Liv52 tablets by The Himalaya Drug Company

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. Topical black nightshade has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small study in young adults with facial acne suggests that application of a cream containing black nightshade leaf 0.8%, elecampane flower and leaf 0.8%, and red soapwort root 0.32%, 2 to 3 times daily for 6 weeks, reduces acne severity index scores by 55%, 85%, and 91% from baseline at 2, 5, and 6 weeks, respectively, compared with no change in the placebo group (105733). It is unclear if this effect is due to black nightshade, other ingredients, or the combination. The poor study methodology and lack of statistical comparison to the placebo group limit the validity of these findings.
• Cirrhosis. Although there is interest in using oral black nightshade for cirrhosis, there is insufficient reliable information about the clinical effects of black nightshade for this condition.
• Herpes zoster (shingles). Although there is interest in using topical black nightshade for shingles, there is insufficient reliable information about the clinical effects of black nightshade for this condition. More evidence is needed to rate black nightshade for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Diabetes. Preliminary clinical research shows that taking caper fruit extract 400 mg three times daily for 2 months reduces fasting blood glucose by 20 mg/dL and improves glycated hemoglobin (HbA1c) by 0.4% when compared to baseline in patients with type 2 diabetes who are already taking antidiabetes drugs. These improvements were significant when compared with the placebo group. Patients taking caper fruit extract also showed improvements in triglyceride levels but not cholesterol levels (96124). However, preliminary clinical research in adults with inadequately controlled type 2 diabetes and metabolic syndrome shows that taking caper fruit extract in a solution of grape vinegar and lactulose for 3 months does not reduce fasting blood glucose, HbA1c, or plasma lipid levels. However, it modestly decreases body weight and body mass index (BMI) when compared to control (101895). More evidence is needed to rate capers for this use.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Breast cancer-related hot flashes. Oral chicory has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A moderate-sized clinical study of breast cancer survivors who use estrogen deprivation therapy shows that taking 5 mL of chicory and fumitory syrup 3 times daily for 4 weeks significantly decreases the frequency and severity of hot flashes when compared with placebo. Hot flash frequency and severity were both reduced by around 57% in the treatment group, as compared with a 10% reduction in the placebo group (110724). The use of a per-protocol analysis limits the validity of these findings. Additionally, it is unclear if these findings are due to chicory, fumitory, or the combination. Cancer. Although there has been interest in using oral chicory for the treatment or prevention of cancer, there is insufficient reliable information about the clinical effects of chicory for this purpose.
• Constipation. Although there has been interest in using oral chicory for constipation, there is insufficient reliable information about the clinical effects of chicory for this purpose.
• Diabetes. Although there has been interest in using oral chicory for diabetes, there is insufficient reliable information about the clinical effects of chicory for this purpose.
• Dyspepsia. Although there has been interest in using oral chicory for dyspepsia, there is insufficient reliable information about the clinical effects of chicory for this purpose.
• Hyperlipidemia. Although there has been interest in using oral chicory for hyperlipidemia, there is insufficient reliable information about the clinical effects of chicory for this purpose.
• Hypertension. Although there has been interest in using oral chicory for hypertension, there is insufficient reliable information about the clinical effects of chicory for this purpose.
• Neonatal jaundice. It is unclear if oral chicory solution is beneficial in neonates with jaundice. Details: A moderate-sized clinical study of nursing mothers shows that taking 50 mL of chicory 10% distillate every 12 hours for 3 days reduces bilirubin levels of breastfed neonates with jaundice by around 0.3 mg/dL when compared with placebo (110723). However, it is unlikely that these findings are clinically significant.
• Nonalcoholic fatty liver disease (NAFLD). It is unclear if oral chicory seed is beneficial in patients with NAFLD. Details: A small clinical trial in patients with NAFLD shows that taking chicory seed 9 grams infused in hot water daily for 12 weeks reduces body mass index (BMI) by 0.66 kg/m2 when compared with placebo. When combined with turmeric 3 grams daily, serum alkaline phosphatase was decreased. Although levels of other liver enzymes decreased when compared to baseline, changes were not significant when compared with placebo. Also, taking chicory seed did not affect plasma lipid levels (102350).
• Osteoarthritis. It is unclear if oral chicory root extract is beneficial in patients with osteoarthritis. Details: A small clinical study in patients with knee or hip osteoarthritis shows that taking chicory root extract 600 mg three times daily for 3 months does not improve pain, stiffness, or functional ability when compared with placebo (93647). However, this small study was likely underpowered to detect differences between groups. More evidence is needed to rate the effectiveness of chicory for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Angina. It is unclear if oral Terminalia arjuna is beneficial in patients with angina. Details: Low-quality clinical research in patients with angina shows that taking Terminalia arjuna extract 500-2000 mg orally daily for 3 months reduces the frequency of angina symptoms by 50% to 71% when compared with baseline. These results were similar to taking conventional therapy (2502,2503). Other preliminary research in adults with chronic stable angina shows that taking Terminalia arjuna 500 mg orally three times daily for 7 days reduces the need for rescue treatment and improves exercise tolerance when compared with placebo. Improvements were similar to taking isosorbide mononitrate 20 mg twice daily (92833).
• Asthma. Although there has been interest in using oral Terminalia arjuna for asthma, there is insufficient reliable information about the clinical effects of Terminalia arjuna for this purpose.
• Athletic performance. It is unclear if oral Terminalia arjuna is beneficial for athletic performance. Details: A small clinical study in young regular exercising males shows that taking Terminalia arjuna extract (Oxyjun, Enovate Biolife Pvt Ltd, India) 400 mg daily for 8 weeks increases the time to exhaustion by approximately 117 seconds when compared with placebo. There were also modest improvements in feelings of perceived exertion and the left ventricular ejection fraction, a measure of blood pumped from the heart with each heartbeat (111093). It is unclear if oral Terminalia arjuna is beneficial other populations such as athletes and females.
• Coronary heart disease (CHD). It is unclear if oral Terminalia arjuna is beneficial in patients with CHD. Details: Preliminary clinical research in patients with CHD shows that taking Terminalia arjuna bark powder 500 mg orally daily for 30 days decreases levels of total cholesterol by about 10% and low-density lipoprotein (LDL) cholesterol by about 16% when compared with baseline. Taking Terminalia arjuna bark powder did not improve high-density lipoprotein (HDL) cholesterol levels (92832).
• Heart failure. The effects of Terminalia arjuna in patients with heart failure is unclear; evidence to date comes from small, short-term clinical studies, and results are conflicting. Details: Preliminary, low-quality clinical research in patients with severe, refractory congestive heart failure shows that taking Terminalia arjuna bark extract 500 mg orally three times daily for 2 weeks, as an adjunct to conventional therapy, improves left ventricular ejection fraction (LVEF) by 17% when compared with placebo (2504). However, other preliminary clinical research in adults with stage II heart failure shows that taking an extract of Terminalia arjuna bark 750 mg orally twice daily as an adjunct to conventional therapy for 12 weeks does not improve LVEF, functional class, or functional capacity when compared with placebo (96726). However, the validity of these trials is limited by short-term treatment and variation in the conventional therapies used to manage heart failure.
• Hyperlipidemia. It is unclear if oral Terminalia arjuna is beneficial for improving lipid levels. Details: Preliminary clinical research in patients with elevated cardiovascular risk factors, such as hypertension, dyslipidemia, or obesity, shows that taking Terminalia arjuna 5 grams orally twice daily for 60 days decreases levels of low-density lipoprotein (LDL) cholesterol and triglycerides by 17% and 35%, respectively, and increases high-density lipoprotein (HDL) cholesterol levels by 9%, when compared with baseline. Improvements in lipid parameters were similar to taking amlodipine 5 mg and atorvastatin 10 mg daily (109677). However, this study may have been inadequately powered to detect a difference between groups.
• Hypertension. It is unclear if oral Terminalia arjuna is beneficial for reducing blood pressure. Details: Preliminary clinical research in patients with elevated cardiovascular risk factors such as hypertension, dyslipidemia, or obesity, shows that taking Terminalia arjuna 5 grams orally twice daily for 60 days reduces systolic and diastolic blood pressure by 11% and 14%, respectively, when compared with baseline. Improvements in blood pressure were similar to taking amlodipine 5 mg and atorvastatin 10 mg daily (109677). However, this study may have been inadequately powered to detect a difference between groups.
• Obesity. It is unclear if oral Terminalia arjuna is beneficial for weight loss. Details: Preliminary clinical research in patients with elevated cardiovascular risk factors, such as hypertension, dyslipidemia, or obesity, shows that taking Terminalia arjuna 5 grams orally twice daily for 60 days reduces body mass index (BMI) by 6% when compared with baseline. Improvements in BMI were similar to taking amlodipine 5 mg and atorvastatin 10 mg daily (109677). This study may have been inadequately powered to detect a difference between groups. More evidence is needed to rate Terminalia arjuna for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Atopic dermatitis (eczema). Although there is interest in using topical yarrow for atopic dermatitis, there is insufficient reliable information about the clinical effects of yarrow for this condition.
• Dysmenorrhea. It is unclear of oral yarrow tea is beneficial for improving symptoms of dysmenorrhea. Details: Preliminary clinical research in patients with moderate to severe dysmenorrhea shows that drinking a tea made with yarrow 4 grams three times daily for the first three days of two menstrual cycles modestly reduces dysmenorrhea pain when compared with a placebo tea (105361).
• Gingivitis. A mouthwash containing yarrow has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that using a mouthwash containing a combination of yarrow, juniper, and stinging nettle for 3 months does not improve dental plaque or gingivitis in patients with gingival inflammation when compared with a control group (76443).
• Irritable bowel syndrome (IBS). Oral yarrow has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with mild to moderate IBS shows that taking a capsule containing yarrow, ginger, and Boswellia serrata three times daily for 30 days improves pain by 46% and gastrointestinal symptoms by 60% when compared with placebo. Patients also experienced an improvement in overall mood when compared with placebo (96673). It is not clear if these effects are due to yarrow, the other ingredients, or the combination.
• Multiple sclerosis (MS). It is unclear if oral yarrow is beneficial for patients with MS. Details: A small clinical study in adults with relapsing-remitting MS shows that taking yarrow whole plant extract 250 mg or 500 mg daily in conjunction with conventional treatments for 12 months reduces the annual relapse rate and increases time to first relapse when compared with placebo. Taking yarrow 500 mg daily also reduced disability scores and improved functional scores when compared with either yarrow 250 mg daily or placebo (100346). However, most of the patients enrolled in the study were under 40 years of age, with undefined disease severity.
• Nipple fissures. It is unclear if topical yarrow is beneficial for patients with nipple fissures. Details: Preliminary clinical research in patients with inflamed nipples and/or nipple fissures shows that topical application with yarrow twice daily after breastfeeding for 7 days reduces redness and pain when compared with baseline. Yarrow 30 grams was boiled in 1 liter of water for 10 minutes. The benefits seen with yarrow were not significantly different from topical mountain honey or breast milk, both of which were also beneficial when compared with baseline (105359).
• Oral mucositis. It is unclear if gargling with yarrow is beneficial for oral mucositis. Details: Preliminary clinical research in patients with chemotherapy-induced oral mucositis shows that gargling with 15 mL of a routine solution containing yarrow distillate 50%, 4 times daily for 14 days, reduces symptom severity by 87%, compared with a worsening in severity in those using the routine solution alone. Of those using yarrow, all patients were able to eat solid foods at 14 days compared with about 40% of those using routine treatment alone. About 3.75 grams of yarrow flower was needed for each 7.5 mL of distillate and the solution was held for 3 minutes in the mouth before gargling (106664). It is unclear if the patients were adequately blinded, as the taste of the two solutions may have differed.
• Tonsillitis. Oral yarrow has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in children 6-18 years of age with acute non-bacterial tonsillitis shows that taking a specific combination product (Imupret, Bionorica AG) containing yarrow and six other herbal ingredients along with standard care reduces the severity of tonsillitis symptoms when compared with standard care alone. Additionally, taking this combination product improved physician- and patient-rated assessments of general condition when compared with standard care alone (100347). It is not clear if these effects are due to yarrow, other ingredients, or the combination.
• Vaginal candidiasis. It is unclear if intravaginal yarrow is beneficial for vaginal candidiasis. Details: Clinical research in patients with vulvovaginal candidiasis shows that intravaginal application of 5 grams of a cream containing yarrow extract 2% for 7 days modestly reduces Candida growth and improves vulvar erythema and other general symptoms when compared with baseline. However, the cream was less effective overall than vaginal clotrimazole 1% cream (105360).
• Wound healing. It is unclear if topical yarrow is beneficial for wound healing. Details: Clinical research in postpartum adults who have had an episiotomy shows that applying approximately 1 cm of an ointment containing yarrow 5% over the clean and dried suture area twice daily for ten days reduces perineal pain, redness, and edema 1-2 weeks after the procedure when compared with placebo ointment or no treatment. However, using the yarrow ointment did not affect discharge time or reduce the occurrence of dehiscence (96910). More evidence is needed to rate yarrow for these uses.

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LIKELY UNSAFE ...when the unripe berries or foliage are used orally (4009,106095). There is insufficient reliable information available about the safety of ripe black nightshade berries when used orally or any part of the black nightshade plant when used topically.

PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally because of concerns it could be teratogenic (4009); avoid using.

(Read more about BLACK NIGHTSHADE)

LIKELY SAFE ...when used orally in amounts commonly found in foods (4912). The pickled flower buds are commonly used without reports of adverse effects.

POSSIBLY SAFE ...when the fruit extract is used orally in medicinal amounts, short-term. Caper fruit extract has been used with apparent safety in doses of up to 3 grams daily for up to 3 months (96124,101895). There is insufficient reliable information available about the safety of capers when used topically.

PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of capers used in medicinal amounts during pregnancy and lactation; avoid using.

(Read more about CAPERS)

LIKELY SAFE ...when consumed in amounts commonly found in food. Chicory and chicory extract have Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when used orally in medicinal amounts, short-term. Chicory root extract has been used with apparent safety at doses of 600 mg three times daily for one month (93647). Chicory seed has been used with apparent safety as a hot water infusion of 4.5 grams twice daily for 12 weeks (102350). There is insufficient reliable information available about the safety of chicory when used orally, long-term, or when used topically.

PREGNANCY: POSSIBLY UNSAFE
when used orally in excessive amounts. Chicory may induce menstruation or miscarriage (19).

LACTATION:
Insufficient reliable information available; avoid using.

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POSSIBLY SAFE ...when used orally and appropriately, short-term. Several small studies have used Terminalia arjuna powdered bark or bark extract with apparent safely in doses up to 2000 mg or 400 mg daily, respectively, for 2 weeks to 3 months (2502,2503,2504,111012,111093); however, patients should avoid self-treatment with this product due to potentially significant cardiovascular effects. Further study is needed to determine the safety of Terminalia arjuna for long-term use.

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

(Read more about TERMINALIA ARJUNA)

LIKELY SAFE ...when used orally in amounts commonly found in foods. Yarrow products that are thujone-free have Generally Recognized As Safe (GRAS) status for use in foods in the US (4912); however, products containing thujone might not be safe. Thujone is a chemical that stimulates the central nervous system and is poisonous in large doses.

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts (2,12,100346). Yarrow whole plant extract has been used with apparent safety at a dose of 250-500 mg daily for 12 months (100346). ...when used intravaginally as a cream containing yarrow extract 2% daily for 7 days (105360). There is insufficient reliable information available about the safety of yarrow when applied topically.

PREGNANCY: LIKELY UNSAFE
when used orally; yarrow is believed to be an abortifacient and affect the menstrual cycle (12).

LACTATION:
Insufficient reliable information available; avoid use.

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ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Some preliminary clinical research shows that taking caper fruit extract 1200 mg daily for 2 months can lower fasting blood glucose and glycated hemoglobin (HbA1c) in patients with type 2 diabetes who are already taking antidiabetes drugs (96124). However, other research does not support this effect (101895). Until more is known, monitor blood glucose levels closely. Medication dose adjustments may be necessary.  Details Some antidiabetes drugs include glimepiride (Amaryl), glyburide (DiaBeta, Glynase PresTab, Micronase), insulin, pioglitazone (Actos), rosiglitazone (Avandia), and others.

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ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, chicory might increase the risk of hypoglycemia when taken with antidiabetes drugs.  Details Animal and in vitro research shows that chicory extracts have antidiabetic effects (93650,108543).

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use of Terminalia arjuna with anticoagulant or antiplatelet drugs may increase the risk of bleeding in some patients.  Details In vitro, Terminalia arjuna bark extract inhibits platelet aggregation, decreases platelet activation, and shows antithrombotic properties (92831).

CYTOCHROME P450 2C9 (CYP2C9) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, use of Terminalia arjuna may increase the levels and clinical effects of CYP2C9 substrates.  Details In vitro research shows that Terminalia arjuna extract inhibits CYP2C9 enzymes and reduces CYP2C9 substrate metabolism (96729).

CYTOCHROME P450 2D6 (CYP2D6) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, use of Terminalia arjuna may increase the levels and clinical effects of CYP2D6 substrates.  Details In vitro research shows that Terminalia arjuna extract inhibits CYP2D6 enzymes and reduces CYP2D6 substrate metabolism (96729).

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, use of Terminalia arjuna may increase the levels and clinical effects of CYP3A4 substrates.  Details In vitro research shows that Terminalia arjuna extract inhibits CYP3A4 enzymes and reduces CYP3A4 substrate metabolism (96729).

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LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, taking yarrow with lithium might increase the levels and adverse effects of lithium.  Details Animal research shows that yarrow has diuretic activity (106018). Theoretically, due to these potential diuretic effects, yarrow might reduce excretion and increase levels of lithium. The dose of lithium might need to be decreased.

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General ...Orally or topically, a thorough evaluation of safety outcomes related to the medicinal use of black nightshade has not been conducted. However, the unripe berries and foliage of black nightshade can cause toxicity due to solanine content.

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General ...Orally, capers seem to be well tolerated. No adverse effects have been reported in clinical research (96124); however, a high-quality assessment of safety has not been conducted. Topically, capers can cause contact dermatitis (12742).

Dermatologic ...Topically, capers can cause contact dermatitis (12742).

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General ...Orally, chicory seems to be well tolerated.
Most Common Adverse Effects:
Orally: Abdominal pain, belching, bloating, and flatulence.

Dermatologic ...Occupational exposure to chicory may cause skin rash, contact dermatitis, or generalized pruritus (41609,93649). The sesquiterpene lactones of the plant may be the allergens (41609). Chicory may cause an allergic reaction in individuals sensitive to the Asterceae/Compositae family (25416). Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs.

Gastrointestinal ...Orally, fructo-oligosaccharides, such as those extracted from chicory, can cause flatulence, belching, abdominal pains, intestinal sounds and bloating, which occur commonly, but are mild at doses of 10 grams daily (740,745,750,8509,93716).

Immunologic ...Occupational exposure to chicory may cause allergic reactions. Dyspnea and anaphylaxis have also been reported in a patient with regular occupational exposure to chicory. This patient also experienced contact dermatitis and generalized pruritus (93649).

Pulmonary/Respiratory ...Occupational exposure to chicory may cause asthma and rhinoconjunctivitis (41617,93648). Dyspnea and anaphylaxis have also been reported in a patient with regular occupational exposure to chicory. This patient also experienced contact dermatitis and generalized pruritus (93649).

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General ...There is currently a limited amount of information available on the adverse effects of oral Terminalia arjuna. A thorough evaluation of safety outcomes has not been conducted.

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General ...Orally and intravaginally, yarrow seems to be well tolerated.
Most Common Adverse Effects:
Topically: Dermatitis.

Dermatologic ...Topically, yarrow can cause atopic or allergic dermatitis or urticaria due to its sesquiterpene lactone content (52558,68385,77007). Yarrow has also been reported to cause phototoxic and photo-allergic dermatitis and airborne contact dermatitis (68385).
Intravaginally, aggravated facial acne was reported by 1 of 40 patients in a clinical trial (105360).

Endocrine ...Intravaginally, an early menses was reported by 1 of 40 patients in a clinical trial (105360).

Genitourinary ...Intravaginally, aggravated vaginal pruritus and dryness were reported by 1 of 40 patients in a clinical trial (105360).

Immunologic ...Topically, yarrow can cause atopic or allergic dermatitis or urticaria due to its sesquiterpene lactone content (52558,68385,77007,96911). It has also been reported to cause phototoxic and photo-allergic dermatitis and airborne contact dermatitis (68385). In one 44-year-old female, handling yarrow flowers resulted in rhinitis and asthma (96911).

(Read more about YARROW)