Ma's Bamboo-Based Medicinal Moxibustion Therapy of Low Back Pain in Lumbar Disc Herniation: Study Protocol for a Randomized Controlled Trial

Background Lumbar disc herniation (LDH) is a common and frequently-occurring disease in clinic. Low back pain and sciatica are the presenting symptoms of LDH. To some extent, it can be considered that measures with the capability to improve low back pain or sciatica have the potential to treat LDH. Ma's bamboo-based medicinal moxibustion therapy can effectively reduce the degree of low back pain and has been widely used. Studies of small sample size have seen significant improvement on pain relief. Methods/design: The trial is a multicenter, randomized, parallel-group, non-inferiority study. Three hundred and twelve patients will be randomly assigned to a Ma's bamboo-based medicinal moxibustion group (n=156) and an acupuncture group (n=156).Patients in each group will receive treatment every day,6 times a week, 12 times in total. Follow-up will be conducted 14 days after treatment. The primary outcome will be the visual analogue scale(VAS)at baseline, after 6 times of treatment,the end of treatment, and follow-up. the secondary outcomes will include Oswestry disability indexes (ODI) ,modified Japanese Orthopaedic Association low back pain (M-JOA) score,serum β-endorphin (β-EP) and serum substance P (SP). β-EP and SP as well as safety evaluation indexes (routine blood test, liver and kidney function, and ECG) will be measure at baseline and after the end of treatment. Discussion The results of the trial will compare the efficacy on low back pain in LDH between Ma's bamboo-based medicinal moxibustion group and acupuncture group and will be expected to make a systematic and objective evaluation on the clinical efficacy and safety of Ma's bamboo-based medicinal moxibustion therapy. Trial registration: ChiCTR, ChiCTR2000038725. Registered on 29 September 2020.

Patient-reported outcomes version of the common terminology criteria for adverse events and quality-of-life linear analogue self-assessment in breast cancer patients receiving radiation therapy: single-institution prospective registry

Purpose/objectives We sought to investigate the impact of patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) on overall quality-of-life (QOL) employing linear analogue self-assessment (LASA) in breast cancer (BC) patients undergoing radiation therapy (RT). Materials/methods All patients treated with RT for BC with curative intent from 2015 to 2019 at our institution were included. Breast specific PRO-CTCAE and overall QOL LASA questionnaires were administered at baseline, end-of-treatment, 3, 6, 12 months, and then annually. Minimal clinically important difference in overall QOL was a 10-point change in LASA. Hypofractionation was any treatment > 2 Gy per fraction. Mixed models for repeated measures were used to determine the association of PRO-CTCAE and overall QOL LASA. Results Three hundred thirty-one (331) patients with a median follow-up of 3.1 years (range 0.4–4.9) were included. Average overall QOL LASA scores were 78.5 at baseline, 79.8 at end-of-treatment, 79.8 at 3 months, 77.1 at 6 months, 79.4 at 12 months, and 79.7 at 24 months. On univariate analysis, patients reporting a grade ≥ 3 PRO-CTCAE had, on average, a 10.4-point reduction in overall LASA QOL (p < 0.0001). On multivariate analysis, not being treated with hypofractionation and higher BMI were predictive for worse overall LASA QOL with a 10-point reduction in LASA for patients reporting a grade ≥ 3 PRO-CTCAE (p < 0.0001). Conclusions Patients reporting a grade ≥ 3 PRO-CTCAE experienced statistically significant and clinically meaningful deterioration in overall QOL LASA. Hypofractionation improved QOL while higher BMI predicted for worse QOL. PRO-CTCAE should be integrated into future clinical trials.

The Effect of Family Psychoeducation on Tuberculosis Treatment Adherence of Children in Indonesia

Tuberculosis (TB) is an infectious disease leading cause of death in the world but treatment adherence the most underrated and understudied factor affecting the outcome of TB therapy. The aim of this study was to determine the effect of family psychoeducation on TB treatment adherence of children. The study used a randomized controlled trial (RCT). The sample was 40 pairs of primary caregivers and children who received TB treatment and experienced no side effects of anti-TB drugs in Wonosari Hospital Indonesia in 2019. The treatment group was given psychoeducation by trained health personnel psychoeducators, while the control group was given education by health workers. Psychoeducation was carried out individually, 3 meetings in the first week of the study. Adherence was measured at the sixth month which was the end of treatment period, using a questionnaire. Data were analyzed by using multiple logistic regression. The results showed that family psychoeducation had a significant effect on TB treatment adherence in children after controlling for mother’s knowledge (P-value 0.05 ≤ 0.05). Family psychoeducation is a preventive factor for non-adherence to TB treatment. It is important that psychoeducation is provided to all TB patients to reduce psychological problems that can lead to treatment non-adherence.

Incidence of acute radiodermatitis in women with breast cancer undergoing hypofractionated radiotherapy

ABSTRACT Objective: To estimate the incidence and degree of acute radiodermatitis at the end and after the end of treatment in women with breast cancer undergoing hypofractionated radiotherapy. Methods: Observational, prospective, and longitudinal study, conducted between March 2019 and January 2020, in a radiotherapy outpatient clinic. Results: Thirty-two women participated in the study, among whom, in the last session of hypofractionated radiotherapy, 15 (46.9%) had radiodermatitis, erythema in 13 (40.6%), and wet peeling in 2 (6.3%). In the post-treatment evaluation, 27 (84.4%) had radiodermatitis, erythema in 17 (53.1%), dry peeling in 8 (25%), and wet peeling in 2 (6.3%). Conclusion: The general incidence of radiodermatitis after hypofractionated radiotherapy in women with breast cancer was 37.5%, erythema, 12.5%, and dry peeling, 25%. The development of care protocols for the management of radiodermatitis after treatment is of paramount importance.

Ways to improve the diagnostics and detection of cervical cancer development and recurrence risk

th and the third most common female cancer worldwide. The purpose of the study was to determine risk factors and time to progression and recurrence in patients with cervical cancer after complex treatment (neoadjuvant chemotherapy + radical hysterectomy + combined radiation therapy). Methods: This retrospective study involved female patients with stage IB-IIA cervical cancer registered at Shymkent city oncological dispensary in 2011- 2021 (n=883). All patients underwent (n=883) radical hysterectomy with pelvic lymph node dissection. The patients were selected who underwent radiation therapy of the lower pelvis at a dose of ≥40 g. The age-, stage-, and tumor morphological structure-dependent survival factors and recurrence risk were analyzed during the research decade. Results: Direct correlation of the disease stage and the recurrence period was established. The progression was most often 5 to 6 months after treatment. 68.7% of progression and 63.1% of recurrences occurred in the first year and a half after the end of treatment, so this period is considered the most “dangerous” regarding the recurrence risk. 5.3% of patients had a recurrence 19 to 24 months after treatment, 31.5% – after more than two years. Conclusions: In this research, cervical cancer progressed in 74 (10.6%) out of 883 women and recurred in 19 (3.0%). The recurrence was most frequent in women aged 45-50 years (28.4%) and 50-60 years (26.3%).

Assessment of Safety of Remdesivir in Covid −19 Patients with Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min per 1.73 m^2

Purpose Safety of remdesivir in patients with renal impairment is unknown. Incidence of liver injury secondary to remdesivir is also unknown. The objective of this study is to assess the incidence of acute kidney injury (AKI) and to trend the liver enzymes during remdesivir treatment and change in eGFR from baseline to end of treatment as well as 48 h post completion of remdesivir therapy. Methods This is a retrospective chart review study including adult patients admitted with COVID-19 receiving remdesivir with a baseline eGFR < 30 ml/min per 1.73 m^2 from December 2020 to May 2021. The primary outcome was to assess the incidence of AKI and hepatic injury. The secondary outcome was to assess the efficacy of remdesivir defined by change in oxygen requirement. Results Seventy-one patients were included in the study. Patients experienced an improvement in eGFR from baseline (T0) to end of remdesivir treatment (T1), as well as 48 h after the end of the treatment (T2) ( + 30.3% and + 30.6% respectively, P < .0001). Creatinine reduced from baseline (T0) to T1 and T2 (-20.9% and −20.5% respectively, P < .0001). Creatinine clearance improved from baseline to T1 and T2 ( + 26.6% and + 26.2% respectively, p < .0001). Elevation of aminotransferase (AST) was observed at T1 ( + 2.5%, P = .727), however, AST reduction was seen at T2 (-15.8%, P = .021). Elevation in alanine transaminase (ALT) was observed at T1 and T2 ( + 25% and + 12%, P = .004 and P = .137 respectively). Both direct and total bilirubin remained stable and were not significantly changed from baseline. Conclusion Our study showed that remdesivir use in renally-impaired patients with eGFR < 30 ml/min is safe. Remdesivir may be considered as a therapeutic option in this population with COVID-19 infection.

Phase II Study of Dichloroacetate (DCA) in Combination with Chemoradiotherapy for Unresected, Locally Advanced Head and Neck Squamous Cell Carcinoma

Background: Chemoradiotherapy (CRT) for locally-advanced head and neck squamous cell carcinoma (LA-HSNCC) yields 5-year survival rates near 50% despite causing significant toxicity. Dichloroacetate (DCA), a pyruvate dehydrogenase kinase metabolic inhibitor, reduces tumor lactate production and has been used in cancer therapy previously. The safety of adding this agent to CRT is unknown. Methods: Our randomized, placebo-controlled, double-blind phase II study added DCA to cisplatin-based CRT in patients with LA-HNSCC. The primary endpoint was safety by adverse events (AEs). Secondary endpoints compared efficacy via 3-month end-of-treatment response, 5-year progression-free and overall survival. Translational research evaluated pharmacodynamics of serum metabolite response. Results: 45 participants (21 DCA, 24 Placebo) were enrolled from May 2011-April 2014. Higher rates of all-grade drug related fevers (43% vs 8%, p = 0.01) and decreased platelet count (67% vs 33%, p = 0.02) were seen in DCA versus placebo. However, there were no significant differences in grade 3/4 AE rates. Treatment compliance to DCA/placebo, radiation therapy, and cisplatin showed no significant difference between groups. While end-of-treatment complete response rates were significantly higher in the DCA group compared to placebo (71.4% vs 37.5%, p = 0.0362), survival outcomes were not significantly different between groups. Treatment to baseline metabolites demonstrated a significant drop in pyruvate (0.47, p <0.005) and lactate (0.61, p <0.005) in the DCA group. Conclusions: Adding DCA to cisplatin-based CRT appears safe with no detrimental effect on survival and expected metabolite changes compared to placebo. This supports further investigation into combining metabolic agents to CRT.Trial registration number: NCT01386632, Date of Registration: July 1, 2011.

Preliminary study of homeopathic treatment of subclinical mastitis evaluated through somatic cells count (SCC) and California mastitis test (CMT)

The present paper presents the results of homeopathic treatment of 25 Holstein breed cows aged 3 to 8 years old diagnosed with subclinical mastitis through California Mastitis Test (CMT). Animals were divided into 3 groups according with infection level. A homeopathic complex was developed on the grounds of clinical aspects, including Phosphorus 30x, Phytolacca 30x, Silicea 30x, Sulphur 30x, Belladona 30x, Bryonia alba 30x, Pulsatilla 30x, Calendula 30x and biotherapic of Staphylococcus aureus 200x. The remedy was added to salt and was administered to cattle 100g/cow/day for 75 days. CMT were carried out every 2 weeks to control incidence and severity of mastitis; somatic cells count (SCC) was performed at the beginning and the end of treatment. CMT showed significant improvement in regression of infection level all throughout the study; final SCC showed decrease in 82% of animals, signaling thus efficacy of the homeopathic treatment. Keywords: Subclinical mastitis; Dairy cows; Homeopathy; California Mastitis Test, Somatic Cells Count.  Estudo preliminar do tratamento homeopático da mastite subclínica avaliado por contagem de células somáticas (SCC) e California Mastitis Test (CMT) Resumo Este artigo apresenta os resultados do tratamento homeopático de 25 vacas raça Holstein entre 3 e 8 anos de idade diagnosticadas com mastite subclínica através do California Mastitis Test (CMT). Os animais foram divididos em 3 grupos de acordo com o nível da infecção. Foi preparado um complexo homeopático com base nos achados clínicos, composto de: Phosphorus 30X, Phytolacca 30x, Sulphur 30x, Belladona 30x, Bryonia alba 30x, Silicea 30x, Pulsatilla 30x, Calendula 30x s 30X, Phytolacca 30x, Sulphur 30x, Belladona 30x, Bryonia alba 30x, Silicea 30x, Pulsatilla 30x, Calendula 30x e bioterápico de Staphylococcus aureus 200x. O complexo foi acrescentado no sal e administrado na dose de 100g/vaca/dia. O CMT foi realizado a cada 2 semanas a fim de monitorar a incidéncia e gravidade da mastitie; a contagem de células somáticas (SCC) foi realizada ao início e no final do tratamento. Os valores do CMT mostraram melhora significativa no sentido de regressão do nível da infecção ao longo do estudo; o valor final da SCC diminuiu em 82% dos animais, apontando para a eficácia do tratamento homeopático. Palavras-chave: Mastite subclínica; Vacas leiteiras; Homeopatia; CMT, contagem de células somáticas.  Estudio preliminar del tratamiento homeopático de la mastitis sublínica evaluado mediante recuento de células somáticas (SCC) y California Mastitis Test (CMT) Resumen Este artículo presenta los resultados del tratamiento homeopático de 25 vacas raza Holstein entre 3 e 8 años de edad diagnosticadas com mastitis sucblínica mediante California Mastitis Test (CMT). Los animales fueron divididos en 3 grupos según el nível de la infección. Fue compuesto un complejo homeopático con base en la presentación clínica, incluyendo Phosphorus 30X, Phytolacca 30x, Sulphur 30x, Belladona 30x, Bryonia alba 30x, Silicea 30x, Pulsatilla 30x, Calendula 30x y bioterápico de Staphylococcus aureus 200x. El complejo fue agregado en sal y administrado a los animales en la dosis de 100g/vaca/día. CMT fue realizado cada 2 semanas para monitorizar la incidencia y gravedad de la mastitis; recuento de células somáticas (SCC) fue realizado al inicio y al final del tratamiento. CMT mostró mejoría significativa en el sentido de regresión del nivel de la infección a lo largo del estudio; el valor final del SCC disminuyó en 82% de los animales, apuntando para la eficacia del tratamiento homeopático. Palabras-clave: Mastitis subclínica; Vacas lecheras; Homeopatía; CMT, recuento de células somáticas.  Correspondence author: Zilda Cristiani Gazim, [email protected] How to cite this article: Barzon CD, Medeiros F, Moraes RE, Silva LCM, Massambani C, Takemura OS, Gazim ZC. Preliminary study of homeopathic treatment of subclinical mastitis evaluated through somatic cells count and California mastitis test. Int J High Dilution Res [online]. 2008 [cited YYYY Mmm DD]; 7(24): 147-151. Available from: http://journal.giri-society.org/index.php/ijhdr/article/view/292/364. ÂÂÂ

Exercise and Childhood Cancer—A Historical Review

Childhood cancer survivors are at risk of developing important adverse effects, many of which persist for years after the end of treatment. The implementation of interventions aiming at attenuating tumor/treatment-associated adverse effects is therefore a major issue in pediatric oncology, and there is growing evidence that physical exercise could help in this regard. The present review aims to summarize the main milestones achieved in pediatric exercise oncology. For this purpose, we conducted a systematic review of relevant studies written in English in the electronic database PubMed (from inception to 14 August 2021). This review traces the field of pediatric exercise oncology throughout recent history based on three fundamental pillars: (i) exercise during childhood cancer treatment; (ii) exercise during/after hematopoietic stem cell transplantation; and (iii) exercise after childhood cancer treatment. Accumulating evidence––although still preliminary in many cases––supports the safety and potential benefits of regular exercise (with no major contraindications in general) in the childhood cancer continuum, even during the most aggressive phases of treatment. Exercise can indeed represent an effective coadjuvant therapy for attenuating cancer-related adverse effects.

Xyloglucan, Hibiscus and Propolis in the Management of Uncomplicated Lower Urinary Tract Infections: A Systematic Review and Meta-Analysis

Background: In the era of antibiotic resistance, an antibiotic-sparing approach presents an interesting alternative treatment of uncomplicated cystitis in women. Our aim is to perform a systematic review and meta-analysis to compare the effectiveness and safety profile of a medical device containing xyloglucan, hibiscus and propolis (XHP) in women with uncomplicated cystitis. Methods: Relevant databases were searched using methods recommended by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. The primary endpoint was clinical or microbiological success, defined as the complete (cure) and/or non-complete (improvement) resolution of symptoms at the end of treatment, or microbiological resolutions. Results: After screening 21 articles, three studies were included, recruiting a total of 178 patients. All three studies used placebo as comparator. A statistically significant difference was found in terms of clinical or microbiological resolution between the medical device and the comparator (3 RCTs, 178 patients, OR: 0.13; 95% CI: 0.05–0.33; p < 0.0001). No clinically significant adverse effects have been reported. Conclusion: A medical device containing xyloglucan, hibiscus and propolis is superior to comparator regimens in terms of clinical effectiveness in adult women with microbiologically confirmed or clinical suspicion of uncomplicated cystitis and is associated with a high patient compliance.