|Clinical Studies in Arrhythmia|
Millions of people between the ages of 50-70 suffer from palpitations, rapid heartbeat, dizziness and shortness of breath, a condition known as arrhythmia (irregular heartbeat). Approximately 30-60 percent of men and women in this age group suffer from some form of arrhythmia at some point in their lives. In most cases, conventional medicine cannot explain why arrhythmia develops. To cover this fact, the diagnostic term “paroxysmal arrhythmia” was introduced, which simply means the causes of irregular heartbeat are unknown.
Aim of the Study
The objective of our Phase II randomized, double-blind placebo-controlled clinical study was to investigate the effects of the long-term administration of a specific nutrient synergy program in combination with conventional basic therapy on the reduction of clinically apparent arrhythmic episodes in participants. The electrical cells of the heart have extraordinary nutritional demands, and a chronic deficiency of specific vitamins and other essential nutrients impairs cellular bioenergy production in heart muscle cells. This can cause disturbances in the generation and conduction of electrical impulses in the myocardium, leading to an irregular heartbeat.
A randomized, double-blind placebo-controlled multi-center study (35 clinics in Germany) was conducted over 24 weeks in 131 patients with paroxysmal atrial arrhythmia. All patients were advised to continue taking their prescribed conventional medications. The nutritional supplement program consisted of specific essential bioenergy nutrients that work in synergistic way.
There was a statistically significant effect of the vitamins on the reduction of clinically apparent arrhythmic episodes in contrast to the placebo group (p=0.0160). The mean number of episodes per patient during the six-month study was lower in the vitamin group than in the placebo group (25.1% vs. 42.4%, p=0.037). Only 47.8% of the supplemented patients reported seven or more arrhythmic episodes during the treatment study, in contrast to 73.9% reported in the placebo group. The number of patients with less then seven episodes in the supplemented group (52.7%) was almost twice that in the placebo group (26.1%). Furthermore, the number of patients with more than 10 episodes was significantly less in the supplemented group (45.5%) than in the placebo group (69.6%). The elapse of time prior to the first arrhythmic episode was shorter in the placebo group than in the supplemented group. (Log Rank Test: p = 0.0332 for PP analysis set)
With a longer period (six months) of vitamin intake, the number of patients without arrhythmia increased and the episode frequency decreased. At three months, 45.5% of the supplemented patients experienced seven or more arrhythmia attacks, in contrast to 27.3% at six months. Approximately 22.7% of the supplemented patients reported no arrhythmic episodes at three months, in contrast to 43.2% at six months.
A longer time to the first episode was observed in the supplemented group (p=0.0332). In addition, post-study quality of life improvement was greater in the supplemented group (p=0.0118). The supplemented group also demonstrated a significantly stronger perceived quality of life than did those in the placebo group (two-sided Wilcoxon rank sum: p=0.0118). An evaluation of the “mental health” measure results, for example, showed an improvement of 7.4 in the supplemented group and a decrease of –1.6 in the placebo group.
By addressing the underlying cause of arrhythmia – a deficiency of nutrients that generate bioenergy in the heart muscle cells – the specific nutrients synergy program provides a safe and statistically effective reduction of arrhythmic episodes, as well as significant enhancement in general health and quality of life.
This vitamin program can be implemented in clinical practice as a safe and effective therapy in patients suffering from arrhythmia.