Herbal Medicines for Post-Acute Sequelae (Fatigue or Cognitive Dysfunction) of SARS-CoV-2 Infection: A Phase 2 Pilot Clinical Study Protocol.

Long-term sequelae refer to persistent symptoms or signs for >6 months after SARS-CoV-2 infection. The most common symptoms of sequelae are fatigue and neuropsychiatric symptoms (concentration difficulty, amnesia, cognitive dysfunction, anxiety, and depression). However, approved treatments have not been fully established. Herbal medicines are administered for 12 weeks to patients who continuously complain of fatigue or cognitive dysfunction for >4 weeks that only occurred after COVID-19 diagnoses. Based on the Korean Medicine syndrome differentiation diagnosis, patients with fatigue will be administered Bojungikgi-tang or Kyungok-go, whereas those with cognitive dysfunction will be administered Cheonwangbosim-dan. Results could support evidence that herbal medicines may mitigate fatigue and cognitive dysfunction caused by COVID-19. Furthermore, by investigating the effects of herbal medicines on changes in metabolite and immune response due to COVID-19, which may be responsible for sequelae, the potential of herbal medicines as one of the therapeutic interventions for post-acute sequelae of SARS-CoV-2 infection can be evaluated. Therefore, the effects of herbal medicine on fatigue and cognitive dysfunction sequelae due to COVID-19 will be elucidated in this study to provide an insight into the preparation of medical management for the post-acute sequelae of SARS-CoV-2 infection.

Saam Acupuncture for Treating Functional Dyspepsia: A Feasibility Randomized Controlled Trial.

Objective: Functional dyspepsia (FD) is a common gastrointestinal disorder that significantly affects sufferers' quality of life and increases the economic burden on society. Saam acupuncture, a form of traditional Korean acupuncture, is frequently used to treat FD in Korean medicine clinical settings. This study aimed to evaluate the feasibility and preliminary effectiveness and safety of Saam acupuncture for treating FD. Methods: We conducted a pilot, pragmatic, assessor-blinded randomized controlled trial. Patients with FD according to the ROME III criteria were randomly allocated to an acupuncture plus usual care group or a usual care group. Saam acupuncture based on individualized FD and systemic symptoms was conducted in the acupuncture group three times per week for 4 weeks. Study feasibility outcomes, including recruitment, completion, and acupuncture adherence rates, were calculated. In addition, preliminary evaluation of participant responses to the intervention was tested using the gastrointestinal symptom (GIS), FD-related quality of life (FD-QoL), visual analog scale (VAS), patient global assessment (PGA), and EuroQol-5 Dimensions (EQ-5D) scores. Results: Twenty-four participants who met the eligibility criteria were included. The recruitment and completion rates of the clinical trials were 60% and 79.2%, and the acupuncture adherence rate was 83.3%. Although there was no significant difference between the two groups in the dyspepsia symptoms as measured by GIS, VAS, and PGA at Week 4, significant differences were found between the two groups at the follow-up assessments (Weeks 8 and 12). In particular, the early satiety subscore of GIS was significantly improved in the Saam acupuncture group compared with the usual care group at Week 4. The quality of life measured by FD-QoL and EQ-5D improved only in the Saam acupuncture group, although there were no significant differences between the two groups. No adverse events related to Saam acupuncture were reported. Conclusions: Saam acupuncture can be a feasible, preliminarily effective, and safe treatment for FD. Further confirmatory trials with a larger sample size are needed to confirm its effectiveness and safety. The trail is registered with CRIS-KCT0000164, URL: https://cris.nih.go.kr/cris/search/detailSearch.do/2098.

Effects of Acupuncture on Lowering Blood Pressure in Postmenopausal Women with Prehypertension or Stage 1 Hypertension: A Propensity Score-Matched Analysis.

Postmenopausal women have a higher prevalence of hypertension compared to premenopausal women. Hypertension is a risk factor for cardiovascular diseases, the prevalence of which is ever increasing. This study investigated the effects of long-term acupuncture on lowering the blood pressure of postmenopausal women with prehypertension and stage 1 hypertension. Participants were 122 postmenopausal women aged less than 65 years, diagnosed with prehypertension or stage 1 hypertension (systolic blood pressure 120-159 mmHg or diastolic blood pressure 80-99 mmHg). We used a propensity score-matched design. The experimental group (n = 61) received acupuncture for four weeks every six months over a period of two years. The control group (n = 61) received no intervention. An Analysis of covariance (ANCOVA) was performed for the primary efficacy analysis. Relative risk ratios were used to compare group differences in treatment effects. Acupuncture significantly reduced the participants' diastolic blood pressure (-9.92 mmHg; p < 0.001) and systolic blood pressure (-10.34 mmHg; p < 0.001) from baseline to follow-up. The results indicate that acupuncture alleviates hypertension in postmenopausal women, reducing their risk of developing cardiovascular diseases and improving their health and quality of life.

The safety and effectiveness of self-administered coffee enema: A systematic review of case reports.

BACKGROUND: As the self-administration of coffee enema is being used as a mean of self-care for detoxication in various indications, it is important that evidence-based public health information is provided for effective and safe use. However, the evidence is so far rare. This systematic review was conducted to investigate the safety and effectiveness of self-administered coffee enema in a wide range of use, and to provide evidence about its benefits and risks. METHODS: Relevant studies were retrieved from Ovid MEDLINE, Ovid Embase, the Cochrane Central Register of Controlled Trials, and the Cumulative Index to Nursing and Allied Health Literature; and also from oriental databases, KoreaMed, Korean Medical Database, Korean Studies Information Service System, National Discovery for Science Leaders, and Korea Institute of Science and Technology Information, Oriental Medicine Advanced Searching Integrated System, China National Knowledge Infrastructure, and Japan Science and Technology Information Aggregator. Considering self-administered coffee enema being used in a various indication, study population was not restricted. Any types of published studies that included outcomes of effectiveness and safety of self-administered coffee enema with or without comparators were eligible for this systematic review. Data on biomedical indications, patient-reported outcomes, and adverse events were collected. Descriptive analyses were planned because diverse health conditions and outcome variables did not allow for quantitative synthesis. RESULTS: Nine case reports that describe adverse events were identified and included in the analysis. Of these, 7 recent ones reported colitis after self-administration, mentioning that the most plausible cause assumed was the coffee fluid itself, which contained numerous chemical substances. Two others reported more critical adverse events. All 9 case reports with acceptable quality of evidence warned against the self-administration of the procedure. No study that reports the effectiveness of coffee enema was found. CONCLUSIONS: Based on the evidences reviewed, this systematic review does not recommend coffee enema self-administration as a complementary and alternative medicine modality that can be adopted as a mean of self-care, given the unsolved issues on its safety and insufficient evidence with regard to the effectiveness.

Metabolic Syndrome and Risk of Lung Cancer: An Analysis of Korean National Health Insurance Corporation Database.

INTRODUCTION: Metabolic syndrome is known to increase the risk of several cancers. However, the association between lung cancer and metabolic syndrome remains unclear. Thus, we investigated the impact of metabolic syndrome on the incidence of lung cancer. METHODS: This study enrolled participants in a health screening program provided by the Korean National Health Insurance Service between January 2009 and December 2012. The incidence of lung cancer was observed until December 2016. We analyzed the risk of lung cancer according to the presence of metabolic syndrome, metabolic syndrome components, and number of metabolic syndrome components. RESULTS: During the study, 45 635 new cases of lung cancer were recorded among 9 586 753 participants. The presence of metabolic syndrome and all its components was positively associated with the risk of lung cancer in men after multivariate adjustment (hazard ratio [HR] of metabolic syndrome 1.15; 95% confidence interval [CI], 1.12-1.18). The risk of lung cancer increased with the number of components present. The effect of metabolic syndrome on the increasing risk of lung cancer is may be higher in underweight male ever-smokers than in other participants. CONCLUSION: Metabolic syndrome was associated with an increased risk of lung cancer in men. Moreover, the higher the number of metabolic syndrome components, the higher the risk of lung cancer.

Moxibustion for prehypertension and stage I hypertension: a pilot randomized controlled trial.

BACKGROUND: Prehypertension and hypertension are associated with cardiovascular disease, ischemic heart disease, and stroke morbidity. The purpose of this study is to evaluate the effectiveness and safety of moxibustion in patients with prehypertension or hypertension. METHODS: Forty-five subjects with prehypertension or stage I hypertension were randomized into three groups: moxibustion treatment group A (2 sessions/week for 4 weeks), moxibustion treatment group B (3 sessions/week for 4 weeks), and control group (nontreated group). The primary outcome measure was the change in blood pressure after 4 weeks of treatment. Safety was assessed at every visit. RESULTS: There were no significant differences in systolic blood pressure (SBP) or diastolic blood pressure (DBP) among three groups after 4 weeks of treatment (p = 0.4798 and p = 0.3252, respectively). In treatment group B, there was a significant decrease in SBP and DBP from baseline to 4 weeks of treatment (mean difference (MD) -9.55; p = 0.0225, MD -7.55; p = 0.0098, respectively). There were no significant differences among groups in secondary outcome measures after 4 weeks of treatment. Six adverse events (AEs) in the treatment group A and 12 AEs in the treatment group B occurred related to the moxibustion treatment. CONCLUSION: In conclusion, the results of this study show that moxibustion (3 sessions/week for 4 weeks) might lower blood pressure in patients with prehypertension or stage I hypertension and treatment frequency might affect effectiveness of moxibustion in BP regulation. Further randomized controlled trials with a large sample size on prehypertension and hypertension should be conducted. TRIAL REGISTRATION: This study was registered with the 'Clinical Research Information Service (CRIS)', Republic of Korea (KCT0000469), and the protocol for this study was presented orally at the 15th International Council of Medical Acupuncture and Related Techniques (ICMART) in Athens, 25-27 May 2012.

Efficacy and safety of acupuncture for functional constipation: a randomised, sham-controlled pilot trial.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: KCT0000926 (Registered on 14 November 2013).

Effects of acupuncture in postmenopausal women with prehypertension or stage 1 hypertension: study protocol for a prospective, comparative, interventional cohort study.

BACKGROUND: Hypertension is a major cause of cardiovascular disease and associated mortality, and postmenopausal women are at a high risk of hypertension. We aim to investigate the hypotensive effect and safety of acupuncture, focusing on postmenopausal women with prehypertension and stage 1 hypertension. In addition, we aim to investigate whether the effect of acupuncture treatment differed, depending on Sasang Constitution and cold-heat pattern. METHODS: This study is designed as an intervention cohort study. Two hundred postmenopausal women aged <65 years with prehypertension or stage 1 hypertension living in Daejeon city in Korea will be recruited, and randomly assigned to either an acupuncture or no-treatment control group. The intervention will consist of four sessions; one session will include acupuncture performed 10 times for 4 weeks. There will be a 20-week observation period after each session, and the total study duration will be 96 weeks. Acupuncture will be applied at the bilateral Fengchi (GB20), Quchi (LI11), Zusanli (ST36), and Sameumgyo (SP6) acupoints. The effect of acupuncture will be evaluated by comparing the change in systolic and diastolic blood pressure between the acupuncture and control groups every 4 weeks until the end of the study. DISCUSSION: To evaluate the success of blood pressure management, long-term observation is required, but no long-term studies have been conducted to evaluate the effect of acupuncture on blood pressure in postmenopausal women. To our knowledge, this study will be the first long-term study to investigate this issue for more than 6-8 weeks.

Development of an adverse events reporting form for Korean folk medicine.

PURPOSE: We developed an adverse events (AEs) reporting form for Korean folk medicine. METHODS: The first version of the form was developed and tested in the clinical setting for spontaneous reporting of AEs. Additional revisions to the reporting form were made based on collected data and expert input. RESULTS: We developed an AEs reporting form for Korean folk medicine. The items of this form were based on patient information, folk medicine properties, and AEs. For causality assessment, folk medicine properties such as classification, common and vernacular names, scientific name, part used, harvesting time, storage conditions, purchasing route, product licensing, prescription, persons with similar exposure, any remnant of raw natural products collected from the patient, and cautions or contraindications were added. CONCLUSIONS: This is the first reporting form for AEs that incorporates important characteristics of Korean folk medicine. This form would have an important role in reporting adverse events for Korean folk medicine. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

Effect of acupuncture and its influence on cerebral activity in functional dyspepsia patients: study protocol for a randomized controlled trial.

BACKGROUND: Functional dyspepsia (FD) is a prevalent gastric disorder that is difficult to manage due to lack of satisfactory treatments. Acupuncture has been studied with regard to the rising need for treating FD, but the mechanism verifying its efficacy has not yet been fully revealed. The aim of this study is to explore the efficacy and mechanism of acupuncture for FD compared with a sham group. METHODS/DESIGN: We describe a proposal for a randomized, assessor-blind, sham-controlled trial with 70 eligible participants who will be randomly allocated either into an acupuncture or a sham group. Participants in the acupuncture group will receive 10 sessions of real acupuncture treatment and those in the sham group will be treated with identical sessions using a Streitberger needle. Functional magnetic resonance imaging (fMRI) and metabolomics studies will be implemented before and after 4 weeks of treatment to investigate the mechanism of acupuncture. The primary outcome is a proportion of responders with adequate symptom relief and the secondary outcomes include the Nepean Dyspepsia Index - Korean version, Functional Dyspepsia-Related Quality of Life questionnaire, Ways of Coping Questionnaire, Coping Strategies Questionnaire, perception of bodily sensation questionnaire, State-Trait Anxiety Inventory, and the Center for Epidemiological Studies - Depression Scale. The outcomes will be evaluated before and after the treatment. DISCUSSION: This is the first large-scale trial evaluating the efficacy and mechanism of acupuncture with fMRI and metabolomic methods. We will compare real acupuncture with the Streitberger sham needle to verify the specific effect of acupuncture. The results of this trial are expected to be relevant evidences affecting policy and decision-makers associated with routine healthcare. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02358486 . Date of Registration: 21 January 2015.

Acupuncture lowers blood pressure in mild hypertension patients: a randomized, controlled, assessor-blinded pilot trial.

OBJECTIVES: To preliminarily assess the effects of acupuncture on prehypertension and stage I hypertension, and to provide data for further research. DESIGN: A randomized, controlled, assessor-blinded study with an 8-week intervention period and a 4-week follow-up. INTERVENTIONS: Participants were patients with systolic blood pressure (SBP) of 120-159mmHg or diastolic blood pressure (DBP) of 80-99mmHg.Thirty participants were allocated to acupuncture group or untreated control group at a 1:1 ratio. The acupuncture group received standard acupuncture twice weekly for 8 weeks, and was followed-up for 4 weeks after treatment; the control group did not receive any type of anti-hypertensive treatment for 12 weeks. MAIN OUTCOME MEASURES: Primary outcome measure was SBP and DBP at post-treatment. The secondary outcomes were SBP and DBP at follow-up; Euro Quality of life (EQ-5D), heart rate variability (HRV), body mass index (BMI), and blood lipid profile. RESULTS: DBP (-5.7mmHg; P=0.025), but not SBP (-6.0mmHg; P=0.123), was significantly different between groups at post-treatment. Both DBP (-7.8mmHg; P=0.004) and SBP (-8.6mmHg; P=0.031) were significantly different at follow-up. Among the HRV indices, only high frequency power was significantly different between groups at weeks 4 and 8 (P=0.047 and P=0.030, respectively). There were no differences between groups in EQ-5D, BMI or lipid profile. CONCLUSION: The results of this study show that acupuncture might lower blood pressure in prehypertension and stage I hypertension, and further RCT need 97 participants in each group. The effect of acupuncture on prehypertension and mild hypertension should be confirmed in larger studies. TRIAL REGISTRATION: KCT0000496.

Bee Venom Acupuncture Augments Anti-Inflammation in the Peripheral Organs of hSOD1G93A Transgenic Mice.

Amyotrophic lateral sclerosis (ALS) includes progressively degenerated motor neurons in the brainstem, motor cortex, and spinal cord. Recent reports demonstrate the dysfunction of multiple organs, including the lungs, spleen, and liver, in ALS animals and patients. Bee venom acupuncture (BVA) has been used for treating inflammatory diseases in Oriental Medicine. In a previous study, we demonstrated that BV prevented motor neuron death and increased anti-inflammation in the spinal cord of symptomatic hSOD1G93A transgenic mice. In this study, we examined whether BVA's effects depend on acupuncture point (ST36) in the organs, including the liver, spleen and kidney, of hSOD1G93A transgenic mice. We found that BV treatment at ST36 reduces inflammation in the liver, spleen, and kidney compared with saline-treatment at ST36 and BV injected intraperitoneally in symptomatic hSOD1G93A transgenic mice. Those findings suggest that BV treatment combined with acupuncture stimulation is more effective at reducing inflammation and increasing immune responses compared with only BV treatment, at least in an ALS animal model.

Acupuncture for chronic fatigue syndrome and idiopathic chronic fatigue: a multicenter, nonblinded, randomized controlled trial.

BACKGROUND: The causes of chronic fatigue syndrome (CFS) and idiopathic chronic fatigue (ICF) are not clearly known, and there are no definitive treatments for them. Therefore, patients with CFS and ICF are interested in Oriental medicine or complementary and alternative medicine. For this reason, the effectiveness of complementary and alternative treatments should be verified. We investigated the effectiveness of two forms of acupuncture added to usual care for CFS and ICF compared to usual care alone. METHODS: A three-arm parallel, non-blinded, randomized controlled trial was performed in four hospitals. We divided 150 participants into treatment and control groups at the same ratio. The treatment groups (Group A, body acupuncture; Group B, Sa-am acupuncture) received 10 sessions for 4 weeks. The control group (Group C) continued usual care alone. The primary outcome was the Fatigue Severity Scale (FSS) at 5 weeks after randomization. Secondary outcomes were the FSS at 13 weeks and a short form of the Stress Response Inventory (SRI), the Beck Depression Inventory (BDI), the Numeric Rating Scale (NRS), and the EuroQol-5 Dimension (EQ-5D) at 5 and 13 weeks. RESULTS: Group A showed significantly lower FSS scores than Group C at 5 weeks (P = 0.023). SRI scores were significantly lower in the treatment groups than in the control group at 5 (Group A, P = 0.032; B, P <0.001) and 13 weeks (Group A, P = 0.037; B, P <0.001). Group B showed significantly lower BDI scores than Group C at 13 weeks (P = 0.007). NRS scores from the treatment groups were significantly reduced compared to control at 5 (Group A and B, P <0.001) and 13 weeks (Group A, P = 0.011; B, P = 0.002). CONCLUSIONS: Body acupuncture for 4 weeks in addition to usual care may help improve fatigue in CFS and ICF patients. TRIAL REGISTRATION: Clinical Research Information Service (CRIS) KCT0000508; Registered on 12 August 2012.

The effects of bee venom acupuncture on the central nervous system and muscle in an animal hSOD1G93A mutant.

Amyotrophic lateral sclerosis (ALS) is caused by the degeneration of lower and upper motor neurons, leading to muscle paralysis and respiratory failure. However, there is no effective drug or therapy to treat ALS. Complementary and alternative medicine (CAM), including acupuncture, pharmacopuncture, herbal medicine, and massage is popular due to the significant limitations of conventional therapy. Bee venom acupuncture (BVA), also known as one of pharmacopunctures, has been used in Oriental medicine to treat inflammatory diseases. The purpose of this study is to investigate the effect of BVA on the central nervous system (CNS) and muscle in symptomatic hSOD1G93A transgenic mice, an animal model of ALS. Our findings show that BVA at ST36 enhanced motor function and decreased motor neuron death in the spinal cord compared to that observed in hSOD1G93A transgenic mice injected intraperitoneally (i.p.) with BV. Furthermore, BV treatment at ST36 eliminated signaling downstream of inflammatory proteins such as TLR4 in the spinal cords of symptomatic hSOD1G93A transgenic mice. However, i.p. treatment with BV reduced the levels of TNF-α and Bcl-2 expression in the muscle hSOD1G93A transgenic mice. Taken together, our findings suggest that BV pharmacopuncture into certain acupoints may act as a chemical stimulant to activate those acupoints and subsequently engage the endogenous immune modulatory system in the CNS in an animal model of ALS.

Effect of self-acupressure for symptom management: a systematic review.

OBJECTIVES: To assess the efficacy and safety of self-administered acupressure to alleviate symptoms of various health problems, including allergic disease, cancer, respiratory disease, dysmenorrhea, perceived stress, insomnia, and sleep disturbances. METHODS: We searched core, Korean, Chinese, and Japanese databases, including Ovid-MEDLINE, Ovid-EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), six representative electronic Korean medical databases, China National Knowledge Infrastructure (CNKI), and Japan Science and Technology Information Aggregator (J-STAGE). We included randomized controlled trials (RCTs) and quasi-RCTs that examined disease-specific effects or symptom relief, adverse reactions, and quality-of-life (QOL) for self-administered acupressure. Data collection and assessment of the methodological quality of the included studies were conducted by two independent reviewers. RESULTS: Eight RCTs and two quasi-RCTs showed positive effects and safety of self-acupressure therapy in clinically diverse populations. Quality assessment revealed moderate quality for the RCTs, with 50% or more of the trials assessed as presenting a low risk of bias in seven domains. All of the selected 10 studies reported positive effects for primary outcomes of self-acupressure therapy for symptom management, including significant improvements in symptom scores in allergic disease, nausea and vomiting in cancer, symptom scores in respiratory disease, pain symptoms in dysmenorrhea, and stress/fatigue scores and sleep disturbances in healthy people. CONCLUSIONS: Our findings suggest that self-administered acupressure shows promise to alleviate the symptoms of various health problems. Therefore, further research with larger samples and methodologically well-designed RCTs is required to establish the efficacy of self-administered acupressure.

Effect of self-administered foot reflexology for symptom management in healthy persons: a systematic review and meta-analysis.

OBJECTIVES: Self-administered foot reflexology is unrestricted by time and space, economical, and practical because it is easy to learn and apply. This study estimated the effectiveness of self-foot reflexology for symptom management in healthy persons through a systematic review and meta-analysis. METHODS: The participants were healthy persons not diagnosed with a specific disease. The intervention was foot reflexology administered by participants, not by practitioners or healthcare providers. The comparative studies either between groups or within group comparison were included. Our search utilized core databases (MEDLINE, EMBASE, Cochrane, and CINAHL). We also searched Chinese (CNKI), Japanese (J-STAGE), and Korean databases (KoreaMed, KMbase, KISS, NDSL, KISTI, and OASIS). The search was used MeSH terminology and key words (foot reflexology, foot massage, and self). RESULTS: Analysis of three non-randomized trials and three before-and-after studies showed that self-administered foot reflexology resulted in significant improvement in subjective outcomes such as perceived stress, fatigue, and depression. However, there was no significant improvement in objective outcomes such as cortisol levels, blood pressure, and pulse rate. We did not find any randomized controlled trial. CONCLUSIONS: This study presents the effectiveness of self-administered foot reflexology for healthy persons' psychological and physiological symptoms. While objective outcomes showed limited results, significant improvements were found in subjective outcomes. However, owing to the small number of studies and methodological flaws, there was insufficient evidence supporting the use of self-performed foot reflexology. Well-designed randomized controlled trials are needed to assess the effect of self-administered foot reflexology in healthy people.

Self-administered foot reflexology for the management of chronic health conditions: a systematic review.

OBJECTIVES: To systematically review the effect of self-administered foot reflexology in patients with chronic health conditions. METHODS: Electronic databases were searched for literature published from 1948 to January 2014. The databases included MEDLINE, EMBASE, the Cochrane Library, CINAHL, CNKI, J-STAGE, Koreamed, Kmbase, KISS, NDSL, KISTI, and OASIS. Key search terms were "exp/relaxation therapy," "foot," "reflexology," "zone therapy," and "self." All study designs were included. Two raters independently extracted data and assessed study quality by using the Cochrane risk of bias tool (for randomized controlled trials) and the risk of bias assessment tool for nonrandomized studies (for nonrandomized and before-and-after studies). A qualitative and descriptive analysis was performed because of the clinical diversity associated with chronic health conditions. RESULTS: Of the 224 records assessed, 4 trials met the inclusion criteria: 3 nonrandomized controlled trials and 1 before-and-after study without comparison. Self-administered foot reflexology might have a positive effect in type 2 diabetes, but the low quality of the included study and the lack of adequately reported clinical outcomes obscure the results. Two studies of hypertensive patients and 1 study of patients with urinary incontinence showed that self-performed foot reflexology may exert a beneficial effect on lowering blood pressure and urinary incontinence; however, given the small sample size and the lack of any description of medications and other cointerventions, there was insufficient evidence to conclusively determine whether foot reflexology had any effect. CONCLUSIONS: The included studies on self-administered foot reflexology in patients with type 2 diabetes, hypertension, or urinary incontinence provided insufficient evidence to determine a treatment effect. Therefore, a well-designed, large-scale, and randomized controlled trial is needed to confirm the effect of self-administered foot reflexology for chronic conditions.

Randomized, controlled trial of qigong for treatment of prehypertension and mild essential hypertension.

CONTEXT: Hypertension treatments include sodium restriction, pharmacological management, and lifestyle modifications. Although many cases of hypertension can be controlled by medication, individuals may experience side effects or incur out-of-pocket expenses, and some may not comply with the treatment regimen. Although some previous studies have shown a favorable effect for qigong on hypertension, well-designed, rigorous trials evaluating the effect of qigong on hypertension are scarce. OBJECTIVE: This study aimed to evaluate the effect of qigong on prehypertension and mild hypertension and to calculate a sample size for a subsequent randomized, clinical trial (RCT). DESIGN: Participants were randomized to a qigong group or an untreated control group. SETTING: This study was conducted at the Oriental Medical Center of Dongeui University, in the Republic of Korea. PARTICIPANTS: Participants were individuals between the ages of 19 and 65 y with systolic blood pressure (SBP) between 120 and 159 mm Hg and/or diastolic blood pressure (DBP) between 80 and 99 mm Hg. INTERVENTION: The qigong group attended qigong classes 3 ×/wk and performed qigong at home at least 2 ×/wk. Participants in the control group did not receive any intervention for hypertension. OUTCOME MEASURES: Outcome measures for this study were (1) changes in blood pressure (BP); (2) quality of life (QOL) using 2 surveys: the Medical Outcomes Study (MOS) 36-item short form (SF-36) (Korean version) and the Measure Yourself Medical Outcome Profile 2 (MYMOP2); and (3) hormone levels. RESULTS: Of 40 participants, 19 were randomly assigned to the qigong group, and 21 were assigned to the control group. After 8 wk, significant differences were observed between the qigong and the control groups regarding changes in SBP (P = .0064) and DBP (P = .0003). Among the categories of the MYMOP2 questionnaire, only wellbeing was significantly different between the 2 groups (P = .0322). The qigong group showed a significantly greater improvement in the physical component score of the SF-36 compared with the control group (P = .0373). Regarding changes in hormone levels, there was no significant difference between the qigong and the control groups. This pilot study demonstrates that regarding sample size, a RCT evaluating the effect of qigong on hypertension should include 22 participants based on DBP and 285 participants based on SBP in each group, thus allowing for a loss to follow-up rate of 20%. CONCLUSION: The results indicate that qigong may be an effective intervention in reducing BP in prehypertension and mild hypertension. Further studies should include an appropriate sample size and methodology to determine the mechanism of qigong on BP.