ObjectivesThe quality of management of hyperuricemia has remained sub-optimal owing to unavoidable toxicities, limitations, and dearth of novel advances. Homeopathy has remained under-researched in hyperuricemia. We investigated the clinical effectiveness of three treatment regimens – individualized homeopathy (IH), Urtica urens mother tincture (UUMT), and both (IH + UUMT) along with lifestyle modifications in a sample of 90 patients with hyperuricemia.MethodsAn open, randomized (1:1:1), 3 parallel arms (IH, UUMT, and IH + UUMT), pragmatic trial was conducted at National Institute of Homoeopathy, Kolkata. Outcome measures were serum uric acid (primary), Gout Assessment Questionnaire version 2 (GAQ2, secondary), and Measure Yourself Medical Outcome Profile version 2 (MYMOP2, secondary); all measured at baseline, and after 3 and 6 months. Intention- to-treat sample was analyzed to detect group differences by unpaired t tests.ResultsAttrition rate was 8.9% (IH: 3, UUMT: 3, IH + UUMT: 2). Groups were comparable at baseline. Reductions in serum uric acid over 3 months were comparatively higher (p=0.057) in the UUMT group than others, however, the differences were narrowed over 6 months (p=0.119). Per protocol analysis of serum uric acid level revealed similar trend of significantly higher reduction in the UUMT group than the other two (3 months: p=0.001; 6 months: p=0.007). No significant differences existed in reductions of GAQ2 scores among the three groups. Few significant differences were detected in MYMOP scores over 3 months favoring IH against others (symptom 2, p=0.001 and wellbeing score, p=0.002), and also over 6 months favoring IH + UUMT against others (symptom 1, p<0.001).ConclusionAlthough all three therapies showed similar improvements, the IH + UUMT group had more positive direction of effects than IH or UUMT alone; however, no definite conclusion could be arrived at. Further trials are warranted with larger sample size. Trial registration: CTRI/2018/05/014026.
Background Chronic rhinosinusitis (CRS) is a common disorder, with up to an estimated 134 million Indian sufferers, and having significant impact on quality of life (QOL) and health costs. Despite the evidence favoring homeopathy in CRS being inadequate, it is highly popular. This trial attempts to study the efficacy of individualized homeopathy (IH) medicines in comparison with placebo in patients with CRS. Methods A double-blind, randomized (1:1), placebo-controlled, preliminary trial (n = 62) was conducted at the National Institute of Homoeopathy, West Bengal, India. Primary outcome measure was the sino-nasal outcome test-20 (SNOT-20) questionnaire; secondary outcomes were the EQ-5D-5L questionnaire and EQ-5D-5L visual analog scale scores, and five numeric rating scales (0–10) assessing intensity of sneezing, rhinorrhea, post-nasal drip, facial pain/pressure, and disturbance in sense of smell, all measured at baseline and after the 2nd and 4th months of intervention. Group differences and effect sizes (Cohen's d) were calculated on the intention-to-treat sample. Results Groups were comparable at baseline. Attrition rate was 6.5% (IH: 1, Placebo: 3). Although improvements in both primary and secondary outcome measures were higher in the IH group than placebo, with small to medium effect sizes, the group differences were statistically non-significant (all p > 0.05, unpaired t-tests). Calcarea carbonica, Lycopodium clavatum, Sulphur, Natrum muriaticum and Pulsatilla nigricans were the most frequently prescribed medicines. No harmful or unintended effects, homeopathic aggravations or any serious adverse events were reported from either group. Conclusion There was a small but non-significant direction of effect favoring homeopathy, which ultimately renders the trial as inconclusive. Rigorous trials and independent replications are recommended to arrive at a confirmatory conclusion. [Trial registration: CTRI/2018/03/012557; UTN: U1111–1210–7201].
Introduction: Evidence favoring homeopathy in generalized anxiety disorder (GAD) remains scarce. The objective of this pilot trial was to test feasibility of a definitive trial in future. We also experimented whether individualized homeopathic medicines (IH) plus psychological counseling (PC) can produce significantly different effects beyond placebo plus PC in the treatment of GAD. Methods: A double-blind, randomized, placebo-controlled, parallel arm, pilot trial was conducted on 62 GAD patients at the National Institute of Homoeopathy, India. GAD-7 questionnaire and Hamilton Anxiety Scale (HAM-A) were used as the primary and secondary outcomes, respectively, measured at baseline and 3 months. Patients received either IH plus PC (n = 31) or identical-looking placebo plus PC (n = 31). Intention-to-treat sample was analyzed to detect group differences using unpaired t tests. Results: Recruitment and retention rates were 56 and 90%, respectively. Mean age was 31.5 years; 56.5% were male. GAD-7 reductions were non-significantly higher in IH than placebo (p = 0.122). Group differences on HAM-A favored IH significantly (p = 0.018). Effect sizes were small to medium. Calcarea carbonica was the most frequently indicated medicine. No serious adverse events happened. Conclusions: A small but positive direction of anxiolytic effect was observed favoring homeopathy over placebo. A definitive trial appeared feasible in future.
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