Sage Journals: Discover world-class research

Abstract

Objective

This study assesses the clinical efficacy and safety of combining traditional Chinese medicine (TCM) external therapy (Xiaozhong Zhitong ointment) with volar locking plate (VLP) fixation for treating complex AO-C2/3 distal radius fractures.

Methods

Sixty patients with complex AO-C2/3 distal radius fractures were randomly assigned into two groups (n = 30 each). The control group received standard VLP fixation alone, while the study group additionally received external application of Xiaozhong Zhitong ointment postoperatively. Clinical endpoints included Visual Analogue Scale (VAS) score, swelling condition, Cooney scores, Generic Quality of Life Inventory-74 (GQOL-74) score, radiographic parameters (palmar tilt, ulnar variance, radial height, joint surface displacement), wrist joint mobility (flexion, extension, pronation, supination, radial and ulnar inclination), and incidence of complications.

Results

Compared to the control group, at 2- and 4-weeks postoperatively, the study group showed lower VAS scores and swelling levels (p < 0.05). The study group also exhibited higher Cooney scores at 4 weeks and 6 months postoperatively and excellent-good rate of Cooney scores at 6 months postoperatively. Additionally, the study group demonstrated better GQOL-74 scores across all dimensions at 6 months postoperatively, along with improved imaging parameters (palmar tilt, ulnar deviation, joint surface displacement) and greater wrist flexion range of motion at 12 months postoperatively (all p < 0.05). There was no significant difference in complication rates between the two groups (p > 0.05).

Conclusion

Combining Xiaozhong Zhitong ointment with VLP fixation improves outcomes for complex distal radius fractures, reducing pain and swelling, enhancing quality of life and wrist function, with no added complication risk, making it a potential adjunct to standard care.

Keywords

complex AO-C2/3 distal radius fracture Xiaozhong Zhitong ointment volar locking plate external application clinical efficacy complications

Introduction

Distal radius fractures are the most common upper extremity fracture, accounting for over a sixth of all fractures seen in emergency departments.¹ The injury can involve the radiocarpal joint, distal radioulnar joint, and distal ulna, with diverse injury mechanisms and treatment strategies.² The treatment of complex AO-C distal radius fractures remains a significant challenge in orthopedic practice, often requiring innovative approaches to achieve optimal outcomes.^3,4

The advent of volar locking plates (VLPs) has significantly improved the fixation of distal radius fractures, becoming the current mainstream treatment method.^5,6 Their biomechanical advantages and cost-effectiveness have led to widespread use across various fracture patterns, with a notable increase in surgical rates among elderly patients.^7,8 International consensus recommends VLP internal fixation for unstable fractures,⁹ with studies demonstrating favorable functional outcomes for both intra-articular and extra-articular fractures.¹⁰ However, stabilizing small marginal volar fragments can be challenging, particularly in complex intra-articular AO-C type fractures.⁵ For severely comminuted fractures with dorsal fragments, a dual-approach combining volar and dorsal fixation may even be necessary.¹¹ Currently, no unified optimal treatment protocol exists for intra-articular distal radius fractures, and the fixation efficacy of volar plates in certain C-type fractures requires further improvement.¹² Therefore, exploring adjuvant treatment strategies alongside VLPs holds significant importance for enhancing functional recovery.

Traditional Chinese medicine (TCM) external therapies offer unique advantages in fracture treatment,¹³ with increasing recognition of their potential to reduce postoperative swelling and pain, thereby promoting rehabilitation.¹⁴ In TCM theory, distal radius fractures fall under the categories of “wrist fractures” and “fracture diseases,” with pathogenesis rooted in meridian damage, qi stagnation, and pain due to impaired circulation, manifesting as local pain; damaged collateral vessels lead to blood extravasation and impaired circulation, resulting in swelling and ecchymosis.¹⁵ Addressing this pathogenesis, our hospital has developed Xiaozhong Zhitong ointment, a formula with blood-activating, stasis-resolving, swelling-reducing, and pain-relieving properties (comprising Xuejie, Dahuang, Chishao, Jianghuang, Baizhi, Duhuo, Moyao, Maqianzi, Danshen, Huai Niuxi, Chuanxiong, Qin Jiao, and Gancao). Ingredients like Xuejie exhibit hemostatic and analgesic effects¹⁶; Dahuang clears heat, detoxifies, and cools the blood¹⁷; Chishao promotes blood circulation and resolves stasis,¹⁸ among others.

However, systematic studies combining TCM ointments with a clear theoretical basis and clinical application for VLP internal fixation in AO-C2/C3 distal radius fractures remain lacking. This study aims to evaluate the efficacy of Xiaozhong Zhitong ointment as an adjuvant therapy to VLP for treating complex AO-C2/C3 distal radius fractures, providing an effective integrated TCM-Western medicine adjuvant strategy for perioperative management of such fractures.

Materials and methods

Ethical approval

All experimental procedures were approved by our hospital. The patient has been notified about the information contained in the consent form.

Participants

The patients with complex AO-C2/3 distal radius fractures treated in our hospital from November 2022 to December 2023 were recruited.

Inclusion criteria for enrolled patients: age >18 years; diagnosis of AO-C2/C3 distal radius fracture confirmed by X-ray and CT, with unilateral fracture and no other fractures in the same upper limb; fresh fracture (time from fracture to surgery ≤14 days); closed fracture; treated with VLP surgery; no significant skin damage or tension blisters at the fracture site; absence of pathological fractures, heart diseases, or other conditions affecting treatment outcomes; and at least 1 year of follow-up with complete clinical data.

Exclusion criteria: old fractures; open fractures requiring immediate surgery; other injuries affecting wrist function assessment; previous wrist surgery; and bone tumors, tuberculosis, or severe osteoporosis.

Randomization and blinding

A total of eligible patients were randomly assigned in a 1:1 ratio to either the control group (VLP) or the study group (VLP combined with external application of Xiaozhong Zhitong ointment) using an envelope randomization method (Figure 1). The randomization sequence was generated by an independent researcher, who prepared two sets of 60 non-repeating numbers and placed them into opaque, sealed envelopes. Each envelope was sequentially numbered on the exterior corresponding to the participant screening order, while the interior indicated the assigned group. Envelopes were opened according to the subject’s visit sequence to determine group allocation. To ensure blinding, outcome assessors and data analysts remained unaware of treatment assignments throughout the study. Data collected were entered into Microsoft Excel with all identifying information removed and replaced with coded identifiers. The blinding was only lifted after all statistical analyses had been completed.

Figure 1.

Flow chart of the study process.

Preoperative preparation

Upon admission, the patient’s relevant medical history, physical examination, and auxiliary examinations were recorded. This included details such as the time and cause of injury, as well as the affected side. We performed wrist X-rays and CT scans, and if necessary, additional X-rays of the contralateral wrist.

Control group

Treatment involved the use of a VLP. After general anesthesia, patients were placed in a supine position, and a tourniquet was applied to the affected limb to ensure a clear surgical field. Intraoperative fluoroscopy was essential to confirm reduction and fixation, ensuring adequate mobility of the shoulder and elbow to obtain standard anteroposterior, lateral, and oblique fluoroscopic images. A modified Henry approach was employed, with a longitudinal incision approximately 10 cm in length made along the course of the flexor carpi radialis to fully expose the fracture site. The tendons of the flexor carpi radialis and flexor pollicis longus, along with the radial nerve, were retracted ulnarly, while the brachioradialis and radial vessels were retracted radially. The pronator quadratus was then detached from its radial origin and retracted ulnarly to fully expose the fracture ends. Each fracture fragment was reduced, and the reduction was repeatedly confirmed under fluoroscopy. For intra-articular or metaphyseal impacted fragments, a periosteal elevator was used to ensure accurate reduction, with autograft or allograft bone implanted in areas of bone defect. Temporary fixation of the fracture ends and fragments was achieved using Kirschner wires, followed by definitive fixation with a 2.4 mm or 3.5 mm T-shaped locking plate and screws. Depending on the complexity of the fracture, additional Kirschner wires were used as necessary. Postoperatively, the affected limb was immobilized with a brace for 4 weeks. On the first postoperative day, patients were instructed to begin active and passive exercises of the fingers, elbow, and shoulder to prevent joint stiffness. Dressings were changed every 2 days, and sutures were removed at 2 weeks postoperatively. The brace was removed at 1 month postoperatively, and any Kirschner wires used were also removed. Active and passive wrist exercises were initiated, with gradual increases in intensity to promote functional recovery.

Study group

In addition to VLP fixation, patients in the study group received external application with a self-made TCM topical plaster in our hospital (Xiaozhong Zhitong ointment) to the posterior aspect of the affected limb, avoiding the surgical wound, starting from the first postoperative day, with one patch applied daily. The ointment prescription was determined by the attending physician based on the patient’s fracture condition and relevant literature.^19,20 The prescription mainly included 120 g of Xuejie (Resina draconis) and Dahuang (Rheum palmatum), 60 g each of Chishao (Paeonia lactiflora), Jianghuang (Curcuma longa), Baizhi (Angelica dahurica), Duhuo (Angelica pubescens), Moyao (Commiphora myrrha), Maqianzi (Strychnos nux-vomica), Danshen (Salvia miltiorrhiza), and Huai Niuxi (Achyranthes bidentata), 30 g each of Chuanxiong (Ligusticum chuanxiong) and Qin Jiao (Gentiana macrophylla), and 18 g of Gancao (Glycyrrhiza uralensis). The ointment was prepared by strictly following the prescription, grinding the herbs into fine powder, and mixing with an appropriate amount of glycerin and cold boiled water to form a paste, which was prepared by a designated person. The application began 6 h postoperatively, with the skin of the swollen and painful area cleaned with saline cotton balls, and the prepared herbal paste evenly spread on the dressing and applied to the swollen and painful area, avoiding the surgical wound. The application lasted for 6-8 h, not exceeding 12 h, after which it was replaced, with a treatment course of 7 days. During the application process, patients were observed for any local or systemic adverse reactions, and any abnormalities were promptly reported to the physician for appropriate management.

Observation indicators

Pain level

Pain in both groups was evaluated at 2 weeks and 4 weeks postoperatively. The Visual Analog Scale (VAS)²¹. J Clin Nurs 2001; 10:706–16.) was used to assess the patient’s pain level. The specific steps are as follows: A ruler with a maximum scale of 10 cm was used, with numbers 0-10 representing the scores. 0 points: painless. 10 points: severe pain. Below 3 points: slight pain, tolerable. 4-6 points: patient experiences pain that affects sleep but is still tolerable. 7-10 points: patient experiences increasingly intense pain that is intolerable, affecting appetite and sleep.

Swelling level

Swelling was evaluated at 2 weeks and 4 weeks postoperatively. The circumference of the wrist crease on both the affected and unaffected sides was measured using a soft tape measure, and the average of three measurements was taken. The swelling value was obtained by subtracting the circumference of the unaffected wrist crease from that of the affected wrist crease. Swelling difference = Circumference at the affected wrist crease - Circumference at the unaffected wrist crease.

Wrist joint function Cooney score

Four weeks and 6 months postoperatively, the Cooney Wrist Function Score²² was adopted to assess overall functional outcomes, which encompassed pain, functional status, range of motion, and grip strength, with a maximum score of 100. Higher scores indicated better wrist function recovery. Based on the Cooney Wrist Function Score, outcomes were categorized into four grades: excellent (90-100 points), good (80-89 points), fair (65-79 points), and poor (<65 points). The excellent and good rate was calculated as (number of excellent + good cases)/total cases × 100%.

Quality of life

At 6 months postoperatively, the Generic Quality of Life Inventory-74 (GQOL-74)²³ was employed to evaluate the quality of life in both groups. The scale included four dimensions: psychological function, physical function, material life, and social function, each scored from 0 to 100, with higher scores indicating better quality of life.

Imaging indicators

At 12 months postoperatively, standard anteroposterior and lateral radiographs were taken to measure radial height (the vertical distance between the tip of the radial styloid process and the distal articular surface of the ulna, normal range: 10-13 mm), palmar tilt angle (the angle between the distal articular surface of the radius and the long axis of the radius in the sagittal plane, normal range: 10–15°), ulnar variance angle (the angle between the distal articular surface of the radius and the long axis of the radius in the coronal plane, normal range: 20–25°), and joint surface displacement degree (measured by drawing two parallel lines perpendicular to the long axis of the radius at the edges of adjacent fracture fragments, with the distance between these lines representing the displacement).

Wrist joint range of motion

Objective functional evaluation at 12 months postoperatively encompassed wrist range of motion, measured using a goniometer for flexion, extension, pronation, supination, radial inclination, and ulnar inclination.

Complications

The incidence of postoperative complications included malunion, ulnar nerve injury, median nerve palsy, carpal tunnel syndrome, and complications related to external plaster application, was observed and recorded in both groups.

Sample size

This study was a preliminary exploratory one. The calculation of the sample size drew on research by Sam,²⁴ which showed that at least 25 participants per group are needed to identify a medium effect size. Considering a possible dropout rate of 20% and an equal allocation ratio (1: 1) between the groups, the adjusted sample size was set at 30 participants per group, leading to a total of 60 participants.

Statistical methods

Statistical analysis was performed using SPSS 21.0 software. The Shapiro-Wilk test was used to assess the normality of the data. Quantitative data conforming to a normal distribution were expressed as mean ± standard deviation (Mean ± SD), and intergroup comparisons were conducted using t-tests. Qualitative data, such as clinical efficacy, were expressed as number (percentage), and intergroup comparisons were performed using chi-square tests. Two-tailed tests were employed, with p < 0.05 considered statistically significant.

Results

General data

Initially, 95 patients were recruited. After screening based on inclusion and exclusion criteria, only 60 patients were ultimately included in this study. The 60 patients were divided into a control group and an study group, each comprising 30 patients. The two groups were well-matched and comparable, as no significant differences were noted in baseline characteristics such as gender, age, body mass index, affected side, cause of injury, time from injury to surgery, operative time, postoperative drainage volume, and AO classification (p > 0.05) (Table 1). No patients were lost to follow-up in this trial.

Table 1.

Comparison of general data between the control and study groups.

Item	Control group (n = 30)	Study group (n = 30)	t/ $χ^{2}$	p
Gender (n)			0.659	0.417
Male	12	9
Female	18	21
Age (years, mean ± SD)	56.47 ± 8.18	57.77 ± 9.15	−0.580	0.564
Body mass index (kg/m², mean ± SD)	21.41 ± 1.96	21.24 ± 1.65	0.365	0.717
Affected side (n)			0.271	0.602
Left	18	16
Right	12	14
Cause of injury (n)			0.665	0.717
Fall	17	20
Machine-related	3	2
Traffic-related	10	8
Time from injury to surgery (days, mean ± SD)	5.27 ± 1.89	5.30 ± 1.78	−0.070	0.944
Operative time (min, mean ± SD)	50.10 ± 6.68	48.93 ± 7.21	0.650	0.518
Postoperative drainage volume (ml, mean ± SD)	43.23 ± 10.12	44.23 ± 9.26	−0.399	0.691
AO classification (n)			0.693	0.405
C2	22	19
C3	8	11

Pain and swelling conditions

We observed and compared the VAS scores of the two groups of patients at 2 weeks and 4 weeks postoperatively. The results showed that the VAS scores of the study group at 2 weeks and 4 weeks postoperatively were both lower than those of the control group (3.90 ± 0.61 points vs 2.17 ± 0.59 points, p < 0.001) (2.20 ± 0.48 points vs 1.07 ± 0.37 points, p < 0.001). Meanwhile, we observed and compared the wrist swelling conditions of the two groups of patients at 2 weeks and 4 weeks postoperatively. The results showed that the swelling degree of the study group at 2 weeks and 4 weeks postoperatively was lower than that of the control group (2.52 ± 0.55 cm vs 1.31 ± 0.25 cm, p < 0.001) (1.99 ± 0.31 cm vs 0.97 ± 0.18 cm, p < 0.001) (Table 2).

Table 2.

Pain and swelling conditions between the study group and the control group at 2 weeks and 4 weeks postoperatively (Mean ± SD).

Item	Time	Control group (n = 30)	Study group (n = 30)	t	p
VAS score (score)	At 2 weeks postoperatively	3.90 ± 0.61	2.17 ± 0.59	11.192	<0.001
VAS score (score)	At 4 weeks postoperatively	2.20 ± 0.48	1.07 ± 0.37	10.235	<0.001
Swelling condition (cm)	At 2 weeks postoperatively	2.52 ± 0.55	1.31 ± 0.25	11.014	<0.001
Swelling condition (cm)	At 4 weeks postoperatively	1.99 ± 0.31	0.97 ± 0.18	15.538	<0.001

Cooney scores for wrist joint function

The Cooney scores for wrist joint function at 4 weeks and 6 months postoperatively were compared between the two groups. The results showed that the Cooney scores of the study group at 4 weeks and 6 months postoperatively were both higher than those of the control group (55.00 ± 7.83 points vs 43.37 ± 5.38 points, p < 0.001) (86.97 ± 7.33 points vs 80.03 ± 8.52 points, p = 0.001). The excellent and good rate of the Cooney score for wrist joint function at 6 months postoperatively was higher in the study group than in the control group (86.67% vs 60.00%, p = 0.041) (Table 3).

Table 3.

Comparison of Cooney scores for wrist joint function at 4 weeks and 6 months postoperatively between the control and study groups.

Item	Time	Control group (n = 30)	Study group (n = 30)	t/ $χ^{2}$	p
Cooney score (score, mean ± SD)	At 4 weeks postoperatively	43.37 ± 5.38	55.00 ± 7.83	−4.401	<0.001
Cooney score (score, mean ± SD)	At 6 months postoperatively	80.03 ± 8.52	86.97 ± 7.33	−3.378	0.001
The excellent and good rate of the Cooney score [n, (%)]				4.176	0.041
Excellent and good	At 6 months postoperatively	18	26
Fair and poor		12	4
Rate of excellent and good (%)		60.00%	86.67%

Quality of life

The quality of life at 6 months postoperatively was compared between the two groups. The results showed that the study group showed better GQOL-74 scores compared to the control group: psychological function (79.93 ± 7.21 vs 74.20 ± 6.61, p = 0.002), physical function (79.90 ± 6.39 vs 76.33 ± 7.03, p = 0.044), material life (79.03 ± 6.57 vs 74.47 ± 8.18, p = 0.020), and social function (84.03 ± 6.68 vs 79.23 ± 6.61, p = 0.007) (Table 4).

Table 4.

Comparison of GQOL-74 scores at 6 months postoperatively between the control and study groups (Mean ± SD).

Item	Control group (n = 30)	Study group (n = 30)	t	p
Psychological function	74.20 ± 6.61	79.93 ± 7.21	−3.212	0.002
Physical function	76.33 ± 7.03	79.90 ± 6.39	−2.056	0.044
Material life	74.47 ± 8.18	79.03 ± 6.57	−2.384	0.020
Social function	79.23 ± 6.61	84.03 ± 6.68	−2.799	0.007

Postoperative imaging indicators

The imaging indicators at 12 months postoperatively were compared between the two groups. The results showed that the study group showed significant superiority over the control group in terms of palmar tilt angle (9.30 ± 2.12° vs 10.88 ± 2.52°, p = 0.012), ulnar variance angle (15.27 ± 3.86° vs 18.27 ± 3.73°, p = 0.003), joint surface displacement degree (1.08 ± 0.33 mm vs 1.33 ± 0.42 mm, p = 0.015). However, no significant difference was observed in radial height between the two groups (9.90 ± 2.19 mm vs 10.77 ± 2.56, p = 0.163) (Table 5).

Table 5.

Comparison of imaging indicators at 12 months postoperatively between the control and study groups (Mean ± SD).

Item	Control group (n = 30)	Study group (n = 30)	t	p
Palmar tilt angle (°)	10.88 ± 2.52	9.30 ± 2.12	2.609	0.012
Ulnar variance angle (°)	18.27 ± 3.73	15.27 ± 3.86	3.061	0.003
Radial height (mm)	10.77 ± 2.56	9.90 ± 2.19	1.411	0.163
Joint surface displacement degree (mm)	1.33 ± 0.42	1.08 ± 0.33	2.518	0.015

Range of motion in wrist flexion

The range of motion in wrist flexion at 12 months postoperatively was compared between the two groups. The results displayed that the study group exhibited a greater range of motion in wrist flexion compared to the control group (68.30 ± 7.24° vs 63.20 ± 8.92°, p = 0.018). However, no marked differences were found between the groups in terms of extension (63.87 ± 8.25° vs 59.87 ± 8.45°, p = 0.067), pronation (73.20 ± 9.03° vs 68.57 ± 9.33°, p = 0.055), supination (62.20 ± 8.92° vs 60.20 ± 7.16°, p = 0.342), radial inclination (19.03 ± 3.15° vs 18.97 ± 4.22°, p = 0.945), or ulnar inclination (27.33 ± 4.72° vs 25.90 ± 5.18°, p = 0.267) (Table 6).

Table 6.

Comparison of the range of motion of the wrist joint at 12 months postoperatively between the control and study groups (Mean ± SD).

Item	Control group (n = 30)	Study group (n = 30)	t	p
Flexion (°)	63.20 ± 8.92	68.30 ± 7.24	−2.433	0.018
Extension (°)	59.87 ± 8.45	63.87 ± 8.25	−1.866	0.067
Pronation (°)	68.57 ± 9.33	73.20 ± 9.03	−1.954	0.055
Supination (°)	60.20 ± 7.16	62.20 ± 8.92	−0.958	0.342
Radial inclination (°)	18.97 ± 4.22	19.03 ± 3.15	−0.069	0.945
Ulnar inclination (°)	25.90 ± 5.18	27.33 ± 4.72	−1.121	0.267

Complication

The incidence of postoperative complications was observed in the two groups. The results exhibited that no significant difference was observed in the complication rates between the two groups, with the control group having a total incidence of 13.33% (4/30), including 2 cases of malunion, 1 case of carpal tunnel syndrome, and 1 case of ulnar nerve injury; the study group had an incidence of 10.00% (3/30), including 1 case of carpal tunnel syndrome, 1 case of ulnar nerve injury, and 1 case of median nerve palsy, with no significant difference (P = 0.688). During the treatment process, none of the patients in the treatment groups experienced any allergic reactions such as blisters, rashes, or skin itching on the skin surface of the affected limb, nor did they experience physical discomforts such as dizziness, nausea, vomiting, or diarrhea. This indicates that the two groups have similar safety profiles, and the external application of the Xiaozhong Zhitong ointment did not increase the risk of complications (Table 7).

Table 7.

Comparison of postoperative complications between the control and study groups [n, (%)].

Complications	Control group (n = 30)	Study group (n = 30)	$χ^{2}$	p
Malunion	2	0	-	-
Carpal tunnel syndrome	1	1	-	-
Ulnar nerve injury	1	1	-	-
Median nerve palsy	0	1	-	-
Overall incidence	4 (13.33%)	3 (10.00%)	0.162	0.688

Discussion

VLP fixation has revolutionized the management of distal radius fractures, establishing itself as the cornerstone of treatment by offering reliable stabilization across a diverse range of fracture patterns.²⁵ In parallel, traditional ointments have demonstrated significant therapeutic potential, particularly in promoting blood circulation, resolving blood stasis, reducing swelling, and alleviating pain, making them effective for treating joint and muscle-related swelling and pain²⁶. The present study investigated the clinical efficacy and safety of combining external application of Xiaozhong Zhitong ointment with VLP fixation in treating complex AO-C2/3 type distal radius fractures. Our findings demonstrated that the combination of Xiaozhong Zhitong ointment and VLP fixation provides superior therapeutic outcomes for patients with complex distal radius fractures, alleviating postoperative pain and wrist swelling while improving quality of life and wrist joint function. This suggests that Xiaozhong Zhitong ointment, as an adjuvant therapy, may exert synergistic effects through multi-component, multi-target mechanisms.

Due to the screw-plate locking fixation mechanism, VLPs offer the advantage of providing rigid fixation for comminuted and osteoporotic fractures.²⁷ Additionally, precise realignment of fractures and joint surfaces, stable fixation during healing, potential for early rehabilitation, and favorable functional outcomes are key advantages of VLPs.²⁸ Multiple studies have confirmed the efficacy of VLPs.^29–31 However, their ultimate therapeutic effectiveness in complex intra-articular AO-C type fractures requires further improvement.^5,11,12 As demonstrated in this study, the study group receiving combined VLP fixation and Xiaozhong Zhitong ointment application showed significant advantages over the control group treated with VLP alone across multiple postoperative recovery indicators. In terms of early recovery, the study group exhibited superior pain and swelling control compared to the control group. Regarding functional recovery, the study group demonstrated sustained and comprehensive improvements. Their Cooney wrist scores were higher at 4 weeks and 6 months postoperatively, with a significantly better functional excellence rate at 6 months. The study group also scored higher across all dimensions of the GQOL-74 quality-of-life scale at 6 months postoperatively. Long-term functional benefits were confirmed, with the study group showing significantly greater wrist flexion range at 12 months postoperatively. Imaging assessments revealed better structural parameter recovery in the study group at 12 months. Moreover, no significant difference in complication rates was observed between the two groups, indicating good safety of the combined treatment protocol.

Recent research has validated the efficacy of Qingpeng Ointment in treating traumatic injuries, sprains, contusions, muscle soreness, joint swelling, and pain, as well as burns and scalds.²⁶ Additionally, Wound Ointment containing herbal ingredients such as Ginseng, Notoginseng, and Rheum palmatum has been reported to relieve pain, prevent infection, promote healing, and exhibit fewer side effects. Its role in increasing vascular endothelial growth factor expression during bone regeneration facilitates angiogenesis, callus formation, and accelerated fracture healing.³² Rheum palmatum, a key ingredient in Xiaozhong Zhitong Ointment, is also present in this formulation. Mechanistically, Resina draconis’s primary component, dracorhodin, exhibits clear anti-inflammatory and analgesic effects¹⁶; Rheum palmatum contains anthraquinones like emodin, which possess anti-inflammatory, antibacterial, and immunomodulatory activities while reducing bleeding^17,33; Commiphora Myrrh contains resin acids with anti-inflammatory and analgesic properties.^34,35 Furthermore, the active component paeoniflorin in Paeonia lactiflora exhibits analgesic and anti-inflammatory effects,³⁶ collectively improving local blood circulation; Curcuma longa’s primary active component, curcumin, demonstrates potent anti-inflammatory properties³⁷; Salvia miltiorrhiza promotes blood circulation by activating blood, cooling the blood, and treating carbuncles, with its main active component tanshinone IIA also exhibiting anti-inflammatory effects³⁸; Ligusticum chuanxiong contains ligustrazine, which significantly promotes local blood circulation and resolves stasis.³⁹ Meanwhile, Strychnos nux-vomica primarily contains strychnine and other alkaloids that unblock collaterals, relieve pain, and disperse swelling^40,41; Achyranthes bidentata contains saponins that promote osteoblast proliferation⁴²; Angelica Dahurica, Angelica pubescens, and Gentiana macrophylla all possess wind-dispelling, dampness-resolving, and pain-relieving properties. Modern studies show they frequently exhibit anti-inflammatory and analgesic effects.^43,44 Finally, Glycyrrhiza uralensis’s primary component, glycyrrhizin, exhibits glucocorticoid-like effects, enhancing the anti-inflammatory effects of other drugs while harmonizing formulations, reducing irritation from other ingredients, and possessing anti-inflammatory and hepatoprotective properties.^45–47 These synergistic mechanisms likely explain the study group’s advantages in pain, swelling, joint function, and quality of life.

In conclusion, this study confirms that the combination of Xiaozhong Zhitong ointment and VLP fixation provides superior therapeutic outcomes for patients with complex distal radius fractures, alleviating postoperative pain and wrist swelling while improving quality of life and wrist joint function without increasing complication risks. This offers an effective integrated TCM-Western medicine adjuvant treatment protocol for complex AO-C2/C3 distal radius fractures. However, this study’s limited sample size and single-center design may restrict the generalizability of its findings. Additionally, while focusing on clinical efficacy observations, the study did not deeply explore the specific molecular pathways through which Xiaozhong Zhitong ointment influences fracture healing and soft tissue repair. Future research could conduct large-scale, multicenter studies and utilize modern biological techniques to investigate the precise targets and pathways of the ointment’s main active ingredients in anti-inflammatory and analgesic effects, providing a solid pharmacological foundation for its clinical application.

Footnotes

ORCID iD

Zheng Feng

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

References

Ali

Ilyas

Riaz

, et al. Outcome of the distal radius fractures managed with across wrist external fixator Vs buttress plates. J Ayub Med Coll Abbottabad 2023; 35(1): 32–36.

Rubio

. Distal radioulnar joint, distal ulna injury, and lunate facet considerations in distal radius fractures. J Orthop Trauma 2021; 35(Suppl 3): s11–s16.

Herzberg

Burnier

. Arthroscopically assisted treatment of volar rim fractures. J Wrist Surg 2022; 11(3): 224–229.

Lim

Loh

Sylvestor

, et al. Perioperative management of distal radius fractures. J Perioperat Pract 2021; 31(10): 1750458920949463.

Garg

Bansal

Mehta

. The “AIIMS hairpin loop” technique for ‘extreme’ volar rim fractures of distal radius. J Clin Orthop Trauma 2021; 15: 46–50.

Garg

Mudgal

. When a volar locking plate is not the right choice in fractures of the distal radius: case based technical considerations. J Clin Orthop Trauma 2020; 11(4): 542–553.

Han

, et al. Nonoperative treatment versus volar locking plate fixation for elderly patients with distal radial fracture: a systematic review and meta-analysis. J Orthop Surg Res 2020; 15(1): 263.

Campbell

Reyes

Neustein

, et al. Outcomes of volar plating distal radius fractures based on surgical timing. Hand 2025; 20(2): 252–257.

Zhu

Liu

, et al. Risk factors for complications following volar locking plate (VLP) fixation of unstable distal radius fracture (DRF). BioMed Res Int 2022; 2022: 9117533.

10.

Tai

Chu

, et al. Current management and volar locking plate fixation with bone cement augmentation for elderly distal radius fractures-an updated narrative review. J Clin Med 2023; 12(21): 6801.

11.

du Plessis

Fournier

. Management of complex wrist fractures with volar and dorsal locked (double-locked) K-lock. OTA Int 2023; 6(4): e286.

12.

Lundqvist

Fischer

Wretenberg

, et al. Volar locking plate compared with combined plating of AO type C distal radius fractures: a randomized controlled study of 150 cases. J Hand Surg Am 2022; 47(9): 813–822.

13.

Liu

Wang

, et al. External treatment of traditional Chinese medicine for constipation after thoracolumbar compression fractures: a protocol for systematic review and meta-analysis. Medicine (Baltim) 2021; 100(35): e27110.

14.

Song

Yanhong

Hongyang

, et al. Effectiveness of acupoint application of Xiaozhong Zhitong Tie on diarrhea in patients: a retrospective cohort study in China. J Tradit Chin Med 2023; 43(4): 809–814.

15.

Zhang

Chen

, et al. Effect of taohong siwu decoction combined with Moxa-wool moxibustion on wrist joint function in patients with distal radius fracture after surgery. Medical Innovation of China 2024; 21(34): 1–5.

16.

Zhou

Chen

, et al. Resina Draconis particles encapsulated in a hyaluronic-acid-based hydrogel to treat complex burn wounds. Pharmaceutics 2022; 14(10): 2087.

17.

Yang

Fan

Yang

, et al. Dissecting alternative splicing patterns of the Rheum palmatum complex with different contents of medicinal constituents. BMC Genom 2025; 26(1): 855.

18.

Bai

Wang

Liang

, et al. Atractylodes macrocephala-Paeonia lactiflora class formula for the treatment of irritable bowel syndrome: a systematic review with meta-analysis and trial sequential analysis. Cureus 2023; 15(12): e49997.

19.

Siu

Zhou

Fung

, et al. Preclinical evaluations on the efficacy of a topical Chinese herbal formula for swelling control and pain relief. J Ethnopharmacol 2015; 162: 346–351.

20.

Liu

, et al. Cartilage protective and anti-edema effects of JTF in osteoarthritis via inhibiting NCOA4-HMGB1-driven ferroptosis and aquaporin dysregulation. Phytomedicine 2024; 129: 155593.

21.

Crichton

. Visual analogue scale (VAS). J Clin Nurs 2001; 10: 706–716.

22.

Fan

Bai

Cheng

, et al. The effectiveness and safety of blood flow restriction training for the post-operation treatment of distal radius fracture. Ann Med 2023; 55(2): 2240329.

23.

Jiang

Fang

, et al. Effects of comfort nursing on pain and quality of life in children undergoing tonsillectomy. Am J Transl Res 2023; 15(2): 1159–1167.

24.

Sim

Lewis

. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol 2012; 65(3): 301–308.

25.

Hadzhinikolova

Zderic

Ciric

, et al. Volar versus combined dorsal and volar plate fixation of complex intraarticular distal radius fractures with small dorsoulnar fragment - a biomechanical study. BMC Muscoskelet Disord 2022; 23(1): 35.

26.

Shang

Dong

Xie

, et al. Efficacy and safety of Tibetan medicine Qingpeng ointment for acute gouty arthritis: protocol for a multi-center, randomized, double-blind, placebo-controlled trial. Trials 2022; 23(1): 387.

27.

Eda

Kohyama

Ikumi

, et al. Three-dimensional analysis of polyaxial volar locking plate position for distal radius fracture. J Wrist Surg 2024; 13(6): 484–491.

28.

Gossett

Reizner

, et al. The role of proximal locking fixation in volar distal radius fracture fixation. J Wrist Surg 2025; 14(2): 151–157.

29.

Zhao

Song

Liu

, et al. Clinical application of multi-direction temporary Kapandji technique and volar locking plate fixation for type C distal radius fractures. BMC Surg 2024; 24(1): 404.

30.

Nasir

Memon

Mersal

, et al. Radiological and functional outcomes following distal radius fixation with a volar locking plate. Cureus 2025; 17(9): e91422.

31.

Singh

Pradeep

Janeson

JDJ

, et al. Clinicoradiological outcome of variable angle volar locking plate in the management of distal radius fractures. J Orthop Case Rep 2025; 15(4): 270–276.

32.

Cheng

Chen

, et al. Chemical characterization of wound ointment (WO) and its effects on fracture repair: a rabbit model. Chin Med 2017; 12: 31.

33.

Nguyen

LTH

Ahn

Shin

, et al. Anti-psoriatic effect of Rheum palmatum L. and its underlying molecular mechanisms. Int J Mol Sci 2022; 23(24): 16000.

34.

Alsharidah

Alehaideb

Alghamdi

, et al. Commiphora myrrha resin extract-modulated cytochrome P-450 2C9 enzyme expression in cultured Hep G2 cells is associated with resin extract-derived metabolites binding to pregnane X receptor. BMC Complement Med Ther 2025; 25(1): 247.

35.

Batiha

Wasef

Teibo

, et al. Commiphora myrrh: a phytochemical and pharmacological update. Naunyn-Schmiedebergs Arch Pharmacol 2023; 396(3): 405–420.

36.

Choi

Kang

. Evaluation of cytotoxic and antibacterial effect of methanolic extract of Paeonia lactiflora. Medicina (Kaunas) 2022; 58(9): 1272.

37.

Hidayat

Parlindungan

Nisa

, et al. Efficacy of Curcuma longa in relieving pain symptoms of knee osteoarthritis patients: a systematic review and meta-analysis of clinical trials. J Rheum Dis 2025; 32(1): 17–29.

38.

Zhang

Gao

, et al. Salvia miltiorrhiza and tanshinone IIA reduce endothelial inflammation and atherosclerotic plaque formation through inhibiting COX-2. Biomed Pharmacother 2023; 167: 115501.

39.

Xiang

Liao

Chen

, et al. Network pharmacology and molecular docking to elucidate the potential mechanism of ligusticum chuanxiong against osteoarthritis. Front Pharmacol 2022; 13: 854215.

40.

Zhang

Gai

Fan

, et al. Exploring the molecular mechanism of Nux Vomica in treating ischemic stroke using network pharmacology and molecular docking methods. Medicine (Baltim) 2023; 102(16): e33625.

41.

Razzaq

Hussain

Rasul

, et al. Strychnos nux-vomica L. seed preparation promotes functional recovery and attenuates oxidative stress in a mouse model of sciatic nerve crush injury. BMC Complement Med Ther 2020; 20(1): 181.

42.

Zhang

Diao

, et al. Achyranthes bidentate saponins protect rat articular chondrocytes against interleukin-1β-induced inflammation and apoptosis in vitro. Kaohsiung J Med Sci 2017; 33(2): 62–68.

43.

Herbet

Widelski

Ostrowska-Leśko

, et al. Exploring the toxicity and therapeutic potential of A. dahurica and A. pubescens in zebrafish larvae: insights into anxiety treatment mechanisms. Int J Mol Sci 2025; 26(7): 2884.

44.

Ciren

Feng

, et al. Gentiana macrophylla flavonoids from Tibetan medicine decreases circ_0059665 to alleviate the progression of non-small cell lung cancer under hypoxia. Thorac Cancer 2024; 15(1): 77–88.

45.

Huang

Wang

, et al. GuUGT, a glycosyltransferase from Glycyrrhiza uralensis, exhibits glycyrrhetinic acid 3- and 30-O-glycosylation. R Soc Open Sci 2019; 6(10): 191121.

46.

Aipire

Yuan

Aimaier

, et al. Preparation, characterization, and immuno-enhancing activity of polysaccharides from Glycyrrhiza uralensis. Biomolecules 2020; 10(1): 159.

47.

Zhang

Zhu

Xie

, et al. Effect of Gan Cao (Glycyrrhiza uralensis Fisch) polysaccharide on growth performance, immune function, and gut microflora of broiler chickens. Poult Sci 2022; 101(10): 102068.

Integrative application of traditional Chinese medicine and internal fixation in complex distal radius fractures: Clinical value of Xiaozhong Zhitong ointment combined with volar locking plate in AO-C2/3 injuries

Abstract

Objective

Methods

Results

Conclusion

Keywords

Introduction

Materials and methods

Ethical approval

Participants

Randomization and blinding

Preoperative preparation

Control group

Study group

Observation indicators

Pain level

Swelling level

Wrist joint function Cooney score

Quality of life

Imaging indicators

Wrist joint range of motion

Complications

Sample size

Statistical methods

Results

General data

Pain and swelling conditions

Cooney scores for wrist joint function

Quality of life

Postoperative imaging indicators

Range of motion in wrist flexion

Complication

Discussion

Footnotes

ORCID iD

Funding

Declaration of conflicting interests

References