Adverse Effects of Homeopathy

A Systematic Review of Published Case Reports and Case Series

P. Posadzki; A. Alotaibi; E. Ernst

Int J Clin Pract. 2012;66(12):1178-1188.

Abstract and Introduction

Abstract

Aim: The aim of this systematic review was to critically evaluate the evidence regarding the adverse effects (AEs) of homeopathy.

Method: Five electronic databases were searched to identify all relevant case reports and case series.

Results: In total, 38 primary reports met our inclusion criteria. Of those, 30 pertained to direct AEs of homeopathic remedies; and eight were related to AEs caused by the substitution of conventional medicine with homeopathy. The total number of patients who experienced AEs of homeopathy amounted to 1159. Overall, AEs ranged from mild-to-severe and included four fatalities. The most common AEs were allergic reactions and intoxications. Rhus toxidendron was the most frequently implicated homeopathic remedy.

Conclusion: Homeopathy has the potential to harm patients and consumers in both direct and indirect ways. Clinicians should be aware of its risks and advise their patients accordingly.

Introduction

Homeopathy can be defined as 'a therapeutic method that often uses highly diluted preparations of substances whose effects when administered to healthy subjects correspond to the manifestation of the disorder (symptoms, clinical signs and pathological states) in the unwell patient'.^[1] It is one of the most popular form of complementary and alternative medicine in the UK and elsewhere.^[2] The reasons for this widespread use are probably complex, but the assumption that homeopathy is safe is certainly an important factor.^[1]

Although most homeopathic remedies are highly diluted, direct adverse effects (AEs) have been reported.^[3] Indirect risks mainly relate to replacing effective conventional treatments with ineffective homeopathic preparations.^[3,4]

The aim of this systematic review was to provide a summary and critical evaluation of the published evidence regarding direct and indirect AEs associated with homeopathy.

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Abstract and Introduction
Method
Results
Discussion
References
Sidebar

Table 1. Case series and case reports of AEs directly related to homeopathy
Author (year) (Reference)	Study design	Number of patients	Homeopathic remedy (potency)	Concomitant treatment	Adverse event	Possible explanation	Causality	Treatment/clinical outcome
Aberer (1991)⁵	Case series	3	C.1. Peruvian bark and Ipecacuanha (D4) C.2. Unspecified slenderness drops (n.m.) C.3. Unspecified mixture of grass pollen (n.m.)	n.m.	C.1. Pruritus, swelling and erythroderma C.2. Morbiliform and pruritic rash C.3. Anaphylaxis	Allergic reactions*	Almost certain	C1 – Anti-histamines. NFI. C2 – Hospital admission. NFI C3 – ICU admission. Adrenaline, steroids and intravenous fluid supplementation. NFI
Audicana (2001)⁶	Case report	1	Mercurius Heel®S containing Mercurius solubilis Hahnemanni (D10), Hepar sulfuris (D8), Lachesis (D12), Phytolacca (D4), Ailanthus glandulosa (D3), Echinacea angustifolia (D3), Belladonna (D4)	Merbromin	Widespread maculopapular vesicular rash	Allergic reaction/mercury intoxication*	Almost certain	Systemic corticosteroids and antihistamines Post-inflammatory hypopigmentation remained
Aviner (2010)⁷	Case series	11	Gali-col Baby containing Phosphorica, bryonia, Nux-vomica, Cuprum metallicum and Veratrum album (n.m.)	n.m.	ALTE including apnoea, cyanosis, regurgitation, flaccidity or vomiting	Overdosing, toxicity*	Almost certain	Hospital admission. Lumbar puncture, lactate, ammonia, ECG, EEG, brain sonography, gastrografin imaging, and echocardiogram. All fully recovered within 13 days
Barquero,Romero (2004)⁸	Case report	1	Nux vomica and Rhus tox (n.m.)	Glimepiride	Acute pancreatitis, necrosis of the pancreatic head	Unclear†	Likely	ICU admission. Respiratory distress, gastrointestinal bleeding and death after 2 weeks
Bernez (2008)¹⁰	Case report	1	Sedativ PC (6 ingredients in 6CH)	n.m.	DRESS syndrome, severe pulmonary involvement	Hypersensitivity*	Certain	Full recovery
Cardinali (2004)¹¹	Case report	1	1. Rhus Toxicodendron mother tincture (alcohol solution) 2. Rhus Toxicodendron (7CH)	n.m.	Widespread dermatitis, leukocytosis	Allergic reaction*	Certain	Full recovery
Chakraborti (2003)¹²	Case series	3	C.1.& C.3. Arsenic Bromide 1-X (n.m.) C.2. Arsenicum Sulfuratum Flavum-1-X (n.m.)	n.m.	C.1. Melanosis and keratosis, C.2. Skin lesions C.3.Acute gastrointestinal illness, leukopaenia, thrombocytopaenia and diffuse dermal melanosis	Arsenic intoxication*	Almost certain	C1-C2 – Improvement on discontinuation C3 – Toxic polyneuropathy and quadriparesis
Curry (2006)¹⁴	Case report	1	Caesium chloride (n.m.)	Chemotherapy, anaesthetic agents, CoQ10, coral calcium, bovine colostrum, seal oil, multivitamin, vitamin D,	Cardiac arrest	Cesium intoxication* or interactions with anaesthetic agents†	Likely	Full recovery. NFI
Duque-Estrada (2009)¹⁶	Case series	1	Injection of Lilium compositum, Solanum compositum, Thuja, and Tanacetum (n.m.)	n.m.	Hair loss	Unclear*	Almost certain	Complete recovery after 7 months
Farrell (1995)¹⁸	Case report	1	Oral Hypericum perforatuma and Ledum palustre (n.m.)	None	Severe acute tubulointerstinal nephritis	Unclear†	Likely	Hospital admission. Hemodialysis and methylprednisone. Improved renal function after 14 days
Forsman (1991)¹⁹	Case series	2	C.1. a. AKO-PLEX containing: Juglans (D6), Silicea (D12), Antimonium (D12), Arnica (D6), Sarsaparilla (D6), Daisies (D6), Mezereum (D6), Dulcamara (D6) b. Forte Saponaria containing: Gramin jugul., Rhamnus cath., Viola od., Cichor., Cent., Inula, Nastur., Sapon., Scroph. Bellis, Viola tr., Dulcam, Hydrocot, Mezer, Sarsap, Thuja (all at D6) c. OT 10 containing: Sennae, Frangula, Phaseoli, Mentha pip., Rubi, Fucus, Malvae, Taraxacum, Betula alba. C.2. Three different unspecified preparations (n.m.)	n.m.	C.1. Atopic dermatitis C.2. Severe swelling, bleeding and rashes	Allergic reaction*	Likely in both cases	C1 – Hospital admission. Topical steroids and antihistamines. Full recovery within several months. C2 – Hospital admission. NFI
Geukens (2001)²⁰	Case report	1	Aconitum 1000, Baryta carbonica, Cantharis 1000,Gambogia, Pulsatilla, Rhus tox (M and 10 M)	n.m.	Heart disease and bladder cancer	Unclear†	Almost certain	Radiotherapy. Full recovery
Goodyear (1990)²¹	Case report	1	Nine different remedies, including iron and arsenic (both at 6 °C)	n.m.	Hyponatraemia, hypoalbuminaemia, erythaema and limb oedema	Unclear*	Almost certain	Hospital admission. Sodium chloride solution, albumin infusions, intravenous flucloxacillin and benzylpenicillin, potassium permanganate baths, topical corticosteroids and antibiotics. Persistent mild eczema at 4 months follow up
Guha (1999)²²	Case report	1	Tincture of aconite	n.m.	Severe bradycardia, reversible panconduction defect, hypotension and syncope	Aconitum intoxication*	Almost certain	Marked improvement in symptoms within a few hours
Kerr (1986)²⁴	Case report	1	Regeneration Tablets- a mixture of 19 ingredients (n.m.)	n.m.	Pancreatitis, pain, nausea, vomiting	Protoanemonin and saponic glycosides toxicity†	Almost certain	Hospital admission. Conservative treatment. Full recovery after 6 days
Kuenzli (2004)²⁵	Case report	1	Topical and/or oral calcium, sulphur, lycopodium, mercurius, cantharis, rhus toxicodendron, calcium carbonicum, sepia and tuberculinum (n.m.)	None	Bullous pemphigoid, severe asthaenia	Mercury intoxication*	Likely	Oral prednisone and sulfapyridine. Rapid improvement within 2 weeks
Menniti-Ippolito (2008)²⁷	Case series	21	Various remedies-both mono and poly-preparations, including Kalium Bichromicum and Mercurius Sublimatus Corrosivus (from D1)	n.m.	Allergic reactions	Immune allergic reactions, hypersensitivity†	Likely	n.r.
Monk (1986)²⁸	Case report	1	Injection of Nat Mur 200 (n.m.)	n.m.	Acute erythroderma	Unknown*	Likely	ICU admission. n.r.
Montoya-Cabrera (1991)²⁹	Case report	1	Mercurius 6a (D6)	n.m.	Dermatitis, irritability and albuminuria	Mercury intoxication*	Almost certain	D-penicillamine administration. Full recovery
Mortelmans (2004)³⁰	Case report	1	Loco X112 drops (n.m.)	Alcohol and amphetamine	Extreme agitation	Interactions of alcohol, thyroid extract free T3 and T4), diethylpropione, and amphetamine * and†	Likely	Diazepam, propofol. Full recovery
Potier (1998)³¹	Case report	1	Unspecified remedies (n.m.)	n.m. but patients with history of depression, cholecystectomy, neurological and vascularaccidents.	Coma	Bromate intoxication*	Likely	Antibiotics, mucolytics and haemodialysis. Full recovery within 15 days
Prasad (2006)³²	Case report	1	Unspecified remedy (n.m.)	n.m. but patient with a history of neck swelling, cough, haemoptysis, shortness of breath, fever and weight loss	Arsenical keratosis and cancer	Arsenic intoxication*	Likely	Hospital admission. Chemotherapy. Death
Rodriguez-Vico (2009)³³	Case report	1	Petroleum (D5)	Carbamazepine	Tachypnoea, high fever, lower limb areflexia, hypotension, pupillary abnormalities, gait ataxia, cognitive-behavioural disorders	Kerosene intoxication*	Almost certain	Hospital admission. Full recovery within 1-week
Sasseville (1995)³⁴	Case series	2	C.1. Ointment containing Rhus toxicodendron (2CH), Rhododendron ferrugineum (2 CH), Ruta graveolens (2 CH), Ledum palustre (2 CH) C.2. Ointment containing Rhus toxicodendron tincture 4.00 g	History of dermatitis	Allergic dermatitis, perioral swelling and vesiculation	Allergic reactions*	Likely	C1 – Clobetasol 17-propionate. Full recovery within 2 weeks C2 – Oral corticosteroids. Full recovery within 5 days
Stevens (1978)³⁵	Case report	1	Unspecified remedy (n.m.)	None	Migraine, retrosternal oppression, paresthesias, pain, burning sensation,	Thall intoxication*	Likely	Prussian blue and potassium chloride. Full recovery within 1-week
Turkoglu-Raach (2010)³⁶	Case report	1	Notakehl® containing Penicillium chrysogenum (D4)	n.m.	Renal failure with metabolic acidosis, interstitial nephritis and hyperkalaemia	Allergic reaction*and†	Likely	Corticosteroids and hemodialysis. Full recovery
Van Ulsen (1988)³⁷	Case report	1	Pentackan Sinnabaum (D4)	n.m.	Severe exacerbation of eczaema with swelling	Chromium intoxication*	Likely	No improvement.
Von Mach (2006)³⁸	Case series	1070	Unspecified remedies (n.m.)	n.m.	Mostly mild symptoms (no details provided)	Unclear*	Unclear	n.r.
Wille (2010)³⁹	Case report	1	Xylitol containing homeopathic globules	n.m.	Severe metabolic acidosis, weight loss, chronic diarrhoea	Enteral bicarbonate loss*	Likely	ICU admission. Full recovery after 3 months
Zuzak (2010)⁴⁰	Case series	9	C.1.–C.2. Calendula officinalis (mother tincture) C.3. Mater perlarum (D4) C.4. Allium cepa (D4–D15) C.5.–C.6. Chamomile globules (n.m.) C.7. Bach flower rescue drops (n.m.) C.8. Chamomilla (D10), Mercurius (D15), sulphur (D12) C.9. Thujas (mother tincture)	n.m.	C.1. Sneezing, rhinitis; C.2. Slight lethargy; C.3. Emesis; C.4. euphoria; C.5. Abdominal pain, flatulence; C.6. Emesis; C.7.Problem with balance, somnolence; C.8. Pain; C.9. Burning lips, nausea, emesis

AEs, adverse effects; ALTE, apparent life-threatening event; DRESS, drug rash with eosinophilia and systemic symptoms; ECG, electrocardiogram; EEG, electroencephalogram; ICU, intensive care unit; NFI, no further information; n.r., not reported; SB, sinus bradycardia; TdP, torsades de pointes; VF, ventricular fibrillation; C, case.
*As judged by the author of primary report.
†As judged by the present author.

Table 2. Case series and case reports of AEs related to substitution of conventional care with homeopathy
Author (year) (Reference)	Study design	Number of patients	Homeopathic remedy (potency)	Concomitant treatment	Condition	Possible explanation	Causality	Treatment/clinical outcome
Benmeir (1991)⁹	Case report	1	Ointment and unspecified remedies (n.m.)	n.m.	Malignant melanoma	Negligence and lack of CT†,‡	Certain	Surgery. Full recovery after 7 months
Colin (2006)¹³	Case series	2	Lycopodium, Pulsatilla and Sulphur*(CH 15 and 30)	n.m.	Deterioration of pulmonary allergy	Unclear‡	Likely	n.r.
Delaunay (2000)¹⁵	Case report	1	Ledum palustre (5CH) and Malaria officinalis (4 CH)	Conventional prophylactic drugs, NFI	Multiple organ system failure	Parasitaemia†	Certain	ICU admission. Intensive care for 2 months. NFI
Edelson (1999)¹⁷	Case report	1	Unspecified remedy (n.m.)	n.m.	Deterioration of sarcoidosis	Discontinuation of CT†	Almost certain	Hospital admission. Corticosteroids. NFI
Forsman (1991)¹⁹	Case report	1	Unspecified ointment	n.m.	Malignant melanoma	Delayed diagnosis‡	Likely	Unknown
Ibsen (1987)²³	Case series	4	Unspecified remedies (n.m.)	n.m.	C.1.–C.4. Severe aggravation of atopic dermatitis	Discontinuation of CT‡	Likely	ICU admission. Full recovery
Lim (2011)⁴¹	Case series	3	Unspecified remedies (n.m.)	n.m.	C.1. Malnutrition, sepsis and death C.2. Malnutrition and oedema C.3. Seizures	Negligence and lack of CT†, ‡	Certain	Hospital admission. NFI
Luder (2000)²⁶	Case series	3	Unspecified remedies (n.m.)	n.m.	C.1. Pneumococcal pneumonia with purulent pericarditis and coma C.2. Glomerulonephritis, hypertensive heart failure and encephalopathy C.3. haemophilus influenzae meningitis, septicaemia high fever and seizures	Negligence and lack of CT†, ‡	Certain	C.1.Death C.2. Permanent hypertension C.3. Hydrocephalus and neuro-surgical drainage

AEs, adverse effects; ICU, intensive care unit; CT, conventional treatment; NFI, no further information; n.m., not mentioned; C, case.
*The most commonly used.
†As judged by the author of primary report.
‡As judged by the present author.

Appendix. Detailed search strategy for medline
Detailed search strategy for medline
1	(homeop$ or homeop$ or homoop$).ti,ab,tw
2	Exp Homeopathy
3	(adrs or adr or complicat$ or aggravat$ or exacerbat$).ti,ab
4	(safe or safety or risk$ or harm$).ti,ab
5	Side effect$.ti,ab
6	(Adverse ADJ3 (effect$ or event$ or interaction$ or outcome$ or reaction$ or response$)).ti,ab
7	(Undesir$ ADJ3 (effect$ or event$ or interaction$ or outcome$ or reaction$ or response$)).ti,ab
8	(Unexpected ADJ3 (effect$ or event$ or interaction$ or outcome$ or reaction$ or response$)).ti,ab
9	(Uninten$ ADJ3 (effect$ or event$ or interaction$ or outcome$ or reaction$ or response$)).ti,ab
10	(Unwanted ADJ3 (effect$ or event$ or interaction$ or outcome$ or reaction$ or response$)).ti,ab
11	(Serious ADJ3 (effect$ or event$ or interaction$ or outcome$ or reaction$ or response$)).ti,ab
12	(tolerate or tolerability or tolerance or tolerant or hypersensativ$ or allerg$).ti,ab
13	(intolerate or intolerability or intolerance or intolerant).ti,ab
14	(toxic$ or toxin$ or intox$ or Poison$ or noxious or septic$ or hepatotoxic$ or phototoxic$ or nephrotoxic$ or carcinogenic$ or cardiotoxic$ or cytotoxic$ or Genotoxic$).ti,ab
15	(adulterat$ or contaminat$ or interact$ or pollut$).ti,ab
16	(Death$ or fatal$).ti,ab
17	(Overdose or Over-dose).ti,ab.
18	Aftereffect$.ti,ab
19	Reaction$.ti,ab
20	secondary respons$.ti,ab
21	chemically induced.ti,ab
22	Contraindication$.ti,ab
23	sequela$.ti,ab
24	(death ADJ3 sudden$).ti,ab
25	exp drug toxicity
26	Exp postmarketing surveillance
27	Exp Case Report$
28	(Case$ Adj3 (stud$ or report$ or histor$ or series$ or record$)).ti,ab
29	1 or 2 AND 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25 or 26 or 27 or 28