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The efficacy of alum sitz baths followed by topical gall ointment in hemorrhoids—a single-arm clinical trial

ABSTRACT: Hemorrhoidal disease is one of the most common gastrointestinal ailments affecting life quality of the patients. Unani classical literature is replete with anti-hemorrhoidal drugs, but scientific evidence is lacking. Therefore, Safūf Zāj (powdered alum) and Marham-e-Māzū (gall ointment) having potent anti-hemorrhoidal actions were selected to evaluate their efficacy in hemorrhoids. This clinical trial was conducted on 30 participants with hemorrhoids, aged > 18 years. All the participants received Safūf Zāj for sitz baths and Marham-e-Māzū to be applied twice daily for 2 weeks. Primary outcome measures were: change in pain intensity, anal itching, and defecate discomfort assessed on 100 mm VAS scale and per-rectal bleeding assessed on 4-point scale. Secondary outcome measures were: change in the size of the external hemorrhoidal mass assessed on 5-point scale, grade of internal hemorrhoid assessed by Goligher classification and quality of life (QoL) assessed on SF-12 questionnaire. The per-protocol analysis was done on 30 participants and statistically significant improvement was seen in primary and secondary outcome measures. Moreover, both the mental and psychological components of QoL were improved. The study inferred that therapeutic approach of Safūf Zāj and Marham-e-Mazu is safe and efficacious in hemorrhoids. Future studies with well-designed RCTs are highly recommended.

Supplementary Information

The online version contains supplementary material available at 10.1007/s13596-022-00634-6.

SUBMITTER: Chaush S

PROVIDER: S-EPMC8819210 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Cutaneous bacterial infections are common in children and adults and frequently are caused by Staphylococcus aureus (S. aureus). Treatment failures with topical agents are not uncommon and have been shown to be secondary to bacterial resistance. OBJECTIVE:To determine clinical and bacteriological efficacy of retapamulin ointment 1% in treatment of patients with cutaneous bacterial infections caused by methicillin-resistant S. aureus (MRSA) and other bacteria. METHODS:Prospective, nonrandomized, uncontrolled, open label, single center trial conducted between April 2008 and November 2012 that evaluated efficacy of retapamulin ointment 1% in the treatment of impetigo, folliculitis, and other minor soft tissue infections in children and adults. Fifty patients, who presented to a dermatology outpatient clinic and were clinically diagnosed with impetigo, folliculitis, or minor soft tissue infection suitable for treatment with a topical antibiotic, were screened. Thirty-eight patients were enrolled and received treatment: topical retapamulin ointment 1% twice daily for 5 days. Seven patients were MRSA positive and qualified for the primary efficacy population. One patient withdrew due to an adverse event. Clinical and microbiological exams were performed at baseline and follow-up 5 to 7 days later to assess clinical, microbiological, and therapeutic responses. Primary outcome was clinical response at follow-up in primary efficacy population with MRSA isolated as the baseline pathogen. Secondary outcomes included clinical, microbiologic, and therapeutic responses in patients who were culture positive for any species of bacteria. RESULTS:Clinical response at follow-up in the primary efficacy population (MRSA-positive patients) was not sufficiently powered to demonstrate significance; however, outcomes were excellent, with 7 of 7 patients demonstrating clinical success (5 of 7) or clinical improvement (2 of 7) at follow-up. Barring lack of significance due to small total sample size for patients who were culture positive for any species of bacteria (n = 35), overall success rates were favorable for clinical, microbiologic, and therapeutic responses with values of 66%, 97%, and 69%, respectively. Adverse events (AEs) were mild or moderate in severity. No serious AEs were reported. CONCLUSION:Safety profile appears favorable given the low number of AEs. Study design limits conclusions that can be drawn. Nevertheless, this study supports use of topical retapamulin 1% ointment in treatment of cutaneous bacterial infections, particularly those caused by S. aureus, including MRSA.

Project description:PurposeBreast cancer-related lymphedema (BCRL) is a chronic, progressive side effect of breast cancer treatment, occurring in one-third of patients treated with axillary lymph node dissection and nodal radiotherapy. Cluster of differentiation 4-positive (CD4+) cells plays a key role in BCRL by facilitating inflammation and inhibiting lymphangiogenesis. Tacrolimus is an anti-inflammatory and immunosuppressive macrolide that targets CD4+ cells. Treatment of lymphedema with topical tacrolimus has revealed promising results in preclinical trials. This clinical trial was aimed at evaluating the feasibility, safety, and effect of tacrolimus in women with stage I or II BCRL, according to the International Society of Lymphology.MethodsWe conducted this open-label, single-arm, phase II pilot trial from September 2020 to April 2021. Eighteen women with BCRL stage I or II BCRL were treated with topical tacrolimus for 6 months and followed up at 3 and 6 months. The primary outcome was arm volume, and secondary outcomes were the lymphedema index (L-Dex), health-related quality of life (HRQoL), lymph flow and function, and safety and feasibility of the trial design.ResultsThe mean lymphedema arm volume and L-Dex reduced significantly by 130.44 ± 210.13 mL (p < 0.05; relative reduction: 3.6%) and 3.54 ± 4.98 (p < 0.05), respectively, and health-related quality of life scores was improved significantly (p < 0.05). According to the MD Anderson scale, in terms of lymph flow and function, three patients (16.7%) showed improvement, while none showed worsening. Lymph flow or function showed no change according to the Arm Dermal Backflow scale.ConclusionIn this trial, treatment with tacrolimus was safe and feasible in women with stage I or II BCRL. Tacrolimus alleviated BCRL in terms of improved arm volume, L-Dex, and HRQoL. Assessments of lymph flow and function were positive, although inconclusive. Larger randomized controlled trials are required to verify these findings.Trial registrationClinicalTrials.gov Identifier: NCT04541290.

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The efficacy of alum sitz baths followed by topical gall ointment in hemorrhoids—a single-arm clinical trial

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