Adverse effect on Pelvilen Forte: role of polydatin?

Palmitoylethanolamide is available as various nutraceutical brands, and Pelvilen Forte is one specific formulation, were 400 mg PEA is combined with 40 mg trans-polydatin. Other brands are Normast and PeaPure, both contain as active ingredient palmitoylethanolamide only.

On nutraceuticals containing palmitoylethanolamide only, since the first relevant clinical trials in the 70s, no troublesome side effects have been reported. In total, within the context of clinical trials, 4000 people have been treated with PEA up t0 1800 mg/day.

Pelvilen is a new PEA formulation, were PEA is combined with trans-polydatin. This resveratrol might induce side effects, as described below.

We describe two patients suffering from neuropathic pain, treated with Pelvilen Forte, were side effects emerged, which disappeared on discontinuation and re-appeared after re-introduction. After treating the patients with pure palmitoylethanolamide without trans-polydatin the side-effects did not re-appear. This supported the clinical suspicion that the side-effects were induced by the resveratrol trans-polydatin.

The first patient was a man, 42 years old, suffering from chronic neuropathic pain due to a hernia on L4L5, with irradiating pains in the right leg, and paresthesia’s as well as numbness. A hernia operation in 2011 did not result in a decrease of pain. We started PEA 1200 mg/daily and the patient noticed after 1 month some improvement, 2 points on the NRS (score 8 went to 6). As this was insufficient and the patient had a weight of around 100 kg we added twice daily 400 mg Pelvilen, to reach a dose of PEA of 2000 mg/daily, and also in the hope that the extra resveratrol might add to the benefit of PEA. The pain decreased to around 4 but the patient complained after starting with Pelvilen about severe pain in the Stomach. We stopped Pelvilen and used PEA only. Pain vanished. After 2 weeks we started Pelvilen again, and directly the stomach pain re-appeared.

We stopped and the patient continued with PEA free of the transresveratrol transpolydatin. The pain in the stomach disappeared.

A second patient was a female patient of 61 years old, suffering from DM type 2 and slight chronic obstructive lungdisease. She was treated with Pelvilen Forte 3 times daily. At the first visit she complained of increased problems breathing, with slight asthma attacks. We stopped Pelvilen and the complains vanished. After re-introducing Pelvilen a sligh asthma attack was provoked and the patient was sure about the causal relationship. We stopped Pelvilen and treated the patient with PEA only, no re-emergence of any asthma attack was seen.

Both cases seem to suggest the polidatin in Pevilen might induce side effects, which are not seen during treatments with pure PEA. Polydatin is a resveratrol and complaints of heaviness in the stomach have been heard more often. However, induction of asthma has not been documented so far.

If patients are treated with Pelvilen, one should be aware of potential mild side effects. These could be induced by the trans-resveratrol polydatin. The side effects described were reversible.

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