Essence Chamber by Health Concerns

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Obesity. A small clinical study in overweight adults shows that taking a combination product containing damiana, guarana, and yerba mate for 45 days increases weight loss when compared with placebo (11866). It is not clear if this effect is due to damiana, other ingredients, or the combination.
• Sexual dysfunction. Preliminary clinical research shows that taking a specific combination product containing damiana, L-arginine, Panax ginseng, ginkgo, vitamins, and minerals (ArginMax for Women, Daily Wellness Co.) improves sexual satisfaction and desire, increases orgasm frequency, and reduces vaginal dryness when compared with placebo in women interested in improving their sexual function (46933). It is not clear if these effects are due to damiana, other ingredients, or the combination. More evidence is needed to rate damiana for these uses.

(Read more about DAMIANA)

There is insufficient reliable information available about the effectiveness of hydrangea.

(Read more about HYDRANGEA)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Cancer. Although there is interest in using oral poria mushroom for cancer, there is insufficient reliable information about the clinical effects of poria mushroom for this condition.
• Chronic fatigue syndrome (CFS). Although there is interest in using oral poria mushroom for CFS, there is insufficient reliable information about the clinical effects of poria mushroom for this condition.
• Chronic kidney disease (CKD). Although there is interest in using oral poria mushroom for CKD, there is insufficient reliable information about the clinical effects of poria mushroom for this condition.
• Coronavirus disease 2019 (COVID-19). Although there has been interest in using oral poria mushroom for COVID-19, there is insufficient reliable information about the clinical effects of poria mushroom for this purpose.
• Dementia. Although there is interest in using oral poria mushroom for dementia, there is insufficient reliable information about the clinical effects of poria mushroom for this condition.
• Diabetes. Oral poria mushroom has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of generally small clinical trials in patients with type 2 diabetes shows that taking Chinese herbal medicine combinations containing poria mushroom for 2-24 weeks along with hypoglycemic medications modestly reduces fasting blood glucose and glycated hemoglobin levels when compared with control groups taking hypoglycemic agents only. There were also modest improvements in levels of triglycerides and low-density lipoprotein (LDL) cholesterol and in insulin sensitivity (111920). Given the large number of other ingredients in the available formulations, it is unclear if any beneficial effects are related to poria mushroom, other ingredients in the formulation, or their combination.
• Diarrhea. Although there is interest in using oral poria mushroom for diarrhea, there is insufficient reliable information about the clinical effects of poria mushroom for this condition.
• Endometriosis. Although there is interest in using oral poria mushroom for endometriosis, there is insufficient reliable information about the clinical effects of poria mushroom for this condition.
• Influenza. Oral poria mushroom has only been evaluated for influenza vaccine enhancement in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in healthy adults shows that taking a product containing poria mushroom extract, rosemary extract, and aloe gel powder twice daily for 28 days prior to and following an influenza vaccination does not affect upper respiratory tract illness symptoms, severity, duration, or medication-related use when compared with taking placebo (111921). It is unclear if this study was large enough to detect differences between groups. Also, the effect of poria mushroom itself on influenza vaccine enhancement is unclear.
• Tinnitus. Although there is interest in using oral poria mushroom for tinnitus, there is insufficient reliable information about the clinical effects of poria mushroom for this condition.
• Urinary tract infections (UTIs). Although there is interest in using oral poria mushroom for UTIs, there is insufficient reliable information about the clinical effects of poria mushroom for this use. More evidence is needed to rate poria mushroom for these uses.

(Read more about PORIA MUSHROOM)

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.

(Read more about SAW PALMETTO)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Abdominal pain. Although there has been interest in using oral storax for abdominal pain, there is insufficient reliable information about the clinical effects of storax for this purpose.
• Amenorrhea. Although there has been interest in using oral storax for amenorrhea, there is insufficient reliable information about the clinical effects of storax for this purpose.
• Atopic dermatitis (eczema). Although there has been interest in using topical storax for atopic dermatitis, there is insufficient reliable information about the clinical effects of storax for this purpose.
• Bronchitis. Although there has been interest in using oral or inhaled storax for bronchitis, there is insufficient reliable information about the clinical effects of storax for this purpose.
• Cancer. Although there has been interest in using oral storax for cancer, there is insufficient reliable information about the clinical effects of storax for this purpose.
• Cough. Although there has been interest in using oral or inhaled storax for cough, there is insufficient reliable information about the clinical effects of storax for this purpose.
• Common cold. Although there has been interest in using oral storax for the common cold, there is insufficient reliable information about the clinical effects of storax for this purpose.
• Diarrhea. Although there has been interest in using oral storax for diarrhea, there is insufficient reliable information about the clinical effects of storax for this purpose.
• Epilepsy. Although there has been interest in using oral storax for epilepsy, there is insufficient reliable information about the clinical effects of storax for this purpose.
• Pharyngitis. Although there has been interest in using oral storax for pharyngitis, there is insufficient reliable information about the clinical effects of storax for this purpose.
• Scabies. Although there has been interest in using topical storax for scabies, there is insufficient reliable information about the clinical effects of storax for this purpose.
• Wound healing. Although there has been interest in using topical storax for wound healing, there is insufficient reliable information about the clinical effects of storax for this purpose. More evidence is needed to rate storax for these uses.

(Read more about STORAX)

LIKELY SAFE ...when used orally in amounts commonly found in foods. Damiana has Generally Recognized As Safe status (GRAS) for use in foods in the US (4912).

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts (12,46933,11866).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

(Read more about DAMIANA)

POSSIBLY UNSAFE ...when used orally in excessive amounts. Doses of dried hydrangea rhizome/root greater than 2 grams have been associated with reports of dizziness and a feeling of tightness in the chest (4,12). There is insufficient reliable information available about the safety of hydrangea when used in lower amounts.

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

(Read more about HYDRANGEA)

There is insufficient reliable information available about the safety of poria mushroom.

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

(Read more about PORIA MUSHROOM)

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.

(Read more about SAW PALMETTO)

LIKELY SAFE ...when used orally in amounts commonly found in foods. Storax has Generally Recognized As Safe (GRAS) status for use in foods as a flavoring agent in the US (4912).

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts. There are no published reports of toxicity from oral use in medicinal amounts (6). ...when used topically on small areas of skin (18).

POSSIBLY UNSAFE ...when used orally in large amounts. ...when applied to large open wounds. Systemic absorption can cause poisoning including kidney damage (e.g., albuminuria and hemorrhagic nephritis) (18).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

(Read more about STORAX)

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, damiana may lower blood glucose levels (4,25016). This might increase the risk of hypoglycemia in patients taking antidiabetes drugs.  Details Some antidiabetes drugs include glimepiride (Amaryl), glyburide (Diabeta, Glynase PresTabs, Micronase), insulin, metformin (Glucophage), pioglitazone (Actos), rosiglitazone (Avandia), and others.

(Read more about DAMIANA)

(Read more about HYDRANGEA)

ANTICHOLINERGIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, poria mushroom might decrease the clinical effects of anticholinergic drugs.  Details In animal research, poria mushroom essential oil reduces acetylcholinesterase activity (111917). This interaction has not been shown in humans.

CHOLINERGIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, poria mushroom might have additive effects when used with cholinergic drugs.  Details In animal research, poria mushroom essential oil reduces acetylcholinesterase activity (111917). This interaction has not been shown in humans.

CNS DEPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking poria mushroom extract may enhance the therapeutic and adverse effects of sedatives.  Details Animal research shows that poria mushroom extract has sedative properties (111916). This interaction has not been shown in humans.

(Read more about PORIA MUSHROOM)

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.

(Read more about SAW PALMETTO)

(Read more about STORAX)

General ...Orally, damiana is generally well tolerated. In a rare case, 200 grams of damiana extract has caused tetanus-like convulsions and paroxysms resulting in symptoms similar to rabies or strychnine poisoning (4).

Neurologic/CNS ...Orally, 200 grams of damiana extract has caused tetanus-like convulsions and paroxysms resulting in symptoms similar to rabies or strychnine poisoning (4).

(Read more about DAMIANA)

General ...Orally, hydrangea may cause gastroenteritis, dizziness, and a feeling of tightness in the chest (4).

Cardiovascular ...Orally, hydrangea may cause a feeling of tightness in the chest (4).

Gastrointestinal ...Orally, hydrangea may cause gastroenteritis (4).

Neurologic/CNS ...Orally, hydrangea may cause dizziness (4).

(Read more about HYDRANGEA)

General ...Orally, poria mushroom seems to be well tolerated. However, a thorough evaluation of safety outcomes has not been conducted.

Immunologic ...Allergic reactions have been reported rarely, including allergic rhinitis and allergic asthma (12).

(Read more about PORIA MUSHROOM)

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).

(Read more about SAW PALMETTO)

General ...There is currently a limited amount of information on the adverse effects of sortax. A thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Diarrhea.
Topically: Allergic reactions, skin sensitization.
Serious Adverse Effects (Rare):
Topically: Nephrotoxicity.

Dermatologic ...Topically, storax can cause skin sensitization and contact allergies (9,18).

Gastrointestinal ...Orally, storax can cause diarrhea (18).

Renal ...When applied to large, open wounds, systemic absorption of storax can cause kidney damage g., albuminuria and hemorrhagic nephritis) (18).

(Read more about STORAX)