Search JIM Advanced Search

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

[1] Pratya Phetkate, Tanawan Kummalue, Prasob-orn Rinthong, Somboon Kietinun, Kusuma Sriyakul. Study of the safety of oral Triphala aqueous extract on healthy volunteers. Journal of Integrative Medicine, 2020, 18(1): 35-40.
[2] Mikhail Teppone. Medicine has always been “Modern” and “Scientific” from ancient times to the present day. Journal of Integrative Medicine, 2019, 17(4): 229-237.
[3] Arthur Yin Fan, Hui Ouyang, Xinru Qian, Hui Wei, David Dehui Wang, Deguang He, Haihe Tian, Changzhen Gong, Amy Matecki, Sarah Faggert Alemi. Discussions on real-world acupuncture treatments for chronic low-back pain in older adults. Journal of Integrative Medicine, 2019, 17(2): 71-76.
[4] L. Elisabeth Burton, Fares Qeadan, Mark R. Burge. Efficacy of equine-assisted psychotherapy in veterans with posttraumatic stress disorder. Journal of Integrative Medicine, 2019, 17(1): 14-19.
[5] Shubha Singhal, Vandana Roy. Awareness, practice and views about integrating AYUSH in allopathic curriculum of allopathic doctors and interns in a tertiary care teaching hospital in New Delhi, India. Journal of Integrative Medicine, 2018, 16(2): 113-119.
[6] Shahnaz Karkon Varnosfaderani, Fataneh Hashem-Dabaghian, Gholamreza Amin, Mahbubeh Bozorgi, Ghazaleh Heydarirad, Esmaeil Nazem, Mohsen Nasiri Toosi, Seyed Hamdollah Mosavat. Efficacy and safety of Amla (Phyllanthus emblica L.) in non-erosive reflux disease: A double-blind, randomized, placebo-controlled clinical trial. Journal of Integrative Medicine, 2018, 16(2): 126-131.
[7] Abdolali Moosavyzadeh, Farzaneh Ghaffari , Seyed Hamdollah Mosavat, Arman Zargaran, Azarakhsh Mokri, Soghrat Faghihzadeh, Mohsen Naseri. The medieval Persian manuscript of Afyunieh: The first individual treatise on the opium and addiction in history. Journal of Integrative Medicine, 2018, 16(2): 77-83.
[8] Maryam Sharifi-Ardani, Leili Yekefallah, Saeed Asefzadeh, Marjan Nassiri-Asl. Efficacy of topical chamomile on the incidence of phlebitis due to an amiodarone infusion in coronary care patients: A double-blind, randomized controlled trial. Journal of Integrative Medicine, 2017, 15(5): 373-378.
[9] Salvatore Chirumbolo, Geir Bjørklund. Homeopathic potencies of Arnica montana L. change gene expression in a Tamm-Horsfall protein-1 cell line in vitro model: The role of ethanol as a possible confounder and statistical bias. Journal of Integrative Medicine, 2017, 15(4): 255-264.
[10] Saeed Ahmad, Tayyeba Rehman, Waheed Mumtaz Abbasi. Effects of homoeopathic ultrahigh dilutions of Aconitum napellus on Baker's yeast-induced fever in rabbits. Journal of Integrative Medicine, 2017, 15(3): 209-213.
[11] Susana Seca, Sebastian Kirch, António S.Cabrita, Henry J.Greten. Evaluation of the effect of acupuncture on hand pain, functional deficits and health-related quality of life in patients with rheumatoid arthritis—A study protocol for a multicenter, double-blind, randomized clinical trial. Journal of Integrative Medicine, 2016, 14(3): 219-227.
[12] Jesmin Mondal, Asmita Samadder, Anisur Rahman Khuda-Bukhsh. Psorinum 6× triggers apoptosis signals in human lung cancer cells. Journal of Integrative Medicine, 2016, 14(2): 143-153.
[13] Santu Kumar Saha, Sourav Roy, Anisur Rahman Khuda-Bukhsh. Ultra-highly diluted plant extracts of Hydrastis canadensis and Marsdenia condurango induce epigenetic modifications and alter gene expression profiles in HeLa cells in vitro. Journal of Integrative Medicine, 2015, 13(6): 400-411.
[14] Arthur Yin Fan. The methodology flaws in Hinman’s acupuncture clinical trial, Part III: Sample size calculation. Journal of Integrative Medicine, 2015, 13(4): 209-211.
[15] Arthur Yin Fan. The methodology flaws in Hinman’s acupuncture clinical trial, Part II: Zelen design and effectiveness dilutions. Journal of Integrative Medicine, 2015, 13(3): 136-139.
Viewed
Full text


Abstract

Cited

  Shared   
  Discussed   
[1] Jun Hu, Jian-ping Liu. Non-invasive physical treatments for chronic/recurrent headache. Journal of Chinese Integrative Medicine, 2008, 6(1): 31
[2] Zhi-chun Jin. Problems in establishing clinical guideline for integrated traditional Chinese and Western medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 5-8
[3] Wei Zhang, Xiang-feng Lu, Xiao-mei Zhang, Jian-jun Wu, Liang-duo Jiang. A rat model of pulmonary fibrosis induced by infusing bleomycin quickly through tracheal intubation. Journal of Chinese Integrative Medicine, 2008, 6(1): 60-67
[4] Min Cheng, Qiong Feng, Shu-wen Qian, Hui Gao, Cui-qing Zhu. Preliminary assay of p-amyloid binding elements in heart-beneficial recipe. Journal of Chinese Integrative Medicine, 2008, 6(1): 68-72
[5] Hai-feng Wei, Bai-liu Ya, Ling Zhao, Cui-fei Ye, Li Zhang, Lin Li. Evaluation of tongue manifestation of blood stasis syndrome and its relationship with blood rheological disorder in a rat model of transient brain ischemia. Journal of Chinese Integrative Medicine, 2008, 6(1): 73-76
[6] Jin-zhou Tian, Jing Shi, Xin-qing Zhang, Qi Bi, Xin Ma, Zhi-liang Wang, Xiao-bin Li, Shu-li Shen, Lin Li, Zhen-yun Wu, Li-yan Fang, Xiao-dong Zhao, Ying-chun Miao, Peng-wen Wang, Ying Ren, Jun-xiang Yin, Yong-yan Wang, Beijing United Study Group on MCI of the Capital Foundation of Medical Developments. Guiding principles of clinical research on mild cognitive impairment (protocol). Journal of Chinese Integrative Medicine, 2008, 6(1): 9-14
[7] Yan-bo Zhu , Qi Wang, Cheng-yu Wu, Guo-ming Pang, Jian-xiong Zhao, Shi-lin Shen, Zhong-yuan Xia , Xue Yan . Logistic regression analysis on relationships between traditional Chinese medicine constitutional types and overweight or obesity. Journal of Chinese Integrative Medicine, 2010, 8(11): 1023-1035
[8] Hong Liu , Guo-liang Zhang, Li Shen , Zhen Zeng, Bao-luo Zhou, Cheng-hai Liu, Guang Nie . Application and evaluation of a pseudotyped virus assay for screening herbs for anti-H5Nl avian influenza virus. Journal of Chinese Integrative Medicine, 2010, 8(11): 1036-1040
[9] Liang-ping Hu , Xiao-lei Bao, Xue Guan. Statistical inference and experimental design of univariate qualitative data of single-group design. Journal of Chinese Integrative Medicine, 2010, 8(11): 1085-1089
[10] Zhi-mei Wang, Bin Zhang. A study on translation of ellipses in Huangdi Neijing from perspective of hermeneutic theory. Journal of Chinese Integrative Medicine, 2010, 8(11): 1097-1100