ABSTRACT
BACKGROUND: Presbycusis is characterized by sensorineural hearing loss in both ears at high frequencies, which affects more than half of the older adults by the age of 75 years and is often accompanied by tinnitus and cognitive deterioration. Unfortunately, there are no treatments available to restore hearing loss. Treatment mainly focuses on improving the quality of life and communication with hearing aids. Traditional medicine like Ayurveda also explains ailments of a similar nature as Badhirya and advises using drugs with antiaging and neuroprotective activity for treatment. In Ayurveda, Badhirya and Karnanada (senile deafness with tinnitus) are due to vitiation of Vata Dosha. Treatments such as topical oil pooling (Karnapurana) are usually advised to counter Vata, improve hearing capacity, and reduce tinnitus. Kshirabala Taila, a medicated oil formulation prepared with Sida cordifolia Linnaeus, is one of the most preferred oils for topical oil pooling in such conditions, as it has a definitive indication for sensory dysfunctions. Drugs like Withania somnifera (L.) Dunal (Ashwagandha) are also used, as they ameliorate neurodegeneration and help to improve cognitive dysfunction. OBJECTIVE: We propose an exploratory randomized controlled trial study for evaluating the efficacy of TOPMAC (Topical Oil Pooling with Kshirabala Taila and Supplementation of Ashwagandha Churna) in tinnitus suppression and hearing and cognitive function protection in patients aged 60-75 years with mild to moderate presbycusis. METHODS: A parallel, 2-group, exploratory randomized controlled trial will be conducted in an Indian Ayurvedic research center at its outpatient service. Participants (N=60) with mild to moderate presbycusis will be recruited by screening. Participants will be randomized (computer-generated 1:1) to receive either basic treatment and health education (BTHE) or BTHE+TOPMAC for 24 weeks. The primary objective is to compare the efficacy of TOPMAC with that of BTHE in the protection of hearing function. The secondary objective is to compare the efficacy of TOPMAC with that of BTHE in tinnitus suppression and cognitive function protection. RESULTS: This project was funded in January 2023. The institutional ethics committees at National Ayurveda Research Institute for Panchakarma (3/1/2020/NARIP/Tech/2036) and Institute for Communicative and Cognitive Neuro Sciences (IEC006) approved this study. The first patient was enrolled in September 2023; 22 participants were enrolled as of August 2024. The data analysis is yet to start, and the results are expected to be published by January 2025. CONCLUSIONS: If this exploratory trial is proven effective, it will steer the setting of a definitive randomized controlled trial to test whether the TOPMAC intervention can be incorporated as a cost-effective integrative approach for managing presbycusis. The Indian government has already launched a National Program for Prevention and Control of Deafness to benefit the deaf population. TOPMAC may later be considered for integration with the national program. TRIAL REGISTRATION: Clinical Trials Registry India CTRI/2023/04/051485; https://tinyurl.com/2h2hry3n. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55089.
Subject(s)
Medicine, Ayurvedic , Presbycusis , Humans , Presbycusis/therapy , Presbycusis/drug therapy , Aged , Male , Female , Randomized Controlled Trials as Topic , Middle AgedABSTRACT
CONTEXT: The safety of vitamin D replacement in subjects with primary hyperparathyroidism (PHPT) and coexistent vitamin D deficiency is not well established. OBJECTIVE: To evaluate the safety of vitamin D replacement in PHPT. DATA SOURCE: Data were searched from Medline, EMBASE, Cochrane CENTRAL and abstracts form annual scientific meetings of various international bone and mineral societies. STUDY SELECTION: Studies examining the effect of preoperative vitamin D replacement in patients with PHPT and coexisting vitamin D deficiency, irrespective of year and language of the publication were included in the present meta-analysis. DATA EXTRACTION: Data were extracted from text of the included publications or abstract of conferences. DATA SYNTHESIS: Ten studies enrolling 340 subjects with PHPT were analysed in this meta-analysis. After vitamin D replacement, there was significant increase in 25(OH) D levels by 55·3 nmol/l (95% CI 33·3-77·3), reduction in serum parathyroid hormone levels by 3·5 pmol/l (5·8 to -1·2) without change in serum calcium (-0·08 mmol/l, -0·2 to +0·03) and urinary calcium levels (0·72 mmol/24 h, P = 0·2) compared to baseline. CONCLUSION: Vitamin D replacement in subjects with PHPT and coexistent vitamin D deficiency increase 25 (OH) D and reduce serum PTH significantly without causing hypercalcaemia and hypercalciuria. The finding of the study needs to be confirmed by a large randomized trial in patient with PHPT and coexistent vitamin D deficiency.