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Author Topic: Clinical Trial Results of Hawthorn Extract for High Blood Pressure.  (Read 40053 times)

Andrew K Fletcher

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Going to give this a whirl as bp is up at the moment.


The patients taking hawthorn had a significant reduction in mean DBP over 16 weeks compared with those on placebo (-2.6 vs +0.5 mm Hg, P = .035). There was no difference between the 2 groups with regard to mean SBP reduction, although a nonsignificant (P = .096) decline of 3.6 mm Hg was seen in the hawthorn group, Dr. Walker and her colleagues reported. There was no significant outcome difference between groups in the indices of glycemic control (fasting glucose, glycated hemoglobin, and fructosamine). No herb-drug interactions were found and minor health complaints were reduced from baseline in both groups.

"The blood pressure lowering effect in this study was real, and worked in addition to the drugs being taken by patients," said Dr. Walker. "There has been a great deal of confusing publicity about herbal remedies affecting the efficacy of prescribed drugs, but we were able to confirm there were no side effects or adverse reactions," she said. "As hypertension is such a huge problem in Western societies, any safe, natural approach, which can be used with or without modern drugs, is worth exploring. It is possible to have modern and herbal medicines working in harmony." http://cme.medscape.com/viewarticle/537304_6

Andrew K Fletcher

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Highlights of Hawthorn Research

*  A four year study on the benefits of hawthorn, commissioned by the German Ministry of Health, found that it improves contractions in the veins and heart while dilating the heart. This increases blood flow in the heart as well as flow speed throughout the body for increased circulation to organs and musculature. The researchers concluded that hawthorn is best used for low heart function, congestion, arrhythmia and tightness in the chest and no side effects were noted (Hoffmann 1995).

 *  In a German clinical trial with 78 patients with class 2 congestive heart failure, hawthorn flower and leaf increased heart working capacity, lowered blood pressure and improved fatigue and endurance while relieving difficult breathing (Schmidt, et. al. 1994). Comparable results from other clinical trials for class 2 as well as class 3 patients have been reported (Hobbs & Foster 1990).

 *  In a controlled Chinese clinical trial with 46 patients suffering from angina, a Chinese variety of hawthorn decreased the number of angina attacks by 85% compared to 37% on placebo (Weilang, et. al. 1984). Other clinical trials have found comparable results for varieties of hawthorn (Weiss 1988) (Chang & But 1986).

*  A German clinical trial with 18 healthy patients found that hawthorn lowered heart rate and blood pressure during exercise and maintained resting heart rate while elevations were noted in the control group (Hellenbrecht, et. al. 1990).

*  Chinese laboratory and clinical trials have reported that hawthorn lowers cholesterol and triglycerides by improving excretion (Chang & But 1986). Hawthorn is also reported to increase urination (DJumlija 1994) (Hoffmann 1995), often an important modality in heart condinons.

*  Laboratory studies suggest that hawthorn's actions on the heart and circulatory system may be created through effects on the central nervous system (Foldi, et. al. 1959).  Oxygen levels increase in the heart and provide a better balance of oxygen supply and demand  (Lianda, et. al. l984).

http://www.zhealthinfo.com/hawthorn.htm

BenV

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Sounds interesting... What part of Hawthorn are they using?  How's it prepared?

Andrew K Fletcher

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Use the leaf, flower and berry or any combination of hawthorn from what I have read.

Been reading about making Haw and Mint Jelly as a preserve, said to taste like apple and mint, sounds nice.

Boiled up some leaves and unripe berries expecting them to taste terrible, had a nice surprise when I tasted it, it is quite palitable.

Going to continue using Hawthorn, as blood pressure is very high and been put on lisinopril also.

Hopefully when BP is back to normal I may be able to experiment with just the Hawthorn closely monitoring bp.

Lisinopril is known to further damage kidneys so have to be careful as mine are not functioning correctly due to drinking bottled water with high levels of salt in it. (read the labels people)

The water, which I mentioned before was Crystaline A french Bottled Water


Andrew K Fletcher

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Using a carrier bag full of ripe berries and leaves, washed then boiled for about 10 minutes in a huge saucepan, straining the first juice when cold, then adding more water and reboiling for 5 minutes again allowing to cool and strain juice. Combine both lots of juice into the saucepan having discarded the spent berries and leaves, add preserving sugar to taste, about a cupful as berries contain some sugar. Bring to the boil and allow to cool. Bottle and refrigerate drinking around a 1/4 cup 3 times a day.

BP is coming down

Although taking calcium, potassium, cod liver and fish oil, using black salt and eliminated normal salt from diet completely. Even making our own bread using black salt and adding a large handful of wholegrain oats to every loaf. Must say this bread is far superior to anything we have tried before.

All for now
« Last Edit: 31/08/2009 08:29:59 by Andrew K Fletcher »

Andrew K Fletcher

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1: Herz. 1999 Oct;24(6):465-74; discussion 475.Links
Erratum in:
Herz 1999 Nov;24(7):586.
[High-dose Crataegus extract WS 1442 in the treatment of NYHA stage II heart failure]
[Article in German]
Tauchert M, Gildor A, Lipinski J.
Klinikum Leverkusen. tauchert@klinikumvlev.de
The efficacy and tolerance of the standardized hawthorn (crataegus) extract WS 1442 were tested in a multicenter utilization observational study. We monitored 1,011 patients with cardiac insufficiency stage NYHA II, treated with this extract (Crataegutt novo 450, 1 tablet b.i.d.) over a period of 24 weeks. During and at the end of the observation period a significant improvement in clinical symptoms (reduced performance in the exercise tolerance test, fatigue, palpitation and exercise dyspnea) was observed. Ankle edema and nocturia disappeared by 83%, and by half of the patients respectively manifesting these symptoms before treatment. The improvement and economization of cardiac performance were additionally shown by a reduction in blood pressure, an increased maximal exercise tolerance and a reduction in the difference in the pressure/heart rate product (PHRP). The positive effects of WS 1442 were further demonstrated by an improved ejection fraction and an increased percentile shortening fraction measured using M-mode echocardiography. The stabilizing effect of the hawthorn extract on the heart rate was shown by a slower rest pulse, as well as by an increase in the number of day and night normorhythmic patients, as documented by long-term ECG. The reduction in the number of patients showing ST depressions, arrhythmias and ventricular extrasystoles at the maximum exercise level is regarded as an indication for an improved myocardial perfusion. Fourteen side effects were noted. In two cases (abdominal discomfort and facial pains accompanied by tachycardia) a possible relationship with the hawthorn therapy, was postulated which however was considered unlikely by the treating physicians. Almost 2/3 of the patients felt better or much better following the 24 weeks of treatment. More than 3/4 of the participating physicians noted a good or a very good efficacy, and 98.7% noted a good or a very good tolerance. High-dose hawthorn therapy is an efficient, well-tolerated and easily regulated therapeutic alternative for patients suffering from cardiac insufficiency stage NYHA II.

Andrew K Fletcher

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1: Phytomedicine. 2003;10 Suppl 4:61-7.Links
Dose-response related efficacy in orthostatic hypotension of a fixed combination of D-camphor and an extract from fresh crataegus berries and the contribution of the single components.
Belz GG, Loew D.
Center for Cardiovascular Pharmacology, ZekaPha GmbH, Mainz-Wiesbaden, Germany.
Independent, double-blinded, randomized, placebo-controlled studies using sublingual/oral administration of D-camphor, an extract from fresh crataegus berries, and a combination of the two (CCC) yielded the following results: Both the D-camphor and the extract from fresh crataegus berries, the components of CCC, contribute to the pressoric effects of the combination. The underlying hemodynamic mechanisms can be attributed to an increase in total peripheral resistance induced by an increased tone of the arterioles with both components and the effect of crataegus is intensified by an additional direct positive action on cardiac performance. Conceivably, the D-camphor component is the main factor in inducing the rapid initial effect, whereas the extract from fresh crataegus berries adds a long-lasting effect. For CCC, a dose-dependent increase in supine blood pressure and prevention of orthostatic fall in blood pressure following tilt table-induced orthostasis in patients with orthostatic dysregulation was demonstrated as well. The effect revealed a very rapid onset of action within 1 min following administration, confirming the traditional use in emergency situations such as orthostatic (pre)syncope. Thus, these studies show that CCC, depending on the pressoric activity of its two mono-components, exerts a significant effect that counteracts an orthostatic fall in blood pressure and thereby provides a rationale for its application that reemphasizes the decades-long usefulness of this phyto-combination.

Andrew K Fletcher

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: Arzneimittelforschung. 2005;55(8):443-50.Links
[Efficacy and safety of a herbal drug containing hawthorn berries and D-camphor in hypotension and orthostatic circulatory disorders/results of a retrospective epidemiologic cohort study]
[Article in German]
Hempel B, Kroll M, Schneider B.
Robugen GmbH Pharmazeutische Fabrik, Esslingen-Zell
BACKGROUND AND OBJECTIVE: Korodin Herz-Kreislauf-Tropfen, a herbal drug containing D-camphor (CAS 76-22-2; 2.5 %) and a liquid extract of fresh hawthorn berries (97.3%), has been used since many years for the treatment of orthostatic hypotension. The combination as well as its constituents were tested in clinical trials against placebo with healthy volunteers and patients using tilt-tests. The objective of this study was to investigate efficacy and safety of the drug under the conditions of medical practice in comparison to other drugs admitted for this indication. PATIENTS AND METHODS: The study was performed as an epidemiological retrospective cohort study in 46 medical practices in Germany. In the practices the files were reviewed for patients who were treated between 1st January 2000 and 31st December 2002 for orthostatic hypotension. Included in the study were all patients who were treated either with the test drug or a control drug containing etilefrine, oxilofrine, midodrine, norfenefrine or dihydroergotamine and who met the inclusion criteria. The data of the files were coded, transferred to case report forms and augmented by the physician's statements about symptoms and success. Effect criteria were the improvement of symptoms and change of blood pressure during treatment. The correctness of the data was controlled using anonymous copies of the files. A total of 490 patients (399 in the test-group and 91 in the control group) between 11 and 102 years were included in the study. To correct heterogeneities in baseline conditions, treatment results were adjusted by regression and stratification to equal baseline conditions using the propensity score. RESULTS: The adjusted odds ratio for improvement was 5.6, the adjusted mean increase of the systolic blood pressure the 2-fold compared to the control group. The difference was highly significant and did not depend on age or initial blood pressure. In the test group two adverse events were observed which had no relation to the medication; in the control group one reversible event with a probable relation to the medication was observed. CONCLUSIONS: The test drug was proven as effective and safe in the treatment of orthostatic hypotension in medical practice for all age groups and independent of the initial blood pressures.

Andrew K Fletcher

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: Br J Gen Pract. 2006 Jun;56(527):437-43.
Hypotensive effects of hawthorn for patients with diabetes taking prescription drugs: a randomised controlled trial.
Walker AF, Marakis G, Simpson E, Hope JL, Robinson PA, Hassanein M, Simpson HC.
Hugh Sinclair Unit of Human Nutrition, School of Food Biosciences, The University of Reading, Reading. a.f.walker@reading.ac.uk
BACKGROUND: Hawthorn (Crataegus laevigata) leaves, flowers and berries are used by herbal practitioners in the UK to treat hypertension in conjunction with prescribed drugs. Small-scale human studies support this approach. AIM: To investigate the effects of hawthorn for hypertension in patients with type 2 diabetes taking prescribed drugs. DESIGN OF STUDY: Randomised controlled trial. SETTING: General practices in Reading, UK. METHOD: Patients with type 2 diabetes (n = 79) were randomised to daily 1200 mg hawthorn extract (n = 39) or placebo (n = 40) for 16 weeks. At baseline and outcome a wellbeing questionnaire was completed and blood pressure and fasting blood samples taken. A food frequency questionnaire estimated nutrient intake. RESULTS: Hypotensive drugs were used by 71% of the study population with a mean intake of 4.4 hypoglycaemic and/or hypotensive drugs. Fat intake was lower and sugar intake higher than recommendations, and low micronutrient intake was prevalent. There was a significant group difference in mean diastolic blood pressure reductions (P = 0.035): the hawthorn group showed greater reductions (baseline: 85.6 mmHg, 95% confidence interval [CI] = 83.3 to 87.8; outcome: 83.0 mmHg, 95% CI = 80.5 to 85.7) than the placebo group (baseline: 84.5 mmHg, 95% CI = 82 to 87; outcome: 85.0 mmHg, 95% CI = 82.2 to 87.8). There was no group difference in systolic blood pressure reduction from baseline (3.6 and 0.8 mmHg for hawthorn and placebo groups, respectively; P = 0.329). Although mean fat intake met current recommendations, mean sugar intake was higher and there were indications of potential multiple micronutrient deficiencies. No herb-drug interaction was found and minor health complaints were reduced from baseline in both groups. CONCLUSIONS: This is the first randomised controlled trial to demonstrate a hypotensive effect of hawthorn in patients with diabetes taking medication.
PMID: 16762125 [PubMed - indexed for MEDLINE]

Andrew K Fletcher

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1: Int J Dev Neurosci. 2009 Aug 24.
Hawthorn extract reduces infarct volume and improves neurological score by reducing oxidative stress in rat brain following middle cerebral artery occlusion.
Elango C, Jayachandaran KS, Devaraj SN.
Department of Biochemistry, University of Madras, Guindy Campus, Chennai-600 025, Tamil Nadu, India.
In our present investigation the neuroprotective effect of alcoholic extract of Hawthorn (Crataegus oxycantha) was evaluated against middle cerebral artery occlusion induced ischemia/reperfusion injury in rats. Male Sprague Dawley rats were pretreated with 100mg/kg body weight of the extract by oral gavage for 15 days. The middle cerebral artery was then occluded for 75minutes followed by 24hours of reperfusion. The pretreated rats showed significantly improved neurological behavior with reduced brain infarct when compared to vehicle control rats. The glutathione level in brain was found to be significantly (p<0.05) low in vehicle control rats after 24hours of reperfusion when compared to sham operated animals, However, in Hawthorn extract pretreated rats the levels were found to be close to that of sham. Malondialdehyde levels in brain of sham and pretreated group were found to be significantly lower than the non treated vehicle group (p<0.05). The nitric oxide levels in brain were measured and found to be significantly (p<0.05) higher in vehicle than in sham or extract treated rats. CONCLUSION: Our results suggest that Hawthorn extract which is a well known prophylactic for cardiac conditions may very well protect the brain against ischemia reperfusion. The reduced brain damage and improved neurological behavior after 24hours of reperfusion in Hawthorn extract pretreated group may be attributed to its antioxidant property which restores glutathione levels, circumvents the increase in lipid peroxidation and nitric oxide levels thereby reducing peroxynitrite formation and free radical induced brain damage.

Andrew K Fletcher

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1: Cardiovasc Drugs Ther. 2008 Feb;22(1):19-28. Epub 2008 Jan 20.  Links
Effects of hawthorn on cardiac remodeling and left ventricular dysfunction after 1 month of pressure overload-induced cardiac hypertrophy in rats.
Hwang HS, Bleske BE, Ghannam MM, Converso K, Russell MW, Hunter JC, Boluyt MO.
Division of Kinesiology, Laboratory of Molecular Kinesiology, University of Michigan, Ann Arbor, MI, USA.
PURPOSE: Hawthorn (Crataegus) is a natural product used to treat patients with heart failure. The effects of hawthorn on cardiac remodeling, however, are not known. The purpose was to determine the effects of hawthorn treatment on remodeling and function of the left ventricle (LV) after 1 month of pressure overload-induced cardiac hypertrophy. MATERIALS AND METHODS: Sprague-Dawley rats (male, 300 g) were subjected to sham operation (SH) or aortic constriction (AC) for 4 weeks and treated with Hawthorn (Crataegus-Extract- WS1442;1.3, 13, 130 mg kg(-1) day(-1); AC-L, AC-M, AC-H) or vehicle (SH-V, AC-V) for 3 weeks after surgery. Systolic and diastolic function were measured using echocardiographic assessment at baseline and 4 weeks after AC. RESULTS: AC increased the LV/body weight ratio by 34% in vehicle and hawthorn treated rats. Hawthorn markedly reduced LV chamber volumes (VOL) after AC [systolic VOL, mean +/- SEM, mm(3): SH-V, 87 +/- 13; AC-V, 93 +/- 12; AC-L, 62 +/- 9; AC-M, 68 +/- 12; AC-H; 50 +/- 11 and diastolic VOL: SH-V, 433 +/- 45; AC-V, 412 +/- 57; AC-L, 313 +/- 25; AC-M, 319 +/- 37; AC-H, 264 +/- 25 (p < 0.05)] and augmented relative wall thickness, mm: SH-V, 0.45 +/- 0.02; AC-V, 0.65 +/- 0.05; AC-L, 0.71 +/- 0.03; AC-M, 0.74 +/- 0.06; AC-H, 0.80 +/- 0.09 (p < 0.05). AC reduced velocity of circumferential shortening (Vcf(c)) by 28% compared with SH-V. Hawthorn attenuated the AC-induced decrease in Vcf(c) (p < 0.05). CONCLUSIONS: Hawthorn treatment modifies left ventricular remodeling and counteracts myocardial dysfunction in early pressure overload-induced cardiac hypertrophy.

Andrew K Fletcher

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1: Phytomedicine. 2003;10(5):363-9.Links
A randomised double blind placebo controlled clinical trial of a standardised extract of fresh Crataegus berries (Crataegisan) in the treatment of patients with congestive heart failure NYHA II.
Degenring FH, Suter A, Weber M, Saller R.
Bioforce AG, Roggwil, Switzerland.
A placebo controlled, randomised, parallel group, multicentre trial conducted in accordance with the guidelines of Good Clinical Practice (GCP) shows the efficacy and safety of a standardised extract of fresh berries of Crataegus oxyacantha L. and monogyna Jacq. (Crataegisan) in patients with cardiac failure NYHA class II. A total of 143 patients (72 men, 71 women, mean age of 64.8 (8.0 years) were recruited and treated with 3 times 30 drops of the extract (n = 69) or placebo (n = 74) for 8 weeks. The primary variable for the evaluation of efficacy was the change in exercise tolerance determined with bicycle exercise testing, secondary variables included the blood pressure-heart rate product (BHP). Subjective cardiac symptoms at rest and at higher levels of exertion were assessed by the patient on a categorical rating scale. An overall assessment of efficacy at the final visit was provided by the patient and the investigator. In the ITT population there was a significant increase in exercise tolerance in both groups between visit 1 and visit 3. The difference between the treatment groups was 8.3 watts in favour of the standardised extract of fresh Crataegus berries (p = 0.045). The result is confirmed in the PP population (p = 0.047). Changes in BHP at 50 watts and at comparable maximum load were in favour of Crataegus extract but the results are not statistically significant. The subjective assessment of cardiac symptoms at rest and at higher levels of exertion did not change significantly and the patient and investigator overall assessment of efficacy were similar for the two groups. The medication was well tolerated and had a high level of patient acceptability. The significant improvement, due to the fact that dyspnoea and fatigue do not occur until a significantly higher wattage has been reached in the bicycle exercise testing allows the conclusion that the recruited NYHA II patients may expect an improvement in their heart failure condition under long term therapy with the standardised extract of fresh Crataegus berries.

Andrew K Fletcher

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: Phytother Res. 2002 Feb;16(1):48-54.  Links
Promising hypotensive effect of hawthorn extract: a randomized double-blind pilot study of mild, essential hypertension.
Walker AF, Marakis G, Morris AP, Robinson PA.
Hugh Sinclair Unit of Human Nutrition, School of Food Biosciences, The University of Reading, Whiteknights, PO Box 226, Reading RG6 6AP, UK. A.F.Walker@afnovell.reading.ac.uk
This pilot study was aimed at investigating the hypotensive potential of hawthorn extract and magnesium dietary supplements individually and in combination, compared with a placebo. Thirty-six mildly hypertensive subjects completed the study. At baseline, anthropometric and dietary assessment, as well as blood pressure measurements were taken at rest, after exercise and after a computer 'stress' test. Volunteers were then randomly assigned to a daily supplement for 10 weeks of either: (a) 600 mg Mg, (b) 500 mg hawthorn extract, (c) a combination of (a) and (b), (d) placebo. Measurements were repeated at 5 and 10 weeks of intervention. There was a decline in both systolic and diastolic blood pressure in all treatment groups, including placebo, but ANOVA provided no evidence of difference between treatments. However, factorial contrast analysis in ANOVA showed a promising reduction (p = 0.081) in the resting diastolic blood pressure at week 10 in the 19 subjects who were assigned to the hawthorn extract, compared with the other groups. Furthermore, a trend towards a reduction in anxiety (p = 0.094) was also observed in those taking hawthorn compared with the other groups. These findings warrant further study, particularly in view of the low dose of hawthorn extract used.

Andrew K Fletcher

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Fortschr Med. 1996 Aug 30;114(24):291-6.Links
    [Crataegus Special Extract WS 1442. Assessment of objective effectiveness in patients with heart failure (NYHA II)]
    [Article in German]

    Weikl A, Assmus KD, Neukum-Schmidt A, Schmitz J, Zapfe G, Noh HS, Siegrist J.

    Hauptkrankenhaus Deggendorf.

    METHOD: In a multicenter, placebo-controlled double-blind study, the efficacy of the Crataegus-Specialextrakt WS 1442 in patients with NYHA stage II cardiac insufficiency was investigated. A total of 136 patients with this diagnosis were admitted to the study and, following a 2-week run-in phase, treated with Crataegus-Specialextract or placebo over a period of 8 weeks. The primary target parameter was the change in the difference of the pressure, heart rate product (systolic blood pressure x heart rate/100) (PHRP 50 W load vs. rest) measured at the beginning and end of treatment. RESULTS: On the basis of this variable, a clear improvement in the performance of the heart was shown in the group receiving the test substance, while the condition of the placebo group progressively worsened. The therapeutic difference between the groups was statistically significant. The positive result for the objective efficacy parameter was confirmed by a statistically obvious superiority of Crataegus in the patient's own assessment of improvement in the main symptoms (reduced performance, shortness of breath, ankle edema etc.). In addition, active treatment led, in comparison with placebo, to a considerably better quality of life for the patient, in particular with respect to mental well-being. The tolerability of the active substance proved to be very good-as shown by comprehensive laboratory investigations and the recording of undesirable events. CONCLUSION: All in all, the results of the present clinical investigation confirm those of previous studies showing that Crataegus-Specialextrakt WS 1442 is an effective and low-risk phytotherapeutic form of treatment in patients with NYHA II cardiac insufficiency.

Andrew K Fletcher

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1: Fortschr Med. 1993 Jul 20;111(20-21):352-4.Links
    [Crataegus Special Extract WS 1442 in NYHA II heart failure. A placebo controlled randomized double-blind study]
    [Article in German]

    Leuchtgens H.

    In 30 patients with stage NYHA II cardiac insufficiency, a placebo-controlled randomized double-blind study was carried out to determine the efficacy of the Crataegus special extract WS 1442. Treatment duration was 8 weeks, and the substance was administered at a dose of 1 capsule taken twice a day. The main target parameters were alteration in the pressure-x-rate product (PRP) under standardised loading on a bicycle ergometer, and a score of subjective improvement of complaints elicited by a questionnaire. Secondary parameters were exercise tolerance and the change in heart rate and arterial blood pressure. The active substance group showed a statistically significant advantage over placebo in terms of changes in PRP (at a load of 50 W) and the score, but also in the secondary parameter heart rate. In both groups, systolic and diastolic blood pressure was mildly reduced. No adverse reactions occurred.

Andrew K Fletcher

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After trying hawthorn berry and leaves stewed several times to extract the compounds, taken regularly with water, small glass 2-3 times a day. I can only add that it had no benefit for me whatsover. MY Bp remained high even when taking prescription drugs also (lisinopril)  nasty side effects from the drug btw.

Have been experimenting with cayenne pepper, a teaspoon a day taken with apple juice, now taking diovan 40 mg which had no effect for a month but adding the cayenne appears to be doing something. Early days yet will come back and let you know of any changes.

Hawthorn has had some good results in trials so don't rule it out without testing it first.

Andrew

SusanChase

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I'm glad to know the positive outcome for this Clinical Trial Results of Hawthorn  extract  for High Blood Pressure. Although there are still arguments between herbal remedies and medicines especially when it comes in their effects. But the most effective way to determine if the drug or medicine are good or bad is through clinical test and study.

 

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