Treatment of fibromyalgia syndrome with Super Malic®: A randomized, double blind, placebo controlled, crossover pilot study

I. J. Russell, Joel E Michalek, J. D. Flechas, G. E. Abraham

Research output: Contribution to journalArticle

71 Citations (Scopus)

Abstract

Objective. To study the efficacy and safety of Super Malic®, a proprietary tablet containing malic acid (200 mg) and magnesium (50 mg), in treatment of primary fibromyalgia syndrome (FM). Methods. Twenty-four sequential patients with primary FM were randomized to a fixed dose (3 tablets bid), placebo controlled, 4-week/course, pilot trial followed by a 6-month, open label, dose escalation (up to 6 tablets bid) trial. A 2-week, medication free, washout period was required before receiving treatment, between blinded courses, and again before starting open label treatment. The 3 primary outcome variables were measures of pain and tenderness but functional and psychological measures were also assessed. Results. No clear treatment effect attributable to Super Malic® was seen in the blinded, fixed low dose trial. With dose escalation and a longer duration of treatment in the open label trial, significant reductions in the severity of all 3 primary pain/tenderness measures were obtained without limiting risks. Conclusions. These data suggest that Super Malic is safe and may be beneficial in the treatment of patients with FM. Future placebo-controlled studies should utilize up to 6 tablets of Super Malic bid and continue therapy for at least 2 months.

Original languageEnglish (US)
Pages (from-to)953-958
Number of pages6
JournalJournal of Rheumatology
Volume22
Issue number5
StatePublished - 1995

Fingerprint

Fibromyalgia
Cross-Over Studies
Placebos
Tablets
Therapeutics
Pain
Super Malic
Magnesium
Psychology
Safety

Keywords

  • ATP
  • Fibromyalgia
  • Magnesium
  • Malic acid
  • Treatment

ASJC Scopus subject areas

  • Rheumatology
  • Immunology

Cite this

Treatment of fibromyalgia syndrome with Super Malic® : A randomized, double blind, placebo controlled, crossover pilot study. / Russell, I. J.; Michalek, Joel E; Flechas, J. D.; Abraham, G. E.

In: Journal of Rheumatology, Vol. 22, No. 5, 1995, p. 953-958.

Research output: Contribution to journalArticle

@article{26b87b5effad4aff87342d4efee37920,
title = "Treatment of fibromyalgia syndrome with Super Malic{\circledR}: A randomized, double blind, placebo controlled, crossover pilot study",
abstract = "Objective. To study the efficacy and safety of Super Malic{\circledR}, a proprietary tablet containing malic acid (200 mg) and magnesium (50 mg), in treatment of primary fibromyalgia syndrome (FM). Methods. Twenty-four sequential patients with primary FM were randomized to a fixed dose (3 tablets bid), placebo controlled, 4-week/course, pilot trial followed by a 6-month, open label, dose escalation (up to 6 tablets bid) trial. A 2-week, medication free, washout period was required before receiving treatment, between blinded courses, and again before starting open label treatment. The 3 primary outcome variables were measures of pain and tenderness but functional and psychological measures were also assessed. Results. No clear treatment effect attributable to Super Malic{\circledR} was seen in the blinded, fixed low dose trial. With dose escalation and a longer duration of treatment in the open label trial, significant reductions in the severity of all 3 primary pain/tenderness measures were obtained without limiting risks. Conclusions. These data suggest that Super Malic is safe and may be beneficial in the treatment of patients with FM. Future placebo-controlled studies should utilize up to 6 tablets of Super Malic bid and continue therapy for at least 2 months.",
keywords = "ATP, Fibromyalgia, Magnesium, Malic acid, Treatment",
author = "Russell, {I. J.} and Michalek, {Joel E} and Flechas, {J. D.} and Abraham, {G. E.}",
year = "1995",
language = "English (US)",
volume = "22",
pages = "953--958",
journal = "Journal of Rheumatology",
issn = "0315-162X",
publisher = "Journal of Rheumatology",
number = "5",

}

TY - JOUR

T1 - Treatment of fibromyalgia syndrome with Super Malic®

T2 - A randomized, double blind, placebo controlled, crossover pilot study

AU - Russell, I. J.

AU - Michalek, Joel E

AU - Flechas, J. D.

AU - Abraham, G. E.

PY - 1995

Y1 - 1995

N2 - Objective. To study the efficacy and safety of Super Malic®, a proprietary tablet containing malic acid (200 mg) and magnesium (50 mg), in treatment of primary fibromyalgia syndrome (FM). Methods. Twenty-four sequential patients with primary FM were randomized to a fixed dose (3 tablets bid), placebo controlled, 4-week/course, pilot trial followed by a 6-month, open label, dose escalation (up to 6 tablets bid) trial. A 2-week, medication free, washout period was required before receiving treatment, between blinded courses, and again before starting open label treatment. The 3 primary outcome variables were measures of pain and tenderness but functional and psychological measures were also assessed. Results. No clear treatment effect attributable to Super Malic® was seen in the blinded, fixed low dose trial. With dose escalation and a longer duration of treatment in the open label trial, significant reductions in the severity of all 3 primary pain/tenderness measures were obtained without limiting risks. Conclusions. These data suggest that Super Malic is safe and may be beneficial in the treatment of patients with FM. Future placebo-controlled studies should utilize up to 6 tablets of Super Malic bid and continue therapy for at least 2 months.

AB - Objective. To study the efficacy and safety of Super Malic®, a proprietary tablet containing malic acid (200 mg) and magnesium (50 mg), in treatment of primary fibromyalgia syndrome (FM). Methods. Twenty-four sequential patients with primary FM were randomized to a fixed dose (3 tablets bid), placebo controlled, 4-week/course, pilot trial followed by a 6-month, open label, dose escalation (up to 6 tablets bid) trial. A 2-week, medication free, washout period was required before receiving treatment, between blinded courses, and again before starting open label treatment. The 3 primary outcome variables were measures of pain and tenderness but functional and psychological measures were also assessed. Results. No clear treatment effect attributable to Super Malic® was seen in the blinded, fixed low dose trial. With dose escalation and a longer duration of treatment in the open label trial, significant reductions in the severity of all 3 primary pain/tenderness measures were obtained without limiting risks. Conclusions. These data suggest that Super Malic is safe and may be beneficial in the treatment of patients with FM. Future placebo-controlled studies should utilize up to 6 tablets of Super Malic bid and continue therapy for at least 2 months.

KW - ATP

KW - Fibromyalgia

KW - Magnesium

KW - Malic acid

KW - Treatment

UR - http://www.scopus.com/inward/record.url?scp=0029057821&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0029057821&partnerID=8YFLogxK

M3 - Article

C2 - 8587088

AN - SCOPUS:0029057821

VL - 22

SP - 953

EP - 958

JO - Journal of Rheumatology

JF - Journal of Rheumatology

SN - 0315-162X

IS - 5

ER -