The Practice of Korean Medicine: An Overview of Clinical Trials in Acupuncture

Acupuncture, one of the Oriental medical therapeutic techniques that can be traced back at least 2500 years, is growing in popularity all over the world. Korea has continued to develop its own unique tradition of medicine throughout its long history, and has formed different types of acupuncture methods. The purpose of this review is to summarize clinical case studies in acupuncture and related therapies, such as acupressure, electric acupuncture, auricular acupuncture and moxibustion in Korea. A survey of Korean journals revealed that a total of 124 studies were published from 1983 to 2001. Results obtained from the survey showed that most clinical studies using acupuncture, electric acupuncture, moxibustion and other traditional therapies could alleviate a relatively broad range of medical problems. However, it should be emphasized that almost all clinical case studies published in various local journals did not follow the ‘good clinical practice’ with respect to regulatory aspects. Since they were not conducted using the randomized double-blinded controls with a large sample size, all the results should be considered as therapeutic indications. This review is an attempt to show the scope of acupuncture in our country and the kind of diseases, after many years of clinical experience, that were deemed valid targets for clinical trials.


Introduction
Acupuncture, one of the Oriental medical therapeutic techniques inherited from ancient East Asia, is gaining popularity in the West as an alternative and complementary therapeutic intervention (1). Acupuncture is now being used in Western medicine to treat postoperative-induced and chemotherapyinduced nausea and vomiting, postoperative dental pain, drug addiction, stroke rehabilitation and asthma (2). Korea has continued to develop its own unique traditional medicine throughout its long history, and has formed different types of acupuncture methods, apart from those of traditional Chinese medicine. An individualized approach based on constitutional energy traits and practical approaches applying new therapeutic modalities have been developed for treatment of disorders (3).
A large number of clinical studies using acupuncture have been performed to demonstrate its efficacy for many kinds of diseases, such as pain (headache, facial pain, neck pain, shoulder pain, lower back pain and knee pain), stroke, facial palsy and other diseases in Korea. A wide range of control groups were used in these studies. Acupuncture and acupuncturerelated therapies have been compared with various forms of control acupuncture, standard care, no treatment, baseline conditions and placebo acupuncture. These inconsistencies make the task of designing and performing systematic reviews or meta-analyses more difficult. However, non-controlled clinical trials might also be useful for the overview that they provide of what is known so far, with data that may inform future research. This review is an attempt to show a variety of applications for acupuncture treatments performed by the traditional Korean medical sector.

Clinical Studies Using Acupuncture Treatment in Korea
Acupuncture for Pain Headache Lee and Kim (4) analyzed the effect of acupuncture treatment at trigger points in 27 patients with headache. Lee et al. (5) compared the effect of acupuncture at trigger points with the effect of acupuncture at remote acupuncture points in patients who were diagnosed as having tension-type headaches. A clinical study of auricular acupuncture was also done in 55 patients with headaches (6). Clinical studies of acupuncture and auricular acupuncture for tension-type headaches were also performed (7,8) (Table 1).

Facial Pain
Temporomandibular disorder (TMD) is a musculoskeletal problem of the masticatory system and is quite commonly treated by acupuncture in the general population. It was reported that 8 and 10 cases, respectively, of TMD were treated by acupuncture (9,10). Wang et al. (11) treated by Dong-Qi acupuncture and subjectively evaluated TMD and facial pain ( Table 2).

Neck Pain
Chun and Lee (12) treated patients with chronic neck pain by using electric acupuncture (0.3 · 40 mm, 3.5-12 Hz, 9 V). Kim and Lee (13) compared the group treated by both acupuncture and manipulation (chuna) treatment with the group only treated by acupuncture. A clinical study investigated the clinical applications of Oriental medical therapies including acupuncture treatment together with herbal therapy and hot pack for patients complaining of cervical pain caused by traffic accidents (14). It was reported that acupuncture treatment was effective in 50 patients with cervical pain (15). Lee and Lee (16) treated 25 patients with neck pain with electric acupuncture together with herbal therapy, cupping therapy and hot pack. It was also reported that acupuncture was effective in treating 50 patients with herniated cervical disc (17) (Table 3).

Shoulder Pain
Forty-three patients suffering from frozen shoulder during physical exercise were treated by acupuncture, moxibustion and electric acupuncture, and evaluated with Apley scratch  test. A total of 16.3% of them reported that the results of treatment were excellent and 30.2% of them reported that they were good (18). Cho and Lee (19) showed the correlation between digital infrared thermography image (DITI) data and changes in clinical symptoms after acupuncture treatment in patients with frozen shoulder (Table 4) (Fig. 1).

Low Back Pain
A series of 20 cases with lumbar herniated disc disease were treated by acupuncture (20). It was reported that acupuncture and herbal medicine alleviated the symptoms of the herniation of lumbar intervertebral disc (21)(22)(23)(24)(25). It was also reported that bee venom acupuncture (BVA) was beneficial for treating herniated intervertebral disc (HIVD) (26 Electric acupuncture decreased the frequency of radiating pain in lumbar spondylosis (36). Clinical studies evaluated Oriental medical treatment and manipulation therapy in patients with scoliosis (37,38). Kim (39) reported the results of 96 patients suffering from sciatica with lower back pain treated by acupuncture and herbal medicine. It was reported that acupuncture, moxibustion and herbal medicine were useful for acute back pain (40). Lee   Cho and Kim (50) compared the acupuncture with electric acupuncture for HIVD patients using DITI. Hur et al. (51) investigated changes in the clinical symptoms of patients with spondylolisthesis after acupuncture treatment and evaluated alterations in DITI. A clinical study also reported a relationship between cigarette smoking and the result of Oriental medical treatment for lower back pain (52). Heo and coworkers studied the treatment of lower back pain and sciatica and found some correlation in the rate of alleviation with alterations in Moire topography (53,54) (Table 5).

Knee Joint Pain
It was reported that acupuncture was useful for the treatment of degenerative arthritis of knee joints (55)(56)(57) (68) investigated the effect of moxibustion on the immune activity in the treatment of patients. Acupuncture treatment was very beneficial for acute gout (69). It was also demonstrated that acupuncture at acupoints on the non-injured side were as effective as acupuncture at acupoints on the injured side in ankle sprain patients (70) (   (Table 8).

Poststroke Diseases
Electric acupuncture could alleviate shoulder pain in cerebrovascular attack patients (77). It was demonstrated that BVA at LI15 and SI10 decreased visual analog scale of pain severity and increased painless passive range of motion of shoulder eternal rotation in hemiplegic shoulder pain patients (78). Kang (Table 9).

Acupuncture for Facial Palsy
Acupuncture treatment was beneficial in 72 cases of patients with facial paralysis (82). Moreover, electric acupuncture was better than needling in the treatment of patients with peripheral facial nerve paralysis (83). The effect of Hominis placenta acupuncture, a kind of HA, on Bell's palsy was reported (84). It was demonstrated that Saam acupuncture at liver and stomach tonification points could treat peripheral facial palsy ( (Table 10).

Eye Disease (Opthalopathy)
Acupuncture and venesection were useful in treating 22 patients who suffered from acute infectious conjunctivitis (91). Kim and Chae (92) reported 32 patients with cataract or glaucoma who were treated by Oriental medicine and acupuncture. The therapeutic effect of acupuncture and moxibustion on the sight of near-sighted patients was also reported (93,94). Clinical studies were carried out to demonstrate the effect of Oriental medicine and acupuncture on amblyopia (95) ( Table 11).

Nose Disease (Rhinopathy)
Acupuncture was effective in the treatment of allergic rhinitis in 30 patients (96). Nasal acupuncture therapy was investigated to treat the chronic paranasal sinusitis and nasal obstruction (97,98) (Table 12).

Ear Disease (Otopathy)
Clinical studies were carried out to investigate acupuncture, moxibustion and venesection for tinnitus (99,100). It was reported that acupuncture at TE5, GI41, TE6 SI5, GI38, KI2 and venesection improved symptoms of patients with otitis media with effusion (101) ( Table 13).  It was reported that acupuncture and herbal medicine were effective in the treatment of acne in 125 patients (102). It was also found that acupuncture and herbal medicine improved the symptoms of the acne patients (103) (Table 14).

Hypertension
Clinical studies with auricular acupuncture were performed on 23 patients with hypertension (104). Lee et al. (105) examined moxibustion at LI11 and CV4 for blood pressure of hypertension patients (Table 15).

Smoking and Drinking Cessation
Auricular acupuncture to stop smoking (106)(107)(108)(109)(110). Kim et al. investigated the effect of auricular acupuncture on cessation of drinking in alcoholic patients (111,112). It was reported that auricular acupuncture and herbal medicine were effective for quitting drinking (113) ( Table 16).

Obesity
Electric acupuncture decreased body weight, abdominal length, size of waist and body mass index (114,115). Lee and Kim (116) compared auricular acupuncture combined with acupuncture with auricular acupuncture combined with herbal medicine for the treating obesity by measuring body weight and percentage of body fat (Table 17).

Nausea and Vomiting
Auricular acupuncture on sympathetic, stomach, shenmen and occiput points for postoperative nausea and vomiting in 100 female patients undergoing transabdominal hysterectomy. It was demonstrated that electric acupuncture at PC6 and PC7 was very effective in preventing nausea, retching and vomiting (118) (Table 18).

Obstetrics and Gynecology
Electric stimulation at acupuncture points significantly shortened the delivery time and attenuated the pain during delivery (119). Moreover, endometrial curettage was successfully performed on 31 female patients under acupuncture anesthesia (120) ( Table 19).

Others
Moxibustion could have an effect on peripheral circulation (121). Ahn et al. (122) examined the temperature change of external genitalia in patients with impotence after herbal medicine and acupuncture treatment. Auricular acupuncture altered hormone and energy metabolism during weight control of athletes (123) ( Table 20).

Acupuncture for Human Study
Acupuncture stimulation significantly decreased electrical resistance under the adiaphoresis, suggesting that the decrease of electrical resistance is caused not only by sweat secretion but also by other internal resistance (124). Youn et al. (125) reported a strong correlation between acupuncture at KI6 and cortical activation in the motor-related region of the human brain by using fMRI. Acupuncture at LI4 in the left hand increased regional CBF (rCBF) in the right parietal lobe, middle temporal gyrus and inferior occipital lobe, and electric acupuncture at ST36 on the right side increased rCBF in the left temporal lobe, the inferior frontal lobe and cerebellar hemisphere using single photon emission computed tomography (126,127). It was shown that acupuncture at LI4 and LV3 could ipsilaterally enlarge a blind spot map (128). Several studies were performed to examine if acupuncture at LI4 changed skin temperature in the LI4 area of the hand, LI11 area of the arm, LI20 area of the face and ST25 area of the abdomen by using DITI (129)(130)(131)(132)(133)(134)(135). It was also examined to see whether the alteration of acupuncture manipulation method could change the temperature in these regions of the body (136,137). Other studies were performed to investigate the effects of acupuncture at LU9 by thermal change in the five shu points or LU9 and LU1 areas of lung meridian (138,139). Yook et al. (140) examined whether HA at BL12, BL13, BL41 and BL42 could affect local thermal change by using DITI. Kim et al. (141) examined whether acupuncture at the WuHu acupoint could affect thermal change in the ankle region (Table 21).

Discussion
A large number of clinical studies have used acupuncture; electric acupuncture, moxibustion and other traditional therapies to target a relatively broad range of medical problems, primarily pain and stroke. Moreover, acupuncture has been widely used for treatment of facial palsy, obesity, hypertension, nausea and vomiting, and many other diseases. However, as mentioned in the beginning of this report, the studies had various weaknesses such as inadequate sample size, inappropriate control treatment, inadequate follow-up, inadequate control of non-specific effects, inadequate reporting of side effects and a few studies' failure to replicate results. These concerns make it difficult to draw clear conclusions about efficacy in most areas where acupuncture has been tested.
A number of systematic reviews on acupuncture for specific conditions have recently been published, including an extensive systematic review on chronic pain, with a far reaching search strategy and a way of scoring trial methodology (142). Recently, the best evidence synthesis review showed that there was only limited evidence that acupuncture is more effective than no treatment (waiting list) and inconclusive evidence that acupuncture is more effective than inert placebo, sham acupuncture or standard medical care (143). In addition, the   Measure rCBF by rest/EA Tc-99m ECD brain SPECT using a same-dose subtraction method Acupuncture at left LI4 increased rCBF in the right hemisphere (the right parietal lobe, a part of the right middle posttemporal gyrus and the right inferior occipital lobe) P < 0.9 Woo and Nam (128) evidence of rigorous randomized controlled trials showed that there was no compelling evidence to show that acupuncture is effective in stroke rehabilitation (144). Yet, as clinicians who treat patients with acupuncture, we have success in these treatments where no efficacy is found. This is due to a complex set of problems at the heart of which is the establishment of a standard for the treatment of the control group. This article is not a systematic review; rather it is an overview of the clinical trials, presented in the hopes of introducing overall information about clinical studies in Korea to the English-speaking world. This review describes a number of clinical studies that were performed to compare the therapeutic effects of different kinds of acupuncture under certain conditions. Conventional acupuncture was compared with electric acupuncture, auricular acupuncture, BVA and manipulation. These comparative studies of different kinds of acupuncture are required in order to proceed with the most adequate method in the future. Since more than two therapies were simultaneously performed to treat the disorders in some studies, it is not likely to demonstrate the efficacy of pure acupuncture apart from other treatments. For instance, given that both acupuncture and auricular acupuncture were effective to treat tension-type headache patients, it is impossible to clarify the extent of the therapeutic benefit of acupuncture. Therefore, in order to investigate the therapeutic benefits of acupuncture, it is necessary to establish a group treated by acupuncture alone.
From the above clinical studies, it is possible to summarize the originality of Korean acupuncture by describing both of its characteristic approaches-individualized and practical. Firstly, a number of clinical studies in Korea have shown the benefits of individualized acupuncture treatment, such as Saam, Taegeuk or Eight constitutions acupuncture (35). Patel et al. (145) noted that individualized treatments significantly favored acupuncture, whereas formulaic approaches, in which all the patients received the same treatment, showed no significant difference. However, in order to demonstrate its superiority, more rigorous and well-designed randomized controlled clinical trials are urgently needed. Secondly, HA-like BVA have been used to treat a variety of painful conditions. HA is a new method of acupuncture where distilled herbal decoction is extracted and purified to be administered to an acupuncture point for stimulation. HA simultaneously exerts pharmacological actions from a bioactive compound isolated from herbal medicine and mechanical actions from acupuncture stimulation. The Korean medical world considers HA as a promising therapeutic method for various diseases (84,140).
An individualized approach based on constitutional energy traits have been widely applied to a number of clinical trials in Korean medicine. HA have also been developed as a new therapeutic modality using integrated and practical approaches. Korean acupuncture in its own way is making a contribution to the emerging need for individualized and integrated approaches to acupuncture. In closing, we stress the need for randomized controlled studies and express our hope that this view into Korean traditional medical practice will lead to evidence-based studies that could form the basis for a metaanalysis in the near future.