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Abstract

This study examines the effects of electroacupuncture treatment on health-related quality of life and heart rate variability in women with fibromyalgia. Twenty women with fibromyalgia received a 10-week treatment with electroacupuncture. Primary outcome measures were the Fibromyalgia Impact Questionnaire, the Short Form 36 Health Survey Questionnaire, and heart rate variability. Compared with pretreatment, there was a significant improvement in health-related quality of life; electroacupuncture significantly increases low frequency, low frequency/high frequency, and decreases high frequency, all indicating rise in sympathetic tone. Fibromyalgia patients showed a significant (P < .05) improvement in pain, fatigue, morning tiredness, stiffness, anxiety, and depression on the Fibromyalgia Impact Questionnaire scores; and physical function, physical role, body pain, general health, and vitality scores on the Short Form 36 Health Survey Questionnaire. These changes mainly in mental status scores could be related to a new autonomic balance with sympathetic predominance at the horary of the study.

Keywords

fibromyalgia electroacupuncture health-related quality of life heart rate variability

Fibromyalgia affects 2% of the Mexican population, of which 80% to 90% are women.¹ Several studies pointed that autonomic imbalance could contribute to the fibromyalgia symptoms.^2,3

Changes in heart rate variability has been correlated with anxiety tests in patients with fibromyalgia,⁴ pain intensity,⁵ and seems to be a useful noninvasive tool for the evaluation of autonomic nervous system.⁶ Furthermore, fibromyalgia patients show sympathetic hyperactivity and abnormal vagal balance.⁷ Interestingly, a correlation between symptoms severity or quality of life and autonomic dysfunction has been described.⁸

Fibromyalgia patients experience a variety of symptoms, including depression, anxiety, sleep disturbances, fatigue, cognitive deficits, and limitations in daily activities.^9
–11

Fibromyalgia patients experience significantly impairment in health-related quality of life.¹² Furthermore, a comparison between matched controls and persons with fibromyalgia showed a statistically significant difference between sleep difficulty symptoms, such as initiating and maintaining sleep, and health-related quality of life.¹³

Despite the interest that fibromyalgia has generated lately, there is no effective treatment. Therefore, patients have turned to nonpharmacological options such as acupuncture.¹⁴ Acupuncture reduce pain and inflammation of various pathologies by stimulating the release of endorphins, and therefore provides improvement of symptoms of fibromyalgia.¹⁵ Electroacupuncture has been reported as an efficacious treatment for fibromyalgia, both in animal fibromyalgia models¹⁶ and in humans.^17,18

The purpose of this study was to compare health-related quality of life with autonomic activity in patients with fibromyalgia, before and after 10 sessions of electroacupuncture treatment.

Materials and Methods

Participants

This study enrolled fibromyalgia outpatients who attend the Acupuncture Clinic of Universidad Autónoma Metropolitana for treatment. Fibromyalgia patients were previously diagnosed by a rheumatologist, using the criteria of the American College of Rheumatology.¹⁹ Twenty women with fibromyalgia participated in the study.

Inclusion Criteria

Patients with fibromyalgia diagnosed based on American College of Rheumatology criteria¹⁹

Patients aged 32 to 65 years

Patients who fully understand the research process and were willing to provide informed consent

Exclusion Criteria

Patients with general musculoskeletal pain due to nonfibromyalgia illness

Patients with mental disorders or other serious organic diseases, such as organ failure

Patients taking oral pain medication or undergoing other interventions for pain relief during the trial

Pregnant or lactating women

Patients currently participating in another clinical trial

Ethical Issue

This study was performed in accordance with the ethical principles for medical research involving human subjects of the Declaration of Helsinki.²⁰ The protocol, including the informed consent document, was submitted to the Institutional Ethics Committee of Universidad Autónoma Metropolitana. All participants agreed to participate in the study and received detailed information about the purpose of this investigation and signed an informed consent document.

Acupuncture Treatment

We based the acupuncture point selections on traditional Chinese medicine meridian theory, extraordinary vessels, and individualized Western acupuncture techniques by using a list of points previously reported as being effective in fibromyalgia.^21
–23 Acupoints GV-20 (head Baihui), CV-17 (Danzhong), PC-6 (Neiguan), H-7 (Shenmen), L-3 (Taichong), K-3 (Taixi), and B-62 (Shenmai) were selected for treatment. Sterile stainless steel needles with a double coil, 0.25 × 60 mm, were used. Electrical stimulation consisted of biphasic constant current (2 mA) pulses of 15 Hz for 20 minutes (Acupuncture Stimulator KWD 808 I, Jiangsu, China). Treatment consisted of 2 sessions per week for 10 weeks. A medical doctor specialized in acupuncture, and with more than 20 years of clinical experience, conducted the electroacupuncture treatments.

Outcomes

For functional and psychological outcomes, we used Fibromyalgia Impact Questionnaire score.²⁴ It is the sum of the 8 Fibromyalgia Impact Questionnaire subscales (each on a 0- to 10-point scale) and 20 items. The subscales are physical function, days wellness and labor capacity, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The first 11 items identify the patient’s function including shopping, laundry, meal preparation, dish washing, sweeping, bed preparing, walking 100 meters, working in the house garden, driving, and going up the stairs. Two items are the number of days that the patient missed work due to disease and the number of days he/she had a good feeling. The final 7 items evaluate psychological status including depression, anxiety, tiredness, stiffness, working problem, fatigue, and pain severity. A higher score indicates a lower health status.²⁵

The validated Mexican version of the Short Form 36 Health Survey Questionnaire was used to assess physical function, mental health, and health-related quality of life.²⁶ This self-reported questionnaire examines 2 main domains of health, namely, the physical and mental components. The questions are summarized into 8 scales: (1) physical function—walking, lifting; (2) role limitations-physical—limitations to perform usual activities; (3) bodily pain—level of bodily pain or discomfort; (4) general health perceptions—global evaluation of health; (5) vitality—energy level or fatigue; (6) social function—impact of health or emotional problems on social activities; (7) role function-emotional; and (8) mental health—anxiety, depression, sense of psychological well-being. For each domain, a score ranging from 0 (worst measured health) to 100 (best-measured health) was calculated. Higher scores represent better health for that particular subitem; the first 4 categories of the scale represent the physical component summary of the survey and measure domains related to physical health, whereas the last 4 categories represent the mental component summary of the survey and measure domains related to mental health.^27,28

Heart rate variability was assessed in the morning between 9:00 and 11:00 am in a quiet study room with a 25°C environmental temperature, with the participant lying in the resting supine position. The procedure was explained in detail to the participants. After a rest period of 15 minutes, a 5-minute electrocardiogram was recorded. The 5-minute electrocardiogram segments were amplified, digitized, and stored on a computer, using the SphygmoCor device (AtCor Medical, Model EM3, Sydney, Australia). The device takes into account the normal heart beats, ignoring ectopic beats, to derive the statistical parameters of the normal R-R intervals (N-N intervals) of the electrocardiogram, and estimates several time- and frequency-domain heart rate variability indices. The time-domain index of heart rate variability used in the present analysis was the root mean square difference of successive normal R-R interval; this measure estimates high-frequency variations in heart rate in short-term N-N recordings that reflects an estimate of the parasympathetic regulation of the heart. It is a measure of parasympathetic autonomic function, and its reduction is a marker of parasympathetic withdrawal. Electrocardiogram recording was performed before electroacupuncture treatment.^29,30

Fibromyalgia Impact Questionnaire, Short Form 36 Health Survey Questionnaire, and heart rate variability data were obtained from each patient pre- and posttreatment.

Statistical Analysis

The data are expressed as the mean ± standard deviation. Statistical software SPSS version 13.0 (SPSS Inc, Chicago, IL) was used for all statistical analysis. Comparisons of heart rate variability before and after electroacupuncture treatment were performed using 2-tailed, paired Student’s t tests. Correlation values of total scores of Fibromyalgia Impact Questionnaire, Short Form 36 Health Survey Questionnaire subitems with indicators of heart rate variability were performed by Pearson correlation analysis. P values of <.05 were considered statistically significant.

Results

The demographics of the patients with fibromyalgia are shown in Table 1.

Table 1.

Characteristics of the Study Population.

Characteristic	n ± SD
Age in years, mean (SD)	47.0 ± 10.8
Body mass index (kg/m²), mean (SD)	27.7 ± 5.8
Employment status—job/home, n (%)	13 (65)/7 (35)
Pain duration in years, mean (SD)	3.0 ± 1.2
Tender points, mean (SD)	5.6 ± 3.3
Severity of pain points in VAS, mean (SD)	6.6 ± 2.3

Abbreviations: SD, standard deviation; VAS, visual analog scale for pain.

Health-Related Quality of Life Indexes

The higher score of the Fibromyalgia Impact Questionnaire, 100, represents greater severity of illness. The Fibromyalgia Impact Questionnaire scores before and after electroacupuncture are shown in Figure 1. The basal Fibromyalgia Impact Questionnaire scores indicate levels of moderate fibromyalgia and were significantly improved by electroacupuncture treatment. It is observed that the greatest and significant (P < .05) impact of electroacupuncture treatment was observed in pain, fatigue, morning tiredness, stiffness, anxiety, and depression.

Figure 1.

Fibromyalgia Impact Questionnaire scores before and after electroacupuncture treatment.

The higher score of Short Form 36 Health Survey Questionnaire, 100, represents better quality of life. Figure 2 shows scores of Short Form 36 Health Survey Questionnaire of patients before and after electroacupuncture treatment. After treatment with electroacupuncture, fibromyalgia patients improves significantly (P < .05) in physical function, physical role, body pain, general health, and vitality scores.

Figure 2.

Short Form 36 Health Survey Questionnaire scores before and after electroacupuncture treatment.

Heart Rate Variability Analysis

Change in heart rate variability components before and after electroacupuncture are presented in Table 2. Electroacupuncture elicited significantly increase in low frequency, 58.3 ± 15.0 to 76.6 ± 4.1 (P < .001); a decrease in high frequency, 41.5 ± 14.8 to 23.3 ± 4.1 (P < .001); and an increase in low frequency/high frequency ratio, 1.7 ± 1.0 to 3.4 ± 1.1 (P < .001); all indicating rise in sympathetic tone.

Table 2.

Heart Rate Variability in Fibromyalgia Patients Before and After Electroacupuncture Treatment.

	Basal (Mean ± SD)	EA (Mean ± SD)	P Value
rMSSD (ms)	38.5 ± 33.0	31.8 ± 22.3	.3112
LF (ms²; 0.04-0.15 Hz)	58.3 ± 15.0	76.6 ± 4.1	<.001
HF (ms²; 0.04-0.4 Hz)	41.5 ± 14.8	23.3 ± 4.1	<.001
LF/HF	1.7 ± 1.0	3.4 ± 1.1	<.001
HRV	8.2 ± 4.3	7.4 ± 3.3	.3269

Abbreviations: SD, standard deviation; EA, electroacupuncture; rMSSD, root mean square of the successive differences; LF, low frequency; HF, high frequency; LF/HF, low frequency/high frequency ratio; HRV, heart rate variability.

Correlation Between Health-Related Quality of Life Indices With Heart Rate Variability

The correlation between heart rate variability parameters with Fibromyalgia Impact Questionnaire is shown in Table 3. Before treatment, heart rate variability parameters and Fibromyalgia Impact Questionnaire scores were negatively correlated with low frequency (−0.481) and positively correlated for high frequency (0.496), both with a P < .1, namely, better Fibromyalgia Impact Questionnaire scores corresponds with higher parasympathetic drive.

Table 3.

Correlation Between Heart Rate Variability and Physical Function of Fibromyalgia Impact Questionnaire^a.

	Basal	EA
rMSSD	−0.079	0.109
LF	−0.481*	0.158
HF	0.496*	−0.158
LF/HF	−0.372	0.021
HRV	−0.267	0.030

Abbreviations: EA, electroacupuncture; rMSSD, root mean square of the successive differences; LF, low frequency; HF, high frequency; LF/HF, low frequency/high frequency ratio; HRV, heart rate variability.

^aData are Pearson correlation coefficients (ρ).

*P < .1.

The correlation between heart rate variability with the Short Form 36 Health Survey Questionnaire is shown in Tables 4 and 5 for physical and mental scores, respectively.

Table 4.

Correlation Between Heart Rate Variability and Physical Components of the Short Form 36 Health Survey Questionnaire^a.

	PF		RP		BP		GH
	Basal	EA	Basal	EA	Basal	EA	Basal	EA
rMSSD	0.350	−0.194	0.117	0.0281	0.099	−0.324	0.236	−0.230
LF	−0.047	−0.045	−0.176	0.271	−0.390	−0.281	−0.132	0.296
HF	0.043	0.045	0.162	−0.271	0.391	0.281	0.1394	−0.296
LF/HF	−0.047	−0.045	−0.176	0.271	−0.390	−0.281	−0.132	0.296
HRV	0.477	0.266	0.450	0.120	0.479	−0.110	0.556*	−0.142

Abbreviations: PF, physical function; RP, role limitations-physical; BP, bodily pain; GH, general health perceptions; EA, electroacupuncture; rMSSD, root mean square of the successive differences; LF, low frequency; HF, high frequency; LF/HF, low frequency/high frequency ratio; HRV, heart rate variability.

^aData are Pearson correlation coefficients (ρ).

*P < .05.

Table 5.

Correlation Between Heart Rate Variability and Mental Components of the Short Form 36 Health Survey Questionnaire.

	VT		SF		RE		MH
	Basal	EA	Basal	EA	Basal	EA	Basal	EA
rMSSD	0.267	0.171	0.381	0.590*	0.194	0.222	0.121	−0.155
LF	−0.021	−0.223	0.017	−0.183	−0.094	0.100	−0.024	0.248
HF	0.027	0.223	−0.007	0.183	0.093	−0.100	0.018	−0.248
LF/HF	0.079	−0.274	−0.004	−0.128	−0.028	0.104	0.013	0.092
HRV	0.470	−0.086	0.393	0.285	0.339	−0.194	0.432	−0.563*

Abbreviations: VT, vitality; SF, social function; RE, role function-emotional; MH, mental health; EA, electroacupuncture; rMSSD, root mean square of the successive differences; LF, low frequency; HF, high frequency; LF/HF, low frequency/high frequency ratio; HRV, heart rate variability.

^aData are Pearson correlation coefficients (ρ).

*P < .05.

For physical components, we observed a significantly positive correlation (ρ = 0.556, P < .05) between general health and heart rate variability at baseline. For mental components, we observed a significantly positive correlations between root mean square of the successive differences with social function (ρ = 0.590, P < .05) and heart rate variability with mental health (ρ = 0.563, P < .05). These positive correlations suggest that improvements in social function and mental health could be related with an increase in vagal activity.

Discussion

The demographics of the population distribution for age with fibromyalgia described were similar to those previously found in Mexico as well as the symptoms associated with fibromyalgia described in long-term studies in similar populations.¹

At baseline, bodily pain in the Short Form 36 Health Survey Questionnaire and morning tiredness in Fibromyalgia Impact Questionnaire were the most remarkable symptoms. Fibromyalgia significantly impairs the quality of life of the patients and can be highly disabling.^31,32 Fibromyalgia Impact Questionnaire is a tool developed and published to measure the impact of fibromyalgia symptoms on daily living abilities and general health status.²⁵ Our results demonstrate that electroacupuncture decreases both clinical and statistically some of the values of the Fibromyalgia Impact Questionnaire, particularly fatigue and morning tiredness.

In fibromyalgia patients, electroacupuncture treatment results in a significant increase in Short Form 36 Health Survey Questionnaire scores and reach values similar to those reported for the general Mexican population.²⁶ The Short Form 36 Health Survey Questionnaire is a general health status instrument often used in clinical trials and health services research and has been demonstrated to have good reliability and validity in chronic pain patients.^33,34

Although acupuncture techniques are a treatment system pointed on normalizing the body’s dysfunction, experimental and clinical investigations have indicated that specific acupuncture techniques have differentiated effects on the autonomic nervous system and hormones. Several studies have investigated the effect of acupuncture on the autonomic nervous system in health and diseases.^35,36 In our study, electroacupuncture elicited a significant decrease in high frequency and an increase in low frequency and low frequency/high frequency ratio.

Several studies have addressed the relationship between heart rate variability with mental and physical disorders such as depression, morning tiredness, and fatigue. There are few reports that relate mood alterations such anxiety and depression with overactive sympathetic tone and subsequently decreased vagal tone at rest.^35,36 Besides, it has been found that fibromyalgia patients had a basal autonomic state characterized by increased sympathetic and decreased parasympathetic tones.³⁷

Nonetheless, it has been reported that the basal state autonomous fibromyalgia patients had low heart rate variability values associated with an increased high frequency and decreased low frequency.³⁸ These data are consistent with the increased vagal and decreased sympathetic morning activity in these patients, which could explain tiredness, fatigue, and sleep during the day.³⁸ Besides, it has been shown that fibromyalgia patients have signs of autonomic dysfunction, particularly both signs of relentless sympathetic activity and sympathetic hypo-reactivity to stress.³⁹

In our study, the balance parasympathetic/sympathetic of the treated patients was displaced to a raised sympathetic tone at the time of the recordings. The morning adrenergic effect seen in the patients could explain the improvements in the physical function in the Fibromyalgia Impact Questionnaire scores, and physical and mental components of Short Form 36 Health Survey Questionnaire. Therefore, we speculate that the sympathetic effect elicited by electroacupuncture in our fibromyalgia patients could be related to the positive changes in health-related quality of life, especially the improvement in mood, depression, and feelings of being sick. Further studies are needed to determine the mechanisms by which electroacupuncture improves fibromyalgia and the long-term effects of electroacupuncture on heart rate variability and its consequences to overall cardiovascular risk.

Study Limitations

The limitations of the study were that the sample size was relatively small and the lack of a control group.

Conclusion

Fibromyalgia is a major clinical problem and its management is of utmost importance. Electroacupuncture was shown to be beneficial for fibromyalgia patients. The improvement in health-related quality of life could be related with changes in the autonomic profile in these fibromyalgia patients. Future researchers must conduct large-scale and long-term electroacupuncture interventions to study the effects of this treatment on fibromyalgia evolution and its pathophysiological components.

Footnotes

Acknowledgments

We would like to acknowledge the technical assistance of Miguel J. Reyes-Campos, MD.

Author Contributions

LGDT: Principal investigator of the project, data analysis and interpretation, manuscript preparation. TRBD: Coinvestigator of the project, data analysis, technical support, manuscript preparation. JFRV: Mentor, data analysis, and manuscript preparation.

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and publication of this article.

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was financially supported by the public funds of Universidad Autónoma Metropolitana, at Iztapalapa.

Ethical Approval

Ethics Committee of Biological and Health Sciences Division of our institution granted approval to this project, and the procedures followed the ethical standards provided by Mexican health laws and Helsinki Convention. Previous Informed consent was obtained from all individuals for participation in this study.

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Impact of Electroacupuncture Treatment on Quality of Life and Heart Rate Variability in Fibromyalgia Patients

Abstract

Keywords

Materials and Methods

Participants

Inclusion Criteria

Exclusion Criteria

Ethical Issue

Acupuncture Treatment

Outcomes

Statistical Analysis

Results

Health-Related Quality of Life Indexes

Heart Rate Variability Analysis

Correlation Between Health-Related Quality of Life Indices With Heart Rate Variability

Discussion

Study Limitations

Conclusion

Footnotes

Acknowledgments

Author Contributions

Declaration of Conflicting Interests

Funding

Ethical Approval

References