Local anesthesia versus saddle block for open hemorrhoidectomy: cost-analysis from a randomized, double blind controlled trial.

BACKGROUND: Despite the benefits attributed to the use of local anesthesia (LA) for open hemorrhoidectomy (OH) in developed countries, this technique is still not considered as the first line technique in low-income countries such as Uganda; therefore, we aimed at comparing the cost of OH under LA versus Saddle block among patients with 3rd or 4th degree hemorrhoids. METHODS: This trial was conducted from December 2021 to May 2022 among patients with primary uncomplicated 3rd or 4th degree hemorrhoids. The operating time, and direct costs in (US$) including medical and non-medical were recorded. We analysed the cost in the two groups (local anesthesia versus saddle block) using SPSS version 23.0. RESULTS: Findings of fifty-eight patients were analysed including 29 participants per group. There was a significant difference in operating time and cost among the two groups (p < 0.05). The mean operating time was 15.52 ± 5.34(SD) minutes versus 33.72 ± 11.54 min for OH under LA and SB respectively. The mean cost of OH under LA was 57.42 ± 8.90 US$ compared to 63.38 ± 12.77US$ in SB group. CONCLUSION: The use of local anesthesia for OH was found to have less operating time with high-cost effectiveness. Being affordable, local anesthesia can help to increase the turnover of patients who would otherwise wait for the availability of anesthesia provider. Policy makers should emphasize its applicability in low-income settings to help in the achievement of 2030 global surgery goals. TRIAL REGISTRATION: Pan African Clinical Trials Registry, PACTR202110667430356. Registered on 08/10/2021.

Electroacupuncture at Baliao point alleviates post-operative pain and anal distension after procedure for prolapse and hemorrhoids (stapled hemorrhoidopexy): a prospective randomized clinical trial.

PURPOSE: The purpose of this study was to explore the effect of electroacupuncture (EA) at Baliao point on short-term complications, such as anal pain and swelling, after procedure for prolapse and hemorrhoids (PPH) in patients with mixed hemorrhoids. METHODS: A total of 124 eligible patients undergoing PPH surgery were included in this study and randomly divided into a control group (n = 67) and an EA group (n = 57), with patients in the control group receiving only PPH surgery and patients in the EA group receiving PPH surgery and EA at Baliao point. RESULTS: The visual analogue scale (VAS) scores of EA group at 8, 24, 48, and 72 h after operation were significantly lower than those of control group. The anal distension scores at 8, 48, and 72 h after operation were also significantly lower than those of control group. The number of postoperative analgesic drug administration per patient was also significantly lower in the EA group. The incidence of urinary retention and tenesmus in EA group was significantly lower than that in control group within the first day after surgery. CONCLUSION: EA treatment at the Baliao point can alleviate short-term anal pain and anal swelling after the procedure for prolapse and hemorrhoids, reduce the incidence of urinary retention, and decrease the use of postoperative analgesic drugs. TRIAL REGISTRATION: This study was approved and registered by the Chinese Clinical Trial Center, Registration number: ChiCTR2100043519, Registration time: February 21, 2021 ( https://www.chictr.org.cn/ ).

[Medical rehabilitation in patients with anal incompetence after surgery for stage IV hemorrhoids]. / Konservativnaya reabilitatsiya patsientov s nedostatochnost'yu anal'nogo sfinktera posle khirurgicheskogo lecheniya gemorroya IV stadii.

The choice of medical rehabilitation in patients with anal incontinence is impossible without diagnostic data revealing the mechanism of fecal incontinence. The most promising are programs of comprehensive physiotherapeutic rehabilitation based on biofeedback training. The rate of anal incompetence (AI) after hemorrhoidectomy is 1.3-12.5%. However, in addition to the organic cause (surgical trauma), functional disorders of the external sphincter and pelvic floor muscles may contribute to the pathogenesis of anal incontinence, aggravating the incontinence symptoms after surgery. Therefore, these functional disorders should be diagnosed before surgery. However, medical rehabilitation programs for anal incontinence after hemorrhoidectomy are not standardized, and functional outcomes have not been studied. OBJECTIVE: To evaluate the outcomes of comprehensive rehabilitation in patients with AI after hemorrhoidectomy to improve quality of life after surgery. MATERIALS AND METHODS: A retrospective study was carried out on 46 patients (mean age 53.8±15.4 years) after hemorrhoidectomy with fecal incontinence, 13 (28.3%) males and 33 (71.7%) females. The main group included 25 patients who received comprehensive rehabilitation, including biofeedback training and tibial neuromodulation (TNM) for 15 days. The control group consisted of 21 patients who received TNM at home also for 15 days. The severity of fecal incontinence was determined using the Wexner score. The functional state of the sphincter before and after surgery was assessed using the anorectal manometry (sphincterometry) (WPM Solar, the Netherlands). RESULTS: Comprehensive rehabilitation resulted in a statistically significant clinical improvement: a decrease in the Wexner score in both males and females. No significant differences in manometry results were observed: the anal sphincter tone increased by 16.0% in females and 10.6% in males, and contractility increased by 17.7% and 15.1%, respectively. Monotherapy with TNM in control group patients improved tone indices by 8.7% in females and 6.8% in males, and contractility by 6.2 and 5.4%, respectively, which was lower than in the main group. CONCLUSION: Contraindications to physiotherapeutic procedures based on electrical stimulation, extracorporeal magnetic stimulation, and magnetic translumbosacral neuromodulation determine the only possible choice of medical rehabilitation, which is the combination of biofeedback training and TNM (as superior to TNM monotherapy). If out-patient medical rehabilitation is not feasible, patients are recommended to complement the home course with a specially designed set of exercises for anal incontinence treatment.

Efficacy and safety of micronized purified flavonoid fractions for the treatment of postoperative hemorrhoid complications: A systematic review and meta-analysis.

BACKGROUND: Hemorrhoids, a common anorectal disease, seriously affects patients' quality of life. Micronized purified flavonoid fractions (MPFF) have been shown to improve hemorrhoid symptoms. PURPOSE: To evaluate the efficacy and safety of MPFF in treating postoperative hemorrhoid complications. STUDY DESIGN: A systematic review and meta-analysis of existing literature on natural compounds for treating postoperative complications of hemorrhoids. METHODS: A literature search was conducted using five databases, namely PubMed, WanFang, CNKI, Embase, and the Cochrane Library, to identify randomized controlled trials (RCTs) on the effects of MPFF treatment on hemorrhoids. Stata 15.1 and Revman 15.4 were used to assess the data, while subgroup and sensitivity analyses were performed to evaluate potential heterogeneity, and trial sequential analysis (TSA) and Egger test were used to evaluate the reliability of each trial. RESULTS: A total of 22 RCTs, including 2,335 participants were included in the analysis. MPFF improved the clinical efficacy of post-hemorrhoidectomy and reduced the bleeding rate, pain score, and edema score, although no substantial effect on adverse reactions was reported. Subgroup analyses showed a significant reduction in pain score and bleeding rate in trials with duration of 4-10 days and an improvement in clinical efficacy. Treatment for ≥ 10 days significantly improved the edema score; a dosage range of 1,800-2,700 mg/day of MPFF significantly reduced edema and pain scores, whereas < 1,800 mg/day significantly improved clinical efficacy. CONCLUSIONS: Based on searching the relevant literatures, this is the first meta-analysis on MPFF treatment of postoperative hemorrhoid complications. Our findings, validated by TSA, suggest that MPFF is safe and effective in reducing postoperative hemorrhoid complications, and that dose and duration are key factors in its efficacy, as illustrated by subgroup analysis. However, due to the small sample size, the standardized treatment regimen of MPFF could not be obtained; therefore, further research is warranted.

Traditional Chinese medicine (Liang-Xue-Di-Huang Decoction) for hemorrhoid hemorrhage: Study Protocol Clinical Trial (SPIRIT Compliant).

BACKGROUND: Hemorrhoidal disease (HD) is one of the commonest proctologic condition in the general population. Medical therapy for HD has not been formally confirmed due to the inconsistent of results. Liang-Xue-Di-Huang Decoction, a kind of ancient Chinese classical prescription, has been used to treat HD from the 19th century in China. However, clinical research of Liang-Xue-Di-Huang Decoction in the treatment of HD was lack. We designed this study to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction in the treatment of HD. METHODS/DESIGN: A randomized, controlled, double blind, double-mimetic agent, and multicenter trial to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction is proposed. HD patients (stage I, II, III) will be randomly assigned into experimental group or control group. HD patients will receive a 7-day treatments and a 7-day follow-up. The primary outcome measure is the Hemorrhoid Bleeding Score in 7 and 14 days. The Secondary outcome measures are Goligher prolapse score and quality-of-life score in 7 and 14 days. DISCUSSION: This study will provide objective evidences to evaluate the efficacy and safety of Liang-Xue-Di-Huang Decoction in treatment of HD.

Twenty Years of a Veterans' Spinal Cord Injury Colorectal Clinic: Flexible Sigmoidoscopy and Multiple Hemorrhoid Ligation.

BACKGROUND: Colorectal and anal problems arise in chronic spinal cord injury care. We review 20 years of experience in a colorectal clinic at a veterans medical center treating mostly male veterans who have spinal cord injury. OBJECTIVE: We aim to show the results of colorectal interventions in a population with chronic spinal cord injury. DESIGN: This study is a retrospective records review. SETTINGS: This study was conducted at a Department of Veterans Affairs regional spinal cord injury center. PATIENTS: Six hundred forty-one individuals (625 males) made 1208 visits. Mean age was 56 ± 13 years; ages ranged from 21 to 90 years. INTERVENTIONS: Flexible sigmoidoscopy was done for diagnosis and screening, and hemorrhoid ligation was performed for symptomatic hemorrhoids. MAIN OUTCOME MEASURES: The primary outcomes measured were the frequency, timing, and results of procedures. RESULTS: Five hundred forty-eight people had 781 flexible sigmoidoscopies. At first examination, mean age was 65 ± 12 and the duration of injury was 19 ± 15 years. Sixty examinations (7.7%) displayed poor preparation. The interval between adequate-prepared examinations was 5.7 ± 2.0 years. The adenoma detection rate was 4.7%. Two hundred fifteen people had 406 hemorrhoid ligations. At first banding, the mean age was 52 ± 13 and the duration of injury was 20 ± 15 years. Mean number of ligations per procedure was 4.9 ± 2.0; a range of 1 to 20. Nine hemorrhoid operations were done in this period. Regarding the futility of procedures, 250 people died, with a mean age at death of 69 ± 11. The median time between any procedure and death was 4.4 years. Seventeen procedures were done within 6 months of death; these deaths were either unexpected or because of conditions identified at or after the procedure. LIMITATIONS: This was a retrospective review of a single institution, it involved a mostly male population, and it used a subjective assessment of bowel preparation. CONCLUSIONS: In a spinal cord injury colorectal clinic, sigmoidoscopy can keep screening current, with an acceptable level of poor preparation. The adenoma detection rate may or may not be adequate. Hemorrhoid ligation can be expanded beyond its limits in the non-spinal cord-injured population, including multiple and external banding, taking the place of an operation in most cases. These procedures are well tolerated and rarely futile.

Predictive Parameters of Symptomatic Hematochezia Following 5-Fraction Gantry-Based SABR in Prostate Cancer.

PURPOSE: This study identified predictors of high-grade late hematochezia (HH) following 5-fraction gantry-based stereotactic ablative radiation therapy (SABR). METHODS AND MATERIALS: Hematochezia data for 258 patients who received 35 to 40 Gy SABR in 5-fractions as part of sequential phase 2 prospective trials was retrieved. Grade 2 or higher late rectal bleeding was labeled HH. Hematochezia needing steroid suppositories, 4% formalin, or 1 to 2 sessions of argon plasma coagulation (APC) was labeled grade 2. More than 2 sessions of APC, blood transfusion, or a course of hyperbaric oxygen was grade 3 and development of visceral fistula, grade 4. Various dosimetric and clinical factors were analyzed using univariate and multivariate analyses. Receiver operating characteristic (ROC) curve analysis and recursive partitioning analysis were used to determine clinically valid cut-off points and identify risk groups, respectively. RESULTS: HH was observed in 19.4%, grade ≥3 toxicity in 3.1%. Median follow-up was 29.7 months (interquartile range [IQR]: 20.6-61.7) Median time to develop HH was 11.7 months (IQR: 9.0-15.2) from the start of radiation. At 2 years, cumulative HH was 4.9%, 27.2%, and 42.1% in patients who received 35 Gy to prostate (4-mm planning target volume [PTV] margin), 40 Gy to prostate (5-mm PTV margin), and 40 Gy to prostate/seminal vesicles (5-mm PTV margin), respectively (P<.0001). In the ROC analysis, volume of rectum receiving radiation dose of 38 Gy (V38) was a strong predictor of HH with an area under the curve of 0.65. In multivariate analysis, rectal V38 (≥2.0 cm(3); odds ratio [OR]: 4.7); use of anticoagulants in the follow-up period (OR: 6.5) and presence of hemorrhoids (OR: 2.7) were the strongest predictors. Recursive partitioning analysis showed rectal V38 < 2.0 cm(3), and use of anticoagulants or rectal V38 ≥ 2.0 cm(3) plus 1 other risk factor resulted in an HH risk of >30%. CONCLUSIONS: Rectal V38 and 2 clinical factors were strong predictors of HH following 5-fraction SABR. Planning constraints should keep rectal V38 below 2.0 cm(3).

Daily sodium butyrate enema for the prevention of radiation proctitis in prostate cancer patients undergoing radical radiation therapy: results of a multicenter randomized placebo-controlled dose-finding phase 2 study.

PURPOSE: To evaluate the efficacy of sodium butyrate enemas (NABUREN) in prostate cancer radiation therapy (RT) in reducing the incidence, severity, and duration of acute RT-induced proctitis. METHODS AND MATERIALS: 166 patients, randomly allocated to 1 of 4 groups (rectal sodium butyrate 1 g, 2 g, or 4 g daily or placebo), were treated with NABUREN during and 2 weeks after RT. The grade of proctitis was registered in a daily diary. The correlation between NABUREN and proctitis was investigated through χ(2) statistics. The toxicity endpoints considered were as follows: total number of days with grade ≥1 proctitis (≥G1); total number of days with grade ≥2 proctitis (≥G2); ≥G1 and ≥G2 proctitis lasting at least 3 and 5 consecutive days starting from week 4 (≥G1+3d, ≥G2+3d); damaging effects of RT on rectal mucosa as measured by endoscopy. The relationship between endpoints and pretreatment morbidities, hormonal therapy, presence of diabetes or hypertension, abdominal surgery, or hemorrhoids was investigated by univariate analysis. RESULTS: The patients were randomly allocated to the 4 arms. No difference in the distribution of comorbidities among the arms was observed (P>.09). The mean ≥G1 and ≥G2 proctitis were 7.8 and 4.9 for placebo and 8.9 and 4.7 for the NABUREN group, respectively. No favorable trend in reduction of incidence, severity, and duration of ≥G1 and ≥G2 proctitis was observed with NABUREN use. In univariate analysis, ≥G1+3d toxicity was found to be related to hemorrhoids (P=.008), and a slight correlation was found between ≥G2 proctitis and hormonal therapy (P=.06). The RT effects on rectal mucosa as based on endoscopic assessment were mainly related to diabetes (P<.01). Endoscopy data at 6 week showed no significant difference between the placebo and butyrate arms. The other investigated endpoints were not correlated with any of the clinical risk factors analyzed. CONCLUSION: There was no evidence of efficacy of NABUREN in reducing the incidence, severity, and duration of acute radiation proctitis. There was a correlation between some endpoints and clinical risk factors.

Same-day assessment and management of urgent (2-week wait) colorectal referrals: an analysis of the outcome of 1606 patients attending an endoscopy unit-based colorectal clinic.

AIM: The Rapid Access Diagnosis and Remedy (RADAR) clinic combines 2-week wait (TWW) specialist consultation with 'straight-to-test' flexible sigmoidoscopy (FS) for left-sided 'red-flag' TWW criteria (excluding right-sided mass or iron-deficiency anaemia). The study aims were to determine the effectiveness of RADAR in differentiating colorectal cancer from benign disease and to evaluate the need for whole colonic investigation (WCI) following FS, in symptomatic patients. METHOD: Prospectively collated data of all RADAR patients from November 2005 to November 2009 were analysed, excluding patients referred internally for a FS. The local histology database was later interrogated to detect any missed cancers. RESULTS: Of 1690 patients (729 men; median (range) age: 68 (18-96) years) assessed in RADAR, 84 were excluded. Colorectal cancer (CRC) was diagnosed in 117 (7.3%). Eighty-seven cancers were diagnosed on the day of attendance and a further 13 within a week (88.9% overall). Two patients after a cancer-free FS were found to have a right-sided CRC on WCI (0.24%) and one synchronous cancer was found. No patient with a cancer-free FS having a WCI was subsequently found to have CRC at a median of 35 (12-58) months. CONCLUSION: Flexible sigmoidoscopy, in the context of an endoscopy unit TWW clinic, allows same-day diagnosis of most patients referred with left-sided symptoms, and immediate reassurance and treatment of most benign diagnoses. For these patients, the use of routine WCI following a cancer-free FS does not appear to be beneficial. Adopting this system would significantly reduce the number of barium enemas and colonoscopies currently performed.

A randomized, double-blind, placebo-controlled trial of a Chinese herbal Sophora flower formula in patients with symptomatic haemorrhoids: a preliminary study.

Dried flowers and buds of Sophora japonica (Huaihua) are used in China, Japan and Korea for treating haematemesis and bleeding haemorrhoids. This study compared the clinical safety and efficacy of a Sophora flower formula with a placebo for the conservative treatment of symptomatic haemorrhoids. The study was a prospective, double-blind, randomized placebo-controlled trial. The clinical effective rate, symptom score and the incidence of important clinical events were used as observation indices to evaluate the effect of the Sophora flower formula. The results showed that after 7 days of treatment, improvement was observed in 87.0% of the patients' major symptoms in the Sophora flower formula group compared with 81.8% of those in the placebo group. After 14 days, 78.2% patients in the Sophora flower formula group were asymptomatic, whereas 40.9% of those in the placebo group exhibited residual symptoms. However, the difference between both groups was not statistically significant. As the bowel habits of the patients improved and as the patients took sitz baths, their symptoms improved drastically, regardless of the use of the Sophora flower formula. These findings indicate that the traditional Chinese Sophora flower formula is clinically safe; however, its effects on haemorrhoids need to be studied in a larger sample size and with different dosages. The present study results may be a potential clinical reference for physicians prescribing medications for patients with symptomatic haemorrhoids.

[Severe anemia caused by haemorrhoids: the casae of a young man with toxic cirrhosis]. / Súlyos anaemia aranyeres csomókból: fiatal, toxikus cirrhosisos férfi beteg esete.

A 38-year-old alcoholic man with severe iron deficient anaemia, and bloody-mucous stool was found to have haemorrhoidal bleeding. In spite of intravenous iron supplements haemoglobin levels were falling. He was admitted because of deteriorating condition, jaundice, severe anaemia (haemoglobin, 38 g/l) and iron deficiency. Except of toxic (alcohol) agent all other causes of liver disease could be excluded. Sclero-, and medical therapy, and abstinence resulted in a rapid improvement in his condition and subsequently rectal bleeding also disappeared. Bleeding from the upper gastrointestinal tract is a well known and serious complication in liver cirrhosis, however, a voluminous blood loss resulting in a life-threatening anaemia from lower gastrointestinal tract or haemorrhoids, as it was detected in this patient, is quite rare. Sclerotherapy seems to be an effective method with only minor complications when compared with other invasive techniques. However, the patient's compliance even in liver cirrhosis with haemorrhoidal nodes is essential for long-term success.

[Postoperative pain of hemorrhoid treated with thread embedding at Changqiang (GV 1)].

OBJECTIVE: To compare the therapeutic effect of postoperative pain of hemorrhoid treated with thread embedding at Changqiang (GV 1) and Indometacin suppository. METHODS: Eighty cases were randomly divided into an acupoint catgut-embedding group (group A) and an Indometacin group (group B), forty case in each group. In group A, thread embedding at Changqiang (GV 1) was applied, and Indometacin suppository was put into rectum in group B. The pain intensity after 6, 12, 24, 72 hours of treatment and the the maximum scores of VAS in 24 hours (T24max VAS) of 1-3 days of postopration were evaluated with pain Visual Analogue Scale (VAS); the quantity demanded of analgesic and the adverse reaction were observed. RESULTS: The scores of VAS after 6, 12, 24, 72 hours of treatment in group A were obviously lower than those in group B (all P < 0.05); the T24max VAS scores in group A were obviously lower than those in group B (all P < 0.05). Six cases in group A and 14 cases in group B were treated with non-steroidal anti-inflammatory drug as well. The total effective rate of 87.5% (35/40) in group A was superior to that of 62.5% (25/40) in group B, indicating the statistically significant differences between two groups (P < 0.05). There was no obvious adverse reaction in group A; in group B, headache, dizziness, nausea, vomiting, distention of chest and palpitation appeared, accounting for 11 cases. CONCLUSION: The therapeutic effect of postoperative pain of hemorrhoid treated with thread embedding at Changqiang (GV 1) is favorable, it can reduce the quantity of analgesic, the adverse reaction, its effect is better than that of Indometacin suppository.

Efficacy and tolerability of hyaluronic acid, tea tree oil and methyl-sulfonyl-methane in a new gel medical device for treatment of haemorrhoids in a double-blind, placebo-controlled clinical trial.

Topical formulations are widely used in anti-haemorrhoidal treatment, but often lacking controlled clinical trials. Here, we report the results from a controlled clinical trial performed with a new gel medical device (Proctoial) containing hyaluronic acid with tea tree oil and methyl-sulfonyl-methane as major components. The total number of 36 haemorrhoidal patients (grade 1-3) was enrolled in a double-blind, placebo-controlled clinical trial and divided into 2 equal parallel groups. The anal pain, pain during defecation, visible bleeding, pruritus and irritation/inflammation were recorded before and after 14-day treatment using a visual analogue scale both by the investigators and by the patients. Safety and tolerability of the treatments were also recorded. The new gel medical device statistically significantly reduced all the symptoms after the treatment compared to placebo. The results indicated also a very good tolerability and safety of the treatments.

Haemorrhoids, constipation and faecal incontinence: is there any relationship?

AIM: Little is known about the association of haemorrhoids and anorectal function. Moreover, available data on the impact of constipation on the presence of haemorrhoids are conflicting. The present study aimed to assess any potential relationship between haemorrhoids and anorectal dysfunction. METHOD: All participants who attended the Austrian nationwide healthcare programme for colorectal cancer screening at four medical institutions were enrolled prospectively between 2008 and 2009. A colonoscopy and detailed anorectal examination were performed on all patients. Haemorrhoids were classified according to an international grading system. Faecal incontinence was defined as the involuntary loss of solid stool, liquid stool or gas, at least once a month. Constipation was recorded by a constipation scoring system. RESULTS: Of 976 participants, 380 (38.9%) were found to have haemorrhoids. There was an association between healthy individuals, patients with symptomatic and patients with asymptomatic haemorrhoids and incontinence of liquid stool. No association was found regarding incontinence for solid stool and gas. The median constipation score was significantly higher in those patients with haemorrhoids (grade I-IV) compared with patients without haemorrhoids (2.5 points (range, 0-19) and 3 points (range, 0-19); P = 0.0113). 'Painful evacuation effort' and 'assistance for defaecation (stimulant laxatives, digital assistance or enema)' showed a significant correlation with haemorrhoids (P = 0.0394 and P = 0.0143). CONCLUSION: Although the median constipation score was low in both groups, there was a significant association between constipation and haemorrhoids in adult patients.

Traditional Chinese Medicine herbs for stopping bleeding from haemorrhoids.

BACKGROUND: Haemorrhoids is a common perianal disease, which often causes haematochezia. Besides a surgical operation or minimally invasive treatment, a variety of traditional Chinese medicinal herbs (TCMHs) have been used to treat bleeding haemorrhoids. OBJECTIVES: To assess the effectiveness of traditional Chinese medicinal herbs for stopping bleeding from haemorrhoids and the adverse effects caused by these herbs. SEARCH STRATEGY: We searched the Cochrane Colorectal Cancer Group Trials Register, Cochrane Central Register of Contolled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, CMCD (Chinese Medicine Conference Disc) and CBMD (Chinese Bio-Medicine Disc). SELECTION CRITERIA: All randomised clinical trials (RCTs) of Chinese herbs for bleeding haemorrhoids were included. DATA COLLECTION AND ANALYSIS: Two authors independently extracted the data, which were analysed using RevMan 5.0 software. We estimated the relative risk for dichotomous data and calculated the weighted mean difference for continuous data. MAIN RESULTS: Nine trials involving 1822 patients with bleeding haemorrhoids were identified. The included trials were generally not of high quality and used one TCMH preparation compared with another TCMH preparation (Type I) (five trials) or western medicines (Type II) (four trials). We could not pool the data to perform a meta-analysis as only two of the included trials used the same intervention or comparison.In the nine trials, TCMHs showed a statistically significant difference for the improvement in the general curative effects or total grade of symptoms in six trials (P < 0.05; P < 0.01), of hematochezia in three trials (P < 0.05; P < 0.001), and of inflammation of perianal mucosa in one trial (P < 0.05). The adverse effects reported were not serious and were scarce. AUTHORS' CONCLUSIONS: This review did not provide strong evidence concerning the effectiveness of TCMHs for stopping bleeding from haemorrhoids. Most of the included studies were of low quality and there was a scarcity of eligible trials and numbers of participants. Limited, weak evidence showed that some herbal formulae, when including Radix Sanguisorbae, Radix Rehmanniae, Fructus Sophorae, Radix Angelicae Sinensis, Radix Scutellariae, etc., may alleviate some symptoms caused by haemorrhoids. These include hematochezia, congestive haemorrhoidal cushions and inflammation of perianal mucosa in the short term. Well-designed clinical trials are required urgently before any confident conclusions can be drawn about the value of TCMHs for stopping bleeding from haemorrhoids.At present, the evidence is not enough that clinical practice should be changed immediately on the basis of these results.

Tratamiento del dolor anal por patología anorrectal aguda en urgencias: ¿baños de asiento con agua fría o caliente? resultados de un ensayo clínico aleatorizado / Cold or hot sitz baths in the emergency t

Introducción: La creencia popular propugna el uso de baños de asiento con agua fría para el tratamiento del dolor anal agudo, pero las guías de práctica clínica recomiendan el uso de agua caliente por su efecto conocido sobre la presión anal de reposo. Objetivo: El objetivo fue estudiar el efecto analgésico, sobre la calidad de vida, datos de manometría y evolución clínica, de 2 temperaturas en los baños de asiento en enfermos con dolor anal. Material y métodos: Ensayo clínico aleatorizado en pacientes con dolor anal agudo por enfermedad hemorroidal o fisura anal divididos en Grupo 1: baños de asiento con agua a Ta inferior a 15°C y Grupo 2: baños con agua a Tasuperior a 30°C. La analgesia fue la misma en ambos grupos. Se analizó: el dolor durante 7 días (escala visual analógica), calidad de vida (SF-36), presión anal de reposo y evolución de la enfermedad. Resultados: De 27 pacientes elegibles, 24 fueron aleatorizados (Grupo 1: n=12 y Grupo 2: n=12). El dolor no mostró diferencias estadísticamente significativas, pero se mantuvo estable en el Grupo 1 y por el contrario fue disminuyendo progresivamente en los pacientes del Grupo 2, siendo la diferencia en los valores del dolor del primer día respecto al séptimo superior en el Grupo 2 (p=0,244). El resto de variables fueron similares. Conclusión: No hubo diferencias estadísticamente significativas en el control del dolor del 1.er al 7 día en el Grupo con baños de asiento con agua caliente (AU)

Introduction: The popular belief advocates the use of sitz (sitting) baths with cold water for the treatment of acute anal pain, but clinical practice guides recommend the use of hot water for its known effect on the at-rest anal pressure. Aim: The objective of the study was to examine the analgesic effect on the quality of life, manometer data and clinical progress, of the two temperatures in sitz baths in patients with anal pain. Material and methods: A randomised clinical trial on patients with acute anal pain due to haemorrhoids or anal fissures, divided into Group 1: Sitz baths with water at a temperature of less than 15°C, and Group 2: Baths with a water temperature above 30°C. The analgesia was the same in both groups. An analysis was made of the pain at 7 days (visual analogue scale), quality of life (SF-36), anal at-rest pressure and disease progress. Results: Of the 27 eligible patients, 24 were randomised (Group 1: n=12 y Group 2: n=12). There were no statistical differences in pain, but it remained stable in Group 1, but gradually decreased in the patients of Group 2, the difference being in the pain scores on the first day compared to the seventh in Group 2 (p=0.244). The rest of the variables were similar. Conclusion: There were no statistically significant differences in pain control from day 1 to day 7 in the Group with sitz baths with hot water (AU)

[Cold or hot sitz baths in the emergency treatment of acute anal pain due to anorectal disease? Results of a randomised clinical trial]. / Tratamiento del dolor anal por patología anorrectal aguda en urgencias: ¿baños de asiento con agua fría o caliente? resultados de un ensayo clínico aleatorizado.

INTRODUCTION: The popular belief advocates the use of sitz (sitting) baths with cold water for the treatment of acute anal pain, but clinical practice guides recommend the use of hot water for its known effect on the at-rest anal pressure. AIM: The objective of the study was to examine the analgesic effect on the quality of life, manometer data and clinical progress, of the two temperatures in sitz baths in patients with anal pain. MATERIAL AND METHODS: A randomised clinical trial on patients with acute anal pain due to haemorrhoids or anal fissures, divided into Group 1: Sitz baths with water at a temperature of less than 15 degrees C, and Group 2: Baths with a water temperature above 30 degrees C. The analgesia was the same in both groups. An analysis was made of the pain at 7 days (visual analogue scale), quality of life (SF-36), anal at-rest pressure and disease progress. RESULTS: Of the 27 eligible patients, 24 were randomised (Group 1: n=12 y Group 2: n=12). There were no statistical differences in pain, but it remained stable in Group 1, but gradually decreased in the patients of Group 2, the difference being in the pain scores on the first day compared to the seventh in Group 2 (p=0.244). The rest of the variables were similar. CONCLUSION: There were no statistically significant differences in pain control from day 1 to day 7 in the Group with sitz baths with hot water. (ISRCTN Number: 50105150).