Table 2. Adverse effects in both groups.
| Symptomsa |
V2 (15 days) |
V9 (4 months) |
||||
|---|---|---|---|---|---|---|
| VLCK diet group (n=45) | LC diet group (n=44) | P-value | VLCK diet group (n=45) | LC diet group (n=44) | P-value | |
| Asthenia | 7 | 0 | 0.0092 | 1 | 0 | 0.3396 |
| Headache | 9 | 1 | 0.0124 | 2 | 0 | 0.1739 |
| Nausea | 9 | 0 | 0.0028 | 3 | 0 | 0.0936 |
| Vomiting | 7 | 0 | 0.0092 | 1 | 0 | 0.3396 |
| Constipation | 2 | 0 | 0.1772 | 8 | 0 | 0.0046 |
| Cramps | 1 | 0 | 0.3429 | 0 | 0 | – |
| Myalgia | 1 | 0 | 0.3429 | 1 | 0 | 0.3396 |
| Muscular weakness | 1 | 1 | 0.9328 | 0 | 0 | – |
| Heaviness and tiredness of legs | 1 | 1 | 0.9328 | 0 | 0 | – |
| Hair loss | 1 | 0 | 0.3429 | 2 | 0 | 0.1739 |
| Orthostatic hypotension | 0 | 0 | – | 6 | 0 | 0.0155 |
| Edema | 0 | 0 | – | 1 | 0 | 0.3396 |
| Othersb,c | 20 | 4 | 0.0004 | 5 | 8 | 0.0731 |
| Patients lost | ||||||
| Due to side-effects | 0 | 0 | 1 | 0 | ||
| Voluntary dropout | 0 | 4 | 4 | 4 | ||
| Total dropout | – | – | 5 | 8 | ||
Abbreviations: LC diet, low-calorie diet; VLCK diet, very low-calorie-ketogenic diet
.
a
All values show the number of patients.
b
Other adverse effects described in V2: anxiety, cold, diarrhea, epigastric pain, shoulder pain, halitosis, hunger, hypoglycemia, sachets intolerance, bad taste, dizziness, bloating, paresthesia, dry mouth, allergic rhinitis, nasal trauma.
c
Other effects described in V9: cold, abdominal pain, back pain, halitosis, diarrhea, urinary tract infection, increased blood pressure, palpitations.