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TABLE 1*

Glutamate-Industry-Sponsored Human Studies:

Subject Selection and Methodology Favoring Production of Negative Results
 

Authors 

Funding sources

Bias toward 
selecting subjects
who might not be
sensitive to monosodium glutamate

Bias toward reducing the likelihood that subjects would react to monosodium glutamate test material

Use of toxic or allergenic material in placebos

Use of too few subjects

Focus on variables irrelevant to production of adverse reactions

xxxxxxxxxxxxx

xxxxxx

xxxxxxxxx

xxxxxxx

xxxxxxxxx

xxxx

xxxxxxxxxxxxx

Altman DR, Fitzgerald T, Chiaramote LT. (1994)

Allerx

IGTC

Stipend given

no other information provided 

Not all reactions were recorded

no other information
 
 

 

3 different doses in a liquid vehicle

IGTC placebos contained aspartame at the time

Bazzano G,
D’Elia JA,
Olson RE. (1970)

Public Health Service

Adult males

no other information provided

Not all reactions were recorded

no other information

Amino acid formula with glutamate as a basic diet

11

Neurologic function; Hepatic function; Serum cholesterol; Weight

Fernstrom JD, Cameron JL, Fernstrom M, McConaha C, Weltzin TE, Kaye WH. (1996)

IGTC

NIH

Well subjects

Informed consent

Beverage

IGTC placebos contained aspartame at the time.

8

Plasma glutamate; Change in plasma glutamate; Pituitary hormone secretion.

Geha RS, Beiser A, Ren C, Patterson R, Greenberger PA, Grammer LC, Ditto AM, Harris KE, Shaughnessy MA, Yarnold PR, Corren J, Saxon A. (2000)

IGTC

Stipend given

Informed consent

Used capsules

Not all reactions were recorded

Observation time was inadequate

Part 1: ”Citrus- flavored beverage.”2

Part 2: Capsules containing sucrose

IGTC placebos contained aspartame at the time the study was initiated.

Reproducible response;3

Pulse; Blood pressure; Respiratory rate;

Relative risk

Germano P, Cohen SG,
Hahn B,
Metcalfe DD. (1991)

no information given

13 non-asthmatic and 30 asthmatic adults

Not all reactions were recorded

Used capsules

no information provided

IGTC placebos contained aspartame at the time

13+30

1

Germano P, Cohen SG, Hibbard V, Metcalfe DD. (1993)

no information given

21 adults with a history of asthma

Not all reactions were recorded

Used capsules

no information provided

IGTC placebos contained aspartame at the time.

21

10

.

Goldschmiedt M, Redfern JS, Feldman M. (1990)

Ajinomoto; NIH; ILSI; VA

Well subjects

Informed consent

180 mL warm beef consommé soup supplied by Ajinomoto Co., Inc. Tokyo

17

15

variables were relevant to the study done, but irrelevant to adverse reactions to MSG

Kenney RA. (1979)

Part 1.

IGTC (with thanks to NESTEC)

Well subjects

Informed consent

Test material was given with carbohydrates

Not all reactions were recorded

Observation time was inadequate

Tomato juice with common salt.

51

16

Kenney RA. (1979)

Part 2.

IGTC

Informed consent

Observation time was inadequate

Sucrose; citric acid; trisodium-citrate; lemon flavor; caramel color; naringin.

57

16

Kenney, RA. (1986)

IGTC

no information provided

Not all reactions were recorded

“...soft-drink solution....” 

IGTC placebos contained aspartame at the time.

6

Objective parameters (routine chemical analyses)

Kerr GR, Wu-Lee M, El-Lozy M, McGandy R, Stare FJ. (1979)

Ajinomoto USA

Randomly drawn stratified random sample

Not all reactions were recorded

Observation time was inadequate

Questionnaire survey 

Morselli P, Garattini S. (1970)

COFAG (IGTC Europe)

Well subjects

Test material was given with carbohydrates

Observation time was inadequate

Beef broth (ingredients not specified) followed by meat, vegetables, and fruit

24

Blood pressure; Pulse; Respiration rate

Prawirohardjono W, Dwiprahasto I, Astuti I, Hadiwandowo S, Kristin E, Muhammad M, Kelly MF. (2000)

IGTC

Well subjects

Stipend given

Informed consent

Small amounts of test material were given with carbohydrates

Used capsules

Lactose in gelatin capsules

52

Blood pressure; Pulse; Respiratory rate

Rosenblum L, Bradley J, Coulston F. (1971)

no information given

Males only

Informed consent

Not all reactions were recorded

Observation time was inadequate

Diluted chicken stock or diluted chicken stock with sodium (ingredients not specified)

95

Schwartzstein RM, Kelleher M, Weinberger WE, Weiss JW, Drazen JM. (1987)

IGTC

Asthmatics

No all reactions were recorded

Used capsules

Medication not given for 12 hours prior to testing

Gelatin capsule containing sodium chloride

12

Stegink LD, Filer J, Baker GL, Bell EF. (1986)

IGTC

Informed consent from parent

no other information given

Test material was given with carbohydrates

Beef consommé supplied by Ajinomoto Co., Tokyo, Japan

8

Plasma glutamate;
Plasma aspartate

Stevenson DD, Simon RA, Woessner KM. (1997)

IGTC

10 alleged CRS-asthmatics and 30 alleged non-CRS asthmatics

Subjects eliminated

Not all reactions were recorded

no information given

IGTC placebos contained aspartame at the time.

10+30

 

Tanphaichitr V, Srianujata S, Pothisiri P, Sammasut R,  Kulapongese S. (1983)

IGTC

Well subjects

Not all reactions were recorded

Test material was given with carbohydrates

Four full days’ menus all different, without added monosodium glutamate: this food being able to mask the addition of monosodium glutamate

50

Plasma glutamate;
Pleasantness or unpleasantness of food

Tanphaichitr V, Srianujata S, Leelahabul P,  Kulapongse S, Patchimasiri S, Pothisiri P. (1985) 

IGTC

Well subjects

Not all reactions were recorded

Test material was given with carbohydrates

A full days menu without added monosodium glutamate

12

Tarasoff L, Kelly MF. (1993)

IGTC

Well subjects

Stipend given

Informed consent

Used capsules

Test material was given with carbohydrates

Not all reaction were recorded

Observation time was inadequate

Both beverage and capsules:

Beverage specified as containing aspartame;4 prepared from powders supplied by the IGTC

Placebos in gelatin capsules
 

After-taste; Intensity

Wilkin JK (1986)

VA

Well subjects

Not all reactions were recorded

no placebo

6

Woessner KM,  Simon RA, Stevenson DD (1999)

IGTC; Scripps Clinic, Green Hospital & Research Institute

30 asthmatics  with alleged CRS asthma and 70 without

Informed consent

Subjects eliminated

Not all reactions were recorded

Test material was given with carbohydrates

Continued medications

5 gelatin capsules containing sucrose

IGTC placebos contained aspartame at the time

30+70

30

 

Yang WH, Drouin MA, Herbert M, Mao Y. (1997)

IGTC

Well subjects (except subjects with symptoms of CRS were accepted)

Stipend given

Informed consent

Not all reactions were recorded

Two or more reactions were required to be counted as a reaction

Observation time was inadequate

Strongly citrus tasting beverage containing sucrose supplied by the IGTC

IGTC placebos contained aspartame at the time
 

.

61

36

Zanda G, Franciosi P, Tognoin G, Risso M, Standen SM, Morselli PL, Garattini S. (1973)

no information given

Well subjects

Not all reactions were recorded

Observation time was inadequate

Small amounts of test material were given with carbohydrates

Beef bouillon (ingredients not specified)

72

Blood pressure; Pulse rate

*Compiled May 1, 2009
 Adrienne Samuels, Ph.D.

LEGEND

FUNDING SOURCES:

 COFAG: IGTC Europe

 IGTC: International Glutamate Technical Committee (includes manufacturers and users of monosodium glutamate)

 ILSI: International Life Sciences Institute (often under contract to the glutamate industry)

 IMC: International Minerals and Chemical Corporation

 NIH: National Institutes of Health

 VA: Veterans Administration

BIAS IN SELECTING SUBJECTS (Not all people are sensitive to monosodium glutamate at levels ordinarily found in food.)

CRS: Chinese Restaurant Syndrome: a limited number of mild and transitory reactions reported in 1968 as being caused by ingestion of monosodium glutamate

INFORMED CONSENT, while ethically appropriate, and required of all experiments using human subjects, biases these studies.

MALES have been reputed to be less sensitive to MSG than females

STIPENDS were given to those who claimed to be sensitive to MSG

SUBJECTS were ELIMINATED  prior to the study for responding to placebos that were going to be used in the study.

WELL SUBJECTS would be persons who had never experienced any of the reactions alleged to be attributable to use of monosodium glutamate (irritable bowel, migraine headache, asthma, skin rash, heart irregularities, mood swings, and depression being possibilities, for example).

BIAS TOWARD REDUCING THE LIKELIHOOD THAT SUBJECTS WOULD REACT TO MONOSODIUM GLUTAMATE TEST MATERIAL

 CAPSULES guarantee slow release and, therefore, less effect of the material they contain

 TEST MATERIAL GIVEN WITH CARBOHYDRATES interferes with the uptake of the test material

PLACEBOS

It would appear that in most, if not all, glutamate-industry-sponsored studies, both test and placebo material were supplied by the IGTC.  According to a 1991 letter from IGTC chairman Andrew G. Ebert to LSRO-FASEB and the FDA, a “beverage mix designed to mask the taste of [monosodium glutamate]”, was modified in 1978 to replace the [former use of] sucrose with the low calorie sweetener Aspartame.  Prior to the time that Northwestern University was alerted to the fact that aspartame was being used in placebo material being used in an IGTC-sponsored study being carried out by Geha et al. at Northwestern, Harvard, and UCLA, the use of aspartame in placebos was not acknowledged in research reports.

(1) BEVERAGE: Citric acid, trisodium citrate, lemon flavoring, caramel coloring, naringenin-7-rhamnosidio-glycoside (grapefruit bitter principle), sodium saccharin; prepared by Ajinomoto

(2) CITRUS-FLAVORED BEVERAGE: Sodium citrate, citric acid, saccharin, citrus flavor, and naringin were cited as ingredients.  Aspartame was used (but not named) with the other ingredients prior to objections filed with Northwestern University by the Truth in Labeling Campaign.

(4) BEVERAGE: Sodium citrate dihydrate, citric acid monohydrate, potassium chloride, naringin, grapefruit flavour, caramel, and aspartame.

IRRELEVANT VARIABLES

(3) REPRODUCIBLE RESPONSE:  Repetition of the same two or more responses to monosodium glutamate on two occasions, and no response to the “placebo” (which contained aspartame).

REFERENCES

Altman DR, Fitzgerald T, Chiaramonte LT. Double-blind placebo-controlled challenge (DBPCC) of persons reporting adverse reactions to monosodium glutamate (MSG). J Allergy Clin Immunol. 1994;93:303 (Abstract 844).

Bazzano G, D’Elia JA, Olson RE. Monosodium glutamate: feeding of large amounts in man and gerbils. Science. 1970;169:1208-1209.

Fernstrom JD, Cameron JL, Fernstrom MH, McConaha C, Weltzin TE, Kaye WH. Short-term neuroendocrine effects of a large, oral dose of monosodium glutamate in fasting male subjects. J Clin Endocrinol Metab. 1996;81:184-191.

Geha R, Beiser A, Ren C, et al. Multicenter multiphase double blind placebo controlled study to evaluate alleged reactions to monosodium glutamate (MSG). J Allergy Clin Immunol. 2000;106:973-980.

Germano P, Cohen SG, Hahn B, Metcalfe DD. An evaluation of clinical reactions to monosodium glutamate (MSG) in asthmatics using a blinded, placebo-controlled challenge. J Allergy Clin Immunol. 1991;87:177 (Abstract 155).

Germano P, Cohen SG, Hibbard V, Metcalfe DD. Assessment of bronchial hyperactivity by methacholine challenge (MTC) in asthmatics before and after  monosodium glutamate (MSG) administration. J Allergy Clin Immunol. 1993;91:340 (Abstract 798).

Goldschmiedt M, Redfern JS, Feldman M. Food coloring and monosodium glutamate: effects on the cephalic phase of gastric acid secretion and gastrin release in humans. Am J Clin Nutr. 1990;51:794-797.

Kenney RA. Placebo-controlled studies of human reaction to oral monosodium L-glutamate. In Filer LJ Jr, Garattini S. Kare MR, Reynolds WA, Wurtman RJ, eds. Glutamic acid: advances in biochemistry and physiology. New York: Raven; 1979:363-373.

Kenney RA. The Chinese restaurant syndrome: an anecdote revisited.  Food Chem Toxicol. 1986;24:351-354.

Kerr GR, Wu-Lee M, El-Lozy M, McGandy R, Stare FJ. Prevalence of the "Chinese restaurant syndrome." J Am Diet Assoc. 1979;75:29-33.

Morselli P, Garattini S. Monosodium-glutamate and the Chinese restaurant syndrome. Nature. 1970;227:611-612.

Prawirohardjono W, Dwiprahasto I, Astuti I, et al.  The administration to Indonesians of monosodium L-glutamate in Indonesian foods; an assessment of adverse reactions in a randomized double-blind, crossover, placebo-controlled study. J Nutr. 2000;130:1074S-1076S.

Rosenblum L, Bradley J, Coulston F. Single and double blind studies with oral monosodium glutamate in man. Toxicol Appl Pharmacol 1971;18:367-373.

Schwartzstein RM, Kelleher M, Weinberger WE, Weiss JW, Drazen JM. Airway effect of monosodium glutamate in subjects with chronic stable asthma. J Asthma. 1987;24:167-172

Stegink LD, Filer J, Baker GL, Bell EF. Plasma glutamate concentrations in 1-year-old infants and adults ingesting monosodium L-glutamate in consommé. Pediatr Res. 1986;20:53-58.

Stevenson DD, Simon RA, Woessner KM. The role of monosodium L-glutamate (MSG) in asthma: does it exist? J Allergy Clin Immunol. 1997;99:S411 (Abstract 1670).

Tanphaichitr V, Srianujata S, Pothisiri P, Sammasut R,  Kulapongese S. Postprandial responses to Thai foods with and without added monosodium L-glutamate.  Nutr Rep Int. 1983;28:783-792.

Tanphaichitr V, Srianujata S, Leelahabul P,  Kulapongse S, Patchimasiri S, Pothisiri P. Effect of monosodium L-glutamate in take on protein-calorie status in healthy Thai adults. Nutr Rep Int. 1985;32:1073-1080.

Tarasoff L, Kelly MF. Monosodium L-glutamate: a double-blind study and review. Food Chem Toxic. 1993;31:1019-1035.

Wilkin JK. Does monosodium glutamate cause flushing (or merely “glutamania”)? J Am Acad Dermatol. 1986;15:225-230.

Woessner KM,  Simon RA, Stevenson DD. Monosodium glutamate sensitivity in asthma. J Allergy Clin Immunol. 1999;104:305-310.

Yang WH, Drouin MA, Herbert M, Mao Y. The monosodium glutamate symptom complex: assessment in a double-blind, placebo-controlled, randomized study. J Allergy Clin Immunol. 1997;99:757-762.

Zanda G, Franciosi P, Tognoin G, et al. A double blind study on the effects of monosodium glutamate in man.  Biomedicine. 1973;19:202-204.

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