Efficacy and Safety of Oral Euphorbia prostrata Tablet and Topical Cream in the Management of Hemorrhoids During Pregnancy: Results From a Prospective Multicenter Study.

This is a non-randomized, open-label, prospective single-arm interventional multicentric study conducted between 2021 and 2022 at three different centers situated in Pune, India. It was conducted to evaluate the efficacy and safety of the Sitcom® tablet (Euphorbia prostrata 100 mg) once daily and Sitcom® cream (Euphorbia prostrata 1%w/w) for 14 days in hemorrhoids during pregnancy. The endpoints were to assess hemorrhoidal symptoms relief during the follow-up periods (one, two, four, and eight weeks and 30 days postpartum), relapse of symptoms, improvement in the disease condition at week two and 30 days postpartum, and adverse events. A total of 100 patients (mean age 24.1 years) were included; the majority (71.0%) had mild per-rectal bleeding, 69.0% with mild itching and 46.0% with moderate pain during defecation. The mean score of per-rectal bleeding and pain at defecation showed a significant reduction at each visit (86.6% and 49.3% (two weeks), 95.3% and 59.9% (four weeks), and 100% and 77.6% (eight weeks)). The mean pain score at defecation, itching, exudates, and swelling showed a significant reduction of 77.6%, 96.9%, 100%, and 84.5% at eight weeks (p<0.001). After two weeks and post postpartum follow-up, >90% and 100% good to excellent overall improvement in the disease condition were noted, respectively. No adverse events in the mother or newborn were noted. This pivotal study underscores the potential of a combination therapy with Euphorbia prostrate 100 mg tablet and cream 1% as a potential solution for managing the distressing burden of hemorrhoids in pregnant women. Furthermore, these observations will empower clinicians in the judicious selection of the most suitable course of action for hemorrhoid management during pregnancy.

Herbal medicine AnoSpray suppresses proinflammatory cytokines COX-2 and RANTES in the management of hemorrhoids, acute anal fissures and perineal wounds.

Hemorrhoids, anal fistula and fissure are common anorectal complications. Anorectal diseases are associated with severe pain, inflammation, swelling, itching and bleeding. These diseases may be managed with different medical treatments or surgical procedures, depending on their severity. Surgical procedures, however, are highly invasive and are associated with higher costs and the possibility of recurrence. In addition, surgical removal of fistula-in-ano leads to the formation of perineal wounds. Therefore, developing therapeutic interventions that are effective in alleviating inflammation and pain are desirable for the effective management of anorectal diseases. Herbal compounds have previously been indicated to suppress inflammation and pain in different pathological conditions. The aim of the present study was to examine the effects elicited by a polyherbal formulation, AnoSpray®, on the migration of inflammatory cells and on the expression of inflammatory cytokines in anorectal diseases. The effect of AnoSpray on cell viability and migration was studied using MTT and wound-migration assays, respectively. Furthermore, the effects of AnoSpray on the expression of the inflammatory cytokines regulated upon activation, normal T cell expressed and presumably secreted (RANTES) and VEGF, as well as on cyclooxygenase-2 (COX)-2, were investigated using western blot analysis. The expression of RANTES and COX-2 in human hemorrhoid specimens was also analyzed to corroborate the in vitro findings. The results obtained revealed that AnoSpray did not exhibit any cytotoxic effects; however, it did lead to a significant suppression in the migration of RAW 264.7 and BJ cells. Furthermore, the results suggested that AnoSpray suppressed the expression of the inflammatory cytokines RANTES and VEGF, and also the expression of COX-2. In addition, RANTES and COX-2 were significantly downregulated in the clinical specimens of AnoSpray-treated hemorrhoids compared with the controls. Taken together, the results of the present study suggested that AnoSpray may be a potential therapeutic agent in the treatment of bleeding hemorrhoids, anal fissures and perineal wounds.

Polyherbal formulation Anoac­H suppresses the expression of RANTES and VEGF for the management of bleeding hemorrhoids and fistula.

Hemorrhoids and fistula are considered the most common anorectal conditions in the general population. These conditions affect the quality of a patient's life by causing pain and bleeding during defecation or even in the resting state. Lower grades of hemorrhoids may be controlled by traditional measures. However, surgery is an effective treatment option in recurrent­lower and higher­grade hemorrhoids. Surgical procedures are associated with various complications, including pain and delayed wound healing. Recurrence of hemorrhoids is also a major concern in the post­operative period. An anal fistula is the connection between the anus and the skin and causes severe pain, swelling, as well as blood and pus discharge. Fistula has serious social and economic consequences. Hence, it is important to understand the pathophysiology and molecular pathology of hemorrhoids and fistula, to identify the molecular targets and to develop pharmacological­interventions. In a previous study by our group, the polyherbal formulation Anoac­H was developed for the treatment of different stages of hemorrhoids and fistula, and it was demonstrated that Anoac­H is an effective formulation for treating hemorrhoids. However, the molecular mode of action of Anoac­H on hemorrhoids and fistula had remained elusive. In the present study, it was determined that this formulation reduces the migration of mesenchymal (fibroblasts) and immune (RAW 264.7) cells without affecting their viability. It was also observed that Anoac­H suppresses the expression of regulated upon activation, normal T cell expressed and presumably secreted (RANTES) and VEGF in fibroblasts and macrophages. Inflammation and elevated expression of RANTES and VEGF were observed in hemorrhoids and fistula. However, inflammation, as well as the expression of RANTES and VEGF, were significantly reduced in treated human hemorrhoid and fistula tissues as compared to untreated ones, confirming the in vitro results.

Laser pilonidotomy - a new approach in management of complex pilonidal sinus disease: an exploratory study / Pilonidotomia a laser - uma nova abordagem no tratamento da doença do seio pilonidal complexo: um estudo exploratório

Abstract Background The treatment of pilonidal sinus disease still remains challenging mainly because of multiple factors responsible for wound healing and its recurrence. With recent advances in surgical field, use of laser found to be an effective technique in the destruction of a pilonidal cyst. Laser Piolonidotomy is a new promising technique. Methodology An exploratory study was planned with the Aim, to evaluate a new technique for the excision of pilonidal sinus. Objectives were to investigate its effectiveness in terms of operation time, healing time, and the duration of hospitalization, resumption of normal activity the degree of postoperative complications and rate of recurrence and patient's satisfaction. All the patients with pilonidal sinus were categorized and laser pilonidotomy was planned for patients satisfying inclusion criteria. Data collected in pre-structured, pre-tested proforma and analyzed using SPSS. Results Mean duration of Procedure was 33 min (SD = 11), mean duration of Hospital Stay was 12 h (SD = 3), resumption of normal activity within 4 days (SD = 2), mean duration for Complete Wound Healing by secondary intention 6 Weeks (SD = 1.25). Among complications, infection reported in 1.08%. The difference between the mean pre and post-operative VAS score was statistically highly significant (p < 0.0001). Recurrence rate was 3.24%. Success rate was 96.75% and Overall patient's satisfaction was 97.84%. Conclusion Laser Pilonidotomy is effective in destruction of a pilonidal cyst with good success rate, fewer complications and with high patient's satisfaction.

Resumo Justificativa O tratamento da doença do seio pilonidal ainda permanece desafiador, principalmente devido a vários fatores responsáveis pela cicatrização das feridas e sua recorrência. Com os recentes avanços no campo cirúrgico, o uso do laser mostrou ser uma técnica eficaz na destruição de um cisto pilonidal. A piolonidotomia a laser é uma nova técnica promissora. Metodologia Foi planejado um estudo exploratório com o objetivo de avaliar uma nova técnica para a excisão de seio pilonidal. Os objetivos foram investigar sua eficácia quanto aos tempos de operação, de cicatrização, de internação e de retomada da atividade normal, além do grau de complicações pós-operatórias, a taxa de recorrência e o índice de satisfação do paciente. Todos os pacientes com seio pilonidal foram categorizados, e a pilonidotomia a laser foi planejada para os pacientes que satisfizessem os critérios de inclusão. Os dados foram coletados em forma pré-estruturada e pré-testada e analisados usando o SPSS. Resultados O tempo médio do procedimento foi de 33 min (DP = 11), o tempo médio da internação hospitalar foi de 12 horas (DP = 3), o tempo médio de retomada da atividade normal foi de 4 dias (DP = 2) e o tempo médio de cicatrização completa por intenção secundário foi de 6 semanas (DP = 1,25). Entre as complicações, infecção foi observada em 1,08%. A diferença entre as médias do escore EVA pré e pós-operatório foi estatisticamente significativa (p < 0,0001). A taxa de recorrência foi de 3,24%. A taxa de sucesso foi de 96,75% e o índice de satisfação geral do paciente foi de 97,84%. Conclusão A pilonidotomia a laser é eficaz na destruição de um cisto pilonidal com boa taxa de sucesso, menos complicações e com alta satisfação do paciente.

A novel four quadrant laser sphincterotomy for idiopathic severe anal stenosis / Nova esfincterotomia a laser nos quatro quadrantes para estenose anal idiopática grave

ABSTRACT Anal stricture or stenosis, though uncommon, is disabling condition. It affects the quality of life due to pain, bleeding and difficulty in defecation, incontinence or increased frequency. It occurs when the normally pliable anoderm is replaced with fibrotic connective tissue, leading to an abnormally tight and inelastic anal canal. Mostly it occurs secondary to trauma, iatrogeny, inflammatory diseases, radiation or neoplasia. The treatment of anal stricture is generally considered to be difficult and various methods of treatment have been suggested. It is often unresponsive to conservative medical management. The surgical procedures such as dilatations and anoplasty are associated with significant complications which make it a difficult treatment challenge. Several good treatment options are available currently. Through this case, we report and explore a new medical treatment for anal strictures with four quadrant laser sphincterotomy.

RESUMO A estritura ou estenose anal, embora incomum, é problema incapacitante. Essa condição afeta a qualidade de vida por causa da dor, do sangramento e da dificuldade de defecação, de incontinência ou aumento da frequência. A estenose anal ocorre quando o anoderma, normalmente flexível, foi substituído por tecido conjuntivo fibrótico, e o resultado é um canal anal anormalmente estenosado e inelástico. Na maioria dos casos, a estenose anal ocorre secundariamente a trauma, por causa iatrogênica, por doença inflamatória, radiação ou neoplasia. Em geral, se considera que o tratamento dessa condição é tarefa difícil, tendo sido sugeridos diversos métodos de tratamento. Com frequência a estenose anal não responde ao tratamento clínico conservador. Procedimentos cirúrgicos como as dilatações ou a anoplastia estão associados a complicações significativas, implicando difícil desafio terapêutico. Atualmente, o cirurgião conta com várias opções terapêuticas satisfatórias. No presente caso, relatamos e exploramos um novo tratamento clínico para estenoses anais, por meio da esfincterotomia a laser nos quatro quadrantes.

Single-dose oritavancin in the treatment of acute bacterial skin infections.

BACKGROUND: Oritavancin is a lipoglycopeptide with bactericidal activity against gram-positive bacteria. Its concentration-dependent activity and prolonged half-life allow for single-dose treatment. METHODS: We conducted a randomized, double-blind trial in which adults with acute bacterial skin and skin-structure infections received either a single intravenous dose of 1200 mg of oritavancin or a regimen of intravenous vancomycin twice daily for 7 to 10 days. Three efficacy end points were tested for noninferiority. The primary composite end point was defined as cessation of spreading or reduction in lesion size, absence of fever, and no need for administration of a rescue antibiotic 48 to 72 hours after administration of oritavancin. Secondary end points were clinical cure 7 to 14 days after the end of treatment, as determined by a study investigator, and a reduction in lesion size of 20% or more 48 to 72 hours after administration of oritavancin. RESULTS: The modified intention-to-treat population comprised 475 patients who received oritavancin and 479 patients who received vancomycin. All three efficacy end points met the prespecified noninferiority margin of 10 percentage points for oritavancin versus vancomycin: primary end point, 82.3% versus 78.9% (95% confidence interval [CI] for the difference, -1.6 to 8.4 percentage points); investigator-assessed clinical cure, 79.6% versus 80.0% (95% CI for the difference, -5.5 to 4.7 percentage points); and proportion of patients with a reduction in lesion area of 20% or more, 86.9% versus 82.9% (95% CI for the difference, -0.5 to 8.6 percentage points). Efficacy outcomes measured according to type of pathogen, including methicillin-resistant Staphylococcus aureus, were similar in the two treatment groups. The overall frequency of adverse events was also similar, although nausea was more common among those treated with oritavancin. CONCLUSIONS: A single dose of oritavancin was noninferior to twice-daily vancomycin administered for 7 to 10 days for the treatment of acute bacterial skin and skin-structure infections caused by gram-positive pathogens. (Funded by the Medicines Company; SOLO I ClinicalTrials.gov number, NCT01252719.).