A randomized controlled trail on the treatment of knee osteoarthritis with acupotomy therapy based on the meridian sinew theory

A randomized controlled trail on the treatment of knee osteoarthritis with acupotomy therapy based on the meridian sinew theory

World Journal of Acupuncture – Moxibustion 28 (2018) 246–250 Contents lists available at ScienceDirect World Journal of Acupuncture – Moxibustion jo...

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World Journal of Acupuncture – Moxibustion 28 (2018) 246–250

Contents lists available at ScienceDirect

World Journal of Acupuncture – Moxibustion journal homepage: www.elsevier.com/locate/wjam

Clinical Research

A randomized controlled trail on the treatment of knee osteoarthritis with acupotomy therapy based on the meridian sinew theoryR Pei WANG () a, Cai-rong ZHANG () b, De-chun CHEN () c, Ke-qing ZHUANG () b, Zhi-lan HUANG () b, Can DONG () b, Han-qing HONG () a, Zhi-zhong RUAN () b,∗ Nanjing University of Chinese Medicine, Nanjing 210046, Jiangsu Province, China (,  210046, ) The Third Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210000, China (, 210000, ) c Daishan Community Health Service Center, Yuhuatai District, Nanjing 210000, China (, 210000, ) a

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a r t i c l e

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Article history: Available online 25 December 2018 Keywords: Acupotomy Meridian sinew theory Anatomy theory Knee osteoarthritis

a b s t r a c t Objective: To compare the clinical efficacy differences of acupotomy therapy guided by the meridian sinew theory and acupotomy therapy guided by the anatomy theory of western medicine in the treatment of knee osteoarthritis. Methods: Sixty-three patients were randomly divided into the acupotomy group of the meridian sinew theory (Group A, n = 32) and the acupotomy group of the anatomy theory (Group B, n = 31). For Group A, with positive reaction points such as the tenderness points of three yang meridians and three yin meridians of the foot, and funicular nodules as the points of needle insertion, the needle-knife, after disinfection and anesthesia, gives priority to longitudinal dissection after insertion, and then carries out subcutaneous sweeping maniplation. For Group B, with 8 points for needle insertion, including the origins and terminations of the medial and lateral collateral ligaments, the origins and terminations of the patellar ligament, the terminations of the quadriceps femoris tendon, and pes anserinus bursa point, the treatment was performed in strict accordance with the four-step procedures of acupotomy (positioning, orientating, pressurizing to separate, and puncturing) after disinfection and anesthesia. The treatment was conducted once a week and three times in total. Statistical analysis was conducted with the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index and Visual Analogue Scale (VAS) for overall pain before treatment and at week 2 and 4 during treatment, and the adverse reactions of patients were observed and recorded to evaluate the curative effect. Results: During the treatment period, the overall response rates (ORRs, that is markedly effective + effective) were compared between the two groups. The ORR of Group A was 90.63% and that of Group B was 87.09%. There was no statistical significant difference between the two groups (P > 0.05). After treatment, the WOMAC function score of Group A was significantly lower than that before treatment (17.28 ± 10.22 vs 32.75 ± 14.88, P < 0.001), and that of Group B was lower than that before treatment (24.87 ± 16.48 vs 30.90 ± 16.64, P < 0.05), there was a statistical significant difference between the two groups (P < 0.05). As for the comparison of VAS pain scores, in Group A, there was statistical significant difference (4.48 ± 1.60 vs 5.05 ± 1.60, P < 0.05) between at Week 2 and before treatment, and statistically significant difference (1.88 ± 1.03 vs 5.05 ± 1.60, P<0.001) between at Week 4 and before treatment. In Group B, there was no significant difference (P>0.05) between at Week 2 and before treatment, and there was statistically significant difference (3.31 ± 1.56 vs 4.77 ± 1.68, P<0.001) between at Week 4 and before treatment. The VAS pain score of Group A was significantly lower than that of Group B (P < 0.001), and 2 cases of mild adverse reactions occurred in Group A and 3 in Group B.

R Supported by Nanjing Municipal Science and Technology Development Project: 201715070. ∗ Corresponding author. E-mail address: [email protected] (Z.-z. RUAN).

https://doi.org/10.1016/j.wjam.2018.12.009 1003-5257/© 2019 Published by Elsevier B.V. on behalf of World Journal of Acupuncture Moxibustion House.

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Conclusion: Both acupotomy therapies guided by the meridian sinew theory and by the anatomy theory of Western medicine have good curative effect on knee osteoarthritis, but acupotomy guided by the meridian sinew theory has more superiorities in operability, safety and effectiveness, which is easy to be generalized in grass-roots and community hospitals. © 2019 Published by Elsevier B.V. on behalf of World Journal of Acupuncture Moxibustion House.

Introduction Knee osteoarthritis (KOA) is a chronic osteoarticular disease (OAD) mainly characterized by degenerative articular cartilage, bone sclerosis and bone hyperplasia and with joint pain, joint swelling, joint stiffness and movement disorder as its main clinical manifestations [1]. KOA occurs more frequently in people older than 40 years old, and attacks more women than men. According to the epidemiological survey, the prevalence of KOA is 50% among people over 60 years old, and as high as 80% among people over 75 years old in China, with the disability rate of 53% [2]. KOA belongs to the category of “bì syndrome” and “bone bì” in traditional Chinese medicine, and its main pathogeny and pathogenesis is deficiency of liver and kidney and insufficiency of essence and blood which cause malnutrition of sinew and bone, attack of cold and dampness, obstruction and stagnation of meridians and collaterals, and pain due to blockage. At present, the etiology of KOA is still unclear in western medicine, and it is mostly believed that KOA’s onset is related to age, obesity, trauma, heredity and other factors [3]. In addition, it was pointed out in some studies that KOA may be related to endocrine disorders, metabolic diseases, acromegaly, hyperparathyroidism and other factors [4]. KOA is treated mainly with non-steroidal anti-inflammatory drugs, glucosamine sulfate, local analgesics, intra-articular injection of sodium hyaluronate and surgery in western medicine [5,6]. In spite of various treatment methods, the curative effect is transient, most western medications have obvious side effects in long-term administration, and patients bear relatively heavy economic burden if accepting western medical treatment. The limitations of these therapies have driven patients to seek for non-drug therapies, such as acupotomy therapy. Needle-knife is a new medical device combining “needle” and “knife” [7]. As a minimally invasive technology, acupotomy therapy has made great progress. Acupotomy can restore the force balance of soft tissue and joint, promote the repair of damaged soft tissue in the periphery of knees and reconstruct the biomechanical environment around knee by cutting scar, dredging blockage, separating adhesion and other methods. At present, acupotomy has been widely used in the treatment of osteoarticular diseases, and are favored greatly by patients for its characteristics of small trauma and good curative effect. In previous studies, however, people’s understanding and treatment of KOA focused on bone changes because the imaging changes of KOA patients mostly indicated the existence of bone hyperplasia in their knee joints, therefore, it was difficult to achieve good curative effect. In recent years, some relevant literature has reported that the clinical symptoms of KOA patients are not directly related to bone hyperplasia, but closely related to the muscles, ligaments and fascia in the periphery of knees which are tissues belonging to the category of “meridian sinew” in traditional Chinese medicine [8]. This suggests that we cannot only focus on bone changes with regard to our understanding and treatment of KOA, but also on the harm caused by the disorder of the meridian sinew system. Though acupotomy has made certain curative effect in the treatment of KOA, the treatment is mostly aimed at all-round release of the ligaments in the periphery of knees, emphasizes the proficiency of operators with anatomy, and sometimes even needs the guidance from imageology, so operations are relatively difficult with certain risks, and patients’ economic burden is heavy, which limit the generalization of acupotomy in grass-roots

and community hospitals. Therefore, the clinical efficacy of acupotomy guided by the meridian sinew theory were compared with those of acupotomy under the guidance of the anatomy theory of western medicine in treatment of KOA, and the effectiveness, safety and feasibility of acupotomy guided by the meridian sinew theory in treatment of KOA were evaluated, providing a clinical basis for the treatment of KOA with acupotomy guided by the meridian sinew theory in this study. Clinical data General information A total of 63 patients with knee osteoarthritis, who were treated in the Outpatient Department of Acupuncture-moxibustion in Nanjing Hospital of Chinese Medicine and Daishan Community Health Service Center from September 2017 to August 2018, were selected. According to the order of clinic admission, 32 cases were divided into group A (acupotomy group of the meridian sinew theory) and 31 cases were divided into group B (acupotomy group of the anatomy theory) in the manner of random number table. There was no statistically significant difference in general data such as gender, age and course of disease between the two groups (P > 0.05), there was comparability between the two groups, as shown in Table 1. Diagnostic criteria The diagnostic criteria for knee arthritis of the American Society of Rheumatology (ACR) (1995) were met [9]: (1) Knee pain existed in most days of a month; (2) The X-ray film showed osteophyte at the edge of the joint; (3) Osteoarthritis was showed according to the joint fluid examination; (4) The patient was older than 40 years old; (5) The duration of morning stiffness was less than 30min; (6) There was clicking when joints move. Those meeting the items of (1) and (2) or (1) and (3) and (5) and (6) or (1) and (4) and (5) and (6) above can be diagnosed with knee osteoarthritis. KOA patients who met the diagnostic criteria were included in the study. Inclusion criteria (1) The diagnostic criteria for knee arthritis of the ACR were met; (2) The knee joint had at least moderate or lower pain (VAS score < 7 points) in most days of the past month; (3) The patient was 40–75 years old (inclusive); (4) The subject stopped taking acesodyne and was not allowed to take hormone medicines, but only allowed to take related medications such as analgesics or nonsteroidal anti-inflammatory agents in case of intolerable pain; (5) The subject agreed to sign informed consent. Patients who met the 5 criteria above at the same time can be included in this study. Exclusion criteria (1) Those who received hormone therapy in the past 3 months; (2) Those who received intra-articular hyaluronidase injection in the past 6 months; (3) Those who received joint irrigation or joint endoscopy in the past year; (4) Those with diseases hindering

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Table 1 Comparison of baseline data of the patients with KOA between the two groups. Group

A B P value

Patients

32 31

Gender(cases) Male

Female

8 7 0.822

24 24

Age (X¯ ± S, years old)

Height (X¯ ± S, cm)

Weight (X¯ ± S, kg)

Course of disease (X ± S, days)

60.47 ± 8.32 61.45 ± 8.32 0.691

161.72 ± 15.46 163.65 ± 6.48 0.36

64.59 ± 7.55 64.74 ± 9.91 0.253

31.646 ± 5.59 31.829 ± 5.72 0.731

Diseased side (knees/%) Left knees

Right knees

Both knees

9/28.13 9/29.03

10/31.25 10/32.26 0.988

13/40.62 12/38.71

WOMAC score (X ± S, points)

VAS score (X ± S, points)

32.75 ± 14.878 30.90 ± 16.640 0.644

5.05 ± 1.603 4.77 ± 1.687 0.513

Note: The baseline data levels of the patients in the two groups are basically consistent and they are comparable between the two groups.

Fig. 1. The location of each acupoints.

the safe participation in the experimental design and affecting the completion of the study, for example, they suffered from myocardial infarction or stroke, congestive heart failure, severe chronic obstructive pulmonary disease, cancer, diabetes and other serious systemic diseases as well as serious mental illness in the past 3 months; (5) Those who had a medical history or clinical manifestation of hemorrhagic tendency, including the use of anticoagulants at that time; (6) Those with inflammatory arthritis (such as rheumatoid or psoriatic arthritis); (7) Those who were also involved in other research; (8) Those who underwent a knee replacement surgery; (9) Those who used to participate in the treatment related to research on knee osteoarthritis in the past; (10) Those who were excessively fear of acupotomy therapy; (11) Those who were receiving local external therapy at the same time, such as local application therapy; (12) Those who cannot complete various scales; (13) Those who were unwilling to participate in random grouping. Patients who met any of the above items were excluded.

 ), Y¯ınlíngshàng ( ) [10] were selected and marked with a marker (Fig. 1). (3) Disinfection and anesthesia: the operator wore a mask, a hat, and sterile gloves, strictly disinfected the treatment area with povidone-iodine, and then used 0.5% lidocaine for local infiltration anesthesia with about 1 mL at each point. (4) Manipulation: Hanzhang brand 4# disposable 0.8 mm × 40 mm needle-knives were used. The needleknife gave priority to longitudinal dissection after insertion, and then carried out subcutaneous sweeping maniplation. The points of insertion were pressed for a moment of hemostasis, and then the needling holes were covered with band-aid. The patients were asked to keep the wound dry and not exercise vigorously. Group B: acupotomy group of the anatomy theory Methods:

Methods For the patients with knee osteoarthritis on both sides, knee osteoarthritis on both sides was treated, and the more severe side was selected for evaluation. Group A: acupotomy group of the meridian sinew theory Methods: (1) Position: The patients were asked as supine position for the anterior, medial and lateral release, with the knee joint flexion of about 30° and a soft pillow under the knee; the prone position was adopted for the posterior release, with a soft pillow in front of the ankle. (2) Positioning: positive reaction points were taken as the points of needle insertion, such as the tenderness points of three yang meridians and three yin meridians of the foot, and funicular nodules, if there was no obvious tenderness ¯ ˘ ( (), Y¯ıngucì points or funicular nodules, We˘ izhongcì ¯ ¯ (), X¯ıguancì (  ), Yánglíngcì ( ), Ququáncì

(1) Position: The patients were asked as the same positions as group A. (2) Positioning: 8 points were taken as needle insertion points by reference to the Acupotomy Fundamentals and Clinic [11], including the origins and terminations of the medial and lateral collateral ligaments, the origins and terminations of the patellar ligament, the terminations of the quadriceps femoris tendon, and pes anserinus bursa point, which were marked with a marker. (3) Disinfection and anesthesia: The operator wore a mask, a hat, and sterile gloves, strictly disinfected the treatment area with povidone-iodine, and then used 0.5% lidocaine for local infiltration anesthesia with about 1 ml at each point. (4) Manipulation: Hanzhang brand 4# disposable 0.8 mm × 40 mm needle-knives were used. The needle knife was perpendicular to skin, and the incision line was consistent with the longitudinal axis direction of the lower limb. The treatment was performed in strict accordance with the four-step procedures of acupotomy (positioning, orientating, pressurizing to separate, and puncturing). The points of insertion were pressed for a moment of

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hemostasis, and then the needling holes were covered with band-aid. The patients were asked to keep the wound dry and not exercise vigorously. Treatment period The subjects in both groups received treatment once a week and were evaluated before the next treatment. After the last treatment, the curative effect was evaluated at the same time point in the next week. The treatment period was 3 weeks.

Table 2 Comparison of clinical effects of KOA patients in the two groups. Group

Patients

Markedly effective

Effective

Ineffective

Response rate (%)

A B

32 31

11 9

18 18

3 4

90.63 87.09

Comparison of WOMAC function scores and VAS pain scores of the patients with KOA before and after treatment between the two groups. Table 3 Comparison of WOMAC function scores after treatment of KOA patients between the two groups. Group

Curative effect evaluation The curative effect evaluation was made by reference to the relevant contents of the Guidelines of Clinical Research on Chinese New Herbal Medicine (Interim) [12]. The specific contents are as follows: Markedly effective: pain and other symptoms disappeared, and the joint movement function was not limited. Effective: pain and other symptoms basically disappeared, and the joint movement was slightly limited. Ineffective: the symptoms such as pain and joint movement were not improved markedly. A comprehensive evaluation was made based on the pain, stiffness, difficulty of daily activities and overall curative effect of the patients. Overall Response Rate (ORR) = (Markedly effective + Effective) cases/Total cases × 100%. Curative effect index (1) Primary evaluation index: WOMAC scale after the last treatment was taken as the primary evaluation index. WOMAC of the Likert version was adopted and a scale of Level 0–4 was applied for recording scores. (2) Secondary evaluation index: VAS scale was used to evaluate the overall pain degree of patients. The intensity of pain was described with 11 points from 0 to 10. Point 0 means no pain, and when the pain becomes more intense, the number of points increases in turn. Point 10 means the most intense pain. The baseline values were measured 1 week before treatment, and the clinical efficacy was evaluated at week 2 and 4 after treatment. Statistical analysis All the experimental data were analyzed with the SPSS20.0 Statistical Software, and expressed with mean ± standard deviation (X¯ ± S). The count data were analyzed with the χ 2 test. Intragroup data of three different time periods were analyzed with oneway ANOVA, and intergroup data comparison was made by using the independent-samples T test. There was a significant difference when P < 0.05. Results Comparison of clinical effects of the patients with KOA between the two groups After the treatment was completed, the difference in ORR was not statistically significant between the two groups (P > 0.05), indicating that both methods had significant effects on KOA during the treatment (Table 2). After treatment for 3 weeks, the WOMAC function scores and VAS pain scores of both groups decreased, but the decrease was more significant in group A than that in group B (P < 0.05, Tables 3 and 4).

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A B

Patients

Before the treatment

Week 2

32 31

32.75 ± 14.878 30.90 ± 16.640

25.59 ± 13.37 27.74 ± 16.85

Week 4 17.28 ± 10.22b , d , c 24.87 ± 16.48

a

Note: a Compared with that before treatment in week 2, P<0.05. b Compared with that before treatment in week 4, P<0.001. c Compared with group B, P<0.05. d Compared with that before treatment in week 4, P<0.05. Table 4 Comparison of VAS pain scores after treatment of KOA patients between the two groups. Group A B

Patients

Before the treatment

Week 2

32 31

5.05 ± 1.60 4.77 ± 1.68

4.48 ± 1.60 4.32 ± 2.19

Week 4 a

1.88 ± 1.03 b , c 3.31 ± 1.56b

Note: a Compared with that before treatment in week 2, P<0.05. b Compared with that before treatment in week 4, P<0.001. c Compared with group B, P<0.001.

Safety analysis Among all the subjects in group A, 2 patients showed slight palpitation and discomfort due to fear of needle-knife during the first treatment, and after communication, no obvious discomfort was reported during the second and third treatment. In group B, 3 patients complained of severe pain during treatment. After local injection of lidocaine, they had a rest for 5 min before the acupotomy manipulation. None of the patients withdrew from the study, and no serious adverse event was reported during the treatment. Discussion Meridian sinew theory and KOA According to studying the ancient and modern literature, we found that KOA belongs to the category of meridian sinew from both the physiological, pathological and clinical manifestations. First of all, “all sinews mainly fetter bones and also governs joints”. Equivalent to muscles, tendon, ligament, fascia and other structures in modern anatomy, meridian sinews are an accessory part of meridians and collaterals, and is a system of deeply nourishing sinews, muscles, and joints. “The knees are the house of the sinews”. Among the twelve meridian sinews, the running routes of the three yang meridians and three yin meridians of the foot pass through the knee joint, and the soft tissue around the knee, namely the meridian sinew system, jointly maintain the stability of the knee joint and its normal physiological activities. Secondly, it can be seen from the meaning of meridian sinews that the meridian sinew system maintains the dynamic and static balance of joint motion. Physiologically, meridian sinews have the functions of connection, restraint, maintenance and so on. Pathologically, the pathological changes of meridian sinews include sinew tension, sinew over-restriction, sinew cramp, sinew pain, sinew we˘ i (atrophy, ), and so on, most of which show dyskinesia and pain of

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muscles and joints where meridian sinews pass and run. Although the occurrence of KOA is the result of the comprehensive action of multiple factors, the mechanical dysequilibrium of the soft tissue in the periphery of knees is the main cause, that is to say, KOA is mainly caused by the imbalance of the meridian sinew system. Thirdly, KOA’s clinical symptoms, such as pain, joint flexion and extension disturbance, joint swelling, and joint stiffness, all belong to the category of meridian sinew diseases. Finally, treatment targeting the articular cartilage alone can only temporarily relieve symptoms and has poor long-term curative effect. In conclusion, we can conclude that meridian sinew lesions are the main source of abnormal stress of knee joints, and KOA is essentially a meridian sinew disease, it is of great practical significance to understand and treat KOA from the perspective of meridian sinews.

is feasible and effective, which can obviously relieve pain and improve function in the short term, thus improving the quality of life of patients. For operators, the acupotomy guided by the meridian sinew theory is easier to manipulate, and the operators are not limited by the acquaintance of fine anatomy, local anatomy or multi-disciplines. For grass-roots and community hospitals, the acupotomy guided by the meridian sinew theory does not rely too much on the guidance of modern imaging and “visualization” equipment, which reduces the requirements for equipment and facilitates the generalization of acupotomy. For patients, the cost of acupotomy is relatively lower, so the acceptance of acupotomy will be improved accordingly.

The feasibility of “taking painful locality as an acupoint” and “taking sinew constipation as an acupoint” for positioning

The acupotomy for KOA guided by the meridian sinew theory features exact curative effect, high safety, strong operability, low cost, and no adverse reactions, so it is worthy of clinical reference and generalization. However, there are still some problems: (1) In clinical application, the meridian sinew theory is easy to be misunderstood as “tenderness point”, which results in falling into the trap of “treating head when headache but not removing root causes”. (2) At present, the evaluation of its curative effect is mostly made upon the subjective feeling of patients, but lack of objective and unified evaluation criteria. A more complete evaluation system of curative effect may be created with the help of electromyography and pathology in the future. (3) The stimulation parameters of acupotomy are still lack of a unified standard. (4) The observation period was shorter, and the sample size was small, so the long-term efficacy or adverse events were not tracked in the study. In the future, the observation period should be appropriately extended, the curative effect mechanism should be clarified through fundamental research, so as to verify the effectiveness, safety and practicality of acupotomy for KOA guided by the meridian sinew theory and provide reliable basis for the clinical selection of the acupotomy methods of KOA.

Classified into the category of bì syndrome, meridian sinew diseases are mostly manifested as sinew cramp, sinew pain, sinew over-restriction, and the like, and pain is the main pathological reaction. In clinical practice, most KOA patients see a doctor with the chief complaint of pain, so it is particularly important to improve pain in the treatment process. The therapeutic principle of meridian sinew diseases was recorded in Lingshu  ( , The Miraculous Pivot): directly taking the disease sites as the treatment points. It should be noted that “taking painful locality as an acupoint” herein differs from “Ashi point”. The treatment principles of “taking painful locality as an acupoint” are determined by the nature of meridian sinews. Relative to meridians, meridian sinews cannot transmit qi and blood, so it is not acupoint, the nidus of meridian sinew disease is where the pathogenic factor invades, relatively fixed localities, and main manifestations of pain. As a result, the point selection method of focusing on “taking painful locality as an acupoint” is an optimized method to treat bi diseases of meridian sinews. In combination with clinical practice, the tenderness points are first identified through palpation, and it is understood to which meridian sinews the tenderness points belong, then the tenderness points are released to restore the physiological functions of the meridian sinews during the treatment. “Taking sinew constipation as an acupoint” is one of the commonly used point selection methods for meridian sinew diseases. The meridian sinew system maintains the stable balance of knee joints. In daily life, some pathogenic factors causing chronic knee strain, such as obesity, overwork, and sports injury, all can induce the meridian sinew system disorder, and these harmful stimulus effects on the periphery of knee for a long time and causes such pathological changes as adhesion, blockage, and contracture, namely, “the meridian sinew nidus”, which are just the important factors causing pain, stiffness, flexion and extension disturbance of knee joints. With the acupotomy therapy, the location of “sinew constipation” can be clarified through palpation, then puncture is performed with “needle”, and cutting and dissection with “knife”, in order to dredge meridians and collaterals, harmonize and free qi and blood, thus achieving the treatment objective of “painlessness when free of blockage”, and embodying the treatment principle of “needling at disease locality”. Therefore, “taking sinew constipation as an acupoint” is indeed an easy and practical method of acupoint selection clinically. According to the results after treatment for 3 weeks in this study, there was no statistical significant difference in ORR between the two groups, but the WOMAC function score and VAS pain score of the two groups all decreased in varying degrees, and the group A showed a greater decrease compared with group B and a significant difference at week 2, indicating that the acupotomy for treatment of KOA guided by the meridian sinew theory

Prospect and deficiencies

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