Treatment of Peripheral Neuropathy: Combination Therapy Using LED Light, Extracorporeal Shockwave Therapy, Platelet Rich Plasma, and an Oral Dietary Supplement

Objectives: Peripheral neuropathy (PN) is a significant contributor to disability in the elderly. It is also one of the most prevalent complications of type 2 diabetes, prediabetes and metabolic syndrome. PN is commonly associated with pain, numbness, tingling, burning, and cramping in the feet and legs. Current treatment options are limited to controlling pain, seizures and use of antidepressant medications. These treatments have undesirable side effects and don’t stop PN progression. Here we utilized a combination of individual-specific modalities to improve local circulation and relieve PN symptoms. Methods: We conducted an open-label, multicenter pilot trial with 34 subjects (19 males and 15 females ranging from 40 - 85 years of age). All of the participants were diagnosed with peripheral neuropathy and had bilateral symptoms in their feet, and many reported the same symptoms (pain, numbness, tingling, burning, and cramping) in their lower legs. The duration of symptoms ranged from four months to over six years. On Day 0, subjects were given a 90-day supply of the oral supplement with dosing instructions and a LED light therapy device. They also received three platelet-rich plasma (PRP) injections in their lower extremities. Subjects also received an extracorporeal shockwave therapy (ESWT) treatment for each foot and subsequently twice per week for the first six weeks, then once weekly for the duration of the study. Subjects filled out the Brief Pain Index (BPI) at weekly intervals. On Day 90, subjects completed the Patient Global Impression of Change (PGIC) survey. Results: There were significant responses to pain, as evidenced by BPI scores at weeks 8, 9, 10 and 11 (p = 0.02, 0.01, 0.02, and 0.003, respectively). Analysis of the final day PGIC survey showed a favorable outcome for 73% of participants (p = 0.003), with the majority reporting Very Much Improved. Conclusions: By utilizing a multi-modality treatment protocol that includes PRP, LED light therapy, ESWT and an oral dietary supplement, we observed significant reductions in BPI scores. Quality of life and their overall impression of change (PGIC) were significantly improved, and there were no significant side effects.

Clinical Effects of Hydrogen Administration: From Animal and Human Diseases to Exercise Medicine

Here we review the literature on the effects of molecular hydrogen (H2) on normal human subjects and patients with a variety of diagnoses, such as metabolic, rheumatic, cardiovascular and neurodegenerative and other diseases, infections and physical and radiation damage as well as effects on aging and exercise. Although the effects of H2 have been studied in multiple animal models of human disease, such studies will not be reviewed in depth here. H2 can be administered as a gas, in saline implants or infusions, as topical solutions or baths or by drinking H2-enriched water. This latter method is the easiest and least costly method of administration. There are no safety issues with hydrogen;it has been used for years in gas mixtures for deep diving and in numerous clinical trials without adverse events, and there are no warnings in the literature of its toxicity or long-term exposure effects. Molecular hydrogen has proven useful and convenient as a novel antioxidant and modifier of gene expression in many conditions where oxidative stress and changes in gene expression result in cellular damage.

膳食补充剂(极爱胶囊^TM)改善患者胃肠道症状与生活质量的临床观察

目的通过一项开放标签研究明确一种含有植物成分和食用油的膳食补充剂(极爱胶囊^TM)是否可以减轻胃肠道不适患者主诉的胃肠道症状,从而改善其生活质量。方法纳入50例(女性40例,男性10例)患有胃肠道疾病或存在胃肠道症状的患者作为研究对象,其平均年龄为(51.1±12.7)岁(年龄范围24~77岁),于每餐餐前30 min服用5粒膳食补充剂,连续服用90 d,研究期间采用功能性消化不良生存质量量表(functional digestive disorder quality of life questionnaire,FDDQL)与患者总体印象变化量表(patient global impression of change,PGIC)评估患者临床症状与生活质量。结果服用膳食补充剂后,患者综合评分显著提高(P=0.018),不适症状、日常活动和焦虑症状均显著改善(P=0.000、0.029、0.018),且多于服用膳食补充剂20 d内改善最明显,而饮食、睡眠、健康认知、疾病应对和压力影响均无明显改善(P=0.398、0.136、0.686、0.309、0.785);服用膳食补充剂90 d后,50例患者中有28例患者完成PGIC问卷调查评估,评分为(4.800±0.169)分,整体症状与生活质量均显著改善(P=0.000);研究期间,所有患者的血液抗氧化物、维生素、矿物质、必需脂肪酸、胰腺酶及氨基酸水平均未出现显著改变,安全性较高。结论极爱胶囊^(TM)可显著缓解肠易激综合征、胃食管反流等多种消化系统疾病患者的腹胀、腹痛等不适症状,改善患者日常活动状态及焦虑情绪等,提高患者生活质量,且安全性较高。

Lipid Replacement Therapy with a Glycophospholipid Formulation with NADH and CoQ10 Significantly Reduces Fatigue in Intractable Chronic Fatiguing Illnesses and Chronic Lyme Disease Patients

Objectives: A preliminary open label study was initiated to determine if a combination oral supplement containing a mixture of phosphoglycolipids, coenzyme Q10 and microencapsulated NADH could affect fatigue levels in long-term patients with intractable fatigue. Fatigue was determined by the validated Piper Fatigue Scale before, during and after the trial. Participants included 58 patients (30 females and 28 males) with chronic fatigue syndrome/myalgic encephalomyelitis, chronic Lyme disease or other fatiguing illnesses, such as fibromyalgia syndrome or Gulf War illness. These patients had been symptomatic for an average of 17.1 ± 0.6 years, had been seen by many physicians (15.2 ± 0.7) and had used many other supplements and drugs (35.4 ± 2.7) without apparent reductions in their fatigue. Results: Participants in the study responded to the combination test supplement, showing a 30.7% reduction in overall fatigue within 60 days (P2 = 0.960). The data also suggested that further reductions were likely if the participants had continued the supplement beyond the 8-week trial. Males responded slightly better to the combination supplement than females, and the patients with the most severe forms of fatigue responded slightly better than those with milder fatigue, independent of their diagnosis. Conclusions: The combination supplement was a safe and effective method to significantly reduce fatigue in long-term patients with intractable chronic fatigue.

Clinical Observations on the Effects of a Dietary Supplement (GI Regenerate^TM) on Patients’ Gastrointestinal Symptoms and Quality of Life Assessments

Background: Different treatments have been developed and used to control symptoms and improve quality of life in patients with digestive diseases and disorders. Although the use of drugs or alternative approaches has improved symptom severity in some but not all patients, often these improvements were not sustainable. Objectives: An open label clinical study was initiated to determine if oral capsules containing a dietary supplement of herbs and oils (GI RegenerateTM) could reduce self-reported gastrointestinal symptoms and improve quality of life (QOL) indicators in patients with gastrointestinal conditions. Methods: Participants included 50 patients (40 females and 10 males) of mean age of 51.1 ± 12.7 years (range, 24 - 77 years) with a diagnosis of a gastrointestinal disorder or gastrointestinal symptoms. These patients consumed five soft-gels containing the test supplement 30 minutes before each meal for 90 days. Symptoms were evaluated by medical staff, and patient health status was self-reported using a validated quality of life questionnaire (Quality of Life Digestive Survey) designed for functional digestive disorders. Exit interviews (Patient Global Impression of Change, PGIC) were conducted by the medical staff. Results: Participants in the study responded with improved symptom severities and QOL scores to the test dietary supplement within the 90 day period;most improvements occurred within 20 days on the test dietary supplement. By the end of the study there were significant overall global improvements in the symptoms and QOL health surveys (p = 0.0183), with significant improvements in symptom discomfort (p = 0.0004), daily activities (p = 0.029) and anxiety (p = 0.018). In contrast, there were insignificant improvements in diet (p = 0.398), sleep (p = 0.136), health perception (p = 0.686), coping with the disease (p = 0.309) and impact of stress (p = 0.785). Using the PGIC exit interview that measured each patient’s impression of overall global change in symptoms and QOL these data also indicated overall significant improvements in symptoms and in satisfaction with the test supplement (moderately better improvements in symptoms and QOL or score of 4.8 ± 0.169, p 50 years) versus younger (Conclusions: The GI RegenerateTM natural dietary supplement safely and significantly reduced gastrointestinal symptoms and improved quality of life in subjects with a broad spectrum of gastrointestinal disorders and symptoms.

Reduction of Pain, Fatigue, Gastrointestinal and Other Symptoms and Improvement in Quality of Life Indicators in Fibromyalgia Patients with Membrane Lipid Replacement Glycerolphospholipids and Controlled-Release Caffeine

Objectives: A preliminary, open label study was initiated to determine if oral wafers containing a combination of membrane glycerolphospholipids and controlled-release caffeine could reduce self-reported pain, fatigue, and gastrointestinal symptoms and improve quality of life (QOL) indicators in fibromyalgia patients. Methods: Pain, fatigue and other symptoms were determined using validated, patient survey forms completed over an 8-day test period and compared to baseline values. Participants included 21 patients (15 females and 6 males) of average age of 48.5 ± 9.8 years with a diagnosis of fibromyalgia. These patients consumed four daily chewable wafers containing glycerolphospholipids (4.8 g) and one controlled-released caffeine (184 mg) wafer that maintained caffeine levels at approximately one cup of coffee for over 8 h. Results: Participants in the study responded to the combination test supplement within days. By the end of the study there were significant overall improvements (36.1%, p p p p p Conclusions: The combination membrane lipid replacement glycerolphospholipid supplement with controlled-release caffeine was safe and effective and significantly reduced pain, fatigue and gastrointestinal symptoms as well as improved QOL indicators in fibromyalgia patients.