Comparison Between Efficacy of Oral Melatonin and Oral L-theanine in Improving Sleep in Cancer Patients Suffering From Insomnia: A Randomised Double-blinded Placebo-controlled Study

The primary objective was to compare the hypnotic efficacy of oral melatonin, oral L-theanine, and placebo in improving sleep in cancer patients with insomnia by the Athens Insomnia Scale (AIS). The secondary objective was to know the prevalence of insomnia in patients with cancer. A prospective, double-blinded, placebo-controlled study was conducted after obtaining Institutional Ethics Committee approval. One hundred and twenty patients were randomly assigned to either Group A (melatonin), Group B (L-theanine), or Group C (placebo). They were instructed to take the tablets for 14 consecutive days, two h (hours) before bedtime, and evaluated with AIS on the 1st day, 7th day, and 14th day. There were seven dropouts: Two in Group A, two in Group B, and three in Group C. Significant differences in favour of melatonin treatment were found. There were statistically significant improvements in insomnia in cancer patients on melatonin intake compared to L-theanine. L-theanine had statistically significant improvements in insomnia in comparison to placebo. The mean ± standard deviation AIS on day one in Group A was 14.82 ± 1.29; on day seven was 10.92 ± 1.12; and on day 14 was 5.00 ± 0.70. Similarly, in Group B, the mean ± standard deviation AIS was 15.39 ± 1.03, 13.05 ± 1.06, and 9.55 ± 1.01, and in Group C, the mean AIS was 14.92 ± 1.40, 14.54 ± 1.35 and 13.05 ± 1.61 on the 1st, 7th and 10th day, respectively. There was an improvement in sleep from 1 to 7 days, 7 days to 14 days, and 1 day to 14 days in all the groups (P < 0.005). The hypnotic efficacy of oral melatonin 3 mg was better than oral L-theanine 200 mg in cancer patients having insomnia. Furthermore, L-theanine had a better hypnotic efficacy when compared to a placebo.