Individualized Homeopathic Medicines in the Treatment of Generalized Anxiety Disorder: A Double-Blind, Randomized, Placebo-Controlled, Pilot Trial

2021 ◽  
pp. 1-11
Author(s):  
Maneet Parewa ◽  
Avijit Shee Burman ◽  
Arabinda Brahma ◽  
Lex Rutten ◽  
Satarupa Sadhukhan ◽  
...  

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.

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1 ◽  
Author(s):  
M.A. Mychaskiw ◽  
J.M. Alvir ◽  
B.K. Herman ◽  
S. Pallanti ◽  
A. Joshi

Aims:To assess the impact of insomnia on quality of life (QoL) and functioning in patients with generalized anxiety disorder (GAD), and evaluate the efficacy of pregabalin and venlafaxine-XR in improving sleep and QoL.Methods:A double-blind trial in adults who met DSM-IV criteria for GAD, with a HAM-A total score ≥20,randomized to 8-weeks of flexible-dose treatment with pregabalin (300-600 mg/d, N=121), venlafaxine-XR (75-225 mg/d, N=125), or placebo (N=128).Results:At baseline, 64% of all subjects had insomnia (according to the Medical Outcomes Study Sleep scale [MOS]-Sleep Problems Index [SPI] criteria).While HAM-A total scores (minus the insomnia item) were similar for patients with and without baseline insomnia (25.7 vs. 25.0) those with reported significantly more impairment on the Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q; 45.4 vs. 53.6; p< 0.0001) and Sheehan Disability Scale (SDS; 17.5 vs.14.3; p< 0.0001) than those without. At endpoint, there was a significantly greater mean improvement in MOS-sleep disturbance factor and MOS-SPI with pregabalin (-29.0 and -21.1, respectively) than venlafaxine-XR (-14.7 and -11.0) or placebo (-15.2 and -12.5; all p< 0.05). In more pregabalin (64%) than venlafaxine-XR (51%) or placebo (52%) subjects, abnormal baseline sleep had normalized by endpoint. Endpoint change in MOS-SPI significantly correlated with improvement in both Q-LES-Q and SDS-total scores (Spearman r-values, -0.48 and 0.46, respectively; both p< 0.0001; all subjects).Conclusion:Significantly greater impairment in QoL and functioning was observed in patients with high (vs. low) levels of insomnia. Pregabalin produced significantly greater improvement in insomnia than venlafaxine-XR or placebo.


2005 ◽  
Vol 15 (6) ◽  
pp. 617-623 ◽  
Author(s):  
Hannu Naukkarinen ◽  
Roope Raassina ◽  
Jukka Penttinen ◽  
Antti Ahokas ◽  
Riitta Jokinen ◽  
...  

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