Bloodletting puncture in the treatment of acute ischemic stroke: protocol for a mixed-method study of a multi-center randomized controlled trial and focus group.

This study is to investigate the effectiveness and safety of bloodletting puncture (BP) for acute ischemic stroke (AIS) when used in combination with standard treatment, as well as the patients' feelings and attitudes toward the treatment. This is a mixed method research which includes a multi-center, superiority, randomized controlled clinical trial, and focus group interview. A total of 360 AIS participants will be enrolled. They will be randomized into one of the following two groups for 7 d: (a) BP with standard treatment group (n = 180); (b) standard treatment group (n = 180). The primary outcome will be National Institute of Health stroke scale (NIHSS) score at day 7 after treatment. Secondary outcomes will be changes of Glasgow Coma Scale score, NIHSS score, mRS and Traditional Chinese Medicine syndrome score from baseline to 7, 14, and 30 d after treatment, recurrence rate and all-cause mortality rate within 30 d, and the safety assessments. The focus group will be conducted with a purposive sample of 1-2 acupuncturists and 1-2 patients respectively at each center at 7 and 30 d after treatment. We designed a mixed method study to evaluate the effect of BP, an acupuncture therapy for patients with AIS. If the findings of this study confirm the effectiveness of BP to reduce the NIHSS score and other related outcomes and patients are willing to accept the therapy, we believe this study will help the implementation of this therapy in clinical practice, and provide new evidence for the treatment of AIS.

Effect of Bloodletting at Shaoshang and Shangyang Acupuncture Points on Outcome and Prognosis of Severe Community-Acquired Pneumonia in the Elderly.

OBJECTIVES: The aim of this study was to explore, whether treatment with bloodletting at Shaoshang and Shangyang acupuncture points would affect therapy outcome and prognosis for severe community-acquired pneumonia (SCAP) in the elderly. METHODS: A total of 62 patients, who met the diagnostic criteria for SCAP, were enrolled in the study and randomly divided into two groups, i.e., treatment group (n = 31) and control group (n = 31). All patients received a therapy according to the Chinese Clinical Practice and Expert Consensus of Emergency Severe Pneumonia from 2016. In addition to that, a bloodletting at Shaoshang (LU11) and Shangyang (LI1) acupuncture points was applied for the treatment group. This intervention was repeated for three times (ones daily), bloodletting a volume of 2-3 ml at each time point. Differences in a main index of clinical efficacy, body temperature (T), respiratory rate (RR), heart rate (Hr), white blood cell count (WBC), neutrophil percentage (N%), and C-reactive protein level (CRP) as well as different scores (CURB-65 score, SOFA score, and Apache II score) were compared between groups. Moreover, the 28-day mortality was compared between treatment and control group. The statistical methods involved in carrying out the current study include t-test, Wilcoxon test, and chi-square test. RESULTS: The clinical effective rate of the treatment group was 82.9%, which was significantly higher than the 17.1% in the control group (P < 0.05). After finishing the intervention, the treatment group showed significantly lower T (37.28 ± 0.54 vs. 37.82 ± 0.81), RR (20.06 ± 2.67 vs. 23.71 ± 6.85), Hr (81.71 ± 10.38 vs. 93.84 ± 15.39), CUBR-65 score (2.16 ± 0.74 vs. 3.03 ± 0.98), and SOFA score (5.84 ± 3.83 vs. 8.16 ± 4.2) compared to the control group (P < 0.05). The 28-day mortality rate of the treatment group was significantly lower than in the control group (12.9% vs. 45.2%, P = 0.05). CONCLUSIONS: Bloodletting at Shaoshang and Shangyang acupuncture points can support improving the clinical treatment efficacy for SCAP and reduce the 28-day mortality rate in the elderly.

Efficacy and safety of bloodletting for herpes zoster: A protocol for systematic review and meta-analysis.

BACKGROUND: The study aims to evaluate the effectiveness and safety of bloodletting therapy for herpes zoster. METHODS: The following electronic databases will be searched from PubMed (1966 to March 2020), the Cochrane Central Register of Controlled Trials (update to March 2020), EMBASE (1980 to March 2020), China National Knowledge Infrastructure (1979 to March 2020), Wan Fang Data (1980 to March 2020), Chinese Scientific Journal Database (1989 to March 2020), Chinese Biomedical Database (1978 to March 2020) and traditional Chinese medicine Literature Analysis and Retrieval Database (1949 to March 2020). All randomized controlled trials without any limitation of blinding or publication language about this topic will be included, exclude cohort studies and case reports. Two independent researchers will operate article retrieval, duplication removing, screening, quality evaluation, and data analyses by Review Manager (V.5.3.5). Meta-analyses, subgroup analysis, and/or descriptive analysis will be performed based on the included data conditions. RESULTS: High-quality synthesis and/or descriptive analysis of current evidence will be provided from cure rate, converting to clinical diagnosis rate, and side effects of bloodletting. CONCLUSION: This study will provide the evidence of whether bloodletting is an effective and safe intervention for herpes zoster. PROSPERO REGISTRATION NUMBER: CRD42020171976.

Bloodletting therapy for treating patients with chronic urticaria: A systematic review and meta-analysis protocol.

BACKGROUND: Chronic urticaria is a common disease affecting patients' quality of life, and leading to substantial burden to both patients and society. Many trials have shown that bloodletting therapy is effective in treating chronic urticaria. There are currently no systematic reviews of bloodletting therapy for chronic urticaria. This protocol aims to present the methods used to assess the effectiveness and safety of bloodletting therapy for patients with chronic urticaria. METHODS: The following databases will be searched from their inception: the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), Chinese Scientific Journal Database (VIP database), and Wan-Fang Database. Clinical randomised controlled trials related to bloodletting therapy for treating chronic urticaria will be included, regardless of publication status and languages. Study selection, data collection, and quality assessment will be independently conducted by 2 researchers. For data synthesis, we will select either the fixed-effects or random-effects model according to heterogeneity assessment. Disease activity control will be assessed as the primary outcomes. Response rate, recurrence rate and adverse events will be evaluated as secondary outcomes. If it is appropriate for meta-analysis, RevMan V.5.3 statistical software will be used. Otherwise, a systematic narrative synthesis will be conducted. The results will be presented as risk ratio (RR) with 95% confidence intervals (CIs) for dichotomous data and weight mean difference (WMD) or standard mean difference (SMD) 95% CIs for continuous data. DISSEMINATION AND ETHICS: The protocol of this systematic review will be disseminated in a peer-reviewed journal and presented at relevant conferences. It is not necessary for a formal ethical approval because the data are not individualised. TRIAL REGISTRATION NUMBER: PROSPERO CRD42018111143.

The effect of traditional wet cupping on shoulder pain and neck pain: A pilot study.

OBJECTIVES: Wet cupping therapy (WCT) is a traditional complementary method recommended to decrease the symptoms of a lot of diseases and used in the treatment of pain syndromes. In this pilot study, the possible effects of wet cupping therapy on nonspecific neck and upper shoulder pain were investigated. METHODS: Sixty one eligible volunteer participants with nonspecific neck and upper shoulder pain for at least 3 months were allocated. The Numeric Rating Scale (NRS) was used to assess pain scores. Pain scores were recorded before and after wet cupping therapy. RESULTS: The mean scores of neck pain in study group were 7.02 (SD = 1.8) before and 3.70 (SD = 2.2) after cupping therapy. The decrease of pain scores between pre- and post-test was statistically significant (p < 0.05). DISCUSSION: It can be stated that WCT has potential therapeutic effect in nonspecific neck and upper shoulder pain. Future full-scale randomized controlled trials will be needed to provide firm evidence of the effectiveness of this intervention.

Unexpected lumbar abscess due to scarification wet cupping: a case report.

OBJECTIVE: This case presents a rare cause of lumbar abscess. METHODS: A 51-year-old male patient was admitted to the emergency department with a complaint of lumbar pain. Spinal magnetic resonance imaging revealed a lumbar abscess. RESULTS: The abscess was treated with drainage of the abscess and antibiotic. CONCLUSION: Scarification wet cupping therapy should be taken into consideration as a rare cause of lumbar abscesses in patients who present with skin findings indicative of scarification. Scarification wet cupping therapy practitioners must pay attention to hygienic measures.

A safer technique of internal jugular venipuncture: experience with 320 cases.

Placement of central venous catheters for monitoring or long-term access has become an indispensable surgical procedure. Various routes to establish central venous access have previously been described. The internal jugular vein can be cannulated percutaneously from several access points, using the clavicle and the sternocleidomastoid muscle as reference landmarks. An alternate method of internal jugular venipuncture using a previously undescribed point of entry is described. Experience with this modified technique in 320 cases where it was used for various purposes is reviewed. The incidence of complication was less than 1% and the improved safety of the procedure is attributed to the vertical direct method of venipuncture through the new access point.

Iron and erythropoietin measurement in autologous blood donors with anemia: implications for management.

BACKGROUND: The importance of autologous blood donation for elective surgery is recognized, and the method is being used at many hospitals. Not all patients are able to deposit a sufficient amount of blood before surgery because they cannot recover rapidly enough from phlebotomy-induced anemia. The ability to donate sufficient blood for autologous use was studied in patients who are particularly susceptible to phlebotomy-induced anemia. STUDY DESIGN AND METHODS: Of 840 patients who donated blood for autologous use in elective surgery from November 1987 through May 1993, 20 with rheumatoid arthritis, 24 with iron deficiency anemia, and 37 aged 65 years and above with normocytic anemia were compared with 24 nonanemic elderly patients who donated a total of 1000 mL of blood for autologous use. Patients received iron sulfate orally and donated blood once a week until operation. RESULTS: The amount of blood collected before surgery per control patient was more than that in others. Consequently, there was a tendency to allogeneic blood transfusion in patients with rheumatoid arthritis or elderly patients. The ferritin levels in controls and in patients with iron deficiency anemia during the donation period were almost within the normal range in spite of iron supplementation, which implied a good utilization of iron sulfate for erythropoiesis. On the other hand, the rise in ferritin levels in the elderly and in patients with rheumatoid arthritis suggested inappropriate iron availability for erythropoiesis and resulted in an increase in iron storage. Since an adequate endogenous erythropoietin response to phlebotomy-induced anemia was not observed in these patients, impaired erythropoietin production was considered one of the reasons for anemia. CONCLUSION: Patients with iron deficiency anemia are able to continue donating blood for autologous use so long as they have sufficient iron supplementation. However, the elderly or those with rheumatoid arthritis occasionally fail to donate a sufficient volume of blood before surgery as a result of phlebotomy-induced anemia, which is caused in turn by impaired erythropoietin production.

Recombinant human erythropoietin in autologous blood donors: a dose-finding study.

A dose-finding study of recombinant human erythropoietin (rhEPO) was performed in 60 autologous donors who donated 2 units of blood prior to orthopaedic or vascular surgery. The correction of phlebotomy-induced anaemia was studied in four groups of 15 patients who received 500 U/kg, 250 U/kg, 125 U/kg or no (controls) rhEPO subcutaneously twice per week during a 3-week period. Haemoglobin concentration in the 500 U/kg, 250 U/kg and 125 U/kg group and in the controls reached respectively 99.2, 98.8, 91.9 and 87.1% of pre-phlebotomy value. Flow cytometric analysis of reticulocytes showed a steady increase of reticulocyte count as the dose increased. Maximal levels of high fluorescence reticulocytes which represent early changes of erythropoiesis were reached after 7 d and decreased thereafter in each group. Serum ferritin decreased significantly to approximately 50% of baseline values in all groups; no differences in the decrease of serum ferritin were observed between the patients who received rhEPO and the controls. No severe adverse events were observed. This study demonstrates a dose-related effect of rhEPO on erythropoiesis in autologous donors during the first 2 weeks. No further increase of reticulocytes was observed despite continued rhEPO therapy, which may be due to the inability of the mononuclear phagocytic system to release additional iron. To restore pre-phlebotomy haemoglobin concentration, a dose of 250 U/kg rhEPO was sufficient.

The efficacy of subcutaneous recombinant human erythropoietin in the correction of phlebotomy-induced anemia in autologous blood donors.

The efficacy of subcutaneous recombinant human erythropoietin (rhEPO) (500 U/kg; administered twice a week during the 3 weeks before surgery) in the recovery of preoperative hemoglobin concentrations within a 3-week period was studied in 40 patients, each of whom donated 2 units (900 mL) of blood for their own use before total hip replacement surgery. Twenty autologous blood donors received rhEPO (EPO group) and 20 were not treated (control group). The initial hemoglobin concentration (14.0 +/- 1.0 g/dL [140 +/- 10 g/L]) was completely recovered before surgery (14.0 +/- 1.6 g/dL [140 +/- 16 g/L]) in the EPO group, while a decrease from 13.8 +/- 1.1 to 12.2 +/- 1.3 g per dL (138 +/- 11 to 122 +/- 13 g/L) was observed in the control group. The preoperative reticulocyte count showed more than sixfold increase in the EPO group, whereas a twofold to threefold increase was found in the control group. Serum ferritin concentration fell to 42 +/- 29 micrograms per L in the EPO group and to 54 +/- 35 micrograms per L in the control group. The postoperative serum erythropoietin concentration in the EPO group was significantly lower than that in the control group, but it did not differ from the pretreatment value and was attended by a higher hemoglobin concentration after surgery. Only transient flu-like symptoms were mentioned by patients who were treated with rhEPO. Changes in blood pressure or platelet count or other adverse events were not observed.(ABSTRACT TRUNCATED AT 250 WORDS)

A study of erythropoiesis and iron metabolism in the rabbit in vivo. II. Dependence of the response on iron storage and transport.

Rabbits subjected to a daily bloodletting schedule of 10 ml blood per kg body weight increase four- or fivefold their erythropoietic production compared to normal non-bled animals. The maximum response they can reach under these conditions mobilizes more than 9 mg of iron per day per rabbit into hemoglobin. When fed ad libitum with their regular diet, they do not need any further iron supplement for full erythropoiesis. The experimental increment in iron body stores and/or serum iron levels does not enhance their erythropoietic response, demonstrating that iron is not rate limiting under the conditions studied. Furthermore, although serum iron levels are elevated onefold in the controls under chronic anemia with respect to non-bled animals, the concentration of serum transferrin is only slightly increased; hence, the iron saturation of this protein changes from a 50% to an 80% level. In the absence of an extra supplement of iron, rabbits subjected to chronic bloodletting show no signs of body iron depletion, as judged by their continuous macrocytic RBC production.

Elderly patients' responses to preoperative autologous blood collection.

OBJECTIVE: To follow the haematological response in elderly patients to preoperative autologous blood collection. DESIGN: A prospective, randomised study. SETTING: Malmö General Hospital, Sweden. PATIENTS: Sixty patients with a mean age of 71 years (range, 60-82 years) who were to undergo total hip replacement were randomly divided into four groups of 15. One group served as control. Three units of blood were collected from patients in the other three groups, the first unit at least 30 days before the planned operation, with an average interval of 10 days between collections. Iron supplementation was given to one group as a substitution remedy, another group was given iron and folic acid and the third group was without supplementation during the collection period. MAIN OUTCOME MEASURES: Haematological and biochemical tests were performed on blood samples taken at the time of each collection, on the morning of the hip replacement operation, and ten days after and six weeks after the operation. RESULTS: No major complication was encountered with blood collection. The patients tolerated the procedure very well including the substitution remedies. Haematological and biochemical parameters remained within the normal range during the collection period and after the operation. No patient in the autologous groups needed homologous blood during the operation; three units of homologous blood were used after the operation in these patients. CONCLUSION: Preoperative blood collection from the elderly is safe and well tolerated. The procedure should be encouraged in elective orthopaedic operations regardless of age.

Effect of repeated phlebotomy on iron status of rhesus monkeys (Macaca mulatta).

Iron status, as determined by hematologic values, serum iron concentration, total iron-binding capacity, and zinc protoporphyrin concentration, was determined in 2 groups of 6 nonpregnant monkeys. Monkeys of groups 1 and 2 had 10 and 5%, respectively, of their blood volume withdrawn per week for up to 10 weeks or until blood hemoglobin concentration was less than or equal to 10 g/dl. A third group of 6 monkeys served as controls. The majority (8/12) of the monkeys became anemic (hemoglobin concentration, less than or equal to 10 g/dl) after approximately 30 to 70% (mean, 49%) of their blood volume was removed. Anemia was accompanied by decrease in serum iron concentration and percentage of transferrin saturation. Microcytosis, hypochromasia, and increased zinc protoporphyrin concentration, all hematologic characteristics of iron deficiency, developed later. The calculated iron stores ranged from 1 to 133 mg, with mean value of 51 mg. Iron-depleted monkeys had mean calculated available iron store of 20.8 mg, whereas iron-replete monkeys had mean available iron store of 114.0 mg. Changes were not observed in monkeys of the control group during the study period. None of the baseline hematologic or biochemical analytes measured were good predictors of iron stores. The diet used at the research center did not provide sufficient iron to prevent iron deficiency in most of the monkeys from which a total amount of 30 to 70% of blood volume at 5 or 10%/week was withdrawn. Studies requiring that much blood may need to be modified to include iron supplementation, reduction of sample volume, or iron replacement after termination of projects.