AbstractBackground and aims
Teething can be very painful in children and create much distress in their parents which is why safe and effective treatment options are of high interest. Complementary and alternative medicine, including homeopathy, may provide this profile. A prospective, multicenter, open, comparative clinical trial assessed the effectiveness and safety of ChamBell-5–02 tablets, a homeopathic medicinal product containing Belladonna D6, Chamomilla D6, Ferrum phosphoricum D6, Hepar sulfuris D12 and Pulsatilla D6, in the treatment of paediatric teething symptoms.Methods
Children aged≤6 years, suffering from painful teething, were randomised to receive either ChamBell-5–02 tablets (intervention) or homeopathic suppositories (Chamomilla recutita D1, Atropa belladonna D2, Solanum dulcamara D4, Plantago major D3, Pulsatilla pratensis D2, Calcium carbonicum Hahnemanni D8; control) for 7 days. Outcome parameters included the total scores of subjective complaints (TSSC; unexplained restlessness, gingival tenderness, appetite disorder, otalgy, softened stool, sleep-onset insomnia, frequent awakenings; maximum 10 points) and clinical symptoms (TSCS; skin pallor, hyperemia around the mouth, drooling, hyperthermia, gingiva condition: hyperemia, swelling, hematoma; maximum 9 points) assessed after 3–5 and 7 days, parent’s satisfaction with the treatment and the number of adverse drug reactions (ADRs).Results
A total of 200 children (100 in each group, ITT) were randomised and analysed. The TSSC/TSCS reduced from baseline median value 7.0/6.0 over 3.0/3.0 (3–5 days) to 1.0/1.0 point (7 days) in the intervention group and in the control group from 5.0/5.5 over 3.0/4.0 to 1.0/1.0 point at the study end. Compared to the control group, children of the intervention group had about 5.0/2.5 higher odds of showing improvement (odds ratio resulting from proportional odds model TSSC/TSCS: 5.1 (95%CI: 2.7–9.4; p<0.0001)/2.5 (95%CI: 1.5–4.4; p=0.0011)). More parents of the intervention group were ‘very satisfied’ with the treatment (n=94; control group: n=58). ADRs (3 mild to moderate, all non-serious) only occurred in the control group.Conclusions
Both homeopathic complex medicinal products reduced children’s teething complaints and symptoms. Children receiving ChamBell-5–02 had significant higher odds of showing improvement after 3–5 and 7 days. ChamBell-5–02 showed to be safe and was well tolerated.