(1) Associated researchers of the project &quot;Translational study with innovative approaches for dealing with problems related to alcohol use, risk and dependence&quot;. Homeopathy is a CAM modality recognized as medical specialty in Brazil. According to the clinical experience of the early homeopaths, Opium was used to treat patients with alcohol dependence. Aim: to perform a preliminary assessment of the effectiveness and tolerability of fifty-millesimal potencies of Opium in the treatment of alcohol-dependent patients. Methods: exploratory, prospective, open-label trial, with pre-treatment measures as control. Confidence intervals were used to estimate the magnitude of the clinical differences. Results: a total of 14 patients were included, from which 12 were evaluated (intention to treat analysis -ITT). There was a significant reduction in the average daily alcohol consumption (-29.37 units of alcohol/day; 95% CI=10.63; 48.11) and in the severity of alcohol dependence, measured by the mean score of the Short Alcohol Dependence Data questionnaire  95% CI= 4.12; 16.22). No serious adverse events were reported. Randomized controlled studies with larger samples are needed

Amarilys De Toledo Cesar

Ana Elisa Madureira Padula

Fernandes Galduróz

José Carlos

Maristela Schiabel Adler

Ubiratan Cardinalli Adler

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Int J High Dilution Res 2012; 11(38):19-24 
 
 
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Short communication 
Homeopathic potencies of Opium in alcohol 
dependence: exploratory open-label study 
 
Ubiratan Cardinalli Adler1, Ana Elisa Madureira Padula1,  
Amarilys de Toledo Cesar1, Maristela Schiabel Adler1,  
José Carlos Fernandes Galduróz2. 
 
(1) Associated researchers of the project “Translational study with innovative 
approaches for dealing with problems related to alcohol use, risk and dependence”. 
(2) Department of Psychobiology – Federal University of São Paulo, UNIFESP 
 
 
ABSTRACT 
 
Background: The conventional pharmacological options for the treatment of alcoholism are 
limited, which led to the search for solutions in alternative or complementary medicine (CAM). 
Homeopathy is a CAM modality recognized as medical specialty in Brazil. According to the 
clinical experience of the early homeopaths, Opium was used to treat patients with alcohol 
dependence. Aim: to perform a preliminary assessment of the effectiveness and tolerability of 
fifty-millesimal potencies of Opium in the treatment of alcohol-dependent patients.  Methods: 
exploratory, prospective, open-label trial, with pre-treatment measures as control. Confidence 
intervals were used to estimate the magnitude of the clinical differences. Results: a total of 14 
patients were included, from which 12 were evaluated (intention to treat analysis - ITT). There 
was a significant reduction in the average daily alcohol consumption (-29.37 units of alcohol/day; 
95% CI=10.63; 48.11) and in the severity of alcohol dependence, measured by the mean score of 
the Short Alcohol Dependence Data questionnaire (-10.17; 95% CI= 4.12; 16.22). No serious 
adverse events were reported. Randomized controlled studies with larger samples are needed. 
Keywords: alcohol dependence, homeopathy. 
 
Introduction 
Pharmacological interventions for the treatment of alcoholism approved by the United States FDA (Food and 
Drug Administration) include disulfiram and drugs that act on the reward system acamprosate and 
naltrexone. Disulfiram is an irreversible inhibitor of enzyme acetaldehyde-dehydrogenase, which breaks down 
alcohol in the acetaldehyde stage leading to accumulation of acetaldehyde in the organism each time alcohol is 
consumed, and a consequent ethanol-disulfiram reaction that discourages further consumption. It is 
potentially hepatotoxic and thus contraindicated in cases of liver cirrhosis, as portal hypertension may evolve 
to visceral bleeding induced by vomiting, during the ethanol-disulfiram reaction [1]. 
In recent reviews by the Cochrane Collaboration, acamprosate, a glutamate antagonist, and naltrexone, an 
opioid antagonist, showed superior efficacy to placebo in the treatment of alcoholism: for acamprosate, the 
risk of returning to drinking was 86% that of the placebo group (RR 0.86; 95% CI 0.81 – 0.91) [2] and for 
naltrexone, the risk of returning to drinking was 83% of the risk in the placebo group (RR 0.83; 95% CI 0.76 – 
0.90) [3]. The risk of drinking any amount of alcohol did not exhibit statistical significance for naltrexone [4].   
Int J High Dilution Res 2012; 11(38):19-24 
 
 
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The authors considered glutamate and naltrexone to be effective strategies, "even though the sizes of 
treatment effects might appear moderate in their magnitudes, these should be valued against the background 
of the relapsing nature of alcoholism and the limited therapeutic options currently available for its treatment” 
[4,5]. 
Limited conventional therapeutic options for the treatment of alcoholism motivate the search for solutions in 
alternative or complementary medicine (CAM), but studies evaluating CAM in the treatment of substance use 
disorders are still rare [6]. 
Homeopathy is a CAM modality recognized as medical specialty in Brazil. Homeopathic medicines are 
produced through sequential agitated dilutions in decimal (D), centesimal (C) or fifty-millesimal 
(Quinquagintamillesimal, Q or LM) potencies. Homeopathic preparations of opium were recommended by one 
of Hahnemann´s closest disciple - Bönninghausen - to treat alcohol-dependent patients, as repeated doses of 
Opium could lead to a "sort of repugnance to spirituous liquors in general" [7]. However, this observation was 
never tested in clinical trials, which is also relevant on the grounds of the current knowledge about the 
pathophysiology of alcohol compulsion, since if ethanol stimulates the endogenous opioid activity of pleasure 
and reward, and an opioid antagonist inhibits it, perhaps Opium could homeopathically modulate the 
pleasure systems in the brain.     
 
Aim 
The present study sought to perform a preliminary assessment of the effectiveness and tolerability of fifty-
millesimal (Quinquagintamillesimal, Q or LM) potencies of Opium in the treatment of alcohol-dependent 
patients.    
 
Methods  
Design: exploratory, prospective, open-label trial, with pre-treatment measures as control. 
Patients: Patients of both sexes, aged between 18 and 65 years old, diagnosed with alcohol dependence 
according to DSM-IV-TR criteria.  Exclusion criteria: dependence in remission; psychiatric medication, 
except for benzodiazepines and antidepressants; other dependence or substance abuse, except for nicotine.  
Sample size:  14 patients were recruited for this exploratory study.       
Intervention: The fifty-millesimal potencies of Opium were supplied in the form of sucrose pills, to avoid 
giving the patients medication in alcohol solution. They were prepared by fractionated grinding of the starting 
material, followed by sequential dilutions and shaking in ratio 1:50,000 for each step or potency. The first 
level of potency, LM1 or Q1, corresponds to a fraction of 5x10-10 of the initially grinded opium (LM2 = 2.5x10-
15, LM3 = 1,25x10-20, LM4 = 5.25x10-24, and so forth) [8]. Initial dose was one globule on the tongue, three 
times a day, adjusted as needed.  The medications were kindly donated by HN-Cristiano Pharmacy (Santana, 
São Paulo, Brazil).  
Measurements: Primary effectiveness measure:  pre-post treatment difference (week 1 – week 5) in daily 
alcohol consumption, measured in units of alcohol. Secondary end-points: difference in daily alcohol 
consumption between weeks 1, 5 and 7 and in the mean score of the Short - Alcohol Dependence Data (SADD) 
scale[9], between weeks 0, 1, 5 and 7. 
Int J High Dilution Res 2012; 11(38):19-24 
 
 
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Procedures: After one week of pre-treatment observation (week 1), the patients were treated with fifty-
millesimal potencies of Opium in weeks 2, 3, 4 and 5 (Q2, Q3, Q4 and Q5 potencies, respectively). This was 
followed by two weeks of recording consumption, without medication (weeks 6 and 7). Adverse events were 
recorded on each visit.  
Statistical evaluation: Confidence intervals of 95% were calculated for the measurements, both 
individually and between periods, by taking two at a time. These intervals were obtained by Student’s t-
distribution due to the small number of individuals in the study. Unidirectional variance analysis (ANOVA) of 
repeated measures was used with last observation carried forward (LOCF) to compare assessments across 
four time-periods. When significant differences were identified, Bonferroni post hoc test was applied for 
multiple comparisons. The level of significance adopted throughout the study was 5% [9]. 
Ethics : The study was approved by the Research Ethics Committee of UNIFESP (CEP 0413/11).  
 
Results  
Between 09/14/2011 and 11/16/2011, 19 subjects were evaluated and 14 were included; 3 women (21.5%) and 
11 men (78.5%), with average of approximately 15 years of alcohol dependence (15.2 ± 11.8 years). 
Concomitant use of risperidone, fluoxetin, cocaine and complete remission of the alcohol dependence were 
reasons for exclusion. Two subjects, one man and one woman, abandoned the trial in the pre-treatment 
observation week, and were not included in ITT analysis.  Nine patients completed the 7 weeks of the trial.  
The weekly evolution of the mean daily consumption of units of alcohol and weekly SADD scale score, as well 
as the respective confidence intervals, are summarized in Table 1. 
 
Table 1 - Weekly evolution of the daily consumption of Units of Alcohol and of the weekly SADD scale score, 
as well as the respective confidence intervals 
  Units of alcohol SADD weekly score 
 Intervention Mean  (95% CI-limits) Mean  (95% CI-limits) 
week 0 Inclusion - 23.42 (18.64; 28.20) 
week 1 Observation 74.1 (43.31; 104.71) 22.17 (16.14; 28.19) 
week 2 Opium 2 LM 49.01 (20.97; 77.05) 18.75 (11.93; 25.57) 
week 3 Opium 3 LM 47.43 (13.01; 81.84) 14.17 (9.08; 19.26) 
week 4 Opium 4 LM 53.47 (20.12; 86.82) 14.33 (9.18; 19.49) 
week 5 Opium 5 LM 44.64 (11.88; 77.40) 13.25 (8.17; 18.33) 
week 6 Observation 38.44 (4.64; 72.24) 13.33 (7.17; 19.50 
week 7 Observation 40.48 (6.74; 74.22) 15.08 (9.11; 21.05) 
 
The evaluation of the primary efficacy measure showed a clinically significant reduction in alcohol 
consumption between weeks 1 and 5, equivalent to one bottle of distilled alcohol less per day (-29.37 units of 
alcohol/day, 95% CI=10.63; 48.11); this reduction was still significant after two weeks without treatment.  
Int J High Dilution Res 2012; 11(38):19-24 
 
 
22 
 
 The mean basal SADD score of patients in the sample was 23.42, thus placing the studied population in the 
“high dependence” category (score 1-9 = low dependence, 10-19 = medium dependence, 20-45 = high 
dependence [4]). During treatment with homeopathic Opium, the SADD score exhibited significant reduction 
to category “medium dependence” (SADD score from week 0 to week 5 = 10.17; 95% CI=10.63; 48.11). With the 
discontinuance of Opium, this reduction in the dependence score lost statistical significance, suggesting a 
reduction in the medication effect, due to reduction in the placebo effect and/or the specific effect of the 
medication. Adverse events (AE) reported during the 7 weeks are listed in Table 2. No serious AE was 
reported. 
 
Table 2 - Reported adverse events during the 7 weeks of follow up 
Patient code Age (yrs.) Disease duration(yrs.) Adverse Events 
1 25 13 - 
2 31 30 prolonged skin bleeding after external lesion, 
acute diarrhea, tachycardia (patient with liver 
disease) 
3 35 20 nausea, precordial pain, anxiety, headache 
4 38 7 - 
5 41 7 polydypsia, myalgia, insomnia, nightmares, 
anxiety, sadness 
6 46 2 - 
7 46 10 - 
8 47 13 (lost for follow up during week 1) 
9 48 44 - 
10 52 14 - 
11 54 30 - 
12 55 5 eye irritation with bleaching agent 
13 57 8 anxiety, bowel bleeding 
14 59 10 (lost for follow up during week 1) 
 
Given the exploratory nature of the study, the small sample size and the absence of control group, no 
conclusion about the effectiveness of Opium in the treatment of alcohol dependence might be drawn, however, 
these results justify recruiting larger samples to perform for randomized controlled studies. 
 
References 
[1] Castro LA & Baltieri DA. Tratamento farmacológico da dependência do álcool. Rev Bras Psiquiatr 2004; 
26(Supl): 43-46  
[2] Rösner S, Hackl-Herrwerth A, Leucht S, Lehert P, Vecchi S, Soyka M. Acamprosate for alcohol 
dependence. Cochrane Database Syst Rev. 2010;(9):CD004332. 
Int J High Dilution Res 2012; 11(38):19-24 
 
 
23 
 
[3] Rösner S, Hackl-Herrwerth A, Leucht S, Vecchi S, Srisurapanont M, Soyka M. Opioid antagonists for 
alcohol dependence. Cochrane Database Syst Rev. 2010;12:CD001867. 
[4] Raistrick D, Dunbar G, Davidson R. Development of a questionnnaire to measure alcohol dependence.  
British Journal of Addiction. 1983, 78:89-95. 
[5] Johnson RA,  Wichern DW. Applied Multivariate Statistical Analisys, 7. ed. 2008. Prentice Hall, 
Englewood Cliffs. 773 p. 
[6] Dean AJ. Natural and complementary therapies for substance use disorders. Curr Opin Psychiatry 2005; 
18(3):271-276. 
[7] Bönninghausen CFM. Über die Philoposie.  Allgemeine homöopathische Zeitung. Meyer V, Leipsig 1860;  
60(22): 171-174. 
[8] Hahnemann CFS. Organon der Heilkunst: aude sapere.  6.Aufl., hrsg. u. mit Vorw. vers. von Richard 
Haehl, Leipzig, Schwuabe, 1921,  Heidelberg, Haug, 1988 § 246, 248, 270). 
[9] Jorge MR & Mansur J. Questionários padronizados para Avaliação do grau de Severidade da Síndrome de 
Dependência do Álcool. Jornal Brasileiro de Psiquiatria. 1986, 35(5), 287-292. 
 
 
 
 
 
Potências homeopáticas de Opium na dependência do álcool:  
estudo exploratório e aberto. 
 
 
RESUMO 
 
 
Contexto: as opções farmacológicas convencionais para o tratamento do alcoolismo ainda são 
limitadas, contribuindo para a busca de soluções na medicina alternativa ou complementar 
(CAM). A homeopatia é uma modalidade de CAM reconhecida como especialidade médica no 
Brasil. Na experiência clínica dos primeiros homeopatas, Opium era usado no tratamento de 
pacientes com dependência do álcool. Objetivo: avaliação preliminar da efetividade e da 
tolerabilidade de dinamizações homeopáticas de Opium no tratamento de pacientes dependentes 
do álcool.  Métodos: estudo exploratório, prospectivo e aberto, com medidas pré-tratamento como 
controle. Intervalos de confiança foram utillizados para se estimar a magnitude das diferenças 
clínicas. Resultados: 14 pacientes foram incluídos e 12 avaliados  (análise segundo a intenção de 
tratar- ITT). Houve uma redução clinicamente significativa no consumo médio diário de álcool (-
29,37 unidades de álcool/dia, 95% CI=10,63; 48,11) e na severidade da dependência do álcool, 
medida pelo  escore médio do questionário Short Alcohol Dependence Data (-10,17 pontos  95% 
CI= 4,12; 16,22). Não foram relatados ou observados eventos adversos graves. Os resultados 
justificam estudos  maiores, randomizados e controlados. 
 
Palavras-chave: dependência do álcool, homeopatia. 
 
 
 
Int J High Dilution Res 2012; 11(38):19-24 
 
 
24 
 
 
 
Potencias homeopáticas de Opium en alcoholismo: 
 estudio exploratorio abierto 
 
 
RESUMEN 
 
Introducción: Las opciones farmacológicas convencionales para el tratamiento del alcoholismo 
son limitadas, por lo que se busca soluciones en las medicinas alternativas y complementarias 
(MAC). Homeopatía es una modalidad de MAC reconocida como especialidad médica en Brasil. 
Según la experiencia clínica de los primeros homeópatas, se utilizaba Opium en el tratamiento de 
pacientes alcohólicos. Objetivo: Realizar una evaluación preliminar de la efectividad y tolerancia 
de potencias cincuenta-milesimales de Opium en el tratamiento de pacientes alcohólicos. 
Métodos: Estudio prospectivo, exploratorio, abierto con medidas pre-tratamiento como control. 
Fueron utilizados intervalos de confianza para estimar la magnitud de las diferencias clínicas. 
Resultados: 14 pacientes fueron incluidos, de los cuales fueron evaluados 12 (intención de 
tratar). Se observó disminución significativa en el consumo diario de alcohol (-29,37 unidades de 
alcohol/día: IC95%=10,63; 48,11) e en la gravedad del alcoholismo, medida como el promedio del 
puntaje en el Cuestionario Breve de Alcoholismo (-10,12; IC95%= 4,12; 16,22). No fueron 
reportados efectos adversos graves. Son necesarios estudios aleatorizados controlados con 
muestras mayores.  
 
Palabras clave: alcoholismo, homeopatía. 
 
 
 
 
 
 
 Licensed to GIRI.   
Support: authors declare that this study received no funding 
Conflict of interest: authors declare there is no conflict of interest. Opium potencies were provided by HN-Cristiano 
Pharmacy, under the responsibility of Cesar, AT (pharmacist), who has also donated Opium Q-potencies to the public 
health system of São Paulo. 
Received: 02 March 2012; Revised: 21 March 2012; Published: 30 March 2012. 
Correspondence author: José Carlos Fernandes Galduróz, Assistant Professor at the Department of Psychobiology,  
Federal University of São Paulo (UNIFESP), galduroz@psicobio.epm.br.  
How to cite this article Adler UC, Padula AEM, Cesar AT, Adler MS, Galduróz JCF. Homeopathic potencies of Opium in 
alcohol dependence: exploratory open-label study. Int J High Dilution Res [online]. 2012 [cited YYYY Month dd]; 11(38): 
19-24. Available from: http://www.feg.unesp.br/~ojs/index.php/ijhdr/article/view/548/556   


Homeopathic potencies of Opium in alcohol dependence: exploratory open-label study

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Homeopathic potencies of Opium in alcohol dependence: exploratory open-label study

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