Effects of Intravascular Photobiomodulation on Insomnia, Muscle Soreness, and Biochemistry Profiles: An Eight-Year Follow-Up Study

doi:10.21203/rs.3.rs-2441831/v1

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Effects of Intravascular Photobiomodulation on Insomnia, Muscle Soreness, and Biochemistry Profiles: An Eight-Year Follow-Up Study

https://doi.org/10.21203/rs.3.rs-2441831/v1

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Background

Existing reviews indicate that insomnia and muscle soreness are usually managed pharmacotherapeutically. However, pharmacotherapy can lead to numerous side-effects. The non-drug strategy intravascular laser irradiation of blood (iPBM) has been advocated to improve blood circulation and blood cell function to relieve insomnia and muscle soreness symptoms. Therefore, we assessed whether iPBM improves blood parameters and compared drug use before and after iPBM therapy.

Methods

Consecutive patients who received iPBM therapy between January 2013 and August 2021 were reviewed. The associations between laboratory data, pharmacotherapies, and iPBM therapy were retrospectively analyzed. We compared patient characteristics, blood parameters, and drug use within the three months before first treatment and the three months after last treatment. We also compared the changes before and after treatment in patients who received ≥ 10 and 1‒9 iPBM treatments.

Result

We assessed 183 eligible patients who received iPBM treatment. HGB and HCT significantly increased after treatment in both the ≥ 10 and 1–9 iPBM treatment groups (HGB p < 0.001 and p = 0.046; HCT p < 0.001 and p = 0.029, respectively). Pharmacotherapy analysis revealed no significant differences in drug use before and after treatment; though drug use tended to decrease after iPBM.

Conclusion

iPBM therapy is an efficient, beneficial, and feasible treatment that increases HGB and HCT. While the results of this study do not support the suggestion that iPBM reduces drug use, further larger studies using symptom scales are needed to confirm the changes in insomnia and muscle soreness after iPBM treatment.

Intravascular Photobiomodulation

pharmacotherapies

blood parameters

According to the World Health Organization, insomnia is highly prevalent and affects one in four adults worldwide(1). This sleep disorder impairs cognitive and physical functioning and has a significant negative impact on an individual's work, physical and social performance, as well as their overall quality of life (2, 3). Muscle pain and fatigue are also common problems in general medicine and neurology (4). Muscle pain and fatigue may coexist and can significantly reduce muscle performance during exercise (5). These symptoms can often be debilitating and are associated with significant adverse consequences for physical health and wellbeing. Therefore, it is important that effective treatments are provided in clinical practice. The treatment options for above symptoms include both a variety of pharmacologic therapies and non-medication strategies. Reviews of the available research indicate that pharmacotherapeutic interventions have therapeutic effects in patients with these symptoms and the risk/benefit profiles of these treatments have been well characterized (6–8).

However, medication use and choice is an important concept in medical care because drugs can have many possible adverse effects on multiple organ systems. Non-steroidal anti-inflammatory drugs, which are antipyretic, anti-inflammatory, and analgesic drugs, and the drugs commonly used for insomnia have been reported to cause many side effects (9, 10). In addition, long-term administration of certain drugs, such as opioid analgesics, is associated with high rates of addictive-like behavior and poor recovery outcomes(11, 12). Moreover, long-term administration of hypnotic agents can lead to drug tolerance, dependence, and rebound insomnia(13). Therefore, non-pharmacologic options may potentially provide longer-lasting benefits and reduce the potential burden of these conditions. In addition, approximately 70% of patients suffering insomnia in Taiwan are willing to try non-drug therapies(14).

Recently, the term photobiomodulation (PBM) has replaced the previous low level laser therapy due to unproperly represent electricity and total energy utilization. PBM acts as a form of light therapy by using nonionized light sources to initiate a non-thermal effect in which endogenous chromoplasts result in photo-physicochemical cascades at varying biological levels (15, 16). Intravascular PBM (iPBM) has been advocated since the 1960s; this non-drug therapy was first applied for the treatment of cardiovascular disease and is believed to improve blood circulation and blood cell function(17). iPBM is considered an innocuous and useful laser therapy technique, particularly when systemic effects are required(18). iPBM therapy is currently used as an adjunct for pain management in patients with conditions such as diabetic neuropathy, fibromyalgia, and arthritis(19–21). In addition, iPBM has been demonstrated to have high efficacy for the treatment of vascular, cardiac, and other various pathologic processes such tissue repair(22, 23). However, most of the existing articles on the efficacy of iPBM in insomnia, muscle pain, and fatigue are case reports with small sample sizes (14, 24). Unfortunately, due to the lack of population verification and quantitative analysis, further research is required to assess the efficacy of iPBM in patients with insomnia, muscle pain, and fatigue.

Previous research indicates iPBM may benefit multiple organ systems by modulating immunity, improving blood cell oxygen-carrying capacity, and increasing blood flow (25, 26). Moreover, the low-power laser treatment may enhance red blood cell oxygenation and red blood cell deformability, and thus potentially promote tissue repair and provide pain relief (27). A few cohort studies have demonstrated that iPBM partially alters red blood cell counts; however, those results were obtained in studies with relatively small cohorts (28, 29). Furthermore, it is still unknown whether iPBM actually improves blood parameters. Therefore, further cohort studies of iPBM treatment that include objective biochemical data are needed.

In consideration of the factors above, we propose that iPBM may relieve symptoms of insomnia, muscle pain, and fatigue by influencing metabolism. Thus, we conducted a controlled analysis of the blood parameters of patients before and after iPBM treatment. Furthermore, we also compared the groups of patients who received ≥ 10 and 1‒9 iPBM treatments to understand whether a higher number of treatments has a more beneficial effect. In addition, we evaluated the outcomes of patients before and after iPBM therapy by assessing their drug use to examine the potential therapeutic efficacy and improve our knowledge of iPBM.

2.1. Participants

This single-center, cross-sectional retrospective study was conducted in Taiwan. The study design was approved by Kaohsiung Veterans General Hospital Committee on Human Research (IRB number: KSVGH20-CT-16); the requirement for informed consent was waived due to the retrospective study design and minimal risk to participants. All data were deidentified, and no names or identifying information were revealed.

We retrospectively reviewed the KSVGH database and retrieved data on all patients who received iPBM (Taiex He-Ne Laser, YJ-iPBM-5, Bio-iPBM Human Energy Corporation, Taiwan) between January 2013 and August 2021. The inclusion criterion was treatment with iPBM selected by charge code (66026C, 66029J, 66039, 66040). Patients with missing data for the three months before the first iPBM treatment or three months after the last iPBM treatment were excluded.

2.2 Data collection

All data were retrospectively collected from medical records. We compared the patients’ characteristics, blood test data, and drug use within the three months before their first iPBM treatment and the three months after their last iPBM treatment. In addition, we also compared the blood test data and drug use before and after iPBM treatment in the groups of patients who received ≥ 10 and 1‒9 iPBM treatments.

The variables assessed included diabetes mellitus (DM), hypertension (HTN), hyperlipidemia, and hematology tests and biochemistry data such as white blood cell count (WBC), hemoglobin (HGB), hematocrit (HCT), platelets (PLT), blood urea nitrogen (BUN), creatinine (Cr), and serum glutamate pyruvate transaminase (GPT).

2.3 Pharmacotherapy assessment

The assessment of drug use included hypnotic drugs, muscle relaxants, and analgesics. These drugs were selected based on the drugs used by Kaohsiung Veterans General Hospital and the ATC codes (N05C, M03BX, N05BX, N02B, M01AE, N02AX02). Days of drug use within the 90 days before the first iPBM treatment and 90 days after the last iPBM treatment were determined to assess the efficacy of iPBM therapy. The sums of the days of use of the same types of drugs were divided by 90 as a daily use assessment.

2.3. Statistical analysis

Statistical analyses were performed using SPSS Version 23.0 for Windows (IBM Corp., Armonk, NY, USA). Continuous variables are reported as mean ± standard deviation (SD); categorical data are presented as numbers (percentages). The Student’s t-test or one-way ANOVA were used to compare continuous variables and the chi-squared test or Fisher’s exact test were used to compare categorical variables. P-values < 0.05 were considered statistically significant.

3.1. Patient characteristics

The subjects and study cohorts were selected according to the process presented in Fig. 1. A total of 208 patients who received iPBM therapy between January 2013 and August 2021 were evaluated. We excluded 19 patients whose clinical profiles were not available or with missing data. A total of 183 patients aged 25 to 75-years-old (86 males, 97 females; mean age, 60.8 ± 14.9) met the selection criteria and were enrolled in this study.

We also classified these 183 patients into two groups according to the number iPBM treatments: 28 patients had ≥ 10 iPBM treatments and the other 155 patients had between 1 and 9 iPBM treatments.

Table 1 presents the baseline clinicopathological characteristics and blood data for the 183 patients and Table 2 summarizes the blood parameters.

Table 1

Characteristics of the 183 patients with iPBM therapy.
Variable	Patients with iPBM (N = 183)
Male	86 (47%)
Age	60.8 ± 14.9
BMI	26.4 ± 16.2
DM	59 (32%)
HTN	21 (12%)
Hyperlipidemia	33 (18%)
WBC	11.3 ± 5.9
HGB	12.1 ± 2.1
HCT	36.1 ± 5.9
PLT	310.0 ± 120.7
Cr	1.2 ± 1.4
GPT	40.3 ± 36.3

Table 2

Comparison of the lab data between the before and after iPBM.
Variable	iPBM times	before	after	P-value
WBC	< 10	11.1 ± 5.9	6.7 ± 2.2	0.010
WBC	> 10	12.5 ± 5.7	7.9 ± 3.9	0.221
HGB	< 10	12.3 ± 2.0	13.1 ± 1.5	< 0.001
HGB	> 10	11.1 ± 1.9	12.0 ± 1.8	0.046
HCT	< 10	36.6 ± 5.8	39.2 ± 4.4	< 0.001
HCT	> 10	32.9 ± 5.8	35.7 ± 5.0	0.029
Cr	< 10	1.1 ± 0.8	0.9 ± 0.4	< 0.001
Cr	> 10	2.0 ± 3.2	1.7 ± 2.8	< 0.001
GPT	< 10	40.6 ± 36.4	23.2 ± 14.3	< 0.001
GPT	> 10	48.5 ± 54.0	18.8 ± 7.8	0.878

3.2. Impact of iPBM on laboratory data

As shown in Table 2, both HGB and HCT significantly increased after treatment in both the ≥ 10 and 1–9 iPBM treatment groups (HGB p < 0.001 and p = 0.046; HCT p < 0.001 and p = 0.029, respectively). WBC and GPT only decreased significantly after treatment in the 1–9 iPBM treatment group (p = 0.010 and p < 0.001, respectively), whereas Cr decreased significantly after treatment in both groups (p < 0.001).

In the comparison of the post-treatment values of the ≥ 10 and 1–9 iPBM treatment groups, WBC (p = 0.024) and Cr (p = 0.003) were significantly higher in the patients who received ≥ 10 treatments; no other parameters were significantly different after treatment between the patients who received ≥ 10 and 1‒9 iPBM treatments (Fig. 2).

3.3. Pharmacotherapy analysis

As shown in Fig. 3, although the days of usage of hypnotic agents, muscle relaxants, and analgesics decreased from 0.987, 0.937, and 1.454 to 0.684, 0.702, and 1.3982, respectively, after treatment in the 1–9 iPBM group, these changes did not reach statistical significance. Similar trends were observed in the ≥ 10 treatment group.

Over the past 40 years, a number of clinical studies have suggested that iPBM can improve insomnia, metabolism, muscle soreness, and muscle pain; however, the effects of iPBM have not been investigated in cohort studies. To our knowledge, this is the first study to assess the associations between drug use for insomnia or muscle pain and muscle relaxants and the efficacy of iPBM. This study aimed to evaluate the clinical impact of iPBM therapy on the laboratory parameters and drug use of patients with insomnia, muscle pain, and fatigue. We retrospectively analyzed 183 patients who were classified according to the number of treatments. The main finding was that both ≥ 10 and 1‒9 iPBM treatments improved HGB and HCT. However, HGB and HCT were not significantly different after treatment between the groups who received ≥ 10 and 1‒9 iPBM treatments. Furthermore, our medication analysis revealed that iPBM tended to reduce drug use, but these changes were not statistically significant.

We found that HGB and HCT significantly improved after iPBM treatment regardless of the number of iPBM treatments. These findings are similar to, but not exactly the same, as the results of Russian comparative study of 120 patients with peritonitis (30). Zimon et al. applied intensive iPBM therapy in 60 patients with peritonitis and found that iPBM stimulated the bone marrow and the organs in which blood elements are stored, and as a result intensified ejection into the circulation. In fact, these changes in RBCs were associated with better morphometry, electrophoretic mobility, and higher levels of adenosine triphosphate (ATP) in RBCs. iPBM has been shown to restore normal red blood cell morphology, reduce transition morphology, and increase electrophoretic mobility (31). Experimental studies in animal models also observed the same results (32, 33). Deryugina et al. conducted a comparative study and found that low-level laser therapy restored RBC phase portraits, improved electrophoretic mobility and osmotic resistance, and increased the RBC count in the peripheral blood of rats (32). Moreover, laser light was reported to alter the levels of ATP in RBCs, which is used as marker for RBC viability, and thus increase the viability of RBCs (34).

However, HGB and HCT were not significantly different after treatment between the groups who received ≥ 10 and 1‒9 iPBM treatments. Patients who received fewer than 10 iPBM treatments had higher HGB and HCT before treatment; thus, the lack of difference between groups who received ≥ 10 and 1‒9 iPBM treatments may be due to the fact that the > 10 iPBM group had more severe disease status. In fact, average HGB and HCT were lower before treatment in the > 10 group (11.1 and 32.9, respectively), compared to the 1‒9 iPBM group (12.3 and 36.6, respectively). More than 10 courses of iPBM increased the average HGB and HCT by 1 and 2.8, which was slightly greater than the amount of change in the < 10 iPBM treatment group. In addition, some patients who received a small number of courses of iPBM received other treatments such as blood transfusion and/or drug therapies including berberine, eperisone hydrochloride, and steroids, which can also improve HGB and HCT (35–37). Therefore, although it was not possible to perform stratified analysis because of the wide variety of drugs, our results demonstrate that > 10 iPBM treatments might lead to better effects than < 10 treatments and that iPBM may even represent an alternative treatment to drugs.

We further investigated whether iPBM therapy can reduce the use of various commonly prescribed drugs. There was no significant reduction in the days of drug use after iPBM, despite the patients’ reports of symptomatic relief. This may be due to several reasons. First, due to the accessibility of Taiwan's medical and health insurance system, patients and doctors largely prescribe medicines according to their own habits, even if the patients’ symptoms reduce. Moreover, theoretically, we originally assumed that patients would have higher medicine use several tens of days after the last iPBM treatment due to ‘therapy withdrawal’ or the ‘rebounding effect’. There was a trend toward lower drug use after iPBM treatment, regardless of the number of treatments, compared to pre-treatment. A similar result was also noted in the recent study by Wu et al. (38), in which drugs and iPBM both led to significant improvements among patients with fibromyalgia. Other studies have also shown that iPBM-treated patients function similarly to patients with certain diseases treated with other drugs (39–41). Hence, we consider that iPBM has a positive effect on reducing drug use. However, the improvements in the patients' symptoms were not fully represented by the number of days of drug use and only a small number of patients received more than 10 iPBM treatments. Larger studies using scales for specific symptoms are needed to more precisely explore the changes in symptoms after iPBM treatment.

This study has some inherent limitations. Firstly, as this was a retrospective analysis, data for several important variables were lost or insufficient, such as the homeostasis model assessment-insulin resistance index and some of the pre- and post-treatment variables. Second, we only included data on medicines from the KSVGH database; some patients may have obtained medicines from other providers not included in the database. However, we believe that the risk of bias was small, because most of the patients were treated and followed-up by the same physicians. Finally, only patients from were Taiwan enrolled in this study. It is necessary to provide additional studies to confirm whether these trends also occur in other cohorts from Asia and Western countries.

In conclusion, the present study confirmed that iPBM therapy is an efficient, beneficial, and feasible strategy to increase HGB and HCT in patients with insomnia, muscle pain, and fatigue. Moreover, this was the first study to assess the association between iPBM therapy and drug use for insomnia or muscle pain and muscle relaxants. Although our results do not support the suggestion that iPBM reduces the days of drug use, a trend towards decreased drug use was observed. These findings provide important insights that will be useful for the development of rehabilitation interventions. Moreover, it is suggested that iPBM may be a novel alternative treatment in the future.

Intravascular Photobiomodulation(iPBM), diabetes mellitus (DM), hypertension (HTN), red blood cell white(RBC), blood cell (WBC), hemoglobin (HGB), hematocrit (HCT), platelets (PLT), blood urea nitrogen (BUN), creatinine (Cr), glutamate pyruvate transaminase (GPT), adenosine triphosphate (ATP)

Ethics approval and consent to participate

The study design was approved by Kaohsiung Veterans General Hospital Committee on Human Research (IRB number: KSVGH20-CT-16). The requirement for informed consent was waived due to the retrospective study design and minimal risk to participants. All data were deidentified, and no names or identifying information were revealed.

Consent for publication

Not applicable

Availability of data and materials

Not applicable

Competing interests

The authors declare that they have no competing interests

Funding

Not applicable

Authors' contributions

Yen-Po Lin was a major contributor in writing the manuscript.Ruei-Sian Ding interpreted the patient data, Chun-Hao Yin and Yao-Shen Chen preformed statistical analysis, Jin-Shuen Chen did the English correction, Shin-Tsu Chang design the study and was the correpondent author. All authors read and approved the final manuscript.

Acknowledgements

Not applicable

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No competing interests reported.

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Effects of Intravascular Photobiomodulation on Insomnia, Muscle Soreness, and Biochemistry Profiles: An Eight-Year Follow-Up Study

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Version 1

Abstract

Background

Methods

Result

Conclusion

Figures

1. Introduction

2. Methods

2.1. Participants

2.2 Data collection

2.3 Pharmacotherapy assessment

2.3. Statistical analysis

3. Results

3.1. Patient characteristics

3.2. Impact of iPBM on laboratory data

3.3. Pharmacotherapy analysis

4. Discussion

Conclusion

List Of Abbreviations

Declarations

References

Additional Declarations

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