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Journal of Integrative Medicine ›› 2018, Vol. 16 ›› Issue (3): 178-184.doi: 10.1016/j.joim.2018.03.004

• Original Clinical Research • Previous Articles     Next Articles

Double-blind evaluation of homeopathy on cocaine craving: A randomized controlled pilot study

Ubiratan Cardinalli Adler a, Ana Carolina Acorinte b, Fernando Oliveira Calzavara b, Adriano Andréda Silva b, Amarilys de Toledo Cesar c, Maristela Schiabel Adler a, Edson Zangiacomi Martinez d, José Carlos Fernandes Galduróz e   

  1. a Department of Medicine, Federal University of Sao Carlos, Washington Luiz 235, Sao Carlos, Sao Paulo 13565-905, Brazil
    b Psychosocial Attention Center for Alcohol and Other Drugs, Sao Sebastiao 3002, Sao Carlos, Sao Paulo 13560-230, Brazil
    c HN Cristiano Homeopathic Laboratory and Pharmacy, Dr. Cesar 212, Sao Paulo, Sao Paulo 02013-001, Brazil
    d Department of Social Medicine, Ribeirão Preto Medical School University of São Paulo, Bandeirantes 3900, Ribeirao Preto, Sao Paulo 14049-900, Brazil
    e Department of Psychobiology, Federal University of Sao Paulo, Napoleao de Barros 925, Sao Paulo, SP 04024-002, Brazil
  • Received:2017-12-03 Accepted:2018-03-05 Online:2018-05-10 Published:2018-03-30
  • Contact: Ubiratan Cardinalli Adler; E-mail: ubiadler@outlook.com

Background
Brazil is among the nations with the greatest rates of annual cocaine usage. Pharmacological treatment of cocaine addiction is still limited, opening space for nonconventional interventions. Homeopathic Q-potencies of opium and Erythroxylum coca have been tested in the integrative treatment of cocaine craving among homeless addicts, but this setting had not proven feasible, due to insufficient recruitment.


Objective

This study investigates the effectiveness and tolerability of homeopathic Q-potencies of opium and E. coca in the integrative treatment of cocaine craving in a community-based psychosocial rehabilitation setting.


Design, setting, participants, and interventions

A randomized, double-blind, placebo-controlled, parallel-group, eight-week pilot trial was performed at the Psychosocial Attention Center for Alcohol and Other Drugs (CAPS-AD), Sao Carlos/SP, Brazil. Eligible subjects included CAPS-AD patients between 18 and 65?years of age, with an International Classification of Diseases-10 diagnosis of cocaine dependence (F14.2). The patients were randomly assigned to two treatment groups: psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca (homeopathy group), and psychosocial rehabilitation plus indistinguishable placebo (placebo group).


Main outcome measures

The main outcome measure was the percentage of cocaine-using days. Secondary measures were the Minnesota Cocaine Craving Scale and 12-Item Short-Form Health Survey scores. Adverse events were reported in both groups.


Results

The study population comprised 54 patients who attended at least one post-baseline assessment, out of the 104 subjects initially enrolled. The mean percentage of cocaine-using days in the homeopathy group was 18.1% (standard deviation (SD): 22.3%), compared to 29.8% (SD: 30.6%) in the placebo group (P?<?0.01). Analysis of the Minnesota Cocaine Craving Scale scores showed no between-group differences in the intensity of cravings, but results significantly favored homeopathy over placebo in the proportion of weeks without craving episodes and the patients’ appraisal of treatment efficacy for reduction of cravings. Analysis of 12-Item Short-Form Health Survey scores found no significant differences. Few adverse events were reported: 0.57 adverse events/patient in the homeopathy group compared to 0.69 adverse events/patient in the placebo group (P?=?0.41).


Conclusions

A psychosocial rehabilitation setting improved recruitment but was not sufficient to decrease dropout frequency among Brazilian cocaine treatment seekers. Psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca were more effective than psychosocial rehabilitation alone in reducing cocaine cravings. Due to high dropout rate and risk of bias, further research is required to confirm our findings, with specific focus on strategies to increase patient retention.


Trial registration

RBR-2xzcwz (http://www.ensaiosclinicos.gov.br).

Key words: Homeopathy, Cocaine-related disorders, Clinical trial, Opium, Erythroxylum coca

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