Purpose: To evaluate the efficacy and safety of electroacupuncture in treating insomnia. Patients and Methods: In a multicenter, randomized, assessor-blinded, controlled trial, 150 patients with DSM-5-diagnosed insomnia with Insomnia Severity Index (ISI) scores ≥ 15 were randomly assigned to three different groups that underwent 10 sessions of electroacupuncture, sham-electroacupuncture, or usual care for 4 weeks from October 2015 to June 2016 at four Korean medicine hospitals, Republic of Korea. The primary outcome included the ISI score at Week 4; the secondary outcomes included evaluations of Pittsburgh Sleep Quality Index (PSQI), sleep diary, Hospital Anxiety and Depression Scale (HADS), EuroQoL five dimension (EQ-5D), Patient Global Impression of Change (PGIC), and salivary melatonin and cortisol levels. Assessments were performed at baseline (Week 0) and at Weeks 2, 4, 8, and 12. Results: Compared with the usual care group, electroacupuncture group showed a greater improvement in ISI, PSQI, sleep diary-derived variables and HADS and EQ-5D scores at Week 4. The effects mostly persisted until Week 12. There were no significant differences between electroacupuncture and sham-electroacupuncture groups at Week 4 in all outcome measures, except sleep diary-derived sleep efficiency. However, the ISI score showed a significant difference between these groups at Weeks 8 and 12. Treatment success as per PGIC was significantly and borderline higher for electroacupuncture compared with usual care and sham-electroacupuncture, respectively. No significant changes in salivary melatonin and cortisol levels before and after treatment were observed in all groups. No serious adverse events were reported. Blinding was maintained in the sham-electroacupuncture group. Conclusion: Ten sessions of electroacupuncture can improve the sleep quality of patients with insomnia without serious adverse effects. Thus, it can be recommended as an effective, safe, and well-tolerated intervention.

Background: Insomnia is one of the most frequent symptoms in people with cancer. Electroacupuncture has been widely used in people with cancer or insomnia. We explored the feasibility and preliminary effectiveness of electroacupuncture for cancer-related insomnia.Methods: People with cancer and insomnia disorder were randomly allocated to electroacupuncture, sham-electroacupuncture, or usual care groups. Participants received either 10 sessions of electroacupuncture at real acupoints, sham-electroacupuncture at non-acupoints, or usual care in each group for 4 weeks. We calculated the recruitment, adherence, and completion rates of participants. The Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), sleep diary and actigraphy-derived sleep parameters, Functional Assessment of Cancer Therapy-Fatigue (FACT-F), Montreal Cognitive Assessment (MoCA), and salivary levels of cortisol and melatonin were evaluated as outcome measures.Results: Twenty-two participants were enrolled (8, 6, and 8 respectively in the electroacupuncture, sham-electroacupuncture, and usual care groups) and 20 participants completed the trials (8, 4, and 8 respectively). The recruitment, adherence, and completion rates were 78.57% (22/28), 95.45% (21/22), and 90.91% (20/22), respectively. Most of the participants had previously received conventional treatment for insomnia, but few had received Korean medicine treatment, without any demographic or clinical differences between groups. In the electroacupuncture group, there was a statistically significant reduction of 10.13 (mean) ± 8.15 (standard deviation) and 5 ± 3.70 points in mean ISI and PSQI scores at 4 weeks post-treatment (P = .0098 and .0066), compared with sham-electroacupuncture (2.06 ± 7.15 and 1.61 ± 4.34;P = .4796 and .3632) and usual care (3.25 ± 2.60 and 1.38 ± 2.13;P = .0096 and .1112). Although there was no significant difference in ISI score between groups at 4 weeks post-treatment, the electroacupuncture group continued to improve significantly at 4 weeks’ follow-up, showing borderline and significant differences compared to the sham-electroacupuncture and usual care (P = .0614 and .0015). The FACT-F scores in electroacupuncture group showed a significant improvement compared with the sham-electroacupuncture group (P = .0305). No electroacupuncture-related adverse events were reported.Conclusions: Electroacupuncture might be feasible for cancer-related insomnia, despite slow participant recruitment. Additional trials with adequately powered sample sizes and a substantial change to the recruitment procedure are needed.Trial registration: Clinical Research Information Service,KCT0002162. Submitted 27 October 2016, Registered 2 December 2016 - Retrospectively registered (The first participant enrolment: 28 November 2016),

Cancer‐related fatigue (CRF) is one of the most common chronic symptoms experienced by cancer patients. As moxibustion is a popular traditional therapy for managing fatigue, it can be an alternative strategy to treat CRF as well. Therefore, we rigorously designed a full‐scale, multicenter, assessor‐blinded, randomized controlled trial to evaluate the efficacy and safety of moxibustion treatment for CRF. Ninety‐six subjects suffering from CRF were recruited and randomly assigned to moxibustion group, sham moxibustion group, or usual care group. Both the moxibustion group and the sham group received moxibustion treatment for 8 weeks and the usual care group did not. Brief fatigue inventory (BFI) score and Functional Assessment of Cancer Therapy‐Fatigue score were used to assess CRF at baseline and weeks 5, 9, and 13. Questionnaires for the assessment of cognitive impairment, quality of life, and Cold–Heat and Deficiency–Excess patterns were also evaluated. BFI scores significantly decreased in moxibustion group compared to the usual care group (mean difference of −1.92, p < 0.001 at week 9 and mean difference of −2.36, p < 0.001 at week 13). Although the sham group also showed significant improvement during the treatment period, only the moxibustion group showed improvement after 4 weeks of follow‐up period (mean difference of −1.06, p < 0.001). There were no serious adverse events. Our findings confirmed the efficacy and safety of moxibustion for CRF compared to usual care. We also found that moxibustion has a prolonged treatment effect during 4 weeks of follow‐up period.

The prevalence of functional constipation (FC) is 3–27%, and FC has been reported to cause discomfort in daily life and various complications. The treatment for FC depends on laxatives, and thus, effective and non-toxic alternative treatments are needed. We conducted a randomised, sham-controlled parallel-design, pilot trial. Participants with FC were randomly assigned to either the real acupuncture (RA) or sham acupuncture (SA) group. The RA consisted of eight fixed acupuncture points (bilateral ST25, ST27, BL52 and BL25) and four additional points targeted to the individual based on Traditional Korean medicine (TKM). SA consisted of shallow acupuncture insertion at 12 non-acupuncture points. Twelve sessions were provided over 4 weeks. The outcome measures were weekly defecation frequency (DF), spontaneous complete bowel movement (SCBM), Bristol stool scale (BSS) score and constipation assessment scale (CAS) score. The participants were followed for 4 weeks after the treatment. Thirty participants were enrolled (15:15). The mean DF were 5.86 ± 5.62, 5.43 ± 3.39 and 5.79 ± 3.64 in the RA group and 3.73 ± 1.62, 5.00 ± 1.77 and 5.40 ± 1.96 in the SA group at weeks 1, 5, and 9, respectively. The increases in weekly SCBMs were 2.50 ± 3.86 and 2.71 ± 4.01 with RA and 2.33 ± 2.74 and 1.93 ± 2.25 with SA at weeks 5 and 9, respectively (mean difference [MD] 0.78). The BSS scores were 0.57 ± 1.72 and 1.09 ± 1.30 with RA and 0.15 ± 1.06 and 0.14 ± 0.88 with SA at weeks 5 and 9, respectively (MD 0.95). The CAS score changes were − 3.21 ± 2.91 and − 3.50 ± 3.98 with RA and − 2.67 + ±2.82 and − 2.87 ± 2.95 with SA at weeks 5 and 9, respectively. Greater improvements were observed in subgroup analysis of participants with hard stool. The numbers of participants who developed adverse events (AEs) were equal in both groups (four in each group), and the AEs were not directly related to the intervention. This clinical trial shows feasibility with minor modifications to the primary outcome measure and comparator. Acupuncture showed clinically meaningful improvements in terms of SCBMs occurring more than 3 times per week and in these improvements being maintained for 4 weeks after treatment completion. As this is a pilot trial, future studies are warranted to confirm the efficacy and safety. KCT0000926 (Registered on 14 November 2013).

Patients seek Korean Medicine (KM) treatment for a broad range of complaints in Korea, but predominantly for musculoskeletal disorders. We investigated lumbar Intervertebral Disc Displacement (IDD) practice patterns of Korean Medicine doctors (KMDs) within a hospital/clinic network specializing in KM treatment of spinal disorders through survey of diagnosis and treatment methods. Questionnaires on clinical practice patterns of KM treatment for lumbar IDD were distributed to 149 KMDs on January 25th, 2015. The questionnaire included items on sociodemographic characteristics, clinical practice patterns, and preferred method of lumbar IDD diagnosis and treatment. KMDs were asked to grade each treatment method for absolute and relative importance in treatment and prognosis, and safety. A total 79.19 % KMDs (n = 118/149) completed the survey, and results showed that integrative care mainly consisting of acupuncture, herbal medicine, Chuna manipulation, and pharmacopuncture was administered to IDD patients. The participant KMDs largely relied on radiological findings (MRI and X-ray) for diagnosis. ‘Eight principle pattern identification’, ‘Qi and Blood syndrome differentiation’ and ‘Meridian system syndrome differentiation’ theories were generally used for KM syndrome differentiation. The most frequently prescribed herbal medication was Chungpa-jun, and most commonly used Chuna technique was ‘sidelying lumbar extension displacement treatment’. IDD patients received 1.9 ± 0.3 treatment sessions/week, and KMDs estimated that an average 9.6 ± 3.5 weeks were needed for 80 % pain relief. This is the first study to investigate expert opinion on KM treatment of IDD. Further randomized controlled trials and clinical guidelines based on clinical practice patterns of KM are called for.

Considering that large variations exist amongst practitioners in lumbar disorder management and the significant costs that lumbar disorders incur, determining clinical practice patterns to provide preliminary data for standardization should be given higher priority. Lumbar spinal stenosis (LSS) is commonly treated using integrative non-surgical methods by Korean medicine doctors (KMDs) in Korea, and this is the first study to assess current Korean medicine practice trends for LSS. A survey on KMD diagnosis, treatment, prognosis and decision-making in LSS treatment was developed in a 3-step procedure of preliminary drafting, revision based on extramural expert opinion, and final editing. The survey was conducted at the internal conference of a spine-specialty Korean medicine hospital on January 25th, 2015. The response rate was high at 79.19% (n = 118/149). Participants replied that they treated 7.3 ± 6.8 LSS patients/day using a multimodal treatment method consisting of acupuncture, pharmacopuncture, herbal medicine, Chuna manipulation, and electroacupuncture. Acupuncture mainly used Ashi points and MSAT, and pharmacopuncture mainly Shinbaro solution. The most frequently prescribed herbal medicine was Chungpa-jun, and the most commonly applied Chuna techniques were sidelying lumbar extension dysfunction correction technique, and prone lumbosacral joint distraction method. Radiological findings were mainly referred to for diagnosis, and clinical symptoms, age, radiological findings, and medical history were regarded to be important for prognosis. Participants replied that 7.8 ± 3.3 weeks were required for 50% reduction in pain, and 16.1 ± 7.7 weeks for 80% reduction. These results suggest that KMDs in Korea combine a conventional approach to LSS and a Korean medicine approach to low back pain for integration of empirical- and evidence-based diagnosis and treatment. The findings may contribute in bridging the divide between evidence and clinical practice guidelines for Korean medicine treatment of LSS and real-world clinical practice in future research.