Carlsson Christer, Axemo P, Bodin A, Ehrenroth B, Madegard-Lind I, Navander C.
Physical Medicine Unit, Department to Rehabilitation, University Hospital, Lund, Sweden andDepartment of Obstetrics and Gynaecology, Academic Hospital, Uppsala, Sweden.
Nausea and vomiting are common complaints in early pregnancy. It occurs in 50-80% of all pregnancies. In about 1-2% of all pregnancies hyperemesis gravidarum, severe vomiting and nausea can be found. The result can be weightloss, dehydration and ketonemi and the woman often requires nutritional support and hospitalisation. The pathogenesis of hyperemesis gravidarum is not fully understood; some claim elevated chorionic gonadotropin level, some thyroid dysfunction or altered gastrointestinal function or hypofunction of the anterior pituitary and adrenal cortex or psychosomatic factors. Methods used to control hyperemesis gravidarum include drugs such as antihistamines, phenotiazines and other antiemetics, parental nutrition, corticosteroids, and psychotherapy. Acupuncture and acupressure, on especially PC6, have been used to prevent and treat nausea and vomiting after short gynaecological operations as well as those associated with Cisplatin-treatments. It has also been used against morning sickness and motion sickness. Normal therapy at our hospitals against hyperemesis gravidarum has so far been parenteral nutrition, B 12 injections and bedrest for some days. Pregnant women in Sweden, as else-where, are reluctant to use any kind of drugs during pregnancy. The aim of this study was to see if acupuncture on the acupoint PC6 could improve the treatment against this severe condition. We therefore performed this randomized placebo-controlled crossover study.
Method:
This study included 33 women suffering from severe nausea, vomiting, wight loss and dehydration. They had failed to respond to conventional treatment, like dietary change or antihistamins. In connection with hospitalisation these women were offered to take part in the study if they were healthy besides from this hyperemesis.
Two methods of acupuncture were used. Both methods included 30 min of treatment each time. Special trained midwives performed the acupuncture treatments.
1. Traditional de-qi (deep) acupuncture at PC6 bilateral. De-qi was searched for three times each treatment.
2. Superficial acupuncture (regarded as placebo treatment) where a needle was inserted 10 cm from the wrist of the thumb side of the forearm (bilateral). The needles were just inserted intracutaneously or superficially subcutaneously. No “de-qi” sensation was searched but the needles were twitched three times each treatment (just as when searching de-qi).
During the whole study the women, besides from acupuncture, got the usual treatments on the clinic. The study was undertaken during seven consecutive days.
Day 0 was just for baseline registrations. On day 1 and 2 as well as day 5 and 6 , acupuncture was given. Day 3 and 4 were “wash-out-period” and no acupuncture was performed.
On day 7 evaluations were terminated. Acupuncture treatments were given three times daily, when given. The women were randomized (random tables) into two groups, A and B. A-group first got real de-qui acupuncture (PC6), while B-group started with superficial acupuncture. Day 5 and 6 treatments were switched. The women were told that we compared two methods of acupuncture as we did not know which one was best.
They were thus not informed that we considered superficial acupuncture to be less effective. On each of the seven study days (as well as on day 0) the women were asked to estimate their degree of inconvenience from nausea on a VAS (Visual Analogue Scale) graded 0-10. Daily number of vomiting and meals were done from a SPSS database where all scorings were stored. T test and non-parametric tests were used. For crossover analysed we used the method described in ordinary medical statistical textbooks.
Results:
All the parameters (VAS, vomiting, intravenous fluids) were significantly reduced from baseline values in both groups immediately from day 0. Vomiting were significantly reduced from day 0 to day 1 only in group A. VAS from day 0-2 and 4-6 were significantly reduced for all women. VAS did not go down day 2-4 (no acupuncture was given day 3 and 4). Crossover analyses showed that there was a significant faster reduction of VAS in the PC6 treatments than in superficial ones. (p=0.031, Mann-Whitney) and this was not a periodic effect (p=0.146).
Conclusions:
It seems that PC6 de-qi acupuncture could be a method to make women with hyperemesis gravidarum better faster than with just usual treatments. For future studies it should be enough comparing real acupuncture with usual treatments since it is here shown that this method is better than superficial acupuncture which can be regarded as strong placebo in acupuncture studies.