculation alterations with total triterpenic fraction of Centella asiatica.

Cesarone MR, Incandela L, De Sanctis MT, Belcaro G, Geroulakos G, Griffin M, Lennox A, Di Renzo AD, Cacchio M, Bucci M.

Irvine Laboratory, St Mary's Hospital at Imperial College, London, UK.

The aim of this study was the evaluation of microcirculatory alterations associated with edema in passengers travelling for more than 3 hours and the study of the effects of TTFCA (total triterpenic fraction of Centella asiatica) on the development of microcirculation alterations and edema, in a prospective, randomized study. Laser Doppler flowmetry (LDF), transcutaneous PO2 and PCO2, rate of ankle swelling (RAS) were used. Subjects were randomized after informed consent into two groups: one control group (no drug or other treatment), and a treatment group (TTFCA 60 mg thrice daily for 2 days before the flight, the day of the flight, and for another day after the flight). Inclusion criteria were age range between 30 and 50, mild-moderate superficial venous disease with varicose veins. Subjects traveled in economy class. In controls there was a progressive increase in CO2, RAS, and edema score and a progressive decrease in flux (RF) and venoarteriolar response with flying time. The variations in all parameters were milder (p>0.05) in the TTFCA group. RAS and edema were significantly lower in the TTFCA-treated group (p<0.025). The progressive increase in RAS, PCO2, and the decrease in VAR and O2 were linearly associated with flight time (up to 10 hours). These results are very interesting and indicate an option for patients prone to edema and microcirculation disturbances during long flights.

Publication Types: Clinical Trial Randomized Controlled Trial

PMID: 11666121 [PubMed - indexed for MEDLINE]

10: Angiology. 2001 Oct;52 Suppl 2:S45-8.

Microcirculatory effects of total triterpenic fraction of Centella asiatica in chronic venous hypertension: measurement by laser Doppler, TcPO2-CO2, and leg volumetry.

Cesarone MR, Belcaro G, Rulo A, Griffin M, Ricci A, Ippolito E, De Sanctis MT, Incandela L, Bavera P, Cacchio M, Bucci M.

Irvine Vascular Laboratory, St Mary's Hospital and Imperial College, London, UK.

The aim of this prospective, randomized study was to demonstrate whether an oral preparation of TTFCA was effective in improving the microcirculation and edema (leg volume) in venous microangiopathy. Forty patients with venous hypertension were included. Treatment was prescribed for 6 weeks (tablets, 60 mg twice daily). Patients were randomized into a treatment and a placebo group. There were 20 patients in each group. In the treatment group the mean age was 42 (SD 7; M:F 10:10); in the placebo group, the mean age was 40 (SD 9; M:F = 10:10). Tolerability and compliance were very good; there were no dropouts. At inclusion there were no differences between placebo and treatment group. After treatment there was a decrease in resting flux (29%) and an improvement (increase) in venoarteriolar response (52%); PO2 was increased (7.2%) and PCO2 decreased (9.6%). There was an important decrease in leg volume (66 mL decrease; 1.3% volume variation). The difference in flux, O2-CO2 and volume parameters were significant and clinically important at 6 weeks in the treatment group. In conclusion, TTFCA improves microcirculation and leg volume in venous hypertension. The effects of TTFCA are observed even in a limited sample of patients.

Publication Types: Clinical Trial Randomized Controlled Trial

PMID: 11666123 [PubMed - indexed for MEDLINE]

11: Angiology. 2001 Oct;52 Suppl 2:S49-54.

Evaluation of treatment of diabetic microangiopathy with total triterpenic fraction of Centella asiatica: a clinical prospective randomized trial with a microcirculatory model.

Cesarone MR, Incandela L, De Sanctis MT, Belcaro G, Bavera P, Bucci M, Ippolito E.

Irvine Vascular Laboratory, St Mary's Hospital and Imperial College, London, UK.

Fifty patients with diabetic microangiopathy were studied by laser Doppler flowmetry (measuring skin blood flow at rest) (RF) and the venoarteriolar response (VAR), by transcutaneous PO2 and PCO2 measurements, and by capillary permeability evaluation (rate of ankle swelling [RAS]). Thirty of these patients were treated for 6 months with total triterpenic fraction of Centella asiatica (TTFCA) (60 mg twice daily), a drug active on microcirculation and capillary permeability. A control group of ten patients was treated with placebo and another group of ten patients was left without treatment thus acting as a second control group. After six months there were no significant changes in the two control groups. There was a significant improvement of microcirculatory parameter in patients treated with TTFCA. RF (abnormally increased at the beginning of the treatment) decreased, and the VAR (impaired at the beginning of the study) improved. PO2 increased and PCO2 decreased the abnormally increased capillary permeability was also improved (decreased). According to these data, TTFCA is useful in diabetic microangiopathy by improving microcirculation and decreasing capillary permeability. Also TTFCA protects against the deterioration of microcirculation due to diabetic microangiopathy.

Publication Types: Clinical Trial Randomized Controlled Trial

PMID: 11666124 [PubMed - indexed for MEDLINE]

12: Angiology. 2001 Oct;52 Suppl 2:S55-9.

Treatment of edema and increased capillary filtration in venous hypertension with total triterpenic fraction of Centella asiatica: a clinical, prospective, placebo-controlled, randomized, dose-ranging trial.

De Sanctis MT, Belcaro G, Incandela L, Cesarone MR, Griffin M, Ippolito E, Cacchio M.

Irvine Vascular Laboratory, St Mary's Hospital and Imperial College, London, UK.

The variation of capillary filtration rate (CFR), ankle circumference (AC), and ankle edema (AE) was evaluated in three groups of patients with venous hypertension (ambulatory venous pressure >42 mm Hg) and in a group of normal subjects before and after treatment for 4 weeks with total triterpenic fraction of Centella asiatica (TTFCA), a venoactive drug acting on the microcirculation and on capillary permeability. Group A (20 patients)was treated with TTFCA 60 mg thrice daily, group B (20 patients) was treated with 30 mg thrice daily; group C (12 patients) was treated with placebo; and group D (10 normal subjects) was treated with TTFCA 60 mg thrice daily in a randomized study. Capillary filtration rate was assessed by venous occlusion plethysmography, ankle edema by a new system called AET (ankle edema tester). Subjective symptoms of venous hypertension were assessed by an analogue scale line considering four symptoms: swelling sensation, restless lower extremity, pain and cramps, and tiredness. CFR, AC, and AE were significantly higher in patients in comparison with normal subjects. After 4 weeks of TTFCA treatment, there was a significant decrease of CFR, AC, and AET time in patients. This was also greater in the higher dose group. No significant change was observed in the placebo group and in normal subjects treated with TTFCA. Symptoms were also significantly improved in the two groups treated with the active drug according to the dose. No significant changes were observed in the placebo group. In conclusion, the improvement of signs and symptoms by TTFCA observed in patients with venous hypertension was well correlated with the improvement of CFR and ankle edema. Dose ranging showed that 180 mg/day is more effective in improving symptoms and CFR.

Publication Types: Clinical Trial Randomized Controlled Trial

PMID: 11666125 [PubMed - indexed for MEDLINE]

13: Angiology. 2001 Oct;52 Suppl 2:S61-7.

Total triterpenic fraction of Centella asiatica in the treatment of venous hypertension: a clinical, prospective, randomized trial using a combined microcirculatory model.

Incandela L, Belcaro G, De Sanctis MT, Cesarone MR, Griffin M, Ippolito E, Bucci M, Cacchio M.

Irvine Vascular Laboratory, St Mary's Hospital and Imperial College, London, UK.

A single-blind, placebo-controlled, randomized study was performed on the effects of different doses of the total triterpenic fraction of Centella asiatica (TTFCA) in patients with venous hypertensive microangiopathy. A combined microcirculatory model that considers laser Doppler flowmetry (LDF) and transcutaneous oxygen (PO2), transcutaneous carbon dioxide tension (PCO2) measurements was combined with the symptom evaluation. LDF tests included the baseline resting flow, the venoarteriolar reflex, and the variation of flow related to the temperature increase. All tests provided a significant difference between drug-treated groups and the placebo group, thereby allowing a distinction to be made between the higher (120 mg daily) and the lower (60 mg daily) dose of TTFCA. Transcutaneous PO2-PCO2 measurements were significantly modified by drug treatments, while no variation could be detected in the placebo group. Important symptomatologic effects (evaluated by subjective scores) followed TTFCA administration, especially at the higher dose level, while no effect was obtained with placebo. The trend of symptom evaluation paralleled the results of objective tests of our microcirculatory model, providing evidence that this model can reveal effects of venoactive drugs on venous hypertensive microangiopathy. TTFCA displays a significant activity. Doses as high as 120 mg daily may be safely used in venous hypertension.

Publication Types: Clinical Trial Randomized Controlled Trial

PMID: 11666126 [PubMed - indexed for MEDLINE]

14: Angiology. 2001 Oct;52 Suppl 2:S69-73.

Modification of the echogenicity of femoral plaques after treatment with total triterpenic fraction of Centella asiatica: a prospective, randomized, placebo-controlled trial.

Incandela L, Belcaro G, Nicolaides AN, Cesarone MR, De Sanctis MT, Corsi M, Bavera P, Ippolito E, Griffin M, Geroulakos G, Sabetai M, Ramaswami G, Veller M.

Irvine Vascular Laboratory, St Mary's Hospital at Imperial College, London, UK.

The aim of this study was to evaluate whether TTFCA (total triterpenic fraction of Centella asiatica), was effective, by modulating collagen production, in a period of 12 months, increasing the echogenicity of echolucent plaques at the femoral bifurcation. Hypoechoic atherosclerotic plaques have been found to be associated with an increased evidence of cerebrovascular events. In this type of plaques stromal composition is limited as the collagen component is generally very low; the plaque composition is mainly due to lipid accumulation or thrombosis. The aim of this study was the evaluation of echogenicity of hyperechoic plaques and how it could be modified by a drug acting on the modulation of collagen synthesis. Antiplatelet agents were used in all patients; cholesterol-lowering agents were used in 34% of patients in the treatment group and in 36% in the placebo group. TTFCA was used at the dose of 60 mg thrice daily (oral tablets). Of the 60 included subjects 26 completed the study in the treatment group and 24 in the placebo group. At inclusion the average GSM in the treatment group was 14 (SD 3) and 14.3 (SD 3) in controls. At 12 months GSM was increased up to 22.8 (SD 4) in the treatment group and it was 15 (SD 3) in controls. Considering texture no significant changes were observed in controls while a qualitative increase in homogenicity was observed in the TTFCA group. Plaque size measured at the beginning and at the end of the study showed a median increase in size, in controls (23%; range 0%-44%); it was unchanged in the TTFCA group (variation 7%; 4%-26%). In conclusion in the treatment group plaques increased in echogenicity and in homogenicity; size and stenosis remained unchanged. Modulating the scarring process within echolucent plaques (low echogenicity, high echolucency, with a very low collagen/stromal component), possibly by collagen modulation, makes plaques more stable. This has been achieved and documented in the present study by an increase in the gray-scale median (plaques become more echogenic, more 'white'). The variation in GSM is generally associated with a lower risk of wall thrombosis, rupture and embolization. These observations indicate a positive action of TTFCA on the stabilization of hypoechoic, low-density femoral plaques.

Publication Types: Clinical Trial Randomized Controlled Trial

PMID: 11666127 [PubMed - indexed for MEDLINE]

15: J Int Acad Periodontol. 2003 Oct;5(4):106-15.

Adjunctive periodontal treatment with Centella asiatica and Punica granatum extracts. A preliminary study.

Sastravaha G, Yotnuengnit P, Booncong P, Sangtherapitikul P.

Out-Patient Department, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.

BACKGROUND: Centella asiatica and Punica granatum are medicinal herbs that have been reported to promote tissue healing and modulate host responses. The purpose of this study was to investigate the effects of the combined extracts from C. asiatica and P. granatum pericarp on periodontal healing following scaling and root planing in adult periodontitis patients. METHODS: An innovative herbal medicament was formulated in the form of biodegradable chips for subgingival application. Twenty patients with initial pocket depth 5-8 mm were enrolled into the study. After baseline examination, scaling and root planing of non-target teeth, the target teeth received scaling and root planing followed by subgingival delivery of medicated chips in the test group and unmedicated chips in the placebo group. Probing pocket depth, attachment level, bleeding on probing, gingival index, and plaque index were recorded at baseline, 3 and 6 months. RESULTS: The results showed significant improvements of pocket depth and attachment level in the test sites when compared with the placebo sites at 3 months and with the placebo and control sites at 6 months. All treatment sites exhibited a similar trend of decreasing plaque score. However, the test sites seemed to show slightly better percentage of bleeding on probing. CONCLUSION: The results indicate that local delivery with C. asiatica and P. granatum extracts plus scaling and root planing significantly reduced the clinical signs of chronic periodontitis.

Publication Types: Clinical Trial Randomized Controlled Trial Research Support, Non-U.S. Gov't

PMID: 14604059 [PubMed - indexed for MEDLINE]

16: J Int Acad Periodontol. 2005 Jul;7(3):70-9.

Adjunctive periodontal treatment with Centella asiatica and Punica granatum extracts in supportive periodontal therapy.

Sastravaha G, Gassmann G, Sangtherapitikul P, Grimm WD.

Department of Oral Medicine and Periodontics, Faculty of Dentistry, Mahidol University, Bangkok, Thailand. sgrindwit@yahoo.com

BACKGROUND: Centella asiatica and Punica granatum are medicinal plants that have been reported to promote tissue healing and modulate host responses. Preliminary study revealed positive clinical effects of an innovative preparation from the two herbal extracts in the form of biodegradable chips as a subgingival adjunct to scaling and root planing. The purpose of this research was to evaluate further augmenting efficacy the combined herbal preparation may have among maintenance patients in comparison to standard supportive periodontal therapy (SPT), with additional monitoring of certain inflammatory markers. METHODS: Fifteen patients in the recall programme who had completed conventional periodontal therapy with remaining probing pocket depths of 5-8 mm were enrolled. After baseline examination and collection of gingival crevicular fluid (GCF) samples, SPT was provided and the target teeth in the test group received subgingival delivery of the medicated chips. The clinical parameters, which included probing pocket depth (PD), attachment level (AL), bleeding index (BI), gingival index (GI) and plaque index (PI) were recorded and GCF samples were collected at baseline, 3 and 6 months. RESULTS: The results showed significant improvement of PD, AL, and GI at 3 and 6 months and of BI at 6 months in the test group as compared to control. No significant differences in PI were found between the two treatment modalities at all subsequent visits. The test group also showed statistically greater reduction of IL-1beta at both 3 and 6 months and lower IL-6 concentration, which almost reached the level of significance at 6 months. CONCLUSION: The results indicate that adjunctive local delivery of extracts from C. asiatica in combination with P. granatum significantly improved clinical signs of chronic periodontitis and IL-1beta level in maintenance patients.

Publication Types: Clinical Trial Randomized Controlled Trial Research Support, Non-U.S. Gov't

PMID: 16022023 [PubMed - indexed for MEDLINE]

17: Cochrane Database Syst Rev. 2005 Jul 20;(3):CD003229.

Phlebotonics for venous insufficiency.

Martinez MJ, Bonfill X, Moreno RM, Vargas E, Capellà D.

Hospital de la Santa Creu i Sant Pau, Iberoamerican Cochrane Center, Service of Epidemiology, Sant Antoni M. Claret, 171, Barcelona, Spain, 08041. mmartinezz@hsp.santpau.es

BACKGROUND: Chronic venous insufficiency (CVI) is a common condition caused by inadequate blood flow through the veins, usually in the lower limbs. It can result in considerable discomfort with symptoms such as pain, itchiness and tiredness in the legs. Sufferers may also experience swelling and ulcers. Phlebotonics are a class of drugs that are often used to treat CVI. OBJECTIVES: To assess the efficacy of oral or topical phlebotonics. SEARCH STRATEGY: We searched the Cochrane Peripheral Vascular Diseases Group trials register (April 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 2, 2005), MEDLINE (January 1966 to April 2005), EMBASE (January 1980 to April 2005) and reference lists of articles. We also contacted pharmaceutical companies. SELECTION CRITERIA: Randomised, double blind, placebo-controlled trials (RCTs) assessing the efficacy of rutosides, hidrosmine, diosmine, calcium dobesilate, chromocarbe, centella asiatica, disodium flavodate, french maritime pine bark extract, grape seed extract and aminaftone in CVI patients at any stage of the disease. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed trial quality. The effects of treatment were estimated by relative risk (RR) or by standardised mean differences (SMD) by applying a random effects statistical model. Sensitivity analyses were also performed. MAIN RESULTS: Fifty-nine RCTs of oral phlebotonics were included, but only 44 trials involving 4413 participants contained quantifiable data for the efficacy analysis: 23 of rutosides, ten of hidrosmine and diosmine, six of calcium dobesilate, two of centella asiatica, one of french maritime pine bark extract, one of aminaftone and one of grape seed extract. No studies evaluating topical phlebotonics, chromocarbe, naftazone or disodium flavodate fulfilled the inclusion criteria.Outcomes included oedema, venous ulcers, trophic disorders, subjective symptoms (pain, cramps, restless legs, itching, heaviness, swelling and paraesthesias), global assessment measures and side effects. The results of many variables were heterogeneous. Phlebotonics showed some global benefit (i.e. oedema reduction) (relative risk 0.72, 95% confidence interval 0.65 to 0.81). The benefit for the remaining CVI signs and symptoms must be evaluated by phlebotonic group. There were no quantifiable data on quality of life. AUTHORS' CONCLUSIONS: There is not enough evidence to globally support the efficacy of phlebotonics for chronic venous insufficiency. There is a suggestion of some efficacy of phlebotonics on oedema but this is of uncertain clinical relevance. Due to the limitations of current evidence, there is a need for further randomised, controlled clinical trials with greater attention paid to methodological quality.

Publication Types: Meta-Analysis Review

PMID: 16034893 [PubMed - indexed for MEDLINE]

 

[vaidya]

Yes, when you can't show any real evidence, start vilifying your opponents and imply a conspiracy. That is soooo effective.

A complete and utter failure to correctly comprehend anything fls has said. She said that we have indeed looked for the benefits of herbal medicine, only that in most cases, they fail to show usefulness when subjected to tests that follow the standards of scientific evidence.

Do you know what "double-blind testing" means and why it's so important, for excample? If you give me something that indicates you understand this basic principle, then maybe there's hope for you yet...

read the studies hawkone
read em and weep

 

[vaidya]

oh, and here are several studies on the efficacy of garlic (there were many more but i haven't the time to post them all)

mmm, little ol'd garlic... definitely a drug eh, esp when saturated in olive oil and eaten with fresh bread and a nice glass of red wine

1: Klin Med (Mosk). 2007;85(3):25-8.

[Use of allicor to lower the risk of myocardial infarction]

[Article in Russian]

Sobenin IA, Prianishnikov VV, Kunnova LM, Rabinovich EA, Orekhov AN.

The aim of the study was to investigate the effects of allicor (a long-action garlic-based preparation) on the risk of acute myocardial infarction (MI) and sudden death (SD) in patients with coronary artery disease (CAD). Fifty one CAD patients were included in this double-blind placebo-controlled study. The prognostic risk of MI and SD during ten following years was counted using Cox proportional hazards model based on the results of Munster study. Allicor administered for 12 months was demonstrated to reduce absolute ten-year risk of acute MI and SD 1.5 times in men and 1.3 times in women. The reduction in calculated risk parameters was associated with changes in blood plasma lipid profile, the most significant of which was reduction in the level of low density lipoprotein cholesterol (p < 0.05) by 32.9 mg/dl in men and 27.3 mg/dl in women. The results of this study demonstrate that allicor is effective for the reduction of multifactor MI and SD risk as a means of secondary CAD prophylaxis.

Publication Types: English Abstract Randomized Controlled Trial

PMID: 17523399 [PubMed - indexed for MEDLINE]

2: Lipids Health Dis. 2007 Mar 1;6:5.

Effects of anethum graveolens and garlic on lipid profile in hyperlipidemic patients.

Kojuri J, Vosoughi AR, Akrami M.

Department of Cardiology, Shiraz University of Medical Sciences, Shiraz, Iran. kojurij@yahoo.com

BACKGROUND: hyperlipidemia as a major risk factor of atherosclerosis is treated with different drugs. Concerning length of therapy and vast majority of side effects, herbal medication may be suitable substitute for these drugs. METHODS: In this single-blind, placebo controlled study, lipid profiles of 150 hyperlipidemic patients in cardiology outpatient department of Shiraz University of Medical Sciences were checked at same conditions. They were divided into three equal groups randomly (each composing of 50 patients). They were given enteric-coated garlic powder tablet (equal to 400 mg garlic, 1 mg allicin) twice daily, anethum tablet (650 mg) twice daily, and placebo tablet. All patients were put on NCEP type Pi diet and Six weeks later, lipid profiles were checked. RESULTS: In garlic group: total cholesterol (decreased by 26.82 mg/dl, 12.1% reduction, and P-value: .000), and LDL-cholesterol (decreased by 22.18 mg/dl, 17.3% reduction, and P-value: .000) dropped. HDL-cholesterol (increased by 10.02 mg/dl, 15.7% increase, and P-value: .000) increased. Although triglyceride dropped by 13.72 mg/dl (6.3%) but this was not significant statistically (P-value: .222). In anethum group: surprisingly, triglyceride increased by 14.74 mg/dl (6.0%). Anethum could reduce total cholesterol by 0.4 % and LDL-cholesterol by 6.3% but these were not significant statistically (P-value: .828, and .210, respectively). CONCLUSION: Anethum has no significant effect on lipid profile, but garlic tablet has significant favorable effect on cholesterol, LDL-cholesterol, and HDL-cholesterol. Garlic may play an important role in therapy of hypercholesterolemia.

Publication Types: Randomized Controlled Trial

PMID: 17328819 [PubMed - indexed for MEDLINE]

3: Arch Intern Med. 2007 Feb 26;167(4):346-53.

Comment in: Arch Intern Med. 2007 Feb 26;167(4):325-6.

Effect of raw garlic vs commercial garlic supplements on plasma lipid concentrations in adults with moderate hypercholesterolemia: a randomized clinical trial.

Gardner CD, Lawson LD, Block E, Chatterjee LM, Kiazand A, Balise RR, Kraemer HC.

Stanford Prevention Research Center and Department of Medicine, Stanford University Medical School, Stanford, Calif 94305, USA. cgardner@stanford.edu

BACKGROUND: Garlic is widely promoted as a cholesterol-lowering agent, but efficacy studies have produced conflicting results. Garlic supplements differ in bioavailability of key phytochemicals. We evaluated the effect of raw garlic and 2 commonly used garlic supplements on cholesterol concentrations in adults with moderate hypercholesterolemia. METHODS: In this parallel-design trial, 192 adults with low-density lipoprotein cholesterol (LDL-C) concentrations of 130 to 190 mg/dL (3.36-4.91 mmol/L) were randomly assigned to 1 of the following 4 treatment arms: raw garlic, powdered garlic supplement, aged garlic extract supplement, or placebo. Garlic product doses equivalent to an average-sized garlic clove were consumed 6 d/wk for 6 months. The primary study outcome was LDL-C concentration. Fasting plasma lipid concentrations were assessed monthly. Extensive chemical characterization of study materials was conducted throughout the trial. RESULTS: Retention was 87% to 90% in all 4 treatment arms, and chemical stability of study materials was high throughout the trial. There were no statistically significant effects of the 3 forms of garlic on LDL-C concentrations. The 6-month mean (SD) changes in LDL-C concentrations were +0.4 (19.3) mg/dL (+0.01 [0.50] mmol/L), +3.2 (17.2) mg/dL (+0.08 [0.44] mmol/L), +0.2 (17.8) mg/dL (+0.005 [0.46] mmol/L), and -3.9 (16.5) mg/dL (-0.10 [0.43] mmol/L) for raw garlic, powdered supplement, aged extract supplement, and placebo, respectively. There were no statistically significant effects on high-density lipoprotein cholesterol, triglyceride levels, or total cholesterol-high-density lipoprotein cholesterol ratio. CONCLUSIONS: None of the forms of garlic used in this study, including raw garlic, when given at an approximate dose of a 4-g clove per day, 6 d/wk for 6 months, had statistically or clinically significant effects on LDL-C or other plasma lipid concentrations in adults with moderate hypercholesterolemia.

Publication Types: Randomized Controlled Trial Research Support, N.I.H., Extramural Research Support, U.S. Gov't, Non-P.H.S.

PMID: 17325296 [PubMed - indexed for MEDLINE]

4: J Nutr. 2006 Mar;136(3 Suppl):821S-826S.

Aged garlic extract has potential suppressive effect on colorectal adenomas in humans.

Tanaka S, Haruma K, Yoshihara M, Kajiyama G, Kira K, Amagase H, Chayama K.

Department of Endoscopy, Hiroshima University Hospital, Japan. colon@hiroshima-u.ac.jp

Epidemiological and animal studies suggest AGE and its organosulfur constituents, such as S-allylcysteine and S-allylmercaptocysteine have anticarcinogenic effects. To confirm these effects in humans, a preliminary double-blind, randomized clinical trial using high-dose AGE (AGE 2.4 mL/d) as an active treatment and low-dose AGE (AGE 0.16 mL/d) as a control was performed on patients with colorectal adenomas-precancerous lesions of the large bowel. The study enrolled 51 patients who were diagnosed as carrying colorectal adenomas. The patients were randomly assigned to the two groups after adenomas larger than 5 mm in diameter were removed by polypectomy. The number and size of adenomas right before intake (0 mo) and at 6 and 12 mo after intake were measured using colonoscopy. Thirty-seven patients (19 in the active group, 18 in the control group) completed the study and were evaluated for the efficacy of AGE. The number of adenomas increased linearly in the control group from the beginning (the baseline), but AGE significantly suppressed both the size and number of colon adenomas in patients after 12 mo of high-dose treatment (P=0.04). The results suggest AGE suppresses progression of colorectal adenomas in humans. It appears that AGE has multiple pathways to reduce cancer incidence and suppress its growth and proliferation.

Publication Types: Multicenter Study Randomized Controlled Trial

PMID: 16484573 [PubMed - indexed for MEDLINE]

5: J Nutr. 2006 Mar;136(3 Suppl):816S-820S.

Aged garlic extract prevents a decline of NK cell number and activity in patients with advanced cancer.

Ishikawa H, Saeki T, Otani T, Suzuki T, Shimozuma K, Nishino H, Fukuda S, Morimoto K.

Department of Molecular-Targeting Cancer Prevention and Epidemiology for Community Health and Medicine, Kyoto Prefectural University of Medicine, Japan. cancer@gol.com

Aged garlic extract (AGE) has manifold biological activities including immunomodulative and antioxidative effects. It is used as a major component of nonprescription tonics and cold-prevention medicines or dietary supplements. Advanced-cancer patients decline in immune functions and quality of life (QOL). The study's subjects were patients with inoperable colorectal, liver, or pancreatic cancer. In a randomized double-blind trial, AGE was administered to one group and a placebo was administered to another for 6 mo. The primary endpoint was a QOL questionnaire based on the Functional Assessment of Cancer Therapy (FACT). The subendpoints were changes in the natural-killer (NK) cell activity the salivary cortisol level from before and after administering AGE. Out of 55 patients invited to participate in the trial, 50 (91%) consented to enroll. They consisted of 42 patients with liver cancer (84%), 7 patients with pancreatic cancer (14%), and 1 patient with colon cancer (2%). Drug compliance was relatively good in both the AGE and placebo groups. Although no difference was observed in QOL, both the number of NK cells and the NK cell activity increased significantly in the AGE group. No adverse effect was observed in either group. The study showed that administering AGE to patients with advanced cancer of the digestive system improved NK cell activity, but caused no improvement in QOL.

Publication Types: Comparative Study Multicenter Study Randomized Controlled Trial

PMID: 16484572 [PubMed - indexed for MEDLINE]

6: J Nutr. 2006 Mar;136(3 Suppl):803S-805S.

Aged garlic extract is a potential therapy for sickle-cell anemia.

Takasu J, Uykimpang R, Sunga MA, Amagase H, Niihara Y.

Department of Medicine, Harbor-UCLA Medical Center, UCLA School of Medicine, Torrance, CA 90502, USA.

Sickle-cell anemia is one of the most prevalent hereditary disorders with prominent morbidity and mortality. Oxidative phenomena play a significant role in the disorder's pathophysiology. A forumlation of garlic (Allium sativum), AGE, has been reported to exert an antioxidant effect in vitro. We evaluated the antioxidant effect of AGE on sickle red blood cells (RBCs). Five patients (two men and three women, mean age 40+/-15 years, range 24-58 years) with sickle-cell anemia participated in the study. AGE was administered at a dose of 5 mL daily. Whole blood samples were obtained at baseline and at 4 wk, primarily for Heinz body analysis. In all patients, the number of Heinz bodies decreased over the 4-wk period (58.9+/-20.0% at baseline to 29.8+/-15.3% at follow-up; P=0.03). These data suggest that AGE has a significant antioxidant activity on sickle RBCs. AGE may be further evaluated as a potential therapeutic agent to ameliorate complications of sickle-cell anemia.

Publication Types: Clinical Trial Research Support, N.I.H., Extramural

PMID: 16484568 [PubMed - indexed for MEDLINE]

7: J Nutr. 2006 Mar;136(3 Suppl):741S-744S.

Aged garlic extract retards progression of coronary artery calcification.

Budoff M.

Division of Cardiology, Harbor-UCLA Medical Center, Torrance, CA, USA.

Prospective epidemiologic studies have identified several risk factors for heart disease, and most can be the target of risk reduction interventions. The most widely recognized risk factors for atherosclerotic cardiovascular disease (ASCVD) include age, gender, cigarette smoking, sedentary lifestyle, elevated LDL, reduced HDL, hypertension, and diabetes. The consistency of associations between these factors and ASCVD risk across populations is substantial. Our understanding of the pathogenesis and etiology of coronary ASCVD, as well as its clinical implications, has grown tremendously over the past 20 y. The role garlic might play in treating ASCVD has been postulated for many years, but until recently no studies on garlic's ability to inhibit the atherosclerotic process have been reported. A pilot study evaluating coronary artery calcification and the effect of garlic therapy in a group of patients who were also on statin therapy suggested incremental benefits. The implications of this study must be put in context of the potential importance of early atherosclerosis detection and prevention.

Publication Types: Comparative Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

PMID: 16484554 [PubMed - indexed for MEDLINE]

8: J Ayub Med Coll Abbottabad. 2005 Jul-Sep;17(3):60-4.

Effects of garlic on dyslipidemia in patients with type 2 diabetes mellitus.

Ashraf R, Aamir K, Shaikh AR, Ahmed T.

Department of Pharmacology and Therapeutics, Basic Medical Science Institute, Jinnah Postgraduate Medical Center, Karachi. drriz72@yahoo.com

BACKGROUND: Garlic (Allium Sativum) has been used in herbal medicine for centuries for various ailments. In recent years garlic has been the focus of serious medical and clinical attention because of beneficial effects on several cardiovascular risk factors like reduction of serum lipids, blood pressure and plasma viscosity. There is also wide spread belief among general public that garlic has beneficial effects on cardiovascular system. The purpose of present study was to evaluate the effects of garlic on one of the major cardiovascular risk factors i.e. dyslipidemia in patients with type 2 diabetes mellitus. METHOD: This 12 week randomized, single-blind, placebo controlled study was conducted on Type 2 diabetic patients with newly diagnosed dyslipidemia (n=70). Patients were selected from Diabetic OPD of Jinnah Post Graduate Medical Centre, Karachi and were divided into two groups each comprising of 35 patients, they were given tablet garlic (Garlex-Bosch Pharmaceuticals) 300 mg (containing 1.3 % allicin) twice daily and identical placebo tablets respectively. Both groups were given diet and exercise plan. RESULTS: After 12 weeks the garlic treated group (n = 33) had a significant reduction in total cholesterol (-28 mg/dl, - 12.03 % P<0.001), LDL - C (-30 mg/dl, - 17.99 % P=<0.001) while the placebo treated group ( n=32) had a non significant decrease in total cholesterol (- 2 mg/dl, - 0.9 % p= ns) and LDL-C (-3 mg/dl, -1.6 % p=ns). HDL cholesterol was significantly increased in patients treated with garlic (3.35 mg/dl, 8.81% P= <0.05) compared with placebo group (0.62, 1.6% P= n.s) but there was no significant difference in triglyceride was observed between two groups. CONCLUSION: This study suggests possible small short term benefits of garlic on dyslipidemia in type 2 diabetic patients. Garlic significantly reduced serum total cholesterol and LDL cholesterol and moderately raised HDL cholesterol as compared to placebo. Controlled Clinical Trials of longer duration are needed to assess the long term benefit of garlic on vascular and circulatory disease processes.

Publication Types: Randomized Controlled Trial

PMID: 16320801 [PubMed - indexed for MEDLINE]

9: Phytother Res. 2005 Apr;19(4):314-9.

Aged garlic extract improves endothelial function in men with coronary artery disease.

Williams MJ, Sutherland WH, McCormick MP, Yeoman DJ, de Jong SA.

Department of Medical and Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.

Endothelium-dependent vasodilation is impaired and predicts the risk of a coronary event in patients with coronary artery disease (CAD). Oxidant stress and increased systemic inflammation may contribute to this endothelial dysfunction. Aged garlic extract (AGE) contains antioxidant compounds and increases nitric oxide production and decreases the output of inflammatory cytokines from cultured cells. The aim of this study was to test the effect of treatment with AGE on brachial artery flow mediated endothelium-dependent dilation (FMD) and circulating markers of oxidative stress and systemic inflammation. The trial included 15 men with angiographically proven CAD in a randomized, placebo-controlled, cross-over design with 2-week treatment and washout periods. During AGE supplementation, FMD increased (44%) significantly (p = 0.04) from the baseline and mainly in men with lower baseline FMD. Levels of FMD at the end of AGE treatment were significantly (p = 0.03) higher compared with the corresponding levels at the end of placebo treatment when the variation in baseline body weight was taken into account. Markers of oxidant stress (plasma oxidized low density lipoprotein and peroxides), systemic inflammation (plasma C-reactive protein ad interleukin-6) and endothelial activation (VCAM-1) did not change significantly during the study. These data suggest that short-term treatment with AGE may improve impaired endothelial function in men with CAD treated with aspirin and a statin. Whether improvement in endothelial function decreases the risk of future cardiovascular events remains to be determined. (c) 2005 John Wiley & Sons, Ltd.

Publication Types: Clinical Trial Randomized Controlled Trial Research Support, Non-U.S. Gov't

PMID: 16041725 [PubMed - indexed for MEDLINE]

10: Trop Doct. 2005 Apr;35(2):99-100.

Efficacy of garlic paste in oral candidiasis.

Sabitha P, Adhikari PM, Shenoy SM, Kamath A, John R, Prabhu MV, Mohammed S, Baliga S, Padmaja U.

Department of Pharmacology, Kasturba Medical College, Mangalore, India. sabita_rao1@rediffmail.com

In a randomized trial of 56 patients, topical application of garlic paste for 14 days was found to be as effective as that of clotrimazole solution in suppressing clinical signs of oral candidiasis. The results of this preliminary study explore the possible role of garlic paste in the treatment of oral candidiasis.

Publication Types: Clinical Trial Randomized Controlled Trial

PMID: 15970035 [PubMed - indexed for MEDLINE]

11: Hiroshima J Med Sci. 2004 Dec;53(3-4):39-45.

Effects of aged garlic extract (AGE) on colorectal adenomas: a double-blinded study.

Tanaka S, Haruma K, Kunihiro M, Nagata S, Kitadai Y, Manabe N, Sumii M, Yoshihara M, Kajiyama G, Chayama K.

Department of Endoscopy, Hiroshima University Hospital, 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, Japan. colon@hiroshima-u.ac.jp

Aged garlic extract (AGE) is a material that has the possibility of a cancer-preventive effect according to epidemiologic and animal studies. In order to confirm the effects of AGE on colorectal adenomas, we conducted a double-blinded randomized study using high-AGE (AGE 2.4 ml/day) and low-AGE (AGE 0.16 ml/day) doses 1 groups. Fifty-one patients who were diagnosed as having colorectal adenomas by colonoscopy were randomly assigned to the high-AGE and low-AGE groups. The number and size of adenomas before intake (0 month) and 6 and 12 months after intake were measured using colonoscopy. In 37 patients chosen as efficacy evaluated subjects, 47.4% (9/19) in the high-AGE and 66.7% (12/18) in the low-AGE group had at least one new adenoma for the first and second interval (0 to 12 months after intake), and its relative risk was 0.71. The decrease rate of at least one adenoma was 50.0% (7/14) in the high-AGE group for the second interval (6 to 12 months after intake), whereas there was no decrease in subjects in the low-AGE group (p=0.02). The difference from the base-line for total size of adenomas increased in the low-AGE group, whereas an increase in the high-AGE group was suppressed for the second interval (p=0.04). The difference from the base-line for the total size of adenomas in subjects who had adenomas on the base-line increased in the low-AGE group and decreased in the high-AGE group for the second interval (p=0.03). The results of this study suggest the possibility of preventive and therapeutic effects of AGE on colorectal adenomas, though it is necessary to investigate these in larger-scale and longer-term trials.

Publication Types: Clinical Trial Randomized Controlled Trial

PMID: 15726891 [PubMed - indexed for MEDLINE]

12: Prev Med. 2004 Nov;39(5):985-91.

Inhibiting progression of coronary calcification using Aged Garlic Extract in patients receiving statin therapy: a preliminary study.

Budoff MJ, Takasu J, Flores FR, Niihara Y, Lu B, Lau BH, Rosen RT, Amagase H.

Division of Cardiology, Harbor-UCLA Medical Center Research and Education Institute, Torrance, CA 90502, USA. Budoff@Flash.net

BACKGROUND: Aged Garlic Extract (AGE) reduces multiple cardiovascular risk factors, including blood pressure, cholesterol, platelet aggregation and adhesion, while stimulating nitric oxide generation in endothelial cells. However, no study has evaluated the ability of AGE to inhibit vascular calcification, a marker of plaque formation in human coronary arteries. OBJECTIVE: To assess the efficacy of Aged Garlic Extract (AGE) on changing the rate of atherosclerosis progression as compared to placebo. DESIGN: A placebo-controlled, double-blind, randomized pilot study to determine whether the atherosclerotic plaque burden detected by electron beam tomography (EBT) will change at a different rate under the influence of AGE as compared to placebo. Twenty-three patients were enrolled, and 19 patients completed the study protocol. AGE 4 ml or the equivalent amount of placebo was given to subjects. Duration of the study was 1 year. S-allylcysteine (SAC), one of the active compound of AGE, was measured in the blood as a compliance marker. RESULTS: The mean change of the calcium score (volumetric method) for the AGE group (n = 9) was 7.5 +/- 9.4% over 1 year. The placebo group (n = 10) demonstrated an average increase in calcium scores of 22.2 +/- 18.5%, significantly greater than the treated cohort (P = 0.046). There were no significant differences in individual cholesterol parameters or C reactive protein between the groups. In patients randomized to AGE, there was a nonsignificant trend for improving cholesterol/high-density lipoprotein ratio (P = 0.07) and homocysteine level (P 0.08). CONCLUSIONS: This small pilot study indicates the potential ability of AGE to inhibit the rate of progression of coronary calcification, as compared to placebo over 1 year. Should these findings be extended and confirmed in larger studies, garlic may prove useful for patients who are at high risk of future cardiovascular events.

Publication Types: Clinical Trial Randomized Controlled Trial Research Support, Non-U.S. Gov't

PMID: 15475033 [PubMed - indexed for MEDLINE]

13: Ter Arkh. 2003;75(3):53-6.

[Effect of long-acting garlic tablets "allicor" on the incidence of acute respiratory viral infections in children]

[Article in Russian]

Andrianova IV, Sobenin IA, Sereda EV, Borodina LI, Studenikin MI.

AIM: To elucidate the prospects administration of allicor (long-releasing garlic tablets) in prevention of acute respiratory diseases (ARD) in children vs benzimidazole (dibazole). MATERIAL AND METHODS: At the first stage, tolerance of allicor (600 mg/day) and its effects on ARD morbidity were investigated in an opened 5-month study in 172 children aged 7-16 years compared to 468 controls. As the second stage, the effects of allicor (300 mg/day) on ASRD morbidity were investigated in a double-blind placebo-controlled randomized 5-month trial in 42 children aged 10-12 years in comparison with 41 placebo-treated children and 73 benzimidazole-treated children. RESULTS: At the first stage of the study allicor was not observed to induce gastrointestinal side effects in children at any dosage while ARD morbidity was reduced 2-4-fold as compared to the controls. At the second stage of the study allicor reduced ARD morbidity 1.7-fold compared to placebo and 2.4-fold vs benzimidazole. There was no significant difference in ARD morbidity between placebo- and benzimidazole-treated groups. Health index in allicor-treated group was 1.5-fold higher as compared either to placebo- or benzimidazole-treated children. CONCLUSION: Thus, the results of this study have demonstrated that allicor is effective for non-specific prevention of acute respiratory infections in children and has no side effects. ARD prevention with benzimidazole appeared ineffective in placebo-controlled study, so the development of new useful and safe preparations is of ultimate importance.

Publication Types: Clinical Trial English Abstract Randomized Controlled Trial

PMID: 12718222 [PubMed - indexed for MEDLINE]

14: Ter Arkh. 2002;74(3):76-8.

[Hypotensive effect of long-acting garlic tablets allicor (a double-blind placebo-controlled trial)]

[Article in Russian]

Andrianova IV, Fomchenkov IV, Orekhov AN.

AIM: To evaluate a hypotensive action of long-acting garlic powder tablets allicor in patients with mild or moderate hypertension and to compare allicor effects with those of foreign analog--kwai garlic tablets. MATERIAL AND METHODS: A double-blind, randomized and placebo-controlled study enrolled 85 patients with mild or moderate hypertension. The patients were divided into 4 groups: group 1 received allicor in a dose 600 mg/day, group 2--2400 mg/day, group 3--kwai in a dose 900 mg/day, group 4--placebo. RESULTS: Allicor produced reaction in both systolic and diastolic pressure. An increase of allicor daily dose to 2400 mg does not provide an additional hypotensive effect. Kwai results in only systolic but not diastolic arterial pressure lowering. CONCLUSION: Allicor is more effective than kwai in reduction of diastolic blood pressure. It can be recommended as a hypotensive treatment in mild and moderate arterial hypertension.

Publication Types: Clinical Trial English Abstract Randomized Controlled Trial

PMID: 11980131 [PubMed - indexed for MEDLINE]

15: Adv Ther. 2001 Jul-Aug;18(4):189-93.

Preventing the common cold with a garlic supplement: a double-blind, placebo-controlled survey.

Josling P.

Garlic Centre, Battle, East Sussex, United Kingdom.

One hundred forty-six volunteers were randomized to receive a placebo or an allicin-containing garlic supplement, one capsule daily, over a 12-week period between November and February. They used a five-point scale to assess their health and recorded any common cold infections and symptoms in a daily diary. The active-treatment group had significantly fewer colds than the placebo group (24 vs 65, P < .001). The placebo group, in contrast, recorded significantly more days challenged virally (366 vs 111, P < .05) and a significantly longer duration of symptoms (5.01 vs 1.52 days, P < .001). Consequently, volunteers in the active group were less likely to get a cold and recovered faster if infected. Volunteers taking placebo were much more likely to get more than one cold over the treatment period. An allicin-containing supplement can prevent attack by the common cold virus.

Publication Types: Clinical Trial Comparative Study Randomized Controlled Trial

PMID: 11697022 [PubMed - indexed for MEDLINE]

16: J Am Coll Nutr. 2001 Jun;20(3):225-31.

Hypocholesterolemic effect of an enteric-coated garlic supplement.

Kannar D, Wattanapenpaiboon N, Savige GS, Wahlqvist ML.

Department of Medicine, Monash Medical Centre, Monash University, Melbourne, Victoria, Australia.

OBJECTIVE: To evaluate the hypocholesterolemic effect of an enteric-coated garlic supplement standardized for allicin-releasing potential in mild to moderate hypercholesterolemic patients. METHODS: A double-blind randomized, placebo-controlled intervention study was conducted in 46 hypercholesterolemic subjects who had failed or were not compliant with drug therapy. Each subject was given dietary counseling to lower fat intake and enteric-coated Australian garlic powder tablets with 9.6 mg allicin-releasing potential or matching placebo tablets. RESULTS: After 12 weeks, the garlic supplement group (n=22) had a significant reduction in total cholesterol (TC, -0.36 mmol/L. -4.2%) and LDL-cholesterol (LDL-C, -0.44 mmol/L, -6.6%) while the placebo group (n=24) had a non-significant increase in TC (0.13 mmol/L, 2.0%) and LDL-C (0.18 mmol/L, 3.7%). HDL-cholesterol was significantly increased in the placebo group (0.09 mmol/L, 9.1%), compared to the garlic group (-0.02 mmol/L, -0.9%). and no significant difference in triglycerides or in LDL/HDL ratio was observed between groups. CONCLUSIONS: The study demonstrates that enteric-coated garlic powder supplements with 9.6 mg allicin-releasing potential may have value in mild to moderate hypercholesterolemic patients when combined with a low fat diet. Taken with other evidence, the efficacy of garlic for lipoprotein metabolism might require allicin bioavailability to be enhanced through the use of, for example, an enteric-coated dose form. If this is the case, the possibility remains that greater hypocholesterolemic efficacy may be evident at a higher allicin dose. Also noteworthy in this study was a small reduction in energy intake with garlic compared with placebo, attributable to reduction in fat, carbohydrate and alcohol intakes. This may also have contributed to the effects on blood lipids. This study suggests that garlic supplementation has a cholesterol-lowering effect, which may be mediated by direct action of a biologically active compound or compounds and in part through the effect on food and nutrient intake.

Publication Types: Clinical Trial Randomized Controlled Trial Research Support, Non-U.S. Gov't

PMID: 11444418 [PubMed - indexed for MEDLINE]

17: J Nutr. 2001 Mar;131(3s):980S-4S.

Aged garlic extract, a modulator of cardiovascular risk factors: a dose-finding study on the effects of AGE on platelet functions.

Steiner M, Li W.

Division of Hematology/Oncology, East Carolina University School of Medicine, Greenville, NC 27858-4354, USA. steiner@brody.med.ecu.edu

Aged garlic extract (AGE) has been shown previously to have moderate cholesterol-lowering and blood pressure-reducing effects. We have now investigated whether platelet function, a potential risk factor for cardiovascular disease, can be inhibited by AGE administration. In a randomized, double-blind study of normal healthy individuals (n = 34), both men and women, the effect of AGE was evaluated in doses between 2.4 and 7.2 g/d vs. equal amounts of placebo. Platelet aggregation and adhesion were measured at 2-wk intervals throughout the study. Threshold concentrations for epinephrine and collagen increased moderately during AGE administration compared with the placebo and baseline periods. Only at the highest supplementation level did AGE show a slight increase in the threshold level of ADP-induced aggregation. Platelet adhesion to collagen, fibrinogen and von Willebrand factor was investigated by perfusing whole blood through a laminar flow chamber under controlled flow conditions. Adherence of platelets was inhibited by AGE in a dose-dependent manner when collagen was the adhesive surface perfused at low shear rates ( approximately 30 s(-1)). At high shear rates (1200 s(-1)), AGE also inhibited platelet adhesion to collagen but only at higher intake levels. Adhesion to von Willebrand factor was reduced only at 7.2 g/d AGE, but adherence to fibrinogen was potently inhibited at all levels of supplementation. Thus, AGE exerts selective inhibition on platelet aggregation and adhesion, platelet functions that may be important for the development of cardiovascular events such as myocardial infarction and ischemic stroke. We briefly review the effect of garlic preparations in general on cardiovascular risk factors and point out differences between AGE and other garlic preparations that we feel are important to explain the efficacy of AGE.

Publication Types: Clinical Trial Randomized Controlled Trial

PMID: 11238801 [PubMed - indexed for MEDLINE]

18: J Nutr. 2000 Nov;130(11):2662-5.

Dietary supplementation with aged garlic extract inhibits ADP-induced platelet aggregation in humans.

Rahman K, Billington D.

School of Biomolecular Sciences, Liverpool John Moores University, Liverpool L3 3AF, UK.

Garlic has been widely reported to protect against cardiovascular disease by reducing serum cholesterol concentrations and blood pressure and by inhibiting platelet aggregation. However, most of these studies have been performed in hypercholesterolemic subjects or in animal models. We performed a 13-wk study in normolipidemic subjects who ingested 5 mL of aged garlic extract (AGE, Kyolic) per day. Blood was drawn from these subjects at the beginning and end of the study. Aggregation of platelet-rich plasma was induced by ADP; full lipid profiles and liver function tests were determined on serum, and plasma concentrations of eicosanoids were also measured. Dietary supplementation with AGE significantly inhibited both the total percentage and initial rate of platelet aggregation at concentrations of ADP up to 10 micromol/L. The KM) for ADP-induced aggregation were approximately doubled after supplementation with AGE, whereas the maximum rate of aggregation was unaffected. No significant changes in plasma thromboxane B(2) and 6-ketoprostaglandin F(1alpha) concentrations or serum lipid profiles were observed. We conclude that AGE, when taken as a dietary supplement by normolipidemic subjects, may be beneficial in protecting against cardiovascular disease as a result of inhibiting platelet aggregation.

Publication Types: Clinical Trial Research Support, Non-U.S. Gov't

PMID: 11053504 [PubMed - indexed for MEDLINE]

19: Am J Clin Nutr. 2000 Oct;72(4):1047-52.

Garlic consumption and cancer prevention: meta-analyses of colorectal and stomach cancers.

Fleischauer AT, Poole C, Arab L.

Departments of Epidemiology and Nutrition, University of North Carolina, Chapel Hill, NC 27599, USA.

BACKGROUND: Animal and in vitro studies have provided evidence of an anticarcinogenic effect of active ingredients in garlic. OBJECTIVE: The objective was to conduct meta-analyses of the epidemiologic literature on the association between garlic consumption and risk of stomach, colon, head and neck, lung, breast, and prostate cancers. DESIGN: Meta-analyses were conducted for all cancers mutually and separately for colorectal and stomach cancers in relation to consumption of exclusively raw garlic, cooked garlic, or both (RC garlic). Eighteen studies reported a relative risk estimate for RC garlic consumption and cancer risk. RESULTS: In the meta-analyses of colorectal and stomach cancer, the reference categories ranged from no consumption to consumption of 3.5 g/wk, whereas the highest categories ranged from any consumption to >28.8 g/wk. The average difference between the highest and lowest categories was 16 g/wk. The random-effects relative risk (RR) estimate of colorectal cancer and RC garlic consumption, excluding garlic supplements, was 0.69 (95% CI: 0.55, 0.89). For stomach cancer, the random-effects RR estimate was 0.53 (95% CI: 0.31, 0.92). The heterogeneity among studies for the latter outcome (P: = 0.0002) indicates the questionableness of the generalizability of this summary estimate. An indication of publication bias for all cancers combined is evident from a funnel plot of RC garlic consumption and cancer risk and from the results of the Begg and Mazumdar test (P: = 0.049). CONCLUSIONS: High intake of RC garlic may be associated with a protective effect against stomach and colorectal cancers. Heterogeneity of effect estimates, differences in dose estimation, publication bias, and possible alternative hypotheses (eg, confounding by total vegetable consumption) preclude sole reliance on summary effect estimates.

Publication Types: Meta-Analysis Research Support, U.S. Gov't, P.H.S.

PMID: 11010950 [PubMed - indexed for MEDLINE]

 

[vaidya]

but even for little garlic, poor little garlic, much injustice is done:

"How does such amazingly moronic material gain access to MEDLINE indexed so called peer reviewed journals? I wonder. So Mustafa Capraz et alia gave 75 patients either placebo, a single clove of garlic or 12 little garlic pills. They took a baseline BP before and measured BP again 1 HOUR after garlic administration. Nothing changed. Really! Duh. SO garlic maybe should not be used in cardiac ICU as a hypotensive drug? Or more to the point, one might recommend that local cardiac patients best look for another cardiac facility than the one that Mustafa and his merry men work at……meanwhile you have been warned. Get educated.

Garlic, hypertension and patient education
Capraz M, Dilek M, Akpolat TInt J Cardiol. 2007 Sep 14;121(1):130-1
The aims of this study are to investigate the frequency of garlic usage in hypertensive population and to evaluate acute effect of garlic and garlic tablets on blood pressure in patients with hypertension. 4102 of the 7703 patients (53.3%) reported that they were using garlic. No significant effect on blood pressure was observed in any of the three groups (placebo, garlic or garlic tablets). Use of garlic is common among the hypertensive population, garlic and garlic tablets do not have acute blood pressure lowering effect, and a special education program informing patients and public about garlic is required."

source: http://www.herbological.com/herblog/?cat=7

 

[vaidya]

in response to vitriol and ignorance, i have responded, hopefully with even a little adequacy

if i have been able to make even a small impression on some of you, then my job is done

however, and more to the point of the original thread:

HERBS ARE NOT DRUGS!!

 

[robinson]

you see guys, i can do this all freakin' day, but no matter what i post, the supposedly rational skeptics won't throw in the towel

at some point i will have to stop because i have better things to do

You seem to be very intelligent, and have figured out the essential truth of Internet message boards. It doesn't really matter.

...
however, and more to the point of the original thread:

HERBS ARE NOT DRUGS!!

I thought the point of the thread was to pimp a brand new Blog.

 

[Gord_in_Toronto]

in response to vitriol and ignorance, i have responded, hopefully with even a little adequacy

if i have been able to make even a small impression on some of you, then my job is done

however, and more to the point of the original thread:

HERBS ARE NOT DRUGS!!

BUT THEY CONTAIN CHEMICALS -- THAT'S HOW THEY WORK!!!!!!!!

AS DO DRUGS!!!!!!!!!

AS DOES DUNG!!!!!!!!!!!!!



PS. Isn't India the place all those great homeopathic researchers are "proving" how great that "modality" is?

 

[robinson]

The reasoning that says herbs are the same as drugs, would mean foods are drugs, as well as bacteria, because they contain substances that are used as drugs.

Yogurt bacteria are drugs! Bread mold is a drug! See? Because drugs are made from bacteria and molds, those must be drugs too! It turns the word "drug" in to a catch all term that defines anything that effects your body.

Such sweeping statements are not scientific, but if you are going to define a substance like that, then coffee, tea, cigarettes and booze are all drugs. If garlic is now a drug, and the FDA wants to regulate garlic, then what about coffee? Nobody doubts coffee contains a potent stimulate drug, same for tea and cigarettes.

So now coffee drinkers are drug addicts! Such loose use of terminology allows all kinds of semantic games to be possible.

Of course plants are the source of many powerful substances that we consider drugs. But to claim "herbs are drugs" is as absurd as to claim meat is a drug, because it contains L-Dopa, a powerful and potentially dangerous drug.

Throwing reality to the winds to try and make a point might make great rhetoric, but it isn't very useful in convincing people of your point.

 

[vaidya]

The reasoning that says herbs are the same as drugs, would mean foods are drugs, as well as bacteria, because they contain substances that are used as drugs.

Yogurt bacteria are drugs! Bread mold is a drug! See? Because drugs are made from bacteria and molds, those must be drugs too! It turns the word "drug" in to a catch all term that defines anything that effects your body.

Such sweeping statements are not scientific, but if you are going to define a substance like that, then coffee, tea, cigarettes and booze are all drugs. If garlic is now a drug, and the FDA wants to regulate garlic, then what about coffee? Nobody doubts coffee contains a potent stimulate drug, same for tea and cigarettes.

So now coffee drinkers are drug addicts! Such loose use of terminology allows all kinds of semantic games to be possible.

Of course plants are the source of many powerful substances that we consider drugs. But to claim "herbs are drugs" is as absurd as to claim meat is a drug, because it contains L-Dopa, a powerful and potentially dangerous drug.

Throwing reality to the winds to try and make a point might make great rhetoric, but it isn't very useful in convincing people of your point.

by gar robinson, you've given me a glimmer of hope for this forum

 

[Gord_in_Toronto]

by gar robinson, you've given me a glimmer of hope for this forum

How sad.

 

[robinson]

Such hope vaidya, will soon be crushed.

 

[vaidya]

PS. Isn't India the place all those great homeopathic researchers are "proving" how great that "modality" is?

i dunno gord, i am not a homeopath or slightly interested in homeopathic medicine, although i have seen a couple products like traumeel effectively relieve pain - i don't try to explain it, but hey if it works i don't care because my practice isn't tied to fundamentalist belief structures

you might also note that apart from the economic and social use of cow dung, people in india are devoutly religious and many also view the cow as a divine symbol, representing love and devotion, like the mother who gives her milk to nourish her child

perhaps you will critique this as well

at some point gord_in_toronto, you will come across as a poo-obsessed uniformed bigot

sorry to spoil your party, but your diapers needed changing

 

[fls]

clinical trials can also be designed and interpreted to yield the answers researchers want, while ignoring or sidelining other "effects", or failing to do accurate comparisons with alternative

Exactly! Which is why we talk about study quality all the time. Good quality studies are those which are designed, performed and analyzed in a way that prevents the biases of the researchers and other participants from influencing the results. We recognize this as very important because we have discovered that biases influence how we choose patients, assess outcomes, choose methods of analysis, and draw conclusions in dozens of subtle and unrecognized ways. And if this happens in lower quality clinical trials, just imagine how much worse it is when you have no control group for comparison, no standardization for evaluation, no attempt to consistently and objectively evaluate outcomes - i.e. when all constraints to your biases are removed. That is my complaint. The bulk of the information that is used to guide the practice of herbal therapy is information gathered without constraints on bias. Which makes it difficult to tell whether any particular observation represents a true effect or the effect of wishful thinking. There's a reason that almost none of the treatments in common use in the 1800's in medicine are used today. Once we began to attempt to reduce and eliminate bias when collecting information, we discovered that most of the effects we had observed without constraints on bias disappeared.

You have gone on to provide information from clinical trials on herbal medicines. Aside from the fact that you have missed the point of what I asked for (which I will address later), many of the trials you referenced allow for the biases of the researchers to influence the results - examples include lack of blinding and lack of a placebo control group. Also, the biases of the researchers show up when the conclusions are not supported by results. For example:

1: Int J Cardiol. 1995 May;49(3):191-9.
Salutary effect of Terminalia Arjuna in patients with severe refractory heart failure.
Bharani A, Ganguly A, Bhargava KD.
Department of Medicine, M.G.M. Medical College, Indore, India.

It is easy to find differences between groups when you start with a very small, heterogeneous group of people subject to a variety of treatments. To conclude that these differences are due to one particular treatment, when other things (patient characteristics, other treatments received) will also cause differences, demonstrates a lack of objectivity.

sorry, missing reference:

Weingart et al, Epidemiology of medical error
see: http://www.bmj.com/cgi/content/full/320/7237/774

"..drug related problems accounted for 116*million extra visits to the doctor per year, 76*million additional prescriptions, 17*million emergency department visits, 8*million admissions to hospital, 3*million admissions to long term care facilities, and 199*000 additional deaths"

If you look at the source of this information, you will see that it is not based on actual data. Instead it is based on asking a group of pharmacists to make a guess.

http://www.ajhp.org/cgi/reprint/54/...e61891b24cb2e630446f7b79&keytype2=tf_ipsecsha

Generally, actual data (i.e. the information I referenced earlier) is considered more reliable than guesses.

not true - i have dealt successfully with severe cases, including diabetic gangrene and retinal hemorrhage, as well as cancer

That you consider those "severe cases" demonstrates my point.

this is a false dichotomy from a failure to offer adequate choice to the patients, which is what i provide - at least 50% patients seek my attention because of dissatisfaction with conventional medicine

I don't think you understood my example since you illustrated the dichotomy incorrectly.

On the scale of outcomes - death, disability, disease, discomfort, and dissatisfaction - it is interesting that when I talk about death, you immediately switch to dissatisfaction.

however, i don't live in an either/or world

there is a great deal of opportunity for our disciplines to work constructively, but the respect needs to be both ways - i won't pretend to be a doctor if you don't pretend to be a herbalist

So you will quit diagnosing and treating disease? Excellent.

and herbs are NOT drugs

The references you have been providing are for the use of herbal treatments in specific medical conditions with the expectation (as per the conclusions) that the herbs can be used to treat those conditions. Regardless of whatever word games you want to play, you are the one treating them as drugs.

Linda

 

[JJM]

i also mentioned another herb, called Arjuna (Terminalia arjuna)
here are the only studies on PubMed (there are many others besides) that refer to its efficacy in CVD:

{snipped data dump}

The data dump you provided exemplifies several things. First it illustrates that (as I said) it is easy to find the data; but it takes a good education to interpret it. Second, the collection typifies the lack of sophistication in study design, and irrational exuberance in the claimed conclusions, seen in most herbal research.

Even I can tell these studies, singly or together, don't support any use of the herb. A cursory count shows the 6 studies looked at 4 conditions. Moreover, the dosages and measured outcomes are inconsistent; therefore, they do not add to strong evidence for any use. In addition, each study has too few subjects to be taken as anything more than a pilot study.

A brief summary:

Studies:
#1 Twelve subjects, no control group, chronic congestive heart failure, added “flexible diuretic, vasodilator and digitalis dosage.” Not Definitive (ND).

#2 Ten subjects, used a proprietary product (Hartone) not TA, stable angina pectoris, no control group, different protocol and outcome measures from #1. ND

#3 Different outcomes assessed (antioxidant), different dosage regimen, … ND

#4 Same dosage regimen as #1, stable angina, different outcomes measured, only <40 patients in TA/placebo arms … ND

#5 Examined endothelial function in smokers, 18 subjects, different outcomes measured. ND

#6 Forty subjects, dosage frequency not stated, different outcomes measured, quantitative results not given. ND

This is why I wrote that I had already seen most of the data supporting use of herbs. These papers are, indeed, new to me; but they look like all the others- just the herb and condition varies from time-to-time.

 

[fls]

"nuggets of useful information" is a derogatory statement, and speaks more to your bias and ignorance about the state of practice

investigate a couple then - i have provided a couple already, but many more exist for herbs such as Commiphora mukul, Withania somnifera, and Terminalia arjuna

i have posted a lot of info already, but either you will do the research or you won't - if you don't, you cannot adequately pass judgment on herbal medicine

the onus is on YOU to disprove, not me, since my practice antedates conventional medicine

The references that you have gone on to provide and your statements here show that you have misunderstood what I am asking for. I already know that research into plant extracts demonstrates that some of them have in vitro effects, in vivo effects on animal models, and even some clinical effects. The bulk of modern pharmaceuticals are based on plant sources, after all. However, none of the in vitro and animal research you have provided confirms information gathered through traditional means. There are no statements in traditional texts that conform to "6-Gingerol facilitated TRAIL-induced apoptosis by increasing TRAIL-induced caspase-3/7 activation". The information derived from traditional use relates to the use of herbs in clinical conditions. So if you want to convince anyone that information gathered from traditional use is reliable, the way to go about it is to show that there is a strong correspondence between what we have discovered using scientific methods and what you discovered using traditional methods. That is, that a particular herbal treatment has demonstrated effectiveness in all or most of the conditions listed for its traditional use and that no other effects (harmful or beneficial) were missed.

You haven't provided any of the information that would demonstrate that connection. Let's take aloe for example (chosen simply because it's first on this list). Traditional uses are as follows:

"Transparent gel from the pulp of the meaty leaves of Aloe vera has been used topically for thousands of years to treat wounds, skin infections, burns, and numerous other dermatologic conditions. Dried latex from the inner lining of the leaf has traditionally been used as an oral laxative."

And

"Alopecia (hair loss), antimicrobial, arthritis, asthma, bacterial skin infections, bowel disorders, chronic fatigue syndrome, chronic leg wounds, congestive heart failure, damaged blood vessels, elevated cholesterol or other lipids, frostbite, heart disease prevention, hepatitis, inflammatory bowel disease (IBS), kidney or bladder stones, leukemia, lichen planus stomach ulcers, Merkel cell carcinoma, parasitic worm infections, protection against some chemotherapy side effects, scratches or superficial wounds of the eye, systemic lupus erythematosus (SLE), tic douloureux, untreatable tumors, vaginal contraceptive, yeast infections of the skin."

Research confirms that it is an effective laxative, and that is one of the circumstances under which observation is more reliable - when the effects are immediate, such as with vomiting, laxatives or pain.

Weaker evidence suggests that it is effective in psoriasis, seborrheic dermatitis and genital herpes. None of those conditions are on the list of traditional uses, although they could fall under "numerous other dermatologic conditions".

Poor evidence suggests that it is useful for lung cancer prevention (not on the list), canker sores (not on the list), type II Diabetes (not on the list), HIV infection (not on the list), skin burns (on the list), Ulcerative Colitis (not on the list, but could fall under "bowel disorder"), wound healing (on the list).

Fair to good evidence suggests that it does not work for mucositis associated with cancer treatment (not on the list but could fall under "protection against some chemotherapy [it was radiation therapy in the study] side effects), pressure ulcers (could fall under some of the listed categories), and radiation dermatitis (could fall under dermatologic conditions).

So far this suggests a poor correspondence. Other than its use as a laxative (one of the few observations which is pretty reliable), its other traditional uses are either poorly supported by the evidence or contradicted by the evidence. And important possible uses for aloe were missed (e.g. diabetes, HIV). This means that it would be foolish to assume, without information gathered through the use of the scientific method, that it would be effective for anything else on that list. And it also suggests that traditional use may not even be a good source of inspiration for areas of exploration.

That is an example of the kind of analysis (albeit in a grossly abbreviated form) that I based my comment about "nuggets of useful information" on. I have already performed an investigation - that is how I came to the conclusion in the first place. Your information is demonstrably unreliable. That you think the onus should be on me to show that information that may be false (by definition) is actually false, else you will continue to believe it true, is a demonstration of exactly what distinguishes alternative medicine from medicine.

Linda

 

[fls]

i have "saved" several gall bladders simply by using herbs that upregulate bile secretion, which overtime, gradually thins the congested heavy bile sitting in the gall bladder, and may or may not gradually break down cholesterol stones (never had it confirmed by ultrasound, but every time pt was negative for murphy's sign after treatment, even after years of portal tenderness)

Murphy's sign is used for acute cholecystitis. Its use as you have described is useless for determining the presence or absence of gall stones, since it is not expected to be present when gall stones without complication are present. Most gall stones are asymptomatic.

don't believe this? too bad - do the research

So what you are saying is that you don't care whether or not you are wrong. And not only that, but you avoid doing a test that can tell you whether you are wrong, so that you can continue to pretend that you are right.

And you want us to take anything you say seriously?

Linda

 

[fls]

in other words, if you cannot validate the benefits of herbal medicine because you don't look for it, you cannot by that same measure say that it has no benefit

But that isn't what I'm saying. I'm saying that it is more useful to proceed using reliable information when it comes to people's lives and health - that it is important to know whether or not what you are doing is wrong beforehand.

what research have you personally conducted into the field of CAM, and herbal medicine specifically?

Do you mean, have I performed any clinical trials testing an herbal medicine? No. What difference do you think this would make?

are you familiar with basic pharmacognosy even?

Yes.

Linda

 

[fls]

you see guys, i can do this all freakin' day, but no matter what i post, the supposedly rational skeptics won't throw in the towel

Unfortunately for you, some of us are already familiar with what you are very carefully not showing us - all those times herbals did not live up to their expectations.

Linda

 

[fls]

read the studies hawkone
read em and weep

You're not doing yourself any favours with the studies you are referencing. I've been going through them and many are of poor quality, allow for multiple conclusions to be drawn, or aren't really relevant. In vitro, animal and pre-clinical, and Phase I and II studies don't really tell us whether or not something is effective - there's a large drop-off at each point (particularly in the early phases).

Linda