Pharmacopuncture is a relatively new acupuncture format that embodies aspects of both manual acupuncture and herbal medicine by injecting purified herbal extracts according to herbal medicine properties and flavors at acupoints relevant to the disease. Its efficacy is considered to take synergistic effect by implementing and combining the physical effect of acupoint stimulation and the chemical effect of herbal extracts. There are reports that pharmacopuncture heightens the clinical effect of acupuncture when combined with acupuncture compared to acupuncture alone, and pharmacopuncture is drawing attention as a possible solution for various refractory diseases [14]. While it can be conjectured that pharmacopuncture usage is high for various diseases from an overview of pharmacopuncture studies conducted in Korea, there are no reports providing clinical information as to which types of pharmacopuncture are used at which acupoints for what diseases. Analysis of previous clinical studies on pharmacopuncture shows that per acupoint and total pharmacopuncture volume are highly variable from 0.01 to 0.5 cc with one study reporting injection of 3.5 cc intra-articularly, and from 0.01 to 1.5 cc, respectively [15]. Meanwhile, a recent survey on pharmacopuncture use for IDD in KMDs reported ranges between 1.3 and 3.5 cc, likewise displaying a wide range [12]. While these figures may be a reflection of differences in disease, patient symptoms or severity, it may also be taken as an indication of absence of a standardized procedure. Moreover, previous studies are highly heterogeneous with regard to intervention with pharmacopuncture agents ranging from single solution ingredients such as hominis placenta and bee venom, to herbal mixtures such as Hwangryunhaedok and Joongseongouhyul, and preparation methods were likewise diverse [15]. Taking these circumstances into account, standardization of pharmacopuncture solution preparation methods and establishment of standard pharmacopuncture procedures by disease would seem to deserve high priority, and efforts are steadily being put toward standardization and improvement of pharmacopuncture efficacy and stability [16–19]. The multiform methods of administration are an added difficulty to standardization and potential inclusion of pharmacopuncture in national insurance coverage. While standardization of administration procedure by disease in addition to solution preparation is a pressing matter, the exact amount of pharmacopuncture used in clinical settings is yet unclear due to noncoverage. The study sites included KM hospitals specializing in spine disorders designated as such by the Korean Ministry of Health and Welfare, and all study sites were KM hospitals and clinics that treated a large number of musculoskeletal patients on a regular basis. A 2009 review of Korean RCTs on pharmacopuncture showed that studies on patients with musculoskeletal disorders such as degenerative knee osteoarthritis, low back and/or leg pain, shoulder and/or arm pain, and ankle sprain were most frequent [7], and taking into account that Korean medicine is mainly used for musculoskeletal disorders in Korea, these KM hospitals were considered suitable sites for investigation of current pharmacopuncture usage. This study investigated current pharmacopuncture use by assessing the electronic medical records of all patients visiting 12 KM hospitals and clinics situated throughout the country from December 17, 2010 to October 2, 2014.
Of included participants, 33,415 were inpatients and 373,755 outpatients, of whom 98.6 and 77.6 % received pharmacopuncture, respectively. The average number of pharmacopuncture sessions was 22.8 ± 18.4 times (median: 19) among inpatients, and 8.2 ± 12.3 times (median: 3) among outpatients. The rate of pharmacopuncture administration by principle diagnosis codes was highest among inpatients in M51, S33, M54, S13, and M48, in this order, and rates varied between 97.2 and 99.3 % for the 10 most frequent principle diagnosis codes, showing small variance. Among outpatients, the rate was highest in order of S33, M51, M54, S13, M50, S93, M17, M47, S83, and M25, and variance was larger at 73.0 to 91.5 % than that of inpatients in rate of pharmacopuncture by 10 most frequent principle diagnosis codes. The reason for this significant divergence in pharmacopuncture usage rate between inpatients and outpatients was inferred to be due to difference in severity of disease. For instance, the rate of pharmacopuncture for minor diseases such as sprain was lower than that of acupuncture in outpatients which suggests that severity of disease is an important factor in determining use of pharmacopuncture, i.e. that pharmacopuncture is generally used more frequently in patients with severe pain to the aim of resolving such issues. Treatment duration for the ambulatory department was not analyzed as treatment period is diverse by patient characteristics and disease severity, and relapse or long-term management is common in musculoskeletal disease with patients frequently seeking medical attention up to several months after initial onset, and resulting in overestimation of period. Meanwhile, frequency of pharmacopuncture use was higher than that of acupuncture in outpatients, possibly as patients receiving pharmacopuncture suffered more severe symptoms requiring more treatment to achieve clinical effect. In addition, considering that the proportion of patients receiving pharmacopuncture (77.6 %), which is paid entirely out of pocket and consequently has lower accessibility compared to acupuncture or electroacupuncture which are covered by national health insurance, was higher than that of electroacupuncture (72.8 %), which incurs only $1–2 in self-payment cost, out of total patients, it may be carefully inferred that KMDs in Korea regard pharmacopuncture to be as or more clinically effective than electroacupuncture.
In analysis of pharmacopuncture-related costs in 32,246 inpatients and 229,219 outpatients, average total pharmacopuncture cost billed per patient during the treatment period was about $556.24 ± 174.62 among inpatients, and $149.16 ± 243.85 among outpatients. While direct comparison between inpatient and outpatient costs is not possible as those covered by automobile insurance were excluded from cost analysis and number of subjects therefore differs, but considering the average frequency of treatment in the inpatient/outpatient department, the estimated average cost per pharmacopuncture session was $23–24 in inpatients, and $17–18 in outpatients. As these hospitals leaves decisions on pharmacopuncture cost pending on overall pharmacopuncture volume and number of acupoints to physicians within a preset range, it is suggested that cost in inpatients was generally higher as they presented more severe cases.
In analysis of pharmacopuncture type, Shinbaro1, bee venom, Hwangryunhaedok, and Shinbaro2 were shown to be most frequently used. Shinbaro1 and 2 solutions contain the herbal compound GCSB-5, derived from Chungpa-jun. The effects of GCSB-5 in anti-inflammation, neuroprotection, and articular cartilage protection have been reported in various experimental studies [20–22], and Shinbaro pharmacopuncture has similarly been proven to be effective for IDD [14, 23] and arthritis [24] through clinical research which explains the frequent use in M51 and M17 patients. The safety of Shinbaro pharmacopuncture has been demonstrated in single intramuscular dose toxicity tests [25] and repeated intramuscular dose toxicity tests [26]. The effects of bee venom [27] and Hwangryunhaedok [28] in spinal diseases have also been reported, indicating that clinically preferred pharmacopuncture types are mainly evidence-based. It may be further conjectured that use of evidence-based pharmacopuncture is gaining in popularity amongst KMDs through heightened credibility drawing from various clinical study results [4]. It has also been suggested that pharmacopuncture is used primarily for musculoskeletal disorders given the fact that the principle diagnosis codes in pharmacopuncture treatment were musculoskeletal. In addition, this study found that commonly used pharmacopuncture solutions were prepared through reflux extraction with 70 % spiritus vinosus, distillation extraction, or isolation and purification. While such methods as low-temperature, and pressure extraction are also used for pharmacopuncture solution preparation in Korea [29], only use of reflux extraction with 70 % spiritus vinosus, distillation extraction, or isolation and purification was confirmed in this study as the included KM hospitals and clinics did not use low-temperature extraction and pressure extraction.
However, this study holds the following limitations. Only principle diagnosis codes were included in analyses and though patients were each assigned one principle diagnosis code during the study period of 2010 to 2014, the disease is likely to have progressed or changed over time in some considering the length of the data extraction period, and the computerized analysis used in this study was not equipped to capture such changes. There is the further limitation that changes in pharmacopuncture type reflecting physician judgment on disease and symptoms could be not detected, and as a result, the pharmacopuncture types most commonly used for each principle diagnosis code could not be established. Moreover, while it was deduced that disease severity may play an influential role in deciding pharmacopuncture use, the possibility that some patients may have refused pharmacopuncture for economic reasons due to noncoverage cannot be excluded. In addition, this study was unable to collect data on the volume of pharmacopuncture solution used for treatment or the number of acupoints to which the treatment was applied. Still, results of a survey on KMDs employed at the current study sites that 2.9–5.8 acupoints were chosen for pharmacopuncture in IDD patients with 1.2–3.9 cc of pharmacopuncture solution injected at each session may be of reference [12].
Many of the hospitals included in this study were spine specialty KM hospitals, and the hospitals accordingly treated a large number of IDD (especially M51) and spinal stenosis patients, which may partially explain the markedly high frequency of Shinbaro pharmacopuncture use. Although this study covered a large number of KM hospitals and patients, most focused on spinal disorders and trends may be disparate from general KM settings. Nevertheless, KM is mainly used for musculoskeletal disorders in Korea, and this study is the first large-scale study on pharmacopuncture use in electronic medical data from KM hospitals specializing in musculoskeletal disease treatment and holds significance as the first report on use of pharmacopuncture for musculoskeletal disorders. The results of this study are expected to contribute to standardization of treatment procedures involving pharmacopuncture, future clinical research design, and inclusion of pharmacopuncture in Korean national health insurance coverage.