The trial ended 26 patients. According to the doctor, an excellent effect was observed in 3.3% of patients, good – in 60%, satisfactory – in 26.7%, no effect – in 15.7%. According to the patients, a good effect was noted by 63.3% of patients, satisfactory – 26.6%, without effect – 6.6%, deterioration – 3.3% (in 1 patient with the development of an adverse reaction of significant severity). Thus, according to the doctor’s assessment, and according to the patient’s assessment, treatment was effective for many in 86.7-89.9% of cases. The positive dynamics of pain and mobility limitations on the WOMAC scale (in mm) are shown on our website and the positive dynamics of difficulties in performing daily activities (according to the WOMAC scale, in mm).
Per day, on average, patients took 3 tablets of Zaldiar, while the average daily dose of tramadol was 131 mg and paracetamol – 1137 mg. An increase in the effect of treatment by the end of the study was noted, while the daily dose of Zaldiar did not increase. Moreover, there was a tendency to a decrease in the daily dose of Zaldiar by the end of the study. None of the patients used additional other analgesics.
There were no changes in the data of laboratory examination after monotherapy with Zaldiar.
Tolerability assessment was performed in all 30 patients (see table). Adverse effects were noted in 21 (70%) patients out of 30, 4 (13%) patients stopped taking Zaldiar due to side effects (dizziness, nausea). The severity of adverse reactions was assessed at 1 point in 9 (42.8%), at 2 points in 10 (48%) patients, at 3 points in only 2 cases (but both patients stopped taking the drug). Despite the fact that undesirable reactions occurred frequently, the overwhelming majority of them were mild or moderate. The most frequent adverse events were dizziness (47%) and drowsiness (33%).
Frequency of major adverse events when taking Zaldiar (n = 30)
- Manifestations of abs. %
- Vertigo 14 47
- Drowsiness 10 33
- Dry mouth 10 33
- Nausea 6 20
- Constipation 2 6.6
- Perspiration 2 6.6
- Paresthesia 1 3.3
- Weakness 1 3.3
- Loss of appetite 1 3.3
In almost half of the cases (48%), side effects occurred on the first day of taking the drug and in 81% of the first week of treatment. For those who completed the full 6-week course of treatment, adverse reactions developed in 17 (65%) of 26 cases. The duration of adverse reactions ranged from 1 to 45 days, an average of 8 days. It is important to note that the side effects of Zaldiar in the majority of patients (in 13, i.e. in 76% of cases) disappeared spontaneously, despite continued Zaldiar administration, and by the end of the study only 4 patients remained. These 4 patients regarded the side effects as mild and continued to receive Zaldiar due to good anesthesia. After treatment, signs of withdrawal syndrome were not observed in any patient. In some studies, mostly short-term, the overall frequency of side effects was lower than in ours; in others, it was similar. Many authors note that adverse events more often develop in the first days of taking the drug and have moderate or weak severity; reversible; There are practically no serious life-threatening complications of therapy.
In the study of the analgesic activity of Zaldiar in monotherapy mode, adequate anesthesia was achieved in most cases – almost 90%. Thus, Zaldiar is an effective drug to relieve moderate to severe pain in osteoarthritis of large joints. The average daily dose of Zaldiar was 3 tablets. Against the background of a 6-week treatment, there was no need to increase the dose development of tolerance was not observed. Adverse events were mild or moderately pronounced. The spectrum of adverse reactions was characteristic of weak opioids – dizziness, drowsiness, nausea. A distinctive feature of adverse reactions was their reversible nature – they independently passed in 76% of patients. In patients who dropped out of the trial, adverse reactions were completely stopped during the first days after stopping the drug (without additional treatment). No vital adverse reactions were observed. Some patients preferred to experience mild adverse reactions (drowsiness, nausea, sweating), but not to cancel the drug, because they were satisfied with the analgesic effect. Thus, the combined analgesic Zaldiar can be recommended for the treatment of chronic pain syndrome in monotherapy for a long time (up to one and a half months) in patients with osteoarthritis of the large joints.