Fundamental Sulfur II [Discontinued] by Douglas Laboratories

POSSIBLY EFFECTIVE

• Osteoarthritis. Most clinical research shows that MSM is modestly beneficial when used alone or in combination with other ingredients. Details: Clinical research shows that taking MSM 1.5-6 grams orally in two to three divided doses daily, either alone or in combination with glucosamine, can modestly improve joint function and some symptoms of osteoarthritis such as pain and swelling (12469,14335,17127,19312). However, MSM does not seem to reduce stiffness or total symptom score (14335). Also, some patients may not consider the modest benefit to be clinically significant (17127). Some clinical research has evaluated MSM in combination with other ingredients. One clinical study in adults with knee osteoarthritis shows that taking MSM 500 mg, glucosamine sulfate 1500 mg, and chondroitin sulfate 1200 mg daily for 12 weeks is associated with greater reductions in pain and osteoarthritis scores when compared with glucosamine sulfate and chondroitin sulfate alone (96447). Clinical studies using combination products containing MSM 5 grams daily and boswellic acid 7.2 mg daily with or without vitamin C (Lignisul, Triterpenol; Artosulfur C, Laborest Italia S.p.A), orally for 60 days show reductions in anti-inflammatory drug use, but conflicting results for pain reduction (19313,96446). Also, one small study suggests that taking a combination of MSM with collagen type II, cetyl myristoleate, lipase, vitamin C, turmeric, and bromelain (AR7 Joint Complex, Robinson Pharma) orally for 12 weeks improves scores for joint pain and tenderness, but does not improve X-rays of affected joints (19314).

POSSIBLY INEFFECTIVE

• Chronic venous insufficiency (CVI). Clinical research suggests that topical MSM is not beneficial in CVI. Details: Clinical research shows that topical application of MSM plus EDTA can reduce the circumference of the calf, ankle, and foot in patients with CVI. However, application of MSM alone appears to increase swelling in these patients (19315).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging skin. It is unclear if oral MSM improves the appearance of aging skin to a clinically meaningful extent. Details: Preliminary clinical research shows that taking MSM (OptiMSM, Bergstrom Nutrition) 3 grams daily for 16 weeks improves facial wrinkles associated with aging by a moderate amount when compared with placebo. When compared with baseline, taking MSM 1 gram daily for 16 weeks is as effective as taking 3 grams for reducing fine lines and wrinkles and improving smoothness, radiance, firmness, and elasticity (102000).
• Allergic rhinitis (hay fever). It is unclear if oral MSM is beneficial in patients with allergic rhinitis. Details: Preliminary clinical research shows that taking MSM (OptiMSM 650 mg) 2600 mg orally for 30 days might relieve some symptoms of seasonal allergic rhinitis when compared with baseline (8574). However, this study lacked blinding and a control group, and also did not provide information on severity of symptoms (12000).
• Alzheimer disease. Although there is interest in using oral MSM for Alzheimer disease, there is insufficient reliable information about the clinical effects of MSM for this condition.
• Androgenic alopecia. Although there is interest in using oral and topical MSM for androgenic alopecia, there is insufficient reliable information about the clinical effects of MSM for this condition.
• Aromatase inhibitor-induced arthralgia. Oral MSM has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with estrogen receptor positive (ER+) breast cancer and aromatase inhibitor-induced arthralgia shows that taking a specific combination product (Opera, GAMFARMA s.r.l) containing MSM 200 mg, boswellia 40 mg, alpha-lipoic acid 240 mg, and bromelain 20 mg once daily for 6 months reduces arthralgia intensity when compared to baseline, with around 22% of patients having complete symptom resolution at the end of the study (109570). The validity of these findings is limited by a lack of control group.
• Asthma. Although there is interest in using oral MSM for asthma, there is insufficient reliable information about the clinical effects of MSM for this condition.
• Athletic performance. It is unclear if topical MSM is beneficial for improving athletic performance. Details: A small clinical study in healthy, physically active adults shows that applying a specific cream containing magnesium and MSM (MagPro, Custom Prescription Shoppe) prior to stretching and pedaling on a stationary bicycle does not appear to improve flexibility or endurance when compared with a placebo cream (19317).
• Chemotherapy-induced peripheral neuropathy. Oral MSM has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults with chemotherapy-induced peripheral neuropathy shows that taking a specific product (OPERA, GAMFARMA s.r.l.) containing MSM 200 mg, alpha-lipoic acid 240 mg, boswellia 40 mg, and bromelain 20 mg daily for 12 weeks reduces overall pain when compared with baseline (96449). The validity of these findings is limited by the lack of a placebo group. Additionally, it is not clear if benefit is associated with MSM, other ingredients, or the combination.
• Chronic fatigue syndrome (CFS). Although there is interest in using oral MSM for CFS, there is insufficient reliable information about the clinical effects of MSM for this condition.
• Chronic obstructive pulmonary disease (COPD). Although there is interest in using oral MSM for COPD, there is insufficient reliable information about the clinical effects of MSM for this condition.
• Constipation. Although there is interest in using oral MSM for constipation, there is insufficient reliable information about the clinical effects of MSM for this condition.
• Diabetes. Although there is interest in using oral MSM for diabetes, there is insufficient reliable information about the clinical effects of MSM for this condition.
• Dyslipidemia. It is unclear if oral MSM is beneficial for dyslipidemia. Details: A very small clinical study in adults with overweight or obesity shows that taking a specific MSM product (OptiMSM, Bergstrom Nutrition) 3 grams daily for 16 weeks modestly increases high-density lipoprotein (HDL) cholesterol when compared with baseline, but not when compared with placebo. Taking MSM also did not improve total cholesterol, low-density lipoprotein (LDL) cholesterol, very-low-density lipoprotein (VLDL) cholesterol, or triglycerides (110572). However, this study may have been underpowered to detect differences between groups.
• Dyspepsia. Although there is interest in using oral MSM for dyspepsia, there is insufficient reliable information about the clinical effects of MSM for this condition.
• Exercise-induced muscle damage. It is unclear if oral MSM is beneficial for preventing exercise-induced muscle damage. Details: Clinical research shows that taking MSM 50 mg/kg in 200 mL water orally daily beginning 10 days prior to a 14-km run can attenuate the increase in creatine kinase (CK) and bilirubin levels caused by exercise-induced muscle damage (19320). However, other clinical research shows that taking MSM (OptiMSM, Bergstrom Nutrition) 3 grams daily beginning 3 weeks prior to a 13.1-mile run and continuing for 2 days after does not reduce muscle or joint pain or alter serum markers of oxidative stress or muscle damage when compared with placebo (96448).
• Hangover. Although there is interest in using oral MSM for hangover, there is insufficient reliable information about the clinical effects of MSM for this condition.
• Hemorrhoids. Topical MSM has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study shows that applying a specific gel containing MSM in combination with hyaluronic acid and tea tree oil (Proctoial, BSD Pharma) for 14 days improves symptoms of hemorrhoids, including pain during defecation, visible bleeding, and inflammation/irritation, when compared with placebo (19318). It is not clear if these effects are due to MSM, the other ingredients, or the combination.
• Insect bite. Although there is interest in using oral MSM for preventing insect bites, there is insufficient reliable information about the clinical effects of MSM for this condition.
• Interstitial cystitis. Although there is interest in using oral MSM for interstitial cystitis, there is insufficient reliable information about the clinical effects of MSM for this condition.
• Muscle cramps. Although there is interest in using oral MSM for muscle cramps, there is insufficient reliable information about the clinical effects of MSM for this condition.
• Obesity. It is unclear if oral MSM is beneficial for obesity. Details: A very small clinical study in adults with overweight or obesity shows that taking a specific MSM product (OptiMSM, Bergstrom Nutrition) 3 grams daily for 16 weeks does not improve body weight, body mass index, waist circumference, or body composition when compared with placebo. (110572). However, this study may have been underpowered to detect differences between groups.
• Osteoporosis. Although there is interest in using oral MSM for osteoporosis, there is insufficient reliable information about the clinical effects of MSM for this condition.
• Periodontitis. Although there is interest in using topical MSM for periodontitis, there is insufficient reliable information about the clinical effects of MSM for this condition.
• Pneumonia. Although there is interest in using oral MSM for pneumonia, there is insufficient reliable information about the clinical effects of MSM for this condition.
• Postoperative pain. Oral MSM has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients who have undergone arthroscopic rotator cuff repair shows that taking a specific combination product (Tenosan, Agave s.r.l.) containing MSM 550 mg, arginine alpha-ketoglutarate 500 mg, collagen peptides 300 mg, apple and grape polyphenols 125 mg, bromelain 40 mg, and vitamin C 60 mg for 3 months can reduce postoperative pain and slightly improve repair integrity (19322). However, improvement in overall functional outcomes was not observed.
• Rheumatoid arthritis (RA). Although there is interest in using oral and topical MSM for RA, there is insufficient reliable information about the clinical effects of MSM for this condition.
• Rosacea. Oral MSM has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with rosacea shows that topical application of a cream containing silymarin and MSM twice daily for one month improves skin redness, papules, itching, hydration, and skin color when compared to baseline (19319). The validity of these findings is limited by the lack of a comparator group.
• Scleroderma. Although there is interest in using oral and topical MSM for scleroderma, there is insufficient reliable information about the clinical effects of MSM for this condition.
• Stretch marks (striae gravidarum). Although there is interest in using topical MSM for stretch marks, there is insufficient reliable information about the clinical effects of MSM for this condition.
• Systemic lupus erythematosus (SLE). Although there is interest in using oral MSM for SLE, there is insufficient reliable information about the clinical effects of MSM for this condition.
• Temporomandibular disorders (TMD). Although there is interest in using oral MSM for TMD, there is insufficient reliable information about the clinical effects of MSM for this condition.
• Tendinopathy. Oral MSM has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with Achilles tendinopathy shows that taking two sachets orally daily of a specific combination product (Tenosan, Agave s.r.l.) each containing MSM 550 mg, arginine alpha-ketoglutarate 500 mg, collagen peptides 300 mg, apple and grape polyphenols (Vinitrox) 125 mg, bromelain 50 mg, and vitamin C 60 mg for 60 days might improve the outcomes of extracorporeal shock wave therapy (ESWT) (19321). However, it is unclear if any benefit is due to MSM, other ingredients, or the combination.
• Wound healing. Although there is interest in using topical MSM for wound healing, there is insufficient reliable information about the clinical effects of MSM for this condition. More evidence is needed to rate MSM for these uses.

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LIKELY EFFECTIVE

• Molybdenum deficiency. Taking or consuming molybdenum can treat or prevent molybdenum deficiency (7135,16478). However, molybdenum deficiency is very rare.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Esophageal cancer. Population research suggests that low intake of molybdenum might be associated with an increased risk of esophageal cancer (16478,17205). However, it is not known if molybdenum supplements reduce the risk of developing esophageal cancer. More information is needed to rate molybdenum for this use.

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POSSIBLY SAFE ...when used orally and appropriately, short term. MSM in doses of 1.5-6 grams daily or 50 mg/kg daily has been used safely in studies lasting up to 6 months (8574,12469,14335,17127,19312,96446,96448,102555). One specific product (OptiMSM, Bergstrom Nutrition) is Generally Recognized As Safe (GRAS) by the United States Food and Drug Administration (FDA) (102555). ...when used topically. Topical cream containing MSM and silymarin, as well as topical gel containing MSM, hyaluronic acid, and tea tree oil, have been used with apparent safety for up to 20 days (19318,19319).

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

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LIKELY SAFE ...when used orally and appropriately. Molybdenum is safe in amounts that do not exceed 2 mg/day, the Tolerable Upper Intake Level (UL) (7135).

POSSIBLY UNSAFE ...when used orally in high doses. Use of molybdenum in doses exceeding the Tolerable Upper Intake Level (UL) of 2 mg/day might not be safe (7135).

CHILDREN: LIKELY SAFE
when used orally and appropriately. Molybdenum is safe in amounts that do not exceed the Tolerable Upper Intake Level (UL) of 0.3 mg/day for children 1 to 3 years, 0.6 mg/day for children 4 to 8 years, 1.1 mg/day for children 9 to 13 years, and 1.7 mg/day for adolescents (7135).

CHILDREN: POSSIBLY UNSAFE
when used orally in high doses. Molybdenum might not be safe when used in doses exceeding the UL of 0.3 mg/day for children 1 to 3 years, 0.6 mg/day for children 4 to 8 years, 1.1 mg/day for children 9 to 13 years, and 1.7 mg/day for adolescents (7135).

PREGNANCY: LIKELY SAFE
when used orally and appropriately. Molybdenum crosses the placenta by passive diffusion and is exchanged freely between the mother and fetus (16482). However, molybdenum is safe when used in amounts that do not exceed the Tolerable Upper Intake Level (UL) of 1.7 mg/day for women 14 to 18 years, or 2 mg/day for women 19 years of age and older (7135).

PREGNANCY: POSSIBLY UNSAFE
when used orally in high doses. Molybdenum might not be safe during pregnancy when used in doses exceeding the UL of 1.7 mg/day for women 14 to 18 years, or 2 mg/day for women 19 and older (7135).

LACTATION: LIKELY SAFE
when used orally and appropriately. Molybdenum is safe when used in amounts that do not exceed the Tolerable Upper Intake Level (UL) of 2 mg/day for breast-feeding women 19 years of age or older, or 1.7 mg/day for breast-feeding women ages 14 to 18 years (7135).

LACTATION: POSSIBLY UNSAFE
when used orally in high doses. Molybdenum might not be safe when used in doses exceeding the UL of 2 mg/day for breast-feeding women 19 or older, or 1.7 mg/day for breast-feeding women ages 14 to 18 years (7135).

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General ...Orally, MSM is generally well tolerated.
Most Common Adverse Effects:
Orally: Bloating, diarrhea, gastrointestinal discomfort, nausea.

Dermatologic ...In rare cases, MSM has caused pruritus when taken orally (8574).

Gastrointestinal ...Orally, MSM may cause mild gastrointestinal discomfort, nausea, bloating, and diarrhea (8574,12469).

Immunologic ...Orally, MSM may increase allergy symptoms (8574).

Neurologic/CNS ...Orally, MSM may cause headache, fatigue, insomnia, and difficulty concentrating (8574,14335).

Ocular/Otic ...In a case report, a 35-year-old female presented with bilateral acute angle closure glaucoma, which resolved 4 days after discontinuing a multi-ingredient product. Although the product contained over 35 vitamins, minerals, and other ingredients, only MSM contained sulfur, which the authors suggest acted like a sulfa-drug to cause acute angle closure glaucoma (90613).

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General ...Orally, molybdenum is well tolerated when used appropriately in amounts that do not exceed the Tolerable Upper Intake Level (UL) of 2 mg/day (7135). People living in an area of Armenia with a very high dietary molybdenum intake of 10 to 15 mg/day due to high local soil levels have reported an increased incidence of hyperuricemia, gout, and arthralgias (7135,16478,16487). Environmental exposure to molybdenum has been reported to cause pneumoconiosis (63365,63547,63510) and to reduce testosterone levels and sperm concentration in men (63482,63484).
Molybdenum is present in some stainless steel angioplasty stents. In some case reports, patients with these stents can develop a contact allergy to molybdenum, which might increase the risk for restenosis of the stented artery (16485).

Genitourinary ...Environmental exposure to molybdenum has been reported to be a reproductive toxicant in men. Circulating levels of molybdenum are inversely associated with testosterone levels and sperm concentration (63482,63484).

Hematologic ...Orally, in an area of Armenia, a very high dietary molybdenum intake of 10 to 15 mg/day due to high local soil levels has resulted in an increased incidence of hyperuricemia (7135,16478,16487). The mechanism likely involves increased xanthine oxidase activity, leading to increased uric acid production (2663).

Immunologic ...Molybdenum is present in some stainless steel angioplasty stents. Multiple cases report on patients with these stents who have developed a contact allergy to molybdenum, as indicated by positive skin patch tests. It is suggested that this increases the risk for restenosis of the stented artery (16485).

Musculoskeletal ...Orally, in an area of Armenia, a very high dietary molybdenum intake of 10 to 15 mg/day due to high local soil levels has resulted in an increased incidence of hyperuricemia, gout, and arthralgias (7135,16478,16487). There is also a case report of gout in a man with industrial exposure to molybdenum metal dust (16480). The mechanism likely involves increased xanthine oxidase activity, leading to increased uric acid production (2663).

Neurologic/CNS ...In one case report of a man in his late thirties, dietary supplementation with molybdenum 300-800 micrograms daily for a cumulative dose of 13. 5 mg over 18 days resulted in acute psychosis with visual and auditory hallucinations, petit mal seizures, and a life-threatening grand mal attack, related to frontal cortical damage. Chelation therapy with calcium ethylene diamine tetraacetic acid (CaEDTA) was required. A year later, the man was diagnosed with toxic encephalopathy with executive deficiencies, learning disability, major depression, and post-traumatic stress disorder (63368).

Psychiatric ...In one case report of a man in his late thirties, dietary supplementation with molybdenum 300-800 micrograms daily for a cumulative dose of 13. 5 mg over 18 days resulted in acute psychosis with visual and auditory hallucinations, petit mal seizures, and a life-threatening grand mal attack, related to frontal cortical damage. Chelation therapy with calcium ethylene diamine tetraacetic acid (CaEDTA) was required. A year later, the man was diagnosed with toxic encephalopathy with executive deficiencies, learning disability, major depression, and post-traumatic stress disorder (63368).

Pulmonary/Respiratory ...Pneumoconiosis has been reported with excessive intake of molybdenum or exposure in the workplace (63365,63547,63510).

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