Double-blind, randomized, placebo-controlled trial of individualized homeopathic medicines in functional dyspepsia

Functional dyspepsia (FD) is a clinical syndrome characterized by chronic or recurrent upper abdominal pain or discomfort with no identifiable cause. Symptoms should be present for a minimum of 3 months; however, symptoms lasting greater than 6 months are typical. This disorder is not a mono-symptomatic entity; several predominant symptoms may be present, including epigastric pain (22%), abdominal fullness (24%), bloating (15%), vomiting (3%), belching (8%), early satiety (12%), nausea (10%), and heartburn (6%). Individuals with functional dyspepsia suffer significant morbidity and expend significant resources through both direct and indirect costs. The prevalence of FD is estimated to be 11.5-14.7%. A double-blind, randomized, placebo-controlled, two parallel arms clinical trial was conducted on 140 patients (70 in each group) suffering from FD at the outpatient department of Clinical Research Unit (Homoeopathy), Siliguri, under Central Council for Research in Homoeopathy, Ministry of AYUSH, Govt. of India; Gokhel Road, Arabindopally, Siliguri, Pin 734006, West Bengal. Patients were randomized in 1:1 ratio into either individualized homeopathic medicinal products (IHMPs) or identical-looking placebo. Outcome measures (primary – Leeds dyspepsia questionnaire – short form; secondary - frequency of use of standard conventional drugs for functional dyspepsia during study period of 3 months) were recorded at baseline, and every month, up to 3 months. The attrition rate was 9.3%. Group differences favored IHMPs against placebos in all the outcomes (LDQ-SF total: P < 0.001; LDQ-SF symptom frequency: P < 0.001; LDQ-SF symptom severity: P < 0.001, number of participants consuming antacids: P = 0.001; and the number of antacids consumed: P < 0.001), with large effect sizes. Nux vomica (18.6%), Sulphur (15%), Lycopodium clavatum (12.1%), Pulsatilla nigricans (6.4%), and Carbo vegetabilis (5%) were the most frequently prescribed remedies. IHMPs acted significantly better than placebos in the treatment of FD. Independent replications are required to validate the findings.