| 1. |
- Jong, Miek C., et al.
(författare)
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A Comparative Randomized Controlled Clinical Trial on the Effectiveness, Safety, and Tolerability of a Homeopathic Medicinal Product in Children with Sleep Disorders and Restlessness
- 2016
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Ingår i: Evidence-based Complementary and Alternative Medicine. - : Hindawi Limited. - 1741-427X .- 1741-4288.
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Tidskriftsartikel (refereegranskat)abstract
- A prospective, multicenter, randomized, open-label, controlled clinical trial was performed to evaluate the effectiveness and safety of the homeopathic product ZinCyp-3-02 in children with sleep disorders for >= one month compared to glycine. Children <= six years old received either ZinCyp-3-02 (N = 89) or comparator glycine (N = 90). After treatment for 28 days, total sleep-disorder-associated complaints severity scores decreased in both groups from median 7.0 (out of maximum 11.0) points to 2.0 (ZinCyp-3-02) and 4.0 (glycine) points, respectively, with overall higher odds of showing improvement for ZinCyp-3-02 (odds ratio: 4.45 (95% CI: 2.77-7.14), p < 0.0001, POM overall treatment related effect). Absence of individual complaints (time to sleep onset, difficulties maintaining sleep, sleep duration, troubled sleep (somniloquism), physical inactivity after awakening, restlessness for unknown reason, and sleep disorders frequency) at study end were significantly higher with ZinCyp-3-02 (all p values < 0.05). More children with ZinCyp-3-02 were totally free of complaints (p = 0.0258). Treatment effectiveness (p < 0.0001) and satisfaction assessments (p < 0.0001) were more favorable for ZinCyp-3-02. Few nonserious adverse drug reactions were reported (ZinCyp-3-02: N = 2, glycine: N = 1) and both treatments were well tolerated. Treatment with the homeopathic product ZinCyp-3-02 was found to be safe and superior to the comparator glycine in the treatment of sleep disorders in children.
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| 2. |
- Jong, Miek C., et al.
(författare)
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Effectiveness, safety and tolerability of a complex homeopathic medicinal product in the prevention of recurrent acute upper respiratory tract infections in children : a multicenter, open, comparative, randomized, controlled clinical trial
- 2016
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Ingår i: Multidisciplinary Respiratory Medicine. - : PAGEPress Publications. - 1828-695X .- 2049-6958. ; 11:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: The present study was initiated to investigate the effectiveness, safety and tolerability of complex homeopathic CalSuli-4-02 tablets on prevention of recurrent acute upper respiratory tract infections (URTIs) in children, in comparison to another complex homeopathic product. Methods: The study was designed as a prospective, multicenter, randomized, open, clinical trial with two parallel treatment groups at four outpatient pediatric clinics in Russia. Children aged <= 6 years with susceptibility to acute URTIs (>= three occasions during the last 6 months) were randomized to receive either CalSuli-4-02 or a comparator homeopathic product (control group) for 3 weeks. Primary outcome was the frequency of acute URTIs after 3 and 6 months post-treatment follow-up. Secondary endpoints were changes in complaints and symptoms (total and individual scores), treatment satisfaction, antibiotic use, safety and tolerability.Results: The intention-to-treat analysis involved 200 children (CalSuli-4-02: N = 99, Control: N = 101). In both treatment groups, the median number of acute URTIs was one for 3 months and two, respectively, for the full 6 months post-treatment (Relative Risk: 0.86 (95 %-CI: 0.72-1.03), p = 0.1099). Seasons had no influence on the outcome. At the end of study, CalSuli-4-02 had overall higher odds of getting lower complaints severity total score (Odds ratio: 1.99 (95 %-CI: 1.31-3.02), p = 0.0012) and showing symptom improvement (Odds ratio: 1.93 (95 %-CI: 1.25-3.00), p = 0.0033). Specifically, the complaint "appetite disorder" and the symptom "child's activities" significantly improved more in the CalSuli-4-02 group (p = 0.0135 and p = 0.0063, respectively). Antibiotic use was decreased in both treatment groups at the study end. Overall assessment for satisfaction with and tolerability of treatment was higher with CalSuli-4-02. A low number of non-serious adverse drug reactions was reported (CalSuli-4-02: N = 4, Control: N = 1). Conclusions: Both complex homeopathic products led to a comparable reduction of URTIs. In the CalSuli-4-02 group, significantly less URTI-related complaints and symptoms and higher treatment satisfaction and tolerability were detected. The observation that the use of antibiotics was reduced upon treatment with the complex homeopathic medications, without the occurrence of complications, is interesting and warrants further investigations on the potential of CalSuli-4-02 as an antibiotic sparing option.
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| 3. |
- Palm, Jürgen, et al.
(författare)
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Effectiveness of an add-on treatment with the homeopathic medication SilAtro-5-90 in recurrent tonsillitis : An international, pragmatic, randomized, controlled clinical trial
- 2017
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Ingår i: Complementary Therapies in Clinical Practice. - : Elsevier BV. - 1744-3881 .- 1873-6947. ; 28, s. 181-191
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Tidskriftsartikel (refereegranskat)abstract
- Objective To investigate the effectiveness and safety of the homeopathic product SilAtro-5-90 in recurrent tonsillitis. Methods In this international, pragmatic, controlled clinical trial, 256 patients (6–60 years) with moderate recurrent tonsillitis were randomized to receive either SilAtro-5-90 in addition to standard symptomatic treatment, or to receive standard treatment only. The primary outcome was the mean time period between consecutive acute throat infections (ATI) within 1 year (analyzed via repeated events analysis). Results During the evaluation year, the risk of getting an ATI was significantly lower (hazard ratio: 0.45, proportional means model, p = 0.0002, ITT) with SilAtro-5-90 compared to control. Tonsillitis-specific symptoms were significantly reduced (p < 0.0001, ITT) and the need of antibiotics to treat acute throat infections (p = 0.0008; ITT) decreased. 3 non-serious adverse drug reactions were reported for SilAtro-5-90. Conclusions An integrative treatment approach where SilAtro-5-90 is given alongside mainstream symptomatic treatment may bring therapeutic benefit to patients suffering from recurrent tonsillitis. Trial registration: ISRCTN registry: Registration number ISRCTN19016626, registered 23 January 2013.
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