Abstract
Objective
We previously demonstrated that short-term treatment with a standardized kudzu extract (NPI-031) reduced alcohol drinking by men and women in a natural setting. The present study was conducted in nontreatment-seeking heavy drinkers to assess the safety and efficacy of 4 weeks of kudzu extract in an outpatient setting.
Method
This randomized between-subject, double-blind, placebo-controlled study involved 2 weeks of baseline, 4 weeks of treatment, and 2 weeks of follow-up. Seventeen men (21–33 years) who reported drinking 27.6 ± 6.5 drinks/week with a diagnosis of alcohol abuse/dependence took either kudzu extract (250 mg isoflavones, t.i.d.) or matched placebo on a daily basis. They reported alcohol consumption and desire to use alcohol using a wrist actigraphy device; twice weekly laboratory visits were scheduled to monitor medication adherence and adverse events.
Results
Medication adherence was excellent and there were no adverse events and changes in vital signs, blood chemistry, and renal or liver function. There was no effect on alcohol craving, but kudzu extract significantly reduced the number of drinks consumed each week by 34–57 %, reduced the number of heavy drinking days, and significantly increased the percent of days abstinent and the number of consecutive days of abstinence.
Conclusions
A standardized formulation of kudzu extract produced minimal side effects, was well-tolerated, and resulted in a modest reduction in alcohol consumption in young nontreatment-seeking heavy drinkers. Additional studies using treatment-seeking alcohol-dependent persons will be necessary to determine the usefulness of this herbal preparation in reducing alcohol use in other populations.
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References
Amer DA, Kretzschmar G, Müller N, Stanke N, Lindemann D, Vollmer G (2010) Activation of transgenic estrogen receptor-beta by selected phytoestrogens in a stably transduced rat serotonergic cell line. J Steroid Biochem Mol Biol 120(4–5):208–217
Anton RF, Myrick H, Baros AM, Latham PK, Randall PK, Wright TM, Stewart SH, Waid R, Malcolm R (2009) Efficacy of a combination of flumazenil and gabapentin in the treatment of alcohol dependence: relationship to alcohol withdrawal symptoms. J Clin Psychopharmacol 29(4):334–342
Beck AT, Epstein N, Brown GJ (1988) An inventory for measuring clinical anxiety. J Consult Clin Psychol 56:893–987
Beck AT, Steer RA, Brown GK (1996) Manual for the Beck Depression Inventory, 2nd edn. The Psychological Corporation, San Antonio
Benlhabib E, Baker JI, Keyler DE, Singh AK (2004) Kudzu root extract suppresses voluntary alcohol intake and alcohol withdrawal symptoms in P rats receiving free access to water and alcohol. J Med Food 7:168–179
Bracken BK, Penetar DM, Maclean RR, Lukas SE (2011) Kudzu root extract does not perturb sleep/wake cycle of moderate drinkers. J Altern Complement Med 17:1–6
Del Boca FK, Kranzler HR, Brown J, Korner PF (1996) Assessment of medication compliance in alcoholics through UV light detection of a riboflavin tracer. Alcohol Clin Exp Res 20:1412–1417
First MB, Gibbon M, Spitzer RL, Williams JBW (2002) Structured clinical interview for DSM-IV-TR axis I disorder (Research Version). Bimetrics Research Department, NY State Psychiatric Institute, New York
Heyman GM, Keung W-W, Vallee BL (1996) Daidzin decreases ethanol consumption in rats. Alcohol Clin Exp Res 20:1083–1087
Keung WM (2002) Preclinical studies of kudzu (Pueraria lobata) as a treatment for alcohol abuse. In: Keung WM (ed) Pueraria: the genus Pueraria. Taylor & Francis, New York, pp 144–158
Keung WM (2003) Anti-dipsotropic isoflavones: the potential therapeutic agents for alcohol dependence. Med Res Rev 23:669–696
Keung W-M, Vallee BL (1993) Daidzin and daidzein suppress free-choice ethanol intake by Syrian Golden hamsters. Proc Natl Acad Sci U S A 90:10008–10012
Keyler DE, Baker JI, Lee DY, Overstreet DH, Boucher TA, Lenz SK (2002) Toxicity study of an antidipsotropic Chinese herbal mixture in rats: NPI-028. J Altern Complement Med 8:175–183
Krystal JH, Cramer JA, Krol WF, Kirk GF, Rosenheck RA (2001) Naltrexone in the treatment of alcohol dependence. N Engl J Med 345:1734–1739
Lu L, Liu Y, Shi J, Liu Y, Ling W, Kosten TR (2009) Traditional medicine in the treatment of drug addiction. Am J Drug Alcohol Abuse 35:1–11
Lukas SE, Penetar D, Berko J, Vicens L, Palmer C, Mallya G, Macklin EA, Lee DYW (2005) An extract of the Chinese herbal root kudzu reduces alcohol drinking by heavy drinkers in a naturalistic setting. Alcohol Clin Exp Res 29:756–762
Ma Z, Wu Q, Lee DYW, Tracy M, Lukas SE (2005) Determination of puerarin in human plasma by high performance liquid chromatography. J Chromatogr B Biomed Appl J Chromatogr B Anal Technol Biomed Life Sci 823:108–114
Maisto SA, Pollock NK, Cornelius JR, Lynch KG, Martin CS (2003) Alcohol relapse as a function of relapse definition in a clinical sample of adolescents. Addict Behav 28(3):449–459
Mark TL, Kranzler HR, Song X, Bransberger P, Poole VH, Crosse S (2003) Physician’s opinions about medications to treat alcoholism. Addiction 98:617–626
Naimi TS, Brewer RD, Mokdad A, Denny C, Serdula MK, Marks JS (2003) Binge drinking among US adults. J Am Med Assoc 289:70–75
O'Malley SS, Garbutt JC, Gastfriend DR, Dong Q, Kranzler HR (2007) Efficacy of extended-release naltrexone in alcohol-dependent patients who are abstinent before treatment. J Clin Psychopharmacol 27(5):507–512
Overstreet DH, Lee YW, Rezvani AH, Pei YH, Criswell HE, Janowsky DS (1996) Suppression of alcohol intake after administration of the Chinese herbal medicine, NPI-028, and its derivatives. Alcohol Clin Exp Res 20:221–227
Penetar D, Teter C, Ma Z, Tracy M, David Y-W, Lee DY-W, Lukas SE (2006) Pharmacokinetic profile of the isoflavone puerarin after acute and repeated administration of a novel kudzu extract to human volunteers. J Altern Complement Med 12:543–548
Penetar DM, MacLean RR, McNeil JF, Lukas SE (2011) Kudzu extract does not increase the intoxicating effects of acute alcohol in human volunteers. Alcohol Clin Exp Res 35:726–734
Potgieter AS, Deckers F, Geerlings PA (1999) Craving and relapse measurement in alcoholism. Alcohol Alcohol 34:254–260
Rezvani AH, Overstreet DH, Perfumi M, Massi M (2003) Plant derivatives in the treatment of alcohol dependency. Pharmacol Biochem Behav 75:593–606
Rooke N, Li DJ, Li J, Keung WM (2000) The mitochondrial monoamine oxidase–aldehyde dehydrogenase pathway: a potential site of action of daidzin. J Med Chem 43:4169–4179
Schiller JS, Lucas JW, Ward BW, Peregoy JA (2012) Summary health statistics for U.S. adults: National Health Interview Survey 2010. National Center for Health Statistics. Vital Health Stat 10(252)
Shebek J, Rindone JP (2000) A pilot study exploring the effect of kudzu root on the drinking habits of patients with chronic alcoholism. J Altern Complement Med 6:45–48
Shen Y, Lindemeyer AK, Gonzalez C, Shao XM, Spigelman I, Olsen RW, Liang J (2012) Dihydromyricetin as a novel anti-alcohol intoxication medication. J Neurosci 32:390–401
Singleton EG, Gorelick DA (1998) Mechanisms of alcohol craving and their clinical implications. In: Galanter M (ed) Recent developments in alcoholism, vol. 14: the consequences of alcoholism. Plenum, New York, pp 177–195
Sun S-M (circa 600 AD) Beiji-Quianjin-Yaofang
Town M, Naimi TS, Mokdad AH, Brewer RD (2006) Health care access among U.S. adults who drink alcohol excessively: missed opportunities for prevention. Prev Chronic Dis [serial online] April. Available at http://www.cdc.gov/pcd/issues/2006/apr/05_0182.htm. Accessed 22 January 2012
Washton AM, Zweben JE (2006) Treating alcohol and drug problems in psychotherapy practice. Guilford, New York
Xu BJ, Zheng YN, Sung CK (2005) Natural medicines for alcoholism treatment: a review. Drug Alcohol Rev 24:525–536
Acknowledgments
This study was supported by grant R01-AA10536 (SEL) from the National Institute on Alcohol Abuse and Alcoholism, grant K05-DA00343 (SEL) from the National Institute on Drug Abuse, and grant P01-AT002038 (DYWL) from the National Center for Complementary and Alternative Medicine. The authors thank Carol Buchanan, Ronna Shostak, and Barbara Beake for the administrative support during the conduct of this study.
Conflicts of interest
Based on data presented in this study, Drs. Lukas and Lee applied for, and were granted, a patent for kudzu extract to treat alcohol abuse and dependence. McLean Hospital has licensed the production of kudzu extract (NPI-031) to Natural Pharmacia International (NPI), Inc. and they are marketing it as Alkontrol-Herbal®. Dr. Lee has a financial interest in NPI, Inc. All other authors declare that they have no actual or potential conflict of interest that could inappropriately influence, or be perceived to influence, this work.
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Lukas, S.E., Penetar, D., Su, Z. et al. A standardized kudzu extract (NPI-031) reduces alcohol consumption in nontreatment-seeking male heavy drinkers. Psychopharmacology 226, 65–73 (2013). https://doi.org/10.1007/s00213-012-2884-9
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DOI: https://doi.org/10.1007/s00213-012-2884-9