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Randomized Controlled Trial
. Fall 2008;14(3):182-91.
doi: 10.1111/j.1755-5949.2008.00052.x.

A Double-Blind, Randomized, Pilot Dose-Finding Study of Maca Root (L. Meyenii) for the Management of SSRI-induced Sexual Dysfunction

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Free PMC article
Randomized Controlled Trial

A Double-Blind, Randomized, Pilot Dose-Finding Study of Maca Root (L. Meyenii) for the Management of SSRI-induced Sexual Dysfunction

Christina M Dording et al. CNS Neurosci Ther. .
Free PMC article

Abstract

We sought to determine whether maca, a Peruvian plant, is effective for selective-serotonin reuptake inhibitor (SSRI)-induced sexual dysfunction. We conducted a double-blind, randomized, parallel group dose-finding pilot study comparing a low-dose (1.5 g/day) to a high-dose (3.0 g/day) maca regimen in 20 remitted depressed outpatients (mean age 36+/-13 years; 17 women) with SSRI-induced sexual dysfunction. The Arizona Sexual Experience Scale (ASEX) and the Massachusetts General Hospital Sexual Function Questionnaire (MGH-SFQ) were used to measure sexual dysfunction. Ten subjects completed the study, and 16 subjects (9 on 3.0 g/day; 7 on 1.5 g/day) were eligible for intent-to-treat (ITT) analyses on the basis of having had at least one postbaseline visit. ITT subjects on 3.0 g/day maca had a significant improvement in ASEX (from 22.8+/-3.8 to 16.9+/-6.2; z=-2.20, P=0.028) and in MGH-SFQ scores (from 24.1+/-1.9 to 17.0+/-5.7; z=-2.39, P=0.017), but subjects on 1.5 g/day maca did not. Libido improved significantly (P<0.05) for the ITT and completer groups based on ASEX item #1, but not by dosing groups. Maca was well tolerated. Maca root may alleviate SSRI-induced sexual dysfunction, and there may be a dose-related effect. Maca may also have a beneficial effect on libido.

Conflict of interest statement

Christina Dording, MD

Research Support: Abbott Laboratories, Alkermes, Aspect Medical Systems, Astra‐Zeneca, Bristol‐Myers Squibb Company, Cephalon, Eli Lilly & Company, Forest Pharmaceuticals Inc., GlaxoSmithkline, J& J Pharmaceuticals, Lichtwer Pharma GmbH, Lorex Pharmaceuticals, Novartis, Organon Inc., PamLab, LLC, Pfizer Inc, Pharmavite, Roche, Sanofi/Synthelabo, Solvay Pharmaceuticals, Inc., Wyeth‐Ayerst Laboratories

Speakers' Honoraria: Wyeth

Maurizio Fava, MD

Advisory/Consulting: Aspect Medical Systems, Astra‐Zeneca, Bayer AG, Biovail Pharmaceuticals, Inc., BrainCells, Inc. Bristol‐Myers Squibb Company, Cephalon, Compellis, Cypress Pharmaceuticals, Dov Pharmaceuticals, Eli Lilly & Company, EPIX Pharmaceuticals, Fabre‐Kramer Pharmaceuticals, Inc., Forest Pharmaceuticals Inc., GlaxoSmithkline, Grunenthal GmBH, Janssen Pharmaceutica, Jazz Pharmaceuticals, J & J Pharmaceuticals, Knoll Pharmaceutical Company, Lundbeck, MedAvante, Inc., Neuronetics, Novartis, Nutrition 21, Organon Inc., PamLab, LLC, Pfizer Inc, PharmaStar, Pharmavite, Roche, Sanofi/Synthelabo, Sepracor, Solvay Pharmaceuticals, Inc., Somaxon, Somerset Pharmaceuticals, Wyeth‐Ayerst Laboratories

Speaking: Astra‐Zeneca, Boehringer‐Ingelheim, Bristol‐Myers Squibb Company, Cephalon, Eli Lilly & Company, Forest Pharmaceuticals Inc., GlaxoSmithkline, Novartis, Organon Inc., Pfizer Inc, PharmaStar, Wyeth‐Ayerst Laboratories

Equity Holdings: Compellis, MedAvante

Royalty/patent, other income: none

David Mischoulon, MD, PhD

Research Support: Lichtwer Pharma GmbH, Bristol‐Myers Squibb Company, Cederroth, Laxdale (Amarin), Nordic Naturals, SwissMedica

Advisory/Consulting: None

Speaking: Bristol‐Meyers Squibb Company, Pamlab LLC, Nordic Naturals, Virbac, Pfizer, Wyeth, AstraZeneca, Cephalon, Janssen, Lilly

Equity Holdings: None

Royalty/patent, other income: PMS Escape (patent co‐holder)

Andrew A. Nierenberg, MD

Grant/Research Support: Bristol‐Myers Squibb, Cederroth, Cyberonics, Forest Pharmaceuticals, GlaxoSmithKline, Janssen Pharmaceutica, Lichtwer Pharma, Eli Lilly, NARSAD, NIMH, Pfizer, Stanley Foundation, Wyeth‐Ayerst

Advisory/Consulting: Bristol‐Myers Squibb, Genaissance, GlaxoSmithKline, Innapharma, Janssen Pharmaceutica, Eli Lilly, Novartis, Pfizer, Sepracor, Shire, Somerset

Equity Holdings: None

Speaking/Honoraria: Bristol‐Myers Squibb, Cyberonics, Forest Pharmaceuticals, GlaxoSmithKline, Eli Lilly, Wyeth‐Ayerst

George I. Papakostas, MD

Research Support: Bristol‐Myers Squibb Company, Pamlab LLC, Pfizer Inc.

Advisory/Consulting: Aphios Corporation, Evotec Ltd., GlaxoSmithKline, Inflabloc Pharmaceuticals, Inc, Jazz Pharmaceuticals, Pamlab, LLC

Honoraria: Evotec Ltd., GlaxoSmithKline, Inflabloc Pharmaceuticals, INC., Jazz Pharmaeuticals,

Pamlab, LLC, Pfizer, Inc., Titan Pharmaceuticals

Equity Holdings: none

Royalty/patent, other income: none

Shamsah Sonawalla, M.D.

Research Support: Abbott Laboratories, Alkermes, Aspect Medical Systems, Astra‐Zeneca, Bristol‐Myers Squibb Company, Cephalon, Eli Lilly & Company, Forest Pharmaceuticals Inc., GlaxoSmithkline, J& J Pharmaceuticals, Lichtwer Pharma GmbH, Lorex Pharmaceuticals, Novartis, Organon Inc., PamLab,LLC, Pfizer Inc, Pharmavite, Roche, Sanofi/Synthelabo, Solvay Pharmaceuticals, Inc., Wyeth‐Ayerst Laboratories

All other authors report no conflicts of interest.

Figures

Figure 1
Figure 1
Change in ASEX and MGH‐SFQ scores over 12 weeks (pre‐/post‐treatment) in intent‐to‐treat sample.
*Change in score was significant (P < 0.05).

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