Prostol [Discontinued] by Nature's Way

POSSIBLY EFFECTIVE

• Transurethral resection of the prostate (TURP). Saw palmetto 320 mg daily seems to improve outcomes after TURP surgery in a dose-dependent manner. Details: Clinical research shows that taking saw palmetto (Permixon, Pierre Fabre Medicament) 320 mg daily for 2 months prior to TURP surgery reduces blood loss, the duration of surgery, the development of intraoperative complications, the duration of catheterization, and the length of hospitalization when compared with placebo (73323,73353). Although these studies found benefit, a small study using a lower dose of saw palmetto (Prostagood Mono, Abdi Ibrahim) 160 mg orally once daily for 5 weeks prior to TURP did not find any decrease in the risk of perioperative hemorrhage, or the density of prostate tissue (17202).

POSSIBLY INEFFECTIVE

• Benign prostatic hyperplasia (BPH). Although individual study results are conflicting, the overall body of evidence suggests that saw palmetto does not offer clinically meaningful improvements in BPH-related symptoms. Details: Research on the use of saw palmetto for improving symptoms of BPH is inconsistent and contradictory. To date, the best available evidence addressing the effectiveness of saw palmetto in patients with BPH comes from two high-quality clinical trials sponsored by the National Institutes of Health (NIH). In one of these trials, saw palmetto 160 mg twice daily for one year was ineffective for reducing moderate to severe symptoms of BPH when compared with placebo (14274). In the other trial, taking saw palmetto 320-960 mg daily for 72 weeks did not significantly improve symptoms when compared with placebo (17684). Additionally, meta-analyses of these trials and many of the small trials described below show that taking saw palmetto does not improve BPH-related signs and symptoms or International Prostate Symptom Scores (IPSS) (89441,102835). While several small, low-quality clinical trials and observational studies in patients with BPH suggest that saw palmetto provides some improvement in urinary symptoms, nocturia, urinary flow, and/or residual urine volume when compared with placebo or baseline (6750,6764,6772,73315,73383,73385,73387,89441,96570,110541), other studies show that saw palmetto has no clinically meaningful effect on BPH-related signs and symptoms, including prostate volume (5093,6752,11314,73343,96409). The validity of several of these studies is limited due to the use of per-protocol analyses and/or a lack of placebo control groups. Beyond this, reasons for these discrepant findings are unclear; however, the mixed results may be due to use of different saw palmetto products, varying study methodologies, different patient populations, and varying symptom scoring tools. Additionally, research shows significant variation in the chemical composition of commercially available saw palmetto extracts (17305,89441). Several clinical trials have compared saw palmetto to 5-alpha reductase inhibitors such as finasteride (Proscar) or dutasteride (Avodart). Some small studies suggest that it may be comparable to these medications for relieving BPH symptoms, but with less effect on prostate size or prostate-specific antigen (PSA) levels (6424,96570). It may also be better tolerated, with a positive effect on sexual dysfunction (6424,6763,18215,89441). Additionally, one observational study in patients with BPH has found that taking saw palmetto 320 mg with tamsulosin 0.4 mg daily for 6 months is associated with similar improvements in IPSS and quality of life scores, but also has a lower risk of reduced libido, when compared with tamsulosin plus dutasteride 5 mg or finasteride 0.5 mg daily (110542). Some research has also compared saw palmetto to alpha-adrenergic blockers. Alpha-adrenergic blockers appear to have a faster onset of symptom relief (2732,6750), and saw palmetto might be less effective than the alpha-adrenergic blocker prazosin (Minipress). Although some studies and a meta-analysis suggest it is similarly effective to tamsulosin (Flomax) after 6-12 months of treatment for improving various symptoms of BPH (6775,6776,11243,89441,96570,104804,107483), another meta-analysis found that alpha-blockers were more effective than saw palmetto for these outcomes (102835). Additionally, tamsulosin appears to be more effective than saw palmetto for reducing prostate volume (104802). However, some research suggests that saw palmetto may be better tolerated than tamsulosin (107483). It is unclear if taking saw palmetto with tamsulosin can improve BPH symptoms. Several low-quality studies and a meta-analysis of two of these studies show no additional benefit over using tamsulosin alone (8901,89443,89448,96410). However, one study suggests that a specific saw palmetto extract (Permixon, Pierre Fabre Medicament) 320 mg daily is associated with a 29% decrease in the IPSS when taken alone, compared with a 37% decrease when taken along with tamsulosin 0.4 mg daily for 6 months. Tamsulosin alone was associated with a 31% decrease (104802). Smaller, lower-quality studies of various combinations of saw palmetto with other ingredients have demonstrated some benefit for improving symptoms of BPH, and some have shown equivalence to finasteride, tamsulosin, or tadalafil (Cialis). These ingredients include stinging nettle root (PRO 160/120, Dr. Willmar Schwabe Pharmaceuticals) (6763,17307,73330,89441); cernitin, beta-sitosterol, and vitamin E (11241); selenium and lycopene (Profluss, Konpharma) (90354,97255); pygeum, lycopene, Epilobium parviflorum, and pumpkin seed oil (ProstateEZE Max, Caruso's Natural Health) (92164); and quercetin and beta-sitosterol (Difaprost, Difass International) (96784). Additionally, one study suggests that an enriched form of saw palmetto oil containing 3% beta-sitosterol seems to be more effective than standard saw palmetto oil containing 0.3% beta-sitosterol in reducing IPSS scores (104803).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Androgenic alopecia. It is unclear if oral or topical saw palmetto is beneficial in patients with androgenic alopecia. Details: Clinical research shows that a combination of saw palmetto extract 200 mg plus beta-sitosterol 50 mg taken twice daily for 18-24 months improves subjective scores of hair quantity and quality in males with androgenic alopecia (15550). However, other clinical research shows that taking saw palmetto extract 320 mg daily for 24 months is less effective for improving hair growth in males with androgenic alopecia when compared with finasteride 1 mg daily (89444). Some clinical research shows that saw palmetto lotion applied topically twice daily for 50 weeks improves hair density by 27% in people with androgenic alopecia. However, a 13% improvement was observed in the placebo group, and no between-group comparisons were made (73435). Additionally, a small clinical study in males with androgenic alopecia receiving platelet-rich plasma every 3 weeks shows that applying 1 mL of topical saw palmetto, redensyl, and biotin daily for 12 weeks modestly improves subjective hair loss scores and photographic assessment of hair growth when compared with 1 mL of topical Procapil daily (112176). However, it is unclear if this effect is due to saw palmetto, other ingredients, or the combination.
• Asthma. Although there has been interest in using oral saw palmetto for asthma, there is insufficient reliable information about the clinical effects of saw palmetto for this purpose.
• Chronic bronchitis. Although there has been interest in using oral saw palmetto for chronic bronchitis, there is insufficient reliable information about the clinical effects of saw palmetto for this purpose.
• Chronic prostatitis and chronic pelvic pain syndrome (CP/CPPS). It is unclear if oral saw palmetto is beneficial in patients with CP/CPPS. Details: Preliminary clinical research shows that oral saw palmetto 325 mg daily for one year does not significantly improve symptoms of CP/CPPS when compared with finasteride 5 mg once daily (11354). However, a clinical trial in patients with moderate to severe CP/CPPS shows that taking saw palmetto 160 mg orally twice daily for 12 weeks improves NIH Chronic Prostatitis Index (NIH-CPSI) score after two weeks of treatment in patients with moderate disease and after 4 weeks of treatment in patients with severe disease when compared with placebo. Independent of severity, 73% of patients taking saw palmetto report a 6-point reduction in NIH-CPSI total score, compared to 33% of patients taking placebo (107482). Saw palmetto extract has also been evaluated in combination with other ingredients. A preliminary clinical study shows that taking a combination of saw palmetto extract 320 mg, selenium 50 mcg, and lycopene oil extract 5 mg daily for 8 weeks improves symptoms and peak flow in patients with CP/CPPS when compared with baseline. However, these effects were not observed or were less significant in patients treated with saw palmetto alone (60442).
• Common cold. Although there has been interest in using oral saw palmetto for the common cold, there is insufficient reliable information about the clinical effects of saw palmetto for this purpose.
• Hirsutism. Although there has been interest in using oral and topical saw palmetto for hirsutism, there is insufficient reliable information about the clinical effects of saw palmetto for this purpose.
• Non-neurogenic lower urinary tract symptoms (LUTS). It is unclear if oral saw palmetto is beneficial in females with non-neurogenic LUTS. Details: A small clinical study in elderly Japanese females with LUTS shows that taking saw palmetto extract 320 mg daily for 12 weeks reduces daytime urinary frequency and might improve nocturia, but it does not seem to reduce urinary urgency, incontinence, straining, bladder pain, or urethral pain when compared with placebo (110540).
• Prostate cancer. Small preliminary studies suggest that saw palmetto does not reduce prostate cancer risk or symptoms associated with prostate cancer. Details: Population research shows that people who take saw palmetto supplements do not have a lower risk of developing prostate cancer (15217). Preliminary clinical research also shows that taking saw palmetto 960 mg daily before, during, and after radiation treatment for early prostate cancer does not significantly improve lower urinary tract symptoms when compared with placebo (96412).
• Prostatitis. Adding saw palmetto to antibiotic therapy seems to relieve some symptoms of bacterial prostatitis more effectively than antibiotics alone. Details: Preliminary clinical research in patients with bacterial prostatitis shows that taking saw palmetto extract daily for eight weeks, with prulifloxacin 600 mg daily for 15 days, reduces pain and urinary symptoms more than prulifloxacin alone, but the combination does not appear to improve bacterial eradication or sexual dysfunction more than the antibiotic alone (89442). One small clinical study in patients with chronic nonbacterial prostatitis shows that a specific saw palmetto extract (Prostamol Uno, Profluss) 320 mg daily improves symptoms when compared with no treatment (73329). Combinations of saw palmetto with other supplements have also been used with fluoroquinolone antibiotics, typically resulting in symptom improvement when compared with the antibiotic alone. These supplement combinations include saw palmetto, indole-3-carbinol, and epigallocatexin-3-gallate (Indigal Plus) 2 capsules twice daily for 3 months (73355); saw palmetto 160 mg, stinging nettle 120 mg, curcumin 200 mg, and quercetin 100mg (ProstaMEV plus FlogMEV) for 2 weeks (73346); and saw palmetto 320 mg, Bacillus coagulans 200 mg, and arbutin 100 mg (Lactorepens) daily for 30 days (96411).
• Sexual desire. Although there has been interest in using oral saw palmetto for sexual desire, there is insufficient reliable information about the clinical effects of saw palmetto for this purpose.
• Sexual dysfunction. Although there has been interest in using oral saw palmetto for sexual dysfunction, there is insufficient reliable information about the clinical effects of saw palmetto for this purpose. More evidence is needed to rate saw palmetto for these uses.

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POSSIBLY EFFECTIVE

• Diabetes. Oral stinging nettle seems to improve glycemic control in patients with diabetes. Details: A meta-analysis of 8 small heterogeneous clinical trials in adults with type 2 diabetes shows that taking stinging nettle 1.5-10 grams in divided doses daily for 8-12 weeks reduces fasting blood glucose (FBG) by 18 mg/dL when compared with placebo (102865). Glycated hemoglobin (HbA1c) was not improved, but the study durations were not adequate to detect an improvement in this measure. Despite positive results on FBG, taking stinging nettle does not seem to improve insulin secretion or measures of insulin sensitivity (91519,102865,108903). Another meta-analysis of 3 small clinical studies in adults with type 2 diabetes shows that taking stinging nettle reduces HbA1c by about 1.3% when compared with placebo. This analysis also suggests stinging nettle reduces post-prandial blood glucose by about 114 mg/dL; however, this is based on a single study. Stinging nettle did not improve fasting blood glucose or insulin resistance in this analysis (111503). The validity of these findings is limited by the low quality and heterogeneity of included studies, as well as unclear dosing. Furthermore, since most research has been conducted in Iran, it is unknown if these findings are generalizable to other geographic locations. Stinging nettle has also been used in combination with other natural medicines. One small clinical study in adults with type 2 diabetes shows that taking a product containing stinging nettle leaf extract 200 mg, milk thistle 200 mg, and Boswellia serrata gum 200 mg three times daily for 3 months reduces FBP by about 28 mg/dL and HbA1c by about 1.5%, compared with a smaller reduction in the placebo group (96742). It is unclear if this effect is due to stinging nettle, the other ingredients, or the combination.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Allergic rhinitis (hay fever). It is unclear if oral stinging nettle is beneficial for hay fever. Details: Taking stinging nettle leaf extract 300 mg 3-7 times daily at the first sign of hay fever symptoms seems to provide subjective improvement (7035). However, adding stinging nettle to conventional allergy medication might not provide any additional benefit. One small clinical study shows that adding stinging nettle tablets (Urtidin, Barij Essence Pharmaceutical Co.) 150 mg four times daily for 1 month to treatment with loratadine and nasal saline rinses does not improve symptoms of allergic rhinitis when compared with placebo with loratadine and nasal saline rinses (96743).
• Anemia. Although there is interest in using oral stinging nettle for anemia, there is insufficient reliable information about the clinical effects of stinging nettle for this condition.
• Asthma. Although there is interest in using oral stinging nettle for asthma, there is insufficient reliable information about the clinical effects of stinging nettle for this condition.
• Benign prostatic hyperplasia (BPH). It is unclear if oral stinging nettle is beneficial for BPH. Details: A meta-analysis of clinical research, including 5 clinical studies and 1,128 patients with BPH, shows that taking stinging nettle root extract 360-600 mg in divided doses daily for 2-12 months improves peak urinary flow rate and symptom scores while modestly reducing prostate volume when compared with control. However, the validity of these results is limited by significant heterogeneity due to the variability in the products used and the specific endpoints investigated (96744). In the largest clinical trial in the analysis, patients took stinging nettle root extract 120 mg three times daily for 6 months (76406). Stinging nettle has also been evaluated in combination products. Clinical research in patients with BPH shows that taking a specific combination product (PRO 160/120, Dr. Willmar Schwabe Pharmaceuticals) containing a specific extract of stinging nettle root (WS 1031) 120 mg plus a specific extract of saw palmetto fruit (WS 1473) 160 mg twice daily for 24-48 weeks seems to improve urinary tract symptoms when compared with control; the effect may last at least 48 weeks after treatment (15195,15551,76409). However, taking a different combination product does not seem to be beneficial. A small clinical study in patients with BPH shows that taking a product containing stinging nettle root extract 240 mg, saw palmetto, pumpkin seed oil, lemon bioflavonoid, and beta-carotene, three times daily for 6 months, does not improve symptoms of BPH (5093).
• Bleeding. Topical stinging nettle has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Some preliminary clinical research shows that applying 4 mL of a specific product (Ankaferd blood stopper, Mefar Ilaç Sanayi A.S) containing alpinia, licorice, thyme, stinging nettle, and common grape vine to the affected area reduces bleeding, but does not improve the time for episiotomy repair, when compared with using saline (31010).
• Gingivitis. Stinging nettle in a mouthwash solution has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with moderate gingival inflammation suggests that using 10 mL of mouthwash solution containing a 1:1:1 mixture of stinging nettle, juniper, and yarrow twice daily for 3 months does not reduce plaque or bleeding when compared with control (76443). It is not clear if this effect is due to stinging nettle, the other ingredients, or the combination.
• Gout. Although there is interest in using oral stinging nettle for gout, there is insufficient reliable information about the clinical effects of stinging nettle for this condition.
• Gulf war syndrome. It is unclear if oral stinging nettle is beneficial for Gulf war syndrome. Details: A very small exploratory clinical trial in males with Gulf war syndrome shows that taking stinging nettle leaf (Nature's Way) 1305 mg in two divided doses daily for 30 days modestly improves symptom severity when compared with placebo (108311). The clinical relevance of this finding is limited by the use of an unvalidated scoring scale. Additionally, it appears that most patients had mild, unspecified symptoms at baseline; it is unclear if stinging nettle is beneficial for moderate to severe symptoms.
• Hyperandrogenism. It is unclear if oral stinging nettle is beneficial in patients with hyperandrogenism. Details: Preliminary clinical research in females with hyperandrogenism shows that taking dried extract of stinging nettle root 300-600 mg daily for approximately 4 months decreases total and free testosterone levels, but not menstrual cycle conditions, oily skin, or acne, when compared with taking spironolactone and cyproterone (91520).
• Insect bite. Oral stinging nettle has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that applying a homeopathic after-bite gel, containing stinging nettle, Echinacea, and marsh Labrador tea, on affected areas does not reduce erythema or itching after a mosquito bite when compared with placebo (89235).
• Kidney stones (nephrolithiasis). Although there is interest in using oral stinging nettle for kidney stones, there is insufficient reliable information about the clinical effects of stinging nettle for this condition.
• Myalgia. Although there is interest in using topical stinging nettle for myalgia, there is insufficient reliable information about the clinical effects of stinging nettle for this purpose.
• Osteoarthritis. Small clinical studies suggest that topical stinging nettle may modestly improve pain in patients with osteoarthritis. It is unclear if oral stinging nettle is beneficial. Details: Topically, stinging nettle leaf may have a counterirritant effect which may improve osteoarthritis pain in some patients. A small clinical study in patients ages 45-82 with osteoarthritis of the thumb shows that applying raw stinging nettle leaf to the thumb for 30 seconds daily for 1 week reduces pain and disability when compared with white dead nettle leaf control (12490). However, in another small clinical study in patients with knee osteoarthritis, topical application of raw stinging nettle leaf to the knee for 1 minute daily for 7 days does not seem to be more effective for reducing pain than applying a leaf from a related stingless nettle (76412). Non-raw stinging nettle has also been tried. In a small open-label study, a formulation of stinging nettle extract (Liquid PhytoCaps Nettle Leaf, Gaia Herbs) 13.33% compounded with lipobase oil-in-water emulsion and applied to the affected area twice daily for 2 weeks, modestly improves pain and function in patients with radiologically confirmed osteoarthritis when compared with baseline (76414). The validity of this finding is limited by the lack of a comparator group. Stinging nettle has also been evaluated orally, in combination with other ingredients. A clinical study in adults with knee osteoarthritis shows that taking a specific combination solution (Rosaxan, medAgil Gesundheitsgesellschaft mbH) containing stinging nettle extract 160 mg, rose hip puree 20 grams, devil's claw 108 mg, and vitamin D 200 IU daily for 12 weeks improves symptoms by an additional 28% and pain scores by an additional 33% when compared with placebo (96741). It is unclear if this effect is due to stinging nettle, the other ingredients, or the combination.
• Tinnitus. Oral stinging nettle has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults with tinnitus shows that taking a specific product containing stinging nettle, tansy, and rose hip (Neurotec, Rose Pharmed), 100 mg orally daily for 3 months does not improve auditory thresholds when compared with placebo. However, the product improved some subjective symptoms scores, such as perceived loudness and severity scores (110512).
• Urinary tract infections (UTIs). Although there is interest in using oral stinging nettle for UTIs, there is insufficient reliable information about the clinical effects of stinging nettle for this condition. More evidence is needed to rate stinging nettle for these uses.

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LIKELY SAFE ...when used orally and appropriately. Saw palmetto has been safely used in clinical studies lasting up to 3 years (2735,6750,6752,6764,6772,6773,11354,14274,15550,17202,17306,17684,73315,73383,73384,73385,73389,89441,96410,96412,110540).

POSSIBLY SAFE ...when used rectally and appropriately. Saw palmetto has been used safely in clinical research at a dose of 640 mg once daily for 30 days (73387). However, the long-term safety of saw palmetto administered rectally is not known.

PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally. Saw palmetto has hormonal activity (6766); avoid using.

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POSSIBLY SAFE ...when used orally and appropriately. Stinging nettle root 360-600 mg has been used safely for up to 1 year (5093,11230,15195,76406,96744). ...when used topically and appropriately (12490).

PREGNANCY: LIKELY UNSAFE
when used orally due to possible abortifacient and uterine-stimulant effects (4,6,19).

LACTATION:
Insufficient reliable information available; avoid using.

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Saw palmetto might increase the risk of bleeding with anticoagulant or antiplatelet drugs.  Details Saw palmetto is reported to prolong bleeding time (8659). Theoretically, it might increase the risk of bleeding when used concomitantly with anticoagulant or antiplatelet drugs.

CONTRACEPTIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Saw palmetto might reduce the effectiveness of contraceptive drugs.  Details Saw palmetto might have antiestrogenic effects (6766). Theoretically, it might interfere with contraceptive drugs taken concomitantly.

ESTROGENS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Saw palmetto might reduce the effectiveness of estrogens.  Details Saw palmetto might have antiestrogenic effects (6766). Theoretically, it might interfere with estrogens taken concomitantly.

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ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, stinging nettle might have additive effects with antidiabetes drugs.  Details Clinical research shows that stinging nettle might decrease blood glucose levels in patients with diabetes (91519,102865).

DIURETIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, combining stinging nettle with diuretic drugs may have additive effects.  Details Animal research suggests that the above ground parts and roots of stinging nettle may have a diuretic effect (1,4,11,76402).

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, stinging nettle might reduce excretion and increase levels of lithium.  Details Animal research suggests that stinging nettle has diuretic and natriuretic properties, which could alter the excretion of lithium (76402). The dose of lithium might need to be decreased.

WARFARIN (Coumadin) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D There is some concern that stinging nettle might decrease the effects of anticoagulant drugs such as warfarin.  Details Stinging nettle contains a significant amount of vitamin K (19). When taken in large quantities, this might interfere with the activity of warfarin.

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General ...Orally, saw palmetto is well tolerated and adverse effects are mild, infrequent, and reversible.
Most Common Adverse Effects:
Orally: Abdominal pain, constipation, decreased libido, diarrhea, dizziness, fatigue, headache, nausea, rhinitis, vomiting.

Cardiovascular ...Occasionally, cases of hypertension, postural hypotension, tachycardia, angina pectoris, arrhythmia, extrasystole, angiopathy, myocardial infarction, and congestive heart failure have been reported in patients using saw palmetto orally (6424,6484,6752,6772,17684,73388,89441). One case of severe bradycardia and second degree heart block was reported in a 64 year-old male taking an unknown amount of saw palmetto for a few weeks (96413).

Dermatologic ...A case report describes a 61-year-old male who developed a fixed drug eruption with localized blisters and erosions three days after starting oral saw palmetto. The lesions resolved when saw palmetto was stopped, but recurred when it was reintroduced six months later. Topical corticosteroid treatment was necessary and the patient was left with some residual hyperpigmented patches (104805). A combination of saw palmetto and beta-sitosterol has been associated with a single report of worsening acne (15550).

Endocrine ...Two case reports involving one 11-year-old female undergoing treatment for telogen effluvium and another 10-year-old female undergoing treatment for hirsutism, describe hot flashes and the onset of menarche associated with use of saw palmetto. One of these patients was consuming saw palmetto in a food supplement; the other was taking a supplement containing saw palmetto 320 mg daily (73361,96414). In both cases, the hot flashes resolved following treatment discontinuation. In one case, a rechallenge with saw palmetto caused a recurrence of hot flashes.

Gastrointestinal ...Gastrointestinal complaints such as nausea, vomiting, constipation, diarrhea, gastralgia, and halitosis are the most frequently reported adverse effects associated with saw palmetto (6484,6752,60442,73315,73320,73348,73354,73383,73385,73388,89441). Less often, cases of duodenal ulcer, dyspepsia, or heartburn have been reported (6772,73329,73354). Meteorism (intestinal gas accumulation) has also been reported with saw palmetto, although causality was unclear (60442).

Genitourinary ...Some clinicians are concerned that saw palmetto might cause erectile dysfunction, ejaculatory disturbance, or altered libido because of its potential effects on 5-alpha-reductase. Some preliminary clinical studies have reported sexual dysfunction, particularly ejaculatory dysfunction, erectile dysfunction, and reduced libido, in patients taking saw palmetto (5093,17202,17684,73383,89441). However, most of these patients were previously diagnosed with prostate disorders, so causality is unclear. Additionally, several clinical studies indicate that the occurrence of impotence in males taking saw palmetto is similar to placebo and tamsulosin (Flomax), and significantly less than finasteride (Proscar) (2732,6424,17306,107481). Rarely, cases of testicular pain, vesical tenesmus, and urinary tract infections have been reported in patients using saw palmetto extract orally (73388).

Hematologic ...Saw palmetto might have antiplatelet effects and potentially increase the risk of bleeding in some patients. There is one report of excessive intraoperative bleeding in a patient who took saw palmetto prior to surgery. Bleeding time normalized when saw palmetto was discontinued (8659). Also, one case of cerebral hemorrhage has been reported, but details are not available to determine causality (6772,73348). A case of retroperitoneal hematoma after bilateral inguinal hernia repair is reported in a male patient taking saw palmetto. The patient was discharged after a 3-day hospitalization in stable condition (112177).

Hepatic ...A case report describes a patient who developed acute hepatitis and pancreatitis while taking saw palmetto. Symptoms resolved when saw palmetto was discontinued, and reemerged upon re-challenge (14457). Other cases of acute hepatitis and pancreatitis, with elevated alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin have been reported in patients using saw palmetto orally (14457,73350,73351).

Musculoskeletal ...Orally, saw palmetto may cause fatigue, weakness, muscle pain, and back pain, although these adverse events are rare (6424,73388,89441). A case of saw palmetto-related rhabdomyolysis was reported in an 82-year-old male presenting with kidney dysfunction, increased C-reactive protein levels, and elevated serum creatine kinase (73358).

Neurologic/CNS ...Orally, saw palmetto can cause headaches, dizziness, insomnia, and fatigue (6750,6752,6772,11354,60442,73348,73385,73388,89441).

Ocular/Otic ...A case of intraoperative floppy-iris syndrome (IFIS) has been reported in a patient using saw palmetto orally (73340). However, no statistically significant association between saw palmetto and IFIS was found in a case series of 660 patients undergoing cataract surgery (73347).

Pulmonary/Respiratory ...Rhinitis is one of the more commonly reported adverse effects of saw palmetto (73348). One patient taking saw palmetto extract 160 mg twice daily reported "breathlessness" (73388). Two cases of respiratory depression have been reported in patients using saw palmetto extract (Permixon) 320 mg (6772).

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General ...Orally, stinging nettle seems to be generally well tolerated.
Most Common Adverse Effects:
Orally: Constipation, diarrhea.
Topically: Contact with the raw plant causes itching, rash, and stinging.

Dermatologic ...Topically, fresh stinging nettle leaves and stalk can cause localized rash, itching, and stinging (12490,76399,76412,76414,76417,76428,76448,96746). Usually, short exposure to stinging nettle results in a transient urticarial reaction and a stinging sensation which may persist for more than 12 hours (76399,76414,76417,96746). In one report, a patient placed a fresh stinging nettle leaf on the tongue to suck out the sap of the leaf. Severe tongue edema, pain, and urticaria developed within 5 minutes. Symptoms continued for several hours after the leaf was removed (15197). In another case report, a young couple intoxicated with methamphetamine fell and laid in a stinging nettle bush for 20 minutes, after which urticaria and pain continued for 2-3 weeks, and a heightened sensitivity to cold persisted for several months (96746).

Endocrine ...A case of gynecomastia has been reported for a 33-year-old male who consumed stinging nettle tea 2 cups daily for one month prior to symptom onset. The condition subsided one month after discontinuing stinging nettle tea (76410).
There have been two cases of galactorrhea associated with the consumption of stinging nettle for one month (76410,108902). In one case, a 33-year-old female consuming stinging nettle tea showed high levels of estradiol and low levels of follicle stimulating hormone (FSH) and luteinizing hormone (LH). The levels of these hormones normalized 6 weeks after discontinuing stinging nettle tea (76410). In the other case report describing a 30-year-old female self-treating with stinging nettle 500 mg daily, hormone levels were not reported; however, a mammogram showed scattered areas of fibroglandular density and benign-appearing calcifications. This patient had complete resolution of symptoms 1 week after discontinuation of stinging nettle (108902).

Gastrointestinal ...Orally, stinging nettle root can cause gastrointestinal complaints, including diarrhea and constipation (1,7,11230). Stinging nettle above ground parts may cause mild gastrointestinal discomfort when taken on an empty stomach (7035). Stinging nettle juice may cause diarrhea (1). One patient taking a combination product containing stinging nettle root extract and pygeum bark extract (Prostatonin, Pharmaton) experienced continual gastrointestinal pain and hyperperistalsis. It is not clear if this effect was due to stinging nettle or pygeum (70230).

Genitourinary ...There is a case report of decreased ejaculatory volume associated with an herbal blend product containing stinging nettle root extract, saw palmetto extract, pumpkin seed oil extract, lemon bioflavonoid extract, and beta-carotene (5093). It is unclear if this was due to stinging nettle, other ingredients, or the combination.

Hepatic ...A case of idiosyncratic drug-induced liver disease (DILI) is reported in a 36-year-old female who presented with abdominal pain after 1 month of taking an herbal liver detox tea containing stinging nettle and other ingredients. Remarkable laboratory values included elevated liver enzymes, alkaline phosphatase, and total bilirubin. The patient received a loading dose of N-acetylcysteine and was hospitalized for 12 days (112178). However, it is unclear if the adverse effect was due to the stinging nettle, other ingredients, or the combination.

Other ...Orally, stinging nettle root can cause sweating (1,7).

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