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If the FEV1 values fell by 20% presumptive screening positive ; , the patient underwent two double-blind, placebocontrolled challenges. An unblinded nurse kept the challenge sequence sequestered until the blinded nurse completed both double-blind challenges. A total of 142 potential subjects responded to advertisements or were referred for studies. Eight patients, with a history of oriental restaurant asthma attacks, could not arrange their schedules to be admitted for challenge studies. One of the eight patients called to complain to the nurse coordinator about the life-threatening danger of MSG challenges and declined the nurse's invitation to participate in the study. A total of 134 patients underwent screening for the presence of asthma and agreed to participate in the challenge studies. However, 34 patients did not successfully meet the placebo challenge criteria for the following reasons: 1 ; they produced low baseline FEV1 values; 2 ; they experienced a 10% change in FEV1 values during the 12-h placebo day; 3 ; they produced significant variations in baseline FEV1 values from placebo to challenge day; or 4 ; they relied upon -agonists to maintain airway stability. Because we were unable to obtain airway stability in these subjects, they were not included in the MSG challenge phase of the study. The remaining 100 patients, who met all study criteria, as previously listed, underwent challenges with MSG 2.5 g ; as follows. Group A. This group MSG history positive ; consisted of 30 subjects. Only one experienced a 20% decline in FEV1 values during the single-blind screening challenge. This patient was asymptomatic when her spirometry recorded a 20% drop in FEV1. The nurse conducting the study asked the patient to expire into the spirometer for only one expiratory blow, which was decreased by 20%. Inexplicably, the nurse did not follow the protocol and conduct the additional two expirations, a standard procedure used to produce consistency. In this patient, serum tryptase baseline was 1 ng mL before and after the 20% decline in FEV1 value. Two double-blind, placebo-controlled challenges with MSG 2.5 g ; were then conducted in this patient, and the FEV1 values varied by 1%. In the studies by Allen et al. 1987 ; and MoneretVautrin 1987 ; , this patient would have been included as being MSG sensitive because neither author included a double-blind confirmatory challenge, with the provoking dose of MSG, after a single-blind positive response. In these 30 patients, there were many candidates, other than MSG, that could act as precipitants for the asthma experienced in oriental restaurants, i.e., gastroesophageal reflux, cigarette smoke sensitivity, food allergy, unstable asthma, aspirin sensitivity and anxiety depression. In most cases, a friend or relative had suggested that MSG was responsible for the original oriental restaurant asthma attacks. All 30 patients were relieved to hear at the conclusion of our study that they were not MSG sensitive. Table 2 lists the symptoms experienced by a minority of the patients during the placebo and MSG challenge days. Headaches predominated and were slightly more common during placebo challenge days. None of the patients experienced any symptoms suggesting asthma. Group B. This group MSG history negative ; consisted of 70 asthmatic patients who were referred to the Scripps Clinic for aspirin challenges, followed by aspirin desensitization. None experienced any symptoms suggesting asthma in oriental restaurants and their FEV1 values did not change significantly during placebo or MSG challenge days. None of these 70 patients experienced chest tightness, wheezing dyspnea or cough during either the placebo or MSG challenge days. Thus the incidence of asthmatic reactions to MSG was 0 of 70. The.
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Nevertheless, changes could be observed at 12 weeks, with the placebo group showing a slight decline in endurance time and more pronounced deterioration in dyspnea scores and health status.
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