Treatment for Persistent Somatoform Pain Disorder via Electroacupuncture and a Low Dosage of Fluoxetine Hydrochloride

Abstract

Context

The clinical treatment of somatoform pain disorder (SPD) commonly combines antianxiety and antidepressant medication with pain medication, yet the method often entails a lengthy treatment, with uncertain outcomes, and, on occasion, significant side effects. Acupuncture can activate a patient’s own pain control system, stimulate blood flow, repair the physical damage of emotional distress, reduce pain, lift mood, and boost the immune system.

Objective

The study intended to evaluate the benefits of adding a small dosage of fluoxetine hydrochloride (Prozac) to electroacupuncture treatment in the treatment of SPD.

Design

The research team performed an observational study.

Setting

The study took place at the 181st Hospital of the Chinese People’s Liberation Army (Guilin, China). Participants: Participants were 64 patients who had been diagnosed with persistent SPD and who were being treated at the hospital.

Intervention

Participants received electroacupuncture treatment in 2 sets of points applied in 40-min sessions on alternating days, for 6 d of continuous treatment per wk, up to 8 wk. Participants were additionally treated with individualized points particular to each person’s pain location. Participants also took 20 mg/d of fluoxetine hydrochloride for 8 wk.

Outcome Measures

At baseline and at 1, 2, 4, and 8 wk of treatment, patients’ degrees of pain, states of mind, and experiences of side effects were evaluated through the short-form McGill pain questionnaire.

Results

With regard to patients who had had trouble controlling chronic somatoform pain, the treatment with electroacupuncture to spots on the head, abdomen, waist, back, and sacrum, in conjunction with a light dosage of fluoxetine hydrochloride, showed reductions in pain, minimal side effects, and a low risk of relapse.

Conclusions

Electroacupuncture, combined with a low dosage of fluoxetine hydrochloride, could be a beneficial treatment for chronic SPD. It avoids the risk of significant side effects from long-term ingestion of antianxiety and antidepressant medications, and the current research team has observed that it provides a relatively low likelihood of relapse. For patients with a history of untreatable persistent somatoform pain while using prescribed antianxiety and antidepression medication, the results can be rather satisfactory. It is hoped that these observations will direct further clinical research.

Somatoform pain is a chronic pain for which no physical cause can be determined, producing distress and often impairing an individual’s normal functioning and decreasing life enjoyment. The diagnosis criteria in the fifth edition of the Diagnostic and Statistical Manual (DSM-5) for somatoform symptom disorder with pain include (1) disproportionate and persistent thoughts about pain, (2) high levels of anxiety, and (3) excessive time and energy devoted to concerns about pain, disrupting daily life.¹ The 10th revision of the International Classification of Diseases (ICD-10) criteria for somatoform pain disorder (SPD) similarly emphasizes that the severe pain experienced by a patient is accompanied by emotional and psychosocial problems.² The diagnosis is usually given after other potential causes of pain are eliminated and results from tests and scans, such as computed tomography (CT) and magnetic resonance imaging (MRI), have not shown any explanations for the experienced pain.

Historically, persistent SPD has been difficult to treat, particularly if multiple areas of pain or shifting sources of pain are reported. Traditionally, treatment includes pain medication coupled with antidepressants and therapy, such as cognitive behavioral therapy. However, some hesitation and resistance can occur from patients who feel that their pain has a physical source that is yet to be found, and uncertain treatment results can exacerbate their worry and cement their distrust. Furthermore, some patients experience significant side effects from antidepressants and antianxiety medication. In general, the long treatment period and the inconsistency of outcomes make the typical approach far from satisfactory.

In light of those issues, research has occurred in recent years that has explored the benefits of traditional Chinese medical practices, such as acupuncture and moxibustion, for SPD. Kondo and Kawamoto³ have provided a systematic review of possible treatments and of acupuncture points used for different stress-related disorders. Acupuncture, the insertion and movement of needles to specific points in the skin, can activate a patient’s own pain control system and stimulate blood flow, thereby also mitigating the physical damage of emotional distress and reducing the perception of pain.

Electroacupuncture, a more controlled application of acupuncture, has been tested as the standalone method of treatment in some research, such as that of Ren et al⁴ and Yu et al.⁵ Currently, some evidence shows that acupuncture can stimulate an increase in the levels and turnover of 5-hydroxytryptamine in the brain, which further strengthens its pain control effects.⁶ Recently, it has also been discovered that the level of certain neurotransmitters in the brains of patients accustomed to long-term acupuncture treatment is altered in a way that aids the efficacy of its use as pain treatment. Acupuncture also helps regulate the endocrine system; as some research has shown, the activities of the hypothalamus, the pituitary gland, and the adrenal gland all respond to acupuncture.⁷

Somatoform disorders may either have causative influences from emotional or psychosocial issues or occur simultaneously with symptoms of depression and anxiety. Although certain kinds of distress felt by patients may be directly linked to their perception of chronic pain and reasonably may alleviate as soon as they perceive the pain to lessen or stop, other kinds might impede their reception of acupuncture treatment, and, therefore, the introduction of medication for such issues seemed appropriate to the current research team.

The current study differed from prior studies because it combined a small dosage of fluoxetine hydrochloride (Prozac) with the electroacupuncture treatment, with the hypothesis that a combination treatment may be a useful alternative treatment approach.

Methods

Participants

Participants were 64 patients who had been diagnosed with persistent SPD and who were being treated at the 181st Hospital of the Chinese People’s Liberation Army (Guilin, China). The patients, who initially visited the hospital between March 2008 and May 2013, were recruited through members of the research team approaching them with the study information while in the waiting room. The recruitment protocols were approved by the administrative department of the hospital in advance. More than 64 people were approached during the period, and 64 signed the consent form to participate in the study. The criteria for inclusion included (1) diagnosis of chronic SPD as defined by the ICD-10, (2) duration of pain that had been longer than 6 months before the start of the study, and (3) prior elimination of organic disorders as the cause of the pain.

Of those patients accepted as participants who had previously sought treatment, repeated CTs; MRIs; B-mode ultrasound imaging; tests of stomach, liver, and kidney functions; and colonoscopies had turned up no abnormal results. The patients had not experienced any significant alleviation of symptoms following treatment of pain with antianxiety and antidepression medications; rather, some experienced worsened symptoms, such as marked anxiety, depressed mood, nervousness, fear, and sleep difficulties, inducing them to seek alternative treatment.

Procedures

The treatment plan had 2 simultaneous components: electroacupuncture therapy and fluoxetine hydrochloride (Prozac) medication. The selection of fluoxetine hydrochloride in particular for the current study was based on the fact that the research team had observed before the study that it had a low rate of side effects compared with those of other medications and knew that the team’s hospital could ensure a consistent supply and quality.

Before treatment at baseline and at 1, 2, 4, and 8 weeks of treatment, patients’ degrees of pain, states of mind, and experiences of side effects were evaluated through the short-form McGill pain questionnaire (SF-MPQ). Patients took the questionnaires on computers in the hospital in a quiet designated room. The questionnaires were administered by trained staff in the hospital who were not involved in the study design.

A standard treatment period was 50 days, and patients were followed for 3 additional years.

Intervention

Electroacupuncture

The electroacupuncture points incorporated traditionally used acupuncture points and direct, unmapped areas for each patient’s areas of perceived pain. Set 1 and set 2 were used for all participants. Set 1 included traditional points for treating anxiety, stress, and sleeping issues—Changqiang (GV-1), Zusanli (ST-36), Hegu (LI-4), Chongyang (ST-42), Shenmen (HE-7), Zhangmen (LV-13), Zhongwan (CV-12), and Baihui (GV-20). Set 2 included traditional points that are commonly used for boosting the immune system and general wellness— Sanyinjiao (SP-6), Zusanli (ST-36), Xiawan (CV-10), Quchi (LI-11), Shousanli (LI-10), Guanyuanshu (BL-26), Renzhong (GV-26), Sishengcong (EZ-HN), and Sanjiaoshu (BL-22). These 2 sets encompass on the head, abdomen, waist, back, and sacrum.

All participants received electroacupuncture using individualized points related to the pain that each experienced; a point was determined by the center of a patient’s perceived pain. When the pain was located near the liver, kidneys, bladder, or back, 1 acupuncture needle was applied to the center of the pain, and then 4 equally spaced needles were applied around it at spots 2-3 cun (6.6-10 cm) from the origin, inserted at 30° slant with the needle pointing toward the origin.

Patients with internal heat due to a deficiency of yin also received electroacupuncture using individualized points—Shenshu (BL-23), Danshu (BL-19), Taiyuan (LU-5), and Zhaohai (KD-6). Patients with liver qi stagnation received electroacupuncture using some supplementary points—Xinshu (BL-15), Ganshu (BL-18), Danshu (BL-19), Weishu (BL-21), and Shangwan (CV-13), and patients with internal disturbance of phlegm-heat received electroacupuncture using some supplementary points— Feishu (BL-13), Pishu (BL-20), Geshu (BL-17), and Fenglong (ST-40).

The combination of points allowed patients to experience the effects of traditional points and to have the satisfaction of seeing and feeling that the practitioners had administered treatment to their pain areas. The research team thought that having stimuli at those points would allow patients to feel that they could have better control of their pain.

The 2 sets of points applicable to all patients were applied on alternating days for 6 days of continuous treatment (ie, 3 times for each set) with 1 day of no acupuncture after every 6 days of treatment. All particular individualized or supplementary points applicable to any one patient were applied each day of treatment, together with whatever general set was used on a particular treatment day. One session per day occurred, with 40 minutes per session.

During each session, when the needle was inserted, the point of application was deemed ready for connection when it generated the sensations of soreness, numbness, or swelling, as reported by the patient. The needles were connected to a Huatuo SDL-IIX electroacupuncture therapy machine (Suzhou Huatuo Medical Instruments Co, Ltd, Suzhou, Jiangsu, China), set at dense vibration, with a maximum output of 40 to 70V, 1-3.5 mA.

Medication

Participants received 20 mg/day of fluoxetine hydrochloride (Jiangsu Zhonghua Pharmaceuticals, Rudong, Jiangsu, China) to be taken after breakfast for 8 weeks.

Outcome Measures

Short-form McGill Pain Questionnaire

The SF-MPQ, designed by Melzack⁴ and validated, contains 3 elements: (1) the pain rating index (PRI), which contains 11 sensory descriptors and 4 affective descriptors, each with a 4-option scale—none, 0; mild, 1; moderate, 2; and severe, 3 (the scores are used to calculate the total PRI); (2) the visual analog scale, which is a 10-cm long straight line, with one end labeled no pain and the other extreme pain, upon which the patient places a mark to indicate his or her level of experienced pain; (3) the present pain intensity scale, which is divided into 6 levels: no pain, 0; light discomfort, 1; discomfort, 2; pain, 3; terrible pain, 4; and extreme pain, 5.

Analysis

Short-form McGill Pain Questionnaire

The rate of a participant’s score decrease was calculated as follows: [(baseline score minus the postintervention score) / the baseline score] × 100%. The percentile decreases were evaluated as follows with respect to the benefits to the patient: (1) ≥75%—very beneficial; (2) ≥50% but <75%— beneficial; and (3) <50%—not beneficial.

Results

 

In May 2015, the data of participants were finalized, and the efficacy of their SPD treatment was determined. Of the 64 patients, 28 were male and 36 were female, and their ages ranged from 18 to 72 years. The length of past treatment for the disorder ranged from 7 to 59 months. The diagnosis was the first for only 9 of the 64 participants; 15 participants reported a previous attempt at seeking treatment at another integrated hospital. The remaining 40 participants had had 3 years or more of treatment history at various integrated hospitals.

Short-form McGill Pain Questionnaire

Of the 64 participants, 35 (54.7%) found the treatment to be very beneficial; 18 (28.1%) found it to be beneficial, and 11 (17.2%) found it not to be beneficial.

Patients were followed for 3 years after their treatment period ended. After 2 years, 3 participants had experienced relapse; after 3 years, 5 more participants had experienced relapse. The total relapse rate after the joint electroacupuncture and fluoxetine hydrochloride therapy was 12.5% (8 of 64). Meanwhile, the total percentage of treatment that showed some beneficial effects, from the SF-MPQ results of the participants, was 82.8%.

Discussion

Physical disorders can be induced by emotions, as has been historically noted by Chinese physicians. The East Han dynasty physician Zhang Zhongjing (150-154 CE) points out in his book Plain Questions: The Big Theories of Yin and Yang, “Hundreds of diseases arise from qi; anger raises qi, while joy slows down qi; sadness dissipates qi, while fear reduces qi,” “alarm disorders qi,” and “thinking immobilizes qi.” SPD often manifests itself as pain in the liver, heart, lungs, stomach, and kidneys.

In traditional Chinese medicine, the pain of the abdomen is called qi of the liver; when one is depressed, pain appears near the navel. During clinical practice, patients’ pain locations should be explained. Acupuncture uses the meridians to adjust the balance of qi in the body and to increase the pain threshold and pain tolerance, removing the sensation of pain.

Chronic somatoform pain is a type of pain that cannot be caused by biological causes, and it affects 5.4% of the population.⁶ Because patients with this condition often repeatedly seek examinations at various hospitals, medical resources are often wasted, and patients themselves experience significant distress. Emotional conflicts or psychosocial problems often are connected to the occurrence of pain and instigate the onset of the disorder. When symptoms of this disorder continue for 7 months or longer, the patient’s social functioning can be adversely affected.

According to the ICD-10, SPD is a prominent subcategory of somatoform disorder; if it is not diagnosed and treated appropriately, patients often will display anxiety, and if repeated treatments cannot alleviate the pain, the downward cycle can cause patients to lose confidence in treatment benefits, and even to commit suicide.

Social and psychological factors can induce feelings of pain, and this type of pain, not caused by any chemical or physical factors, is categorized as psychological pain. Psychological factors can affect the severity of the pain, not only reducing it, but also increasing it. Because of that fact, histories of fear, tensions in daily life, difficult situations, or emotional conflicts can bring the onset of pain. Although this pain is sometimes accompanied by emotional disorders, it might not always be associated with psychological factors.

According to traditional Chinese medicine’s view of bodily and mental health as inseparable, the main reason patients exhibit physical symptoms to express mental distress is that they then can logically explain their inner troubles and worries by describing their distress in a different way. Thus, it can be said that patients with SPD describe their physical symptoms but are actually conveying their suppressed psychological problems.

Because this study is observational, the conclusions that can be drawn from it are not as powerful as those from an experimental study. It seems to indicate that the combined treatment can be beneficial, but it is not known how this would specifically compare against other treatment regimens and against a control group. However, it serves as a solid first step in indicating that this would be a promising area worthy of further experimental design.

Conclusions

Electroacupuncture, combined with a low dosage of fluoxetine hydrochloride, could be a beneficial treatment for chronic SPD. It avoids the risk of significant side effects from long-term ingestion of antianxiety and antidepressant medications, and the current research team has observed that it provides a relatively low likelihood of relapse. For patients with a history of untreatable persistent somatoform pain that continues while using prescribed antianxiety and antidepression medication, the results can be satisfactory. It is hoped that these observations will direct further clinical research.

Biographies

Yi Bai, MD, is a physician

Su-liang Ouyang, MD, is a physician

Ya-jun Bai, MD, is the chief physician in the 181st Hospital of Chinese People’s Liberation Army, in Guilin, Guangxi, China

Dai-hong Wu, MBA, is an instructor at Guangxi Normal University in Guilin, Guangxi, China