RESUMEN
OBJECTIVE: Premenstrual syndrome (PMS) affects millions of women. While over-the-counter products have helped with the physical symptoms of PMS, emotional symptoms have been less well supported. The objective of this trial was to measure the effect of an oxaloacetate/vitamin C combination on the major emotional symptoms of PMS, including depression, anxiety, perceived stress, aggression, and suicidal ideation. METHODS: Forty-eight women experiencing PMS completed a baseline survey comprising the Beck's Depression Inventory, Cohen Perceived Stress Scale, Generalized Anxiety Disorder Test, and Buss-Perry Aggression Questionnaire. After baseline measurements, participants were randomly assigned to take either 2 capsules of 100 mg oxaloacetate/150 mg ascorbic acid, or 2 capsules of rice flour (placebo) for their entire menstrual cycle. At menstruation, the women completed the 4 surveys again. The women then switched capsules in a cross-over design and continued the study for an additional menstrual cycle. The final assessment was repeated at menstruation. Statistical analysis of the 4 surveys was performed to examine efficacy. RESULTS: Oxaloacetate/vitamin C supplementation during PMS significantly improved depression, perceived stress, anxiety, aggression, and suicidal ideation. The mean improvement in depression was 54.1%, 35.8% for perceived stress, 51.43% for generalized anxiety, and 17.8% for aggression. Suicidal ideation was reduced by 47.9%. All results were highly significant. CONCLUSION: A combination of oxaloacetate and vitamin C supplementation helped to alleviate depression, anxiety, perceived stress, aggression, and suicidal ideation symptoms associated with PMS. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03509714.
RESUMEN
PREMISE: Applied Kinesiology (AK) is a diagnostic technique widely used within the Integrative Medical community. In essence, it posits that a question can be mentally held in a person's mind, sometimes while they are holding a substance like a vitamin, or a food sample, and by measuring relative muscular weakness an answer as to whether the substance or the condition represented by the question is good for that person can be obtained. This AK is presumed to have a diagnostic capability. That being presumed, this study asks the following questions: (1) Is there a difference in muscular strength when an individual holds a substance that is inimical to life processes (a poison solution), as compared to a substance that is essential for life (normal saline)? (2) Is this effect a transaction involving input from both the person being measured and the kinesiologist doing the measurement or is it only the person being measured? (3) As an extension of question 2, is the result the same when different kinesiologists take the measurement or when no kinesiologist is involved? (4) Does belief, expectation, gender, or time cognition play a role in determining response? METHODOLOGY: To answer these questions, which would help to define the parameters of the AK process, 51 participants were tested during three trials each, first by one kinesiologist, then by another, and finally, with no kinesiologist present by grip strength indicated using a hand dynamometer. Grip strength being a self-administered AK test of relative muscular strength. For each trial, a pair of randomly numbered sealed vials, each pair in a randomly numbered plastic bag, were used as the objects of the trial. In each bag, one vial contained saline solution while the other was filled with a slightly smaller amount of saline solution to which had been added ionic hydroxylamine hydrochloride (NH3OH)(+), producing a toxic solution of 9mg/ml. Each trial consisted of a separate muscle test for each vial. All present at the trials were blind as to which vial contained the toxin. And all who prepared the vials were blind to the trials. The force used by the kinesiologists in each of their trials was measured via a pressure pad system. The hand dynamometer trials were conducted with no kinesiologist present. RESULTS: Of the 151 sets of trials, the toxic vial was identified correctly in 80 of them (53%), resulting in a one-tailed exact binomial P-value of .258. Results for two of the kinesiologists were almost exactly at chance. For the third kinesiologist, there was a one-tailed exact binomial P-value of .18 (unadjusted for multiple testing). Results for the dynamometer were also almost exactly at chance. Testing whether there was a significant difference in proportions for whom the AK test worked based on belief about whether it would work resulted in non-significant χ(2) values of 0.6 (P = .439) for the trials with one kinesiologist and 2.222 (P = .136) for the hand dynamometer trials. The final variable examined was gender. While there was no significant difference in performance for males and females for the trials of the male kinesiologist or the hand dynamometer, the combined data for the two female kinesiologists did reveal a difference. Of the 33 sessions with females, only 15 were successful (45%), while for the 18 sessions with males, 14 were successful (78%), resulting in a χ(2) statistic of 4.96, P = .026. However, given all of the χ(2) tests performed in this section, the results must be interpreted with caution because of multiple testing. Results indicate belief in whether the AK test will work was not significantly related to whether it actually did work. A χ(2) test of the relationship between time perception and correct vial choice showed no significant relationships. The χ(2) statistic for the relationship using the hand dynamometer data was 0.927, P = .629. CONCLUSION: The data in this study, particularly when seen in the larger context of a review of the literature from the AK field itself by Klinkoski and Leboeuf (1990), which considered 50 papers published between 1981 and 1987 by the International College of Applied Kinesiology, and the survey by Hall, Lewith, Brien, and Little (2008), using standard evaluation criteria [quality assessment tool for studies of diagnostic accuracy included in systematic reviews (QUADAS), Standards for Reporting of Diagnostic Studies (STARD), JADAD, and Consolidated Standards of Reporting Trials (CONSORT)], for research methodology, as well as six prior non-clinical studies by Radin (1984), Quintanar and Hill (1988), Braud (1989), Arnett et al. (1999), Ludtke (2001), and Kendler and Keating (2003), all together suggest the following: The research published by the Applied Kinesiology field itself is not to be relied upon, and in the experimental studies that do meet accepted standards of science, Applied Kinesiology has not demonstrated that it is a useful or reliable diagnostic tool upon which health decisions can be based.