4. Discussion
PCOS-related, bloating, hyperandrogenaemia, fatigue, abdominal pain, Weight loss, non-PCOS, PCOS, constipation, weight loss
INSULIN RESISTANCE, CHOLECYSTITIS, OBESE
In this first randomised controlled trial looking into the effects of a VLCD compared to a conventional energy deficit approach on PCOS-related outcomes, we showed that although both strategies can induce short-term weight loss with favourable changes in body composition, implementation of a VLCD resulted in greater weight loss and more pronounced improvements in body composition, hyperandrogenaemia, and metabolic parameters in obese women with PCOS.Excess weight is an independent risk factor for hyperandrogenaemia, insulin resistance, and menstrual irregularities in women living with PCOS. Weight loss with lifestyle and dietary changes is the mainstay of management of women with PCOS, and it is associated with significant improvements in hyperandrogenaemia, menstrual irregularities, ovulation, and emotional wellbeing in this population [In this study, we presented both within-group and between-group analyses. Although the within-group analysis in a setting for RCT could be biased due to small sample sizes [There are very limited data on the effects of VLCDs on hyperandrogenaemia and metabolic outcomes in women with PCOS [In this study, we showed that the significant weight loss after eight weeks after both interventions was due to improvements in total and trunk fat masses but also due to reductions in FFM, with these results being in line with earlier studies in PCOS and non-PCOS populations [This study shows that both VLCD and energy deficit diets can be effectively used in women with PCOS to achieve weight loss with relatively few side effects. One of the study participants in the VLCD had abdominal pain, was diagnosed with cholecystitis, and recovered completely. Some participants had some gastrointestinal side effects, such as constipation and bloating, after starting the VLCD; they were prescribed a fibre supplement to resolve these symptoms, and none of them withdrew from the study due to this reason. It should also be noted that there was a rise in AST and ALT levels in the VLCD arm, which, however, did not reach significance. Increases in hepatic enzymes are a known consequence of rapid weight loss [Our study had several limitations. This study was a small, single-centre trial, and thus, future multicentre trials will be needed to further understand the feasibility and efficacy of VLCDs in PCOS. Furthermore, half of the study participants did not complete the clinical trial after randomisation in both study arms. Similar to our study, some previous weight loss studies in PCOS have also reported low completion rates, whilst qualitative studies have shed light on a number of barriers to weight management in this population. In our study, several participants randomised to the conventional energy deficit approach were disappointed by their randomisation order, and some of them were lost to follow-up a few weeks after the initiation of the intervention despite the repeated efforts of the research team to keep them in the study and explain to them the benefits of weight loss and the advantages of the conventional energy deficit approach. In the VLCD arm, many participants limited their engagement with the trial in the food reintroduction period. This limited engagement could be because the main study dietician who was in constant touch with the study participants had moved away in the later stage of the trial and highlights the importance of the interpersonal touch during dietary intervention studies in young populations. It is also possible that the participants did not feel the need to engage with the trial protocols after losing a considerable amount of weight. Other challenges mentioned by the participants over the follow-up were fatigue with sticking to study regimens, challenges in keeping up with social life and family issues, and commitment for follow-up. Finally, the last follow-up after the end of the intervention (eight weeks) was at twelve weeks, and the sustainability of weight loss with these two approaches beyond this period will have to be examined with studies with longer follow-up periods.