Efficacy of Individualized Homeopathic Medicines in the Treatment of Hemorrhoids: Double-Blind, Randomized, Placebo-Controlled Trial.

Objectives: To investigate the efficacy and safety of individualized homeopathic medicines (IHMs) in treating hemorrhoids compared with placebo. Design: This is a double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. Setting: The trial was conducted at the surgery outpatient department of the State National Homoeopathic Medical College and Hospital, Lucknow, Uttar Pradesh, India. Subjects: Patients were 140 women and men, aged between 18 and 65 years, with a diagnosis of primary hemorrhoids grades I-III for at least 3 months. Excluded were the patients with grade IV hemorrhoids, anal fissure, and fistula, hypertrophic anal papillae, inflammatory bowel disease, coagulation disorders, rectal malignancies, obstructed portal circulation, patients requiring immediate surgical intervention, and vulnerable samples. Interventions: Patients were randomized to Group 1 (n = 70; IHMs plus concomitant care; verum) and Group 2 (n = 70; placebos plus concomitant care; control). Outcome measures: Primary-the anorectal symptom severity and quality-of-life (ARSSQoL) questionnaire, and secondary-the EuroQol 5-dimensions 5-levels (EQ-5D-5L) questionnaire and EQ visual analogue scale (VAS); all of them were measured at baseline, and every month, up to 3 months. Results: Out of the 140 randomized patients, 122 were protocol compliant. Intention-to-treat sample (n = 140) was analyzed. The level of significance was set at p < 0.05 two tailed. Statistically significant between-group differences were elicited in the ARSSQoL total (Mann-Whitney U [MWU]: 1227.0, p < 0.001) and EQ-5D-5L VAS (MWU: 1228.0, p = 0.001) favoring homeopathy against placebos. Sulfur was the most frequently prescribed medicine. No harm or serious adverse events were reported from either of the groups. Conclusions: IHMs demonstrated superior results over placebo in the short-term treatment of hemorrhoids of grades I-III. The findings are promising, but need to be substantiated by further phase 3 trials. Clinical Trial Registration Number: CTRI/2020/03/024342.

Evaluating Ayurvedic mouthwash and soda-salt mouthwash for oral mucositis in head and neck cancer: A randomized controlled trial.

BACKGROUND: Patients undergoing radiotherapy (RT) or concurrent chemo-radiation (CCRT) for head and neck squamous cell carcinoma (HNSCC) often suffer from side effects such as mucositis, xerostomia, pharyngitis, laryngitis, and pain, which are being managed symptomatically by alcohol-based mouthwashes. OBJECTIVES: To determine the effectiveness of Ayurvedic mouthwash "Draksha Guduchyadi Kashaya" in reducing the severity of oral side effects of chemo-radiation. MATERIAL AND METHODS: This concurrent parallel randomized controlled study was conducted at Sir Sunderlal Hospital, BHU, on 70 HNSCC patients scheduled to undergo RT/CCRT. Patients who met the inclusion-exclusion criteria were enrolled, and 35 were randomly assigned to either the intervention group (Ayurveda) or the control group using a simple random technique (lottery method). Blinding was not implemented in this study. Patients in the intervention group (Ayurveda) were instructed to perform kavala with 50 ml of "Draksha Guduchyadi Kashaya" for 2 min, ten times daily, while the control group performed 2-min gargling with soda-salt mouthwash ten times daily. RESULTS: Out of the 70 patients enrolled, data from 60 patients were analyzed, revealing statistically significant differences in the onset of mucositis (p = 0.049), pharyngitis (p = 0.034), laryngitis (p = 0.009) and intensity of variables such as mucositis (p = 0.000), xerostomia (p = 0.046), pharyngitis (p = 0.002), laryngitis (p = 0.035), and pain (p = 0.000). These findings indicate that Ayurvedic mouthwash may be beneficial in managing the oral side effects of chemo-radiation in HNSCC. CONCLUSION: This AYUSH financially supported trial (Reg No: CTRI/2020/04/024672) demonstrates promise as a safe and cost-effective alternative for managing oral complications of RT/CCRT, offering complementary treatment for comprehensive cancer care.

The healing potential of Draksha-guduchyadi kavala in radiotherapy induced oral mucositis in non-metastatic squamous cell carcinoma of head and neck: A comparative case study.

Patients undergoing Radiotherapy (RT) for Head and Neck carcinoma often suffer from side effects such as mucositis, xerostomia, pharyngitis, laryngitis and pain which are being managed symptomatically by mouthwashes of soda-salt, chlorhexidine or betadine. Among the side effects, oral mucositis is the most debilitating one. This comparative case study comprises of 4 patients undergoing RT. Here, 2 patients each are randomly allocated into two groups. One group received the existing prophylactic management i.e., Sodium bicarbonate-salt solution mouth wash and the other group received, Draksha-guduchyadi yoga for kavala (gargling). Both the sets of patients were asked to perform gargling, from the first day of radiation to 15 days thereafter. The effectiveness of both mouthwashes was compared for their healing potential on oral mucositis by RTOG grading. The reduction in mucositis was significant in the group which received Ayurvedic mouthwash compared to the other group. This study positively highlights the contribution of Ayurveda in cancer treatment especially in the field of quality of life.