ABB by Marco Pharma International

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Alopecia areata. Although there has been interest in using oral aconite for alopecia areata, there is insufficient reliable information about the clinical effects of aconite for this purpose.
• Amenorrhea. Although there has been interest in using oral aconite for amenorrhea, there is insufficient reliable information about the clinical effects of aconite for this purpose.
• Asthma. Although there has been interest in using oral aconite for asthma, there is insufficient reliable information about the clinical effects of aconite for this purpose.
• Coronavirus disease 2019 (COVID-19). Although there has been interest in using injectable aconite for COVID-19, there is insufficient reliable information about the clinical effects of aconite for this purpose.
• Diarrhea. Although there has been interest in using oral aconite for diarrhea, there is insufficient reliable information about the clinical effects of aconite for this purpose.
• Heart failure. It is unclear if oral aconite is beneficial in patients with left ventricular failure. Details: Preliminary clinical research in patients with left ventricular failure shows that taking heat processed aconite tuber 1000 mg daily for up to 7 months modestly improves heart and kidney function when compared with placebo (30314).
• Pneumonia. Injectable aconite has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Oral aconite has not been evaluated for this use. Details: A meta-analysis of 20 small, low-quality randomized and non-randomized studies in older Chinese adults with severe pneumonia shows that 77% of patients receiving an injection containing aconite extract 0.1 mg/mL and panax ginseng extract 0.8 mg/mL had improvement in symptoms such as fever, cough, and chest tightness when compared with 61% of those who received standard treatment. This combination injection may also modestly reduce disease severity and the risk of mortality when compared with standard treatment. However, these outcomes were not evaluated in all studies, and dosing regimens were heterogenous, with doses ranging from 60-100 mL daily or twice daily for 7-14 days (110472).
• Raynaud syndrome. Although there has been interest in using oral aconite for Raynaud syndrome, there is insufficient reliable information about the clinical effects of aconite for this purpose. More evidence is needed to rate aconite for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Asthma. Although there is interest in using oral belladonna for asthma, there is insufficient reliable information about the effects of belladonna for this condition.
• Common cold. Although there is interest in using oral belladonna for the common cold, there is insufficient reliable information about the effects of belladonna for this condition.
• Hemorrhoids. Although there is interest in using rectal belladonna for hemorrhoids, there is insufficient reliable information about the effects of belladonna for this condition.
• Irritable bowel syndrome (IBS). It is unclear if oral belladonna is beneficial in patients with IBS. Details: A prescription-only oral combination of belladonna and phenobarbital, first marketed prior to the passing of the Food, Drug, and Cosmetic Act of 1938, is considered an unapproved drug, but is allowed to remain on the market while the FDA evaluates its effectiveness and safety (106908). However, preliminary clinical research suggests that taking a combination of belladonna and phenobarbital orally for one month does not improve symptoms of IBS when compared with placebo (34156).
• Kidney stones (nephrolithiasis). It is unclear if rectal belladonna is beneficial in patients with ureteral spasm associated with kidney stones. Details: A prescription-only rectal combination of belladonna and opium, first marketed prior to the passing of the Food, Drug, and Cosmetic Act of 1938, is considered an unapproved drug, but is allowed to remain on the market while the FDA evaluates its effectiveness and safety (106909). Clinical trials for this indication have not been published, and clinical data are not included in the package insert.
• Parkinson disease. Although there is interest in using oral belladonna for Parkinson disease, there is insufficient reliable information about the effects of belladonna for this condition.
• Rheumatoid arthritis (RA). Although there is interest in using topical belladonna for RA, there is insufficient reliable information about the effects of belladonna for this condition. More evidence is needed to rate belladonna for these uses.

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UNSAFE ...when used orally or topically. Aconite root contains toxic alkaloids that are strong, fast-acting poisons that affect the heart and central nervous system, causing severe arrhythmias, reduced consciousness, and death (15499,19669,30294,30300,30301,30303,30309,30334,30335,30336,92276,104514,106706). All species of this plant are dangerous. Severe poisoning has been reported after ingestion of 0.2-2 mg of aconitine, 1 gram of the raw plant, or 6 grams of processed and cured aconite (3490,104514). Even when a processed product is used, aconite can cause toxicity including nausea, vomiting, dizziness, muscle spasms, hypothermia, paralysis of the respiratory system, and heart rhythm disorders (15499). Aconite can also be absorbed through the skin and cause significant toxicity (12).

PREGNANCY AND LACTATION: UNSAFE
when used orally or topically (15499).

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POSSIBLY UNSAFE ...when used rectally. It is not known whether significant amounts of the toxic alkaloids are absorbed from the rectum (106909). ...when used topically. It is not known whether significant amounts of the toxic alkaloids are absorbed through the skin (106909).

LIKELY UNSAFE ...when used orally. Belladonna contains toxic alkaloids and has been linked to reports of serious adverse effects (12,553,34144).

CHILDREN: LIKELY UNSAFE
when used orally. Fatalities in children may occur at doses of belladonna providing atropine 0.2 mg/kg (34168). Two belladonna berries, which contain 2 mg atropine per fruit, may be lethal for a small child (34144). Severe adverse effects and fatalities have been reported in infants treated with topical homeopathic teething products containing belladonna (17493,34142,34146,93537).

PREGNANCY: LIKELY UNSAFE
when used orally. Belladonna contains toxic alkaloids and has been linked to reports of serious adverse effects (12,553,34144).

LACTATION: LIKELY UNSAFE
when used orally. Belladonna can reduce milk production and is secreted into breast milk (15).

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, combining aconite with other antiplatelet or anticoagulant drugs might increase the risk of bruising and bleeding.  Details Higenamine, a constituent of aconite, is thought to have antiplatelet and antithrombotic effects. In an animal model of thrombosis, higenamine inhibited platelet aggregation and reduced the size of thrombus formation (92282).

STIMULANT DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, combining aconite with other stimulant drugs might alter the effects of the stimulant drug or increase the risk of cardiovascular toxicity.  Details Aconite and its constituents have stimulant effects due to agonist activity at beta-2-adrenoreceptors. In cardiac muscle, aconite appears to have a positive inotropic effect and increases heart rate and blood pressure (2634,15499,30296,92282). However, some constituents of aconite can reduce heart rate and blood pressure (15499,30343).

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ANTICHOLINERGIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Belladonna may increase the risk of adverse effects when used concomitantly with anticholinergic drugs.  Details Belladonna has anticholinergic activity and increases the activity of anticholinergic drugs (2,12).

CISAPRIDE (Propulsid) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, belladonna might reduce the effects of cisapride.  Details Belladonna contains atropine. In vivo evidence suggests that atropine can prevent cisapride from increasing motility in the gastrointestinal tract (25191).

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General ...Orally and topically, aconite is generally regarded as unsafe for use. Any benefits of therapy might not outweigh the risk of toxicity.
Most Common Adverse Effects:
All routes of administration: Serious neurologic, cardiovascular, gastrointestinal, and respiratory adverse effects have been reported.

Cardiovascular ...Orally and topically, aconite can cause hypotension, palpitations, chest tightness, pulmonary edema, arrhythmia, bradycardia, tachycardia, sustained or bidirectional ventricular tachycardia, ventricular fibrillation, and Torsade de pointes (558,559,561,562,563,3490,15499,15650,30294,30295)(30300,30305,30323,30336,92276,92277,92278,104514,106706,110473)(112901). Cardioversion has been reported to be ineffective for the reversal of aconite-induced dysrhythmia, but the use of agents such as amiodarone, lidocaine, and magnesium have been successful in some cases (2634,3490,106706,112901).

Gastrointestinal ...Orally, aconite can cause nausea, vomiting, diarrhea, and gastric pain (563,30297,30341,92277,92278). Topically, aconite can cause nausea and vomiting (92276).

Neurologic/CNS ...Orally, aconite can cause weakness, sweating, restlessness, dizziness, numbness, paresthesia, seizures, and reduced consciousness (558,559,561,562,563,3490,15499,15650,30335,30336,30341,92277,92278,104513). Topically, aconite can cause generalized paresthesia, fatigue, sweating, dizziness and tongue numbness (92276).

Ocular/Otic ...Orally, aconite has been reported to cause visual blurring and yellow-green vision with pupil dilation (30319).

Pulmonary/Respiratory ...Orally, aconite overdose can lead to respiratory failure (104513).

Renal ...Orally and topically, aconite can cause hypokalemia and metabolic and/or respiratory acidosis (558,559,561,562,563,3490,15499,15650).

Other ...Orally and topically, aconite has been reported to cause death in both adults and children (559,3490,3491,30301,30334,30341,92276,92278). In one case report, topical application of aconite to an infant led to cardiogenic shock with multi-organ failure and death (92276). Poisoning has been reported in 15 patients after consuming a homemade liquor containing aconite. Patients presented with tongue or extremity numbness, vomiting, dizziness, or heart palpitations, and 5 died (110471). Death has also been reported in individuals who cooked aconite tubers as vegetables or for health purposes (92278).
The first symptoms of aconite poisoning after oral ingestion of the leaves or root usually occur within 10-90 minutes, although toxicity may be delayed until a second or third dose (559,15499,104513,110471). Recovery time from aconite poisoning ranges from 1.5-2 days for mild intoxication to 7-9 days for patients with cardiovascular complications; fatalities in treated patients are about 5% (15499). Treatment of aconite toxicity is typically supportive, although charcoal hemoperfusion has aided in detoxification (15499,106706).

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General ...Orally, belladonna can cause anticholinergic side effects even at low doses, and is considered poisonous.
Most Common Adverse Effects:
Orally: Anticholinergic side effects, including blurred vision, constipation, delirium, dilated pupils, dizziness, dry mouth, fever, headache, hypertension, muscle rigidity and tremor, psychosis, respiratory failure, and slurred speech.

Cardiovascular ...Orally, belladonna can cause anticholinergic side effects such as hypertension, hypotension, tachycardia, and ventricular premature beats (553,34168,34180).

Dermatologic ...Orally, belladonna can cause anticholinergic side effects such as dry, red skin and decreased perspiration (553,34146,34152). One case of rash and another case of hives have been reported in patients taking belladonna with phenobarbital and ergotamine orally; it is unclear if the adverse effects were due to belladonna or the other ingredients (34154).
Topically, belladonna plaster (Cuxon Gerrard) can cause contact dermatitis (34152).

Gastrointestinal ...Orally, belladonna can cause anticholinergic side effects such as dry mouth and constipation (553,34162,34163,34176,34180,34181).

Genitourinary ...Orally, belladonna can cause anticholinergic side effects such as urinary retention (553,34145,34150,34163).

Neurologic/CNS ...Orally, belladonna can cause anticholinergic side effects such as memory and attention impairment, headache, and confusion (553,34163,34180).

Ocular/Otic ...Orally and topically, belladonna can cause anticholinergic side effects such as dilation of pupils and blurred vision (553,34157,34168,34169,34180). A case report describes anisocoria (unequal pupil sizes) in a 70-year-old female who used homeopathic pink eye relief drops (Similasan) containing belladonna, eyebright, and hepar sulphuris (calcium sulfide) in one eye for 3 days. The pupil dilation lasted more than 2 weeks and did not respond to bright light or pilocarpine (106907). Another report describes a case of acute angle closure glaucoma, requiring referral to an ophthalmologist, in a 55-year-old female who used these eye drops for 2 days (106906).

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