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Archive for the ‘Diseases of genitourinary system’ Category

Phytotherapy in the Treatment of Benign Prostatic Hyperplasia

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June 21, 2011 at 9:48 am

The use of plants or plant extracts for a variety of medicinal purposes (phytotherapy), including the treatment of voiding disorders, dates from ancient times. There is currently wide variation in the use of phytotherapeutic agents in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia in different parts of the world. In some European countries, for example France and Germany, plant extracts are among the most commonly recommended initial treatment options in men with voiding symptoms. These agents are available by prescription in many cases and patients may be reimbursed for their cost by health ministries or insurance companies. Although many Americans use phytotherapeutic products, few physicians in the United States recommend such therapy for men with benign prostatic hyperplasia, and all costs associated with such treatment are borne by the patient. Despite the lack of reimbursement by third-party payers for medicinal botanicals, it is estimated that $500 million to $1 billion is spent annually in the United States for such products. While it is widely perceived by many patients that it is advantageous to treat a variety of chronic medical conditions, such as lower urinary tract symptoms, with “natural” remedies, there is limited scientific evidence to support the use of these agents in most cases.

Phytotherapeutic agents used for treating men with lower urinary tract symptoms have not generally been subjected to the same rigorous testing standards as other more commonly accepted therapies, such as alpha-blockers and 5 a-reductase inhibitors. This situation has changed somewhat in recent years as several European companies that market phytotherapeutic products have responded to this criticism and sponsored multicenter clinical trials. In contrast, medicinal botanicals are generally categorized as food additives in the United States and are therefore not eligible for patent protection. This is a significant financial disincentive for American companies to support clinical research into these products. In addition, most European companies have elected not to pursue approval of their phytotherapeutic products in the United States due to a variety of economic and other factors.

Most medicinal botanicals contain multiple chemical components and it is generally unclear which, if any, of these ingredients are responsible for clinical activity.

There is also a lack of standardization of phytotherapeutic agents in the United States, potentially leading to marked variability in the chemical composition of natural products sold by different companies. Saw palmetto, the most popular plant extract used for treating lower urinary tract symptoms, is sold in one form or another by 30 or more companies in the United States. In some cases, these products include saw palmetto alone while others contain a mixture of herbal products, vitamins, and minerals. In Europe, saw palmetto is most commonly marketed as a prescribable agent (Permixon), which is manufactured in France. Permixon is the most extensively studied form of saw palmetto but it is not clear that similar results reported with this specific agent will be seen with other forms of saw palmetto available in the United States. Most patients are not aware of the vast potential differences that may exist between the chemical composition and efficacy of products with similar or identical names.

Proposed Mechanisms of Action of Phytotherapeutic Agents

There have been a wide variety of plant extracts recommended for patients with lower urinary tract symptoms and benign prostatic hyperplasia. The most common components of these agents include phytosterols, fatty acids, terpenoids, and plant oils. The improvement in voiding symptoms and benign prostatic hyperplasia are most often attributed to phytosterols, a class of compounds related to cholesterol. Beta-sitosterol is felt to be the most important phytosterol, and a variety of forms are present in most plant extracts used for treating benign prostatic hyperplasia.

There have been a number of suggested mechanisms of action associated with phytosterols, including antiandrogenic effects, direct inhibition of prostatic growth, and anti-inflammatory effects, These actions have been most commonly demonstrated using in vitro studies and experimental models in which supra-physiologic doses are frequently utilized. While these studies may suggest important mechanisms, it is difficult to assess the clinical relevance of these actions in some cases. The most important example of this discrepancy concerns the evidence that saw palmetto acts as a 5 a-reductase inhibitor. Although this action has been demonstrated in a variety of in vitro studies, clinical studies performed among men receiving saw palmetto have generally failed to show significant enzyme inhibition (based on changes in prostate size and serum prostate-specific antigen levels). In addition to concerns regarding mechanisms of phytotherapeutic agents, there is limited available information concerning bioavailability, and some plant extracts have been shown to be poorly absorbed from the gastrointestinal tract. Finally, in many cases scant information regarding pharmacodynamics is available.

Saw Palmetto

Pygeum africanum

Phytosterols

Pollen Extract

Mepartricin

Although Mepartricin is not truly a plant extract, it is best grouped with other phytotherapeutic agents used for treating symptomatic benign prostatic hyperplasia. Mepartricin is a semisynthetic polyene derived from a Streptomyces strain. It appears to have favorable effects in men with benign prostatic hyperplasia by selective binding activity with estrogens. This agent is produced in Italy and is marketed under the trade name Ipertrofan. Mepartricin binds to estrogen in the intestine, thus inhibiting its reabsorption. Since most estrogens are reabsorbed in the intestine after excretion into the bile, a decrease in reabsorption leads to a reduction in circulating serum levels. This leads to a decline in estrogen-induced stimulation of prostatic growth. In animal experiments, Mepartricin has been demonstrated to increase fecal excretion of estrogen and reduce blood and prostate estrogen concentrations as well as estrogen receptor levels within the ventral prostatic lobes. In patients with benign prostatic hyperplasia, treatment with Mepartricin has led to a significant decrease in the serum concentration of estrone, estradiol, and estriol.

In a multicenter trial conducted in several European countries, 198 men with untreated symptoms secondary to benign prostatic hyperplasia with an IPSS of 12 to 24 were randomized to receive Mepartricin or placebo for 24 weeks. Patients also were required to have a peak urinary flow rate of 6 to 15 cc per second to be enrolled in the study. The patients treated with Mepartricin had a significantly greater reduction in symptom score and increase in urinary flow rate compared to controls as well as an improved quality-of-life measure. No significant differences were seen in the two groups with regard to changes in prostate size, prostate-specific antigen level, or postvoid residual urine volume. No serious adverse events were noted among men in either group. Mepartricin appears to be a promising treatment option, with a unique mechanism of action, for men with symptomatic benign prostatic hyperplasia. Further study of this agent is planned.

Other Plant Extracts

In addition to the phytotherapeutic agents discussed above, a variety of other plant extracts have been investigated in men with symptomatic benign prostatic hyperplasia. Bazoton is the trade name of an extract from the plant Radix urticae and has a steroid-glycoside composition. This product has been tested in Hungary and appears to be an inhibitor of intra-cellular sex hormone-binding globulin receptors. In a limited, nonrandomized study, treatment with Bazoton led to symptomatic improvement as well as improvements in urinary flow rate and postvoid residual volume.

In Germany, extracts from the roots of Urtica dioica (stinging nettles) are widely used for treating men with benign prostatic hyperplasia. The suggested mechanisms of nettles include suppression of prostatic cell growth and metabolism, inhibition of a variety of prostatic growth factor interactions, and blockage of the attachment of sex hormone-binding globulins to prostatic membrane receptors. Although randomized, placebo-controlled trials demonstrating subjective and objective benefit using nettles have been reported in Germany, these studies have generally included small numbers of patients treated for intervals of only 1 to 3 months. The value of stinging nettles in men with benign prostatic hyperplasia therefore remains unclear.

Other studies have investigated combination products incorporating two or more phytotherapeutic agents that have been used in men with benign prostatic hyperplasia.’ These trials have frequently demonstrated subjective and objective benefit in treated patients compared to controls. The value of these studies, however, has generally been limited by small numbers of patients and short treatment intervals.

Finally, therapeutic benefit has been suggested for other plant extracts such as those from pumpkin seeds, unicorn root, and rye pollen. No recognized studies using these agents in men with benign prostatic hyperplasia have been presented to date.

Summary

There is growing interest in the United States in the use of “natural remedies” to treat patients with chronic medical conditions such as benign prostatic hyperplasia. Most American physicians have limited knowledge concerning these treatments and are unable to advise patients regarding their use. Due to the proliferation of health food and vitamin stores, the growing popularity of the Internet, and aggressive direct marketing to consumers, there has been a significant increase in the overall use of medicinal botanicals. Unlike therapies such as alpha-blockers and 5 a-reductase inhibitors, there have been few properly conducted trials of plant extracts in men with benign prostatic hyperplasia. One of the primary reasons for the lack of scientific study of these agents is the absence of significant financial incentive for American companies marketing phytotherapeutic products to support such research, given that such products are generally not eligible for patent protection.

Additional difficulties in assessing the efficacy of plant extracts in men with benign prostatic hyperplasia include the lack of standardization of these agents. Vast differences are likely to exist between similar products sold by different manufacturers. This issue is further confused by the widespread availability of combination products that often contain vitamins and minerals as well as a variety of plant extracts. There is a clear need for randomized, controlled trials of phytotherapeutic products in men with benign prostatic hyperplasia to ascertain the true value of these agents.

Saw Palmetto

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June 21, 2011 at 9:47 am

The most popular plant extract used for treating lower urinary tract symptoms is derived from the berry of the American dwarf palm tree (saw palmetto [Serenoa repens]), which is found in Florida and other areas of the southeastern United States. As described above, saw palmetto is sold under a variety of trade names in the United States and Europe. Permixon, the most extensively studied form of saw palmetto, is a liposterolic extract of the berry that contains a complex mixture of free fatty acids, phytosterols, and other compounds and is available in parts of Europe. In animal studies, some components of Permixon have been demonstrated to accumulate in normal and hyperplastic prostatic cells. In addition, bioavailability studies in humans have shown that at least some of the compounds contained in Permixon are absorbed through the intestinal tract.

Mechanisms of Action

Many mechanisms of action of saw palmetto have been proposed, including anti-inflammatory effects, anti-androgenic effects (mediated via androgen-receptor blockade), antiestrogenic effects, growth factor inhibition, and others.” Popular belief, however, centers on the action of saw palmetto as an inhibitor of the conversion of testosterone (T) to dihydrotestosterone (dihydrotestosterone) by the enzyme, 5 a-reductase. There have been a variety of in vitro studies performed with Permixon using human skin fibroblasts, primary cultures of human benign prostatic hyperplasia, and other models.”’ These studies have generally demonstrated inhibition of type 1 and type 2 5 a-reductase activity, leading to a decrease in dihydrotestosterone production. In many cases, these studies have used supraphysiologic doses of Permixon, which raises concern regarding the true clinical effect of this agent.

TABLE. Plant Extracts Available for the Treatment of Benign Prostatic Hyperplasia

Saw palmetto (Serenoa repens)
African plum (Pygeum africanum)
β-sitosterol (Harzol)
Pollen extract (Cernilton)
Stinging nettles
South African star grass (Hypoxis rooperi)

TABLE. Suggested Mechanisms of Action of Phytotherapeutic Agents Used to Treat Benign Prostatic Hyperplasia

Inhibition of 5 a-reductase
Anti-inflammatory effects
Antiandrogenic effects (via androgen-receptor blockage)
Antiestrogenic effects
Growth factor inhibition
Protection or improvement in bladder (detrusor) function
Effects on cholesterol metabolism
Reduction in sex hormone-binding globulin

Clinical studies in humans have included a 3-month trial in 33 men awaiting suprapubic prostatectomy. These patients were randomized to receive finasteride, flutamide, placebo, or Permixon for 2 to 3 months prior to surgery. Following removal of the prostate, T, dihydrotestosterone, and growth factor levels were measured in the removed tissue. In the control group, regional distribution of all three measured factors was highest in the periurethral area and lowest in the subcapsular zone. After treatment with Permixon or finasteride, dihydrotestosterone and growth factor levels decreased significantly, with no difference in the intraprostatic distribution as was seen in those patients receiving placebo. In men treated with flutamide, there was no change in T or dihydrotestosterone levels although growth factor levels decreased throughout the prostate. The authors concluded that both finasteride and Permixon led to important changes in androgen support, primarily within the periurethral zone of the prostate. Rhodes et al. have also compared the effects of finasteride and Permixon using in vivo and in vitro studies. In rats stimulated with T or dihydrotestosterone, finasteride inhibited prostate growth while there was no change with Permixon. In a 7-day trial in 32 healthy male volunteers, finasteride led to decreased dihydrotestosterone levels while no significant change was seen in those men receiving Permixon. Strauch et al. have also demonstrated that Permixon does not lead to any significant change in serum dihydrotestosterone levels in men treated with this agent. Further evidence against clinically relevant 5 a-reductase activity associated with saw palmetto includes a lack of effect on serum prostate-specific antigen levels noted in several studies, and a minimal reduction in prostate size seen among men treated with Permixon for 6 months in one large clinical trial in Europe.

In vitro studies have also suggested alternative mechanisms of action associated with saw palmetto. Using human foreskin fibroblasts, Sultan et al. found that this agent inhibits receptor binding of androgens. As has been noted for 5 a-reductase inhibition, evidence of clinically significant antiandrogenic activity has not been presented to date. Studies using Permixon have also suggested possible antiestrogenic effects. In a placebo-controlled trial in 35 men with benign prostatic hyperplasia who underwent surgery after treatment for 3 months, a significant decrease in estrogen receptor activity was noted in the Permixon-treated patients compared to those receiving placebo. The authors concluded that this antiestrogenic effect was likely mediated by competitive blocking of the translocation of cystosolic estrogen receptors to the nucleus, which may lead to inhibition of estrogen-mediated prostatic growth. Finally, German investigators have found evidence that saw palmetto has anti-inflammatory effects in patients with benign prostatic hyperplasia. Among a small group of men who subsequently underwent open prostatectomy, those receiving saw palmetto showed a significant reduction in periglandular stromal edema, intraglandular congestion, and congestive prostatitis compared to controls.

Clinical Studies

In the mid-1980s, several placebo-controlled clinical trials were performed in Europe with saw palmetto in men with symptomatic benign prostatic hyperplasia. Champault et al. studied 110 men and reported a significant improvement in dysuria and nocturia in patients treated with saw palmetto compared to those receiving placebo. The mean urinary flow rate increased significantly in the saw palmetto group and was unchanged among the controls. Limitations of this study included the short duration of only 1 month and the absence of standardized assessment of subjective symptoms since validated instruments such as the American Urological Association (AUA) symptom score were not then available. Smith et al. performed a similar controlled trial using saw palmetto in 80 men with voiding symptoms and benign prostatic hyperplasia. Although an improvement in the subjective assessment of symptoms and urinary flow rate were seen in both the placebo group and among those men treated with saw palmetto, there was no significant difference between the results of treatment in either group. In general, the early trials concerning saw palmetto are limited by small numbers of patients and brief, one- to two-month treatment intervals.

More recent, larger scale clinical trials using saw palmetto in men with lower urinary tract symptoms have also been reported. In an open-label study conducted in Belgium, 505 men with mild to moderate symptoms were treated with saw palmetto for 3 months. The mean peak flow rate improved from 9.8 mL per second to 12.2 mL per second, and the mean AUA symptom score decreased from 19.0 to 12.4. Overall, 88% of patients and physicians considered the therapy to be effective for relieving urinary symptoms. There was also a small but statistically significant decrease in prostate volume assessed by transrectal ultrasound, of 9.2% noted in men treated with saw palmetto. While saw palmetto appeared to lead to subjective and objective improvement in men with benign prostatic hyperplasia, the lack of placebo controls in this trial limits drawing conclusions from it. In a 6-month open-label study conducted at the University of Chicago that incorporated urodynamic evaluation of patients treated with saw palmetto, the current author and colleagues found that the mean AUA symptom score improved from 19.5 to 12.3 (p < .001). No improvements in urodynamic parameters such as peak flow rate, detrusor pressure, or postvoid residual were demonstrated, however. Men receiving saw palmetto reported no adverse effects, and there were no changes in routine serum chemistries or prostate-specific antigen levels noted. Finally, in a meta-analysis of 2794 men treated with Permixon, information on changes in peak urinary flow rate and nocturia were available and compared to placebo groups. Based on this analysis, the estimated effect of Permixon on peak flow rate beyond the placebo effect is 1.87 mL per second, and frequency of nocturia is decreased by a mean of 0.55 over placebo.

In the largest randomized trial concerning saw palmetto reported to date, 1098 men with moderate symptoms received Permixon or finasteride for 6 months. The study was conducted at 87 centers in Europe and did not include a placebo control group. There was a significant improvement in the mean symptom score from 15.7 to approximately 9.5 noted in both groups. While both groups demonstrated a significant increase in the mean peak urinary flow rate, the improvement was statistically better in those men treated with finasteride. There were few adverse effects noted in either group although there was less evidence of sexual dysfunction among the men receiving Permixon. Prostate volume was measured by transrectal ultrasound and showed a significant decline in both groups. Patients treated with finasteride, however, had an 18% decrease compared to only 6% in those treated with Permixon (p < .001). In addition, there was a 41% decrease in serum prostate-specific antigen levels and a 3% increase in those patients treated with finasteride and Permixon, respectively. These findings appear to indicate that saw palmetto leads to no or minimal clinically relevant 5 a-reductase inhibition. In a separate analysis of these results, the investigators demonstrated that the response to finasteride and Permixon was independent of pretreatment prostate size.

The results of the Veterans Administration (VA) Cooperative Trial in the United States, in which men were randomized to receive finasteride, terazosin, both drugs, or placebo, must be taken into account when assessing the results of this large European trial of Permixon versus finasteride. Since the findings of the VA trial suggested that finasteride was no more effective than placebo, it is possible that the results of the European study may largely indicate a placebo effect in patients receiving Permixon as well as in those treated with finasteride.

Summary

Saw palmetto is a well-tolerated plant extract that appears to lead to few, if any, significant adverse effects. While much attention has focused on the action of saw palmetto as a 5 a-reductase inhibitor, there is little evidence to suggest that it has a significant, clinically relevant effect on prostate size or serum prostate-specific antigen levels. Therefore, it seems unlikely that saw palmetto can be considered to have a similar efficacy as finasteride. Alternative proposed mechanisms of action may play a role in improving urinary symptoms although further study is necessary concerning possible effects on prostatic inflammation, edema, and others. Overall, while a number of clinical trials have suggested that saw palmetto leads to significant improvement in voiding symptoms and urodynamic measures of obstruction, there is a need for properly conducted, placebo-controlled trials to determine whether this agent is truly effective in treating men with benign prostatic hyperplasia.

Pygeum africanum

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June 21, 2011 at 9:46 am

The African plum tree, Pygeum africanum, is the source of another popular phytotherapeutic agent. The medicinal portion of the plant comes from the deeply fissured bark, which has been used by natives of southern Africa for many centuries. The primary components of Pygeum that are felt to be active in alleviating voiding symptoms secondary to benign prostatic hyperplasia are phytosterols, linear alcohols, and triterpenoids. In vitro studies have demonstrated that Pygeum is a potent inhibitor of prostatic fibroblast proliferation in response to direct activators of protein kinase C and to a variety of growth factors. These actions are felt to lead to anti-inflammatory effects within the prostate. Also, it appears that phytosterols have an inhibitory effect on the production of prostaglandin E2 and F2 alpha, which may help relieve vascular congestion and local hyperemia.

Although most research concerning Pygeum has focused on anti-inflammatory actions, the salutary effects of this agent may also be attributed to effects on the detrusor. Using Tadenan, an extract of Pygeum marketed by a French pharmaceutical company, Levin and his colleagues have conducted a series of investigations on bladder physiology. The initial response of the detrusor muscle to bladder outlet obstruction is smooth muscle hypertrophy and an increase in bladder mass. These changes in the detrusor may lead to reduced bladder capacity, hypercon-tractility, and other effects leading to a variety of voiding symptoms. In rabbits, the experimental creation of partial bladder outlet obstruction rapidly results in urothelial hyperplasia, smooth muscle hypertrophy, and increased collagen synthesis and deposition within the bladder. These changes lead to a decrease in the contractile response of the detrusor to stimulation and biochemical evidence of bladder dysfunction, with a reduction in the activities of citrate synthase and calcium ATPase.

Among the first responses to bladder outlet obstruction is fibroblast hyperplasia induced by an increase in basic fibroblast growth factor activity. It has been demonstrated that Tadenan inhibits fibroblast hyperproliferaton caused by growth factors, giving rise to the suggestion that this plant extract may improve bladder function in patients with prostatic obstruction. In their initial study, Levin et al. randomized rabbits to receive Tadenan at various doses for 3 weeks or to a control group. Partial bladder outlet obstruction was then experimentally created to simulate the effects of benign prostatic hyperplasia; the animals were sacrificed 2 weeks later. Pretreatment with Tadenan led to a significant protective effect on the contractile response of the detrusor to a variety of forms of stimulation while having no measurable effect on the overall increase in bladder mass. Subsequently, these same investigators reported that pretreatment of rabbits with Tadenan had a beneficial effect on metabolic dysfunction seen in the partially obstructed bladder. While both control and treated animals had an initial decrease in citrate synthase and calcium ATPase levels, only those rabbits receiving Tadenan had a return of both enzymes to near normal levels within 7 to 14 days after the obstruction was created. The clinical relevance of these effects is unclear, however, since the dosages utilized in the study were well above physiologic levels. In addition, pretreatment of patients prior to the development of bladder outlet obstruction is rarely feasible. Therefore, it is unclear what effect Tadenan might have on detrusor function and physiology if administered after a prolonged period of obstruction, as typically occurs in patients with benign prostatic hyperplasia.

Clinical Studies

There has been only limited study of the effectiveness of Pygeum in men with symptomatic benign prostatic hyperplasia. Similar to the situation with other phytotherapeutic agents, most of these studies involved short treatment intervals and lacked standard means of assessing therapeutic outcome. In a placebo-controlled French study of 120 men treated for 6 weeks, patients receiving Pygeum had a significant improvement in symptoms of nocturia, hesitancy, and sense of incomplete bladder emptying compared to controls. Barlet et al. studied 263 patients treated with Pygeum or placebo for 2 months and found that the percentage of patients with symptomatic improvement was significantly greater among those men receiving Pygeum (66% versus 31%). Overall, the efficacy of Pygeum in men with benign prostatic hyperplasia remains unproven and further study of this agent is required.

Phytosterols

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June 21, 2011 at 9:45 am

Phytosterols are a class of compounds that have been suggested to be the most important component of several phytotherapeutic products used for treating benign prostatic hyperplasia. Phytosterols are derived from a number of plants, including Hypoxis rooperi (South African star grass). There have been a variety of mechanisms proposed by which  phytosterols may improve voiding symptoms, including 5 a-reductase inhibition, anti-inflammatory effects, antiandrogenic actions, growth factor inhibition, antiestrogenic effects, and others. Beta-sitosterol has been suggested to be the most important phytosterol in treating voiding symptoms secondary to benign prostatic hyperplasia.

Harzol is a prescribable phytotherapeutic product manufactured in Germany. This agent is composed of a mixture of phytosterols that include primarily beta-sitosterol as well as smaller amounts of campesterol, stigmasterol, and other compounds. Although it has been suggested that beta-sitosterol is the most important active component of Harzol, it is not known which compounds are responsible for its effect on men with benign prostatic hyperplasia. Following initial study suggesting an improvement in urinary symptoms and flow rates in patients with benign prostatic hyperplasia treated with Harzol, Berges et al. published the results of a randomized, multicenter, placebo-controlled trial. In this study, 200 men with symptomatic benign prostatic hyperplasia were treated with Harzol or placebo three times per day for 6 months. Among men receiving Harzol, the International Prostate Symptom Score (IPSS) improved from a mean of 14.9 to 7.5 while those treated with placebo showed a mean symptom score improvement from 15.1 to 12.8 (p < .01). Similarly, mean peak urinary flow rate increased from 9.9 to 15.2 cc per second in the Harzol group, compared to 10.2 to 11.4 cc per second among controls (p < .01). There was also a significant decrease in postvoid residual urine volume seen in men treated with Harzol compared to controls. No severe adverse effects were noted secondary to Harzol, and there was no significant change in prostate volume.

Other studies concerning the use of phytosterol preparations composed primarily of beta-sitosterol have also been presented. Klippel et al. randomized 177 men with benign prostatic hyperplasia to receive Azuprostat, a phytosterol preparation marketed in Europe, or placebo for 6 months. In results presented at the 4th International Consultation on benign prostatic hyperplasia in 1997, there was a significant difference in IPSS improvement between men receiving Azuprostat and those receiving placebo (5.4 points, p < .01). In addition, the difference in peak urinary flow rate improvement (4.5 cc per second) and reduction in postvoid residual volume (33.5 cc) also indicated a significantly better response to the plant extract than to placebo.

Pollen Extract

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June 21, 2011 at 9:44 am

Studies have suggested that a number of phytotherapeutic products derived from the pollen extract of a variety of plants are of value in treating men with benign prostatic hyperplasia. Most of these studies have used Cernilton, a pharmaceutical product composed of the pollen extract from several plants grown in Sweden. The two principal active constituents of Cernilton are a water soluble fraction and an acetone soluble fraction containing three betasterols. Animal studies using Cernilton have demonstrated a significant decrease in the size of the prostate associated with epithelial cell atrophy, a decline in total and prostatic acid phosphatase levels, and an increase in zinc concentrations within the prostate. In addition, the water soluble fraction of Cernilton has been shown to inhibit the immortal human cell line growth in culture derived from prostate carcinoma. Finally, it has been shown that the hormone-stimulated growth of benign prostatic hyperplasia tissue transplanted into nude mice is significantly inhibited by Cernilton extract.

Clinical studies with Cernilton have included a double-blind, randomized trial in which 60 men awaiting surgery for benign prostatic hyperplasia were randomized to receive Cernilton or placebo for 6 months. No adverse effects or changes in hematologic parameters were seen in patients treated with this plant extract. Based on a modified Boyarsky symptom score, men treated with Cernilton showed statistically significant improvement in subjective symptoms compared to men in the control group (69% versus 29%, respectively, p < .009). When analyzed by individual voiding symptoms, only nocturia and a sense of incomplete emptying significantly improved in the men treated with Cernilton compared to those receiving placebo. Although no change in peak urinary flow rate or voided volume was noted in either group of patients, residual urine volume declined significantly in those men treated with Cernilton (mean 145 cc to 102 cc after 6 months) compared to controls (p = .025). Finally, based on transrectal ultrasound measurements performed prior to treatment and after 6 months, a small but statistically significant decrease in prostate size in patients receiving Cernilton was noted compared to those in the placebo group (p = .025).

The use of Cernilton has also been studied in men with chronic prostatitis and prostatodynia. In a non-randomized, open-label investigation, 90 men who had had symptoms for 1 year or more and had no evidence of bacterial infection received the pollen extract for 6 months. Subjective assessment of perineal pain, frequency, and dysuria were assessed as well as the results of digital rectal examination, white blood cell counts in expressed prostatic secretions, complement levels in the seminal fluid, and uroflowmetry. There was a favorable response seen in 78% (56 of 72) of those without complicating factors such as urethral strictures or bladder neck contracture, and complete resolution of all symptoms and signs of prostatitis was noted in 36% (26 of 72). Results were poor in those with complicating factors, with only 1 of 18 (6%) showing any significant improvement in subjective or objective outcome measures. Although these results suggest that there may be a role for Cernilton in men with nonbacterial prostatitis and pelvic pain syndromes, the lack of placebo controls in this study makes it difficult to draw conclusions regarding the efficacy of this agent.

Finally, the results of a study comparing Cernilton with the Pygeum extract Tadenan in men with symptomatic benign prostatic hyperplasia have been reported. Superior improvements in voiding symptoms, urine flow rate, and postvoid residual volume were noted among men treated with Cernilton.

Uterine Problems

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July 15, 2010 at 11:17 am

Uterus, Weak/Prolapsed

Best Single Herb: Motherwort

Best Combinations: Motherwort; red raspberry

Other Helpful Supplements: B-complex vitamins

Possible Causes: Constipation; prolapsed transverse colon

Complementary Help: Slant board exercises; bowel cleansing; bayberry or witch hazel tea or decoction used as douche

Uterus Support During Childbirth

Best Single Herb: Squawvine

Best Combinations: Squawvine; black cohosh, squawvine, dong quai, butcher’s broom, red raspberry (five weeks or less before scheduled child delivery only)

Other Helpful Supplements: Magnesium

Possible Causes: Not applicable

Complementary Help: Tangerine oil to relax during delivery

When there’s a problem with the uterus, it may be due to a weakness or a prolapsus. A prolapsed uterus is a uterus that has either tipped backward because of other sagging organs putting pressure directly on it, because of a lack of tissue integrity of the uterus, causing it to sag.

To help a tipped uterus, consider the colon. If the lower bowel is heavy with waste materials due to constipation, the bowel can sag under this weight and can drop down on top of the uterus, causing discomfort, problems conceiving, or painful periods.

Try cleansing the bowel if you have trouble with your uterus. Any organ that is lying underneath a constipated, toxic-laden, heavy colon can only create an unhealthy environment for that organ. The position can cause constricted blood flow and may encourage adhesions or other growths to occur. Read for more on cleansing with herbs.

Other things that can help a prolapsed transverse colon or a prolapsed uterus are slant board exercises. All you need for a slant board exercise is an exercise incline bench or some other type of board that you can raise one end of and lie on safely with your feet higher than your head. These exercises are designed to bring back tone to a prolapsed colon, but the uterus will be affected also.

  1. Lie on your back with your head at the low end of the board.
  2. Gently and rapidly tap the area below your belly button with your cupped hand for a few minutes.
  3. You can also find a tennis ball or similar ball and roll it around the same area.

Gravitational force will help pull the bowel and uterus back into place, and the tapping and rolling motions will bring blood supply to the area and may help give tone back to the muscles. This exercise is also helpful if you experience tiredness, a groggy head, or forgetfulness.

Warnings about the use of herbs

Be careful getting up from this position! If you are not used to it, you can become dizzy because of the extra blood and oxygen flow to the brain.

Motherwort for the Weak Uterus

Motherwort (Leonurus cardiaca) is an herb used for its antispasmodic, astringent, diuretic, and nervine properties. This herb is considered a tonic made for female problems because it has been used to ease the pain associated with menstruation, to relieve pain during childbirth, and to ease frigidity. Motherwort has some laxative effects as well. The Japanese celebrate motherwort at a festival called Kikousouki, where they add the flowers of the plant to their food and eat them.

Warnings about the use of herbs

Because of its laxative effects, motherwort should not be used during pregnancy, but to may be used to help ease pain during childbirth.

Although this herb can be used to ease pain during labor, it should not be taken during pregnancy.

Red raspberry is an herb that can help support the uterus during pregnancy. A tea containing red raspberry, witch hazel, and motherwort or bayberry can be made into a douche and used to help contract and tone the uterus.

Squawvine Support

Squawvine (Mitchella repens) is used to help support the tone of the uterus while pregnant, as well as during and after childbirth. Native American women have taken squawvine as a tea during pregnancy to aid delivery and to help nourish breast milk.

Unlike motherwort, which should be used only during labor, squawvine is a uterine tonic that is safe to use during pregnancy. This herb can be combined with black cohosh, dong quai, butcher’s broom, and red raspberry and taken five weeks before your scheduled delivery date to help make labor easier. My clients who have used this combination have always had great testimonials about the effects of this combination, even when giving birth to a first child (which can be a more difficult delivery, for some).

Squawvine also has been used as a diuretic and has been helpful in eliminating stones from the kidneys and the bladder. Pregnancy and breastfeeding can make the nipples sore, and a squawvine fomentation has helped ease this tenderness for many women.

About overcoming an ailment with herbs

Magnesium acts as a muscle-relaxant and can help in labor pain. Aroma-therapists also have diffused tangerine into the birthing room to calm and relax nerves and to soothe the soul.

Urinary Problems

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July 13, 2010 at 11:10 am

Urinary Problems: Urine for a Treat

Best Single Herb: Uva ursi

Best Combinations: Uva ursi, hydrangea, parsley, dandelion, schizandra, Siberian ginseng, lemon, dong quai, cornsilk, horsetail, hops (for strengthening)

Other Helpful Supplements: B-complex vitamins

Possible Causes: Infection; constipation

Complementary Help: Dry-skin brushing; Kegel exercises; bowel cleansing; treatments for bladder problems or kidney problems

We have already addressed problems with the urinary tract during our discussions about bladder infections and kidney problems. But for general malice wrought on the urinary tract, such as incontinence, infections of the urinary tract, and water retention, I’d like to introduce you to a popular herb that you will probably see more and more of for its positive effects on the urinary system. The herb is called uva ursi.

Uva Ursi Is Good for U

Uva ursi (Arctostaphylos uva-ursi) is also called bearberry. The Greek translation of uva is “grape,” and ursi means “of the bear” — put together, this plant can also be referred to as bearberry, although I cannot verify whether bears eat the berries from the uva ursi plant. I plan to question the next one I run into!

For human consumption, the berries can be cooked or made into a cider. When chewed raw, they are bland but will stimulate the flow of saliva in your mouth and help you quench your thirst — in fact, uva ursi has been used as a survival herb.

It was only a decade earlier, when I consulted with an herbalist who put me on capsules of uva ursi for a bladder infection, that I found its medicinal uses for the urinary system.

Warnings about the use of herbs

Uva ursi contracts the tissues in the genito-urinary region, so you should not take this herb if you are pregnant because it may limit blood flow to the uterus. Too much of this herb and frequent doses can irritate the stomach. Use uva ursi as you would an antibiotic — not for more than 10 days in a row.

Uva ursi acts as an antiseptic, astringent, diuretic, and vasoconstrictor (that is, it reduces blood flow). It can be helpful in cases of severe diarrhea to slow things down, and it has been used as a mouthwash for thrush and as a douche for urinary trouble and infection. Uva ursi should be used as a medicine, for temporary use as needed. For urinary tract infections take two capsules twice daily, not more than 10 days in a row. Or you can make a tea (add chamomile for a better taste) and take V2 cup two times a day. Uva ursi is best taken for wet conditions such as water-retentive type ailments. Don’t take it if you are dehydrated.

Herb Lore: information related to holistic health

If you live in the West, you have probably seen uva ursi growing. This is a green, leafed plant with small red berries and small, oval, shiny leaves that grow low to the ground and spread wide. I first discovered this plant on my parent’s mountain property in Colorado, where a distant, elderly neighbor of ours (who was also a mountain man and a teacher of nature) identified it as kinnik-kinnik. He told me that the Native Americans used to smoke a mixture of kinnik-kinnik and tobacco, and that they would use it as a cleansing smoke in their sweat lodges.

And Don’t Forget

When there is infection in the body, a bowel cleansing is always helpful to eliminate excess toxins from circulating throughout the body. Do a dry-skin brush daily to take a load off your kidneys; read for more on kidney and bladder health.

For overall nutrition for the urinary tract, see the combination of herbs listed in the table at the end of this chapter. This table contains nutrients that will act as an antiseptic for the urinary tract. Use this combination to strengthen the urinary system, and then maintain your health with proper nutrition and your daily herbal program. (I’ll give you a daily program later in the book.) Also incorporate Kegel exercises to strengthen the pelvic floor muscles, and sip cornsilk and/or parsley tea each night for urinary nourishment.

About overcoming an ailment with herbs

Kegel exercises were designed especially to help women prone to bladder prolapses or anyone with incontinence (trouble holding back urine). To perform Kegels, tighten your lower pelvis muscles as if you were restricting urine flow. Contractions should be held for six to 10 seconds, followed by relaxing the muscles completely. This should be done four or five times in a row, three to four times a day.

Prostate Trouble

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June 18, 2010 at 5:44 am

Prostate Trouble: The Pressure Is On

Best Single Herb: Saw palmetto

Best Combinations: Saw palmetto; nettles; Siberian ginseng; pumpkin seeds; grape seed or pine bark extract

Other Helpful Supplements: Zinc; vitamin E with selenium

Possible Causes: Constipation; lack of exercise; caffeine abuse

Complementary Help: Bowel cleansing

Prostate trouble usually comes in the form of an enlarged prostate gland, which is the small, donut-shaped gland surrounding the neck of the bladder in males. Prostatitis is an inflammation of the prostate gland due to a bacteria infection. Either can cause difficulty with urination and may interrupt sexual function.

How can you tell if you could have prostate trouble? Here’s a list of the most common symptoms:

  • A need to urinate often, especially in the middle of the night
  • A weak or interrupted urinary stream
  • A feeling that you cannot empty your bladder completely A feeling of delay or hesitation when you start to urinate
  • A feeling that you must urinate right away
  • Continuing pain in the lower back, pelvis, or upper thighs

He Saw Palmetto and Was Cured

If you tell almost anyone who knows anything about herbs these days (even a complete idiot) that you have prostate trouble, you won’t be surprised to hear about the herb saw palmetto (Serenoa serrulata). Saw palmetto berries are used as a tonic to all the glands in the body and also prove helpful as a diuretic. These berries have been used not only for prostate problems, but also for respiratory ailments, diabetes, nerve problems, and digestive trouble.

In addition, this herb helps those who wish to put on weight, and it has been observed that animals that munch on these berries in the wild get plump!

About overcoming an ailment with herbs

Saw palmetto is also a well-known aphrodisiac — added to damiana, it makes a powerful remedy to help both men and women get back that loving feeling.

Besides being helpful for the prostate gland, saw palmetto is also used for asthma, bladder health, chronic bronchitis, head colds, gonorrhea, impotence, kidney disease, lung congestion, neuralgia, and sterility.

Women use this herb for breast problems, frigidity, hot flashes, gonorrhea, reproductive organs, sexual stimulation, and urinary problems.

Herbs for Prostate Health

Although saw palmetto has been one of the best-known herbs for men suffering from prostate conditions, a few more can prove useful as well. Because zinc is a mineral that is carried in the prostate, this gland may need some more for replenishment. An herbal source of zinc is pumpkin seeds — or, you can eat raw pumpkin seeds, but you’ll have to eat a lot of them and chew them well to get enough zinc to help correct your problem.

Nettle is another excellent male tonic (listed earlier in this chapter) because it has astringent-like effects on the tissues. It not only can help tighten swollen or inflamed tissues, but it also provides lots of minerals to nourish your body. Siberian ginseng is another overall body tonic, and grape seed and/or pine bark extract are powerful antioxidants for the prostate and other tissues of the body.

If you are suffering from an enlarged prostate, cut back on your coffee intake, get some exercise, and do some bowel cleansing. These can all enhance your herbal program and get you back into shape.

Premenstrual Syndrome (PMS)

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June 14, 2010 at 5:27 am

Best Single Herb: Wild yam

Best Combinations: Wild yam; evening primrose oil; red raspberry, dong quai, ginger, licorice, black cohosh, queen of the meadow, blessed thistle, marsh-mallow

Other Helpful Supplements: B-complex vitamins; calcium/magnesium with vitamin D

Possible Causes: Constipation; water retention; hypoglycemia; stressed liver

Complementary Help: Avoid fatty foods; reflexology; acupuncture; cleansing the bowel

Premenstrual syndrome encompasses a variety of symptoms, which is why it is referred to as a syndrome. Symptoms of Premenstrual Syndrome include irritability, moodiness, nausea, bloating, cramping, facial break-outs, swollen abdomen or breasts, and tension. These symptoms are usually caused by an overproduction of estrogen and a lack of progesterone production, which is caused by unknown reasons. (We have to keep those men guessing don’t we?) Actually, since the liver has the job of filtering excess estrogens from the blood, a couple capsules of milk thistle added to your daily herb program can help. Milk thistle cleanses and boosts a sluggish liver and can help keep your hormones balanced.

Several herbs listed in this book can help you during any of these symptoms. For instance, see for nausea; and for menstrual troubles. Here we will address an herb used to help tame the wild feelings and tension that accompany PMS symptoms.

Wild Yam to Tame a Wild Woman

Wild yam (Dioscorea villosa) is another one of God’s gifts to women. This herb has been misunderstood by some; it can be confused with the potato-like vegetable tuber, sometimes called sweet potatoes or candied yams that are served at many holiday dinners. Wild yam is different from these vegetables; although the herb is a root, too, it is derived from a tropical vine found in Mexico.

The Japanese discovered that they could derive steroid components from the wild Mexican yam species and process them many times to create steroid drugs. Drugs derived from the wild yam include oral birth control pills and corticosteroids. (However, if you really don’t want to get pregnant ladies, don’t rely on wild yam as a viable birth control!)

A component in wild yam called diosgenin is a hormone-like substance that acts like progesterone in the body. Progesterone is a female hormone that helps keep estrogen in check. When progesterone and estrogen are in the right balance in the body, women do not experience Premenstrual Syndrome (PMS) symptoms.

Terms related to herbs or holistic health

Progesterone is a hormone made in the ovaries that helps keep estrogen levels in balance within the body to create harmony. If progesterone levels drop for some reason (menopause, PMS, and other unknown causes), there is nothing to keep estrogen in balance. The result is experienced as the cranky symptoms of estrogen overload — otherwise known as Premenstrual Syndrome.

This is why supplementing with wild yam during your usual PMS time can be helpful. This herb taken 10 days to two weeks before menstruation can ease PMS symptoms by assisting a hormonal balance. Wild yam is also used to relax muscle tissue, which can help ease menstrual cramps. Consider supplementing with wild yam if you have any spasmodic conditions in the muscles because this herb may be able to ease the pain associated with tension and cramping. Two capsules taken three times daily have been helpful for many, but dosage is always an individual thing.

A Premenstrual Syndrome (PMS) Plan

Evening primrose oil contains hormone-like substances and has also been helpful as a supplement for PMS suffers. My recommendation is that you try wild yam or evening primrose oil separately. If one doesn’t seem to work for you, try the other. How many tablets or capsules you take will depend on your body and will differ for everyone. If you are not working with an herbalist or practitioner who can guide you, read the label on the bottle and start there.

Cleansing the bowel can help take away that bloated feeling you get when PMS-ing. Also, B-complex tablets will help your body rid itself of excess water and should be considered as a daily supplement; you can increase your intake during Premenstrual Syndrome (PMS) times.

Here are some helpful tips in keeping you more steady during your cycle:

  • Supplement with wild yam or evening primrose oil capsules 10 days before your scheduled period, or try the combination listed in the table at the end of the chapter.
  • Avoid excess salt in the diet, which can cause water retention and lead to bloating and irritability.
  • Take extra B-complex vitamins to help get rid of excess water.
  • Avoid fatty foods such as dairy products. These can actually have a change on your own hormones, so eat more vegetables, fruits, and grains.
  • Try reflexology. This therapy has been studied extensively for its effectiveness on PMS symptoms.

Also keep your blood sugar in check; fluctuating blood sugar levels (see on hypoglycemia) caused by sugar consumption and a weak liver can cause a person to be irritable with or without Premenstrual Syndrome (PMS).

Menstrual Disorder

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May 21, 2010 at 1:44 pm

Menstrual Problems, Balancing on Your Cycle

Menstrual Irregularity/Late

Best Single Herb: Pennyroyal

Best Combinations: Black cohosh, squawvine, dong quai, butcher’s broom, red raspberry; ginger; licorice root; evening primrose oil

Other Helpful Supplements: Vitamin E

Possible Cause: Stress; glandular imbalance; anorexia

Complementary Help: Reflexology; acupuncture

Menstruation can be viewed as your body’s monthly house cleaning. Each month, the body prepares the uterus while the ovaries are busy preparing an egg with the anticipation of attracting the best sperm and creating new life. If no lucky sperm make the grade, the lining of the uterus is shed and the process repeats again.

There are three important stages during this cycle which include:

  • Actual menstruation: This is the three to seven days of your period, when the uterus is shedding its lining. This is when all your hormone levels drop. You can use this time as a time of rest, for gentle exercise like walking, and clean eating (less fats and sugar) to help your entire body get the most from this cleansing time.
  • The follicular phase: After your period is the time when your body is being prompted by hormones to produce eggs in the ovaries. At this time, estrogen levels begin to build and reach a peak. This is a time when your immune system strengthens in order to rid the body of germs and prepare for new life. (Note that some women become compelled to enthusiastically scrub their homes just before baby is due!) During the last part of this stage, is the time when most women feel their best and strongest (just before ovulation), skin tends to clear, and sexual urges rise. Nature designed this for the female to be better able to attract her mate just at the right time for fertility — isn’t that cool?
  • The luteal phase: This is the time when the produced egg leaves the ovary on its journey to the uterus. This is the time when progesterone takes over to prep the lining of the uterus to support a growing fetus. At this time, the immune system drops so that the potential sperm and (hopefully) fertilized egg can do their thing without being attacked by the immune system. If no sperm happens to show, the body goes back to the next phase, menstruation, and the cycle continues.

Terms related to herbs or holistic health

Epimenorrhea is a period that comes in shorter than normal intervals.

Amenorrhea is an absence of menstruation (other than pregnancy) caused by a host of factors, including glandular abnormalities, diabetes, mental illness, anorexia, stress, and excessive exercise.

Menorrhagia is abnormally heavy bleeding at menstruation.

Dysmenorrhea is a painful period that can lead to nausea, vomiting, and fainting.

Menstrual problems are frustrating and include all the symptoms of PMS, irregularity in the cycle, late periods or no periods (amenorrhea), periods that come too frequently (epimenorrhea), periods that are heavy and may last too long (menorrhagia), and painful periods (dysmenorrhea).

If you have any of these problems, you should get a check-up and find out what is causing the irregularities or pain. Endometriosis and other abnormal growths, pregnancy, and hormonal imbalances and anorexia can all be factors.

Warnings about the use of herbs

Consider sanitary napkins instead of tampons. Some doctors and holistic practitioners recommend against tampons and believe that blocking the natural flow and release of dead cells may be a factor in endometriosis and other female-related disorders. See for herbal help with endometriosis and PMS.

In this section, we will focus on herbs for you ladies who are not pregnant but that need a little herbal help to bring on a late period (amenorrhea).

Pennyroyal for That Womanly Period

Pennyroyal (Hedeoma pulegioides), or the more potent version from Europe (Mentha pulegium), is an herb that is hard to find. Because of its possible misuse, many manufacturers will not offer it to the consumer. Pennyroyal is an abortifacient, which means that it should never be taken while pregnant because it may cause the mother to abort a fetus.

Terms related to herbs or holistic health

Abortifacient is an herbal property meaning that an herb may cause miscarriage — therefore, an abortifacient herb is never suggested during pregnancy.

If you are a generally healthy woman, however, pennyroyal can be effective in bringing on a late period. Others have used the herb after giving birth to help the delivery of the placenta (known as the afterbirth). Just a little pennyroyal also may lessen the cramps and bloating associated with menstruation. In this case, a penny goes a long way!

Pennyroyal should also be noted for its use in getting rid of bugs and pests. This herb is one of the most powerful bug repellents and seems to be effective against a wide range of bugs.

Here are some uses of pennyroyal as a bug repellent:

  • The plant itself has been grown in pots or flower beds surrounding porches to repel mosquitoes. Because of this, it has also been commonly known as mosquito plant.
  • Used externally, the essential oil repels mosquitoes, fleas, and flies.
  • The dried herb can be made into a sachet and put in with wool clothing to repel moths.
  • The dried herb, burned for incense, can also serve as a great repellent.
  • The plant has been rubbed directly on the skin not only as a bug repellent but also for the relief of poison oak or poison ivy rashes.

Warnings about the use of herbs

Pennyroyal should be taken only in situations where a period is overdue due to stress. Pennyroyal may cause you to abort a fetus or can bring on hemorrhaging if taken when pregnant or if you have a weak uterus. Never take pennyroyal during pregnancy or if you are planning a pregnancy.

Again, remember to avoid any applications of pennyroyal — whether internal or external — if you are pregnant.

Hormonal Helpers

For other female problems, see the associated chapters: PMS; endometriosis; infertility. For irregular periods, take vitamin E to help increase fertility and bring more oxygen into the blood; licorice root has helped some of my menopausal clients rid themselves of hot flashes. Licorice root nourishes adrenals, regulates menstruation, and helps the body to release excess water retention. Sip ginger root tea to help promote the menstrual flow once

you do get your period. Dong quai has come to the rescue for many women and is used to regulate periods, ease PMS, help menopausal symptoms, nourish female glands, calm nervousness, expel retained placenta after birth, reduce hot flashes, and eliminate anemia.

Evening primrose oil has also been a saving grace for many women with raging hormones, has been used to help regulate periods, eases PMS symptoms, aids skin and hair health, and boosts the immune system. Try taking up to six evening primrose capsules daily 7 to 10 days before your period is due. Stay consistent. You will need to give your herbal hormonal helpers at least a few months to be able to correctly evaluate if your cycle is becoming regular. Patience and experimentation will be needed unless you are working with a holistic practitioner who can help guide you, of course.

About overcoming an ailment with herbs

Reflexology or acupuncture can release blocked energy, induce relation, and balance the glands. Reflexology has always helped me balance my own cycle, and frequently my female clients will get their period after their reflexology appointments.