Photo-infrared pulsed bio-modulation (PIPBM): a novel mechanism for the enhancement of physiologically reparative responses.

OBJECTIVE: The present manuscript describes the non-invasive, long-range, energy transport of a singular infrared pulsed laser device (IPLD) and the upstream components of the original action mechanism, designated photo-infrared pulsed bio-modulation (PIPBM). BACKGROUND DATA: Major strides have been taken in recent years towards scientifically acceptable clinical applications of low-energy lasers. Nevertheless, challenges still abound. For instance, the range of potential target tissues for laser therapy in medicine has been, until now, limited by the optical penetration of the beam or to sites accessible by fiberoptics. In addition, much needs to be learned about the action mechanisms of pulsed lasers, which can induce unique biological effects. METHODS: We present a review of the IPLD laser technology and the PIPBM mechanism. RESULTS: The studies reviewed suggest that the PIPBM enhances physiologically reparative processes in a non-toxic and selective manner through the activation and modulation of chaotic dynamics in water. These, in turn, lead not only to local, but also long-distance (systemic) effects. CONCLUSIONS: Though additional studies are necessary to fully explore the biological effects of the PIPBM induced by the IPLD, this mechanism may have multiple potential applications in medicine that are the subject of active current and future investigations.

Microdensitometry of T2-weighted magnetic resonance (MR) images from patients with advanced neoplasias in a phase I clinical trial of an infrared pulsed laser device (IPLD).

BACKGROUND AND OBJECTIVE: The aim of this study was to determine whether an infrared pulsed laser device (IPLD)-induced pathophysiologic changes could be identified before measurable modifications in tumor volume. STUDY DESIGN/PATIENTS AND METHODS: Pre-and post-IPLD treatment magnetic resonance (MR) images of tumor heterogeneities and peritumoral tissues were digitized and a linear transformation was performed to convert images to 256 intensity levels. Data were analyzed by using the Student's t-test and the Kolmogorov-Sminov test (alpha = 0.05). RESULTS: The post-treatment mean intensity values of tumor heterogeneities increased significantly (P < 0.001) for all of the seven patients (n = 7) evaluated. For peritumoral tissues, a significant increase (P < 0.001) was measured in four patients (n = 4). The Kolmogorov-Sminov test showed significant values for the tumor tissue of six (n = 6) patients. CONCLUSION: This is the first study of early evidence of anti-cancer activity of a novel IPLD showing a significant increase in the water content of tumor heterogeneities before measurable changes in tumor volume.

H-NMR spin-lattice and correlation times of burned soft-tissue after treatment with an infrared pulsed laser device.

BACKGROUND AND OBJECTIVES: The aim of this study was to investigate the spin-lattice (T(1), 1/T(1)) and correlation times (tau(c)) of burned soft-tissue after treatment with an infrared (IR) pulsed laser device (IPLD, 904 nm pulsed at 3 MHz). STUDY DESIGN/MATERIALS AND METHODS: Seven groups (GI-GVII), each consisting of four albino rats, were used. Groups I-VI were anesthetized and burned with a hot tip: GI, GIII, GV were not irradiated; GII, GIV, GVI were irradiated at 0; 0 and 24; and 0, 24, and 48 hours, respectively. A control group (GVII) was neither burned nor irradiated. Samples from all groups were evaluated using a 90 MHz hydrogen nuclear magnetic resonance (H-NMR) spectrometer. An unpaired Student's t-test and an ANOVA I were preformed (alpha = 0.05). RESULTS: At 0 and 24 hours, 1/T(1) and tau(c) data revealed significant differences between GVII and both the non-irradiated (GI, GIII), and irradiated (GII, GIV) groups. At 48 hours, only the difference in tau(c) between GVII and the irradiated group (GVI) remained significant. CONCLUSIONS: Spin-lattice data reflected significant changes in tissues induced by the burn and a tendency towards control values for all burned groups. Meanwhile, the tau(c) value of GVI suggests the possibility of enhanced reparative effects attributable to chaotic intra- and inter-molecular energy transport to biopolymers in injured soft-tissue.

Phase I trial of an infrared pulsed laser device in patients with advanced neoplasias.

PURPOSE: The objective of this study was to evaluate the toxicity/radiant exposure/time relationship of an infrared pulsed laser device (IPLD) treatment in patients with advanced neoplasias. Karnofsky performance status (KPS), Spitzer quality of life index (QLI), and potential antitumor activity, if any, were also assessed. EXPERIMENTAL DESIGN: Seventeen patients (n = 17) received a daily IPLD radiant exposure of 4.5 x 10(5) J/m(2) (904 nm pulsed at 3 MHz) under a one-dose schedule and procedure design. Toxicity was evaluated under the parameters of the WHO; indirect toxic ocular effects were also monitored. KPS and QLI measurements were conducted before treatment and at six 3-months intervals. Scores for the seventh interval are the last available (range, 19-39 months). For statistical purposes, patients were classified into group 1, those alive at the end of the study, and group 2, those who had died. RESULTS: Dose-limiting toxicity was not observed. Five patients (n = 5) reported occasional headaches (grade 2), and four (n = 4) referred local pain (grade 2). In group 1 (n = 7), statistically significant increases in KPS and QLI were observed in all of the follow-up intervals compared with pretreatment values. One patient had a complete response, 1 a partial response, 4 stable diseases > or =12 months, and 1 progressive disease. In group 2 (n = 10), statistically significant increases in QLI were observed during the first two intervals. Eight patients had stable disease > or =6 months and 2 had uninterrupted progressive diseases. CONCLUSIONS: The IPLD treatment studied is safe for clinical use and may have potential effects on KPS, QLI, and antitumor activity in patients with advanced neoplasias.

Photo-induced cytomorphologic changes in an advanced cancer phase I clinical trial.

BACKGROUND AND OBJECTIVES: The aim of this study was to investigate whether the application of an Infrared Pulsed Laser Device (IPLD) photo-induced significant cytomorphologic changes during the monitoring of advanced cancer patients participating in a phase I clinical trial. MATERIALS AND METHODS: Patients were irradiated with an IPLD (904 nm pulsed at 3 MHz) under a one-dose, one-schedule, and one-procedure design. Total daily dose consisted of a Radiant Exposure of 4.5x10(5) J/m(2). Thirty-one tissue samples from eleven patients with progressive solid neoplastic diseases (TNM IV, UICC) were obtained at three intervals: Time 0 (15-90 days pre-treatment, n=11); Time I (2-5 months post-treatment; n=11); Time II (6-12 months post-treatment, n=09). Three blinded pathologists evaluated samples; scores were determined by consensus. Data were evaluated by using the Wilcoxon matched-pairs signed-rank test and Spearman rank correlation coefficient. The level of statistical significance was alpha=0.05. RESULTS: Increased apoptosis (Time I, P<0.003; Time II, P<0.007), necrosis (Time I, NS; Time II, P<0.01), cytoplasmic vacuoles (Time I, P<0.03; Time II, P<0.02), and nuclear vacuoles (Time I, NS; Time II, P<0.01), reduced cell size (Time I, P<0.007; Time II, P<0.01) and intercellular adhesion (Time I, P<0.01; Time II, P<0.02) were present in neoplastic cells after IPLD treatment. No apparent changes were noted in non-neoplastic cells. The Spearman rank correlation coefficient between apoptosis, necrosis, nuclear vacuoles, cytoplasmatic vacuoles, intercellular adhesion, and cell size was positive and highly significant (P<0.006). CONCLUSIONS: Although further research is necessary, our preliminary results support the novel possibility that the IPLD photo-induces chaotic dynamics that modulate complex physiologically reparative bioeffects.