1. Introduction
Sleep disorders and psychological distress are swiftly emerging as paramount health challenges on a global scale. Their profound ramifications on physical and mental well-being, as well as on overall life quality, are irrefutable.[1] Epidemiological research underscores that sleep disorders, spanning from insomnia to obstructive sleep apnea, correlate with a spectrum of health ailments, encompassing cardiovascular diseases, metabolic imbalances, and cognitive declines.[2] The symbiotic relationship between sleep and psychological stress is also compellingly evidenced: chronic stress can perturb sleep patterns, and in a vicious cycle, compromised sleep quality can amplify stress, potentially culminating in psychological maladies such as anxiety and depression.[3]
In the realm of Western medicine, pharmacologic interventions remain the linchpin for managing sleep and stress-related afflictions.[4,5] Nonetheless, the potential caveats of these modalities – including side effects, dependency concerns, and tolerance onset – highlight the pressing need to venture into alternative and complementary therapeutic avenues.[5] Eszopiclone, a non-benzodiazepine hypnotic agent, has gained prominence for insomnia management, attributed to its adeptness in facilitating sleep initiation and prolonging sleep duration.[6] Yet, its administration comes with inherent challenges. The medical community, along with patients, has voiced apprehensions regarding its side effects, such as unpleasant taste, headaches, dizziness, fatigue, and nausea.[7,8] This predicament has catalyzed a pivot towards holistic approaches that enhance sleep quality while sidestepping the adverse repercussions of conventional drugs.
For millennia, Traditional Chinese Medicine (TCM) has championed a comprehensive, holistic paradigm in healthcare.[9] Within the vast TCM therapeutic arsenal, warm acupuncture and gua sha stand out for their purported efficacy in ameliorating sleep and stress-induced disorders.[10] Warm acupuncture marries the foundational tenets of acupuncture with moxibustion’s therapeutic nuances, seeking not only to balance the body’s intrinsic “qi” or energy but also to instill a warming sensation, which resonates with specific energy meridians.[10] Gua sha, with its distinctive technique, is lauded for augmenting blood circulation, dispelling energy stasis, and fostering recuperation.[11] Intriguingly, warm acupuncture and gua sha have demonstrated potential in mitigating some prevalent side effects of eszopiclone, including the likes of headaches, dizziness, fatigue, and nausea.[12–14]
While historical testimonies and anecdotal narratives vouch for the virtues of these TCM techniques, an unyielding scientific probe is pivotal to corroborate their merits and discern their operational mechanisms. As the international health landscape evolves towards an integrative stance, this study aims to bridge this knowledge void, using eszopiclone-administered insomnia patients as the investigative framework. Through a meticulous evaluation of the synergistic effects of warm acupuncture and gua sha on sleep quality and psychological stress, our endeavor is to fortify the evidence base underscoring these time-honored therapies.
2. Methods
2.1. Study design and participants
The study was approved by the Ethics Committee of Gansu Baoshihua Hospital (2023-k0715-No. 24). This retrospective study was conducted at hospital between January and December 2022. We examined 138 insomnia patients, aged 18 to 65, who were undergoing treatment with eszopiclone tablets. All participants met the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for primary insomnia and had been on eszopiclone therapy for at least 1 month. This study excluded any condition or medication known to influence sleep significantly, including insomnia secondary to major mental disorders like depression or anxiety, sleep disturbances due to neurological conditions (e.g., epilepsy, traumatic brain injury, brain tumors, encephalitis, cerebrovascular disease), diagnosed sleep apnea, and other significant sleep disorders. Additionally, patients on medications known to affect sleep architecture, such as some antidepressants (e.g., SSRIs, SNRIs), stimulants (e.g., amphetamines), and corticosteroids, were also excluded to minimize confounding factors.
2.2. Interventions
Participants were divided into 2 distinct groups. The intervention group, consisting of 67 patients, received warm needle moxibustion and gua sha treatment in addition to eszopiclone therapy. Moxibustion involves igniting dried mugwort on specific body points to stimulate circulation and promote healing. Gua Sha, conversely, uses massage tools to scrape the skin, aiming to increase blood flow. The combined therapies were administered for 30 minutes, twice weekly over an 8-week period. The control group, comprising 71 patients, received standard care and eszopiclone tablets without any TCM interventions.
2.3. Outcome measures
Primary outcomes encompassed changes in sleep quality and psychological stress levels, evaluated using the Pittsburgh Sleep Quality Index (PSQI), the Perceived Stress Scale-10 (PSS-10) and the Epworth Sleepiness Scale (ESS). Secondary outcomes are adverse reactions, including nausea, headache, dizziness, and fatigue, were meticulously recorded before and after the interventions. All assessments were conducted at the study’s outset and conclusion.
2.4. Statistical analysis
Data processing utilized SPSS version 26.0 (IBM Inc., Chicago). The Kolmogorov–Smirnov test determined data normality. Continuous variables with a normal distribution were represented by mean ± standard deviation, while those without a normal distribution were represented by the median (interquartile range). Categorical variables were represented by frequency (percentage). Depending on the data distribution, group comparisons for continuous variables were conducted using either independent t-test or Mann-Whitney U-test. Categorical variables were compared using the chi-square test or Fisher exact test. All statistical analyses were 2-tailed, and a P-value of less than .05 was considered statistically significant.
3. Results
3.1. Demographic and clinical characteristics of participants at baseline
A total of 138 insomnia patients were included in the study, with 67 in the intervention group (eszopiclone, warm needle moxibustion, and gua sha) and 71 in the control group (eszopiclone alone). The baseline demographics of 2 groups were presented in Table 1. The median age for the intervention group was 43.0 years (IQR: 29.5–60.5) while it was 47.0 years (IQR: 33.0–59.0) for the control group (P > .05). Sex distribution showed that 64.18% were female in the intervention group, while 56.34% were female in the control group (P > .05). There were no significant differences between the 2 groups regarding education background, marital status, BMI, smoking habits, alcohol consumption, or duration of insomnia (P > .05). Besides, both intervention and control groups demonstrated similar baseline scores for the PSQI, PSS-10, and ESS (P > .05). In terms of baseline symptoms, there were no significant differences between the 2 groups regarding the prevalence of nausea, headache, dizziness, and fatigue (P > .05).
Table 1 - Demographic and clinical characteristics of participants at baseline.
Parameter | Intervention group (n = 67) | Control group (n = 71) | P-value |
---|---|---|---|
Age, yr | 43.0 (29.5, 60.5) | 47.0 (33.0, 59.0) | .873 |
Sex, female | 43 (64.18%) | 40 (56.34%) | .443 |
Education background | |||
High school or below | 16 (23.88%) | 16 (22.54%) | .535 |
Bachelor degree | 33 (49.25%) | 41 (57.75%) | |
Master or above | 18 (26.87%) | 14 (19.72%) | |
Marital status | |||
Married | 21 (31.34%) | 16 (22.54%) | .449 |
Single | 22 (32.84%) | 29 (40.85%) | |
Divorced | 24 (35.82%) | 26 (36.62%) | |
BMI | 24.3 (20.45, 26.4) | 22.4 (20.6, 26.65) | .821 |
Smoking | 18 (26.9%) | 22 (31.0%) | .730 |
Alcohol consumption | 30 (44.8%) | 33 (46.5%) | .976 |
Duration of insomnia, mo | 25.90 (18.40, 33.70) | 24.8 (17.20, 30.20) | 0.357 |
Baseline PSQI Score | 11.0 (8.0, 12.0) | 11.0 (8.5, 13.0) | 0.279 |
Baseline PSS-10 score | 19.0 (15.5, 24.5) | 20.0 (15.5, 27.0) | 0.179 |
Baseline ESS score | 12.0 (10.0, 14.5) | 12.0 (9.0, 14.0) | 0.355 |
Baseline nausea | 33 (49.3%) | 37 (52.1%) | 0.869 |
Baseline headache | 27 (40.3%) | 34 (47.9%) | 0.468 |
Baseline dizziness | 39 (58.2%) | 34 (47.9%) | 0.297 |
Baseline fatigue | 33 (49.3%) | 33 (46.5%) | 0.876 |
Data were represented by the median (interquartile range) or frequency (percentage). Abbreviations: BMI = body mass index, ESS = Epworth Sleepiness Scale, PSQI = Pittsburgh Sleep Quality Index, PSS = Perceived Stress Scale.
3.2. Post-intervention sleep and stress parameters
As shown in Table 2, significant reduction of PSQI and ESS scores were observed in the intervention group after the intervention (P < .05), while the control group displayed a nonsignificant change in the post-intervention PSQI and ESS scores (P > .05). For the PSS-10 score, no significant changes were observed post-intervention in both groups (P > .05).
Table 2 - Sleep quality and psychological stress assessment after intervention.
Parameter | Intervention group (n = 67) | Control group (n = 71) | ||||
---|---|---|---|---|---|---|
Baseline | Post-intervention | P-value | Baseline | Post-intervention | P-value | |
PSQI score | 11.0 (8.0, 12.0) | 8.0 (2.0, 12.0)† | .015* | 11.0 (8.5, 13.0) | 10.0 (6.5, 13.5)† | .397 |
PSS-10 score | 19.0 (15.5, 24.5) | 20.0 (14.0, 26.0) | .928 | 20.0 (15.5, 27.0) | 22.0 (18.5, 25.0) | .305 |
ESS score | 12.0 (10.0, 14.5) | 11.0 (8.0, 13.0)† | .014* | 12.0 (9.0, 14.0) | 12.0 (9.0, 15.0)† | .540 |
Data were represented by the median (interquartile range). Abbreviations: ESS = Epworth Sleepiness Scale, PSQI = Pittsburgh Sleep Quality Index, PSS = Perceived Stress Scale. *P indicates a significant within-group difference (P-value < .05) between baseline and post-intervention. †P indicates a significant between-group difference (P-value < .05) at a particular time point.
3.3. Prevalence of adverse effects
In terms of adverse reactions, the intervention group demonstrated a significant reduction in the prevalence of nausea post-intervention, with 29.9% of participants experiencing nausea compared to the 49.3% at baseline (P < .05). Similarly, the prevalence of dizziness in the intervention group decreased significantly from 58.2% at baseline to 37.3% post-intervention (P < .05). However, changes in the prevalence of headache and fatigue were not statistically significant (P > .05). In the control group, no significant changes in the prevalence of nausea, headache, dizziness, or fatigue were observed post-intervention (P > .05). Upon comparing post-intervention prevalence of adverse effects between 2 groups, the intervention group reported significantly lower nausea prevalence compared to the control group (P < .05). There were no significant differences between the 2 groups in terms of post-intervention headache, dizziness, and fatigue prevalence (P > .05) (Table 3).
Table 3 - Prevalence of adverse effects before and after intervention.
Parameter | Intervention group (n = 67) | Control group (n = 71) | ||||
---|---|---|---|---|---|---|
Baseline | Post-intervention | P-value | Baseline | Post-intervention | P-value | |
Nausea | 33 (49.3%) | 20 (29.9%)† | .034* | 37 (52.1%) | 39 (54.9%)† | .866 |
Headache | 27 (40.3%) | 18 (26.9%) | .143 | 34 (47.9%) | 29 (40.8%) | .499 |
Dizziness | 39 (58.2%) | 25 (37.3%) | .025* | 34 (47.9%) | 32 (45.1%) | .866 |
Fatigue | 33 (49.3%) | 26 (38.8%) | .296 | 33 (46.5%) | 35 (49.3%) | .867 |
Data were represented by the frequency (percentage). *P indicates a significant within-group difference (P-value < .05) between baseline and post-intervention. †P indicates a significant between-group difference (P-value < .05) at a particular time point.
4. Discussion
The present retrospective study aimed to compare the effects of warm needle moxibustion and gua sha nursing care combined with eszopiclone tablet treatment versus eszopiclone alone on sleep quality and psychological stress in insomnia patients. Our findings revealed the potential synergistic benefits of integrating TCM technology and traditional medicine in the management of insomnia.
Warm needle moxibustion is a TCM technique that involves the ignition of dried Artemisia absinthium at specific acupuncture points, which is believed to stimulate circulation and promote healing.[15] The heat generated by moxibustion penetrates deep into the body to warm the meridians and dispel cold, helping to regulate the balance of yin and yang in the body.[16] In recent years, warm needle moxibustion has been shown to improve sleep quality.[17] The underlying mechanism may involve stimulation of specific acupoints, resulting in the release of neurotransmitters that regulate the sleep-wake cycle.[18,19] In addition, the pharmacological effects of moxa, in combination with heat and needling, can enhance analgesic properties and have the potential to improve the quality of sleep. Similarly, gua sha, a traditional scraping therapy, has been shown to improve blood circulation and reduce muscle tension, which may help improve sleep and reduce stress.[20] In the present study, all the patients received eszopiclone for more than 1 month, and the control patients who continued to receive eszopiclone did not experience significant improvement in sleep, but PSQI and ESS scores were significantly reduced after receiving the combined regimen of eszopiclone, warm needle moxibustion and gua sha, indicating the significant improvement of sleep quality in insomnia patients. This suggested that the addition of warm needle moxibustion and gua sha might enhance the efficacy of eszopiclone, and that insomnia patients who do not respond to eszopiclone may be able to benefit from warm needle moxibustion and gua sha.
On the other hand, warm needle moxibustion and gua sha mainly interfere with insomnia through physical means, and the adverse reactions are lower than those of drug treatment.[21] In this study, after the intervention of warm needle moxibustion and gua sha, the incidence of nausea and dizziness decreased significantly, but this decrease was not observed in the patients receiving eszopiclone alone. This indicated that Chinese medicine technology might have a protective effect on some side effects of eszopiclone. It might be due to the placebo effect of gua sha and warm needle moxibustion which relieve the undesirable symptoms.[20] The exact mechanism behind this protective effect deserves further study.
In addition, the PSS-10 scores of the 2 groups did not change significantly after the intervention. This showed that although warm needle moxibustion and gua sha nursing care combined with eszopiclone improved sleep quality, they might not have a significant impact on psychological stress. Previous studies have found that acupuncture treatment can effectively relieve anxiety, depression and burnout, and improve sleep quality.[22,23] Therefore, future research with larger sample size and longer treatment duration are needed to provide more insights in this regard.
This study has several limitations that should be acknowledged. Firstly, as a single-center retrospective study with a relatively small sample size, the findings may not be generalizable to broader populations. The demographic and clinical characteristics of the included patients may not represent those of insomnia patients in other regions or healthcare systems. Secondly, the reliance on self-reported measures, such as the PSQI, PSS-10, and ESS, introduces potential recall and reporting biases, limiting the objectivity of the results. Thirdly, the intervention period of 8 weeks was relatively short, which may have constrained the ability to detect long-term effects on sleep quality, psychological stress, or sustained reduction in adverse effects. Lastly, while the study observed a reduction in some adverse reactions, the underlying mechanisms of how warm needle moxibustion and gua sha reduce these effects remain unclear and warrant further exploration.
To address these limitations, future studies will be designed as prospective, multi-center clinical trials with larger sample sizes to enhance the external validity of the findings. These studies will incorporate objective measures, such as actigraphy or polysomnography, to provide more robust assessments of sleep quality and stress. Additionally, the intervention duration will be extended to explore long-term efficacy and safety. Mechanistic studies will also be conducted to elucidate the biological processes by which TCM therapies, such as warm needle moxibustion and gua sha, exert their effects on insomnia and associated symptoms. Ultimately, these efforts aim to build a more comprehensive evidence base to support integrative approaches in the management of insomnia.
5. Conclusion
The combined regimen of eszopiclone, warm needle moxibustion and gua sha seems to provide better benefits in improving sleep quality and reducing the incidence of some adverse reactions Compared with eszopiclone monotherapy. These findings emphasize the potential of combining TCM technology with modern pharmacological treatment to improve the therapeutic effect of insomnia patients.
Author contributions
Conceptualization: Linlin Fan.
Data curation: Changxia Lu.
Formal analysis: Linlin Fan, Caiyun Wu, Changxia Lu.
Methodology: Linlin Fan.
Software: Changxia Lu.
Supervision: Caiyun Wu.
Validation: Caiyun Wu.
Visualization: Changxia Lu.
Writing – original draft: Linlin Fan.
Writing – review & editing: Caiyun Wu.
Abbreavtions:
- ESS
- Epworth Sleepiness Scale
- PSQI
- Pittsburgh Sleep Quality Index
- PSS-10
- Perceived Stress Scale-10
- TCM
- traditional Chinese medicine.
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Keywords:
eszopiclone tablet; gua sha; insomnia; warm needle moxibustion