Clinical therapeutic effect of self-prescribed Sanhanchushi Tongbi on lumbar disc herniation

Abstract

BACKGROUND

Lumbar disc herniation (LDH) commonly occurs during spinal surgery; LDH is on the increase in younger patients and is classified as "paralysis" and "back pain.” Sanhanchushi Tongbi (SPST) is a customized prescription. It disperses cold, relieves pain, removes cold from the meridians and viscera, and treats neuropathic pain. However, few studies have investigated its mechanism of pain relief.

AIM

To observe the clinical therapeutic effects on LDH treated with self-prescribed SPST.

METHODS

A total of 211 patients with LDH syndrome were divided into two groups: 107 patients in the control group were treated with conventional massage combined with traction, and 104 patients in the observation group were treated with a combination of the control regimen and self-prescribed oral SPST. The patients were treated for 4 wk. Indices of traditional Chinese medicine (TCM) syndrome score and serum inflammatory factor levels were measured.

RESULTS

After therapy, the TCM syndrome score in the observation group was significantly lower than that in the control group (P < 0.05). The main symptoms, clinical signs, daily activities, and Japanese Orthopedic Association scores in the observation group were significantly higher than those in the control group after therapy (P < 0.05). The levels of tumor necrosis factor-α, interleukin-6, and C-reactive protein were lower in the observation group than in the control group (P < 0.05). In the observation group, superoxide dismutase levels were significantly higher, whereas malondialdehyde levels were significantly lower, compared with the control group (P < 0.05). The overall efficacy rate in the observation group was 96.15%, which was substantially higher than that in the control group (88.79%; P < 0.05).

CONCLUSION

Self-prescribed SPST can reduce the levels of inflammatory and pain-causing factors as well as lumbar pain in patients with LDH.

Key Words: Self-prescribed Sanhanchushi Tongbi, Lumbar disc herniation, Pain factors, Visual analog scale, Japanese Orthopedic Association scores, Inflammatory factor

Core Tip: A total of 211 patients with lumbar disc herniation (LDH) syndrome and cold dampness due to kidney deficiency were divided into two groups based on therapeutic strategies to evaluate the clinical therapeutic effect of self-prescribed Sanhanchushi Tongbi (SPST) on LDH. Observation indicators, such as the Japanese Orthopedic Association and visual analog scale scores, were used to compare the therapeutic effects between the two groups. The study showed that SPST reduced inflammation, pain-causing factors, and lumbar pain in patients with LDH.

INTRODUCTION

Lumbar disc herniation (LDH) is a condition in which the nerve roots and cauda equina are irritated or compressed due to a combination of disc degeneration, annulus fibrosus rupture, and nucleus pulposus herniation[1,2]. The disease is most common in middle-aged and older persons; however, as people's standard of living improves and they become more sedentary for longer periods of time, the prevalence of LDH is rapidly increasing in younger populations[3,4]. Conventional treatment with medication or physiotherapy provides quick recovery in the short term, but is prone to recurrence[5]. Compression of the nerve roots causes a local inflammatory response, producing large amounts of inflammatory and pain-causing factors; thus, reducing both the inflammatory response and the level of pain-causing factors can effectively cure lower back pain[6]. Self-prescribed Sanhanchushi Tongbi (SPST) is the result of long-term clinical practice and is effective in dispersing cold, removing dampness and paralysis, strengthening the bones, and tonifying the kidneys. This study presents the use of self-prescribed SPST for the treatment of LDH.

MATERIALS AND METHODS

Study design and patients

This was a single-center retrospective cohort study conducted in Department of Orthopedics of our hospital from January 2019 to October 2021. 211 patients with LDH syndrome and cold dampness due to kidney deficiency who were hospitalized in the Department of Orthopedics of our hospital were divided into two groups according to the treatment method: 107 patients in the control group were treated with conventional massage combined with traction, and 104 patients in the observation group were treated with a combination of the control regimen and oral treatment with self-prescribed SPST. The control group comprised 57 men and 50 women, aged 25 to 56 years (mean 42.31 ± 7.42 years), with a disease duration ranging from 1–24 months (mean 12.34 ± 5.21 months). There were 23, 21, 22, 20, and 21 patients with lesions located at L1–L2, L2–L3, L3–L4, L4–L5, and L5–S1, respectively, there were 19 patients had smoking history, 24 patients had hypertension history and 11patients had diabetes history. The observation group comprised 54 men and 50 women, aged 25 to 56 years (mean 43.11 ± 7.51 years), with a disease duration between 1–24 months (mean 12.56 ± 5.53 months). There were 22, 20, 21, 19, and 22 patients with lesions located at L1–L2, L2–L3, L3–L4, L4–L5, and L5–S1, respectively, there were 20 patients had smoking history, 22 patients had hypertension history and 12 patients had diabetes history. The two groups did not show significant differences in general characteristics (P > 0.05). The hospital’s ethics committee approved this study. Informed consent was obtained from all patients and their families.

Case selection

Diagnostic criteria: The diagnostic criteria for LDH used in Western medicine are those described in Practical Orthopaedics, fourth edition[7].

The diagnostic criteria for LDH in traditional Chinese medicine (TCM) are kidney deficiency, coldness, and dampness-type lumbago, as described in the Science of Practical Chinese Medicine and Bone Injury[8]. The main symptoms are cold pain in the lumbar region with unfavorable turning, which is aggravated on rainy days, when the skin is not warm and is reduced by heat. Secondary symptoms are pale tongue with a white and greasy coating, and moist and thin pulse.

Inclusion criteria: The inclusion criteria of this study were: (1) Significant pressure pain in the lower back which radiated to the lower limbs; (2) A positive straight leg raise test result, defined as an elevation of the affected limb to < 80°, and the presence of posterior radiating pain; (3) Changes in skin sensation, muscular reflexes, and reduced muscle strength; and (4) Nerve compression observed on computed tomography or magnetic resonance imaging.

Exclusion criteria: The exclusion criteria used in this study were: (1) A combination of lumbar fractures, lumbar tuberculosis, tumor metastases; (2) A combination of severe neoplastic lesions of the heart, liver, and kidneys; (3) Blood clotting disorders, diabetes mellitus, and other hematological disorders; (4) A combination of lumbar instability, slippage; and (5) Psychiatric disorders and communication difficulties.

Interventions

The patients in the control group underwent massage and traction. The patient took a prone position and exposed the painful area, which was relaxed using palm kneading and massaged for 2 min. A mixture of wine and Shu Tendon grass liquid was applied to the palm, and palm pushing and pressing on the painful area was performed for 5 min each. After massage, clothing was quickly put on, and the painful areas were warmed up with the body's residual warmth, helping to invigorate the blood and relieve tension in the lumbar muscles. Massages were performed on alternate days. During traction therapy, with the patient in the prone position, the lumbar traction fixation belt was fixed to the pelvis and upper chest. The degree of tightness was modified based on the patient's tolerance. The traction weight was 2/5 of the patient's body weight, and the duration of each traction was 30 min. The patients underwent traction once a day, five times a week.

In the observation group, the aforementioned regimen was combined with self-prescribed SPST consisting of Shaoyao, 10 g; Huangqi, 15 g; Chuanwu, 5 g; Danggui, 10 g; Baizhui, 10 g; Weilingxian, 10 g; Duzhong, 15 g; Xuduan, 15 g; Sangjisheng, 10 g; Chuanxiong, 10 g; Duhuo, 10 g; and Gancao, 10 g. Before decoction, Chuanwu was crushed and decocted in 400 mL of honey water to 200 mL, which was then removed and decocted with the remaining medicine, and 1000 mL was decocted to 250 mL for consumption. This was performed once in the morning and once in the evening for 28 days. Both groups were treated for 28 d.

TCM syndrome score

The scoring was performed according to the assessment criteria of the Guidelines for Clinical Research on New Chinese Medicines[9]. Back pain was scored as follows: 0 points for none, and 2, 4, and 6 points for occasional, intermittent, and frequent pain, respectively. Lower limb twitching pain was scored as follows: 0 points for none, and 2, 4, and 6 points for occasional, intermittent, and frequent pain, respectively. Lumbar and knee tenderness scores were as follows: 0 points for none, 2 points for walking lumbar and knee tenderness, 3 points between the two sets of locations, and 4 points for persistent inability to walk or stand. Limb numbness was scored as 0 points for none, and 1, 2, and 3 points for mild, moderate, and severe numbness, respectively. Scores for restricted lumbar movement were 0 points for none, 1 point for occasional difficulty, 2 points for intermittent difficulty, and 3 points for inability to move. The TCM syndrome scores before and after therapy were compared between the two groups.

Japanese Orthopedic Association scores

The Japanese Orthopedic Association (JOA)score[10] was used to observe the pre- and post-treatment scores of the two groups. The JOA score was 29 points, and the primary assessment items included subjective symptoms (9 points), such as lower back and leg pain; clinical signs (6 points), such as straight leg raise and femoral nerve pull tests; and activities of daily living (14 points) such as motor and sensory impairments. The higher the JOA score, the better the recovery.

Visual analog scale scores

Patients in both groups were scored before and after therapy using a visual analog scale (VAS)[11]. The total VAS score was 10 points, with 0 indicating no pain and 3 or less indicating mild, tolerable pain. Scores ranging from 4 to 6 points indicated pain that interfered with sleep but was bearable. Scores ranging from 7 to 10 points indicated intense and unbearable pain. The subjective pain intensified as the score increased.

Oswestry disability index

The Oswestry disability index (ODI) score[12] was assessed by evaluating the ability to live, walk, stand, sleep, and carry objects. The ODI is scored on a scale of 50, with higher scores indicating more severe dysfunction. The ODI scores were observed before and after treatment in both groups.

Serum inflammatory factor levels

To observe the changes in interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and C-reactive protein (CRP) levels before and after therapy, 5 mL of fasting venous blood was collected before and after treatment, and the serum was centrifuged for 15 min at 3000 rpm using a GL-25MS high-speed frozen centrifuge (Shanghai Precision Instrument Co., Shanghai, China). The serum was collected, and the inflammatory marker levels were measured using IL-6, TNF-α, and CRP (solid phase sandwich ELISA) kits (Shanghai ELISA Biotechnology Co., Shanghai, China).

Serum pain transmitter factors

In both groups, 5 mL of fasting venous blood was collected before and after therapy and centrifuged for 15 min using a GL-25MS high-speed freezing centrifuge at 3000 rpm. The serum was retained. A substance P (SP) test kit for the double-antibody one-step enzyme-linked immunosorbent assay technique and the neuropeptide Y (NPY) test kit for the coating antigen comparison method (Shanghai Jining Biotechnology Co., Ltd., Shanghai, China) were used to test NPY and SP levels.

Serum oxidation indicators

To observe changes in superoxide dismutase (SOD) and malondialdehyde (MDA) levels before and after treatment, 5 mL of fasting venous blood was drawn from both groups before and after therapy and centrifuged for 15 min using a GL-25MS high-speed frozen centrifuge at 3000 rpm. The serum oxidation indicator levels were measured using the SOD and MDA (solid phase sandwich enzyme-linked adsorption assay) kits (Shanghai EnzymeLink Biotechnology Co., Shanghai, China).

Clinical outcomes

The Diagnostic Efficacy Criteria for Chinese Medical Conditions[13] were used to compare clinical efficacy of the treatment in the two groups of patients. Cures were defined as the disappearance of back and leg pain and a straight leg raising test score of > 80°. Improvement was defined as a reduction in back and leg pain, and a significant improvement in activity. Failure to heal indicated no improvement in symptoms.

Statistical methods

SPSS22.0 software was used for statistical analysis, with the measurement data expressed as means ± SD. Means were compared between the two groups using the independent samples t-test, and mean values before and after treatment were tested using the paired t-test. For statistical data, the χ² test was utilized to compare the two groups, and differences were considered statistically significant at P < 0.05.

RESULTS

Comparison of the TCM syndrome scores

No significant difference in the TCM syndrome scores was observed between the two groups before treatment (P > 0.05). After treatment, the TCM syndrome score was significantly lower in the observation group than in the control group (P > 0.05; Table 1).

Table 1 Comparison of the traditional Chinese medicine syndrome scores.

Group	n	TCM syndrome score
		Before treatment	After treatment
Observation group	104	14.36 ± 3.57	6.21 ± 2.11
Control group	107	14.28 ± 3.43	7.46 ± 3.08
t value		0.166	3.429
P value		> 0.05	< 0.05

TCM: Traditional Chinese medicine.

Comparison of the JOA scores

Before treatment, no significant differences were observed in the main symptoms, clinical signs, daily activities, or JOA scores between the two groups (P > 0.05). After treatment, these variables were significantly higher in the observation group than in the control group (P < 0.05; Table 2).

Table 2 Comparison of the Japanese Orthopedic Association scores.

Group	n	Main symptoms		Clinical signs		Daily activity		JOA scores
		Before treatment	After treatment	Before treatment	After treatment	Before treatment	After treatment	Before treatment	After treatment
Observation group	104	5.24 ± 0.56	7.84 ± 1.03	2.54 ± 0.50	4.58 ± 0.63	7.79 ± 1.68	12.06 ± 1.16	15.57 ± 1.89	24.48 ± 1.56
Control group	107	5.19 ± 0.62	6.79 ± 1.13	2.51 ± 0.50	3.54 ± 0.57	7.81 ± 1.54	11.34 ± 1.87	15.51 ± 1.84	21.67 ± 2.37
t value		0.614	7.048	0.436	12.581	0.090	3.350	0.234	10.143
P value		> 0.05	< 0.05	> 0.05	< 0.05	> 0.05	< 0.05	> 0.05	< 0.05

JOA: Japanese Orthopedic Association.

Comparison of the VAS scores

Before treatment, no significant difference was observed in the VAS scores between the two groups (P > 0.05). After treatment, the VAS scores of the observation group were significantly lower than those of the control group (P < 0.05; Table 3).

Table 3 Comparison of the visual analog scale scores.

Group	n	VAS
		Before treatment	After treatment
Observation group	104	8.25 ± 1.11	2.25 ± 0.54
Control group	107	8.12 ± 1.24	3.12 ± 0.87
t value		0.802	8.698
P value		> 0.05	< 0.05

VAS: Visual analog scale.

Comparison of the ODI

Before treatment, there was no significant difference in the ODI between the two groups (P > 0.05). After treatment, the ODI of the observation group was significantly lower than that of the control group (P < 0.05; Table 4).

Table 4 Comparison of the Oswestry disability index.

Group	n	ODI
		Before treatment	After treatment
Observation group	104	41.56 ± 4.21	14.15 ± 7.25
Control group	107	41.52 ± 4.24	22.54 ± 7.14
t value		0.069	8.469
P value		> 0.05	< 0.05

ODI: Oswestry disability index.

Comparison of serum inflammatory factor levels

No significant differences were confirmed in IL-6, TNF-α, and CRP between the two groups before treatment (P > 0.05). After treatment, these serum inflammatory factor levels were lower in the observation group than in the control group (P < 0.05; Table 5).

Table 5 Comparison of interleukin-6, tumor necrosis factor-α and C-reactive protein levels.

Group	n	IL-6 (μg/L)		TNF-α (ng/L)		CRP (mg/L)
		Before treatment	After treatment	Before treatment	After treatment	Before treatment	After treatment
Observation group	104	134.25 ± 7.34	90.24 ± 5.25	2.88 ± 0.25	1.05 ± 0.12	24.32 ± 3.58	9.24 ± 2.64
Control group	107	133.55 ± 7.28	109.62 ± 6.77	2.86 ± 0.22	1.36 ± 0.34	24.28 ± 3.44	14.68 ± 2.97
t value		0.695	23.191	0.617	8.878	0.082	14.048
P value		> 0.05	< 0.05	> 0.05	< 0.05	> 0.05	< 0.05

IL-6: Interleukin-6; TNF-α: Tumor necrosis factor-α; CRP: C-reactive protein.

Comparison of serum pain factor levels

No significant differences between the two groups were observed in SP and NPY levels before treatment (P > 0.05). After treatment, SP and NPY levels were lower in the observation group than in the control group (P < 0.05; Table 6).

Table 6 Comparison of S substance P and neuropeptide Y levels.

Group	n	SP (ng/L)		NPY (ng/L)
		Before treatment	After treatment	Before treatment	After treatment
Observation group	104	368.84 ± 27.54	102.38 ± 19.87	142.28 ± 15.87	38.69 ± 5.34
Control group	107	367.94 ± 27.78	131.65 ± 20.34	142.11 ± 15.84	69.64 ± 5.87
t value		26.489	10.570	0.077	40.028
P value		> 0.05	< 0.05	> 0.05	< 0.05

SP: Substance P; NPY: Neuropeptide Y.

Comparison of serum oxidation indicators

No significant differences were observed in SOD and MAD levels between the two groups before treatment (P > 0.05). After treatment, SOD levels in the observation group were significantly higher, and MAD levels were significantly lower, than those in the control group (P < 0.05; Table 7).

Table 7 Comparison of superoxide dismutase and malondialdehyde levels.

Group	n	SOD (mg/L)		MAD (μg/L)
		Before treatment	After treatment	Before treatment	After treatment
Observation group	104	92.74 ± 5.44	134.57 ± 7.42	5.82 ± 1.54	2.15 ± 0.54
Control group	107	93.47 ± 5.51	112.54 ± 6.24	5.76 ± 1.49	4.05 ± 0.67
t value		0.968	23.365	0.287	22.641
P value		> 0.05	< 0.05	> 0.05	< 0.05

SOD: Superoxide dismutase; MAD: Malondialdehyde.

Comparison of clinical outcomes

The overall efficacy rate in the observation group was 96.15%, which was substantially higher than that in the control group (88.79%, P < 0.05; Table 8).

Table 8 Comparison of clinical outcomes, n (%).

Group	n	Cure	Improvement	Failure to heal	Overall efficiency
Observation group	104	68 (65.38)	32 (30.77)	4 (3.85)	100 (96.15)
Control group	107	52 (48.60)	43 (40.19)	12 (11.21)	95 (88.79)
χ2		-	-	-	4.086
P value		-	-	-	< 0.05

DISCUSSION

LDH commonly occurs during spinal surgery, and its incidence is higher in younger patients. The most common symptom is lower back pain, with an incidence of approximately 91%, and in most cases, low back pain occurs in the lower back or lumbosacral region. Sinus nerve fibers in the outer fibrous ring and posterior longitudinal ligament are irritated, causing back and lumbar pain. When the herniated lumbar disc is more extensive, the dura is irritated and produces neuralgia, a usually dull and radiating pain that is relieved by bed rest[14,15]. In most patients, herniated lumbar discs occur in the L4–L5 and L5–S1 spaces, predisposing them to sciatica.

According to one study[16], neuropathic pain is caused by the local compression of nerve roots and an inflammatory response. Elevated levels of inflammatory and nociceptive factors can stimulate nerve endings and exacerbate the condition. TNF-α, which induces the secretion of inflammatory factors, directly causes and exacerbates the inflammatory response when the nerve is irritated by disc damage and increases the inflammatory factor marker IL-6, ultimately exacerbating LDH degeneration and damage. Simultaneously, neurotransmitter levels are elevated. SP and NPY are pain transmitters, and their elevation increases patients’ pain[17,18]. Therefore, lowering of IL-6, TNF-α, SP, and NPY levels is a clear target to address LDH. SOD and MAD are oxygen radicals that can cause protein polymerization and fracture, rendering proteins non-functional. This leads to reduced elasticity of collagen fibers and matrix laxity, further causing rupture of the lumbar fibrous ring and back pain[19,20].

According to TCM theory, LDH is a category of "paralysis" and "back pain.” This condition is characterized by “cold dampness due to kidney deficiency” back pain. According to Chinese medicine, patients suffer from kidney deficiency, external dampness, and fall injury, resulting in poor flow of qi and blood. Cold and dampness in the joints can paralyze qi and blood, with cold being the worst. Thus, heat decreases pain, whereas cold increases it. Treatment should focus on dispersing cold, removing dampness, tonifying the kidneys, and benefiting from the essence. SPST is a customized prescription, which promotes blood circulation to support the nutritional supply and functional recovery of local nerves and muscles, thus relievin pain. Besides, SPST showed strong anti-inflammatory and immunosuppressive effects to improve bone metabolism. The monarch drug in a prescription is aconitum, which belongs to the liver and kidney meridian family. It disperses cold, relieves pain, removes cold from the meridians and viscera, and effectively treats neuropathic pain. Modern pharmacological studies have demonstrated that aconitine relieves pain. Huangqi, Xuduan, Sangjisheng, Chuanxiong, Duhuo, Duzhong, and Danggui are the official medicines, among which Huangqi benefits qi and the blood. Xuduan tonifies the liver and kidneys and strengthens muscles and bones. According to Dian Nan Ben Cao, it nourishes the liver and kidneys, strengthens muscles and bones, passes through the meridians, and stops soreness (tendons and bones). Sangjisheng belongs to the liver and kidney meridian family. It supports the liver, kidneys, tendons, and bones, removes wind dampness, and opens the meridians. It is also utilized to treat soreness of the waist and knees and wind-cold and damp paralysis. An article called Ri Hua Zi Bencao mentioned that it can help tendons and bones and benefit the blood. Chuanxiong enters the liver meridian, moves qi, opens depressions, dispels wind dampness, activates blood circulation, and relieves pain. It is also used to treat wind-cold paralysis, dampness paralysis, and soreness of the waist and knees. It has been mentioned in the book Bielu as a remedy for all winds and gout in a hundred joints. In Shennong Ben Cao Jing, Duzhong is mentioned as a unique medicinal herb in China that can treat pain in the waist and knees, tonify the middle, benefit the essence, and strengthen tendons and bones. Danggui tonifies the blood and invigorates it to treat bruises and injuries. Modern pharmacological research has shown that it effectively improves blood circulation and has anti-inflammatory and analgesic effects. ShaoYao, Baishu, and Weilingxian are adjuvants. ShaoYao has analgesic and promotional impact. This so-called dampness evil entraps the spleen. The spleen is home to a middle energizer. Baishu warms the middle, removes dampness in the spleen and stomach, strengthens the spleen, and replenishes qi. Weilingxian dispels wind and dampness, dredges the collaterals, and relieves pain. Gancao is a messenger drug that invigorates the qi and strengthens the spleen. Gancao is used to reconcile various drugs, weaken the toxicity of Chuanwu, and plays a role in abirritation and neutralization.

The findings of this study revealed that the levels of inflammatory factors (TNF-α, IL-6, and CRP) and pain factors (SP and NPY) were significantly lowered after treatment with SPST in the observation group of patients with LDH, compared with the control group that received conventional massage combined with traction. A modern pharmacological study showed that the Chuanxiong rhizome has analgesic effects, Dushu has an anti-inflammatory effect, and Angelica can improve blood circulation. These properties may have led to the increase in the levels of the serum oxidative indicator, SOD, and the decrease in MAD levels in the observation group after treatment with SPST, compared with the control group that received conventional massage combined with traction. This suggests that the self-prescribed SPST formula may successfully lower the levels of inflammatory factors, pain factors, and oxygen-free radicals, thereby achieving the goal of treating patients with LDH. And we will continue to design comparative studies to investigate the therapeutic effects between different dosages and formulationd (such as decoction and granules) to further refine our treatment plan in the future study, aiming to optimization patients' overall curative effect with SPST.

CONCLUSION

Self-prescribed SPST relieves pain, improves clinical outcomes, and reduces the inflammatory responses and hyperoxia in patients with LDH. It is recommended that this therapy be promoted in the clinical practice.